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Department of Regulatory Agencies State Board of Pharmacy Policies

Table of Contents

Section 10 – Disciplinary Policies 10-01 Protocol for Complaints………………………………………………..…………………… 3

10-02 Disciplinary Actions by Other Board or Agencies………………………………..……… 4

10-03 Anonymous Complaints…………………………………………………………….……… 5

10-04 Eligibility to Serve as a Practice Monitor……………………………………………….… 6

10-05 Practice Monitoring Compliance Policy………………………………………………...… 7

10-06 Delegation of Authority to Program Director or Section Director……………………… 8

10-07 Cases Dismissed with Letters of Concern…………………………………………….…. 11

10-08 Reinstatement of Suspended Licenses………………………………………………..… 13

10-09 Process for Handling Complaints Involving Board Members………………………..… 14

Section 20 – Licensing Policies 20-01 Reinstatement of Expired Licenses or Registrations…………………………………… 15

20-02 Board Criteria to Identify Applications which Require Board Review……………….… 16

20-03 Administrative Approval of Licenses and Registrations…………………………….….. 17

20-04 Purging Incomplete Applications……………………………………………………..…… 18

20-05 Referral of Applicants and Licenses to Peer Health Assistance Diversion………...… 19

20-07 Administrative Approval of Other Outlet Protocol……………………………………..… 20

20-11 Board Criteria to Identify Wholesaler Applications……………………………………… 21

20-12 Board Criteria to Identify Non-Resident Pharmacy……………………………………… 22

20-13 Approved colleges or Schools of Pharmacy………………………………………...…… 23

20-14 Designation of Clearinghouse for License Transfer…………………………………..… 20-15 Pharmacy Intern Disenrollment from Schools or Colleges of Pharmacy……………..

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Section 30 – Administrative Policies 30-01 Electronic Maintenance of Controlled and Non-Controlled………………………..…… 26

30-03 Approval of Off-Site Store of Record for Pharmacy…………………………………..… 27

30-04 Security Violations……………………………………………………………………..…… 27

30-05 Unregistered Unlicensed Activity……………………………………………………..…… 30

30-06 In-State Prescription Drug Wholesaler Designation………………………………..…… 31

30-07 Prescription Drug Monitoring Program – New Pharmacy…………………………….… 33

30-08 Prescription Drug Monitoring Program – Pharmacies …..…………………………..… 34 1

30-09 In-State Prescription Drug Outlet Pharmacist Manager………………………………… 36

30-10 Issuances of Licenses or Registrations to Facilities with prior C&D’s………………… 38

30-11 Continuing Education Audit……………………………………………………………...… 39

30-12 Nonresident Prescription Drug Outlet Pharmacist Manager Changes……………..… 40

30-13 Out-of-State Wholesaler Designated Representative changes................................... 42

30-14 Failure to Timely Report a Past Disciplinary Action…………………………………….. 44

Section 40 – Miscellaneous Policies 40-01 Continuing Education………………………………………………………………….…… 45

40-02 Policy for Prescribing and Dispensing Opioids……………………………………..…… 46

40-03 Board Approval of Wholesaler Accreditation Body……………………………………… 59

40-04 Appropriateness of Labeling Prescriptions to Patients…………………………….…… 60

40-06 Pharmacy Technician Certification Boards…………………………………………….… 61

40-07 Changes to Schedule II Controlled Substances………………………………………… 62

40-08 Prescriptions Brought in from Home in Hospital………………………………………… 63

40-09 Approved Hospital Residency Programs………………………………………………… 64

40-10 Confidential Agreements to Limit Practice……………………………………………..… 65

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Colorado State Board of Pharmacy Policy

POLICY NUMBER: 10-1 Title: Protocol for Complaints Date Issued: November 16, 2006 Date(s) Revised: 5/15/08, 10/16/08, 4/15/10, 1/20/11, 4/21/11, 9/20/12, 5/18/17 Purpose: To authorize staff to initiate complaints upon receipt of specific types of information POLICY: It is the policy of the Board of Pharmacy that upon receipt of a report or other notification from one of the entities generally described below; staff shall establish a numbered complaint file with the licensee or registrant as the Respondent.. In the event the written notification from the reporting entity does not include a substantive account of the potential unprofessional conduct issues, staff shall either correspond with the reporting entity and request additional information or conduct a preliminary investigation.. The original report, the response, if a letter of complaint has been issued to the Respondent, and any other information which has been collected shall be forwarded to the appropriate staff for review, which may include an investigation. The case will then be placed on an upcoming Board agenda for Board review, if appropriate. This policy shall apply to reports or notifications forwarded to the Board of Pharmacy by or on behalf of the following: Hospitals/HMOs; other DORA agencies; other government agencies (e.g., Department of Corrections, Department of Health, Department of Public Safety, Department of Social Services, US Drug Enforcement Administration, US Department of Health and Human Services, US Department of Justice, the Department of Defense or its component services, the Veterans Administration, other law enforcement agencies); a written report from a Board inspector which details a violation of the Pharmaceuticals and Pharmacists Act and/or the Board’s Rules and Regulations; another state pharmacy board; licensee or registrant; licensee or registrant specialty societies; miscellaneous sources with generally accepted credibility (e.g., Pharmacy Peer Health Assistance Diversion Program); the staff may, in its discretion, bring the information to the attention of the Board for review and further direction prior to issuance of a complaint. In addition, it is the policy of the Board for staff to initiate complaints based upon discovery or knowledge of any of the following:

A.) Applicants/licensees/registrants who submit false information to the Board. In the case of an applicant, the application will not be approved until such time the Board reviews and acts upon the case;

B.) Unlicensed practice of pharmacy; C.) An outlet receiving prescription drugs and/or controlled substances from an unlicensed/unregistered

person or entity; D.) The license of a person in charge of the outlet that receives prescription drugs and/or controlled

substances from an unlicensed/unregistered person or entity, if applicable; E.) Inspection Reports detailing repeated non-compliance. In such instance, complaints shall be initiated

against both the outlet and the Board licensee responsible for the outlet, if applicable; F.) Reports from the inspectors detailing unaccountabilities of drugs. In such instance, complaints shall be

initiated against both the outlet and the Board licensee responsible for the outlet, if applicable; G.) A wholesaler, prescription drug outlet, non-resident prescription drug outlet, or other outlet, failing to

change its designated representative (wholesaler), pharmacist manager (prescription drug outlet or nonresident prescription drug outlet), or consultant pharmacist (other outlet) within the time frames set forth in statute or rule;

H.) Other individuals identified as being responsible for an incident in the course of a complaint investigation; and

I.) Significant dispensing errors discovered by the Board’s inspectors during the normal course of routine pharmacy inspections. The significance of such errors will be determined on a case-by-case basis by the Program Director. In determining the significance of such errors, the Program Director will consider the following factors: wrong drug; wrong strength; wrong patient; or substantially wrong directions for use.

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COLORADO STATE BOARD OF PHARMACY

Policy Number: 10-2

Title: Disciplinary actions taken by other state pharmacy boards or governmental agencies against an expired or inactive Colorado pharmacist license

Date Issued: 11/16/06

Date(s) Revised: 1/17/13

PURPOSE: To clarify action to be taken by Board staff when disciplinary reports are received.

POLICY: It is the policy of the Board of Pharmacy that no investigation will be undertaken in those instances when a report of disciplinary action is received from another state pharmacy board or governmental agency involving a pharmacist who holds a Colorado license that is either expired or inactive. Board staff will place an alert on the record of this individual indicating disciplinary action in another state. At such time as the Colorado pharmacist chooses to apply for reinstatement or reactivation of his or her Colorado license, it shall be the policy of the Board to inquire with the noted jurisdiction as to the pharmacist's disciplinary history. This information shall be presented to the Board in the customary fashion.

Exceptions to this policy may occur at the discretion of the Board when the conduct at issue is such that immediate action is warranted.

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Colorado State Board of Pharmacy

POLICY NUMBER: 10-3 Title: Anonymous Complaints Date Issued: 11/16/2006

PURPOSE: To clarify the Board’s position regarding consideration of anonymous complaints.

POLICY: It is the policy of the Board of Pharmacy to discourage anonymous complaints. Further, the Board will not automatically investigate anonymous complaints. Rather, they will be subject to review on a case-by-case basis.

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Policy Number: 10-4 Title: Eligibility to serve as a practice monitor Date Issued: 11/16/2006

PURPOSE: To clarify when a pharmacist is not eligible to serve as a practice monitor for a licensee or registrant under probation with the Board.

POLICY: It is the policy of the Board of Pharmacy that a pharmacist who has been disciplined by the Board or a pharmacist against whom a formal complaint has been filed by the Attorney General's Office, is not eligible to serve as a practice monitor for another licensee or registrant under probation with the Board. In these instances, Board staff will notify the licensee or registrant under probation that a new practice monitor must be nominated in a timely fashion.

A pharmacist who works for the same employer may not be the practice monitor for another licensee who works for the same employer, whether the two individuals work at the same outlet or not.

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Colorado State Board of Pharmacy POLICY NUMBER: 10-5 Title: Practice Monitoring Compliance Policy Date Issued: 11/16/2006 Date Revised: 1/20/11, 5/18/17

PURPOSE: To provide guidance to Board staff and to licensees practicing pursuant to a Stipulation or Final Board Order requiring practice monitoring as to how the practice monitoring provisions are enforced.

POLICY: Board staff shall notify a licensee or registrant whose practice monitoring report is late by sending correspondence directing the licensee to come into compliance with the terms of the Stipulation or Final Board Order within 14 days. If the licensee does not come into compliance within this time frame, Board staff will initiate a complaint against the licensee.

Non-compliance issues will be reported by Board staff to the Office of the Attorney General as appropriate. Practice monitors whose reports are not timely and complete on at least two occasions shall be deemed to have failed to perform their duties as a practice monitor and may be terminated as the practice monitor at the discretion of the Program Director or his or her designee. If the individual is terminated as the licensee's or registrant’s practice monitor, the licensee shall be instructed to nominate a new practice monitor within thirty days of the date of notification. A licensee's or registrant’s probationary period shall be tolled pursuant to the terms of the Stipulation or Final Board Order.

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Colorado State Board of Pharmacy POLICY NUMBER: 10-6 Title: Delegation of Authority to Program Director Date Issued: 11/16/2006 Dates Revised: 8/21/08, 10/16/08, 9/17/09, 1/21/10, 7/15/2010, 1/20/11, 3/30/2012, 7/1/12, 12/10/12,

1/17/13, 3/21/13, 5/18/17 PURPOSE: To clarify the authority which has been delegated to the Program Director or his/her

designee. POLICY: The Board of Pharmacy has delegated to the Program Director or his/her designee the authority to:

1. Sign Stipulations and Final Agency Orders ("Stipulations") and Final Board Orders ("Final Agency/Board Orders") on its behalf.

2. Issue Final Agency/Board Orders on its behalf when no exceptions are filed to the initial decision, the statutorily allowed time frame for the filing of exceptions has passed, the recommended sanction from the Administrative Law Judge is the same as that sought by the Board, and no further decisions are required by the Board.

3. Process reports of settlement of malpractice claims in the same manner as signed complaints are handled.

4. Accept, on the Board's behalf, practice and treatment monitoring reports and any other such reports submitted as required by the Stipulation or Final Agency/Board Order, provided such reports are in compliance with the terms of the Stipulation or Final Agency/Board Order.

5. Initiate complaints and issue 30-day letters to licensees or registrants currently under Stipulation or Final Agency/Board Order if, in the opinion of the Program Director or his/her designee, the licensee or registrant has failed to comply with any of the terms of the Stipulation or Final Agency/Board Order..

6. Sign Suspension Orders as required by the Child Support Enforcement Program.

7. Subpoena documents and gather information in order to assist the Board in carrying out its duties.

8. Approve practice monitors for licensees and registrants as required pursuant to Stipulations or Final Board Orders.

9. Sign suspension orders on its behalf.

10. Sign cease and desist orders on its behalf.

11. Perform the initial review of complaints relating to the practice of licensees or registrants under the Board's jurisdiction, conduct investigations, and to issue 30-day letters relating to the

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complaints as appropriate...The Program Director or his/her designee, at his or her discretion, may refer the matter to the Board for consideration prior to proceeding.

12. Determine non-substantive procedural matters relating to the rendering of initial decisions, including, but not limited to, granting extensions of time for the filing of exceptions, and granting requests for oral argument.

13. Perform additional delegated duties as set forth in Board policies.

14. Make referrals for assessment to the Pharmacy Peer Health Assistance Diversion Program.

15. Suspend the licenses of individuals under Stipulation or Final Agency/Board Order if licensee is required to participate in the Pharmacy Peer Health Assistance Diversion Program as a requirement of his/her Stipulation or Final Agency/Board Order and fails to comply with his/her contract with the Pharmacy Peer Health Assistance Diversion Program. The Program Director or his/her designee may lift the Board suspension when the licensee has resumed compliance.

16. Release licensees and registrants from the terms of their Stipulations or Final Agency/Board Orders provided the licensee submits satisfactory evidence of completion of all terms of the Stipulation or Final Agency/Board Order. The Program Director or his/her designee, at his/her discretion, may refer any request for discharge to the Board for review.

17. Deny requests from licensees and registrants for discharge from the terms of Stipulations or Final Agency/Board Orders when the licensee or registrant has not completed the terms of the Stipulation or Final Agency/Board Order. Requests for early discharge from Stipulations and Final Agency/Board Orders shall be denied.

18. Suspend the licenses or registrations of facilities which have been ordered to pay a fine pursuant to a Stipulation or Final Agency/Board Order and fail to remit the required payment. In the event the licensee or registrant is to pay the fine in installments, the Program Director or his/her designee may suspend the license or registration if the licensee or registrant fails to remit a required payment. The Program Director or his/her designee may lift the Board suspension on such licenses or registrations when the licensee or registrant has come into compliance with fine requirements.

19. Enter into, on its behalf, written agreements with public or private entities whereby the Board may provide information from the Electronic Prescription Drug Monitoring Program that does not identify a patient, prescriber or dispenser of a prescription drug. Such agreements may only be entered into for the purposes of bona fide research or education pursuant to CRS 12-42.5-404(5).

20. Conduct stakeholder meetings on its behalf prior to the commencement of a rulemaking hearing.

21. Notice, on its behalf, proposed rules or proposed amendments or deletions to rules for a hearing before the board pursuant to CRS 24-4-103.

22. In the absence of additional exculpatory evidence or information not previously before the board, reject any counteroffer from respondents with cases at the Office of Expedited Settlement that is not within the board's settlement parameters.

23. Issue on its behalf, the "Board Procedural Order regarding Review of Initial Decision" upon receipt of an Initial Decision from an Administrative Law Judge at the Office of Administrative Courts.

24. Release information from the Prescription Drug Monitoring Program {"POMP") which is not authorized for release by the POMP statute, now codified at C.R.S. section 12-42.5-401, et. seq., to federal law enforcement officials, upon presentation of a subpoena or court order only if the Program Director,

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Section Director, or his/her designee consults with legal counsel and counsel provides an opinion that the federal law preempts state law in the matter.

25. Order a pharmacist or pharmacy intern to obtain an evaluation pursuant to CRS 12-42.5-204(3) from the Pharmacy Peer Health Assistance Diversion Program when Board staff receives credible information that the licensee may have practiced pharmacy under the influence of drugs or alcohol and/or diverted controlled substances from his or her employer. In the event the pharmacist or pharmacy intern fails to obtain the evaluation within a period of time determined by the Program Director or his or her designee, the Program Director shall summarily suspend the license of the pharmacist or pharmacy intern.

26. Upon receipt of credible evidence that a pharmacist or pharmacy intern may have practiced under the influence of drugs or alcohol and or diverted controlled substances from his or her employer, request that the licensee enter into a Stipulation for Interim Cessation of Practice (“Stipulation”) with the Board. If the licensee fails to enter into such a Stipulation within a period of time determined by the Program Director, the Program Director shall refer the matter to the Office of the Attorney General for Summary Suspension Proceedings.

27. Accept, on the Board's behalf, Confidential Agreements in which a pharmacist or pharmacy intern with a physical or mental illness, who has been determined able to render limited services with reasonable skill and safety, agrees to limit practice based on restrictions imposed by the illness or condition pursuant to Board Policy 40-10.

28. Pursuant to C. R. S. 12-42.5-115, grant six-month compliance extensions to licensees unable to comply with the continuing education requirements set forth in law. Should the licensee fail to complete and submit the required continuing education within the six-month compliance extension, the Program Director or his/her designee shall inactivate the pharmacist's license.

29. Pursuant to C.R.S. 12-42.5-113(3), waive the requirement for registration for a manufacturer that must obtain a non-controlled prescription drug or device solely for use in research, development, or testing. This drug or device may not be further distributed. The manufacturer must submit an affidavit to the Board certifying that the drug or device will only be used for necessary research, development, or testing procedures and will not be further distributed.

30. Approve or disapprove remote pharmacy practice policy and procedure manuals for prescription drug outlets and other outlets pursuant to Board Rule 26.00.00.

31. Unless an emergency, refer matters involving veterinary pharmaceuticals to the Veterinary Pharmaceutical Advisory Committee for a recommendation on how the Board should proceed.

32. Determine, on the Board’s behalf, whether to accept the timely notification of a licensee’s or registrant’s report of disciplinary action in another state, criminal conviction, plea or deferred sentence pursuant to Board Rule 9.00.00 and document into the Board’s records or to initiate a complaint against the licensee or registrant on the basis of the notification of a licensee’s or registrant’s report of disciplinary action in another state, criminal conviction, plea, or deferred sentence.

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POLICY NUMBER: 10-7 Title: Cases Dismissed with Letters of Concern: clarification of basis for

dismissal, reopening of such cases and case retention period Date Issued: March 20, 2008 Date(s) Revised: April 21, 2011 Reference: Purpose: To clarify the basis for this type of dismissal, when the Pharmacy Board

may reopen such a case and designation of a specific retention period for these types of cases.

POLICY: It is the policy of the Colorado State Board of Pharmacy that complaints that are dismissed with letters of concern are not dismissed as being without merit but rather are dismissed due to no reasonable cause to warrant further action at that time. Retention and reopening of such cases shall be handled has follows: 1. Cases, other than those arising for failing to comply with the reporting and/or registration requirements of the Electronic Prescription Drug Monitoring Program, that are dismissed with a letter of concern will be retained in the Pharmacy Board files for a period of five years. The Pharmacy Board may reopen a case that was dismissed with a letter of concern in the face of a change in circumstances. Such a change in circumstances would include but not be limited to:

• discovery of new evidence supporting the underlying charges • evidence that the licensee or registrant has engaged in further unprofessional

conduct/grounds for discipline following issuance of the letter of concern in which there is a nexus between the new conduct and that was addressed in the case that was dismissed with the letter of concern

After five years from the date of the letter of concern, the file will be disposed of in accordance with the Division’s records management procedures. If the licensee has other active cases pending at the end of the five year retention period, the letter of concern may be kept for a longer period of time at the discretion of the Board staff. 2. Cases arising from failure to comply with the reporting and/or registration requirements of the Electronic Prescription Drug Monitoring Program that are dismissed with a letter of concern will be retained in the Pharmacy Board files for a period of three years. The Pharmacy Board may reopen a case that was dismissed with a letter of concern in the face of a change in circumstances. Such a change in circumstances would include but not be limited to:

• discovery of new evidence supporting the underlying charges

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• evidence that the licensee or registrant has engaged in further unprofessional conduct/grounds for discipline following issuance of the letter of concern in which there is a nexus between the new conduct and that was addressed in the case that was dismissed with the letter of concern

After three years from the date of the letter of concern, the file will be disposed of in accordance with the Division’s records management procedures. If the licensee or registrant has other active cases pending at the end of the three year retention period, the letter of concern may be kept for a longer period of time at the discretion of the Board staff.

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POLICY NUMBER:

Title:

Date Issued:

Date(s) Revised:

Reference:

Purpose:


10-8

Reinstatement of Suspended Licenses

January 17, 2013

To clarify the Board's position on reinstating suspended licenses which have expired

POLICY: It is the policy of the Colorado State Board of Pharmacy that individuals whose license is suspended for over five years must take and pass the North American Pharmacist Licensure Examination (NAPLEX) in addition to all other reinstatement requirements prior to their license being returned to an active status.

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Colorado State Board of Pharmacy POLICY NUMBER:

10-9

Title: Process for Handling Complaints Involving Board of Pharmacy Members

Date Issued:

July 16, 2009

Date(s) Revised:

References: Purpose: To provide written notice regarding the process by which specific types of

complaints against current Board members, licensees who have served on the Board within the past five years, or licensees who have an ongoing formal relationship with the Board will be handled. The purpose of this policy is to assure the integrity of the disciplinary process and prevent any appearance of bias or preferential treatment.

POLICY: It is the policy of the Board of Pharmacy that any signed complaint received by the Board against a current licensee who is a member of the Board or one who has served on the Board within the past five years, or a licensee who has an ongoing formal relationship with the Board will be handled as follows:

• If the complaint alleges a violation of the Practice Act, the complaint will be investigated by the Pharmacy Board’s inspectors.

• If the complaint alleges substandard practice, the Office of Investigations will also have the case reviewed by an independent consultant selected by the Office of Investigations.

• If the complaint alleges boundary violations, allegations of substance abuse, or allegations of a physical or mental impairment, the licensee will be required to undergo evaluation by the designated peer assistance provider to the Board.

Upon completion of the investigation, the report will be referred to the Board for appropriate action. If the complaint is against a current board member, he or she shall recuse from all discussions regarding the complaint and physically leave the meeting room during these discussions. All other customary procedures for the handling of a complaint by the Board will apply. These include but are not limited to issuance of a 30-day letter, notification to the licensee and complainant of Board decisions, and the confidentiality of the complaint and investigation as provided by the Practice Act. Anonymous complaints filed against a current licensee who is a member of the Board or one who has served on the Board within the past five years, or a licensee who has an ongoing formal relationship with the Board will be evaluated by the Board in accordance with the Board’s policy regarding anonymous complaints (Policy 10-3).

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Policy Number: 20-1

Title: Reinstatement of Expired Licenses or Registrations


Date(s) Revised: 7/21/11, 7/1/12

PURPOSE: To provide guidance to licensees, registrants and staff regarding the Board's position on reinstatement of an expired license or registration when the licensee has been practicing pharmacy with an expired license or the registrant has been engaging in activity requiring a registration.

POLICY: Pursuant to section 12-42.5-114, C.R.S., a licensee or registrant, who has not timely renewed and wishes to resume practice or engage in activity requiring a registration, must file an application to reinstate the license or registration. If all documentation is in order and no issues arise during the application process which would require Board review, staff is authorized to administratively reinstate the license or registration. If the applicant has practiced or has engaged in activity requiring a registration on an expired license or registration and that license or registration has been expired for 60 days or more, staff shall automatically initiate a complaint against the applicant.

It is also the position of the Board that pharmacists, interns, and registrants must immediately cease practice upon learning that their license or registration has expired. Further, the pharmacist, pharmacy intern, or registration shall not return to practice or conduct activity requiring a registration until the license or registration has been reinstated.

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Colorado State Board of Pharmacy POLICY NUMBER: 20-2 Title: Board Criteria to Identify Applications which Require Board Review Date Issued: 9/21/2006 Date Revised: 10/16/08, 1/20/11 Purpose: To delineate the criteria which will be used by staff in determining whether the application will be reviewed by the Board. 1) Any misdemeanors involving domestic violence that occurred in the last five years will be reviewed by the Board. 2) Any felony pleas, indictments, convictions, deferred prosecutions, deferred sentences, or deferred judgments, irrespective of the date of occurrence will be reviewed by the Board. If, however, the felony charges at issue are for substance abuse, and the applicant has previously been disciplined by another state board for the incident, and documentation is provided that the applicant has completed a board-approved pharmacist recovery program at least five years prior to the application date, the applicant may be licensed by staff. 3) Applicants with two or more alcohol-related convictions or charges within the past five years or three or more such convictions or charges within the past ten years will be directed to obtain an evaluation from Peer Assistance Services. If the evaluation indicates that the individual does not meet the criteria for substance abuse, staff will issue the license. If, however, the evaluation indicated substance abuse issues, the applicant would be referred to the Board. A report of one alcohol-related conviction within the past five years will be approved with a letter regarding alcohol abuse being sent to the applicant. 4) Any applicant who reports that he or she is under investigation by another state board will be reviewed by the Board. 5) An applicant who has been disciplined by another licensing board for substance abuse related issues may be granted a license without Board review if documentation is provided that the applicant has completed a board-approved pharmacist recovery program at least five years prior to the application date. 6) Applicants with a history of two of more disciplinary actions involving dispensing errors within the five years preceding the application will be referred to the Board. Dispensing errors over five years old will not be referred. 7) Applicants with a history of disciplinary action involving recordkeeping issues, such as controlled substance losses, will be referred to the Board. 8) Applicants who appear, in the Program Director’s or his/her designee’s opinion, to have a general pattern of disregard for the law will be referred to the Board. 9) Any applicant whom staff believes has provided false information on an application or otherwise will be referred to the Board.

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Policy Number: 20-3

Title: Administrative Approval of Licenses and Registrations


Date(s) Revised: 1/21/2010, 1/17/13, 3/21/2013

PURPOSE: To allow staff the authority to administratively approve applicants possessing the required credentials necessary for licensure and to process the licensure of these applicants into the database on a timely basis.

POLICY:

The Board delegates to the Program Director, or his/her designee, the authority to license or register pharmacists, interns, in-state prescription drug outlets, nonresident prescription drug outlets, wholesalers, other outlets, manufacturers, hospital satellites, specialized prescription drug outlets, and limited licenses which meet the necessary requirements. Such delegation includes the approval of transfer of ownership, pharmacist manager change, designated representative, relocation, and name change applications for businesses previously registered with the Board.

Applications will be presented to the Board for review when there is uncertainty if requirements are met.

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Policy Number: 20-4 Title: Purging Incomplete Applications Date Issued: 11/16/2006

PURPOSE: To provide staff with guidance regarding the length of time an application will remain open and active.

POLICY:

The Board will hold incomplete applications for licensure or registration open and active for one year from the date of receipt. Failure to complete the application within that time period, unless the Board has required additional information or activities that will take longer than the one year to complete, will result in the application being purged and the application fee being forfeited.

Applicants for a pharmacist license by score transfer must complete licensure within one-year from the date the Board received their scores. Failure to complete the application within that time period will result in the application being purged and the application fee being forfeited.

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Policy Number: 20-5

Title: Referral of Applicants and licensees to the Pharmacy Peer Health Assistance Diversion Program

Date Issued: July 20, 2006

Dates Revised: October 16, 2008, January 21, 2010, January 17, 2013

PURPOSE: To provide direction to staff and notice to applicants of the Board's requirement for evaluation.

POLICY: It is the policy of the Colorado State Board of Pharmacy that Board staff will refer to the Pharmacy Peer Health Assistance Diversion Program for assessment any applicant reporting that he/she has had two or more drug or alcohol related infractions within the previous five years or three or more such infractions within the past ten years. Depending on the results of the assessment, staff may issue the license or refer the applicant to the Board for review.

If the applicant has been disciplined and has completed a board-approved pharmacist recovery program in another state less than five-years prior to application, the applicant shall be referred to the Pharmacy Peer Health Assistance Diversion Program for assessment. Depending on the results of the assessment, Board staff may issue the license or refer the applicant to the Board for review.

Any licensee who Board staff is aware has two or more alcohol-related infractions within the previous five years or three or more such convictions within the previous ten years shall be referred to the Pharmacy Peer Health Assistance Diversion Program for an evaluation. If such licensee fails to comply with the referral within 45 days, the licensee shall be summarily suspended.

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Policy Number: 20-7 Title: Administrative Approval of Other Outlet Protocols


PURPOSE: To allow staff the authority to administratively approve protocols for other outlets.

POLICY: The Board delegates to the Program Director, or his/her designee, the authority to approve or disapprove protocols submitted by other outlets.

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Policy Number: 20-11 Title: Board Criteria to Identify Wholesaler Applications which Require Board Review Date Issued: 8/21/08 Date Revised: 7/16/09 Purpose: To delineate the criteria which will be used to staff in determining whether the application will be reviewed by the Board. 1) Any applications wherein it is disclosed that anybody associated with the application has had two or more alcohol-related infractions within the prior five years or has had three or more such infractions within the past ten years will be referred to the Board. 2) Any application wherein it is disclosed that anybody associated with the application has been involved in criminal activity involving drug diversion, drug smuggling, drug counterfeiting, or drug importation will be referred to the Board, irrespective of when the activity occurred. 3) Any applicant who reports that it is under investigation by another state board will be reviewed by the Board. 4) Applicants who appear to have a general pattern of disregard for the law will be referred to the Board. 5) Any applicant whom staff believes has provided false information on an application or otherwise will be referred to the Board. 6) Applicants reporting disciplinary actions from other state boards of pharmacy within the five years prior to

application will be referred to the Board. (If such action is pursuant to criminal activity involving drug diversion, drug smuggling, drug counterfeiting, or drug importation, the application will be referred to the Board, irrespective of when the activity occurred.)

7) Applicants who report disciplinary actions from either the Food and Drug Administration or Drug

Enforcement Administration within five years prior to application will be referred to the Board. If such action is pursuant to criminal activity involving drug diversion, drug smuggling, drug counterfeiting, or drug importation, the application will be referred to the Board, irrespective of when the activity occurred.)

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Policy Number: 20-12 Title: Board Criteria to Identify Nonresident Pharmacy Applications which Require Board Review Date Issued: 1/15/09 Purpose: To delineate the criteria which will be used to staff in determining whether the application will be referred to the Board. 1) Any applications which disclose disciplinary actions due to controlled substance recordkeeping violations,

dispensing errors, and unlabeled medications will be referred to the Board if the actions occurred within the five years preceding application will be referred to the Board.

2) Any application wherein it is disclosed that anybody associated with the application has been involved in criminal activity involving drug diversion, drug smuggling, drug counterfeiting, or drug importation will be referred to the Board, irrespective of when the activity occurred. 3) Any applicant who reports that it is under investigation by another state board will be referred to the Board. 4) Applicants who appear to have a general pattern of disregard for the law will be referred to the Board. 5) Any applicant whom staff believes has provided false information on an application or otherwise will be referred to the Board.

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POLICY NUMBER: 20-13 Title: Approved Colleges or Schools of Pharmacy Date Issued: April 23, 2009 Date(s) Revised: Reference: Purpose: To clarify the school or colleges of pharmacy which are approved by the

Board. POLICY: The board hereby approves schools or colleges of pharmacy that are accredited by the Accreditation Council for Pharmacy Education (“ACPE”). Graduates from ACPE-approved programs, no matter where the program is located, may take an examination before the Board.

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POLICY NUMBER:

Title:

Date Issued: Date(s) Revised:

Reference:

Purpose:

20-14

Designation of Clearinghouse for License Transfer (Endorsement) Applicants

March 21, 2013

To designate the clearinghouse for applicants applying for pharmacist licensure by license transfer (endorsement).

POLICY: As required by C.R.S. 12-42.5-112(8), the Board hereby designates the NABP Clearinghouse to be utilized by applicants applying for pharmacist licensure by license transfer (endorsement). Information may be obtained at www.nabp.net.

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Policy Number: 20-15

Title: Pharmacy Intern Disenrollment from Schools or Colleges of Pharmacy

Date Issued:

Date(s) Revised:

PURPOSE: To provide guidance to pharmacy interns, schools and colleges of pharmacy, and Board staff of procedures to be followed when a Colorado-licensed pharmacy intern disenrolls from a school or college of pharmacy.

POLICY: Upon the Board receiving notification that a actively licensed Colorado pharmacy intern is no longer enrolled in a school or college of pharmacy, Board staff will offer, by letter, the affected pharmacy intern an opportunity to cancel his or her license with the Board. If no written response to the offer to cancel the license is received by the Board within 30 days of the date of the offer, Board staff will initiate a case and refer the matter to the Expedited Settlement Program to offer the intern a stipulation and final agency order for relinquishment of the pharmacy intern’s license. If the pharmacy intern does not accept a relinquishment stipulation and final agency order within 30 days of such an offer, ESP shall send the matter back to the Board, whereupon Board staff shall refer the matter to the Office of the Attorney General for initiation of formal proceedings for revocation and a hearing held in accordance with section 24-4-104(9), C.R.S.

At any time in this process, the Program Director or designee, at his or her discretion, may refer such a matter to the Board for review.

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Policy Number: 30-1

Title: Electronic maintenance of Schedule III, IV, and V Controlled substance and Non-Controlled Substance Orders

Date Issued: March 17, 2005, revised May 18, 2006, October 18, 2007, December 12, 2011, & March 19, 2015

PURPOSE: To delineate the criteria by which Board staff uses to approve electronic maintenance of orders.

Policy: Board staff may use the following criteria to approve or disapprove the electronic maintenance of schedule III, IV, and V controlled substance and non-controlled orders in prescription drug outlets: 1) The pharmacy’s computer system must be backed up every 24 hours. 2) The orders must be electronically imaged into the system as soon as received and prior to dispensing. 3) The electronically imaged order cannot be edited. 4) The electronically imaged orders must be electronically available and legible to the naked eye for at least

two years from the date of the last transaction of the order. 5) The Board or its inspectors must have access to the orders without delay. The pharmacy must provide a

terminal and staff to assist. 6) The pharmacy is following its posted method of recording the identities of pharmacists conducting the

initial interpretation of orders and corresponding refills as well as the final evaluation of corresponding prescriptions and refills.

7) The orders must indicate the serial number assigned to the order, the date of dispensing, the appropriate information regarding substitution, if applicable, and clarifications to the order, if applicable. If a schedule III, IV, and V controlled substance prescription order, the order also must indicate the address of the practitioner and patient as well as the individual DEA registration number of the practitioner.

8) All order information must be printable upon request. 9) If there are software revisions or enhancements, the system must be capable of complying with the

items listed above. 10) The computer system shall be capable of displaying, printing or creating a readily retrievable report that

allows for the review of at least 600 orders per hour. 11) All original copies of schedule III, IV, and V controlled substance prescription orders shall still be

maintained on the premises for not less than two years. 12) All electronically transmitted prescription orders shall be electronically available and legible for at least

two years from the date of latest transaction related to the order. 13) A copy of the approval letter from the Board must be posted in the pharmacy next to the prescription

drug outlet registration.

The Program Director, or his or her designee, may immediately suspend or withdraw any prior approval of a pharmacy to electronically maintain schedule III, IV, and V controlled substance and non-controlled substance prescription orders if one or more of the following are determined during the course of an inspection or investigation:

A. Electronically imaged orders are in fact being edited; B. Imaged orders are not consistently available in electronic form for the past 2 years; C. No terminal or staff is available to the inspector to review orders; D. Order information cannot be consistently printed; or E. The computer system is not capable of displaying for review at least 600 orders per hour.

In such instance, the pharmacy must maintain all hard-copy prescription orders in one of three separate files (one for non-controlled substance orders, another for schedule III, IV and V controlled substance orders, and another for schedule II controlled substance orders) and in numerical sequence by serial number as assigned to each order by the pharmacy until it receives written re-approval to maintain them electronically.

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Policy Number: 30-3

Title: Approval of Off-Site Storage of Records for Pharmacies


PURPOSE: To allow the Program Director or his/her designee to approve or disapprove off-site storage of records for pharmacies.

Policy:

The Program Director or his/her designee to approve or disapprove the off-site storage of records for pharmacies if the pharmacy meets the following requirements:

1. The off-site storage of executed DEA 222 forms, required controlled substance inventories, controlled substance prescription orders, and controlled substance LTCF chart orders for the two years preceding a request will not be allowed.

2. The off-site storage of a pharmacy’s employee list and any other list detailing symbols and codes as

required by regulations 11.08.00 and 11.09.00, respectively, will not be allowed.

3. If approval for the off-site storage of all other required records (not detailed in Items 1 and 2 above) is granted, each pharmacy shall, at all times, maintain all required records on the premises of the pharmacy for the preceding six months..

4. After six months, the storage of the remaining required records (not detailed in Items 1 and 2 above)

for the two years proceeding a request shall meet the following requirements:

A. The off-site storage of records shall be stored in such a manner so as to restrict unauthorized access.

B. The off-site storage of records shall be stored in a climate-controlled environment which

maintains the physical (i.e. – readable) integrity of the records.

C. All required records maintained at an approved off-site location shall be readily available upon request of the Board or its staff within 48 hours of the request.

D. Only one location may be used for off-site record keeping storage. The name, address,

phone number, and contact person will be detailed on a Board issued approval letter. This letter shall be posted next to the current pharmacy registration with this Board. The pharmacist manager shall notify the Board in writing within 48 hours of any change in this information and, if approved, a new approval letter will be issued.

E. The DEA registrant must send a notice declaring the off-site storage of controlled

substance records to the Special Agent in Charge of the DEA in the area where the registrant is located.

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Policy Number: 30-4

Title: Security Violations

Date Issued: January 15, 2009

Revised: July 1, 2012

PURPOSE: To provide guidance to licensees and prescription drug outlets (“pharmacies”) on the disciplinary sanctions surrounding the failure to maintain proper security of pharmacies. Additionally, the Board delegates the disposition of complaints (cases) arising from security violations as detailed below.

POLICY:

Board staff will initiate a complaint (case) against the license of a pharmacist when it receives information that the licensee failed to secure the pharmacy when leaving for the day. An example of this would be, but is not limited to, closing the gates, but failing to secure them. Disposition of such a case will be handled as follows:

a) For the first complaint against the pharmacist for such activity, and the pharmacist admits the oversight, the complaint will be dismissed with a confidential letter of concern.

b) For the second complaint against the same pharmacist for such activity, and the pharmacist admits the oversights, the pharmacist will be disciplined with a Letter of Admonition.

c) In the event the pharmacist contests the allegations, the complaint and response will be referred to the Board for disposition in the regular course of business.

d) Any subsequent complaints for such activity will be referred to the Board for disposition in the regular course of business.

Board staff will initiate a complaint (case) against the license of a pharmacist when it receives information that the licensee has failed to properly secure the pharmacy and leaves the building while the pharmacy remains open and no other pharmacist is present. Examples of this would be, but are not limited to, leaving the pharmacy open (with no other pharmacist present) and leaving the building to run an errand or eat lunch.

e) For the first complaint against the pharmacist for such activity, and the pharmacist admits the activity, the pharmacist will be disciplined with a Letter of Admonition.

f) In the event the pharmacist contests the allegations, the complaint and response will be referred to the Board for disposition in the regular course of business.

g) Any subsequent complaints for such activity will be referred to the Board for disposition in the regular course of business.

Board staff will initiate a complaint against the registration of a pharmacy when it is made aware that the security of a pharmacy has been breached by a non-pharmacist for a non-emergency reason. Examples of activity that would lead to a complaint include, but are not limited to, a non-pharmacist entering the pharmacy without a pharmacist being present to obtain a prescription for a patient to pick up, or to close the cash register.

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h) For the first complaint against the pharmacy for such activity, and the pharmacy admits that such activity occurred, Board staff will issue a Letter of Admonition.

i) For the second complaint against the pharmacy for such activity, and the pharmacy admits that such activity occurred, Board staff will refer the matter to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable $500 fine and agreement from the pharmacy that it will comply with all security requirements in the future. If ESP fails to obtain settlement, the matter will be referred to the Office of the Attorney General (“OAG”) with the same guidance.

j) In the event the pharmacy contests the allegations, the complaint and response will be referred to the Board for disposition in the regular course of business.

k) Any subsequent complaints for such activity will be referred to the Board for disposition in the regular course of business.

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Policy Number: 30-5

Title: Unregistered/Unlicensed Activity


Dates Revised: April21, 2011, July 1, 2012, March 21,2013

PURPOSE: To delegate to Board staff the authority to issue Cease and Desist Orders and in certain instances, as detailed below, to issue complaints against entities who are conducting business in the State of Colorado without the required license or registration or to unlicensed individuals who have been found to be practicing pharmacy at a Boardregistered prescription drug outlet in the State of Colorado.

POLICY:

Upon credible evidence as presented in written complaint that an entity is acting or has acted without the required license or registration or that an unlicensed individual is practicing or has practiced pharmacy at a Board-registered prescription drug outlet located in the State of Colorado, and upon verification of a lack of a license or registration through a review of the Board's license or registration records, Board staff shall issue the entity or individual a Cease and Desist Order as allowed under CRS 12-42.5-124(9).

Upon credible evidence of existence of a license or registration issued prior to the issuance of the Cease and Desist Order, Board staff may vacate the entry of the Cease and Desist Order.

Upon credible evidence, as presented in a written report, that an entity is acting or has acted outside the scope of its current Board registration, in addition to the Issuance of a Cease and Desist Order as allowed under CRS 12-42.5-124(9), Board staff shall initiate a complaint against the outlet. This may include, but is not limited to, the following examples:

• A nonresident pharmacy registered in State of Colorado which delivers drugs into Colorado without a valid, patient-specific prescription order;

• An out-of-state prescription drug wholesaler registered in the State of Colorado which distributes drugs into Colorado that are not approved to be introduced into interstate commerce under federal law.

Upon credible evidence of the existence of a license or registration issued prior to initiating the complaint, Board staff shall dismiss the complaint as being without merit.

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Policy Number: 30-6

Title: In-State Prescription Drug Wholesaler Designated Representative Changes


Dates Revised: October 21, 2010, April 21, 2011, July 1, 2012, January 19, 2017

PURPOSE:

To delegate to board staff structured settlement authority to administratively handle complaints in cases where in-state prescription drug wholesalers fail to submit the proper application and fee to change a designated representative within fourteen days of the previous designated representative leaving that position as required by Board rule. This policy delegates to Board staff the disposition of such complaints (cases) by settling them as detailed below, potentially eliminating the need for direct involvement of the Board.

POLICY:

Note: This policy does not apply to in-state prescription drug wholesalers who distribute prescription drugs or controlled substances into Colorado intended for animal use.

For the first instance of an in-state prescription drug wholesaler failing to make application and pay the required fee within 14-days of the previous designated representative leaving the position, the matter will be handled as follows:

a) Board staff will initiate a complaint (case) against the registration of the in-state prescription drug wholesaler.

b) If the wholesaler provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

c) If the wholesaler does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous designated representative leaving, the complaint will be dismissed with a confidential letter of concern.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous designated representative leaving, Board staff will issue a Letter of Admonition to the wholesaler.

iii) If the application and fee are received by the Board on or after the 60th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter,

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the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

For the second instance of an in-state prescription drug wholesaler failing to make application and pay the required fee within 14-days of the previous designated representative leaving the position, the matter will be handled as follows:

d) Board staff will initiate a complaint (case) against the registration of the in-state prescription drug wholesaler.

e) If the wholesaler provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

f) If the wholesaler does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $5000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

iii) If the application and fee are received by the Board on or after the 60th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $6000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

g) This policy is intended as settlement guidance only and is not intended to deprive the Board of its authority to exercise discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle under the above terms and proceeds to a hearing.

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Policy Number: 30-7 Title: Prescription Drug Monitoring Program— New Pharmacies that Fail to Register and Submit Data Date Issued: January 15, 2009 Revised: January 21, 2010, April 21, 2011, July 1, 2012, January 15, 2015 _____________________________________________________________________________ PURPOSE: To delegate to Board staff structured settlement authority to administratively handle complaints which arise from pharmacies failing to comply with the registration and data submission requirements of the Prescription Drug Monitoring Program (“PDMP”) after becoming registered as a prescription drug outlet (“PDO”) or non-resident prescription drug outlet (“OSP”), hereafter referred to as pharmacy or pharmacies, with the Colorado State Board of Pharmacy. _____________________________________________________________________________ POLICY: Board staff will follow the following process: a) Board staff will send notification to all newly registered pharmacies notifying them of the

PDMP registration and data submission requirements. The pharmacy will be given thirty days to register and begin daily data submission.

b) If, after thirty days, the pharmacy has failed to register with the PDMP and begin daily data

submission, Board staff will initiate a complaint against the pharmacy’s board registration a complaint will be initiated against the pharmacy. The pharmacy shall have thirty days within which to respond to the complaint. The case will be processed as follows:

i) If, within thirty days from the due date of the response to the complaint, the

pharmacy registers with the PDMP and maintains daily data upload compliance for one consecutive week, the case will be dismissed with a confidential letter of concern. Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection B of Board Policy 30-8.

ii) If, within thirty days from the date of the response to the complaint, the pharmacy

fails to register with the PDMP or to maintain daily data submission compliance for one consecutive week, Board staff will issue a Letter of Admonition to the pharmacy. Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection C of Board Policy 30-8.

c) This policy is intended as settlement guidance only and is not intended to deprive the

board of its authority to exercise discretion in the event a case does not settle under the above terms and proceeds to a hearing.

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Policy Number: 30-8

Title: Prescription Drug Monitoring Program—Pharmacies that Fail to Submit Required Data to the Prescription Drug Monitoring Program


Revised: November 19, 2009, April 21, 2011, July 1, 2012, January 15, 2015

PURPOSE: To delegate to Board staff structured settlement authority to administratively handle complaints which arise from pharmacies (both prescription drug outlets and nonresident prescription drug outlets) which fail to comply with the data submission requirements of the Prescription Drug Monitoring Program (“PDMP”) on either a first time or repeated basis.

POLICY: Board staff shall follow the process set forth below when processing instances wherein either in-state or nonresident prescription drug outlets fail to maintain compliance with the reporting requirements of the PDMP.

A. Pharmacies with no record of prior actions by the Board for failure to comply with the reporting requirements of the PDMP.

Pharmacies with no record of prior actions by the Board for previous failure(s) to comply with the data submission requirements of the PDMP will be sent a warning letter directing them to come into compliance within 14 days. This shall be referred to as the “14-day letter.” Disposition of matters involving a 14-day letter will be handled as follows:

1) Compliance Following 14-Day Letter. If the pharmacy comes into compliance and maintains compliance for one consecutive week of reporting following the date of the 14-day letter, no further action will be taken on the 14-day letter.

2) Failure to Comply Following 14-Day Letter. If the pharmacy fails to come into compliance and to maintain compliance for one consecutive week of reporting following the date of the 14-day letter, a complaint will be initiated against the pharmacy. The pharmacy shall have thirty days within which to respond to the complaint. The case will be processed as follows.

a) If the pharmacy comes into compliance and maintains compliance for one consecutive week of reporting following the due date of the complaint response, the complaint will be dismissed with a confidential letter of concern (LOC). Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection B below.

b) If the pharmacy fails to come into compliance and maintain compliance for one consecutive week of reporting following the due date of the complaint response, Board staff will issue a Letter of Admonition to the pharmacy. Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection C below.

3) Compliance During Twelve-Month Period Following 14-Day Letter where no prior LOC’s issued.

a) If the pharmacy has come into compliance with a 14-day letter, has maintained complete compliance for a period of at least twelve months following the date of a 14-day letter and thereafter falls out of compliance, a new 14-day letter shall be issued and the pharmacy shall be given the opportunity to come into compliance pursuant to this subsection A.

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b) If the pharmacy has come into compliance with a 14-day letter but fails to maintain complete compliance for a period of at least twelve months following the date of a 14-day letter, a second 14-day letter will not be issued and a complaint will be initiated against the pharmacy. The pharmacy shall have thirty days within which to respond to the complaint. The case will be processed as follows:

i) If the pharmacy comes into compliance and maintains compliance for one consecutive week of reporting following the due date of the complaint response, the complaint will be dismissed with an LOC. Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection B below.

ii) If the pharmacy fails to come into compliance and maintain compliance for one consecutive week of reporting following the due date of the complaint response, Board staff will issue a Letter of Admonition to the pharmacy. Subsequent instances of failure to maintain complete compliance will be processed in accordance with subsection C below.

B. Pharmacies with prior LOC and no prior disciplinary action for noncompliance.

In the event of any instances of non-compliance within three years following a prior LOC against a pharmacy, no 14-day letter will be issued and Board staff will open a new case. Board staff will issue a Letter of Admonition to the pharmacy. C. Pharmacies with one or more prior disciplinary actions for non-compliance.

In the event of any instances of non-compliance with the PDMP reporting requirements by a pharmacy with one or more prior disciplinary actions for noncompliance, no 14-day letter will be issued and no complaint will be initiated. Board staff will open a case and automatically refer it as a disciplinary action to ESP with settlement guidance requiring one of the following:

Payment of a non-negotiable $1,000 fine plus any surcharge as required by the Executive Director at relevant times pursuant to §24-34-108, C.R.S. and agreement to comply with the data submission requirements of the PDMP, or relinquishment of registration.

Should the pharmacy decline settlement of the matter on the above terms, the case will be referred to the

Office of the Attorney General with the same terms as settlement guidance. D. This policy is intended as settlement guidance only and is not intended to deprive the Board of its authority to exercise discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle and proceeds to a hearing.

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Policy Number: 30-9

Title: In-State Prescription Drug Outlet Pharmacist Manager Changes


Dates Revised: July 15, 2010, April 21, 2011, July 1, 2012

PURPOSE:

To delegate to board staff structured settlement authority to administratively handle complaints in cases where in-state prescription drug outlets ("pharmacy" or "pharmacies") fail to submit the proper application and fee to change a pharmacist manager within thirty days of the previous pharmacist manager leaving that position as required by law and rule. This policy delegates to Board staff the disposition of such complaints (cases) by settling them as detailed below, potentially eliminating the need for direct involvement of the Board.

POLICY:

For the first instance of a pharmacy failing to make application and pay the required fee within 30-days of the previous manager leaving the position, the matter will be handled as follows:

a) Board staff will initiate a complaint (case) against the registration of the pharmacy.

b) If the phannacy provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

c) If the pharmacy does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous phannacist manager leaving, the complaint will be dismissed with a confidential letter of concern.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous pharmacist manager leaving, the pharmacy will be issued a Letter of Admonition.

iii) If the application and fee are received by the Board on or after the soth day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement ("ESP") with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all pharmacist manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General with the same settlement guidance.

For the second instance of a pharmacy failing to make application and pay the required fee within 30-days of the previous manager leaving the position, the matter will be handled as follows:

d) Board staff will initiate a complaint (case) against the registration of the pharmacy.

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e) If the pharmacy provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

f) If the pharmacy does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement ("ESP") with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General ("OAG") with the same settlement guidance.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement ("ESP") with guidance for a non-negotiable fine of $5000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General ("OAG") with the same settlement guidance.

iii) If the application and fee are received by the Board on or after the soth day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement ("ESP") with guidance for a non-negotiable fine of $6000 and agreement for future compliance with all pharmacist manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General with the same settlement guidance.


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Title: Issuance of Licenses or Registrations to Facilities with Prior Cease and Desist Orders

Date Issued: February 2, 2009

Date Revised: April 20, 2011

PURPOSE: To delegate to Board staff the authority to deny the applications for licensure or registration of facilities with previous Cease and Desist Orders and, at its discretion, offer the applicant a stipulated license or registration.

POLICY:

Upon receipt of an application for a facility which has been the recipient of a previous Cease and Desist Order for unlicensed/unregistered activities, Board staff may deny the license or registration and, at its discretion, offer the applicant a stipulated license or registration with the following terms and conditions:

• Payment of a non-negotiable $5000 fine; and • Stipulated Agreement to comply with all applicable Colorado laws and rules at all times while licensed or

registered by the Board.

Board staff, at its discretion, may refer any application to the Board for review.

This policy is intended as settlement guidance only and is not intended to deprive the Board of its authority to exercise discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle under the above terms and proceeds to a hearing.

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Title: Continuing Education Audit


5/17/12 Date(s) Revised:

PURPOSE:

POLICY:

To provide structured guidance to Board staff on handling the Continuing Education ("CE") audit and complaints that arise from such audit.

After the completion of each two year renewal period, which for the purpose of this policy includes the 60-day grace period required by statute, Board staff shall randomly audit up to 5% of actively licensed pharmacists with Colorado addresses. This 5% will not include those individuals who, during the course of renewal, requested a six-month extension.

Board staff will send letters to those pharmacists selected for audit directing each selected pharmacist to submit proof of completion of 24 hours of CE within the renewal period or explain why the selected pharmacist was exempt from the CE requirement. Responses must be submitted within 30 days from the date of the letter.

If the selected pharmacist does not submit proof of the required CE within the 30-day period or explain why the pharmacist was exempt from the CE requirement, Board staff will initiate a complaint against the license of the pharmacist for failing to complete the required CE, and, if appropriate, providing false information to the Board during renewal. The pharmacist shall be issued a 30-day letter.

Disposition of such complaints shall be handled as follows:

1) If the response to the complaint includes proof that 24 hours of CE has been completed but was not completed within the renewal period, Board staff shall dismiss the matter with a confidential letter of concern. Any portion of CE completed after the renewal period may not be used for subsequent renewal of the license.

2) If the response to the complaint includes proof that the pharmacist either completed 24 hours of CE within the renewal period or was statutorily exempt from the CE requirement, Board staff shall dismiss the matter as being without merit.

3) Should the pharmacist fail to provide proof that either the pharmacist completed 24 hours of CE within the renewal period or otherwise, or that the pharmacist was statutorily exempt from the CE requirement, the complaint shall be referred to the Office of Expedited Settlement ("ESP") with the following settlement guidance:

a) Non-negotiable probationary stipulation to include a requirement that the pharmacist complete and submit to the Board proof of completion of any remaining amount of the required CE within 30-days from the effective day of the order. Failure to complete the required CE will result in suspension of the pharmacist's license until which point he or she submits proof of the required CE. Any CE obtained for compliance with the stipulation may not be used for subsequent renewal of the license.

b) Should ESP fail to obtain a settlement in the matter, the case will be referred to the Office of the Attorney General with the same settlement guidance.

4) This policy is intended as settlement guidance only and it is not intended to deprive the Board of its authority to exercise its discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle and proceeds to a hearing.

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POLICY NUMBER: 30-12

Title: Nonresident Prescription Drug Outlet Pharmacist Manager Changes


Date Revised: 4/21/11, 7/1/2012

PURPOSE:

To delegate to board staff structured settlement authority to administratively handle complaints in cases where nonresident prescription drug outlets (“pharmacy” or “pharmacies”) fail to submit the proper application and fee to change a pharmacist manager within thirty days of the previous pharmacist manager leaving that position as required by Board rule. This policy delegates to Board staff the disposition of such complaints (cases) by settling them as detailed below, potentially eliminating the need for direct involvement of the Board.

POLICY:

For the first instance of a nonresident prescription drug outlet failing to make application and pay the required fee within 30-days of the previous manager leaving the position, the matter will be handled as follows:

a) Board staff will initiate a complaint (case) against the registration of the nonresident prescription drug outlet.

b) If the pharmacy provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

c) If the pharmacy does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous pharmacist manager leaving, the complaint will be dismissed with a confidential letter of concern.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous pharmacist manager leaving, a Letter of Admonition will be issued to the pharmacy.

iii) If the application and fee are received by the Board on or after the 60th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

For the second instance of a nonresident prescription drug outlet failing to make application and pay the required fee within 30-days of the previous manager leaving the position, the matter will be handled as follows:

d) Board staff will initiate a complaint (case) against the registration of the nonresident prescription drug outlet.

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e) If the pharmacy provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

f) If the pharmacy does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the pharmacist manager, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $5000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

iii) If the application and fee are received by the Board on or after the 60th day following the previous pharmacist manager leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $6000 and agreement for future compliance with all manager changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.


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Title: Out-of-State Prescription Drug Wholesaler Designated Representative Changes

Date Issued: October 21, 2010

Date Revised: April 21, 2011, July 1, 2012, January 19, 2017

PURPOSE: To delegate to board staff structured settlement authority to administratively handle complaints in cases where out-of-state prescription drug wholesalers fail to submit the proper application and fee to change a designated representative within fourteen days of the previous designated representative leaving that position as required by Board rule. This policy delegates to Board staff the disposition of such complaints (cases) by settling them as detailed below, potentially eliminating the need for direct involvement of the Board.

POLICY:

Note: This policy does not apply to out-of-state prescription drug wholesalers who distribute prescription drugs or controlled substances into Colorado intended for animal use.

For the first instance of an out-of-state prescription drug wholesaler failing to make application and pay the required fee within 14-days of the previous designated representative leaving the position, the matter will be handled as follows:

a) Board staff will initiate a complaint (case) against the registration of the out-of-state prescription drug wholesaler.

b) If the out-of-state prescription drug wholesaler provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

c) If the out-of-state prescription drug wholesaler does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or does not contest the alleged failure to make the application and fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous designated representative leaving, the complaint will be dismissed with a confidential letter of concern.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous designated representative leaving, a Letter of Admonition will be issued.


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For the second instance of an out-of-state prescription drug wholesaler failing to make application and pay the required fee within 14-days of the previous designated representative leaving the position, the matter will be handled as follows:

d) Board staff will initiate a complaint (case) against the registration of the out-of-state prescription drug wholesaler.

e) If the out-of-state prescription drug wholesaler provides credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or contests the alleged failure to make the application and pay the fee, the complaint and response shall be referred to the Board for disposition in the regular course of business.

f) If the out-of-state prescription drug wholesaler does not provide credible evidence in its response to the complaint that it submitted a timely application and fee to the Board to change the designated representative, or does not contest the alleged failure to make the application and pay the fee, disposition of the case will occur as follows:

i) If the application and fee are received by the Board by the 45th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $1000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.

ii) If the application and fee are received by the Board from the 46th through the 59th day following the previous designated representative leaving, the case will be referred to the Office of Expedited Settlement (“ESP”) with guidance for a non-negotiable fine of $5000 and agreement for future compliance with all designated representative changes. Should ESP fail to obtain a settlement in the matter, the matter shall be referred to the Office of the Attorney General (“OAG”) with the same settlement guidance.


g) This policy it intended as settlement guidance only and is not intended to deprive the Board of its authority to exercise discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle under the above terms and proceeds to a hearing.

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Title: Failure to Timely Report a Past Disciplinary Action, Conviction, Plea or Deferred Judgment

Date Issued: March 19, 2015

Date Revised:

PURPOSE: To delegate to Board staff the handling of instances in which a licensee or registrant fails to timely report to the Board a past disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state. Specifically, Board Rule 9.00.10 requires all Board licensees and registrants to report to the Board any disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state within 30 days of the effective date of the discipline, conviction, plea or deferred sentence.

POLICY:

For the first instance of a licensee or registrant who fails to timely report to the Board a past disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state:

a) Board staff will initiate a complaint (case) against the licensee or registrant, and then dismiss the complaint with a Confidential Letter of Concern.

For the second instance of a licensee or registrant who fails to timely report to the Board a past disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state (after a Confidential Letter of Concern was issued for a first occurrence):

a) Board staff will initiate a complaint (case) against the licensee or registrant, and then issue a Letter of Admonition to the licensee or registrant.

For a third or subsequent instance of a licensee or registrant who fails to timely report to the Board a past disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state, Board staff will refer the matter to the Board for its review.

Regardless of a first, second or subsequent instance of a licensee or registrant who fails to timely report to the Board a past disciplinary action in another state or a criminal conviction, plea or deferred sentence in any state, Board staff may refer the matter to the Board if, in the opinion of the Board’s staff, the incidence(s) that led to the discipline, conviction, plea or deferred sentence requires the Board’s review.

This policy is intended as settlement guidance only and is not intended to deprive the Board of its authority to exercise discretion in seeking a penalty within the range of reasonable alternatives in the event a case does not settle under the above terms and proceeds to a hearing.

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Policy Number: 40-1

Title: Continuing Education


Date(s) revised: 10/18/07, 1/21/10,7/1/12

PURPOSE: To provide guidance to Board staff and licensees as to the continuing education credits accepted by the Colorado State Board of Pharmacy

POLICY:

The Colorado State Board of Pharmacy requires 24 hours of continuing education for license renewal pursuant to CRS 12-42.5-115. Up to six hours of pharmacy-related hours approved by the Accreditation Council for Continuing Medical Education ("CME") may be obtained to meet the requirement. All other hours must be approved by the Accreditation Council for Pharmacy Education ("ACPE").

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Policy for Prescribing and Dispensing Opioids

Colorado Dental Board, Colorado Medical Board, State Board of Nursing, and State Board of Pharmacy In collaboration with the Nurse-Physician Advisory Task Force for Colorado Healthcare

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PREAMBLE Prescribing and dispensing medication for the appropriate treatment of pain is a priority for Colorado healthcare providers. However, in 2013 the misuse and abuse of prescription opioids became a public health epidemic in the United States in general, and Colorado in particular, leading to drug addiction, death from overdose, and increased costs to society. In order to address this crisis, the Colorado Dental Board, Colorado Medical Board, State Board of Nursing, State Board of Pharmacy, and the Nurse-Physician Advisory Task Force for Colorado Healthcare collaborated to identify opportunities and provide meaningful guidance to prescribers and dispensers in Colorado. The Boards recognize that reversing the trend of opioid misuse and abuse requires coordinated efforts to increase public awareness, take-back events for safe disposal, addiction treatment and recovery options, and enforcement, among others. The Boards and the practitioners they license are one part of a multi-pronged solution. The Boards recognize the complexities faced by prescribers in the appropriate management of pain.1 The demands on practitioners considering opioid prescribing differ depending on patient diagnosis, practice settings, and/or conditions. Importantly, long-term therapies addressing cancer-related treatment, palliative and/or hospice care involve different considerations from short-term therapies appropriate for acute or chronic non-cancer pain. Pain and addiction specialists play an important role in healthcare and the communities they serve to compassionately and safely care for patients. Many of the tools and practices referenced in this policy were developed by such specialists. The need for therapeutic care of pain in Colorado patients exceeds the supply of specialists in the state. However, other types of providers can successfully treat many painful conditions and achieve the function and relief the patient seeks. Accordingly, this policy is intended to educate prescribers and dispensers broadly by providing useful tools that may be utilized at the point-of-care to support clinical decision making. The Boards further recognize that decreasing opioid misuse and abuse in Colorado should be addressed by collaborative and constructive policies aimed at improving prescriber education and practice, decreasing diversion, and establishing the same guidelines for all opioid prescribers and dispensers. This includes opioid therapies for both acute and chronic non-cancer pain, 2 because the Boards find that treatment for pain often does not fall clearly into one category or another.

1 “Boards” as used in this policy means the Boards overseeing prescribing and dispensing of opioids and involved in the drafting of this policy: the Colorado Medical Board, State Board of Nursing, Colorado Dental Board, and the State Board of Pharmacy. 2 Pain is categorized by a number of descriptors ranging from duration, impact, or physiological response, among others. For the purpose of this policy, the term "chronic, non-cancer pain" is utilized to refer to pain that lasts longer than 90 days and is non-terminal. It does not include conditions such as cancer, scleroderma, multiple sclerosis, muscular dystrophy, or rheumatoid arthritis.

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Diversion and “doctor shopping” accounts for 40% of drug overdose deaths.3 To address the dual issues of access to appropriate pain management and opioid-related adverse outcomes, prescribers have dual obligations: to manage pain and improve function while reducing problems resulting from misuse and abuse of prescription opioids in the patient and community. Pharmacists share a corresponding responsibility with the prescriber to assure that a prescription order is valid in all respects and is appropriate for the patient and condition being treated. Therefore, the Boards have agreed to the following guidelines regarding opioid prescriptions in Colorado. Providers prescribing and/or dispensing opioids should:

● Follow the same guidelines ● Use the Colorado Prescription Drug Monitoring Program (PDMP) ● Be informed about evidence-based practices for opioid use in healthcare and

risk mitigation ● Educate patients on appropriate use, storage and disposal of opioids, risks and

the potential for diversion ● Collaborate within the integrated healthcare team to decrease over-prescribing,

misuse and abuse of opioids. Opioid prescribers and dispensers must conform to the regulations set forth by the respective licensing board and other laws. To this end, we, the Boards regulating the prescribers and dispensers in Colorado, have developed this joint policy incorporating the guidelines above. This policy provides guidelines, and does not set a standard of care for prescribers and dispensers. This policy represents the Boards’ current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind Boards or the public. Prescribers may use an alternative approach if the approach satisfies the requirements of the applicable statutes, regulations, and standard of care. The Boards will refer to current clinical practice guidelines and expert review in approaching cases involving the management of pain. 4

3 Paulozzi, L., Baldwin, G., Franklin, G., Ghiya, N., & Popovic, T. (2012). CDC Grand Rounds: Prescription drug overdoses — a U.S. epidemic. Center for Disease Control and Prevention, Morbidity and Mortality Weekly Report (MMWR), 61(01), 10-13. Retrieved from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6101a3.htm 4 A “policy” is adopted by a board to provide guidance to licensees regarding the board’s position on various

subjects. Policies are unlike statutes or rules in that they are not law. Conversely, “board rules” have the force of law and set forth requirements to which licensees must adhere.

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Table of Contents

BEFORE PRESCRIBING OR DISPENSING ...................................................................................................... 1

WHEN PRESCRIBING OR DISPENSING ........................................................................................................ 2

PRESCRIBING AND DISPENSING FOR ADVANCED DOSAGE, FORMULATION OR DURATION .................................... 4

PATIENT EDUCATION ............................................................................................................................ 5

DISCONTINUING OPIOID THERAPY ........................................................................................................... 5

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BEFORE PRESCRIBING OR DISPENSING

Develop and maintain competence Prescribers, including prescribers who dispense, must maintain competence to assess and treat pain to improve function. This includes understanding current, evidenced-based practices and using other resources and tools related to opioid prescribing and dispensing. In some clinical situations consultation with a specialist is appropriate. Pharmacists must maintain competence in the appropriateness of therapy. See the Appendix for a list of resources and tools for developing and maintaining competence.

Utilize safeguards for the initiation of pain management The decision to prescribe or dispense opioid medication for outpatient use may be made only after a proper diagnosis and complete evaluation which should include a risk assessment, pain assessment, and review of relevant PDMP data. These safeguards apply to acute and chronic, non-cancer pain but not to palliative end-of-life care. Not all pain requires opioid treatment. Prescribers should not prescribe opioids when non-opioid medication is both effective and appropriate for the level of pain.

Prescribers should establish a diagnosis and legitimate medical purpose appropriate for opioid therapy through a history, physical exam, and/or laboratory, imaging or other studies. A bona fide provider-patient relationship must exist.

Prescribers should conduct a risk assessment prior to prescribing opioids for outpatient use and again before increasing dosage or duration. Risk assessment is defined as identification of factors that may lead to adverse outcomes and may include:

● Patient and family history of substance use (drugs including alcohol and marijuana)

● Patient medication history (among other reasons, this is taken to avoid unsafe combinations of opioids with sedative-hypnotics, benzodiazepines, barbiturates, muscle relaxants or to determine other drug-drug interactions)

● Mental health/psychological conditions and history ● Abuse history including physical, emotional or sexual ● Health conditions that could aggravate adverse reactions (including COPD, CHF,

sleep apnea, elderly, or history of renal or hepatic dysfunction) ● Prescribers and dispensers should observe the patient for any aberrant drug-

related behavior and follow-up appropriately when aberrant drug-related behavior is presented. See the Appendix for a description of such behaviors.

1. Diagnose

2. Assess Risk

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2


See the Appendix for additional resources related to assessment, including resources for alcohol and substance use screening and guidelines for treating patients with risk factors. If the assessment identifies risk factors, prescribers should exercise greater caution before prescribing opioids as detailed in subsequent sections, consider conducting a drug test or consulting a specialist and put in place additional safeguards as part of the treatment plan.

An appropriate pain assessment should include an evaluation of the patient’s pain for the:

● Nature and intensity ● Type ● Pattern/frequency ● Duration ● Past and current treatments ● Underlying or co-morbid disorders or conditions ● Impact on physical and psychological functioning

Prescribers and dispensers should utilize the Prescription Drug Monitoring Program (PDMP) prior to prescribing or dispensing opioids.

Collaborate with the healthcare team Prescribers and dispensers should collaborate within the healthcare team to prevent under-prescribing, over-prescribing, misuse and abuse of opioids. See the Appendix for additional resources.

WHEN PRESCRIBING OR DISPENSING

Verify a provider-patient relationship A bona fide provider-patient relationship must exist. The prescriber or dispenser should verify the patient’s identification prior to prescribing or dispensing opioids to a new or unknown patient. For pharmacists, this includes exercising judgment and conducting research if appropriate (such as use of the PDMP or communication with the prescriber or relevant pharmacies) when the prescription order is:

● For a new or unknown patient

3. Assess Pain

4. Review PDMP

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3


● For a weekend or late day prescription ● Issued far from the location of the pharmacy or patient’s residential address ● Denied by another pharmacist.

Additional Safeguards Ensure the dose, quantity, and refills for prescription opioids are appropriate to improve the function and condition of the patient, at the lowest effective dose and quantity, in order to avoid over-prescribing opioids. Factors that have been associated with adverse outcomes include: 1) opioid doses greater than 120 mg morphine equivalents per day 2) certain formulations and 3) treatment exceeding 90 days. Additional safeguards have been found to reduce these risks.

Opioid doses >120 mg morphine equivalents per day is a dosage that the Boards agree is more likely dangerous for the average adult (chances for unintended death are higher) over which prescribers should use clinical judgment, put in place additional safeguards for the treatment plan (such as utilizing a treatment agreement), consult a specialist or refer the patient; and dispensers should be more cautious.5 Benzodiazepines are known to potentiate the effects of opioids and may increase the risk of adverse outcomes. See the Appendix for additional resources on dose calculators

In addition to noting and responding to this dosage marker, prescribers and dispensers must use clinical judgment regardless of dose, especially when:

The prescription is considered an outlier to what is normally prescribed, or

Transdermal, extended relief or long-acting preparation is prescribed.

Treatment exceeding 90 days should be re-evaluated as opioids may no longer be as effective. One way to distinguish pain is as either acute (that lasting less than 90 days) or chronic (that lasting 90 days or greater). Management of each presents its own unique challenges. The overwhelming majority of prescribers treat patients with acute pain; in fact the pain for these patients lasts considerably less than 90 days.

5 Dunn KM, Saunders KW, Rutter CM, Banta-Green CJ, Merrill JO, Sullivan MD, Weisner CM, Silverberg MJ, Campbell CI, Psaty BM, Von Korff M. Opioid prescriptions for chronic pain and overdose: a cohort study. Ann Intern Med 2010;152(2):85-92.

Dosage

Formulation

Duration

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If a prescriber extends short-term treatment, and results in exceeding 90 days, prescribers should re-conduct the risk and pain assessments, review the PDMP and undertake the additional safeguards.

PRESCRIBING AND DISPENSING FOR ADVANCED DOSAGE, FORMULATION OR

DURATION

Tools and Trials Prior to issuing prescriptions that are outliers to the dosage, formulation and duration guidelines described above (for chronic, non-cancer pain), prescribers should determine whether the patient improves functionally on opioids, which could include an opioid trial, and whether the pain relief improves his/her ability to comply with the overall pain management program.

Monitoring The prescribing and dispensing of opioids for chronic pain must be monitored on an ongoing basis, such as:

assessing for improved function

rechecking the PDMP, and

random drug screening according to the prescriber’s clinical assessment. These monitoring tools and others should be documented in a treatment agreement signed by the patient, described more below. Prescribers should not increase an initial opioid dosage without rechecking the PDMP.

Treatment Agreements Prescribers should utilize treatment agreements (also commonly referred to as a plan or contract) and should ensure the patient understands the terms of the agreement. This may be accomplished by having the patient review and sign the treatment agreement. A treatment agreement often includes information about proper:

● Goals of treatment ● Patient education (proper use, risks of addiction, alternatives) ● Controls (single prescriber, single pharmacy for refills) ● Random drug testing and restrictions on alcohol use ● Storage, disposal, and diversion precautions (including detailed precautions

related to adolescents and/or children and visitors to the home). ● Process and reasons for changing/discontinuing the treatment plan;

communicating reduction or increase of symptoms; and referring to a specialist. See the Appendix for resources on sample agreements.

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PATIENT EDUCATION Prescribers should educate patients regardless of the dosage, formulation and duration of opioid therapy on proper use, risks of addiction, alternatives, storage, and disposal of opioids and the potential for diversion (see the Appendix for resources on disposal). Risks may include but are not limited to: overdose, misuse, diversion, addiction, physical dependence and tolerance, interactions with other medications or substances, and death. Pharmacists should offer to review information with the patient about risks, disposal, and other applicable topics. Providers should educate patients about the risks and benefits of medications that exceed the dosage, formulation and duration guidelines indicated above which may place them at increased risk for long-term dependence and unintended adverse drug effects. Patients who have a previous history of substance use disorder (including alcohol) are at elevated risk. When alerted to these risk factors, patients can make more informed decisions about their healthcare treatment. For example, some patients have reduced or forgone opioids when alerted to the risk factors. If a decision is made to continue with opioid therapy, a satisfactory response to treatment would be indicated by a reduced level of pain, increased level of function and/or improved quality of life. The use of an interdisciplinary team and family members may be considered as a part of the treatment plan and ongoing monitoring.

DISCONTINUING OPIOID THERAPY The prescriber should consider discontinuing opioid therapy when:

● The underlying painful condition is resolved; ● Intolerable side effects emerge; ● The analgesic effect is inadequate; ● The patient’s quality of life fails to improve; ● Functioning deteriorates; or ● There is aberrant medication use.

The prescriber discontinuing opioid therapy should employ a safe, structured tapering regimen through the prescriber or an addiction or pain specialist. There is a risk of patients turning to street drugs or alcohol abuse if tapering is not done with appropriate supports. Prescribers of opioids should be familiar with treatment options for opioid addiction. See the Appendix for tips on tapering.

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Appendix Page 1


APPENDIX

PDMP Colorado Prescription Drug Monitoring Program (PDMP): http://www.hidinc.com/copdmp

Preventing diversion through appropriate disposal

In order to prevent diversion, providers should provide information regarding appropriate disposal, including the following:

● Secure unused prescription opioids until such time they can be safely disposed. Specifically, ensure that prescription opioids are not readily accessible to other family members (including adolescents and/or children) or visitors to the home.

● Take-back events are preferable to flushing prescriptions down the toilet or throwing them in the trash. Only some medications may be flushed down the toilet. See the FDA’s guidelines for a list of medications that may be flushed: www.fda.gov

● Utilize take-back events and permanent drop box locations ● Utilize DEA disposal guidelines if take-back or drop boxes are unavailable. Those

guidelines include: ● Take the drugs out of their original containers and mix them with an

undesirable substance, such as used coffee grounds or kitty litter; then put them in a sealable bag, empty can, or other container to prevent the medication from leaking out of a garbage bag;

● Before throwing out a medicine container, tell the patient to scratch out all identifying information on the prescription label to protect their identity and personal health information; and

● Educate patients that prescriptions are patient specific. Patients may not share prescription opioids with friends, family or others and may pose serious health risks, including death.

● Use activated charcoal absorption technologies to inactivate unused medications or used fentanyl patches.

Record keeping Prescribers who treat patients with opioids should maintain accurate and complete medical records according to the requirements set forth by their licensing board.

Discontinuing/tapering opioid therapy Weaning from opioids can be done safely by slowly tapering the opioid dose and taking into account several factors related to risk, symptom, and alternatives. Opioid Taper Plan and Calculator: “Interagency Guidelines on Opioid Dosing for Chronic Non-Cancer Pain” State of

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http://www.hidinc.com/copdmp

Appendix Page 2


Washington Agency Medical Directors Group. 2010 Online: www.agencymeddirectors.wa.gov Withdrawal Symptoms Assessment: “Clinical Opiate Withdrawal Scale” The National Alliance for Advocates for Buprenorphine Treatment. Online at: www.naabt.org

Aberrant drug-related behavior

Prescribers and dispensers should use clinical judgment when aberrant drug-related behaviors are observed. Such behavior should be reported to the proper authorities and/or healthcare team as appropriate. Aberrant drug-related behaviors broadly range from mildly problematic (such as hoarding medications to have an extra dose during times of more severe pain) to felonious acts (such as selling medication). These are any medication-related behaviors that depart from strict adherence to a prescribed therapeutic plan of care. Prescribers and dispensers should observe, monitor and take precautionary measures when a patient presents aberrant drug-related behaviors such as:

● Requesting early and/or repeated refills ● Presents at or from an emergency department seeking high quantities of a

prescription ● Denied by other prescribers or dispensers ● Presents what is suspected to be a forged, altered or counterfeit prescription. ● Forging prescriptions ● Stealing or borrowing drugs ● Frequently losing prescriptions ● Aggressive demand for opioids ● Injecting oral/topical opioids ● Unsanctioned use of opioids ● Unsanctioned dose escalation ● Concurrent use of illicit drugs ● Failing a drug screen ● Getting opioids from multiple prescribers ● Recurring emergency department visits for chronic pain management*

Prescribers and dispensers should be alert for subjective behaviors such as being nervous, overly talkative, agitated, emotionally volatile, and evasive, as these may be signs of a psychological condition that may be considered in a treatment plan or could suggest drug misuse.** *“Interagency Guidelines on Opioid Dosing for Chronic Non-Cancer Pain” State of Washington Agency Medical Directors Group. 2010 Online: http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf **Webster LR, Dove B. Avoiding Opioid Abuse While Managing Pain. Sunrise River Press, North Branch, MN 2007.

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http://www.naabt.org/

http://www.agencymeddirectors.wa.gov/Files/OpioidGdline.pdf

Appendix Page 3


Practitioner Considerations

Healthcare team: Consider that the patient may be receiving opioids from another prescriber. Contact the patient’s healthcare team when appropriate which may include the following:

● Physician ● Specialist (pain, addiction, etc.) ● Dentist ● Advanced Practice Nurse (APN) ● Physician assistant ● Pharmacists ● Area emergency rooms ● Surrounding (within 5 miles) or historical pharmacies

Authorities:

● If the prescriber or dispenser suspects illegal activity, the matter should be referred to the Drug Enforcement Agency (DEA) and local law enforcement.

● If a prescriber or dispenser suspect illegal activity on behalf of another prescriber or dispenser, at a minimum, the matter should be reported to the appropriate licensing board.

Prescribers and dispensers should be aware that:

● There is no legal obligation to prescribe or dispense a prescription; and, ● Colorado law strongly encourages prescribers and dispensers of opiate

antagonists “to educate persons receiving the opiate antagonist on the use of an opiate antagonist for overdose, including but not limited to instructions concerning risk factors for overdose, recognition of overdose, calling emergency medical services, rescue breathing and administration of an opiate antagonist.” (Section 18-1-712(3)(b), C.R.S.)

Additional Resources and Tools Establishing and maintaining competence: Tenney, Lili and Lee Newman. “The Opioid Crisis: Guidelines and Tools for Improving Pain Management” Center for Worker Health and Environment, Colorado School of Public Health. Functional and pain assessment: “Functional Assessment” Colorado Division of Workers Compensation Patient agreements: “Screener and Opioid Assessment for Patients with Pain - Revised (SOAPP - R)” PainEDU.org Online at: www.painedu.org Pain tool kit: Various resources for assessing and managing pain including risk assessments, patient

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http://www.painedu.org/

Appendix Page 4


agreements, dose and conversion calculators among others. Center for Worker Health and Environment, Colorado School of Public Health. Online at: http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/maperc/online/Pages/Pain-Management-CME.aspx Substance use screening and brief counseling: SBIRT Colorado www.ImprovingHealthColorado.org Drug abuse resources: Substance Abuse and Mental Health Services Administration: www.samhsa.gov NIH National Institute on Drug Abuse: www.drugabuse.gov or www.nida.nih.gov

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http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/maperc/online/Pages/Pain-Management-CME.aspx

http://www.ucdenver.edu/academics/colleges/PublicHealth/research/centers/maperc/online/Pages/Pain-Management-CME.aspx

http://www.samhsa.gov/

http://www.drugabuse.gov/

http://www.nida.nih.gov/

Policy Number: 40-3

Title: Board Approval of Wholesaler Accreditation Body Date Issued:

PURPOSE: To define which wholesaler accreditation bodies are acceptable to the Colorado State Board of Pharmacy

POLICY:

The Board approves the following accreditation bodies to inspect out of state wholesalers: a) Verified Accredited Wholesaler Distributors™

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POLICY NUMBER: 40-4 Title: Appropriateness of Labeling Prescriptions to Partners of Patients with

Sexually Transmitted Infections Date Issued: July 19, 2007 Purpose: To clarify the Colorado Pharmacy Board’s position concerning the

appropriateness of labeling prescriptions to partners of patients with sexually transmitted infections.

POLICY: The Board acknowledges the concern and dilemma which occurs when a pharmacist encounters a patient with a sexually transmitted infection, and the partner does not come to the physician’s office to obtain a prescription order. The ideal situation would be that each partner visits his or her primary healthcare provider for treatment to obtain a prescription order. However, the Board recognizes that what is idealistic may not be realistic. There is compelling need for the partner to receive treatment in the form of prescription medications. Treating partners of patients with sexually transmitted infections is generally considered acceptable and desirable if the partner will not seek treatment from his or her primary healthcare provider. The overriding public policy concern must be to treat the infected partner. It must be made clear to the patient that his or her partner must take the medication as prescribed and should follow-up with his or her own healthcare provider. If the partner has any drug allergy or is on any medication, he or she should consult with a healthcare provider before obtaining the prescription. It is the position of the Colorado Pharmacy Board that the public risk of untreated sexually transmitted infection is greater than the risk of complications from dispensing in this less than ideal setting. Therefore, the Board approves of the labeling of prescriptions for partners of patients with sexually transmitted infections pursuant to prescription orders issued by a licensed practitioner in the following manner:

1. Label the treated patient’s prescription by the patient’s own name. 2. Label the untreated partner’s prescription by the treated patient’s name immediately followed

by the word “Partner”. For example, for the treated patient – “Joe Smith”, then for the untreated patient – “Joe Smith’s Partner.”

3. Assign a separate and unique identifying number to each prescription and clearly identify this

number on each corresponding prescription label.

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POLICY NUMBER: 40-6 Title: Pharmacy Technician Certification Boards Date Issued: April 17, 2008 Date(s) Revised: July 1, 2012 Purpose: To clarify the Board’s position on which Pharmacy Technician

Certification Boards are “nationally recognized” pursuant to CRS 12-42.5-119.

POLICY: The Colorado State Board of Pharmacy defines a “nationally recognized certification board” for pharmacy technicians as those certification boards that are approved by the National Association of Boards of Pharmacy (NABP). The Board does not recognize pharmacy technician certification from a non-NABP approved certification board as meeting the requirement of CRS 12-42.5-119 which allows a pharmacist to supervise up to three pharmacy technicians at the same time provided that: a) At least one technician has been certified by a nationally recognized certified accreditation board; or b) Possesses a degree from an accredited pharmacy technician training program; or c) Has completed at least five hundred hours of experiential training in pharmacy practice.

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POLICY NUMBER: 40-7 Title: Changes to Schedule II Controlled Substance Orders Date Issued: January 15, 2009 Date(s) Revised: Reference: Purpose: To clarify the Board’s position on what a pharmacist may change on a

Schedule II Controlled Substance Order

POLICY: The Colorado State Board of Pharmacy realizes there is conflict between the Drug Enforcement Administration’s (DEA’s) policy and rule on what a pharmacist may change on a Schedule II order after contacting the prescribing practitioner. The DEA has advised pharmacists to adhere to state regulations and policy on this issue until it resolves the issue. The Colorado State Board of Pharmacy’s position is that the following items may be changed on a Schedule II Controlled Substance order after the pharmacist consults orally with the prescribing practitioner: a) Change or add the dosage form; b) Change or add the drug strength; c) Change or add the drug quantity; d) Change or add the directions for use; and e) Change or add the issue date of the order.

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POLICY NUMBER: 40-8 Title: Prescriptions brought in from home in hospital settings Date Issued: September 15, 2011 Date(s) Revised: Reference: Purpose: To clarify the Board’s position on the manner in which a hospital

prescription drug outlet may identify and label personal medications brought into the facility by the patient.

POLICY: The Colorado State Board of Pharmacy (“Board”) realizes that there are situations in which a hospital prescription drug outlet must identify and label medications which were brought into the facility by a patient after having been dispensed by another prescription drug outlet. The Board further understands that such patient-owned medications incorporate either bar-code label or other form of identification in order to meet the hospital prescription drug outlet’s protocols for identifying and labeling the medications. Board Rule 3.01.10(b) prohibits a prescription that was previously dispensed by another pharmacy to be packaged into another container and relabeled by the hospital or its pharmacy. The Board’s position is that a hospital prescription drug outlet shall not in any way repackage or relabel a prescription previously dispensed by another pharmacy. Therefore, to address the need to incorporate a bar-code label or other form of identification onto a patient’s personal medication prior to administration, the Board agrees that a bar coded label or other form of identification may be affixed by the hospital prescription drug outlet either to a separate container in which the patient’s original medication container may be placed, or to the patient’s prescription container as long as such a label does not obscure the original pharmacy label and may be removed without compromising the original prescription label when the patient is dismissed from the hospital.

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POLICY NUMBER:

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POLICY:


40-9

Approved Hospital Residency Programs

May 17, 2012

C.R.S 12-22-116.5

To clarify which hospital residency programs are approved by the Board. Pharmacists licensed in other states accepted into such an approved hospital residency program do not need licensure in Colorado as long as their practice is restricted to the residency program.

The Board hereby approves hospital residency programs who are accredited by (including preliminary or conditional), or in candidate or pre-candidate status with, the American Society of Health-System Pharmacists ("ASHP").

Pharmacists licensed in other states accepted into such ASHP accredited residency programs do not need a pharmacist license in Colorado provided that the following conditions are met:

a) The residency occurs within a hospital or a hospital system licensed by the Colorado Department of Public Health and Environment; and

b) The pharmacist restricts their practice to the residency program.

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Policy Number:

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40-10

Confidential Agreements to Limit Practice

January 17, 2013

CRS 12-42.5-134 and Board Rule 24.00.00

To clarify certain terms and thereby notify licensees and the public regarding the physical and mental illnesses and conditions that must be reported to the Colorado State Board of Pharmacy ("Board"). The purpose is to also provide guidance regarding the time frame and process for such reporting.

Prior to the 2012 sunset process, the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act defined unprofessional conduct to include having a physical or mental disability that rendered the licensee unable to practice pharmacy with reasonable skill and safety. Pharmacists and pharmacy interns who had done nothing wrong, but suffered from a disability, were subject to discipline by the Board by virtue of the disability. Not only could discipline be imposed under the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act, it defined the underlying conduct, i.e., having a disability, as unprofessional conduct. Following the sunset review in 2012, the General Assembly amended the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act to allow a pharmacist or pharmacy intern to address a physical or mental illness or condition without the stigma of a disciplinary action provided the pharmacist or pharmacy intern acts within the limitations created by that physical or mental illness or condition. A pharmacist or pharmacy intern would only be subject to disciplinary action if the pharmacist or pharmacy intern failed to comply with the limitations of a confidential agreement entered into pursuant to section 12-42.5-134, C.R.S, failed to act within the limitations created by the physical or mental illness or condition, or failed to notify the Board of a physical or mental illness or condition that impacts a licensee's ability to pharmacy practice with reasonable skill and safety.

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POLICY:

1. Section 12-42.5-134(1), C.R.S. states:

If a pharmacist or intern has a physical or mental illness or condition that renders the person unable to practice pharmacy with reasonable skill and with safety to clients, the pharmacist or intern shall notify the board of the illness or condition in a manner and within a period determined by the board. The board may require the pharmacist or intern to submit to an examination or refer the pharmacist or intern to the pharmacy peer health assistance diversion program established in Part 2 of Article 42.5, Title 12 of the Colorado Revised Statutes to evaluate the extent of the illness or condition and its impact on the pharmacist's or intern's ability to practice pharmacy with reasonable skill and with safety to clients.

The Board interprets terms and requirements used in the above provision as follows:

A. "Renders the person unable to practice pharmacy with reasonable skill and safety to clients": The purpose of this reporting requirement is to assure that a pharmacist or pharmacy intern with a physical or mental illness or condition has made appropriate accommodations to his or her practice as are reasonable to provide safe pharmacy practice. The standard for requiring reporting is whether a reasonable pharmacist or pharmacy intern would conclude that the physical or mental illness or condition impacts, or is likely to impact, the licensee's ability to practice pharmacy with reasonable skill and safety to clients. It is NOT the purpose of this reporting requirement to compel licensees to report illnesses or conditions that do not impact the licensee's ability to practice pharmacy with reasonable skill and safety, or are not likely to do so even if the condition progresses, relapses or otherwise worsens.

B. The following are illustrative of illnesses or conditions that DO NOT need to be reported:

1) A physical or mental illness or condition that is acute and self limited or is stable and controlled by treatment and, as such, a reasonable pharmacist or pharmacy intern would conclude that such illness or condition, with such treatment, does not impact the licensee's ability to practice pharmacy with reasonable skill and safety to patients. Examples of illnesses or conditions that may be subject to successful treatment include but are not limited to: appendicitis, diabetes, coronary heart disease, depression, and bi-polar disorder.

2) A physical or mental illness or condition that would impact the licensee's ability to practice pharmacy with reasonable skill and safety to patients but for which the licensee has voluntarily ceased, modified or otherwise altered his or her practice to accommodate the illness or condition so that a reasonable pharmacist or pharmacy intern would conclude that the impact to patients has been eliminated and the licensee is able to practice pharmacy with skill and safety to clients. Examples include but are not limited to: limiting practice hours to reduce the physical demands of a longer work day, or a voluntary leave of absence from work while undergoing chemotherapy.

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C. The following are illustrative of illnesses or conditions that MUST be reported:

1) Any physical or mental illness or condition that results in the licensee ceasing, limiting or otherwise altering practice as a result of a requirement imposed upon the licensee by an employer. Examples include but are not limited to: restricting or placing conditions on the licensee's ability to perform specific pharmacy practice functions such as dispensing prescriptions, administering vaccines, consulting with prescribing practitioners, or counseling patients.

2) Any physical or mental illness or condition that a reasonable physician or physician assistant would conclude results or is likely to result, in the licensee failing to meet generally accepted standards of practice. Examples include but are not limited to: obstructive sleep apnea which could result in sleeping through calls or pages or falling asleep while practicing pharmacy; or acute mania or depression associated with bi-polar disorder which could result in poor medical judgment or inappropriate interactions with patients.

D. "Shall notify the board of the illness or condition": The purpose of this reporting requirement is to ensure that a licensee with a physical or mental illness or condition is able, without being subject to disciplinary proceedings, to appropriately manage that illness or condition such that the licensee can continue to practice pharmacy with reasonable skill and safety to patients.

E. The Board encourages early reporting to the Board (before 30 days have elapsed) of any physical or mental illness or condition that a reasonable physician or physician assistant would conclude is likely to impact the licensee's ability to practice pharmacy with reasonable skill and safety to patients should the condition progress, relapse, or worsen. The Board strongly encourages such early reporting to the Board when the physical or mental illness or condition is likely to impair cognition or judgment, even if such illness or condition has not yet caused impairment but could do so should it progress, relapse or otherwise worsen.

2. It is the Board's expectation that a licensee who is addicted to, dependent on, or engages in the habitual or excessive use or abuse of intoxicating liquors, a habit-forming drug, or a controlled substance as defined in Section 12-42.5-123(1)(e}, C.R.S., shall seek assistance from the Diversion Program as governed by Section 12-42.5-204, C.R.S. Such pharmacists or pharmacy interns are not eligible to enter into a confidential agreement with the Board pursuant to Section 12-42.5-134, C.R.S. A pharmacist or pharmacy intern who is addicted to, dependent on, or engages in the habitual or excessive use or abuse of intoxicating liquors, a habit-forming drug, or a controlled substance as defined in Section 12-42.5-123(1)(e), C.R.S., who comes to the attention of the Board and who has failed to voluntarily seek assistance from the Diversion Program, may be subject to discipline as set forth in the Pharmacists, Pharmacy Businesses and Pharmaceuticals Act.

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