Legislative Update Brenda Denson, Pharm.D.ALBOP member, institutional position

Objectives - Pharmacists Explain the roles of board members

and staff in 2017 Understand the purpose and activities

of the 5 board members Identify the role of a new board

member Review the state legislation that

applies to pharmacy in 2017

Objectives - Technicians Identify the roles of the ALBOP

members and staff in 2017 Recognize the purpose and activities

of the 5 board members Review the activities of a new board

member

Poll the audience…. How many people work for the

Alabama Board of Pharmacy?◦ Answer: 20+

How many members sit on the Alabama Board of Pharmacy?◦ Answer: Five

How is the ALBOP office organized? Administration Licensing Enforcement Board members

Administration Susan Alverson,

Executive Secretary

Responsibilities include:◦ Office administration◦ Board policies◦ Compounding

policies

Administration Cristal Anderson,

Director of Compliance

Responsibilities include:◦ Case review process

of complaints◦ Pharmacy

Applications Review◦ Compounding

inspections

Administration Vance Alexander,

RPh, JD Adminstrative

Hearing Officer

Adminstration James Ward, Esq. ALBOP attorney for

over 20 years

Licensing Rhonda Coker,

Licensing Supervisor

Responsible for:◦ All licensing

activities◦ Verification request◦ Reporting

disciplinary actions

Licensing - Pharmacists Lynn Martin

Licensing - Technicians Terry Lawrence

The Crew behind the scenes

Who at ALBOP oversees pharmacist licensure?

A. Eddie BradenB. Terry LawrenceC. Lynn MartinD. Jim Ward

Who at ALBOP oversees pharmacist licensure?

A. Eddie BradenB. Terry LawrenceC. Lynn MartinD. Jim Ward

Enforcement Eddie Braden Chief Investigator Coordinates case

activities, investigates complaints and violations of the Pharmacy Practice Act

Enforcement Glenn Wells Investigator for

Blount, Calhoun, Cherokee, Cleburne, Colbert, Cullman, Dekalb, Etowah, Fayette, Franklin, Jackson, Lamar, Lauderdale, Lawrence, Limestone, Madison, Marion, Marshall, Morgan, St. Clair, Walker, and Winston counties

Enforcement Henry Burks Investigator for

Marion, Winston, Lamar, Fayette, Walker, Blount, Etowah, St. Clair, Calhoun, Cherokee, and Cleburne counties

Enforcement Mark Delk Investigator for

Bibb, Chambers, Chilton, Clay, Coosa, Elmore, Green, Hale, Jefferson, Lee, Perry, Pickens, Randolph, Russell, Shelby, Sumter, Talladega, Tallapoosa, and Tuscaloosa counties

Enforcement Peyton Zarzour Investigator for

Bibb, Chambers, Chilton, Clay, Coosa, Elmore, Green, Hale, Lee, Perry, Pickens, Randolph, Russell, Sumter, Talladega, Tallapoosa, Tuscaloosa counties.

Enforcement Richard

Lambruschi Investigator for Blount,

Calhoun, Cherokee, Cleburne, Colbert, Cullman, Dekalb, Etowah, Fayette, Franklin, Jackson, Lamar, Lauderdale, Lawrence, Limestone, Madison, Marion, Marshall, Morgan, St. Clair, Walker, and Winston counties.

Enforcement Todd Brooks Investigator Currently completing a

797 program through Critical Point

Territory: Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Dallas, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox Counties

Enforcement Scott Daniel Investigator for

Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox counties

Enforcement Mark Herbert Investigator for

Autauga, Baldwin, Barbour, Bullock, Butler, Choctaw, Clarke, Coffee, Conecuh, Covington, Crenshaw, Dale, Dallas, Escambia, Geneva, Henry, Houston, Lowndes, Macon, Marengo, Mobile, Monroe, Montgomery, Pike, Washington, and Wilcox counties

ALBOP members Three appointed positions◦ One independent pharmacy (Buddy

Bunch)◦ One chain pharmacy (Donna Yeatman)◦ One hospital (Brenda Denson)

Two at large positions ◦ Voted upon by pharmacists within the

state◦ David Darby and Ralph Sorrell

2017 ALBOP members

Pharmacy Laws to NoteSuccess in 2017

HB170….passed!!!Now ACT#2017-422 (signed by Gov Ivey 5/26/17)

Pharmacists…”Health Care Providers” Investigators instead of the term

“inspector” The legislation is LAW but will not go

into code until next year when the Legislative Reference Service puts the new wording in code and is approved in the next legislative session.

Xanax….NOT a Schedule 2 CS Thank goodness! Pharmacy groups worked together to

convince legislators that making Xanax a schedule 2 controlled substance in Alabama is not the answer to the addition issue.

Board Policy Changes Changing a 30 day supply to a 90 day

supply on non-controlled maintenance medications.

Board Rule Changes Parenteral Sterile Therapy A rule addition (will be published 6/30

and public has until August 4th for comment)◦ Rule Number: 680-X-2.43◦ Title of Rule: Requirements for Compounding◦ All pharmacies that engage in the

compounding of drugs or drug products shall comply with all applicable and current regulations of United States Pharmacopeia –National Formulary.◦ Statutory Authority: Code of AL 1975, 34-23-

Board Rule Changes 680-X-2.19 Changed because the

accurate definition of parenteral is “any drug dosage form that is not oral”.

The title changed to include “Sterile” and is now titled Parenteral Sterile Therapy.

The rule was changed to accurately reflect items that are compounding that should be STERILE and not just the inferred injectables

True or False???? Xanax is now a schedule II controlled

substance in the state of Alabama.

True or False???? Xanax is now a schedule II controlled

substance in the state of Alabama.

HB170 designates that pharmacists are…. A. Prescribers B. Health Care Providers C. Scientists

HB170 designates that pharmacists are….A. PrescribersB. Health Care ProvidersC. Scientists

ASHP House of DelegatesPolicies discussed at ASHP summer meeting

Policies and Recommendations 28 policies from five councils were

reviewed. All passed except for one that was referred back for review by the Pharmacy Management Council

Joint Council Task force policy on medical aid in dying passed with a stance of neutrality.

Pharmaceutical Distribution Systems

To support drug distribution business models that meet the requirements of hospitals and health systems with respect to availability and timely delivery of products, minimizing short-term outages and long-term product shortages, managing and responding to product recalls, fostering product-handling and transaction efficiency, preserving the integrity of products as they move through the supply chain, and maintaining affordable service costs; further,

Pharmaceutical Distribution Systems (Cont’d)

To oppose manufacturers, distributors, and wholesalers making availability of drug products contingent on how those products are used.

Controlled Substance Diversion Prevention – New ASHP Policy To encourage healthcare organizations to

develop controlled substance diversion prevention programs and policies that delineate the roles, responsibilities, and oversight of all personnel who have access to controlled substances to ensure compliance with applicable laws and scopes of practice; further,

To encourage healthcare organizations to ensure that all healthcare workers are appropriately screened for substance abuse prior to initial employment and surveillance, auditing, and monitoring conducted on an ongoing basis to support a safe patient-care environment, protect co-workers, and discourage controlled substances diversion.

Ready to Administer Packaging for Hazardous Drug Products intended for home use. To advocate that pharmaceutical manufacturers provide

hazardous drug products intended for home use in ready-to-administer packaging; further,

To advocate that regulators (e.g., FDA) have the authority to impose requirements on pharmaceutical manufacturers to provide hazardous drug products intended for home use in ready-to-administer packaging; further,

To advocate that, when hazardous drug products intended for home use are not available from manufacturers in ready-to-administer packaging, pharmacies repackage those drug products to minimize the risk of exposure; further,

To advocate that hazardous drug products intended for home use be labeled to warn that special handling is required for safety; further,

To advocate that pharmacists provide education to patients and caregivers regarding safe handling and disposal of hazardous drug products intended for home use.

Restricted Drug Distribution – A Revision of an ASHP policy To oppose restricted drug distribution

systems that (1) limit patient access to medications; (2) undermine continuity of care; (3) impede population health management; (4) adversely impact patient outcomes; (5) erode patients' relationships with their healthcare providers, including pharmacists; (6) are not supported by publicly available evidence that they are the least restrictive means to improve patient safety; (7) interfere with the professional practice of healthcare providers; or (8) are created for any reason other than patient safety.

Collaborative Drug Therapy Management – Revision of Policy To pursue the development of federal and state laws

and regulations that authorize pharmacists as providers within collaborative practice; further,

To advocate expansion of federal and state laws and regulations that optimize pharmacists’ ability to provide the full range of professional services within their scope of expertise; further,

To advocate for state and federal laws and regulations that would allow pharmacists to prescribe and transmit prescriptions electronically; further,

To acknowledge that as part of these advanced collaborative practices, pharmacists, as active members in team-based care, must be responsible and accountable for medication‐related outcomes; further,

To support affiliated state societies in the pursuit of state-level regulations allowing collaborative practice for pharmacists.

Drug Testing –Revision of Policy To recognize the use of pre-employment and

random or for-cause drug testing during employment based on defined criteria and with appropriate testing validation procedures; further,

To support employer-sponsored drug programs that include a policy and process that promote the recovery of impaired individuals; further,

To advocate that employers use validated testing panels that have demonstrated effectiveness detecting commonly abused or illegally used substances.

Therapeutic and Psychosocial Considerations of Transgender

Patients – NEW policy To support medication and disease management

of transgender patients as part of care unique to this population; further,

To advocate that transgender patients have access to pharmacist care to ensure safe and effective medication use; further,

To promote research on, education about, and development and implementation of therapeutic and biopsychosocial best practices in the care of transgender patients; further,

To encourage structured documentation of both a patient’s birth sex and self-identified gender in electronic health records.

Safe and Effective Use of Invertebrates To recognize use of medical invertebrates as an

alternative treatment in limited clinical circumstances; further,

To educate pharmacists, patients, and the public about the risks and benefits of medical invertebrates use and about best practices for use; further,

To advocate that pharmacy departments, in cooperation with other departments, provide oversight of medical invertebrates to assure appropriate formulary consideration and safe procurement, storage, control, prescribing, preparation, dispensing, administration, documentation, clinical and regulatory monitoring, and disposal; further,

To encourage independent research and reporting on the therapeutic use of medical invertebrates

The first year on ALBOPIn the words of a 29 year old with a few years experience

Thank you to all who support our joint endeavorsThank you to all who support and believe that I can help accomplish wonderful things in this position.

First of all, what do I do???? Hearings on one (or more) Tuesdays

per month from 8am-until… One Wednesday per month for public

Board Meeting, Executive session, Candidates for licensure

Emails, emails, emails Law, law, law, and other things that I

need another degree for. Texts and calls because all of the

sudden I know the answer (LOL)

Secondly, what have I learned? I need to learn more about all of the

groups and laws that involve pharmacy. There are a lot of moving parts.

We all need to get more engaged with our legislators (they know we contribute to better health care – REMIND them!)

Some things just take a lot of time. Sometimes you feel like you are watching paint dry on a humid day.

Enlightenment at how much politics are involved in the profession at times.

Thirdly, how has it changed my outlook on pharmacy? I am very proud of our profession now

and for what it can be. Very heartbroken over the people who

make bad choices. Very proud of those who do make the

right choices and put the patient first.

Lastly, what do I hope for the future in the next 4 ½ years on the board? Collaborative Practice in our State Clarifications or guidance for

pharmacists on laws/rules To make ALBOP rules that will benefit

our patients in Alabama (e.g. 30 day to 90 day rule on maintenance medications)

More prescriber accountability To see some progress in the war

against addiction

Conclusion Working together in

pharmacy we can accomplish much.

Brenda.denson@childrensal.org