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Business Meeting 1
Freedom Court Reporting, Inc 877-373-3660
1
2 ALABAMA STATE BOARD OF PHARMACY
3
4
5
6
7
8 BUSINESS MEETING
9
10 Wednesday, July 15, 2015
11
12 9:20 a.m.
13
14
15
16
17
18 LOCATION: Alabama State Board of Pharmacy
19 111 Village Street
20 Hoover, Alabama 35242
21
22
23 REPORTER: Sheri G. Connelly, RPR
Business Meeting 2
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1 ATTENDEES
2
3 BOARD MEMBERS:
4 Dan McConaghy, President
5 Tim Martin, Vice President
6 Buddy Bunch, Treasurer
7 David Darby, Member
8 Donna Yeatman, Member
9
10 ALSO PRESENT:
11 Jim Ward, Attorney
12 Susan Alverson, Ph.D., Executive Secretary
13 Cristal Anderson, Director of Compliance
14 Mark Delk, Inspector
15 Todd Brooks, Inspector
16 Scott Daniel, Inspector
17 Richard Lambruschi, Inspector
18 Jim Easter
19 Cara Leos
20 Jay McEniry
21 Angie Harris
22 Chris Burgess
23 Ronda Lacey
Business Meeting 3
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1 Derek Sapone
2 Chris Evans
3 Wayne Cornutt
4 Daniel Baker
5 Julie Hunter
6 Jeff Freese
7 Matthew Muscato
8 Bart Bamberg
9 Rick Stephens
10 Becky Sorrell
11 Louise Jones
12 Sharon Hester
13 Eddie Vanderver
14 Carter English
15 Bill Maguire
16 Al Barber
17 Getose Altine
18
19
20
21
22
23
Business Meeting 4
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1 MR. MCCONAGHY: I'm going to call the
2 July 15, 2015, Alabama meeting of the State
3 Board of Pharmacy to order. Seeing that we have
4 a quorum present, I would like to ask for a
5 motion to adopt the agenda.
6 MR. DARBY: I make a motion we adopt
7 the agenda as presented.
8 MS. YEATMAN: Second.
9 MR. MCCONAGHY: All in favor?
10 DR. MARTIN: Aye.
11 MR. BUNCH: Aye.
12 MR. DARBY: Aye.
13 MS. YEATMAN: Aye.
14 MR. MCCONAGHY: Approved. Now under
15 our usual process, would y'all begin with Jim
16 Easter or Todd, whoever is most front there, and
17 introduce yourself and tell us who you are and
18 where you're from.
19 MR. EASTER: Jim Easter, Baptist
20 Health System.
21 MR. BROOKS: Todd Brooks, Board of
22 Pharmacy.
23 MS. LEOS: Cara Leos, ALSHP.
Business Meeting 5
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1 MR. MCENIRY: Jay McEniry, Patients
2 and Physicians for RX Access.
3 MS. HARRIS: Angie Harris, Solutions
4 RX.
5 MR. BURGESS: Chris Burgess, Heritage
6 Pharmacy.
7 MS. LACEY: Ronda Lacey, McWhorter
8 School of Pharmacy.
9 MR. SAPONE: Derek Sapone,
10 Institutional Pharmacy Solutions.
11 MR. EVANS: Chris Evans, fourth year
12 pharmacy student.
13 MR. CORNUTT: Wayne Cornutt, director
14 of pharmacy, Gadsden Regional Medical Center.
15 MR. BAKER: Daniel Baker, assistant
16 director, Gadsden Regional.
17 MS. HUNTER: Julie Hunter, Omnicare.
18 MR. FREESE: Jeff Freese, Turenne
19 PharMedCo.
20 MR. MUSCATO: Matthew Muscato,
21 Walgreens Pharmacies.
22 MR. BAMBERG: Bart Bamberg, Publix
23 Supermarket.
Business Meeting 6
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1 MR. STEPHENS: Rick Stephens, Senior
2 Care Pharmacy.
3 MS. SORRELL: Becky Sorrell, Ritch's
4 Pharmacy.
5 MS. JONES: Louise Jones, Alabama
6 Pharmacy Association.
7 MS. HESTER: Sharon Hester,
8 Transdermal Therapeutics.
9 MR. VANDERVER: Eddie Vanderver, CAPS,
10 Incorporated.
11 MR. ENGLISH: Carter English,
12 Department of Mental Health.
13 MR. MAGUIRE: Bill Maguire, Omnicell.
14 MR. BARBER: Al Barber, AlixaRx.
15 MR. DELK: Mark Delk, State Board of
16 Pharmacy.
17 MR. DANIEL: Scott Daniel, Alabama
18 State Board of Pharmacy.
19 MR. MCCONAGHY: Okay. The next item
20 on the agenda is presentations and number one on
21 my list is Institutional Pharmacy Solutions.
22 Are they here? Good morning.
23 MR. SAPONE: Good morning.
Business Meeting 7
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1 DR. MARTIN: Good morning.
2 MR. SAPONE: I don't have a formal
3 presentation, per se, including PowerPoint but
4 I'm here formally to ask the permission of the
5 Board to process orders remotely from my
6 pharmacy in Virginia Beach, Virginia, license
7 number 113800 and 201931, the mail order permit.
8 I've included current policy and procedure for
9 the call center operations, as well as the
10 policy and procedure for the remote data entry
11 piece at the pharmacy.
12 The service that I'm asking to provide
13 is three-fold. Number one, a telephone service.
14 Actually, let me back up a little bit. I
15 apologize.
16 The two sites that I'm requesting that
17 we assist within the same -- are owned by the
18 same company. The first one is Mountain View
19 Hospital in Gadsden, Alabama, and the second one
20 is the Laurel Oaks Behavioral Health Center in
21 Dothan, Alabama.
22 The Mountain View Hospital currently
23 has hours of Monday through Friday 8:00 a.m. to
Business Meeting 8
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1 4:00 p.m. for a total of 40 hours. The Laurel
2 Oaks Behavioral Health Center is currently open
3 11:00 -- well, the pharmacy is open 11:00 a.m.
4 to 8:00 p.m., Monday, Wednesday, Thursday, and
5 Friday for roughly 36 hours.
6 What I'm requesting to do is after
7 those on-site hours at the local hospital
8 pharmacy is to provide telephone service, remote
9 order entry processing, and also emergency
10 medication ordering and delivery after the scope
11 of the normal on-site pharmacy hours.
12 MR. WARD: I think there should be
13 something in writing so you can look at it and
14 approve it.
15 DR. MARTIN: So some correspondence.
16 MR. DARBY: Can you get us something
17 in writing, you know, what you're specifically
18 planning to do? Can you get that for us?
19 MR. SAPONE: Did Mitzi not provide
20 that?
21 MR. DARBY: Tell me if I'm missing it
22 but all I've got is just a letter -- a short
23 letter asking to appear -- have you got it?
Business Meeting 9
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1 MS. YEATMAN: No, it's just a short
2 letter.
3 MR. WARD: You have to have policy and
4 procedures.
5 MR. DARBY: Yeah. I think Dan has got
6 more than I think what we --
7 MR. SAPONE: I have extra copies.
8 MR. DARBY: Yeah, yeah, if you'd give
9 me a copy of that.
10 MR. SAPONE: Okay.
11 DR. ALVERSON: Excuse me, are you an
12 institutional license or a retail license?
13 MR. SAPONE: In the actual pharmacy in
14 Virginia --
15 DR. ALVERSON: Right.
16 MR. SAPONE: -- or the one that we
17 have registered with Alabama?
18 DR. ALVERSON: Well, both.
19 MR. SAPONE: Okay. The Virginia is
20 retail. We're set up as retail in Virginia.
21 The two that I have with Alabama, one I believe
22 is 113800 I think is a retail pharmacy and then
23 the other one is the mail order permit.
Business Meeting 10
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1 DR. ALVERSON: Can we do remote on
2 retail? I'm just asking the question.
3 DR. MARTIN: Both the Laurel Oaks
4 Behavioral Center and the Mountain View
5 Hospital, are they institutional?
6 DR. ALVERSON: That's what I just
7 asked.
8 MR. SAPONE: That's the -- this is the
9 policy and procedure for the call center.
10 DR. ALVERSON: I understand the need.
11 I'm just wondering about issues with license
12 types.
13 MR. WARD: He's a retail pharmacist
14 wants to do remote processing with an
15 institution. Is that --
16 DR. MARTIN: I guess there are two
17 questions. Thank you. I'll let you hand those
18 out and then we'll have some other questions for
19 you.
20 MR. SAPONE: Okay, got you.
21 MR. WARD: What kind of permit do they
22 have? What kind of permit do you have? You
23 have a retail permit, don't you?
Business Meeting 11
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1 MR. SAPONE: In Virginia we're set
2 up -- we're licensed as a retail pharmacy.
3 MR. WARD: How about -- how about
4 here?
5 MR. SAPONE: I believe it's retail and
6 then there's a second permit issued for mail
7 order permit.
8 DR. MARTIN: So --
9 MR. SAPONE: If there's additional
10 licensure I need to acquire here --
11 DR. ALVERSON: Right. I just want to
12 be sure we get it all straight so when we get --
13 MR. SAPONE: Yeah, I didn't -- I
14 wasn't sure.
15 DR. ALVERSON: -- ready to do this, we
16 do it right.
17 MR. SAPONE: Right, right.
18 DR. ALVERSON: I'm not arguing you
19 need it.
20 MR. SAPONE: What's that?
21 DR. ALVERSON: I'm not arguing that
22 you need it.
23 MR. SAPONE: Oh, yeah, yeah, I can
Business Meeting 12
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1 elaborate more into the need for it but --
2 DR. ALVERSON: Right.
3 DR. MARTIN: Let's just take it one at
4 a time and be clear. So the Mountain View
5 Hospital in Gadsden, is it a -- does it have a
6 permit -- does it have a pharmacy permit as an
7 institutional pharmacy?
8 MR. SAPONE: Yes, they are set up -- I
9 believe they are set up as an institutional
10 pharmacy.
11 DR. MARTIN: Okay. On-site in-house
12 institutional pharmacy Monday through Friday
13 8:00 to 4:00?
14 MR. SAPONE: Monday through Friday,
15 yes, sir.
16 DR. MARTIN: Okay. Laurel Oaks
17 Behavioral Center in Dothan is set up as an
18 institutional -- as a permit -- as an
19 institutional pharmacy --
20 MR. SAPONE: Institutional on site.
21 DR. MARTIN: -- operating 11:00 a.m.
22 to 8:00 p.m. Monday, Wednesday, Thursday, and
23 Friday?
Business Meeting 13
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1 MR. SAPONE: Correct.
2 DR. MARTIN: So you've got two
3 institutional facilities in the State of
4 Alabama. Now, the location where the remote
5 processing is going to take place, tell us about
6 that site.
7 MR. SAPONE: Okay. We are a
8 closed-door institutional pharmacy. We have
9 facilities that we actually service as well in
10 the Hampton Roads area in Virginia, so the
11 pharmacist is in direct contact with the
12 technicians, so it's a registered retail
13 pharmacy with the Virginia Board of Pharmacy and
14 the DEA as well.
15 DR. MARTIN: So the permit you have
16 with the Alabama Board of Pharmacy for the site
17 in Virginia Beach is a retail permit or an
18 institutional permit?
19 MR. SAPONE: I believe it's retail.
20 DR. MARTIN: Retail permit, okay. So
21 this -- that's the -- so we've got a retail
22 permitted facility in the State of Virginia
23 seeking to perform remote order processing for
Business Meeting 14
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1 two institutional facilities in the State of
2 Alabama.
3 MS. ANDERSON: Now, what was the
4 license number for the Laurel Oaks facility
5 again?
6 MR. SAPONE: I have no idea.
7 MS. ANDERSON: Don't have it. Is it
8 also known as Institutional Pharmacy Solutions?
9 MR. SAPONE: It is, yes.
10 MS. ANDERSON: Okay.
11 MR. SAPONE: Yes.
12 MS. ANDERSON: I think I actually got
13 a phone call earlier this week and the DEA is
14 going to make them go from institutional to
15 retail because they're privately owned. Does
16 that sound right? Have you heard that?
17 MR. SAPONE: It does sound right, yes.
18 Yeah, I met with the DEA in March and we had
19 quite a discussion because there's a conflict
20 between Alabama law and the DEA law and the DEA
21 says we have to do one thing. Alabama says we
22 have to do another but we're going to obviously
23 comply.
Business Meeting 15
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1 MR. WARD: No, I don't know what
2 you're talking about.
3 MS. YEATMAN: What's the conflict
4 between Alabama and the DEA?
5 MR. SAPONE: The conflict to the best
6 of my understanding is that the DEA does not
7 recognize institutional -- they said we have to
8 be either set up with the DEA as a hospital --
9 when I say we, I mean the Laurel Oaks, that
10 Laurel Oaks has to be set up as either a
11 hospital with the DEA or retail. They don't --
12 there is no institutional class with the DEA.
13 That's a state specific thing here in Alabama,
14 so they said we either have to change to retail
15 with the DEA or hospital. Those are the only
16 two choices.
17 DR. MARTIN: That's going to have some
18 pretty significant indications for the way you
19 do business and label products.
20 DR. ALVERSON: Wouldn't that mean
21 every hospital in the State of Alabama would
22 have to become a retail license?
23 DR. MARTIN: It means anything that's
Business Meeting 16
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1 an institutional facility other than a hospital
2 would have to, yes.
3 MS. ANDERSON: Anything that's
4 privately owned?
5 DR. MARTIN: I don't know what the
6 ownership has to do with it. It's confusing.
7 MR. SAPONE: And from what I
8 understand, the -- being that IPS, Institutional
9 Pharmacy Solutions, doesn't own the hospital,
10 that's why they said, you know, we can't
11 register as a hospital because we do not own the
12 hospital. We contract to the hospital to
13 provide a service to them. So the pharmacy is
14 not --
15 MR. WARD: What's the name of the
16 hospital?
17 MR. SAPONE: I'm sorry?
18 MR. WARD: What's the name of the
19 hospital?
20 MR. SAPONE: Laurel Oaks Behavioral
21 Health Center.
22 MR. WARD: And the other one?
23 MR. SAPONE: Institutional Pharmacy
Business Meeting 17
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1 Solutions.
2 MR. WARD: No, the other hospital.
3 MS. YEATMAN: The other hospital.
4 MR. SAPONE: Oh, I'm sorry, Mountain
5 View Hospital.
6 MR. WARD: Yeah, who is that owned by?
7 MR. SAPONE: Mountain View, I guess.
8 MR. WARD: It's not owned by a company
9 that has other hospitals?
10 MR. SAPONE: I'm not sure.
11 DR. ALVERSON: Can I ask was it DEA in
12 Virginia or DEA in Alabama?
13 MR. SAPONE: You can ask and it was
14 DEA in Virginia and the agent in Virginia had
15 quite a discussion with the agent in Alabama and
16 they disagreed on the law as well.
17 DR. MARTIN: Of course.
18 DR. ALVERSON: Welcome to our world.
19 MR. SAPONE: Yeah, so the DEA agent in
20 Alabama, the field agent here, said that's
21 perfectly fine the way you're doing it but the
22 DEA agent in Virginia where we are said no,
23 that's not the way. So they went back and forth
Business Meeting 18
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1 within the DEA to reach a resolution and basic
2 patient care has suffered in the meantime so we
3 are just going to comply with what they're
4 looking at right -- this, so.
5 DR. ALVERSON: Would you mind if we
6 spoke to DEA in Alabama? I don't want to mess
7 anything up for you.
8 MR. SAPONE: No. I mean, DEA in
9 Alabama said the way that it's set up now is
10 fine, you can operate that way.
11 DR. ALVERSON: Right.
12 MR. SAPONE: I think the biggest
13 problem was we don't own the hospital. The DEA
14 told us you are not -- you don't own the
15 hospital, you are not a hospital, you cannot
16 have a hospital permit, you know. So that's
17 what the DEA in Virginia -- at the Virginia
18 field office told us.
19 MR. DANIEL: So you guys have the same
20 situation at the hospital in Eufaula?
21 MR. SAPONE: Not --
22 MR. DANIEL: But I mean, you don't own
23 the hospital.
Business Meeting 19
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1 MR. SAPONE: We don't own the
2 hospital. I'm not familiar with that site
3 because we don't do any call for that -- you
4 know, we're not requested to do any --
5 MR. DANIEL: It's the same setup.
6 MR. SAPONE: Yeah.
7 MR. DANIEL: They came in and took
8 over pharmacy services directly with the
9 hospital.
10 MR. SAPONE: Yeah, I've spoken briefly
11 with Alan, the pharmacist there, and I know -- I
12 just don't keep in touch with that department
13 too often, so.
14 DR. ALVERSON: I thought there were
15 more and more instances where outside groups ran
16 pharmacies and maybe that means they don't --
17 they run them but they don't own them.
18 MR. SAPONE: Correct, and that's the
19 problem that we run into is that we run them,
20 provide a service, but we do not own the
21 hospital.
22 MR. DARBY: But you own the pharmacy;
23 right?
Business Meeting 20
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1 MR. SAPONE: We own the pharmacy, yes,
2 sir.
3 DR. ALVERSON: That makes no sense
4 whatsoever. I'm sorry.
5 MR. SAPONE: And I agree too and we --
6 you know, we're in Alexandria with DEA for six
7 hours discussing this and they weren't very open
8 to what the Alabama field office said.
9 DR. MARTIN: All right. So DEA in
10 Virginia wants your closed-door operation in
11 Virginia Beach to be a retail --
12 MR. SAPONE: Well, we already are
13 retail.
14 DR. MARTIN: You already are retail.
15 MR. SAPONE: I think they want Laurel
16 Oaks to switch over to --
17 DR. MARTIN: Well, how -- so the DEA
18 in Virginia is telling Alabama how it all
19 begins.
20 MR. DARBY: But the DEA in Alabama
21 disagrees with the DEA in Virginia.
22 MR. SAPONE: The DEA in Virginia went
23 to -- the local field officer there went to her
Business Meeting 21
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1 supervisor in DC and the three of them -- the DC
2 office, you know, the Richmond office in
3 Virginia, and down here.
4 DR. MARTIN: What is the -- I'm sorry,
5 this is real fundamental and maybe I should know
6 this, but what does the DEA care if you're
7 processing orders? That doesn't have anything
8 to do with moving product.
9 MR. SAPONE: In their eyes, it does.
10 Their law -- the DEA is very specific and we
11 talked about that for a while too. If we -- if
12 I as a pharmacist enter an order in Virginia and
13 authorize the release of a medication from a
14 Pyxis machine, that's considered dispensing. So
15 if I am going to dispense a controlled drug in
16 another state, that's where they are allowed to
17 step in.
18 MS. ANDERSON: Do y'all do discharge
19 orders?
20 MR. SAPONE: No.
21 MS. ANDERSON: No, okay.
22 MR. SAPONE: Those are all handled
23 outside.
Business Meeting 22
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1 DR. MARTIN: I think there are two --
2 two rubs we're going to have to get over and one
3 is the issue, potentially, of a retail pharmacy
4 performing order processing for an institutional
5 facility. That's new to us. We might get
6 there, we might not. And then the second thing
7 is this DEA stuff has got to get resolved
8 somehow. We've got to all get on the same page
9 and that's probably the harder of the two.
10 MR. SAPONE: Yeah.
11 MR. BUNCH: Did they give you any time
12 line on that?
13 MR. SAPONE: This has been since 2013
14 that we've been working with them.
15 MR. MCCONAGHY: Tim, we do have some
16 precedence about the retail and that and just in
17 small rural hospital instance where you've got
18 one pharmacy and one hospital in the
19 community.
20 DR. MARTIN: Yeah.
21 MR. MCCONAGHY: And we have allowed
22 that -- that retail pharmacy to process orders
23 or review or verify basically the orders from
Business Meeting 23
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1 the -- from that small hospital but it's a
2 really small scale. And the other thing with
3 hospitals that have been doing the remote
4 processing, we've been requiring them to give us
5 numbers --
6 MR. SAPONE: Record data, yeah.
7 MR. MCCONAGHY: -- that how many your
8 pharmacists in Virginia are processing
9 currently --
10 MR. SAPONE: Right.
11 MR. MCCONAGHY: -- and how many this
12 is going to add to it and that kind of thing.
13 So we would -- to be fair to everybody else that
14 has gotten one, we would need those numbers.
15 MR. SAPONE: Yeah, absolutely, yeah,
16 and we use -- obviously use Pyxis and all the
17 orders come in through Pyxis Connect, the secure
18 server, so it's very easy to tally numbers --
19 number of orders that come in for a certain site
20 by time, so that would be a relatively easy
21 number to report monthly, weekly, however it's
22 required.
23 Our site in Virginia is for all
Business Meeting 24
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1 purposes an institutional pharmacy. When
2 Mr. Mims set up the pharmacy and did the
3 registration, it was recommended, you know,
4 basically facilities that we service are -- you
5 know, locally in Virginia are long-term
6 residential so we do bill Medicaid for a lot of
7 those patients. So in order to do that, we had
8 to set our Virginia pharmacy up as retail in
9 order to bill Virginia Medicaid for those. We
10 are an institutional pharmacy in Virginia but
11 Virginia doesn't have an institutional class of
12 licensure similar to the State of Alabama.
13 DR. ALVERSON: Part of my concern
14 would be that in an institutional setting, we're
15 working with orders and we don't have to worry
16 about refills. Nurses have certain privileges.
17 Physician orders are treated very differently
18 than a prescription. We're not looking at
19 prescriptions as pieces of paper with certain
20 documentation. I mean, it changes the whole
21 perspective of what goes on in that building.
22 MR. SAPONE: Yeah.
23 DR. ALVERSON: Everything changes.
Business Meeting 25
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1 DR. MARTIN: Does the site, Virginia
2 Beach, perform remote processing for other
3 facilities outside of Alabama?
4 MR. SAPONE: Yes.
5 DR. MARTIN: Tell us about those. Are
6 they -- are they hospitals?
7 MR. SAPONE: They're all hospitals,
8 yes.
9 DR. MARTIN: So you're already
10 processing orders from hospitals at sites
11 outside of Alabama in this location?
12 MR. SAPONE: Correct. Basically we
13 are for all intents and purposes an
14 institutional pharmacy. The only orders that we
15 see are hospital orders. We do not see any
16 prescriptions like a retail prescription, you
17 know, like you drop off at CVS or Walgreens.
18 All of the prescriptions that we see are actual
19 physician orders. I'll add that for our sites
20 in Virginia, there were -- the DEA said there
21 were some things that we had to add to those
22 physician orders to become compliant with DEA
23 laws and regulations like the quantity, you
Business Meeting 26
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1 know, for sites that we, you know, actually
2 provide the medications for physicians at my
3 sites in the Hampton Roads area, they have to
4 put a quantity on there. The doctors have to
5 put their DEA number, all the laws that
6 regularly apply to a retail prescription, and
7 that's something the DEA said that we have to do
8 because we're set up as a retail pharmacy.
9 It's a little confusing but you know,
10 it's -- but what I'm asking to do here is, you
11 know, just remote data entry and all the orders
12 that, you know, that we type to allow the nurses
13 to, you know, go on a profile mode after hours
14 and on the weekends are, you know, obviously
15 typed by a pharmacist. They also leave them in
16 the queue. They are reviewed by the on-site
17 pharmacist as soon as they open up in the
18 morning, so everything that, you know, we enter
19 from our site in Virginia does get reviewed, you
20 know, as soon as the on-site pharmacist is back
21 on site.
22 DR. MARTIN: How many others -- how
23 many other institutional sites are you serving
Business Meeting 27
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1 out of the Virginia Beach location from a remote
2 processing standpoint?
3 MR. SAPONE: Thirty -- about 30.
4 DR. MARTIN: Thirty other hospitals
5 being serviced out of that site already doing
6 remote processing?
7 MR. SAPONE: Correct.
8 DR. ALVERSON: Do you own any of
9 those?
10 MR. SAPONE: No, Institutional
11 Pharmacy Solutions owns -- we own all the --
12 yeah, the company owns all the pharmacies,
13 yeah.
14 DR. ALVERSON: So you're changing this
15 in every state?
16 MR. SAPONE: Some of the states don't
17 require it -- us to change our permits and
18 things like that. One of the things that -- a
19 decision that was made, you know, we won't
20 process any controlled drug orders, you know,
21 because the DEA said that you could not, you
22 know, as a retail pharmacy in Virginia, you
23 can't authorize the release of a controlled
Business Meeting 28
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1 medication for a resident in another state.
2 DR. MARTIN: But that may not be a
3 problem because you're probably going to allow
4 those to be overridden in the facility and then
5 the pharmacist coming in in the morning is going
6 to process the order.
7 MR. SAPONE: Right, correct, yeah,
8 exactly. But yes, we are changing it in a lot
9 of the states. I was in Arkansas yesterday and
10 requested the same thing because they do
11 require -- it's a similar situation there with
12 the sites being similar.
13 MR. MCCONAGHY: I do know, I mean,
14 we're going to have to have those numbers up
15 front --
16 MR. SAPONE: Oh, okay, absolutely.
17 MR. MCCONAGHY: -- showing what you're
18 doing now so that our issue in the past has been
19 that if you were going to add a quantity of
20 orders on to your current staff that was going
21 to push them to the point where they could
22 potentially be making mistakes and you didn't
23 have enough staff in there, then you would need
Business Meeting 29
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1 to provide some explanation of why you add the
2 staff.
3 MR. SAPONE: Absolutely.
4 MR. DARBY: How many pharmacists do
5 you have on staff?
6 MR. SAPONE: On staff.
7 DR. MARTIN: At Virginia Beach.
8 MR. DARBY: At Virginia Beach.
9 MR. SAPONE: At Virginia, nine
10 including myself.
11 MR. DARBY: And how many technicians?
12 MR. SAPONE: Twelve.
13 MR. WARD: What hours will this be
14 going on?
15 MR. SAPONE: The pharmacy in Virginia
16 is open 24 hours.
17 MR. WARD: When will you be doing the
18 remote processing for these folks?
19 MR. SAPONE: Outside the normal
20 hours.
21 MR. MCCONAGHY: How many are working
22 now?
23 MR. SAPONE: How many are working --
Business Meeting 30
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1 how many pharmacists?
2 MR. WARD: The outside hours doing the
3 remote processing, what's the staffing?
4 MR. SAPONE: Minimum -- currently
5 minimum two pharmacists at all times and four
6 techs.
7 MS. YEATMAN: What's the tech ratio in
8 Virginia?
9 MR. SAPONE: Three to one. They'll
10 grant an exception of four to one but we don't
11 have that. Three to one is what we use.
12 MS. YEATMAN: Is there a stipulation
13 on the three?
14 MR. SAPONE: No, it's just a straight
15 three to one, I believe, and then they'll allow
16 four to one but you have to have special
17 permission from the Board.
18 MS. YEATMAN: So you don't have to
19 have one nationally certified in your ratio?
20 MR. SAPONE: Oh, yeah, they -- if you
21 have three to one, one has to be nationally
22 certified and obviously Virginia certifies their
23 technicians, so the other two have to be state
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1 certified.
2 In reference to the numbers, do you
3 want the total that we're currently processing,
4 the after hours and then what --
5 MR. MCCONAGHY: What you'd be adding.
6 MR. SAPONE: What we assume or could
7 guess that Alabama would add to that.
8 DR. MARTIN: The standard spreadsheet,
9 just fill in.
10 MR. SAPONE: Okay. I'll work on
11 getting that.
12 MR. DARBY: Do you want to wait to get
13 the numbers?
14 MR. MCCONAGHY: Yeah, I think we need
15 to wait and get the numbers and get some
16 clarification because quite frankly, the DEA
17 doesn't care what we do. They're going to make
18 their decision independent of what ours is.
19 MR. SAPONE: Right, absolutely.
20 MR. MCCONAGHY: So we need to see what
21 they're going to tell you the final product is
22 and have those numbers in hand before we can
23 approve it.
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1 MR. SAPONE: So the volume we process
2 now, what adding Alabama --
3 MR. DARBY: What you project, yeah.
4 MR. SAPONE: What Alabama would add to
5 that.
6 MR. DARBY: Yeah.
7 MR. SAPONE: And just submit that?
8 DR. MARTIN: Yeah, Susan, can you ask
9 Shirley to send him the template those numbers
10 go in?
11 MR. MCCONAGHY: It will include your
12 personnel too, you know, like if you've got --
13 how many people are processing how many
14 orders.
15 MR. SAPONE: Absolutely. Thank you
16 very much. Appreciate your time.
17 MR. MCCONAGHY: Okay. Gadsden
18 Regional Medical Center.
19 MR. DARBY: Go ahead.
20 DR. MARTIN: Good morning.
21 MR. CORNUTT: Thank you. I just want
22 to thank the Board for allowing us to bring this
23 issue to you this morning. I think we're a
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1 little short on time so do you have a copy of
2 the policy and the request?
3 MR. DARBY: Request.
4 MR. CORNUTT: Request letter that I
5 sent, just make sure you got it.
6 MR. DARBY: Yeah, we do.
7 MR. CORNUTT: Okay, all right.
8 Gadsden Regional Medical Center is a community
9 hospital in Gadsden, Alabama. We're licensed
10 for 346 beds. We have 12 pharmacists and 11
11 technicians, so that's the status of the
12 hospital.
13 What we're bringing for you today is a
14 request that the Board allow an Alabama licensed
15 pharmacist to provide at-home order entry review
16 for Gadsden Regional Medical Center as a full
17 employee of Gadsden Regional Medical Center.
18 The background that brings us to this
19 request is I have a current pharmacist on staff
20 at Gadsden who her husband has been assigned
21 with his work to Lake Charles, Louisiana, so
22 they will be moving. She's already turned in
23 her notice and she's unable to find a hospital
Business Meeting 34
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1 position in that area and she wants to remain
2 working in the institutional hospital
3 environment.
4 So she's been -- she's been employed
5 with us for about five years and so our goal is
6 as a hospital to keep Lindsey Arrington, who is
7 licensed in Alabama already, on as an employee
8 of the hospital, to have her -- to move her into
9 a part-time position that we have available
10 that's open and then rehire her full-time
11 position as soon as possible.
12 We feel that with today's technology
13 in the hospital and the electronic medical
14 record and the situation at Gadsden -- we've
15 been on a full electronic health record for
16 about a year now. Eighty-three percent of our
17 physician orders are -- are electronic orders
18 that come into the system. The pharmacist's
19 position at that is to review the order to
20 verify it, to do all the checks that's required
21 by the Board and for patient safety and then to
22 verify those which releases the medicine either
23 to be dispensed from the pharmacy or coming out
Business Meeting 35
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1 of the Pyxis devices at the hospital.
2 All the connections that the
3 pharmacist would use in an off-site at-home
4 situation are secure VPNs. They are
5 specifically the same access points that our
6 physicians are using to do their off-site orders
7 and they are secure VPNs provided by our
8 corporate structure, Community Health Systems
9 out of Nashville, and we feel that we can
10 provide the same service from an off-site
11 location as you can sitting at a computer in
12 the -- inside the hospital because you're
13 essentially looking at the same information.
14 The pharmacist at an off-site location
15 would have full access to the medical record,
16 the dictations from any physicians. They can
17 see all the labs. Everything that the physician
18 is seeing to make the determination of what to
19 order, the pharmacist can see in order to
20 approve and verify the order in that situation.
21 So we have a proposal before you and I
22 can go through the process controlleds if you
23 would like for me to go through those with you
Business Meeting 36
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1 and a policy that we started with to try to help
2 the situation. Our intent is not to replace
3 pharmacists at the hospital. I've got a good
4 employee, who's an excellent clinician and has a
5 good rapport with the medical staff that I
6 really just don't want to lose and she could
7 provide some help for us in busy times to
8 provide some order entry situations.
9 So if you'd like to go to the process
10 controls, I'll be glad to do that and then open
11 for questions or whatever you'd like for me to
12 do.
13 DR. MARTIN: I think we can just ask a
14 few questions.
15 MR. DARBY: Yeah.
16 DR. MARTIN: Let's just ask a few
17 questions --
18 MR. CORNUTT: Okay.
19 DR. MARTIN: -- and we might
20 eventually, you know, go to that.
21 MR. CORNUTT: All right.
22 DR. MARTIN: So would Ms. Arrington be
23 processing orders in a work-balancing type mode
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1 or an after-hours type mode?
2 MR. CORNUTT: It's more of a work
3 balancing. I see her position -- mainly to use
4 her would be in the middle of the day when the
5 bulk of the orders are being processed. There's
6 two things that will happen from that. She can
7 either provide some clinical services, you know,
8 direct patient care review, calling doctors
9 looking for utilization review, and also the way
10 the electronic record works in Gadsden, the
11 physician and providers enter their orders.
12 They come into an order queue. It gets backed
13 up in an order queue.
14 DR. MARTIN: Right.
15 MR. CORNUTT: And pharmacists are
16 going through that queue looking at stat orders
17 first, you know, and verifying those and
18 processing them and then get to the routine
19 orders and do those, so.
20 DR. MARTIN: Right.
21 MR. CORNUTT: So she can be two-fold.
22 She can be in the queue at the same time
23 pharmacists are and that's no different than we
Business Meeting 38
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1 are in the department. You can't get on top of
2 another pharmacist. It locks you out or you
3 have to break through a lock to get into the
4 same patient, so all the processes are in place
5 for hospitals. So initially we intend to
6 position her in the middle of the day at our
7 peak order times and work a part-time status
8 would be about -- somewhere around 60 hours in a
9 two-week period and there's a method in the
10 hospital for her to actually clock in
11 electronically and clock out electronically so
12 we'd know the hours that she is working.
13 DR. MARTIN: So let me see if I can
14 repeat back to you what I think I heard you say.
15 MR. CORNUTT: Okay. Thank you.
16 DR. MARTIN: You have a system in the
17 hospital where 83 percent of the time the
18 physicians are entering the orders themselves.
19 You have the option for those orders to --
20 you've chosen not to but you have the option for
21 those orders to just become live and acted on.
22 MR. CORNUTT: Yes.
23 DR. MARTIN: But you've chosen to
Business Meeting 39
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1 inject a pharmacist in the process --
2 MR. CORNUTT: Yes.
3 DR. MARTIN: -- to do a quality review
4 of those orders.
5 MR. CORNUTT: Yes, sir.
6 DR. MARTIN: So that pharmacist is
7 really performing, at least on the minor orders,
8 a verification.
9 MR. CORNUTT: Yes.
10 DR. MARTIN: And if adjustments need
11 to be made, they're adjusting orders then.
12 MR. CORNUTT: Yeah, and the pharmacist
13 would work under medical staff protocols and
14 rules and regulations, you know, for formulary
15 issues and for anything to make a call to the
16 physician, she would have full access to the
17 on-call list, the physician list, to make the
18 calls. She's known by the medical staff now,
19 so.
20 MR. DARBY: You don't have a
21 license -- you're not in a licensed facility.
22 MS. YEATMAN: Yeah.
23 MR. WARD: That's the biggest issue.
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1 MR. MCCONAGHY: I know you've got a
2 comment and I want to hear it.
3 MS. YEATMAN: Well, I do and I don't
4 mean this to sound the way that it's going to
5 sound but it sounds like you're coming before
6 the Board to make a position for an employee you
7 don't want to lose and it's a bigger picture for
8 me personally because we don't do this for
9 anybody else right now and I'm sure she's a
10 fantastic pharmacist but you know, I guess my
11 question would be if she weren't leaving, would
12 you have even come before the Board asking for
13 this and this would dramatically change how
14 we're practicing or what we're allowing from the
15 practice of pharmacy.
16 MR. CORNUTT: Right. In coming before
17 you and reading the rules as they exist now,
18 there's no rule that addresses the institutional
19 pharmacy specifically for off-site order entry
20 and looking at the rule for remote-order entry,
21 there is one that says not from home.
22 MR. WARD: That's being a pharmacist.
23 I mean, some things --
Business Meeting 41
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1 MR. DARBY: The supervising
2 pharmacist --
3 MR. WARD: Yeah, I mean, it's got to
4 be in the pharmacy. I mean, not every -- I
5 mean, there's not a law that says you can't beat
6 up somebody. I mean, some of it is just common
7 sense. It's got to be in the pharmacy.
8 MR. CORNUTT: So the question that
9 really we're asking was the -- with the CPOE,
10 the physician can put in an order from a
11 bathroom on an iPad on a secure connection that
12 comes to our pharmacy that we then verify, of
13 course, is it the right drug, right patient, all
14 of that stuff. So the question herein lies with
15 technology where it lies, it's not -- the
16 practice of medicine and the practice of
17 pharmacy is kind stepping outside of walls so --
18 and that's why we're asking is everything that
19 can be seen on site, and I'm in front of a
20 computer in my office, I can see on a laptop
21 from home, absolutely everything that I can see.
22 Now, part of that is we're not
23 actually replacing -- pulling someone out of a
Business Meeting 42
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1 hospital to put into a home to order -- you
2 know, to take care of patients. We're actually
3 adding to the staff. She's just filling an open
4 part-time position. We're going to fill her
5 void as an on-site person. So at the end of the
6 day, this is only in addition to what we're
7 already providing.
8 MR. WARD: You're asking this Board to
9 do something that's never done before to help
10 you out because you want to help this lady,
11 which is great, but it's a bigger question than
12 that.
13 MR. CORNUTT: And we think the
14 technology --
15 MR. WARD: I know but -- I know but we
16 just can't look at it for your -- because you
17 want to try to help this lady.
18 MR. CORNUTT: Sure.
19 MR. WARD: And then next week we get
20 someone from CVS who wants to do it from their
21 home and pretty soon -- so it's a lot bigger
22 question than that. I agree, it's not what you
23 want to do is wrong. It's just that we have to
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1 look at it --
2 MR. CORNUTT: Right.
3 MR. WARD: -- in a lot broader scope.
4 MR. CORNUTT: And I understand this
5 is -- this is -- our question was we're looking
6 at maybe reviewing the process because as
7 technology has advanced, that's what we need to
8 be looking at because that's what -- we won't be
9 the first person who's looking to do this
10 because the technology allows and previously it
11 wouldn't. Previously you couldn't do it but now
12 the technology allows us, so there will be more
13 and more questions of people asking the same
14 question, can you process an order for a Tylenol
15 at home the same way you can verify it inside of
16 a hospital.
17 MS. YEATMAN: So let me ask you this:
18 She's going to be at home verifying and you have
19 no control over monitoring how she's verifying
20 and I'm playing devil's advocate.
21 MR. CORNUTT: Sure. That's fine.
22 MS. YEATMAN: If I'm in my house with
23 my four kids running around, you do not want me
Business Meeting 44
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1 verifying prescriptions. How do you control the
2 environment to insure -- I mean, that's the
3 reason we've always said it had to be in a
4 pharmacy.
5 MR. CORNUTT: Right.
6 MS. YEATMAN: It has to be in a
7 controlled environment to make sure that we are
8 doing everything we can to maintain public
9 health and decrease errors and all of that.
10 MR. CORNUTT: Sure.
11 MS. YEATMAN: So that -- that's my
12 concern --
13 MR. CORNUTT: Right.
14 MS. YEATMAN: -- anytime it's ever
15 come up and you know, this would be just the
16 beginning of the snowball that will become an
17 avalanche because I guarantee you that there are
18 lots of other -- to your point, lots of others
19 that are looking at this and that's my concern,
20 how do we control that environment.
21 MR. DARBY: There was a group last
22 year I think from Illinois that we did not
23 approve and they actually had the capability of
Business Meeting 45
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1 having a separate, dedicated office in their
2 house with a camera system and all of that. We
3 didn't approve them and I don't think you're
4 proposing anything like that, are you --
5 MR. CORNUTT: No, no.
6 MR. DARBY: -- that she would actually
7 have a separate office -- lockable, accessible
8 only to her with a camera system you can verify
9 that she was in there.
10 MS. YEATMAN: And how do you know the
11 patient information is secure?
12 MR. CORNUTT: The patient information
13 is secure because of the VPN that you're on.
14 MS. YEATMAN: No, I'm saying in her --
15 in her house.
16 MR. DARBY: Yeah.
17 MS. YEATMAN: If it's up on her laptop
18 in her house, who else has access there.
19 MR. DARBY: Who else is -- who else is
20 in there looking at it.
21 MR. CORNUTT: I mean, we would have to
22 depend on the professional, say just like you do
23 inside the hospital.
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1 MS. YEATMAN: Yeah.
2 MR. BAKER: Inside the hospital,
3 everybody personally is held for HIPAA
4 compliance.
5 MR. DARBY: Yeah, but you've got
6 physical boundaries inside that hospital that --
7 MS. YEATMAN: And you have
8 professionals working in the hospital. You
9 don't have --
10 MR. CORNUTT: Right.
11 MS. YEATMAN: Again, a noncontrolled
12 environment.
13 MR. BUNCH: I think your point, the
14 technology is there. I'm just not sure the law
15 and everything else that goes with it is there.
16 MR. CORNUTT: And we knew that coming
17 in.
18 MR. BAKER: And that's why we're
19 wanting to get --
20 MR. CORNUTT: Insights.
21 MR. BAKER: -- to bring the issue
22 before you because I think there is going to be
23 more issues like this that are -- may need to be
Business Meeting 47
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1 looked at from the standpoint of what may be the
2 future but in our situation, I can -- I can
3 utilize somebody to help our patient care
4 situation. We feel we can do it safely with the
5 technology and not -- and put us in a position
6 to -- you know, to better serve the patients
7 also to the hospital for what we've got now, so,
8 and it's a request. We knew that it's on the
9 edge of what --
10 MS. YEATMAN: I mean, believe me, I
11 think the idea, I can appreciate. I'm just not
12 sure how we implement it in such a way that we
13 can guarantee that we're upholding all the
14 pieces of the law.
15 MR. CORNUTT: Sure, sure.
16 MR. MCCONAGHY: And we know the
17 technology is out there and like your example
18 for the doctor, you know, he may do his best
19 thinking in the bathroom.
20 MR. BAKER: Just the first example
21 that came to my head, not a special example.
22 MR. MCCONAGHY: But in my opinion,
23 that's not the most professional place that you
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1 should be writing orders for your patients.
2 MR. CORNUTT: That's true.
3 MR. MCCONAGHY: And what you should be
4 accessing at the time you're writing them but
5 from a regulatory point of view, this Board's --
6 for our inspectors, what they would be tasked
7 with is trying to make sure that she at her site
8 was approved and doing what she's supposed to
9 do.
10 MR. CORNUTT: Sure.
11 MR. MCCONAGHY: And then that would be
12 impossible to do on a widespread basis.
13 MS. YEATMAN: Yeah, I think what
14 you're asking for would require us to make
15 adjustments to the current rules and regulations
16 that are in place. That's not certainly
17 something we could do for you today.
18 MR. WARD: Let's pretend. Is she
19 licensed -- is she going to be licensed where
20 she's going?
21 MR. CORNUTT: She's attempting to get
22 a Louisiana license now and -- she'll have it
23 when it when she gets involved in the area.
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1 MR. BAKER: She'll have -- she'll
2 have -- she's planning on getting -- she has an
3 Alabama now. She'll be planning on getting a
4 Louisiana as well.
5 MR. CORNUTT: She's going through the
6 process.
7 MR. WARD: And does Louisiana allow
8 practicing pharmacy from someone's house?
9 MR. CORNUTT: I mean, she's -- she
10 won't be providing services for Louisiana
11 pharmacies so I --
12 MR. WARD: She'll be practicing --
13 well, if she's in Louisiana, she'll have a
14 license there, won't she?
15 MR. CORNUTT: Well, yeah, I guess --
16 MR. WARD: Under that theory, she
17 doesn't need a license because she's not going
18 to be treating -- so she's going to get a
19 license so I mean, I'm not even sure the state
20 that she wants to go to is going to allow it.
21 MR. CORNUTT: Right.
22 MR. MCCONAGHY: Anybody want to make a
23 motion?
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1 MS. YEATMAN: David is the only one
2 that knows how to do one.
3 MR. DARBY: I don't want to make a
4 motion. I don't want to do it.
5 MR. WARD: Yeah, let's not have a
6 negative. Just say, thank you.
7 MR. DARBY: Yeah, all right.
8 MR. CORNUTT: Thank you.
9 MR. BUNCH: We will take it under
10 advisement.
11 MR. MCCONAGHY: Thank you for your
12 presentation.
13 MR. CORNUTT: Thank you.
14 MR. BAKER: Thank you.
15 MR. MCCONAGHY: Were there any other
16 presentations that I might be missing on my
17 agenda?
18 (No response.)
19 MR. MCCONAGHY: All right. Buddy is
20 up.
21 MR. WARD: Treasurer's report, all
22 right. Again, nothing much has changed since
23 last month. We -- we are on income above our
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1 budgeted amount for the year. We do have -- we
2 will have an expense of -- a large expense
3 coming up before I think too awfully long in
4 cars, I think close to 90,000 or so, and the
5 money is in the budget for the vehicles.
6 Everyone get a copy of the report?
7 MR. DARBY: Yeah.
8 MR. BUNCH: Any questions? I think
9 this pretty much -- nothing has changed. I'm
10 lucky to be the treasurer this year when money
11 is here. David gets it next year when we pay
12 out, so have you got any questions?
13 (No response.)
14 MR. BUNCH: That is the treasurer's
15 report.
16 MR. MCCONAGHY: Thank you, Buddy.
17 Who's going to do the Wellness Committee report?
18 MR. DARBY: Do we need to accept that
19 report?
20 MR. MCCONAGHY: Do we, yeah.
21 MR. DARBY: I make a motion that we
22 accept the treasurer's report.
23 MS. YEATMAN: Second.
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1 MR. MCCONAGHY: All in favor?
2 DR. MARTIN: Aye.
3 MR. DARBY: Aye.
4 MS. YEATMAN: Aye.
5 MR. BUNCH: Aye.
6 MR. MCCONAGHY: The Wellness Committee
7 report.
8 DR. ALVERSON: I've got that from
9 Dr. Garver.
10 MR. MCCONAGHY: Are you Dr. Garver?
11 DR. ALVERSON: I am. I'd be glad to
12 tell you about my mother.
13 We have one pharmacist in inpatient,
14 one pharmacist going for evaluation. It was
15 interrupted because of some surgery, and one
16 tech in treatment, one pharmacist trying to make
17 a decision whether or not to continue with
18 pharmacy as a career. That license is not
19 presently active.
20 We have had 22 people identified in
21 2015. That does not include holdovers from the
22 previous year. There are 84 people in facility-
23 driven aftercare.
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1 Dr. Garver would like to mention that
2 he met with investigators at the meeting last
3 month, which I think -- or before the meeting
4 last month, which I think he reported that he
5 meets with all licensees who are returning to
6 work and gets signed contracts and thanks you
7 for allowing him to serve in the position he's
8 in. That's his report.
9 MR. MCCONAGHY: Do y'all want to make
10 a motion to accept that report?
11 MS. YEATMAN: I make a motion to
12 accept Dr. Garver's Wellness report.
13 MR. BUNCH: Second.
14 MR. MCCONAGHY: All in favor?
15 DR. MARTIN: Aye.
16 MR. BUNCH: Aye.
17 MS. YEATMAN: Aye.
18 MR. DARBY: Aye.
19 MR. MCCONAGHY: Opposed?
20 (No response.)
21 MR. MCCONAGHY: Okay. David, you're
22 the professional board minutes reader here.
23 MR. DARBY: I make a motion we approve
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1 the June 17, 2015, board business minutes.
2 MS. YEATMAN: Second.
3 MR. MCCONAGHY: All in favor?
4 DR. MARTIN: Aye.
5 MS. YEATMAN: Aye.
6 MR. BUNCH: Aye.
7 MR. DARBY: I also make a motion we
8 approve the June 17, 2015, interview minutes.
9 MS. YEATMAN: Second.
10 MR. MCCONAGHY: All in favor?
11 DR. MARTIN: Aye.
12 MR. DARBY: Aye.
13 MS. YEATMAN: Aye.
14 MR. BUNCH: Aye.
15 MR. MCCONAGHY: The inspector's
16 report.
17 DR. ALVERSON: Mr. Braden took some
18 vacation time and then went to a training
19 session in Seattle. He'll be back in the office
20 tomorrow and so I've asked Todd Brooks to give
21 his report. Todd if you would, please.
22 MR. BROOKS: We completed 73
23 inspections in June, one nonsterile, one
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1 sterile; received 15 complaints, completed nine.
2 Since January -- from January to June 2015, 94
3 complaints have been received and 13 of those
4 being diversion, medication error being 12, and
5 47 being PDMP, pricing, other -- in another
6 category and we had inspectors attend an APA
7 conference.
8 Inspectors attended FDA training in
9 Nashville and an inspector attended FBI National
10 Academy training in Orange Beach and several
11 inspectors assisted the DEA on four pharmacies
12 in the Birmingham metro area and we had one
13 inspector assist FDA on an inspection in
14 Florence, Alabama.
15 MS. YEATMAN: I make a motion we
16 accept the inspector's report.
17 MR. DARBY: Second.
18 MR. MCCONAGHY: All in favor?
19 DR. MARTIN: Aye.
20 MR. BUNCH: Aye.
21 MR. DARBY: Aye.
22 MS. YEATMAN: Aye.
23 MR. MCCONAGHY: Susan, secretary's
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1 report, you've got two minutes.
2 DR. ALVERSON: Two minutes, wow.
3 Well, my report is not pulling up in my
4 computer, thank you very much.
5 MR. DARBY: Do you want mine?
6 DR. ALVERSON: I think I remember.
7 You can tell me if I've missed something.
8 First I'd like you to know that
9 Shirley Feagin, who is the woman that you meet
10 when you first come into the building, has
11 decided in favor of her fiance over us and so
12 she's going to be moving to Richmond, Virginia,
13 and based on her experience here, she was able
14 to interview for a job and got it immediately.
15 So we were glad we assisted her in that way.
16 We're going to begin looking for someone to
17 replace her immediately and we will miss her.
18 I have given you a guidance draft from
19 the FDA about what the FDA is expecting on
20 wholesale licenses. As I've mentioned before,
21 we have to separate wholesale from repackager,
22 yada, yada, yada. This is the only one that I
23 can I find that they've actually published
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1 something and so I would like to know from the
2 Board would you like our office to begin a draft
3 of items that need to be in that license for you
4 to look at, so at least it would be a starting
5 point for you.
6 MR. WARD: Well, you need to get the
7 law changed first.
8 MR. DARBY: Yeah, this is going to
9 take a law change, isn't it?
10 DR. ALVERSON: Yes, but we're going to
11 have to be able to tell them --
12 MR. WARD: No, we're just going to
13 have -- it's going to be one line -- do it by
14 rule. Otherwise, you have to go to legislature
15 every time something changed. You just have to
16 have a new category. I thought we talked about
17 this last time -- a new category.
18 DR. ALVERSON: We did but we have to
19 have specific requirements in there.
20 MR. WARD: By rule. You do it by
21 rule.
22 DR. ALVERSON: Would you like us to
23 begin writing some of those things which will
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1 have to be in the rules is my --
2 MR. DARBY: Yeah --
3 MR. MCCONAGHY: Yes.
4 MR. DARBY: -- in the rule but we also
5 need to get it -- the legislation drafted so we
6 can get that approved pretty quickly.
7 MR. WARD: We couldn't get it in the
8 special call of the legislature or something.
9 MR. DARBY: Would it be a prudent
10 thing to do to go ahead and put the language in
11 there to add other types of licenses that we
12 might want to add in the future?
13 MR. WARD: Yeah, I mean, that's what
14 we talked about before, like the methadone
15 stuff, yeah.
16 MR. DARBY: Just a good time to redo
17 it and so why don't we begin working on that.
18 DR. ALVERSON: So my question is:
19 Would you like us to begin creating a draft you
20 can accept, get rid of, whatever?
21 MR. DARBY: I would like for you to
22 begin creating a draft to change the legislation
23 and in addition to that, begin creating the
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1 rules that you would want to use once the
2 legislation got changed.
3 DR. ALVERSON: All right. The next
4 item is the Governor's office has proposed a new
5 office or commission to deal with potential
6 antitrust issues because of the Supreme Court
7 decision based on the North Carolina dental
8 board case, it seems that the Governor's office
9 is nervous about something similar happening in
10 Alabama.
11 They've proposed an office that would
12 have three lawyers, two paralegals, and
13 everything that goes along with an office, which
14 is going to cost $1.2 million or that's the
15 proposed budget and any legislation or rule
16 proposed by any licensing agency would have to
17 go through this group to be sure that it's
18 written in the interest of the public and not in
19 the interest of financial security for the Board
20 members.
21 Right now that group of committees or
22 that group of agencies are meeting to discuss
23 how to fund that because we've been told we will
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1 have to pay that $1.2 million. So at first --
2 DR. MARTIN: We being all the
3 regulatory boards.
4 DR. ALVERSON: All regulatory
5 agencies, all right. The first thought was
6 divided by the number of agencies but there are
7 some agencies that only license 18 people, I
8 believe, so there's no way they can uphold their
9 portion of it. Then it was proposed that
10 their -- take the 1.2 million divided by the
11 number of people licensed by all those agencies
12 put together and whatever that number is, tack
13 that on to every license.
14 The Nursing Board licensed 90,000
15 people, so that means the Nursing Board would be
16 funding one-third of this 1.2 million, so
17 they're not pleased with that proposal. They
18 proposed a sliding scale so if you license from
19 one to 1,000, you pay a flat fee. If you
20 licensed -- when we worked it out the other day,
21 that turns out -- just the way we fall into that
22 is that we'd be paying four dollars per
23 licensee. The Nursing Board would be paying one
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1 dollar per licensee.
2 So there was -- it didn't appear to be
3 fair on how it worked out. There's a meeting in
4 Montgomery at nine o'clock Monday morning that
5 we will be attending but I'd be interested in
6 any proposals that you have.
7 MR. WARD: Where is the meeting going
8 to be?
9 DR. ALVERSON: I can't tell you which
10 building it's in. I know it's Montgomery at
11 9:00.
12 DR. MARTIN: Previously the meeting
13 was at the --
14 MS. ANDERSON: Real estate.
15 DR. MARTIN: -- Alabama Association of
16 Homebuilders, I think. It's right beside --
17 right beside APA.
18 DR. ALVERSON: Cristal has -- Cristal
19 and Scott attended one.
20 MR. WARD: Can you copy me with it? I
21 want to start being copied on it.
22 MS. ANDERSON: Yeah.
23 MR. WARD: Because I'm going to go and
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1 put my two cents in.
2 MS. ANDERSON: I'm not sure if they're
3 going to hold it at the same place but I want to
4 stay it was like the -- the Real Estate
5 Commission office that we met in down there last
6 week.
7 MR. WARD: Will you send me those?
8 MS. ANDERSON: Do you want a copy on
9 all of those emails I'm getting?
10 MR. WARD: Yeah.
11 MR. DARBY: On the bill that's being
12 introduced in the special session on this,
13 because under the executive order, it's
14 voluntary. We can opt in or out; correct?
15 DR. MARTIN: That's my
16 understanding.
17 MR. DARBY: But under the bill, would
18 we be able to opt in or out because what you're
19 doing if you -- if you go into this group,
20 you're putting yourself under the supervision of
21 another board.
22 MR. WARD: Plus can you imagine the
23 delay?
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1 MR. DARBY: Yeah.
2 MR. WARD: I mean, I think we really
3 need to help with this.
4 DR. MARTIN: Also a good point was
5 made, I forgot who made this that I was talking
6 to earlier, that we have insurance for this
7 purpose already.
8 DR. ALVERSON: My concern is that --
9 that this passed, that it becomes mandatory in
10 Alabama, we're going to have to go through this
11 group whether we like it or not and we've had no
12 say-so in how we are going to fund our part. I
13 just don't want to end up on the short end.
14 MR. DARBY: And we -- I think we paid
15 our money to be a part of this -- this group,
16 didn't we?
17 DR. ALVERSON: There's an organization
18 that meets all the time --
19 MR. DARBY: Right.
20 DR. ALVERSON: -- that's not -- that
21 didn't form because of this issue.
22 MR. DARBY: Yeah.
23 DR. ALVERSON: It's just a group of
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1 boards that gets together and talks about common
2 problems and --
3 MR. DARBY: I think we continue to
4 have our input on how the fees are done but I do
5 not think we should commit to be in agreement
6 with the bill or being a part of the executive
7 order --
8 DR. ALVERSON: All right.
9 MR. DARBY: -- until we know more
10 about it.
11 MR. WARD: Well, you know, this all --
12 it all -- this all starts with what this case
13 was about -- the North Carolina case was about
14 and it's a group of a profession trying to limit
15 who can practice what they practice. That's
16 what it was about and so those are scope issues
17 and those usually appear more with medicine and
18 physical therapy, so I'm having a hard time
19 understanding what all this stampede is about.
20 It's antitrust. That's what it's about. It's
21 about limiting competition so they will start a
22 one-million-dollar deal and you have to send
23 everything down there to make sure you aren't
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1 violating antitrust when that's rarely even
2 factor.
3 MR. MCCONAGHY: And we're going to
4 send it to three lawyers.
5 MR. WARD: Yeah, right, I mean.
6 MR. BUNCH: Susan, do you --
7 MR. WARD: Plus Tim makes a good
8 point, you have -- the State has insurance.
9 DR. MARTIN: Well, the State's
10 insurance won't cover us but if we have separate
11 insurance, it will.
12 MR. WARD: Yeah, they will. How much
13 do they pay?
14 DR. MARTIN: Well, according to the
15 FDC, if a board that's regulating is made up of
16 more than a majority of --
17 MR. WARD: Right.
18 DR. MARTIN: -- the people who
19 practice in the profession, then the State
20 indemnity fund, whatever that's called, will not
21 cover in that case.
22 MR. WARD: I'm not sure about that.
23 It says you don't have a state -- state
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1 immunity. I don't think it's --
2 DR. MARTIN: Yeah.
3 MR. WARD: I don't think -- that
4 doesn't mean you don't have insurance.
5 DR. MARTIN: Well, I think the
6 insurance part -- do we have insurance aside
7 from what the State covers from the --
8 MR. MCCONAGHY: Yeah, this Board has a
9 policy through Pharmacists Mutual for their
10 liability.
11 DR. MARTIN: That's what I was
12 thinking. So I would think that would be a
13 point of discussion at the meeting next week,
14 kind of like David said that as we're entering
15 into the dialogue with these other regulatory
16 boards by what that legislation ought to look
17 like, and as I understand it, the legislation
18 that's been proposed is only a placeholder.
19 They already know it's going to be rewritten,
20 that we introduce the concept that if an
21 individual regulatory board chooses to maintain
22 its own insurance, they could opt out of this
23 mandatory involvement in this additional
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1 commission.
2 MR. BUNCH: Do you have any indication
3 on any of the other boards -- their thinking on
4 this like the Medical Board?
5 DR. ALVERSON: Everyone I've talked to
6 has felt that this is a dramatic reaction to
7 something that might never happen.
8 MR. BUNCH: Do you think they may be
9 in the same mindset as us as maybe not
10 participating?
11 DR. ALVERSON: I most certainly can
12 talk to them about it.
13 MR. BUNCH: Yeah, it would be good to
14 know kind of what they're --
15 MS. ANDERSON: I'm pretty sure the
16 Medical Board, they're ready to jump on board.
17 MR. BUNCH: Jump on board.
18 MS. ANDERSON: Yeah, they were --
19 DR. MARTIN: As a matter of fact, they
20 were driving the process before ARB ever got
21 into it.
22 MS. ANDERSON: Yes.
23 MR. BUNCH: It probably would affect
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1 it.
2 MS. YEATMAN: Again, that's a
3 different scope.
4 MR. WARD: Yeah, they have scope
5 issues all the time, yeah.
6 MR. DARBY: Well, and they're much --
7 they're very protective of what other people can
8 do.
9 MS. YEATMAN: Uh-huh.
10 DR. MARTIN: I don't think there's a
11 chance this is going to be acted upon in the
12 special session.
13 DR. ALVERSON: I'm sure it won't be.
14 DR. MARTIN: So I would say continue
15 the dialogue, continue to listen to what the
16 group is saying, remember those points that
17 we've talked about and plan for something to
18 come out in the spring that's probably going to
19 be introduced.
20 DR. ALVERSON: I did send you an email
21 with the legislation.
22 MR. DARBY: Yeah, I got it.
23 DR. ALVERSON: Did you get it?
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1 MR. DARBY: Yeah, I've got it pulled
2 up right here.
3 DR. ALVERSON: Okay. We had a meeting
4 with the DEA supervisor in our area to discuss
5 issues that have been brought up that
6 pharmacists were having difficulty with and some
7 of those we discussed at the APA meeting. The
8 first one was about addresses on prescriptions.
9 Apparently some DEA agents have been trained
10 that if the doctor didn't write it on the
11 prescription, you have to send the patient back
12 to the doctor's office. Some of them feel
13 that's ridiculous, including the person that we
14 met with, and so they have agreed that as long
15 as the address gets put on the prescription by
16 the patient, by whoever takes in the
17 prescription by the time it gets to the
18 pharmacist to fill it, if there is an address on
19 it, they're going to be happy with that, all
20 right.
21 The second thing is they agreed the
22 front and the back of the prescription can be
23 used to record information for the prescription
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1 that they --
2 MS. YEATMAN: Does that mean the
3 address also?
4 MS. ANDERSON: They said the address
5 could be on the back but it should be
6 handwritten before it's turned over to the
7 pharmacist.
8 DR. ALVERSON: Before it gets to the
9 point where it's filled.
10 MR. BUNCH: So the sticker -- the
11 label on the prescription is not good enough
12 with the address. It has to be handwritten.
13 DR. ALVERSON: Correct, because that's
14 after the prescription has been processed.
15 MS. YEATMAN: I still argue that point
16 but.
17 DR. ALVERSON: We were --
18 MS. YEATMAN: I understand.
19 DR. ALVERSON: All right.
20 MR. BUNCH: That's on all -- that's on
21 all controlleds.
22 DR. ALVERSON: Correct.
23 MR. BUNCH: CIIs and everything.
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1 DR. ALVERSON: CIIs and everything,
2 all right. But they did hold firm on the idea
3 that a pharmacist cannot, even with a call to a
4 physician, on the CII where there are multiple
5 prescriptions and the physician has written
6 on -- on those prescriptions do not fill before,
7 that that date could not be changed because they
8 saw that as the beginning of a slippery slope.
9 So we did well on two and had to give on the
10 third.
11 We've discussed how we can put
12 background checks on our computer system and
13 have looked at -- the computer company has found
14 a company that they have used before that does
15 background checks that integrates into their
16 system, so we have to look into that in addition
17 to others but I just want you to know we're
18 moving forward on that.
19 And I think I mentioned last meeting
20 that we have obtained the Grand Hotel for next
21 year's District III meeting, which we are
22 hosting. I think I said that last month but I
23 just wanted to be sure I did.
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1 Did I get it all?
2 DR. MARTIN: MOU public affairs update
3 on that. That's in the Dropbox.
4 DR. ALVERSON: Yes, the FDA came out
5 with a different version or a concession on one
6 of the MOU issues and I'm ashamed to say I put
7 it in and now I've forgotten exactly which one
8 it was.
9 MR. WARD: They haven't published a
10 new revised one yet, have they?
11 DR. ALVERSON: No, they haven't.
12 MR. WARD: See, I've been looking. I
13 haven't seen it.
14 DR. ALVERSON: They have not published
15 a new one.
16 DR. MARTIN: Who is PCCA?
17 DR. ALVERSON: Pharmacy Compounding
18 Centers of America.
19 DR. MARTIN: Thank you.
20 DR. ALVERSON: I believe it had to do
21 with the 30-percent rule if I remember.
22 MR. DARBY: It does.
23 MR. WARD: It did. What did it say?
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1 MS. YEATMAN: It says right here.
2 DR. MARTIN: It's got about ten bullet
3 points.
4 MR. DARBY: Ill defined.
5 MS. YEATMAN: Ill defined and
6 arbitrary.
7 DR. ALVERSON: I think they made
8 the -- they used us really as one of their
9 excuses or their defenses in that all of this
10 work that FDA is proposing is going to be dumped
11 on the state boards of pharmacy. State boards
12 of pharmacy are going to have to go in and count
13 prescriptions, how many are in state, how many
14 are out of state. It is going to be a lot of
15 work.
16 MR. WARD: Hence the saying, I'm for
17 the federal government and I'm here to help.
18 DR. ALVERSON: Correct.
19 MR. WARD: Check's in the mail.
20 DR. ALVERSON: Yes. I took more than
21 my allotted time but.
22 MR. MCCONAGHY: Do you think the DEA
23 would be willing to put what they told you in
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1 writing and provide a number so that when one of
2 their agents comes in telling you something
3 different, they can call?
4 DR. ALVERSON: I think if they don't
5 get in writing -- we will send them a document
6 that says, as a result of our meeting our
7 understanding is this. If you think otherwise,
8 please let us know but we are going to begin
9 notifying pharmacies that this is your agreement
10 if we don't hear back but I think they'll put it
11 in writing.
12 MR. MCCONAGHY: I guess my interest is
13 because I've heard several folks that have had
14 that issue going on. If they came in and told
15 the pharmacist, you know, I'm writing you up
16 because of this --
17 DR. ALVERSON: Right.
18 MR. MCCONAGHY: -- and they've said
19 otherwise, do they have somebody they can call
20 at the DEA as recourse to say hey, you need to
21 talk to these people.
22 DR. ALVERSON: I agree and we did get
23 the letter out about front and back of
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1 prescriptions and perhaps we should do the same
2 thing about addresses and the CII.
3 MR. MCCONAGHY: Jim Ward, have you got
4 an attorney's report?
5 MR. WARD: No, sir, not except for
6 executive session. Oh, yeah, one thing is
7 Matthew Muscato, yeah, you know, the legislature
8 passed House Bill 208 about allowing doctors to
9 write a prescription or authorize certain
10 individuals to use the drug that counteracts a
11 drug overdose. I can't remember the name of
12 it.
13 DR. ALVERSON: Naloxone.
14 MR. WARD: Right. And it mentions
15 pharmacies -- pharmacists in the bill and the
16 way I read it, it protects -- it's a good
17 faith if you -- if you dispense it in good
18 faith, you're -- you're okay, you can do it.
19 You aren't subject to being sued but Matt wants
20 to know if we're going to issue any rules about
21 that or do anything. I said I would make sure
22 and tell them. Do I have that right, Matt?
23 MR. MUSCATO: Correct, we're just
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1 putting together our plans and just some states
2 have taken -- 14 states have passed similar
3 bills and some boards have had just some -- some
4 guidance on proceeding.
5 MR. WARD: For me -- for me, the law
6 is pretty clear but if you all want to look at
7 it, see if we need to make a rule to make sure,
8 we can do that.
9 MR. DARBY: Yeah, why don't we look at
10 it.
11 MR. WARD: I'll send it -- do y'all
12 have a copy? I'll get you a copy of it.
13 MR. DARBY: Yeah, yeah.
14 MR. WARD: You can put it on the
15 agenda for the next meeting.
16 MR. MCCONAGHY: You can add that to
17 Susan's statements that she is sending out to
18 everybody.
19 MS. YEATMAN: Dan, do we need to
20 accept the secretary's report?
21 MR. MCCONAGHY: If you want to.
22 MS. YEATMAN: Well, I'm just -- we
23 were audited. I'm trying to make sure we do it
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1 right.
2 MR. DARBY: No, I don't think you have
3 to.
4 MS. YEATMAN: We don't have to, okay.
5 I'm still learning.
6 MR. DARBY: Susan, will you maybe send
7 the state organizations, you know, what y'all
8 talked with the DEA about on those
9 clarifications so they can help maybe get that
10 out to all the pharmacists?
11 DR. ALVERSON: Yes, I will.
12 MR. MCCONAGHY: Old business. Tim,
13 would you like to start with the 680-X-2.18?
14 DR. MARTIN: Sure, I'd be glad to.
15 The part about that rule that we're concerned
16 with is the one where automated drug cabinets
17 are allowed in skilled nursing facilities and we
18 talked about this last month and it was the
19 feeling of the Board that there was still too
20 much confusion about what is and is not allowed,
21 what would or would not be allowed, especially
22 from a labeling standpoint to go forward with
23 what had been proposed earlier.
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1 So you can expect some alternative
2 wording to be presented to the Board. The plan
3 is for that to be presented to the Board next
4 month for consideration. I'd be glad to try to
5 answer any other questions that you might have
6 about it.
7 MR. MCCONAGHY: I guess the only
8 question I have is on the technical or legal
9 part of it, we started that process going and
10 we -- we've been through the hearing and the
11 30-day comment period. During that period, we
12 voted to not accept it as written, so are we
13 starting back as if we're doing a new one now
14 and then we'll post it and have the 30-day -- 30
15 days before the hearing on it and then the
16 30-day comment period again?
17 MR. WARD: Yeah, if it wasn't amended,
18 if you -- you can not accept it as written and
19 change it and then vote in the changes. You
20 didn't do that. What you did was you didn't do
21 anything in essence, then you have to start over
22 again.
23 MS. YEATMAN: Yeah.
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1 MR. MCCONAGHY: Okay. I know that's
2 not what a lot of y'all wanted to hear there, me
3 either, but that's -- if we -- any other
4 comments on that?
5 DR. MARTIN: I don't have anything
6 else.
7 MR. MCCONAGHY: Okay. We'll move into
8 new business. Does anyone have any new
9 business?
10 MR. MCENIRY: Mr. President, Members
11 of the Board, I'd like to follow up on a new
12 business that we brought up last -- at last
13 meeting and to request -- I don't believe Blue
14 Cross Blue Shield of Alabama is present as it
15 deals with the elimination of coverage for
16 compounded medications in Alabama. I would like
17 to request that we place the matter on the
18 August agenda or another agenda that the Board
19 sees fit and maybe give Blue Cross notice, I
20 guess to the extent that the Board does decide
21 to take some action.
22 I'm not sure if due process is the
23 right word, Jim, but maybe for equitable
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1 concerns I think that Blue Cross should at least
2 be allowed to respond. I've provided written
3 materials that supplement what was stated on the
4 record in June and I hope you'll find those
5 helpful.
6 MR. WARD: I'm sorry, what -- was
7 stated in June about what, Jay?
8 MR. MCENIRY: I'm sorry?
9 MR. WARD: I didn't hear the last
10 part. Your voice kind of dropped.
11 MR. MCENIRY: Oh, I'm sorry. I
12 provided written materials to supplement what I
13 presented to the Board in June.
14 MR. WARD: About the Blue Cross issue?
15 MR. MCENIRY: Yes, yes, just for the
16 Board's consideration and I'm certainly happy to
17 provide whatever materials you need in addition
18 to what's already been submitted but I'm not
19 sure what the process is for getting us on the
20 agenda and getting notice to Blue Cross but I'm
21 certainly going to help in any way possible.
22 MR. WARD: What's the status of it?
23 Could you give us a little update?
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1 MR. MCENIRY: The status is that as of
2 July 1, Blue Cross Blue Shield of Alabama
3 effectuated its plan to effectively end coverage
4 for compounded medications for most patients in
5 Alabama. There are some patients for which that
6 decision will go in effect on September 1. I
7 believe that deals with plans that have a 90-day
8 notice provision for -- for its members and
9 beneficiaries but the -- otherwise, the status
10 is as -- as stated at the June meeting.
11 MR. WARD: Are you asking the Board to
12 do -- to do something?
13 MR. MCENIRY: Yes, I believe that --
14 and I'm happy to run through it to the extent
15 that you guys need it or you all need it, excuse
16 me -- but I believe given the fact that Blue
17 Cross insures over 90 percent of insured lives
18 in Alabama; in addition, given the fact
19 compounded medications by their nature are a lot
20 of times the only option -- the only treatment
21 option for patients that I believe this is an
22 issue of -- a potential threat to public health
23 for which the Board has jurisdiction.
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1 Outside of that, there was a question
2 presented last time what can the Board do. I
3 actually spoke with a former board member. The
4 suggestions were, number one, the Board can take
5 a public position through resolution or other
6 public statement as to its position as to these
7 issues. The Board could seek a meeting with
8 Blue Cross or a delegation from the Board seek a
9 meeting with Blue Cross if it saw fit. The
10 Board could work with other boards in the
11 State -- Medical Board, Board of Dentistry,
12 other boards that may be affected by potentially
13 to look at legislation to address the issue were
14 the things suggested to me.
15 MR. DARBY: Doesn't Blue Cross -- what
16 they quit covering was paying for compounds from
17 bulk chemicals -- bulk ingredients but they
18 still will pay for compounds that are billed by
19 NDC number; is that correct?
20 MR. MCENIRY: The jury is still out as
21 to whether Blue Cross will continue to pay for
22 compounding from manufacturing from commercially
23 available ingredients. I do understand in some
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1 circumstances those compounds are still being
2 covered. If you look at the language of the
3 Blue Cross provider notice, one of the
4 requirements would be that the route of
5 administration be FDA indicated, which would
6 mean that even compounding from commercially
7 available ingredients would not be covered, so I
8 think the jury is still out on that issue.
9 I think you have a separate issue, of
10 course, that by compounding with commercially
11 available ingredients, you are still putting a
12 lot of patients at risk because a lot of times
13 you compound to get around the additives, dyes,
14 glutens, incipients that you find in
15 commercially available medications for which a
16 patient is allergic or otherwise cannot
17 tolerate. Past that, of course, compounding
18 with commercially available ingredients can be
19 more difficult but I'll leave that to the
20 pharmacists to discuss. I don't feel that it's
21 within my -- my license to discuss that. But
22 overall I do believe that based upon Blue Cross'
23 definitions and based upon what we're seeing
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1 right now that we're still seeing a public
2 health threat for which the Board may have
3 jurisdiction.
4 MR. WARD: Has anybody contacted
5 Luther Strange?
6 MR. MCENIRY: I have been working with
7 various folks in Montgomery. I have not
8 contacted the attorney general directly.
9 MR. WARD: Are you -- you are a smart
10 young lawyer.
11 MR. MCENIRY: I appreciate that.
12 MR. WARD: The same thoughts I had
13 last time -- well, you are. How do we -- how
14 does anybody force a private company to mandate
15 to them what risks they cover or what services
16 they cover? I mean, I'm just trying to think of
17 a way -- how do you tell any business how
18 they -- how they -- what they can sell or not
19 sell or what they can cover and not cover unless
20 it's otherwise against the law.
21 MR. MCENIRY: I think there are legal
22 arguments for which a regulatory board may look
23 at the issue. It may be within your purview to
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1 the extent that Blue Cross' move violates the
2 Affordable Care Act, for example, by pharmacy
3 being one of the enshrined rights for patients
4 as passed in the ACA. I do agree with you
5 that -- and I believe we'll find that it's Blue
6 Cross' argument, we're a private company and we
7 can do what we want to. But that argument only
8 goes so far when you start doing things that
9 affects the public health. Again, I don't know
10 whether this Board has direct regulatory
11 authority over Blue Cross but I do believe that
12 this Board has the authority to take some action
13 that it sees fit based upon the threat of public
14 health.
15 MR. WARD: You're aware of the line of
16 cases that say that if someone violates a
17 regulatory statute, that doesn't give them a
18 private cause of action.
19 MR. MCENIRY: Yes, yes.
20 MR. WARD: So that's just what I'm
21 trying to think even if let's say -- will you
22 stop for a minute.
23 (Brief off the record discussion.)
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1 MR. WARD: I guess it would be up,
2 Dan, to y'all if you want to -- what, if
3 anything, you want to do.
4 MR. MCCONAGHY: As far as what I can
5 speak to, we've done traditional type
6 compounding for all of my career and I do have
7 patients that this will affect but I suspect
8 Blue Cross is counting on us to go ahead and do
9 it for them anyway because we're not going to
10 leave them out there in the cold and that we'll
11 bear the brunt of the expense. So I do think
12 it's an issue for folks that -- that can't
13 afford to pay for the medications that are being
14 compounded, especially in pediatrics.
15 There's so much of it that's going on
16 in the hospital and in traditional type pharmacy
17 settings for pediatrics being formulated, so I
18 do see it as a true issue. I don't know where
19 we can stand on it other than to say that
20 personally I feel like it's -- it's a pretty big
21 issue for them to just kind of carte blanche it
22 across the board probably because there were
23 some bad players in the game, they -- they
Business Meeting 87
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1 attacked everyone.
2 MR. MCENIRY: Either that or piling
3 on. Of course, Blue Cross has been working
4 under a pretty strict cap as it deals with
5 reimbursement for compounds for years in Alabama
6 through its pharmacy benefit manager, Prime
7 Therapeutics, and so even the bad guys who may
8 have used some payers in the country, I don't
9 think they could have done a whole lot with Blue
10 Cross due that cap but certainly it is an
11 industry under some pressure and arguably, I
12 can't speak for Blue Cross, but it could be a
13 simple -- as simple as, well, we have an
14 opportunity, let's take it.
15 What I would like to point out and
16 what is pointed out in my letter and I believe I
17 pointed out in my presentation -- I won't call
18 it a presentation -- in speaking with you in
19 June, Alabama is in a public health crisis as it
20 deals with opioid use. Alabama is the top
21 consuming, along with Tennessee, equal top
22 consuming state of opioids in the country right
23 now -- 143 prescriptions per 100 lives according
Business Meeting 88
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1 to the CDC last year. Those materials are
2 actually within the -- the links to that are
3 within the materials I submitted to the Board.
4 That issue alone I believe justifies
5 at least consideration of the public health
6 issue. You have an issue now, President
7 McConaghy, you mentioned, well, pharmacies are
8 going to be expected to just do it on their own.
9 Well, what's going to happen, especially as you
10 deal with pain, is you're going to find patients
11 who can take an opioid and get it under a very
12 basic copay and you're going to find doctors and
13 pharmacies pushing patients -- continuing to
14 push patients to a mode of therapy that is being
15 proven to be a real problem in this state and a
16 real public health threat in this state where
17 you have a viable alternative that is
18 nonaddictive, that has not seen systemic effects
19 as opioids at your disposal.
20 But we have the largest payer in the
21 state that insures over two million people in
22 this state -- that was in 2012 before the ACA
23 passed. I don't know where it is now but the
Business Meeting 89
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1 last reported figures of over two million people
2 in the state arbitrarily eliminating coverage
3 for a line of medications that really could
4 serve to the benefit of public health.
5 My request is I'm -- my hope is that a
6 public position by this Board, public positions
7 in Montgomery, may force Blue Cross to the table
8 to talk about alternatives other than cutting it
9 off and -- but understanding the limitations, I
10 am still hoping that the Board will consider
11 taking some position on this issue.
12 MR. WARD: Jay, I have a special needs
13 son, who a lot of people in this room know, who
14 is going to be affected by this because he can't
15 swallow pills, so he has to have a lot of his
16 medication in liquid and it has to be compounded
17 for him and you know, so I'm with you. I
18 want -- I just -- I'm frustrated because I can't
19 think of something that would really hit them
20 other than somehow affecting them money wise
21 financially.
22 MR. MCENIRY: Absolutely, and the
23 AL.com story that posted on June 29, again
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1 within your materials, there was a parent who
2 was interviewed. The medication coverage was
3 cut off. They can't afford it. Well, I guess
4 I'm going to have to get the pill and crush it
5 up and try to force it through the feeding tube.
6 You've got real -- you've got real issues here.
7 I submitted a number of patient
8 testimonials regarding the importance of
9 compounding, why commercially available doesn't
10 work. It's about that thick (indicating). I
11 submit it not expecting that you read it all but
12 just so that you have some information at your
13 disposal.
14 MR. BUNCH: Is there a grass roots
15 effort maybe with the -- again, I'd go back to
16 Blue Cross being a business and folks who were
17 taking medicine of their customers. Normally a
18 business listens to who is paying the bills and
19 if you've got a really -- I don't know how you
20 go about getting that many people but you know,
21 just affected by compounding, it's more than
22 just compounding, you'd have a great outcry but
23 compounding is not as -- it's a large segment
Business Meeting 91
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1 but it's not what -- you know, it's not the
2 total segment so.
3 But if you have people calling Blue
4 Cross every day complaining about what they're
5 going to do to get their -- to be able to get
6 their child's medication, their elderly parents'
7 medication, this type thing, and not only call
8 them but call their employers who maybe have a
9 contract with Blue Cross, to me, that would be
10 the most important group at Blue Cross they
11 would probably listen to because they're very
12 attuned to -- to not lose their patients.
13 MR. MCENIRY: And that is -- and I
14 appreciate that. That is occurring. That is
15 definitely occurring as we speak and has been
16 for -- ever since Blue Cross gave notice --
17 again 30 days notice, if you recall from our
18 last discussion, which is very difficult for
19 patients who have no commercially available
20 option. It doesn't give you a lot of time,
21 which is another issue that I believe could be
22 taken off as a part of the discussion but the --
23 the grass roots effort from the patient, from
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1 the physician, from the employer both to Blue
2 Cross directly and to the state legislature is
3 ongoing.
4 MR. MCCONAGHY: Yeah, I -- like I say,
5 I don't know -- we'll do a little research and
6 see what we think we could do would be most
7 effective but just personally speaking, it's
8 really offensive to me doing the traditional
9 type compounding for years and years and it's
10 basically what pharmacy was. I mean, it was --
11 when my dad was a pharmacist, that's what
12 pharmacy was, so that's the whole business and
13 for them to just take a total assault on it
14 is -- is pretty offending to me.
15 MR. MCENIRY: There are other ways
16 than cutting it off and I am hoping that
17 respected members of the Board and other
18 community legislators may convince Blue Cross
19 that that's the option they should take.
20 MR. DARBY: Have you personally made
21 an appointment with Blue Cross and gone and
22 talked with them?
23 MR. MCENIRY: Many of us are
Business Meeting 93
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1 attempting and maybe -- I don't know if Louise
2 has had any luck yet. I have been in
3 communication with Blue Cross and I think I was
4 getting slow played until the July 1 date and
5 we'll see what happens from here. But yes, I
6 have attempted to reach out.
7 MS. YEATMAN: Just a thought. I mean,
8 in reading because I've been trying to research
9 it because I know it's had an impact on special
10 needs patients that I'm -- that I deal with. I
11 think it might be prudent, at least in my
12 opinion, is to let Blue Cross know that we've
13 had it brought up before the Board, that it is a
14 public health consideration.
15 Based on what Blue Cross is stating,
16 is their reason for no longer covering it is a
17 safety issue because of the Massachusetts case
18 where they had fungal meningitis. So maybe we
19 present to them that we'd like to sit down with
20 them and talk about how we -- what we do from a
21 board standpoint to insure that Alabama lives
22 are not at risk because of the significant
23 inspections that we do to insure compounding is
Business Meeting 94
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1 top line and see if they would at least
2 entertain a discussion on how we can insure
3 their issues and safety concerns aren't a
4 concern and they might be open, you know, to
5 expanding their compounding. If that is indeed
6 the reason that they are concerned, then we
7 should be able to alleviate a lot of those
8 concerns by showing them what we do to insure
9 that compounding in the State of Alabama is not
10 dangerous, so that would be my thought.
11 DR. MARTIN: I think a lot of the
12 concern is that the employers who have their
13 employees covered under the Blue Cross plan are
14 reporting that compounded products are the
15 number one cost item in their coverage plans and
16 do a push back against that.
17 MS. YEATMAN: Then maybe they should
18 consider the fact that if they're not given the
19 medications in the proper dosage, what are the
20 potential outcomes and complications that the
21 patient -- hospitalizations or what else is
22 going to incur financially.
23 DR. MARTIN: I think that's a very
Business Meeting 95
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1 good point and we haven't talked a lot about the
2 employers. I'm sure Jay and his folks have
3 considered that aspect of it but they're
4 probably pretty uninformed.
5 MR. MCENIRY: I think that's a great
6 idea and would be more than willing to assist
7 the Board in any way that the Board sees fit.
8 MS. YEATMAN: Just my two cents.
9 MR. MCCONAGHY: Thank you, Jay.
10 MR. MCENIRY: Thank you.
11 MR. MCCONAGHY: Any other new
12 business?
13 (No response.)
14 MR. MCCONAGHY: Mr. Ward suggested we
15 need to go into executive session, so I would
16 entertain a motion as such.
17 DR. MARTIN: Would you like to make a
18 motion, Mr. President, that the Board go into
19 executive session?
20 MR. MCCONAGHY: Okay, yeah, the motion
21 will be that we will now go into executive
22 session for the purpose of discussing
23 qualifications or competencies of professionals,
Business Meeting 96
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1 permitholders, or registrants. Other legal
2 matters may be discussed, including existing and
3 pending cases or litigation.
4 The executive session will start at
5 11:05 and we should be out by 11:30 and at that
6 time, there will be no further business other
7 than to read into the record anything that was
8 discussed during the executive session.
9 MR. WARD: As an attorney licensed to
10 practice law in the State of Alabama, I certify
11 that one of the reasons for going into executive
12 session is to discuss pending matters and
13 potential resolution of pending matters before
14 the Board.
15 MR. MCCONAGHY: That's a motion.
16 MR. DARBY: Second.
17 MR. MCCONAGHY: We've got a second.
18 DR. MARTIN: Yeah, it would be an
19 individual vote.
20 MR. MCCONAGHY: Buddy?
21 MR. BUNCH: Yes.
22 MR. MCCONAGHY: Donna?
23 MS. YEATMAN: Yes.
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1 MR. MCCONAGHY: Tim?
2 DR. MARTIN: Yes.
3 MR. MCCONAGHY: David?
4 MR. DARBY: Aye.
5 MR. MCCONAGHY: And aye.
6 We are adjourned to executive session.
7
8 (Whereupon, a recess was taken for
9 executive session from 10:56 a.m. to
10 12:44 p.m.)
11
12 MR. MCCONAGHY: We will come out of
13 the executive session for the meeting and David
14 will read the cases discussed in the meeting.
15 MR. DARBY: Case number 15-0037,
16 recommended action is a letter of concern to the
17 pharmacy.
18 DR. MARTIN: I move we accept the
19 recommendation as submitted.
20 MS. YEATMAN: Second.
21 MR. MCCONAGHY: All in favor?
22 DR. MARTIN: Aye.
23 MR. DARBY: Aye.
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1 MS. YEATMAN: Aye.
2 MR. BUNCH: Aye.
3 MR. DARBY: Case number 15-0071, a
4 letter of warning to the pharmacist and a
5 corrective action plan to be sent in to the
6 Board.
7 DR. MARTIN: I move we accept the
8 recommendation as submitted.
9 MS. YEATMAN: Second.
10 MR. MCCONAGHY: All in favor?
11 DR. MARTIN: Aye.
12 MR. BUNCH: Aye.
13 MR. DARBY: Aye.
14 MS. YEATMAN: Aye.
15 MR. DARBY: Case number 15-0072, a
16 letter of warning to all pharmacy staff and
17 corrective action plan to be sent in and
18 approved by the compliance officer.
19 DR. MARTIN: I move we accept the
20 recommendation as submitted.
21 MS. YEATMAN: Second.
22 MR. MCCONAGHY: All in favor?
23 MS. YEATMAN: Aye.
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1 DR. MARTIN: Aye.
2 MR. DARBY: Aye.
3 MR. BUNCH: Aye.
4 MR. DARBY: And case number 14-0192,
5 refer it back to the investigator for follow-up
6 investigation.
7 DR. MARTIN: I move we accept the
8 recommendation as submitted.
9 MS. YEATMAN: Second.
10 MR. MCCONAGHY: All in favor?
11 DR. MARTIN: Aye.
12 MS. YEATMAN: Aye.
13 MR. BUNCH: Aye.
14 DR. MARTIN: I move we adjourn.
15 MS. YEATMAN: Second.
16 MR. MCCONAGHY: All in favor?
17 DR. MARTIN: Aye.
18 MS. YEATMAN: Aye.
19 MR. BUNCH: Aye.
20 MR. MCCONAGHY: Adjourned.
21
22 (Whereupon, the hearing was adjourned
23 at 12:47 p.m.)
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1 CERTIFICATE
2
3 STATE OF ALABAMA
4 SHELBY COUNTY
5
6 I, Sheri G. Connelly, RPR, Certified
7 Court Reporter, hereby certify that the above
8 and foregoing hearing was taken down by me in
9 stenotype and the questions, answers, and
10 statements thereto were transcribed by means of
11 computer-aided transcription and that the
12 foregoing represents a true and correct
13 transcript of the said hearing.
14 I further certify that I am neither of
15 counsel, nor of kin to the parties to the
16 action, nor am I in anywise interested in the
17 result of said cause.
18
19
20 /s/ Sheri G. Connelly
21 SHERI G. CONNELLY, RPR
22 ACCR No. 439, Expires 9/30/2015
23
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Business Meeting 102
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12:2 15:20 17:11,18 18:5, 11 19:14 20:3 24:13, 23 27:8, 14 52:8, 11 54:17 56:2, 6 57:10, 18, 22 58:18 59:3 60:4 61:9, 18 63:8, 17, 20, 23 64:8 67:5, 11 68:13, 20, 23 69:3 70:8, 13, 17, 19, 22 71:1 72:4, 11, 14,17, 20 73:7, 18, 20 74:4, 17, 22 75:13 77:11amended 78:17America 72:18amount 51:1Anderson 2:13 14:3, 7, 10, 12 16:3 21:18, 21 61:14, 22 62:2, 8 67:15, 18,22 70:4Angie 2:21 5:3answer 78:5answers 100:9antitrust 59:6 64:20 65:1anybody 40:9 49:22 84:4, 14anytime 44:14anyway 86:9anywise 100:16APA 55:6 61:17 69:7apologize 7:15Apparently 69:9appear 8:23 61:2 64:17apply 26:6appointment 92:21Appreciate 32:16 47:11 84:11 91:14approve 8:14 31:23 35:20 44:23 45:3 53:23 54:8Approved 4:14 48:8 58:6 98:18ARB 67:20
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BUSINESS 1:8 15:19 54:1 77:12 79:8, 9, 12 84:17 90:16, 18 92:12 95:12 96:6busy 36:7
< C >cabinets 77:16call 4:1 7:9 10:9 14:13 19:3 39:15 58:8 71:3 74:3, 19 87:17 91:7, 8called 65:20calling 37:8 91:3calls 39:18camera 45:2, 8cap 87:4, 10capability 44:23CAPS 6:9Cara 2:19 4:23Care 6:2 18:2 21:6 31:17 37:8 42:2 47:3 85:2career 52:18 86:6Carolina 59:7 64:13cars 51:4carte 86:21Carter 3:14 6:11case 59:8 64:12,13 65:21 93:17 97:15 98:3, 15 99:4cases 85:16 96:3 97:14category 55:6 57:16, 17cause 85:18 100:17CDC 88:1Center 5:14 7:9,20 8:2 10:4, 9 12:17 16:21 32:18 33:8, 16, 17Centers 72:18cents 62:1 95:8certain 23:19 24:16, 19 75:9
certainly 48:16 67:11 80:16, 21 87:10CERTIFICATE 100:1certified 30:19, 22 31:1 100:6certifies 30:22certify 96:10 100:7, 14chance 68:11change 15:14 27:17 40:13 57:9 58:22 78:19changed 50:22 51:9 57:7, 15 59:2 71:7changes 24:20, 23 78:19changing 27:14 28:8Charles 33:21checks 34:20 71:12, 15Check's 73:19chemicals 82:17child's 91:6choices 15:16chooses 66:21chosen 38:20, 23Chris 2:22 3:2 5:5, 11CII 71:4 75:2CIIs 70:23 71:1circumstances 83:1clarification 31:16clarifications 77:9class 15:12 24:11clear 12:4 76:6clinical 37:7clinician 36:4clock 38:10, 11close 51:4closed-door 13:8 20:10cold 86:10come 23:17, 19 34:18 37:12 40:12 44:15 56:10 68:18
97:12comes 41:12 74:2coming 28:5 34:23 40:5, 16 46:16 51:3comment 40:2 78:11, 16comments 79:4commercially 82:22 83:6, 10, 15,18 90:9 91:19commission 59:5 62:5 67:1commit 64:5Committee 51:17 52:6committees 59:21common 41:6 64:1communication 93:3community 22:19 33:8 35:8 92:18company 7:18 17:8 27:12 71:13,14 84:14 85:6competencies 95:23competition 64:21complaining 91:4complaints 55:1, 3completed 54:22 55:1Compliance 2:13 46:4 98:18compliant 25:22complications 94:20comply 14:23 18:3compound 83:13compounded 79:16 81:4, 19 86:14 89:16 94:14Compounding 72:17 82:22 83:6,10, 17 86:6 90:9,21, 22, 23 92:9 93:23 94:5, 9compounds 82:16,18 83:1 87:5computer 35:11 41:20 56:4 71:12,13
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computer-aided 100:11concept 66:20concern 24:13 44:12, 19 63:8 94:4, 12 97:16concerned 77:15 94:6concerns 80:1 94:3, 8concession 72:5conference 55:7conflict 14:19 15:3,5confusing 16:6 26:9confusion 77:20Connect 23:17connection 41:11connections 35:2Connelly 1:23 100:6, 20, 21consider 89:10 94:18consideration 78:4 80:16 88:5 93:14considered 21:14 95:3consuming 87:21,22contact 13:11contacted 84:4, 8continue 52:17 64:3 68:14, 15 82:21continuing 88:13contract 16:12 91:9contracts 53:6control 43:19 44:1,20controlled 21:15 27:20, 23 44:7controlleds 35:22 70:21controls 36:10convince 92:18copay 88:12copied 61:21copies 9:7
copy 9:9 33:1 51:6 61:20 62:8 76:12, 12Cornutt 3:3 5:13,13 32:21 33:4, 7 36:18, 21 37:2, 15,21 38:15, 22 39:2,5, 9, 12 40:16 41:8 42:13, 18 43:2, 4,21 44:5, 10, 13 45:5, 12, 21 46:10,16, 20 47:15 48:2,10, 21 49:5, 9, 15,21 50:8, 13corporate 35:8Correct 13:1 19:18 25:12 27:7 28:7 62:14 70:13,22 73:18 75:23 82:19 100:12corrective 98:5, 17correspondence 8:15cost 59:14 94:15counsel 100:15count 73:12counteracts 75:10counting 86:8country 87:8, 22COUNTY 100:4course 17:17 41:13 83:10, 17 87:3Court 59:6 100:7cover 65:10, 21 84:15, 16, 19, 19coverage 79:15 81:3 89:2 90:2 94:15covered 83:2, 7 94:13covering 82:16 93:16covers 66:7CPOE 41:9creating 58:19, 22,23crisis 87:19Cristal 2:13 61:18,18
Cross 79:14, 19 80:1, 14, 20 81:2,17 82:8, 9, 15, 21 83:3, 22 85:1, 6, 11 86:8 87:3, 10, 12 89:7 90:16 91:4, 9,10, 16 92:2, 18, 21 93:3, 12, 15 94:13crush 90:4current 7:8 28:20 33:19 48:15currently 7:22 8:2 23:9 30:4 31:3customers 90:17cut 90:3cutting 89:8 92:16CVS 25:17 42:20
< D >dad 92:11Dan 2:4 9:5 76:19 86:2dangerous 94:10Daniel 2:16 3:4 5:15 6:17, 17 18:19, 22 19:5, 7Darby 2:7 4:6, 12 8:16, 21 9:5, 8 19:22 20:20 29:4,8, 11 31:12 32:3, 6,19 33:3, 6 36:15 39:20 41:1 44:21 45:6, 16, 19 46:5 50:3, 7 51:7, 18, 21 52:3 53:18, 23 54:7, 12 55:17, 21 56:5 57:8 58:2, 4,9, 16, 21 62:11, 17 63:1, 14, 19, 22 64:3, 9 68:6, 22 69:1 72:22 73:4 76:9, 13 77:2, 6 82:15 92:20 96:16 97:4, 15, 23 98:3,13, 15 99:2, 4data 7:10 23:6 26:11date 71:7 93:4
David 2:7 50:1 51:11 53:21 66:14 97:3, 13day 37:4 38:6 42:6 60:20 91:4days 78:15 91:17DC 21:1, 1DEA 13:14 14:13,18, 20, 20 15:4, 6, 8,11, 12, 15 17:11, 12,14, 19, 22 18:1, 6, 8,13, 17 20:6, 9, 17,20, 21, 22 21:6, 10 22:7 25:20, 22 26:5, 7 27:21 31:16 55:11 69:4,9 73:22 74:20 77:8deal 59:5 64:22 88:10 93:10deals 79:15 81:7 87:4, 20decide 79:20decided 56:11decision 27:19 31:18 52:17 59:7 81:6decrease 44:9dedicated 45:1defenses 73:9defined 73:4, 5definitely 91:15definitions 83:23delay 62:23delegation 82:8delivery 8:10Delk 2:14 6:15, 15dental 59:7Dentistry 82:11Department 6:12 19:12 38:1depend 45:22Derek 3:1 5:9determination 35:18devices 35:1devil's 43:20dialogue 66:15 68:15dictations 35:16
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different 37:23 68:3 72:5 74:3differently 24:17difficult 83:19 91:18difficulty 69:6direct 13:11 37:8 85:10directly 19:8 84:8 92:2Director 2:13 5:13,16disagreed 17:16disagrees 20:21discharge 21:18discuss 59:22 69:4 83:20, 21 96:12discussed 69:7 71:11 96:2, 8 97:14discussing 20:7 95:22discussion 14:19 17:15 66:13 85:23 91:18, 22 94:2dispense 21:15 75:17dispensed 34:23dispensing 21:14disposal 88:19 90:13District 71:21diversion 55:4divided 60:6, 10doctor 47:18 69:10doctors 26:4 37:8 75:8 88:12doctor's 69:12document 74:5documentation 24:20doing 17:21 23:3 27:5 28:18 29:17 30:2 44:8 48:8 62:19 78:13 85:8 92:8dollar 61:1dollars 60:22Donna 2:8 96:22
dosage 94:19Dothan 7:21 12:17DR 4:10 7:1 8:15 9:11, 15, 18 10:1, 3,6, 10, 16 11:8, 11,15, 18, 21 12:2, 3,11, 16, 21 13:2, 15,20 15:17, 20, 23 16:5 17:11, 17, 18 18:5, 11 19:14 20:3, 9, 14, 17 21:4 22:1, 20 24:13, 23 25:1, 5, 9 26:22 27:4, 8, 14 28:2 29:7 31:8 32:8, 20 36:13, 16, 19, 22 37:14, 20 38:13, 16,23 39:3, 6, 10 52:2,8, 9, 10, 11 53:1, 12,15 54:4, 11, 17 55:19 56:2, 6 57:10, 18, 22 58:18 59:3 60:2, 4 61:9,12, 15, 18 62:15 63:4, 8, 17, 20, 23 64:8 65:9, 14, 18 66:2, 5, 11 67:5, 11,19 68:10, 13, 14, 20,23 69:3 70:8, 13,17, 19, 22 71:1 72:2, 4, 11, 14, 16,17, 19, 20 73:2, 7,18, 20 74:4, 17, 22 75:13 77:11, 14 79:5 94:11, 23 95:17 96:18 97:2,18, 22 98:7, 11, 19 99:1, 7, 11, 14, 17draft 56:18 57:2 58:19, 22drafted 58:5dramatic 67:6dramatically 40:13driven 52:23driving 67:20drop 25:17Dropbox 72:3dropped 80:10
drug 21:15 27:20 41:13 75:10, 11 77:16due 79:22 87:10dumped 73:10dyes 83:13
< E >earlier 14:13 63:6 77:23Easter 2:18 4:16,19, 19easy 23:18, 20Eddie 3:13 6:9edge 47:9effect 81:6effective 92:7effectively 81:3effects 88:18effectuated 81:3effort 90:15 91:23Eighty-three 34:16either 15:8, 10, 14 34:22 37:7 79:3 87:2elaborate 12:1elderly 91:6electronic 34:13, 15,17 37:10electronically 38:11,11eliminating 89:2elimination 79:15email 68:20emails 62:9emergency 8:9employed 34:4employee 33:17 34:7 36:4 40:6employees 94:13employer 92:1employers 91:8 94:12 95:2English 3:14 6:11,11enshrined 85:3enter 21:12 26:18 37:11entering 38:18 66:14
entertain 94:2 95:16entry 7:10 8:9 26:11 33:15 36:8 40:19, 20environment 34:3 44:2, 7, 20 46:12equal 87:21equitable 79:23error 55:4errors 44:9especially 77:21 86:14 88:9essence 78:21essentially 35:13estate 61:14 62:4Eufaula 18:20evaluation 52:14Evans 3:2 5:11, 11eventually 36:20everybody 23:13 46:3 76:18exactly 28:8 72:7example 47:17, 20,21 85:2excellent 36:4exception 30:10Excuse 9:11 81:15excuses 73:9Executive 2:12 62:13 64:6 75:6 95:15, 19, 21 96:4,8, 11 97:6, 9, 13exist 40:17existing 96:2expanding 94:5expect 78:1expected 88:8expecting 56:19 90:11expense 51:2, 2 86:11experience 56:13Expires 100:22explanation 29:1extent 79:20 81:14 85:1extra 9:7eyes 21:9
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< F >facilities 13:3, 9 14:1 24:4 25:3 77:17facility 13:22 14:4 16:1 22:5 28:4 39:21 52:22fact 67:19 81:16,18 94:18factor 65:2fair 23:13 61:3faith 75:17, 18fall 60:21familiar 19:2fantastic 40:10far 85:8 86:4favor 4:9 52:1 53:14 54:3, 10 55:18 56:11 97:21 98:10, 22 99:10, 16FBI 55:9FDA 55:8, 13 56:19, 19 72:4 73:10 83:5FDC 65:15Feagin 56:9federal 73:17fee 60:19feeding 90:5feel 34:12 35:9 47:4 69:12 83:20 86:20feeling 77:19fees 64:4felt 67:6fiance 56:11field 17:20 18:18 20:8, 23figures 89:1fill 31:9 42:4 69:18 71:6filled 70:9filling 42:3final 31:21financial 59:19financially 89:21 94:22
find 33:23 56:23 80:4 83:14 85:5 88:10, 12fine 17:21 18:10 43:21firm 71:2first 7:18 37:17 43:9 47:20 56:8,10 57:7 60:1, 5 69:8fit 79:19 82:9 85:13 95:7five 34:5flat 60:19Florence 55:14folks 29:18 74:13 84:7 86:12 90:16 95:2follow 79:11follow-up 99:5force 84:14 89:7 90:5foregoing 100:8, 12forgot 63:5forgotten 72:7form 63:21formal 7:2formally 7:4former 82:3formulary 39:14formulated 86:17forth 17:23forward 71:18 77:22found 71:13four 30:5, 10, 16 43:23 55:11 60:22fourth 5:11frankly 31:16Freese 3:6 5:18, 18Friday 7:23 8:5 12:12, 14, 23front 4:16 28:15 41:19 69:22 74:23frustrated 89:18full 33:16 34:15 35:15 39:16full-time 34:10fund 59:23 63:12
65:20fundamental 21:5funding 60:16fungal 93:18further 96:6 100:14future 47:2 58:12
< G >Gadsden 5:14, 16 7:19 12:5 32:17 33:8, 9, 16, 17, 20 34:14 37:10game 86:23Garver 52:9, 10 53:1Garver's 53:12general 84:8Getose 3:17getting 31:11 49:2,3 62:9 80:19, 20 90:20 93:4give 9:8 22:11 23:4 54:20 71:9 79:19 80:23 85:17 91:20given 56:18 81:16,18 94:18glad 36:10 52:11 56:15 77:14 78:4glutens 83:14go 14:14 26:13 32:10, 19 35:22, 23 36:9, 20 49:20 57:14 58:10 59:17 61:23 62:19 63:10 73:12 77:22 81:6 86:8 90:15, 20 95:15, 18, 21goal 34:5goes 24:21 46:15 59:13 85:8going 4:1 13:5 14:14, 22 15:17 18:3 21:15 22:2 23:12 28:3, 5, 14,19, 20 29:14 31:17,21 37:16 40:4 42:4 43:18 46:22 48:19, 20 49:5, 17,
18, 20 51:17 52:14 56:12, 16 57:8, 10,12, 13 59:14 61:7,23 62:3 63:10, 12 65:3 66:19 68:11,18 69:19 73:10, 12,14 74:8, 14 75:20 78:9 80:21 86:9,15 88:8, 9, 10, 12 89:14 90:4 91:5 94:22 96:11Good 6:22, 23 7:1 32:20 36:3, 5 58:16 63:4 65:7 67:13 70:11 75:16,17 95:1gotten 23:14government 73:17Governor's 59:4, 8Grand 71:20grant 30:10grass 90:14 91:23great 42:11 90:22 95:5group 44:21 59:17,21, 22 62:19 63:11,15, 23 64:14 68:16 91:10groups 19:15guarantee 44:17 47:13guess 10:16 17:7 31:7 40:10 49:15 74:12 78:7 79:20 86:1 90:3guidance 56:18 76:4guys 18:19 81:15 87:7
< H >Hampton 13:10 26:3hand 10:17 31:22handled 21:22handwritten 70:6,12happen 37:6 67:7 88:9
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happening 59:9happens 93:5happy 69:19 80:16 81:14hard 64:18harder 22:9Harris 2:21 5:3, 3head 47:21Health 4:20 6:12 7:20 8:2 16:21 34:15 35:8 44:9 81:22 84:2 85:9,14 87:19 88:5, 16 89:4 93:14hear 40:2 74:10 79:2 80:9heard 14:16 38:14 74:13hearing 78:10, 15 99:22 100:8, 13held 46:3He'll 54:19help 36:1, 7 42:9,10, 17 47:3 63:3 73:17 77:9 80:21helpful 80:5Heritage 5:5Hester 3:12 6:7, 7hey 74:20HIPAA 46:3hit 89:19hold 62:3 71:2holdovers 52:21home 40:21 41:21 42:1, 21 43:15, 18Homebuilders 61:16Hoover 1:20hope 80:4 89:5hoping 89:10 92:16Hospital 7:19, 22 8:7 10:5 12:5 15:8, 11, 15, 21 16:1, 9, 11, 12, 12,16, 19 17:2, 3, 5 18:13, 15, 15, 16, 20,23 19:2, 9, 21 22:17, 18 23:1 25:15 33:9, 12, 23
34:2, 6, 8, 13 35:1,12 36:3 38:10, 17 42:1 43:16 45:23 46:2, 6, 8 47:7 86:16hospitalizations 94:21hospitals 17:9 23:3 25:6, 7, 10 27:4 38:5hosting 71:22Hotel 71:20hours 7:23 8:1, 5,7, 11 20:7 26:13 29:13, 16, 20 30:2 31:4 38:8, 12house 43:22 45:2,15, 18 49:8 75:8Hunter 3:5 5:17,17husband 33:20
< I >idea 14:6 47:11 71:2 95:6identified 52:20III 71:21Ill 73:4, 5Illinois 44:22imagine 62:22immediately 56:14,17immunity 66:1impact 93:9implement 47:12importance 90:8important 91:10impossible 48:12incipients 83:14include 32:11 52:21included 7:8including 7:3 29:10 69:13 96:2income 50:23Incorporated 6:10incur 94:22indemnity 65:20independent 31:18
indicated 83:5indicating 90:10indication 67:2indications 15:18individual 66:21 96:19individuals 75:10industry 87:11information 35:13 45:11, 12 69:23 90:12ingredients 82:17,23 83:7, 11, 18in-house 12:11initially 38:5inject 39:1inpatient 52:13input 64:4inside 35:12 43:15 45:23 46:2, 6Insights 46:20inspection 55:13inspections 54:23 93:23Inspector 2:14, 15,16, 17 55:9, 13inspectors 48:6 55:6, 8, 11inspector's 54:15 55:16instance 22:17instances 19:15institution 10:15Institutional 5:10 6:21 9:12 10:5 12:7, 9, 12, 18, 19,20 13:3, 8, 18 14:1,8, 14 15:7, 12 16:1,8, 23 22:4 24:1, 10,11, 14 25:14 26:23 27:10 34:2 40:18insurance 63:6 65:8, 10, 11 66:4, 6,6, 22insure 44:2 93:21,23 94:2, 8insured 81:17insures 81:17 88:21
integrates 71:15intend 38:5intent 36:2intents 25:13interest 59:18, 19 74:12interested 61:5 100:16interrupted 52:15interview 54:8 56:14interviewed 90:2introduce 4:17 66:20introduced 62:12 68:19investigation 99:6investigator 99:5investigators 53:2involved 48:23involvement 66:23iPad 41:11IPS 16:8issue 22:3 28:18 32:23 39:23 46:21 63:21 74:14 75:20 80:14 81:22 82:13 83:8, 9 84:23 86:12, 18, 21 88:4,6, 6 89:11 91:21 93:17issued 11:6issues 10:11 39:15 46:23 59:6 64:16 68:5 69:5 72:6 82:7 90:6 94:3item 6:19 59:4 94:15items 57:3its 66:22 81:3, 8 82:6 87:6
< J >January 55:2, 2Jay 2:20 5:1 80:7 89:12 95:2, 9Jeff 3:6 5:18Jim 2:11, 18 4:15,19 75:3 79:23
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job 56:14Jones 3:11 6:5, 5Julie 3:5 5:17July 1:10 4:2 81:2 93:4jump 67:16, 17June 54:1, 8, 23 55:2 80:4, 7, 13 81:10 87:19 89:23jurisdiction 81:23 84:3jury 82:20 83:8justifies 88:4
< K >keep 19:12 34:6kids 43:23kin 100:15kind 10:21, 22 23:12 41:17 66:14 67:14 80:10 86:21knew 46:16 47:8know 8:17 15:1 16:5, 10 18:16 19:4, 11 20:6 21:2,5 24:3, 5 25:17 26:1, 1, 9, 11, 12, 13,14, 18, 20 27:19, 20,22 28:13 32:12 36:20 37:7, 17 38:12 39:14 40:1,10 42:2, 15, 15 44:15 45:10 47:6,16, 18 56:8 57:1 61:10 64:9, 11 66:19 67:14 71:17 74:8, 15 75:7, 20 77:7 79:1 85:9 86:18 88:23 89:13,17 90:19, 20 91:1 92:5 93:1, 9, 12 94:4known 14:8 39:18knows 50:2
< L >label 15:19 70:11labeling 77:22labs 35:17
Lacey 2:23 5:7, 7lady 42:10, 17Lake 33:21Lambruschi 2:17language 58:10 83:2laptop 41:20 45:17large 51:2 90:23largest 88:20Laurel 7:20 8:1 10:3 12:16 14:4 15:9, 10 16:20 20:15law 14:20, 20 17:16 21:10 41:5 46:14 47:14 57:7,9 76:5 84:20 96:10laws 25:23 26:5lawyer 84:10lawyers 59:12 65:4learning 77:5leave 26:15 83:19 86:10leaving 40:11legal 78:8 84:21 96:1legislation 58:5, 22 59:2, 15 66:16, 17 68:21 82:13legislators 92:18legislature 57:14 58:8 75:7 92:2Leos 2:19 4:23, 23letter 8:22, 23 9:2 33:4 74:23 87:16 97:16 98:4, 16liability 66:10license 7:6 9:12,12 10:11 14:4 15:22 39:21 48:22 49:14, 17, 19 52:18 57:3 60:7, 13, 18 83:21licensed 11:2 33:9,14 34:7 39:21 48:19, 19 60:11, 14,20 96:9licensee 60:23 61:1licensees 53:5
licenses 56:20 58:11licensing 59:16licensure 11:10 24:12lies 41:14, 15limit 64:14limitations 89:9limiting 64:21Lindsey 34:6line 22:12 57:13 85:15 89:3 94:1links 88:2liquid 89:16list 6:21 39:17, 17listen 68:15 91:11listens 90:18litigation 96:3little 7:14 26:9 33:1 80:23 92:5live 38:21lives 81:17 87:23 93:21local 8:7 20:23locally 24:5LOCATION 1:18 13:4 25:11 27:1 35:11, 14lock 38:3lockable 45:7locks 38:2long 51:3 69:14longer 93:16long-term 24:5look 8:13 42:16 43:1 57:4 66:16 71:16 76:6, 9 82:13 83:2 84:22looked 47:1 71:13looking 18:4 24:18 35:13 37:9, 16 40:20 43:5, 8, 9 44:19 45:20 56:16 72:12lose 36:6 40:7 91:12lot 24:6 28:8 42:21 43:3 73:14 79:2 81:19 83:12,12 87:9 89:13, 15
91:20 94:7, 11 95:1lots 44:18, 18Louise 3:11 6:5 93:1Louisiana 33:21 48:22 49:4, 7, 10,13luck 93:2lucky 51:10Luther 84:5
< M >machine 21:14Maguire 3:15 6:13,13mail 7:7 9:23 11:6 73:19maintain 44:8 66:21majority 65:16making 28:22manager 87:6mandate 84:14mandatory 63:9 66:23manufacturing 82:22March 14:18Mark 2:14 6:15Martin 2:5 4:10 7:1 8:15 10:3, 16 11:8 12:3, 11, 16,21 13:2, 15, 20 15:17, 23 16:5 17:17 20:9, 14, 17 21:4 22:1, 20 25:1,5, 9 26:22 27:4 28:2 29:7 31:8 32:8, 20 36:13, 16,19, 22 37:14, 20 38:13, 16, 23 39:3,6, 10 52:2 53:15 54:4, 11 55:19 60:2 61:12, 15 62:15 63:4 65:9,14, 18 66:2, 5, 11 67:19 68:10, 14 72:2, 16, 19 73:2 77:14 79:5 94:11,
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23 95:17 96:18 97:2, 18, 22 98:7,11, 19 99:1, 7, 11,14, 17Massachusetts 93:17materials 80:3, 12,17 88:1, 3 90:1Matt 75:19, 22matter 67:19 79:17matters 96:2, 12, 13Matthew 3:7 5:20 75:7McConaghy 2:4 4:1, 9, 14 6:19 22:15, 21 23:7, 11 28:13, 17 29:21 31:5, 14, 20 32:11,17 40:1 47:16, 22 48:3, 11 49:22 50:11, 15, 19 51:16,20 52:1, 6, 10 53:9,14, 19, 21 54:3, 10,15 55:18, 23 58:3 65:3 66:8 73:22 74:12, 18 75:3 76:16, 21 77:12 78:7 79:1, 7 86:4 88:7 92:4 95:9, 11,14, 20 96:15, 17, 20,22 97:1, 3, 5, 12, 21 98:10, 22 99:10, 16,20McEniry 2:20 5:1,1 79:10 80:8, 11,15 81:1, 13 82:20 84:6, 11, 21 85:19 87:2 89:22 91:13 92:15, 23 95:5, 10McWhorter 5:7mean 15:9, 20 18:8, 22 24:20 28:13 40:4, 23 41:3, 4, 5, 6 44:2 45:21 47:10 49:9,19 58:13 63:2 65:5 66:4 70:2 83:6 84:16 92:10 93:7
means 15:23 19:16 60:15 100:10Medicaid 24:6, 9Medical 5:14 32:18 33:8, 16, 17 34:13 35:15 36:5 39:13, 18 67:4, 16 82:11medication 8:10 21:13 28:1 55:4 89:16 90:2 91:6, 7medications 26:2 79:16 81:4, 19 83:15 86:13 89:3 94:19medicine 34:22 41:16 64:17 90:17meet 56:9MEETING 1:8 4:2 53:2, 3 59:22 61:3, 7, 12 66:13 69:3, 7 71:19, 21 74:6 76:15 79:13 81:10 82:7, 9 97:13, 14meets 53:5 63:18Member 2:7, 8 82:3MEMBERS 2:3 59:20 79:10 81:8 92:17meningitis 93:18Mental 6:12mention 53:1mentioned 56:20 71:19 88:7mentions 75:14mess 18:6met 14:18 53:2 62:5 69:14methadone 58:14method 38:9metro 55:12middle 37:4 38:6million 59:14 60:1,10, 16 88:21 89:1Mims 24:2mind 18:5
mindset 67:9mine 56:5Minimum 30:4, 5minor 39:7minute 85:22minutes 53:22 54:1, 8 56:1, 2missed 56:7missing 8:21 50:16mistakes 28:22Mitzi 8:19mode 26:13 36:23 37:1 88:14Monday 7:23 8:4 12:12, 14, 22 61:4money 51:5, 10 63:15 89:20monitoring 43:19Montgomery 61:4,10 84:7 89:7month 50:23 53:3,4 71:22 77:18 78:4monthly 23:21morning 6:22, 23 7:1 26:18 28:5 32:20, 23 61:4mother 52:12motion 4:5, 6 49:23 50:4 51:21 53:10, 11, 23 54:7 55:15 95:16, 18, 20 96:15MOU 72:2, 6Mountain 7:18, 22 10:4 12:4 17:4, 7move 34:8 79:7 85:1 97:18 98:7,19 99:7, 14moving 21:8 33:22 56:12 71:18multiple 71:4Muscato 3:7 5:20,20 75:7, 23Mutual 66:9
< N >Naloxone 75:13name 16:15, 18 75:11
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opinion 47:22 93:12opioid 87:20 88:11opioids 87:22 88:19opportunity 87:14Opposed 53:19opt 62:14, 18 66:22option 38:19, 20 81:20, 21 91:20 92:19Orange 55:10order 4:3 7:7 8:9 9:23 11:7 13:23 21:12 22:4 24:7, 9 28:6 33:15 34:19 35:19, 19, 20 36:8 37:12, 13 38:7 40:19 41:10 42:1 43:14 62:13 64:7ordering 8:10orders 7:5 21:7,19 22:22, 23 23:17,19 24:15, 17 25:10,14, 15, 19, 22 26:11 27:20 28:20 32:14 34:17, 17 35:6 36:23 37:5, 11, 16,19 38:18, 19, 21 39:4, 7, 11 48:1organization 63:17organizations 77:7ought 66:16outcomes 94:20outcry 90:22outside 19:15 21:23 25:3, 11 29:19 30:2 41:17 82:1overall 83:22overdose 75:11overridden 28:4owned 7:17 14:15 16:4 17:6, 8ownership 16:6owns 27:11, 12
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perform 13:23 25:2performing 22:4 39:7period 38:9 78:11,11, 16permission 7:4 30:17permit 7:7 9:23 10:21, 22, 23 11:6,7 12:6, 6, 18 13:15,17, 18, 20 18:16permitholders 96:1permits 27:17permitted 13:22person 42:5 43:9 69:13personally 40:8 46:3 86:20 92:7,20personnel 32:12perspective 24:21Ph.D 2:12Pharmacies 5:21 19:16 27:12 49:11 55:11 74:9 75:15 88:7, 13pharmacist 10:13 13:11 19:11 21:12 26:15, 17, 20 28:5 33:15, 19 35:3, 14,19 38:2 39:1, 6, 12 40:10, 22 41:2 52:13, 14, 16 69:18 70:7 71:3 74:15 92:11 98:4pharmacists 23:8 29:4 30:1, 5 33:10 36:3 37:15, 23 66:9 69:6 75:15 77:10 83:20pharmacist's 34:18PHARMACY 1:2,18 4:3, 22 5:6, 8,10, 12, 14 6:2, 4, 6,16, 18, 21 7:6, 11 8:3, 8, 11 9:13, 22 11:2 12:6, 7, 10, 12,19 13:8, 13, 13, 16 14:8 16:9, 13, 23
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19:8, 22 20:1 22:3,18, 22 24:1, 2, 8, 10 25:14 26:8 27:11,22 29:15 34:23 40:15, 19 41:4, 7,12, 17 44:4 49:8 52:18 72:17 73:11,12 85:2 86:16 87:6 92:10, 12 97:17 98:16PharMedCo 5:19phone 14:13physical 46:6 64:18Physician 24:17 25:19, 22 34:17 35:17 37:11 39:16,17 41:10 71:4, 5 92:1Physicians 5:2 26:2 35:6, 16 38:18picture 40:7piece 7:11pieces 24:19 47:14piling 87:2pill 90:4pills 89:15place 13:5 38:4 47:23 48:16 62:3 79:17placeholder 66:18plan 68:17 78:2 81:3 94:13 98:5,17planning 8:18 49:2, 3plans 76:1 81:7 94:15played 93:4players 86:23playing 43:20please 54:21 74:8pleased 60:17Plus 62:22 65:7point 28:21 44:18 46:13 48:5 57:5 63:4 65:8 66:13 70:9, 15 87:15
95:1pointed 87:16, 17points 35:5 68:16 73:3policy 7:8, 10 9:3 10:9 33:2 36:1 66:9portion 60:9position 34:1, 9, 11,19 37:3 38:6 40:6 42:4 47:5 53:7 82:5, 6 89:6, 11positions 89:6possible 34:11 80:21post 78:14posted 89:23potential 59:5 81:22 94:20 96:13potentially 22:3 28:22 82:12PowerPoint 7:3practice 40:15 41:16, 16 64:15, 15 65:19 96:10practicing 40:14 49:8, 12precedence 22:16prescription 24:18 25:16 26:6 69:11,15, 17, 22, 23 70:11,14 75:9prescriptions 24:19 25:16, 18 44:1 69:8 71:5, 6 73:13 75:1 87:23PRESENT 2:10 4:4 79:14 93:19presentation 7:3 50:12 87:17, 18presentations 6:20 50:16presented 4:7 78:2,3 80:13 82:2presently 52:19President 2:4, 5 79:10 88:6 95:18pressure 87:11pretend 48:18
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project 32:3proper 94:19proposal 35:21 60:17proposals 61:6proposed 59:4, 11,15, 16 60:9, 18 66:18 77:23proposing 45:4 73:10protective 68:7protects 75:16protocols 39:13proven 88:15provide 7:12 8:8,19 16:13 19:20 26:2 29:1 33:15 35:10 36:7, 8 37:7 74:1 80:17provided 35:7 80:2, 12provider 83:3providers 37:11providing 42:7 49:10provision 81:8prudent 58:9 93:11public 44:8 59:18 72:2 81:22 82:5, 6 84:1 85:9, 13 87:19 88:5, 16 89:4, 6, 6 93:14published 56:23 72:9, 14Publix 5:22pulled 69:1pulling 41:23 56:3purpose 63:7 95:22purposes 24:1 25:13purview 84:23push 28:21 88:14 94:16pushing 88:13put 26:4, 5 41:10 42:1 47:5 58:10 60:12 62:1 69:15
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71:11 72:6 73:23 74:10 76:14putting 62:20 76:1 83:11Pyxis 21:14 23:16,17 35:1
< Q >qualifications 95:23quality 39:3quantity 25:23 26:4 28:19question 10:2 40:11 41:8, 14 42:11, 22 43:5, 14 58:18 78:8 82:1questions 10:17, 18 36:11, 14, 17 43:13 51:8, 12 78:5 100:9queue 26:16 37:12,13, 16, 22quickly 58:6quit 82:16quite 14:19 17:15 31:16quorum 4:4
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run 19:17, 19, 19 81:14running 43:23rural 22:17RX 5:2, 4
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22 14:1 15:13, 21 21:16 24:12 27:15 28:1 30:23 49:19 65:8, 19, 23, 23 66:7 73:11, 11, 13,14 77:7 82:11 87:22 88:15, 16, 21,22 89:2 92:2 94:9 96:10 100:3stated 80:3, 7 81:10statement 82:6statements 76:17 100:10states 27:16 28:9 76:1, 2State's 65:9stating 93:15status 33:11 38:7 80:22 81:1, 9statute 85:17stay 62:4stenotype 100:9step 21:17Stephens 3:9 6:1, 1stepping 41:17sterile 55:1sticker 70:10stipulation 30:12stop 85:22story 89:23straight 11:12 30:14Strange 84:5Street 1:19strict 87:4structure 35:8student 5:12stuff 22:7 41:14 58:15subject 75:19submit 32:7 90:11submitted 80:18 88:3 90:7 97:19 98:8, 20 99:8sued 75:19suffered 18:2suggested 82:14 95:14
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Page 1 1
2 ALABAMA STATE BOARD OF PHARMACY 3
4
5
6
7
8 BUSINESS MEETING 9
10 Wednesday, July 15, 201511
12 9:20 a.m.13
14
15
16
17
18 LOCATION: Alabama State Board of Pharmacy19 111 Village Street20 Hoover, Alabama 3524221
22
23 REPORTER: Sheri G. Connelly, RPR
Page 2 1 ATTENDEES 2
3 BOARD MEMBERS: 4 Dan McConaghy, President 5 Tim Martin, Vice President 6 Buddy Bunch, Treasurer 7 David Darby, Member 8 Donna Yeatman, Member 9
10 ALSO PRESENT:11 Jim Ward, Attorney12 Susan Alverson, Ph.D., Executive Secretary13 Cristal Anderson, Director of Compliance14 Mark Delk, Inspector15 Todd Brooks, Inspector16 Scott Daniel, Inspector17 Richard Lambruschi, Inspector18 Jim Easter19 Cara Leos20 Jay McEniry21 Angie Harris22 Chris Burgess23 Ronda Lacey
Page 3 1 Derek Sapone 2 Chris Evans 3 Wayne Cornutt 4 Daniel Baker 5 Julie Hunter 6 Jeff Freese 7 Matthew Muscato 8 Bart Bamberg 9 Rick Stephens10 Becky Sorrell11 Louise Jones12 Sharon Hester13 Eddie Vanderver14 Carter English15 Bill Maguire16 Al Barber17 Getose Altine18
19
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Page 4 1 MR. MCCONAGHY: I'm going to call the 2 July 15, 2015, Alabama meeting of the State 3 Board of Pharmacy to order. Seeing that we have 4 a quorum present, I would like to ask for a 5 motion to adopt the agenda. 6 MR. DARBY: I make a motion we adopt 7 the agenda as presented. 8 MS. YEATMAN: Second. 9 MR. MCCONAGHY: All in favor?10 DR. MARTIN: Aye.11 MR. BUNCH: Aye.12 MR. DARBY: Aye.13 MS. YEATMAN: Aye.14 MR. MCCONAGHY: Approved. Now under15 our usual process, would y'all begin with Jim16 Easter or Todd, whoever is most front there, and17 introduce yourself and tell us who you are and18 where you're from.19 MR. EASTER: Jim Easter, Baptist20 Health System.21 MR. BROOKS: Todd Brooks, Board of22 Pharmacy.23 MS. LEOS: Cara Leos, ALSHP.
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Page 5 1 MR. MCENIRY: Jay McEniry, Patients 2 and Physicians for RX Access. 3 MS. HARRIS: Angie Harris, Solutions 4 RX. 5 MR. BURGESS: Chris Burgess, Heritage 6 Pharmacy. 7 MS. LACEY: Ronda Lacey, McWhorter 8 School of Pharmacy. 9 MR. SAPONE: Derek Sapone,10 Institutional Pharmacy Solutions.11 MR. EVANS: Chris Evans, fourth year12 pharmacy student.13 MR. CORNUTT: Wayne Cornutt, director14 of pharmacy, Gadsden Regional Medical Center.15 MR. BAKER: Daniel Baker, assistant16 director, Gadsden Regional.17 MS. HUNTER: Julie Hunter, Omnicare.18 MR. FREESE: Jeff Freese, Turenne19 PharMedCo.20 MR. MUSCATO: Matthew Muscato,21 Walgreens Pharmacies.22 MR. BAMBERG: Bart Bamberg, Publix23 Supermarket.
Page 6 1 MR. STEPHENS: Rick Stephens, Senior 2 Care Pharmacy. 3 MS. SORRELL: Becky Sorrell, Ritch's 4 Pharmacy. 5 MS. JONES: Louise Jones, Alabama 6 Pharmacy Association. 7 MS. HESTER: Sharon Hester, 8 Transdermal Therapeutics. 9 MR. VANDERVER: Eddie Vanderver, CAPS,10 Incorporated.11 MR. ENGLISH: Carter English,12 Department of Mental Health.13 MR. MAGUIRE: Bill Maguire, Omnicell.14 MR. BARBER: Al Barber, AlixaRx.15 MR. DELK: Mark Delk, State Board of16 Pharmacy.17 MR. DANIEL: Scott Daniel, Alabama18 State Board of Pharmacy.19 MR. MCCONAGHY: Okay. The next item20 on the agenda is presentations and number one on21 my list is Institutional Pharmacy Solutions.22 Are they here? Good morning.23 MR. SAPONE: Good morning.
Page 7 1 DR. MARTIN: Good morning. 2 MR. SAPONE: I don't have a formal 3 presentation, per se, including PowerPoint but 4 I'm here formally to ask the permission of the 5 Board to process orders remotely from my 6 pharmacy in Virginia Beach, Virginia, license 7 number 113800 and 201931, the mail order permit. 8 I've included current policy and procedure for 9 the call center operations, as well as the10 policy and procedure for the remote data entry11 piece at the pharmacy.12 The service that I'm asking to provide13 is three-fold. Number one, a telephone service.14 Actually, let me back up a little bit. I15 apologize.16 The two sites that I'm requesting that17 we assist within the same -- are owned by the18 same company. The first one is Mountain View19 Hospital in Gadsden, Alabama, and the second one20 is the Laurel Oaks Behavioral Health Center in21 Dothan, Alabama.22 The Mountain View Hospital currently23 has hours of Monday through Friday 8:00 a.m. to
Page 8 1 4:00 p.m. for a total of 40 hours. The Laurel 2 Oaks Behavioral Health Center is currently open 3 11:00 -- well, the pharmacy is open 11:00 a.m. 4 to 8:00 p.m., Monday, Wednesday, Thursday, and 5 Friday for roughly 36 hours. 6 What I'm requesting to do is after 7 those on-site hours at the local hospital 8 pharmacy is to provide telephone service, remote 9 order entry processing, and also emergency10 medication ordering and delivery after the scope11 of the normal on-site pharmacy hours.12 MR. WARD: I think there should be13 something in writing so you can look at it and14 approve it.15 DR. MARTIN: So some correspondence.16 MR. DARBY: Can you get us something17 in writing, you know, what you're specifically18 planning to do? Can you get that for us?19 MR. SAPONE: Did Mitzi not provide20 that?21 MR. DARBY: Tell me if I'm missing it22 but all I've got is just a letter -- a short23 letter asking to appear -- have you got it?
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Page 9 1 MS. YEATMAN: No, it's just a short 2 letter. 3 MR. WARD: You have to have policy and 4 procedures. 5 MR. DARBY: Yeah. I think Dan has got 6 more than I think what we -- 7 MR. SAPONE: I have extra copies. 8 MR. DARBY: Yeah, yeah, if you'd give 9 me a copy of that.10 MR. SAPONE: Okay.11 DR. ALVERSON: Excuse me, are you an12 institutional license or a retail license?13 MR. SAPONE: In the actual pharmacy in14 Virginia --15 DR. ALVERSON: Right.16 MR. SAPONE: -- or the one that we17 have registered with Alabama?18 DR. ALVERSON: Well, both.19 MR. SAPONE: Okay. The Virginia is20 retail. We're set up as retail in Virginia.21 The two that I have with Alabama, one I believe22 is 113800 I think is a retail pharmacy and then23 the other one is the mail order permit.
Page 10 1 DR. ALVERSON: Can we do remote on 2 retail? I'm just asking the question. 3 DR. MARTIN: Both the Laurel Oaks 4 Behavioral Center and the Mountain View 5 Hospital, are they institutional? 6 DR. ALVERSON: That's what I just 7 asked. 8 MR. SAPONE: That's the -- this is the 9 policy and procedure for the call center.10 DR. ALVERSON: I understand the need.11 I'm just wondering about issues with license12 types.13 MR. WARD: He's a retail pharmacist14 wants to do remote processing with an15 institution. Is that --16 DR. MARTIN: I guess there are two17 questions. Thank you. I'll let you hand those18 out and then we'll have some other questions for19 you.20 MR. SAPONE: Okay, got you.21 MR. WARD: What kind of permit do they22 have? What kind of permit do you have? You23 have a retail permit, don't you?
Page 11 1 MR. SAPONE: In Virginia we're set 2 up -- we're licensed as a retail pharmacy. 3 MR. WARD: How about -- how about 4 here? 5 MR. SAPONE: I believe it's retail and 6 then there's a second permit issued for mail 7 order permit. 8 DR. MARTIN: So -- 9 MR. SAPONE: If there's additional10 licensure I need to acquire here --11 DR. ALVERSON: Right. I just want to12 be sure we get it all straight so when we get --13 MR. SAPONE: Yeah, I didn't -- I14 wasn't sure.15 DR. ALVERSON: -- ready to do this, we16 do it right.17 MR. SAPONE: Right, right.18 DR. ALVERSON: I'm not arguing you19 need it.20 MR. SAPONE: What's that?21 DR. ALVERSON: I'm not arguing that22 you need it.23 MR. SAPONE: Oh, yeah, yeah, I can
Page 12 1 elaborate more into the need for it but -- 2 DR. ALVERSON: Right. 3 DR. MARTIN: Let's just take it one at 4 a time and be clear. So the Mountain View 5 Hospital in Gadsden, is it a -- does it have a 6 permit -- does it have a pharmacy permit as an 7 institutional pharmacy? 8 MR. SAPONE: Yes, they are set up -- I 9 believe they are set up as an institutional10 pharmacy.11 DR. MARTIN: Okay. On-site in-house12 institutional pharmacy Monday through Friday13 8:00 to 4:00?14 MR. SAPONE: Monday through Friday,15 yes, sir.16 DR. MARTIN: Okay. Laurel Oaks17 Behavioral Center in Dothan is set up as an18 institutional -- as a permit -- as an19 institutional pharmacy --20 MR. SAPONE: Institutional on site.21 DR. MARTIN: -- operating 11:00 a.m.22 to 8:00 p.m. Monday, Wednesday, Thursday, and23 Friday?
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Page 13 1 MR. SAPONE: Correct. 2 DR. MARTIN: So you've got two 3 institutional facilities in the State of 4 Alabama. Now, the location where the remote 5 processing is going to take place, tell us about 6 that site. 7 MR. SAPONE: Okay. We are a 8 closed-door institutional pharmacy. We have 9 facilities that we actually service as well in10 the Hampton Roads area in Virginia, so the11 pharmacist is in direct contact with the12 technicians, so it's a registered retail13 pharmacy with the Virginia Board of Pharmacy and14 the DEA as well.15 DR. MARTIN: So the permit you have16 with the Alabama Board of Pharmacy for the site17 in Virginia Beach is a retail permit or an18 institutional permit?19 MR. SAPONE: I believe it's retail.20 DR. MARTIN: Retail permit, okay. So21 this -- that's the -- so we've got a retail22 permitted facility in the State of Virginia23 seeking to perform remote order processing for
Page 14 1 two institutional facilities in the State of 2 Alabama. 3 MS. ANDERSON: Now, what was the 4 license number for the Laurel Oaks facility 5 again? 6 MR. SAPONE: I have no idea. 7 MS. ANDERSON: Don't have it. Is it 8 also known as Institutional Pharmacy Solutions? 9 MR. SAPONE: It is, yes.10 MS. ANDERSON: Okay.11 MR. SAPONE: Yes.12 MS. ANDERSON: I think I actually got13 a phone call earlier this week and the DEA is14 going to make them go from institutional to15 retail because they're privately owned. Does16 that sound right? Have you heard that?17 MR. SAPONE: It does sound right, yes.18 Yeah, I met with the DEA in March and we had19 quite a discussion because there's a conflict20 between Alabama law and the DEA law and the DEA21 says we have to do one thing. Alabama says we22 have to do another but we're going to obviously23 comply.
Page 15 1 MR. WARD: No, I don't know what 2 you're talking about. 3 MS. YEATMAN: What's the conflict 4 between Alabama and the DEA? 5 MR. SAPONE: The conflict to the best 6 of my understanding is that the DEA does not 7 recognize institutional -- they said we have to 8 be either set up with the DEA as a hospital -- 9 when I say we, I mean the Laurel Oaks, that10 Laurel Oaks has to be set up as either a11 hospital with the DEA or retail. They don't --12 there is no institutional class with the DEA.13 That's a state specific thing here in Alabama,14 so they said we either have to change to retail15 with the DEA or hospital. Those are the only16 two choices.17 DR. MARTIN: That's going to have some18 pretty significant indications for the way you19 do business and label products.20 DR. ALVERSON: Wouldn't that mean21 every hospital in the State of Alabama would22 have to become a retail license?23 DR. MARTIN: It means anything that's
Page 16 1 an institutional facility other than a hospital 2 would have to, yes. 3 MS. ANDERSON: Anything that's 4 privately owned? 5 DR. MARTIN: I don't know what the 6 ownership has to do with it. It's confusing. 7 MR. SAPONE: And from what I 8 understand, the -- being that IPS, Institutional 9 Pharmacy Solutions, doesn't own the hospital,10 that's why they said, you know, we can't11 register as a hospital because we do not own the12 hospital. We contract to the hospital to13 provide a service to them. So the pharmacy is14 not --15 MR. WARD: What's the name of the16 hospital?17 MR. SAPONE: I'm sorry?18 MR. WARD: What's the name of the19 hospital?20 MR. SAPONE: Laurel Oaks Behavioral21 Health Center.22 MR. WARD: And the other one?23 MR. SAPONE: Institutional Pharmacy
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Page 17 1 Solutions. 2 MR. WARD: No, the other hospital. 3 MS. YEATMAN: The other hospital. 4 MR. SAPONE: Oh, I'm sorry, Mountain 5 View Hospital. 6 MR. WARD: Yeah, who is that owned by? 7 MR. SAPONE: Mountain View, I guess. 8 MR. WARD: It's not owned by a company 9 that has other hospitals?10 MR. SAPONE: I'm not sure.11 DR. ALVERSON: Can I ask was it DEA in12 Virginia or DEA in Alabama?13 MR. SAPONE: You can ask and it was14 DEA in Virginia and the agent in Virginia had15 quite a discussion with the agent in Alabama and16 they disagreed on the law as well.17 DR. MARTIN: Of course.18 DR. ALVERSON: Welcome to our world.19 MR. SAPONE: Yeah, so the DEA agent in20 Alabama, the field agent here, said that's21 perfectly fine the way you're doing it but the22 DEA agent in Virginia where we are said no,23 that's not the way. So they went back and forth
Page 18 1 within the DEA to reach a resolution and basic 2 patient care has suffered in the meantime so we 3 are just going to comply with what they're 4 looking at right -- this, so. 5 DR. ALVERSON: Would you mind if we 6 spoke to DEA in Alabama? I don't want to mess 7 anything up for you. 8 MR. SAPONE: No. I mean, DEA in 9 Alabama said the way that it's set up now is10 fine, you can operate that way.11 DR. ALVERSON: Right.12 MR. SAPONE: I think the biggest13 problem was we don't own the hospital. The DEA14 told us you are not -- you don't own the15 hospital, you are not a hospital, you cannot16 have a hospital permit, you know. So that's17 what the DEA in Virginia -- at the Virginia18 field office told us.19 MR. DANIEL: So you guys have the same20 situation at the hospital in Eufaula?21 MR. SAPONE: Not --22 MR. DANIEL: But I mean, you don't own23 the hospital.
Page 19 1 MR. SAPONE: We don't own the 2 hospital. I'm not familiar with that site 3 because we don't do any call for that -- you 4 know, we're not requested to do any -- 5 MR. DANIEL: It's the same setup. 6 MR. SAPONE: Yeah. 7 MR. DANIEL: They came in and took 8 over pharmacy services directly with the 9 hospital.10 MR. SAPONE: Yeah, I've spoken briefly11 with Alan, the pharmacist there, and I know -- I12 just don't keep in touch with that department13 too often, so.14 DR. ALVERSON: I thought there were15 more and more instances where outside groups ran16 pharmacies and maybe that means they don't --17 they run them but they don't own them.18 MR. SAPONE: Correct, and that's the19 problem that we run into is that we run them,20 provide a service, but we do not own the21 hospital.22 MR. DARBY: But you own the pharmacy;23 right?
Page 20 1 MR. SAPONE: We own the pharmacy, yes, 2 sir. 3 DR. ALVERSON: That makes no sense 4 whatsoever. I'm sorry. 5 MR. SAPONE: And I agree too and we -- 6 you know, we're in Alexandria with DEA for six 7 hours discussing this and they weren't very open 8 to what the Alabama field office said. 9 DR. MARTIN: All right. So DEA in10 Virginia wants your closed-door operation in11 Virginia Beach to be a retail --12 MR. SAPONE: Well, we already are13 retail.14 DR. MARTIN: You already are retail.15 MR. SAPONE: I think they want Laurel16 Oaks to switch over to --17 DR. MARTIN: Well, how -- so the DEA18 in Virginia is telling Alabama how it all19 begins.20 MR. DARBY: But the DEA in Alabama21 disagrees with the DEA in Virginia.22 MR. SAPONE: The DEA in Virginia went23 to -- the local field officer there went to her
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Page 21 1 supervisor in DC and the three of them -- the DC 2 office, you know, the Richmond office in 3 Virginia, and down here. 4 DR. MARTIN: What is the -- I'm sorry, 5 this is real fundamental and maybe I should know 6 this, but what does the DEA care if you're 7 processing orders? That doesn't have anything 8 to do with moving product. 9 MR. SAPONE: In their eyes, it does.10 Their law -- the DEA is very specific and we11 talked about that for a while too. If we -- if12 I as a pharmacist enter an order in Virginia and13 authorize the release of a medication from a14 Pyxis machine, that's considered dispensing. So15 if I am going to dispense a controlled drug in16 another state, that's where they are allowed to17 step in.18 MS. ANDERSON: Do y'all do discharge19 orders?20 MR. SAPONE: No.21 MS. ANDERSON: No, okay.22 MR. SAPONE: Those are all handled23 outside.
Page 22 1 DR. MARTIN: I think there are two -- 2 two rubs we're going to have to get over and one 3 is the issue, potentially, of a retail pharmacy 4 performing order processing for an institutional 5 facility. That's new to us. We might get 6 there, we might not. And then the second thing 7 is this DEA stuff has got to get resolved 8 somehow. We've got to all get on the same page 9 and that's probably the harder of the two.10 MR. SAPONE: Yeah.11 MR. BUNCH: Did they give you any time12 line on that?13 MR. SAPONE: This has been since 201314 that we've been working with them.15 MR. MCCONAGHY: Tim, we do have some16 precedence about the retail and that and just in17 small rural hospital instance where you've got18 one pharmacy and one hospital in the19 community.20 DR. MARTIN: Yeah.21 MR. MCCONAGHY: And we have allowed22 that -- that retail pharmacy to process orders23 or review or verify basically the orders from
Page 23 1 the -- from that small hospital but it's a 2 really small scale. And the other thing with 3 hospitals that have been doing the remote 4 processing, we've been requiring them to give us 5 numbers -- 6 MR. SAPONE: Record data, yeah. 7 MR. MCCONAGHY: -- that how many your 8 pharmacists in Virginia are processing 9 currently --10 MR. SAPONE: Right.11 MR. MCCONAGHY: -- and how many this12 is going to add to it and that kind of thing.13 So we would -- to be fair to everybody else that14 has gotten one, we would need those numbers.15 MR. SAPONE: Yeah, absolutely, yeah,16 and we use -- obviously use Pyxis and all the17 orders come in through Pyxis Connect, the secure18 server, so it's very easy to tally numbers --19 number of orders that come in for a certain site20 by time, so that would be a relatively easy21 number to report monthly, weekly, however it's22 required.23 Our site in Virginia is for all
Page 24 1 purposes an institutional pharmacy. When 2 Mr. Mims set up the pharmacy and did the 3 registration, it was recommended, you know, 4 basically facilities that we service are -- you 5 know, locally in Virginia are long-term 6 residential so we do bill Medicaid for a lot of 7 those patients. So in order to do that, we had 8 to set our Virginia pharmacy up as retail in 9 order to bill Virginia Medicaid for those. We10 are an institutional pharmacy in Virginia but11 Virginia doesn't have an institutional class of12 licensure similar to the State of Alabama.13 DR. ALVERSON: Part of my concern14 would be that in an institutional setting, we're15 working with orders and we don't have to worry16 about refills. Nurses have certain privileges.17 Physician orders are treated very differently18 than a prescription. We're not looking at19 prescriptions as pieces of paper with certain20 documentation. I mean, it changes the whole21 perspective of what goes on in that building.22 MR. SAPONE: Yeah.23 DR. ALVERSON: Everything changes.
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Page 25 1 DR. MARTIN: Does the site, Virginia 2 Beach, perform remote processing for other 3 facilities outside of Alabama? 4 MR. SAPONE: Yes. 5 DR. MARTIN: Tell us about those. Are 6 they -- are they hospitals? 7 MR. SAPONE: They're all hospitals, 8 yes. 9 DR. MARTIN: So you're already10 processing orders from hospitals at sites11 outside of Alabama in this location?12 MR. SAPONE: Correct. Basically we13 are for all intents and purposes an14 institutional pharmacy. The only orders that we15 see are hospital orders. We do not see any16 prescriptions like a retail prescription, you17 know, like you drop off at CVS or Walgreens.18 All of the prescriptions that we see are actual19 physician orders. I'll add that for our sites20 in Virginia, there were -- the DEA said there21 were some things that we had to add to those22 physician orders to become compliant with DEA23 laws and regulations like the quantity, you
Page 26 1 know, for sites that we, you know, actually 2 provide the medications for physicians at my 3 sites in the Hampton Roads area, they have to 4 put a quantity on there. The doctors have to 5 put their DEA number, all the laws that 6 regularly apply to a retail prescription, and 7 that's something the DEA said that we have to do 8 because we're set up as a retail pharmacy. 9 It's a little confusing but you know,10 it's -- but what I'm asking to do here is, you11 know, just remote data entry and all the orders12 that, you know, that we type to allow the nurses13 to, you know, go on a profile mode after hours14 and on the weekends are, you know, obviously15 typed by a pharmacist. They also leave them in16 the queue. They are reviewed by the on-site17 pharmacist as soon as they open up in the18 morning, so everything that, you know, we enter19 from our site in Virginia does get reviewed, you20 know, as soon as the on-site pharmacist is back21 on site.22 DR. MARTIN: How many others -- how23 many other institutional sites are you serving
Page 27 1 out of the Virginia Beach location from a remote 2 processing standpoint? 3 MR. SAPONE: Thirty -- about 30. 4 DR. MARTIN: Thirty other hospitals 5 being serviced out of that site already doing 6 remote processing? 7 MR. SAPONE: Correct. 8 DR. ALVERSON: Do you own any of 9 those?10 MR. SAPONE: No, Institutional11 Pharmacy Solutions owns -- we own all the --12 yeah, the company owns all the pharmacies,13 yeah.14 DR. ALVERSON: So you're changing this15 in every state?16 MR. SAPONE: Some of the states don't17 require it -- us to change our permits and18 things like that. One of the things that -- a19 decision that was made, you know, we won't20 process any controlled drug orders, you know,21 because the DEA said that you could not, you22 know, as a retail pharmacy in Virginia, you23 can't authorize the release of a controlled
Page 28 1 medication for a resident in another state. 2 DR. MARTIN: But that may not be a 3 problem because you're probably going to allow 4 those to be overridden in the facility and then 5 the pharmacist coming in in the morning is going 6 to process the order. 7 MR. SAPONE: Right, correct, yeah, 8 exactly. But yes, we are changing it in a lot 9 of the states. I was in Arkansas yesterday and10 requested the same thing because they do11 require -- it's a similar situation there with12 the sites being similar.13 MR. MCCONAGHY: I do know, I mean,14 we're going to have to have those numbers up15 front --16 MR. SAPONE: Oh, okay, absolutely.17 MR. MCCONAGHY: -- showing what you're18 doing now so that our issue in the past has been19 that if you were going to add a quantity of20 orders on to your current staff that was going21 to push them to the point where they could22 potentially be making mistakes and you didn't23 have enough staff in there, then you would need
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Page 29 1 to provide some explanation of why you add the 2 staff. 3 MR. SAPONE: Absolutely. 4 MR. DARBY: How many pharmacists do 5 you have on staff? 6 MR. SAPONE: On staff. 7 DR. MARTIN: At Virginia Beach. 8 MR. DARBY: At Virginia Beach. 9 MR. SAPONE: At Virginia, nine10 including myself.11 MR. DARBY: And how many technicians?12 MR. SAPONE: Twelve.13 MR. WARD: What hours will this be14 going on?15 MR. SAPONE: The pharmacy in Virginia16 is open 24 hours.17 MR. WARD: When will you be doing the18 remote processing for these folks?19 MR. SAPONE: Outside the normal20 hours.21 MR. MCCONAGHY: How many are working22 now?23 MR. SAPONE: How many are working --
Page 30 1 how many pharmacists? 2 MR. WARD: The outside hours doing the 3 remote processing, what's the staffing? 4 MR. SAPONE: Minimum -- currently 5 minimum two pharmacists at all times and four 6 techs. 7 MS. YEATMAN: What's the tech ratio in 8 Virginia? 9 MR. SAPONE: Three to one. They'll10 grant an exception of four to one but we don't11 have that. Three to one is what we use.12 MS. YEATMAN: Is there a stipulation13 on the three?14 MR. SAPONE: No, it's just a straight15 three to one, I believe, and then they'll allow16 four to one but you have to have special17 permission from the Board.18 MS. YEATMAN: So you don't have to19 have one nationally certified in your ratio?20 MR. SAPONE: Oh, yeah, they -- if you21 have three to one, one has to be nationally22 certified and obviously Virginia certifies their23 technicians, so the other two have to be state
Page 31 1 certified. 2 In reference to the numbers, do you 3 want the total that we're currently processing, 4 the after hours and then what -- 5 MR. MCCONAGHY: What you'd be adding. 6 MR. SAPONE: What we assume or could 7 guess that Alabama would add to that. 8 DR. MARTIN: The standard spreadsheet, 9 just fill in.10 MR. SAPONE: Okay. I'll work on11 getting that.12 MR. DARBY: Do you want to wait to get13 the numbers?14 MR. MCCONAGHY: Yeah, I think we need15 to wait and get the numbers and get some16 clarification because quite frankly, the DEA17 doesn't care what we do. They're going to make18 their decision independent of what ours is.19 MR. SAPONE: Right, absolutely.20 MR. MCCONAGHY: So we need to see what21 they're going to tell you the final product is22 and have those numbers in hand before we can23 approve it.
Page 32 1 MR. SAPONE: So the volume we process 2 now, what adding Alabama -- 3 MR. DARBY: What you project, yeah. 4 MR. SAPONE: What Alabama would add to 5 that. 6 MR. DARBY: Yeah. 7 MR. SAPONE: And just submit that? 8 DR. MARTIN: Yeah, Susan, can you ask 9 Shirley to send him the template those numbers10 go in?11 MR. MCCONAGHY: It will include your12 personnel too, you know, like if you've got --13 how many people are processing how many14 orders.15 MR. SAPONE: Absolutely. Thank you16 very much. Appreciate your time.17 MR. MCCONAGHY: Okay. Gadsden18 Regional Medical Center.19 MR. DARBY: Go ahead.20 DR. MARTIN: Good morning.21 MR. CORNUTT: Thank you. I just want22 to thank the Board for allowing us to bring this23 issue to you this morning. I think we're a
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Page 33 1 little short on time so do you have a copy of 2 the policy and the request? 3 MR. DARBY: Request. 4 MR. CORNUTT: Request letter that I 5 sent, just make sure you got it. 6 MR. DARBY: Yeah, we do. 7 MR. CORNUTT: Okay, all right. 8 Gadsden Regional Medical Center is a community 9 hospital in Gadsden, Alabama. We're licensed10 for 346 beds. We have 12 pharmacists and 1111 technicians, so that's the status of the12 hospital.13 What we're bringing for you today is a14 request that the Board allow an Alabama licensed15 pharmacist to provide at-home order entry review16 for Gadsden Regional Medical Center as a full17 employee of Gadsden Regional Medical Center.18 The background that brings us to this19 request is I have a current pharmacist on staff20 at Gadsden who her husband has been assigned21 with his work to Lake Charles, Louisiana, so22 they will be moving. She's already turned in23 her notice and she's unable to find a hospital
Page 34 1 position in that area and she wants to remain 2 working in the institutional hospital 3 environment. 4 So she's been -- she's been employed 5 with us for about five years and so our goal is 6 as a hospital to keep Lindsey Arrington, who is 7 licensed in Alabama already, on as an employee 8 of the hospital, to have her -- to move her into 9 a part-time position that we have available10 that's open and then rehire her full-time11 position as soon as possible.12 We feel that with today's technology13 in the hospital and the electronic medical14 record and the situation at Gadsden -- we've15 been on a full electronic health record for16 about a year now. Eighty-three percent of our17 physician orders are -- are electronic orders18 that come into the system. The pharmacist's19 position at that is to review the order to20 verify it, to do all the checks that's required21 by the Board and for patient safety and then to22 verify those which releases the medicine either23 to be dispensed from the pharmacy or coming out
Page 35 1 of the Pyxis devices at the hospital. 2 All the connections that the 3 pharmacist would use in an off-site at-home 4 situation are secure VPNs. They are 5 specifically the same access points that our 6 physicians are using to do their off-site orders 7 and they are secure VPNs provided by our 8 corporate structure, Community Health Systems 9 out of Nashville, and we feel that we can10 provide the same service from an off-site11 location as you can sitting at a computer in12 the -- inside the hospital because you're13 essentially looking at the same information.14 The pharmacist at an off-site location15 would have full access to the medical record,16 the dictations from any physicians. They can17 see all the labs. Everything that the physician18 is seeing to make the determination of what to19 order, the pharmacist can see in order to20 approve and verify the order in that situation.21 So we have a proposal before you and I22 can go through the process controlleds if you23 would like for me to go through those with you
Page 36 1 and a policy that we started with to try to help 2 the situation. Our intent is not to replace 3 pharmacists at the hospital. I've got a good 4 employee, who's an excellent clinician and has a 5 good rapport with the medical staff that I 6 really just don't want to lose and she could 7 provide some help for us in busy times to 8 provide some order entry situations. 9 So if you'd like to go to the process10 controls, I'll be glad to do that and then open11 for questions or whatever you'd like for me to12 do.13 DR. MARTIN: I think we can just ask a14 few questions.15 MR. DARBY: Yeah.16 DR. MARTIN: Let's just ask a few17 questions --18 MR. CORNUTT: Okay.19 DR. MARTIN: -- and we might20 eventually, you know, go to that.21 MR. CORNUTT: All right.22 DR. MARTIN: So would Ms. Arrington be23 processing orders in a work-balancing type mode
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Page 37 1 or an after-hours type mode? 2 MR. CORNUTT: It's more of a work 3 balancing. I see her position -- mainly to use 4 her would be in the middle of the day when the 5 bulk of the orders are being processed. There's 6 two things that will happen from that. She can 7 either provide some clinical services, you know, 8 direct patient care review, calling doctors 9 looking for utilization review, and also the way10 the electronic record works in Gadsden, the11 physician and providers enter their orders.12 They come into an order queue. It gets backed13 up in an order queue.14 DR. MARTIN: Right.15 MR. CORNUTT: And pharmacists are16 going through that queue looking at stat orders17 first, you know, and verifying those and18 processing them and then get to the routine19 orders and do those, so.20 DR. MARTIN: Right.21 MR. CORNUTT: So she can be two-fold.22 She can be in the queue at the same time23 pharmacists are and that's no different than we
Page 38 1 are in the department. You can't get on top of 2 another pharmacist. It locks you out or you 3 have to break through a lock to get into the 4 same patient, so all the processes are in place 5 for hospitals. So initially we intend to 6 position her in the middle of the day at our 7 peak order times and work a part-time status 8 would be about -- somewhere around 60 hours in a 9 two-week period and there's a method in the10 hospital for her to actually clock in11 electronically and clock out electronically so12 we'd know the hours that she is working.13 DR. MARTIN: So let me see if I can14 repeat back to you what I think I heard you say.15 MR. CORNUTT: Okay. Thank you.16 DR. MARTIN: You have a system in the17 hospital where 83 percent of the time the18 physicians are entering the orders themselves.19 You have the option for those orders to --20 you've chosen not to but you have the option for21 those orders to just become live and acted on.22 MR. CORNUTT: Yes.23 DR. MARTIN: But you've chosen to
Page 39 1 inject a pharmacist in the process -- 2 MR. CORNUTT: Yes. 3 DR. MARTIN: -- to do a quality review 4 of those orders. 5 MR. CORNUTT: Yes, sir. 6 DR. MARTIN: So that pharmacist is 7 really performing, at least on the minor orders, 8 a verification. 9 MR. CORNUTT: Yes.10 DR. MARTIN: And if adjustments need11 to be made, they're adjusting orders then.12 MR. CORNUTT: Yeah, and the pharmacist13 would work under medical staff protocols and14 rules and regulations, you know, for formulary15 issues and for anything to make a call to the16 physician, she would have full access to the17 on-call list, the physician list, to make the18 calls. She's known by the medical staff now,19 so.20 MR. DARBY: You don't have a21 license -- you're not in a licensed facility.22 MS. YEATMAN: Yeah.23 MR. WARD: That's the biggest issue.
Page 40 1 MR. MCCONAGHY: I know you've got a 2 comment and I want to hear it. 3 MS. YEATMAN: Well, I do and I don't 4 mean this to sound the way that it's going to 5 sound but it sounds like you're coming before 6 the Board to make a position for an employee you 7 don't want to lose and it's a bigger picture for 8 me personally because we don't do this for 9 anybody else right now and I'm sure she's a10 fantastic pharmacist but you know, I guess my11 question would be if she weren't leaving, would12 you have even come before the Board asking for13 this and this would dramatically change how14 we're practicing or what we're allowing from the15 practice of pharmacy.16 MR. CORNUTT: Right. In coming before17 you and reading the rules as they exist now,18 there's no rule that addresses the institutional19 pharmacy specifically for off-site order entry20 and looking at the rule for remote-order entry,21 there is one that says not from home.22 MR. WARD: That's being a pharmacist.23 I mean, some things --
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Page 41 1 MR. DARBY: The supervising 2 pharmacist -- 3 MR. WARD: Yeah, I mean, it's got to 4 be in the pharmacy. I mean, not every -- I 5 mean, there's not a law that says you can't beat 6 up somebody. I mean, some of it is just common 7 sense. It's got to be in the pharmacy. 8 MR. CORNUTT: So the question that 9 really we're asking was the -- with the CPOE,10 the physician can put in an order from a11 bathroom on an iPad on a secure connection that12 comes to our pharmacy that we then verify, of13 course, is it the right drug, right patient, all14 of that stuff. So the question herein lies with15 technology where it lies, it's not -- the16 practice of medicine and the practice of17 pharmacy is kind stepping outside of walls so --18 and that's why we're asking is everything that19 can be seen on site, and I'm in front of a20 computer in my office, I can see on a laptop21 from home, absolutely everything that I can see.22 Now, part of that is we're not23 actually replacing -- pulling someone out of a
Page 42 1 hospital to put into a home to order -- you 2 know, to take care of patients. We're actually 3 adding to the staff. She's just filling an open 4 part-time position. We're going to fill her 5 void as an on-site person. So at the end of the 6 day, this is only in addition to what we're 7 already providing. 8 MR. WARD: You're asking this Board to 9 do something that's never done before to help10 you out because you want to help this lady,11 which is great, but it's a bigger question than12 that.13 MR. CORNUTT: And we think the14 technology --15 MR. WARD: I know but -- I know but we16 just can't look at it for your -- because you17 want to try to help this lady.18 MR. CORNUTT: Sure.19 MR. WARD: And then next week we get20 someone from CVS who wants to do it from their21 home and pretty soon -- so it's a lot bigger22 question than that. I agree, it's not what you23 want to do is wrong. It's just that we have to
Page 43 1 look at it -- 2 MR. CORNUTT: Right. 3 MR. WARD: -- in a lot broader scope. 4 MR. CORNUTT: And I understand this 5 is -- this is -- our question was we're looking 6 at maybe reviewing the process because as 7 technology has advanced, that's what we need to 8 be looking at because that's what -- we won't be 9 the first person who's looking to do this10 because the technology allows and previously it11 wouldn't. Previously you couldn't do it but now12 the technology allows us, so there will be more13 and more questions of people asking the same14 question, can you process an order for a Tylenol15 at home the same way you can verify it inside of16 a hospital.17 MS. YEATMAN: So let me ask you this:18 She's going to be at home verifying and you have19 no control over monitoring how she's verifying20 and I'm playing devil's advocate.21 MR. CORNUTT: Sure. That's fine.22 MS. YEATMAN: If I'm in my house with23 my four kids running around, you do not want me
Page 44 1 verifying prescriptions. How do you control the 2 environment to insure -- I mean, that's the 3 reason we've always said it had to be in a 4 pharmacy. 5 MR. CORNUTT: Right. 6 MS. YEATMAN: It has to be in a 7 controlled environment to make sure that we are 8 doing everything we can to maintain public 9 health and decrease errors and all of that.10 MR. CORNUTT: Sure.11 MS. YEATMAN: So that -- that's my12 concern --13 MR. CORNUTT: Right.14 MS. YEATMAN: -- anytime it's ever15 come up and you know, this would be just the16 beginning of the snowball that will become an17 avalanche because I guarantee you that there are18 lots of other -- to your point, lots of others19 that are looking at this and that's my concern,20 how do we control that environment.21 MR. DARBY: There was a group last22 year I think from Illinois that we did not23 approve and they actually had the capability of
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Page 45 1 having a separate, dedicated office in their 2 house with a camera system and all of that. We 3 didn't approve them and I don't think you're 4 proposing anything like that, are you -- 5 MR. CORNUTT: No, no. 6 MR. DARBY: -- that she would actually 7 have a separate office -- lockable, accessible 8 only to her with a camera system you can verify 9 that she was in there.10 MS. YEATMAN: And how do you know the11 patient information is secure?12 MR. CORNUTT: The patient information13 is secure because of the VPN that you're on.14 MS. YEATMAN: No, I'm saying in her --15 in her house.16 MR. DARBY: Yeah.17 MS. YEATMAN: If it's up on her laptop18 in her house, who else has access there.19 MR. DARBY: Who else is -- who else is20 in there looking at it.21 MR. CORNUTT: I mean, we would have to22 depend on the professional, say just like you do23 inside the hospital.
Page 46 1 MS. YEATMAN: Yeah. 2 MR. BAKER: Inside the hospital, 3 everybody personally is held for HIPAA 4 compliance. 5 MR. DARBY: Yeah, but you've got 6 physical boundaries inside that hospital that -- 7 MS. YEATMAN: And you have 8 professionals working in the hospital. You 9 don't have --10 MR. CORNUTT: Right.11 MS. YEATMAN: Again, a noncontrolled12 environment.13 MR. BUNCH: I think your point, the14 technology is there. I'm just not sure the law15 and everything else that goes with it is there.16 MR. CORNUTT: And we knew that coming17 in.18 MR. BAKER: And that's why we're19 wanting to get --20 MR. CORNUTT: Insights.21 MR. BAKER: -- to bring the issue22 before you because I think there is going to be23 more issues like this that are -- may need to be
Page 47 1 looked at from the standpoint of what may be the 2 future but in our situation, I can -- I can 3 utilize somebody to help our patient care 4 situation. We feel we can do it safely with the 5 technology and not -- and put us in a position 6 to -- you know, to better serve the patients 7 also to the hospital for what we've got now, so, 8 and it's a request. We knew that it's on the 9 edge of what --10 MS. YEATMAN: I mean, believe me, I11 think the idea, I can appreciate. I'm just not12 sure how we implement it in such a way that we13 can guarantee that we're upholding all the14 pieces of the law.15 MR. CORNUTT: Sure, sure.16 MR. MCCONAGHY: And we know the17 technology is out there and like your example18 for the doctor, you know, he may do his best19 thinking in the bathroom.20 MR. BAKER: Just the first example21 that came to my head, not a special example.22 MR. MCCONAGHY: But in my opinion,23 that's not the most professional place that you
Page 48 1 should be writing orders for your patients. 2 MR. CORNUTT: That's true. 3 MR. MCCONAGHY: And what you should be 4 accessing at the time you're writing them but 5 from a regulatory point of view, this Board's -- 6 for our inspectors, what they would be tasked 7 with is trying to make sure that she at her site 8 was approved and doing what she's supposed to 9 do.10 MR. CORNUTT: Sure.11 MR. MCCONAGHY: And then that would be12 impossible to do on a widespread basis.13 MS. YEATMAN: Yeah, I think what14 you're asking for would require us to make15 adjustments to the current rules and regulations16 that are in place. That's not certainly17 something we could do for you today.18 MR. WARD: Let's pretend. Is she19 licensed -- is she going to be licensed where20 she's going?21 MR. CORNUTT: She's attempting to get22 a Louisiana license now and -- she'll have it23 when it when she gets involved in the area.
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Page 49 1 MR. BAKER: She'll have -- she'll 2 have -- she's planning on getting -- she has an 3 Alabama now. She'll be planning on getting a 4 Louisiana as well. 5 MR. CORNUTT: She's going through the 6 process. 7 MR. WARD: And does Louisiana allow 8 practicing pharmacy from someone's house? 9 MR. CORNUTT: I mean, she's -- she10 won't be providing services for Louisiana11 pharmacies so I --12 MR. WARD: She'll be practicing --13 well, if she's in Louisiana, she'll have a14 license there, won't she?15 MR. CORNUTT: Well, yeah, I guess --16 MR. WARD: Under that theory, she17 doesn't need a license because she's not going18 to be treating -- so she's going to get a19 license so I mean, I'm not even sure the state20 that she wants to go to is going to allow it.21 MR. CORNUTT: Right.22 MR. MCCONAGHY: Anybody want to make a23 motion?
Page 50 1 MS. YEATMAN: David is the only one 2 that knows how to do one. 3 MR. DARBY: I don't want to make a 4 motion. I don't want to do it. 5 MR. WARD: Yeah, let's not have a 6 negative. Just say, thank you. 7 MR. DARBY: Yeah, all right. 8 MR. CORNUTT: Thank you. 9 MR. BUNCH: We will take it under10 advisement.11 MR. MCCONAGHY: Thank you for your12 presentation.13 MR. CORNUTT: Thank you.14 MR. BAKER: Thank you.15 MR. MCCONAGHY: Were there any other16 presentations that I might be missing on my17 agenda?18 (No response.)19 MR. MCCONAGHY: All right. Buddy is20 up.21 MR. WARD: Treasurer's report, all22 right. Again, nothing much has changed since23 last month. We -- we are on income above our
Page 51 1 budgeted amount for the year. We do have -- we 2 will have an expense of -- a large expense 3 coming up before I think too awfully long in 4 cars, I think close to 90,000 or so, and the 5 money is in the budget for the vehicles. 6 Everyone get a copy of the report? 7 MR. DARBY: Yeah. 8 MR. BUNCH: Any questions? I think 9 this pretty much -- nothing has changed. I'm10 lucky to be the treasurer this year when money11 is here. David gets it next year when we pay12 out, so have you got any questions?13 (No response.)14 MR. BUNCH: That is the treasurer's15 report.16 MR. MCCONAGHY: Thank you, Buddy.17 Who's going to do the Wellness Committee report?18 MR. DARBY: Do we need to accept that19 report?20 MR. MCCONAGHY: Do we, yeah.21 MR. DARBY: I make a motion that we22 accept the treasurer's report.23 MS. YEATMAN: Second.
Page 52 1 MR. MCCONAGHY: All in favor? 2 DR. MARTIN: Aye. 3 MR. DARBY: Aye. 4 MS. YEATMAN: Aye. 5 MR. BUNCH: Aye. 6 MR. MCCONAGHY: The Wellness Committee 7 report. 8 DR. ALVERSON: I've got that from 9 Dr. Garver.10 MR. MCCONAGHY: Are you Dr. Garver?11 DR. ALVERSON: I am. I'd be glad to12 tell you about my mother.13 We have one pharmacist in inpatient,14 one pharmacist going for evaluation. It was15 interrupted because of some surgery, and one16 tech in treatment, one pharmacist trying to make17 a decision whether or not to continue with18 pharmacy as a career. That license is not19 presently active.20 We have had 22 people identified in21 2015. That does not include holdovers from the22 previous year. There are 84 people in facility-23 driven aftercare.
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Page 53 1 Dr. Garver would like to mention that 2 he met with investigators at the meeting last 3 month, which I think -- or before the meeting 4 last month, which I think he reported that he 5 meets with all licensees who are returning to 6 work and gets signed contracts and thanks you 7 for allowing him to serve in the position he's 8 in. That's his report. 9 MR. MCCONAGHY: Do y'all want to make10 a motion to accept that report?11 MS. YEATMAN: I make a motion to12 accept Dr. Garver's Wellness report.13 MR. BUNCH: Second.14 MR. MCCONAGHY: All in favor?15 DR. MARTIN: Aye.16 MR. BUNCH: Aye.17 MS. YEATMAN: Aye.18 MR. DARBY: Aye.19 MR. MCCONAGHY: Opposed?20 (No response.)21 MR. MCCONAGHY: Okay. David, you're22 the professional board minutes reader here.23 MR. DARBY: I make a motion we approve
Page 54 1 the June 17, 2015, board business minutes. 2 MS. YEATMAN: Second. 3 MR. MCCONAGHY: All in favor? 4 DR. MARTIN: Aye. 5 MS. YEATMAN: Aye. 6 MR. BUNCH: Aye. 7 MR. DARBY: I also make a motion we 8 approve the June 17, 2015, interview minutes. 9 MS. YEATMAN: Second.10 MR. MCCONAGHY: All in favor?11 DR. MARTIN: Aye.12 MR. DARBY: Aye.13 MS. YEATMAN: Aye.14 MR. BUNCH: Aye.15 MR. MCCONAGHY: The inspector's16 report.17 DR. ALVERSON: Mr. Braden took some18 vacation time and then went to a training19 session in Seattle. He'll be back in the office20 tomorrow and so I've asked Todd Brooks to give21 his report. Todd if you would, please.22 MR. BROOKS: We completed 7323 inspections in June, one nonsterile, one
Page 55 1 sterile; received 15 complaints, completed nine. 2 Since January -- from January to June 2015, 94 3 complaints have been received and 13 of those 4 being diversion, medication error being 12, and 5 47 being PDMP, pricing, other -- in another 6 category and we had inspectors attend an APA 7 conference. 8 Inspectors attended FDA training in 9 Nashville and an inspector attended FBI National10 Academy training in Orange Beach and several11 inspectors assisted the DEA on four pharmacies12 in the Birmingham metro area and we had one13 inspector assist FDA on an inspection in14 Florence, Alabama.15 MS. YEATMAN: I make a motion we16 accept the inspector's report.17 MR. DARBY: Second.18 MR. MCCONAGHY: All in favor?19 DR. MARTIN: Aye.20 MR. BUNCH: Aye.21 MR. DARBY: Aye.22 MS. YEATMAN: Aye.23 MR. MCCONAGHY: Susan, secretary's
Page 56 1 report, you've got two minutes. 2 DR. ALVERSON: Two minutes, wow. 3 Well, my report is not pulling up in my 4 computer, thank you very much. 5 MR. DARBY: Do you want mine? 6 DR. ALVERSON: I think I remember. 7 You can tell me if I've missed something. 8 First I'd like you to know that 9 Shirley Feagin, who is the woman that you meet10 when you first come into the building, has11 decided in favor of her fiance over us and so12 she's going to be moving to Richmond, Virginia,13 and based on her experience here, she was able14 to interview for a job and got it immediately.15 So we were glad we assisted her in that way.16 We're going to begin looking for someone to17 replace her immediately and we will miss her.18 I have given you a guidance draft from19 the FDA about what the FDA is expecting on20 wholesale licenses. As I've mentioned before,21 we have to separate wholesale from repackager,22 yada, yada, yada. This is the only one that I23 can I find that they've actually published
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Page 57 1 something and so I would like to know from the 2 Board would you like our office to begin a draft 3 of items that need to be in that license for you 4 to look at, so at least it would be a starting 5 point for you. 6 MR. WARD: Well, you need to get the 7 law changed first. 8 MR. DARBY: Yeah, this is going to 9 take a law change, isn't it?10 DR. ALVERSON: Yes, but we're going to11 have to be able to tell them --12 MR. WARD: No, we're just going to13 have -- it's going to be one line -- do it by14 rule. Otherwise, you have to go to legislature15 every time something changed. You just have to16 have a new category. I thought we talked about17 this last time -- a new category.18 DR. ALVERSON: We did but we have to19 have specific requirements in there.20 MR. WARD: By rule. You do it by21 rule.22 DR. ALVERSON: Would you like us to23 begin writing some of those things which will
Page 58 1 have to be in the rules is my -- 2 MR. DARBY: Yeah -- 3 MR. MCCONAGHY: Yes. 4 MR. DARBY: -- in the rule but we also 5 need to get it -- the legislation drafted so we 6 can get that approved pretty quickly. 7 MR. WARD: We couldn't get it in the 8 special call of the legislature or something. 9 MR. DARBY: Would it be a prudent10 thing to do to go ahead and put the language in11 there to add other types of licenses that we12 might want to add in the future?13 MR. WARD: Yeah, I mean, that's what14 we talked about before, like the methadone15 stuff, yeah.16 MR. DARBY: Just a good time to redo17 it and so why don't we begin working on that.18 DR. ALVERSON: So my question is:19 Would you like us to begin creating a draft you20 can accept, get rid of, whatever?21 MR. DARBY: I would like for you to22 begin creating a draft to change the legislation23 and in addition to that, begin creating the
Page 59 1 rules that you would want to use once the 2 legislation got changed. 3 DR. ALVERSON: All right. The next 4 item is the Governor's office has proposed a new 5 office or commission to deal with potential 6 antitrust issues because of the Supreme Court 7 decision based on the North Carolina dental 8 board case, it seems that the Governor's office 9 is nervous about something similar happening in10 Alabama.11 They've proposed an office that would12 have three lawyers, two paralegals, and13 everything that goes along with an office, which14 is going to cost $1.2 million or that's the15 proposed budget and any legislation or rule16 proposed by any licensing agency would have to17 go through this group to be sure that it's18 written in the interest of the public and not in19 the interest of financial security for the Board20 members.21 Right now that group of committees or22 that group of agencies are meeting to discuss23 how to fund that because we've been told we will
Page 60 1 have to pay that $1.2 million. So at first -- 2 DR. MARTIN: We being all the 3 regulatory boards. 4 DR. ALVERSON: All regulatory 5 agencies, all right. The first thought was 6 divided by the number of agencies but there are 7 some agencies that only license 18 people, I 8 believe, so there's no way they can uphold their 9 portion of it. Then it was proposed that10 their -- take the 1.2 million divided by the11 number of people licensed by all those agencies12 put together and whatever that number is, tack13 that on to every license.14 The Nursing Board licensed 90,00015 people, so that means the Nursing Board would be16 funding one-third of this 1.2 million, so17 they're not pleased with that proposal. They18 proposed a sliding scale so if you license from19 one to 1,000, you pay a flat fee. If you20 licensed -- when we worked it out the other day,21 that turns out -- just the way we fall into that22 is that we'd be paying four dollars per23 licensee. The Nursing Board would be paying one
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Page 61 1 dollar per licensee. 2 So there was -- it didn't appear to be 3 fair on how it worked out. There's a meeting in 4 Montgomery at nine o'clock Monday morning that 5 we will be attending but I'd be interested in 6 any proposals that you have. 7 MR. WARD: Where is the meeting going 8 to be? 9 DR. ALVERSON: I can't tell you which10 building it's in. I know it's Montgomery at11 9:00.12 DR. MARTIN: Previously the meeting13 was at the --14 MS. ANDERSON: Real estate.15 DR. MARTIN: -- Alabama Association of16 Homebuilders, I think. It's right beside --17 right beside APA.18 DR. ALVERSON: Cristal has -- Cristal19 and Scott attended one.20 MR. WARD: Can you copy me with it? I21 want to start being copied on it.22 MS. ANDERSON: Yeah.23 MR. WARD: Because I'm going to go and
Page 62 1 put my two cents in. 2 MS. ANDERSON: I'm not sure if they're 3 going to hold it at the same place but I want to 4 stay it was like the -- the Real Estate 5 Commission office that we met in down there last 6 week. 7 MR. WARD: Will you send me those? 8 MS. ANDERSON: Do you want a copy on 9 all of those emails I'm getting?10 MR. WARD: Yeah.11 MR. DARBY: On the bill that's being12 introduced in the special session on this,13 because under the executive order, it's14 voluntary. We can opt in or out; correct?15 DR. MARTIN: That's my16 understanding.17 MR. DARBY: But under the bill, would18 we be able to opt in or out because what you're19 doing if you -- if you go into this group,20 you're putting yourself under the supervision of21 another board.22 MR. WARD: Plus can you imagine the23 delay?
Page 63 1 MR. DARBY: Yeah. 2 MR. WARD: I mean, I think we really 3 need to help with this. 4 DR. MARTIN: Also a good point was 5 made, I forgot who made this that I was talking 6 to earlier, that we have insurance for this 7 purpose already. 8 DR. ALVERSON: My concern is that -- 9 that this passed, that it becomes mandatory in10 Alabama, we're going to have to go through this11 group whether we like it or not and we've had no12 say-so in how we are going to fund our part. I13 just don't want to end up on the short end.14 MR. DARBY: And we -- I think we paid15 our money to be a part of this -- this group,16 didn't we?17 DR. ALVERSON: There's an organization18 that meets all the time --19 MR. DARBY: Right.20 DR. ALVERSON: -- that's not -- that21 didn't form because of this issue.22 MR. DARBY: Yeah.23 DR. ALVERSON: It's just a group of
Page 64 1 boards that gets together and talks about common 2 problems and -- 3 MR. DARBY: I think we continue to 4 have our input on how the fees are done but I do 5 not think we should commit to be in agreement 6 with the bill or being a part of the executive 7 order -- 8 DR. ALVERSON: All right. 9 MR. DARBY: -- until we know more10 about it.11 MR. WARD: Well, you know, this all --12 it all -- this all starts with what this case13 was about -- the North Carolina case was about14 and it's a group of a profession trying to limit15 who can practice what they practice. That's16 what it was about and so those are scope issues17 and those usually appear more with medicine and18 physical therapy, so I'm having a hard time19 understanding what all this stampede is about.20 It's antitrust. That's what it's about. It's21 about limiting competition so they will start a22 one-million-dollar deal and you have to send23 everything down there to make sure you aren't
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Page 65 1 violating antitrust when that's rarely even 2 factor. 3 MR. MCCONAGHY: And we're going to 4 send it to three lawyers. 5 MR. WARD: Yeah, right, I mean. 6 MR. BUNCH: Susan, do you -- 7 MR. WARD: Plus Tim makes a good 8 point, you have -- the State has insurance. 9 DR. MARTIN: Well, the State's10 insurance won't cover us but if we have separate11 insurance, it will.12 MR. WARD: Yeah, they will. How much13 do they pay?14 DR. MARTIN: Well, according to the15 FDC, if a board that's regulating is made up of16 more than a majority of --17 MR. WARD: Right.18 DR. MARTIN: -- the people who19 practice in the profession, then the State20 indemnity fund, whatever that's called, will not21 cover in that case.22 MR. WARD: I'm not sure about that.23 It says you don't have a state -- state
Page 66 1 immunity. I don't think it's -- 2 DR. MARTIN: Yeah. 3 MR. WARD: I don't think -- that 4 doesn't mean you don't have insurance. 5 DR. MARTIN: Well, I think the 6 insurance part -- do we have insurance aside 7 from what the State covers from the -- 8 MR. MCCONAGHY: Yeah, this Board has a 9 policy through Pharmacists Mutual for their10 liability.11 DR. MARTIN: That's what I was12 thinking. So I would think that would be a13 point of discussion at the meeting next week,14 kind of like David said that as we're entering15 into the dialogue with these other regulatory16 boards by what that legislation ought to look17 like, and as I understand it, the legislation18 that's been proposed is only a placeholder.19 They already know it's going to be rewritten,20 that we introduce the concept that if an21 individual regulatory board chooses to maintain22 its own insurance, they could opt out of this23 mandatory involvement in this additional
Page 67 1 commission. 2 MR. BUNCH: Do you have any indication 3 on any of the other boards -- their thinking on 4 this like the Medical Board? 5 DR. ALVERSON: Everyone I've talked to 6 has felt that this is a dramatic reaction to 7 something that might never happen. 8 MR. BUNCH: Do you think they may be 9 in the same mindset as us as maybe not10 participating?11 DR. ALVERSON: I most certainly can12 talk to them about it.13 MR. BUNCH: Yeah, it would be good to14 know kind of what they're --15 MS. ANDERSON: I'm pretty sure the16 Medical Board, they're ready to jump on board.17 MR. BUNCH: Jump on board.18 MS. ANDERSON: Yeah, they were --19 DR. MARTIN: As a matter of fact, they20 were driving the process before ARB ever got21 into it.22 MS. ANDERSON: Yes.23 MR. BUNCH: It probably would affect
Page 68 1 it. 2 MS. YEATMAN: Again, that's a 3 different scope. 4 MR. WARD: Yeah, they have scope 5 issues all the time, yeah. 6 MR. DARBY: Well, and they're much -- 7 they're very protective of what other people can 8 do. 9 MS. YEATMAN: Uh-huh.10 DR. MARTIN: I don't think there's a11 chance this is going to be acted upon in the12 special session.13 DR. ALVERSON: I'm sure it won't be.14 DR. MARTIN: So I would say continue15 the dialogue, continue to listen to what the16 group is saying, remember those points that17 we've talked about and plan for something to18 come out in the spring that's probably going to19 be introduced.20 DR. ALVERSON: I did send you an email21 with the legislation.22 MR. DARBY: Yeah, I got it.23 DR. ALVERSON: Did you get it?
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Page 69 1 MR. DARBY: Yeah, I've got it pulled 2 up right here. 3 DR. ALVERSON: Okay. We had a meeting 4 with the DEA supervisor in our area to discuss 5 issues that have been brought up that 6 pharmacists were having difficulty with and some 7 of those we discussed at the APA meeting. The 8 first one was about addresses on prescriptions. 9 Apparently some DEA agents have been trained10 that if the doctor didn't write it on the11 prescription, you have to send the patient back12 to the doctor's office. Some of them feel13 that's ridiculous, including the person that we14 met with, and so they have agreed that as long15 as the address gets put on the prescription by16 the patient, by whoever takes in the17 prescription by the time it gets to the18 pharmacist to fill it, if there is an address on19 it, they're going to be happy with that, all20 right.21 The second thing is they agreed the22 front and the back of the prescription can be23 used to record information for the prescription
Page 70 1 that they -- 2 MS. YEATMAN: Does that mean the 3 address also? 4 MS. ANDERSON: They said the address 5 could be on the back but it should be 6 handwritten before it's turned over to the 7 pharmacist. 8 DR. ALVERSON: Before it gets to the 9 point where it's filled.10 MR. BUNCH: So the sticker -- the11 label on the prescription is not good enough12 with the address. It has to be handwritten.13 DR. ALVERSON: Correct, because that's14 after the prescription has been processed.15 MS. YEATMAN: I still argue that point16 but.17 DR. ALVERSON: We were --18 MS. YEATMAN: I understand.19 DR. ALVERSON: All right.20 MR. BUNCH: That's on all -- that's on21 all controlleds.22 DR. ALVERSON: Correct.23 MR. BUNCH: CIIs and everything.
Page 71 1 DR. ALVERSON: CIIs and everything, 2 all right. But they did hold firm on the idea 3 that a pharmacist cannot, even with a call to a 4 physician, on the CII where there are multiple 5 prescriptions and the physician has written 6 on -- on those prescriptions do not fill before, 7 that that date could not be changed because they 8 saw that as the beginning of a slippery slope. 9 So we did well on two and had to give on the10 third.11 We've discussed how we can put12 background checks on our computer system and13 have looked at -- the computer company has found14 a company that they have used before that does15 background checks that integrates into their16 system, so we have to look into that in addition17 to others but I just want you to know we're18 moving forward on that.19 And I think I mentioned last meeting20 that we have obtained the Grand Hotel for next21 year's District III meeting, which we are22 hosting. I think I said that last month but I23 just wanted to be sure I did.
Page 72 1 Did I get it all? 2 DR. MARTIN: MOU public affairs update 3 on that. That's in the Dropbox. 4 DR. ALVERSON: Yes, the FDA came out 5 with a different version or a concession on one 6 of the MOU issues and I'm ashamed to say I put 7 it in and now I've forgotten exactly which one 8 it was. 9 MR. WARD: They haven't published a10 new revised one yet, have they?11 DR. ALVERSON: No, they haven't.12 MR. WARD: See, I've been looking. I13 haven't seen it.14 DR. ALVERSON: They have not published15 a new one.16 DR. MARTIN: Who is PCCA?17 DR. ALVERSON: Pharmacy Compounding18 Centers of America.19 DR. MARTIN: Thank you.20 DR. ALVERSON: I believe it had to do21 with the 30-percent rule if I remember.22 MR. DARBY: It does.23 MR. WARD: It did. What did it say?
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Page 73 1 MS. YEATMAN: It says right here. 2 DR. MARTIN: It's got about ten bullet 3 points. 4 MR. DARBY: Ill defined. 5 MS. YEATMAN: Ill defined and 6 arbitrary. 7 DR. ALVERSON: I think they made 8 the -- they used us really as one of their 9 excuses or their defenses in that all of this10 work that FDA is proposing is going to be dumped11 on the state boards of pharmacy. State boards12 of pharmacy are going to have to go in and count13 prescriptions, how many are in state, how many14 are out of state. It is going to be a lot of15 work.16 MR. WARD: Hence the saying, I'm for17 the federal government and I'm here to help.18 DR. ALVERSON: Correct.19 MR. WARD: Check's in the mail.20 DR. ALVERSON: Yes. I took more than21 my allotted time but.22 MR. MCCONAGHY: Do you think the DEA23 would be willing to put what they told you in
Page 74 1 writing and provide a number so that when one of 2 their agents comes in telling you something 3 different, they can call? 4 DR. ALVERSON: I think if they don't 5 get in writing -- we will send them a document 6 that says, as a result of our meeting our 7 understanding is this. If you think otherwise, 8 please let us know but we are going to begin 9 notifying pharmacies that this is your agreement10 if we don't hear back but I think they'll put it11 in writing.12 MR. MCCONAGHY: I guess my interest is13 because I've heard several folks that have had14 that issue going on. If they came in and told15 the pharmacist, you know, I'm writing you up16 because of this --17 DR. ALVERSON: Right.18 MR. MCCONAGHY: -- and they've said19 otherwise, do they have somebody they can call20 at the DEA as recourse to say hey, you need to21 talk to these people.22 DR. ALVERSON: I agree and we did get23 the letter out about front and back of
Page 75 1 prescriptions and perhaps we should do the same 2 thing about addresses and the CII. 3 MR. MCCONAGHY: Jim Ward, have you got 4 an attorney's report? 5 MR. WARD: No, sir, not except for 6 executive session. Oh, yeah, one thing is 7 Matthew Muscato, yeah, you know, the legislature 8 passed House Bill 208 about allowing doctors to 9 write a prescription or authorize certain10 individuals to use the drug that counteracts a11 drug overdose. I can't remember the name of12 it.13 DR. ALVERSON: Naloxone.14 MR. WARD: Right. And it mentions15 pharmacies -- pharmacists in the bill and the16 way I read it, it protects -- it's a good17 faith if you -- if you dispense it in good18 faith, you're -- you're okay, you can do it.19 You aren't subject to being sued but Matt wants20 to know if we're going to issue any rules about21 that or do anything. I said I would make sure22 and tell them. Do I have that right, Matt?23 MR. MUSCATO: Correct, we're just
Page 76 1 putting together our plans and just some states 2 have taken -- 14 states have passed similar 3 bills and some boards have had just some -- some 4 guidance on proceeding. 5 MR. WARD: For me -- for me, the law 6 is pretty clear but if you all want to look at 7 it, see if we need to make a rule to make sure, 8 we can do that. 9 MR. DARBY: Yeah, why don't we look at10 it.11 MR. WARD: I'll send it -- do y'all12 have a copy? I'll get you a copy of it.13 MR. DARBY: Yeah, yeah.14 MR. WARD: You can put it on the15 agenda for the next meeting.16 MR. MCCONAGHY: You can add that to17 Susan's statements that she is sending out to18 everybody.19 MS. YEATMAN: Dan, do we need to20 accept the secretary's report?21 MR. MCCONAGHY: If you want to.22 MS. YEATMAN: Well, I'm just -- we23 were audited. I'm trying to make sure we do it
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Page 77 1 right. 2 MR. DARBY: No, I don't think you have 3 to. 4 MS. YEATMAN: We don't have to, okay. 5 I'm still learning. 6 MR. DARBY: Susan, will you maybe send 7 the state organizations, you know, what y'all 8 talked with the DEA about on those 9 clarifications so they can help maybe get that10 out to all the pharmacists?11 DR. ALVERSON: Yes, I will.12 MR. MCCONAGHY: Old business. Tim,13 would you like to start with the 680-X-2.18?14 DR. MARTIN: Sure, I'd be glad to.15 The part about that rule that we're concerned16 with is the one where automated drug cabinets17 are allowed in skilled nursing facilities and we18 talked about this last month and it was the19 feeling of the Board that there was still too20 much confusion about what is and is not allowed,21 what would or would not be allowed, especially22 from a labeling standpoint to go forward with23 what had been proposed earlier.
Page 78 1 So you can expect some alternative 2 wording to be presented to the Board. The plan 3 is for that to be presented to the Board next 4 month for consideration. I'd be glad to try to 5 answer any other questions that you might have 6 about it. 7 MR. MCCONAGHY: I guess the only 8 question I have is on the technical or legal 9 part of it, we started that process going and10 we -- we've been through the hearing and the11 30-day comment period. During that period, we12 voted to not accept it as written, so are we13 starting back as if we're doing a new one now14 and then we'll post it and have the 30-day -- 3015 days before the hearing on it and then the16 30-day comment period again?17 MR. WARD: Yeah, if it wasn't amended,18 if you -- you can not accept it as written and19 change it and then vote in the changes. You20 didn't do that. What you did was you didn't do21 anything in essence, then you have to start over22 again.23 MS. YEATMAN: Yeah.
Page 79 1 MR. MCCONAGHY: Okay. I know that's 2 not what a lot of y'all wanted to hear there, me 3 either, but that's -- if we -- any other 4 comments on that? 5 DR. MARTIN: I don't have anything 6 else. 7 MR. MCCONAGHY: Okay. We'll move into 8 new business. Does anyone have any new 9 business?10 MR. MCENIRY: Mr. President, Members11 of the Board, I'd like to follow up on a new12 business that we brought up last -- at last13 meeting and to request -- I don't believe Blue14 Cross Blue Shield of Alabama is present as it15 deals with the elimination of coverage for16 compounded medications in Alabama. I would like17 to request that we place the matter on the18 August agenda or another agenda that the Board19 sees fit and maybe give Blue Cross notice, I20 guess to the extent that the Board does decide21 to take some action.22 I'm not sure if due process is the23 right word, Jim, but maybe for equitable
Page 80 1 concerns I think that Blue Cross should at least 2 be allowed to respond. I've provided written 3 materials that supplement what was stated on the 4 record in June and I hope you'll find those 5 helpful. 6 MR. WARD: I'm sorry, what -- was 7 stated in June about what, Jay? 8 MR. MCENIRY: I'm sorry? 9 MR. WARD: I didn't hear the last10 part. Your voice kind of dropped.11 MR. MCENIRY: Oh, I'm sorry. I12 provided written materials to supplement what I13 presented to the Board in June.14 MR. WARD: About the Blue Cross issue?15 MR. MCENIRY: Yes, yes, just for the16 Board's consideration and I'm certainly happy to17 provide whatever materials you need in addition18 to what's already been submitted but I'm not19 sure what the process is for getting us on the20 agenda and getting notice to Blue Cross but I'm21 certainly going to help in any way possible.22 MR. WARD: What's the status of it?23 Could you give us a little update?
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Page 81 1 MR. MCENIRY: The status is that as of 2 July 1, Blue Cross Blue Shield of Alabama 3 effectuated its plan to effectively end coverage 4 for compounded medications for most patients in 5 Alabama. There are some patients for which that 6 decision will go in effect on September 1. I 7 believe that deals with plans that have a 90-day 8 notice provision for -- for its members and 9 beneficiaries but the -- otherwise, the status10 is as -- as stated at the June meeting.11 MR. WARD: Are you asking the Board to12 do -- to do something?13 MR. MCENIRY: Yes, I believe that --14 and I'm happy to run through it to the extent15 that you guys need it or you all need it, excuse16 me -- but I believe given the fact that Blue17 Cross insures over 90 percent of insured lives18 in Alabama; in addition, given the fact19 compounded medications by their nature are a lot20 of times the only option -- the only treatment21 option for patients that I believe this is an22 issue of -- a potential threat to public health23 for which the Board has jurisdiction.
Page 82 1 Outside of that, there was a question 2 presented last time what can the Board do. I 3 actually spoke with a former board member. The 4 suggestions were, number one, the Board can take 5 a public position through resolution or other 6 public statement as to its position as to these 7 issues. The Board could seek a meeting with 8 Blue Cross or a delegation from the Board seek a 9 meeting with Blue Cross if it saw fit. The10 Board could work with other boards in the11 State -- Medical Board, Board of Dentistry,12 other boards that may be affected by potentially13 to look at legislation to address the issue were14 the things suggested to me.15 MR. DARBY: Doesn't Blue Cross -- what16 they quit covering was paying for compounds from17 bulk chemicals -- bulk ingredients but they18 still will pay for compounds that are billed by19 NDC number; is that correct?20 MR. MCENIRY: The jury is still out as21 to whether Blue Cross will continue to pay for22 compounding from manufacturing from commercially23 available ingredients. I do understand in some
Page 83 1 circumstances those compounds are still being 2 covered. If you look at the language of the 3 Blue Cross provider notice, one of the 4 requirements would be that the route of 5 administration be FDA indicated, which would 6 mean that even compounding from commercially 7 available ingredients would not be covered, so I 8 think the jury is still out on that issue. 9 I think you have a separate issue, of10 course, that by compounding with commercially11 available ingredients, you are still putting a12 lot of patients at risk because a lot of times13 you compound to get around the additives, dyes,14 glutens, incipients that you find in15 commercially available medications for which a16 patient is allergic or otherwise cannot17 tolerate. Past that, of course, compounding18 with commercially available ingredients can be19 more difficult but I'll leave that to the20 pharmacists to discuss. I don't feel that it's21 within my -- my license to discuss that. But22 overall I do believe that based upon Blue Cross'23 definitions and based upon what we're seeing
Page 84 1 right now that we're still seeing a public 2 health threat for which the Board may have 3 jurisdiction. 4 MR. WARD: Has anybody contacted 5 Luther Strange? 6 MR. MCENIRY: I have been working with 7 various folks in Montgomery. I have not 8 contacted the attorney general directly. 9 MR. WARD: Are you -- you are a smart10 young lawyer.11 MR. MCENIRY: I appreciate that.12 MR. WARD: The same thoughts I had13 last time -- well, you are. How do we -- how14 does anybody force a private company to mandate15 to them what risks they cover or what services16 they cover? I mean, I'm just trying to think of17 a way -- how do you tell any business how18 they -- how they -- what they can sell or not19 sell or what they can cover and not cover unless20 it's otherwise against the law.21 MR. MCENIRY: I think there are legal22 arguments for which a regulatory board may look23 at the issue. It may be within your purview to
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Page 85 1 the extent that Blue Cross' move violates the 2 Affordable Care Act, for example, by pharmacy 3 being one of the enshrined rights for patients 4 as passed in the ACA. I do agree with you 5 that -- and I believe we'll find that it's Blue 6 Cross' argument, we're a private company and we 7 can do what we want to. But that argument only 8 goes so far when you start doing things that 9 affects the public health. Again, I don't know10 whether this Board has direct regulatory11 authority over Blue Cross but I do believe that12 this Board has the authority to take some action13 that it sees fit based upon the threat of public14 health.15 MR. WARD: You're aware of the line of16 cases that say that if someone violates a17 regulatory statute, that doesn't give them a18 private cause of action.19 MR. MCENIRY: Yes, yes.20 MR. WARD: So that's just what I'm21 trying to think even if let's say -- will you22 stop for a minute.23 (Brief off the record discussion.)
Page 86 1 MR. WARD: I guess it would be up, 2 Dan, to y'all if you want to -- what, if 3 anything, you want to do. 4 MR. MCCONAGHY: As far as what I can 5 speak to, we've done traditional type 6 compounding for all of my career and I do have 7 patients that this will affect but I suspect 8 Blue Cross is counting on us to go ahead and do 9 it for them anyway because we're not going to10 leave them out there in the cold and that we'll11 bear the brunt of the expense. So I do think12 it's an issue for folks that -- that can't13 afford to pay for the medications that are being14 compounded, especially in pediatrics.15 There's so much of it that's going on16 in the hospital and in traditional type pharmacy17 settings for pediatrics being formulated, so I18 do see it as a true issue. I don't know where19 we can stand on it other than to say that20 personally I feel like it's -- it's a pretty big21 issue for them to just kind of carte blanche it22 across the board probably because there were23 some bad players in the game, they -- they
Page 87 1 attacked everyone. 2 MR. MCENIRY: Either that or piling 3 on. Of course, Blue Cross has been working 4 under a pretty strict cap as it deals with 5 reimbursement for compounds for years in Alabama 6 through its pharmacy benefit manager, Prime 7 Therapeutics, and so even the bad guys who may 8 have used some payers in the country, I don't 9 think they could have done a whole lot with Blue10 Cross due that cap but certainly it is an11 industry under some pressure and arguably, I12 can't speak for Blue Cross, but it could be a13 simple -- as simple as, well, we have an14 opportunity, let's take it.15 What I would like to point out and16 what is pointed out in my letter and I believe I17 pointed out in my presentation -- I won't call18 it a presentation -- in speaking with you in19 June, Alabama is in a public health crisis as it20 deals with opioid use. Alabama is the top21 consuming, along with Tennessee, equal top22 consuming state of opioids in the country right23 now -- 143 prescriptions per 100 lives according
Page 88 1 to the CDC last year. Those materials are 2 actually within the -- the links to that are 3 within the materials I submitted to the Board. 4 That issue alone I believe justifies 5 at least consideration of the public health 6 issue. You have an issue now, President 7 McConaghy, you mentioned, well, pharmacies are 8 going to be expected to just do it on their own. 9 Well, what's going to happen, especially as you10 deal with pain, is you're going to find patients11 who can take an opioid and get it under a very12 basic copay and you're going to find doctors and13 pharmacies pushing patients -- continuing to14 push patients to a mode of therapy that is being15 proven to be a real problem in this state and a16 real public health threat in this state where17 you have a viable alternative that is18 nonaddictive, that has not seen systemic effects19 as opioids at your disposal.20 But we have the largest payer in the21 state that insures over two million people in22 this state -- that was in 2012 before the ACA23 passed. I don't know where it is now but the
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Page 89 1 last reported figures of over two million people 2 in the state arbitrarily eliminating coverage 3 for a line of medications that really could 4 serve to the benefit of public health. 5 My request is I'm -- my hope is that a 6 public position by this Board, public positions 7 in Montgomery, may force Blue Cross to the table 8 to talk about alternatives other than cutting it 9 off and -- but understanding the limitations, I10 am still hoping that the Board will consider11 taking some position on this issue.12 MR. WARD: Jay, I have a special needs13 son, who a lot of people in this room know, who14 is going to be affected by this because he can't15 swallow pills, so he has to have a lot of his16 medication in liquid and it has to be compounded17 for him and you know, so I'm with you. I18 want -- I just -- I'm frustrated because I can't19 think of something that would really hit them20 other than somehow affecting them money wise21 financially.22 MR. MCENIRY: Absolutely, and the23 AL.com story that posted on June 29, again
Page 90 1 within your materials, there was a parent who 2 was interviewed. The medication coverage was 3 cut off. They can't afford it. Well, I guess 4 I'm going to have to get the pill and crush it 5 up and try to force it through the feeding tube. 6 You've got real -- you've got real issues here. 7 I submitted a number of patient 8 testimonials regarding the importance of 9 compounding, why commercially available doesn't10 work. It's about that thick (indicating). I11 submit it not expecting that you read it all but12 just so that you have some information at your13 disposal.14 MR. BUNCH: Is there a grass roots15 effort maybe with the -- again, I'd go back to16 Blue Cross being a business and folks who were17 taking medicine of their customers. Normally a18 business listens to who is paying the bills and19 if you've got a really -- I don't know how you20 go about getting that many people but you know,21 just affected by compounding, it's more than22 just compounding, you'd have a great outcry but23 compounding is not as -- it's a large segment
Page 91 1 but it's not what -- you know, it's not the 2 total segment so. 3 But if you have people calling Blue 4 Cross every day complaining about what they're 5 going to do to get their -- to be able to get 6 their child's medication, their elderly parents' 7 medication, this type thing, and not only call 8 them but call their employers who maybe have a 9 contract with Blue Cross, to me, that would be10 the most important group at Blue Cross they11 would probably listen to because they're very12 attuned to -- to not lose their patients.13 MR. MCENIRY: And that is -- and I14 appreciate that. That is occurring. That is15 definitely occurring as we speak and has been16 for -- ever since Blue Cross gave notice --17 again 30 days notice, if you recall from our18 last discussion, which is very difficult for19 patients who have no commercially available20 option. It doesn't give you a lot of time,21 which is another issue that I believe could be22 taken off as a part of the discussion but the --23 the grass roots effort from the patient, from
Page 92 1 the physician, from the employer both to Blue 2 Cross directly and to the state legislature is 3 ongoing. 4 MR. MCCONAGHY: Yeah, I -- like I say, 5 I don't know -- we'll do a little research and 6 see what we think we could do would be most 7 effective but just personally speaking, it's 8 really offensive to me doing the traditional 9 type compounding for years and years and it's10 basically what pharmacy was. I mean, it was --11 when my dad was a pharmacist, that's what12 pharmacy was, so that's the whole business and13 for them to just take a total assault on it14 is -- is pretty offending to me.15 MR. MCENIRY: There are other ways16 than cutting it off and I am hoping that17 respected members of the Board and other18 community legislators may convince Blue Cross19 that that's the option they should take.20 MR. DARBY: Have you personally made21 an appointment with Blue Cross and gone and22 talked with them?23 MR. MCENIRY: Many of us are
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Page 93 1 attempting and maybe -- I don't know if Louise 2 has had any luck yet. I have been in 3 communication with Blue Cross and I think I was 4 getting slow played until the July 1 date and 5 we'll see what happens from here. But yes, I 6 have attempted to reach out. 7 MS. YEATMAN: Just a thought. I mean, 8 in reading because I've been trying to research 9 it because I know it's had an impact on special10 needs patients that I'm -- that I deal with. I11 think it might be prudent, at least in my12 opinion, is to let Blue Cross know that we've13 had it brought up before the Board, that it is a14 public health consideration.15 Based on what Blue Cross is stating,16 is their reason for no longer covering it is a17 safety issue because of the Massachusetts case18 where they had fungal meningitis. So maybe we19 present to them that we'd like to sit down with20 them and talk about how we -- what we do from a21 board standpoint to insure that Alabama lives22 are not at risk because of the significant23 inspections that we do to insure compounding is
Page 94 1 top line and see if they would at least 2 entertain a discussion on how we can insure 3 their issues and safety concerns aren't a 4 concern and they might be open, you know, to 5 expanding their compounding. If that is indeed 6 the reason that they are concerned, then we 7 should be able to alleviate a lot of those 8 concerns by showing them what we do to insure 9 that compounding in the State of Alabama is not10 dangerous, so that would be my thought.11 DR. MARTIN: I think a lot of the12 concern is that the employers who have their13 employees covered under the Blue Cross plan are14 reporting that compounded products are the15 number one cost item in their coverage plans and16 do a push back against that.17 MS. YEATMAN: Then maybe they should18 consider the fact that if they're not given the19 medications in the proper dosage, what are the20 potential outcomes and complications that the21 patient -- hospitalizations or what else is22 going to incur financially.23 DR. MARTIN: I think that's a very
Page 95 1 good point and we haven't talked a lot about the 2 employers. I'm sure Jay and his folks have 3 considered that aspect of it but they're 4 probably pretty uninformed. 5 MR. MCENIRY: I think that's a great 6 idea and would be more than willing to assist 7 the Board in any way that the Board sees fit. 8 MS. YEATMAN: Just my two cents. 9 MR. MCCONAGHY: Thank you, Jay.10 MR. MCENIRY: Thank you.11 MR. MCCONAGHY: Any other new12 business?13 (No response.)14 MR. MCCONAGHY: Mr. Ward suggested we15 need to go into executive session, so I would16 entertain a motion as such.17 DR. MARTIN: Would you like to make a18 motion, Mr. President, that the Board go into19 executive session?20 MR. MCCONAGHY: Okay, yeah, the motion21 will be that we will now go into executive22 session for the purpose of discussing23 qualifications or competencies of professionals,
Page 96 1 permitholders, or registrants. Other legal 2 matters may be discussed, including existing and 3 pending cases or litigation. 4 The executive session will start at 5 11:05 and we should be out by 11:30 and at that 6 time, there will be no further business other 7 than to read into the record anything that was 8 discussed during the executive session. 9 MR. WARD: As an attorney licensed to10 practice law in the State of Alabama, I certify11 that one of the reasons for going into executive12 session is to discuss pending matters and13 potential resolution of pending matters before14 the Board.15 MR. MCCONAGHY: That's a motion.16 MR. DARBY: Second.17 MR. MCCONAGHY: We've got a second.18 DR. MARTIN: Yeah, it would be an19 individual vote.20 MR. MCCONAGHY: Buddy?21 MR. BUNCH: Yes.22 MR. MCCONAGHY: Donna?23 MS. YEATMAN: Yes.
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Page 97 1 MR. MCCONAGHY: Tim? 2 DR. MARTIN: Yes. 3 MR. MCCONAGHY: David? 4 MR. DARBY: Aye. 5 MR. MCCONAGHY: And aye. 6 We are adjourned to executive session. 7
8 (Whereupon, a recess was taken for 9 executive session from 10:56 a.m. to10 12:44 p.m.)11
12 MR. MCCONAGHY: We will come out of13 the executive session for the meeting and David14 will read the cases discussed in the meeting.15 MR. DARBY: Case number 15-0037,16 recommended action is a letter of concern to the17 pharmacy.18 DR. MARTIN: I move we accept the19 recommendation as submitted.20 MS. YEATMAN: Second.21 MR. MCCONAGHY: All in favor?22 DR. MARTIN: Aye.23 MR. DARBY: Aye.
Page 98 1 MS. YEATMAN: Aye. 2 MR. BUNCH: Aye. 3 MR. DARBY: Case number 15-0071, a 4 letter of warning to the pharmacist and a 5 corrective action plan to be sent in to the 6 Board. 7 DR. MARTIN: I move we accept the 8 recommendation as submitted. 9 MS. YEATMAN: Second.10 MR. MCCONAGHY: All in favor?11 DR. MARTIN: Aye.12 MR. BUNCH: Aye.13 MR. DARBY: Aye.14 MS. YEATMAN: Aye.15 MR. DARBY: Case number 15-0072, a16 letter of warning to all pharmacy staff and17 corrective action plan to be sent in and18 approved by the compliance officer.19 DR. MARTIN: I move we accept the20 recommendation as submitted.21 MS. YEATMAN: Second.22 MR. MCCONAGHY: All in favor?23 MS. YEATMAN: Aye.
Page 99 1 DR. MARTIN: Aye. 2 MR. DARBY: Aye. 3 MR. BUNCH: Aye. 4 MR. DARBY: And case number 14-0192, 5 refer it back to the investigator for follow-up 6 investigation. 7 DR. MARTIN: I move we accept the 8 recommendation as submitted. 9 MS. YEATMAN: Second.10 MR. MCCONAGHY: All in favor?11 DR. MARTIN: Aye.12 MS. YEATMAN: Aye.13 MR. BUNCH: Aye.14 DR. MARTIN: I move we adjourn.15 MS. YEATMAN: Second.16 MR. MCCONAGHY: All in favor?17 DR. MARTIN: Aye.18 MS. YEATMAN: Aye.19 MR. BUNCH: Aye.20 MR. MCCONAGHY: Adjourned.21
22 (Whereupon, the hearing was adjourned23 at 12:47 p.m.)
Page 100 1 CERTIFICATE 2
3 STATE OF ALABAMA 4 SHELBY COUNTY 5
6 I, Sheri G. Connelly, RPR, Certified 7 Court Reporter, hereby certify that the above 8 and foregoing hearing was taken down by me in 9 stenotype and the questions, answers, and10 statements thereto were transcribed by means of11 computer-aided transcription and that the12 foregoing represents a true and correct13 transcript of the said hearing.14 I further certify that I am neither of15 counsel, nor of kin to the parties to the16 action, nor am I in anywise interested in the17 result of said cause.18
19
20 /s/ Sheri G. Connelly21 SHERI G. CONNELLY, RPR22 ACCR No. 439, Expires 9/30/201523
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WORD LIST
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Cornutt (43)corporate (1)Correct (12)corrective (2)correspondence (1)cost (2)counsel (1)count (1)counteracts (1)counting (1)country (2)COUNTY (1)course (5)Court (2)cover (6)coverage (5)covered (3)covering (2)covers (1)CPOE (1)creating (3)crisis (1)Cristal (3)Cross (33)crush (1)current (4)currently (5)customers (1)cut (1)cutting (2)CVS (2)
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NDC (1)need (25)needs (2)negative (1)neither (1)nervous (1)never (2)new (11)nine (3)nonaddictive (1)noncontrolled (1)nonsterile (1)normal (2)Normally (1)North (2)notice (7)notifying (1)number (19)numbers (9)Nurses (2)Nursing (4)
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operations (1)opinion (2)opioid (2)opioids (2)opportunity (1)Opposed (1)opt (3)option (6)Orange (1)order (26)ordering (1)orders (33)organization (1)organizations (1)ought (1)outcomes (1)outcry (1)outside (8)overall (1)overdose (1)overridden (1)owned (5)ownership (1)owns (2)
< P >p.m (5)page (1)paid (1)pain (1)paper (1)paralegals (1)parent (1)parents (1)Part (10)participating (1)parties (1)part-time (3)passed (5)patient (14)Patients (17)pay (7)payer (1)payers (1)paying (4)PCCA (1)PDMP (1)peak (1)pediatrics (2)
pending (3)people (15)percent (3)perfectly (1)perform (2)performing (2)period (4)permission (2)permit (15)permitholders (1)permits (1)permitted (1)person (3)personally (5)personnel (1)perspective (1)Ph.D (1)Pharmacies (9)pharmacist (29)pharmacists (13)pharmacist's (1)PHARMACY (71)PharMedCo (1)phone (1)physical (2)Physician (12)Physicians (5)picture (1)piece (1)pieces (2)piling (1)pill (1)pills (1)place (6)placeholder (1)plan (6)planning (3)plans (3)played (1)players (1)playing (1)please (2)pleased (1)Plus (2)point (12)pointed (2)points (3)policy (7)portion (1)
position (14)positions (1)possible (2)post (1)posted (1)potential (4)potentially (3)PowerPoint (1)practice (7)practicing (3)precedence (1)prescription (11)prescriptions (10)PRESENT (4)presentation (4)presentations (2)presented (5)presently (1)President (5)pressure (1)pretend (1)pretty (10)previous (1)previously (3)pricing (1)Prime (1)private (3)privately (2)privileges (1)probably (7)problem (4)problems (1)procedure (3)procedures (1)proceeding (1)process (16)processed (2)processes (1)processing (18)product (2)products (2)profession (2)professional (3)professionals (2)profile (1)project (1)proper (1)proposal (2)proposals (1)
Business Meeting 7
Freedom Court Reporting, Inc 877-373-3660
proposed (8)proposing (2)protective (1)protects (1)protocols (1)proven (1)provide (14)provided (3)provider (1)providers (1)providing (2)provision (1)prudent (2)public (16)published (3)Publix (1)pulled (1)pulling (2)purpose (2)purposes (2)purview (1)push (3)pushing (1)put (14)putting (3)Pyxis (4)
< Q >qualifications (1)quality (1)quantity (3)question (11)questions (10)queue (5)quickly (1)quit (1)quite (3)quorum (1)
< R >ran (1)rapport (1)rarely (1)ratio (2)reach (2)reaction (1)read (4)reader (1)reading (2)
ready (2)real (7)really (10)reason (3)reasons (1)recall (1)received (2)recess (1)recognize (1)recommendation (4)recommended (2)Record (9)recourse (1)redo (1)refer (1)reference (1)refills (1)regarding (1)Regional (6)register (1)registered (2)registrants (1)registration (1)regularly (1)regulating (1)regulations (3)regulatory (8)rehire (1)reimbursement (1)relatively (1)release (2)releases (1)remain (1)remember (4)remote (13)remotely (1)remote-order (1)repackager (1)repeat (1)replace (2)replacing (1)report (18)reported (2)REPORTER (2)reporting (1)represents (1)request (9)requested (2)
requesting (2)require (3)required (2)requirements (2)requiring (1)research (2)resident (1)residential (1)resolution (3)resolved (1)respected (1)respond (1)response (4)result (2)retail (29)returning (1)review (6)reviewed (2)reviewing (1)revised (1)rewritten (1)Richard (1)Richmond (2)Rick (2)rid (1)ridiculous (1)Right (52)rights (1)risk (2)risks (1)Ritch's (1)Roads (2)Ronda (2)room (1)roots (2)roughly (1)route (1)routine (1)RPR (3)rubs (1)rule (10)rules (6)run (4)running (1)rural (1)RX (2)
< S >safely (1)
safety (3)Sapone (88)saw (2)saying (3)says (7)say-so (1)scale (2)School (1)scope (5)Scott (3)se (1)Seattle (1)Second (17)Secretary (1)secretary's (2)secure (6)security (1)see (16)Seeing (4)seek (2)seeking (1)seen (3)sees (3)segment (2)sell (2)send (9)sending (1)Senior (1)sense (2)sent (3)separate (5)September (1)serve (3)server (1)service (8)serviced (1)services (4)serving (1)session (13)set (11)setting (1)settings (1)setup (1)Sharon (2)SHELBY (1)she'll (6)Sheri (4)Shield (2)Shirley (2)
Business Meeting 8
Freedom Court Reporting, Inc 877-373-3660
short (4)showing (2)signed (1)significant (2)similar (5)simple (2)sir (4)sit (1)site (12)sites (7)sitting (1)situation (8)situations (1)six (1)skilled (1)sliding (1)slippery (1)slope (1)slow (1)small (3)smart (1)snowball (1)Solutions (7)somebody (3)someone's (1)son (1)soon (4)Sorrell (3)sorry (7)sound (4)sounds (1)speak (3)speaking (2)special (7)specific (3)specifically (3)spoke (2)spoken (1)spreadsheet (1)spring (1)staff (11)staffing (1)stampede (1)stand (1)standard (1)standpoint (4)start (6)started (2)starting (2)
starts (1)stat (1)STATE (37)stated (3)statement (1)statements (2)states (4)State's (1)stating (1)status (5)statute (1)stay (1)stenotype (1)step (1)Stephens (3)stepping (1)sterile (1)sticker (1)stipulation (1)stop (1)story (1)straight (2)Strange (1)Street (1)strict (1)structure (1)student (1)stuff (3)subject (1)submit (2)submitted (7)sued (1)suffered (1)suggested (2)suggestions (1)Supermarket (1)supervising (1)supervision (1)supervisor (2)supplement (2)supposed (1)Supreme (1)sure (30)surgery (1)Susan (5)Susan's (1)suspect (1)swallow (1)switch (1)
System (7)systemic (1)Systems (1)
< T >table (1)tack (1)take (13)taken (4)takes (1)talk (4)talked (9)talking (2)talks (1)tally (1)tasked (1)tech (2)technical (1)technicians (4)technology (9)techs (1)telephone (2)tell (11)telling (2)template (1)ten (1)Tennessee (1)testimonials (1)Thank (15)thanks (1)theory (1)Therapeutics (2)therapy (2)thereto (1)thick (1)thing (11)things (8)think (59)thinking (3)third (1)Thirty (2)thought (5)thoughts (1)threat (4)three (8)three-fold (1)Thursday (2)Tim (5)time (21)
times (5)today (2)today's (1)Todd (5)told (5)tolerate (1)tomorrow (1)top (4)total (4)touch (1)traditional (3)trained (1)training (3)transcribed (1)transcript (1)transcription (1)Transdermal (1)Treasurer (2)Treasurer's (3)treated (1)treating (1)treatment (2)true (3)try (4)trying (7)tube (1)Turenne (1)turned (2)turns (1)Twelve (1)two (20)two-fold (1)two-week (1)Tylenol (1)type (7)typed (1)types (2)
< U >Uh-huh (1)unable (1)understand (6)understanding (5)uninformed (1)update (2)uphold (1)upholding (1)use (8)usual (1)
Business Meeting 9
Freedom Court Reporting, Inc 877-373-3660
usually (1)utilization (1)utilize (1)
< V >vacation (1)Vanderver (3)various (1)vehicles (1)verification (1)verify (7)verifying (4)version (1)viable (1)Vice (1)View (7)Village (1)violates (2)violating (1)Virginia (42)voice (1)void (1)volume (1)voluntary (1)vote (2)voted (1)VPN (1)VPNs (2)
< W >wait (2)Walgreens (2)walls (1)want (31)wanted (2)wanting (1)wants (6)Ward (75)warning (2)way (16)Wayne (2)ways (1)Wednesday (3)week (4)weekends (1)weekly (1)Welcome (1)well (26)Wellness (3)
went (4)We're (41)we've (15)whatsoever (1)wholesale (2)widespread (1)willing (2)wise (1)woman (1)wondering (1)word (1)wording (1)work (10)work-balancing (1)worked (2)working (10)works (1)world (1)worry (1)wow (1)write (2)writing (9)written (6)wrong (1)
< Y >yada (3)y'all (7)Yeah (67)year (8)years (4)year's (1)Yeatman (60)yesterday (1)young (1)