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…………………………………..…
24
20-15 Pharmacy Intern Disenrollment from Schools or Colleges of Pharmacy……………..
25
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
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
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, 9/21/17
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.) B.) C.) D.) E.)
F.) G.)
H.) I.)
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; Unlicensed practice of pharmacy; An outlet receiving prescription drugs and/or controlled substances from an unlicensed/unregistered person or entity; 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; Inspection Reports detailing repeated non-compliance over the past 3 inspections. In such instance, complaints shall be initiated against both the outlet and the Board licensee responsible for the outlet, if applicable; 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; 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; Other individuals identified as being responsible for an incident in the course of a complaint investigation; and 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.
3
Colorado State Board of Pharmacy POLICY NUMBER: Title: Date Issued:
10-3 Anonymous Complaints 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.
Policy Number:10-4 Title: Eligibility to serve as a practice monitor Date Issued: 11/16/2006
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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.
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
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,
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.
Colorado State Board of Pharmacy Policy POLICY NUMBER:
10-7
Title:
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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: x
If the complaint alleges a violation of the Practice Act, the complaint will be investigated by the Pharmacy Board’s inspectors.
x
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.
x
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).
Colorado State Board of Pharmacy
Policy Number:
20-1
Title:
Reinstatement of Expired Licenses or Registrations
Date Issued:
11/30/07
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.
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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¶VRUKLVKHUGHVLJQHH¶VRSLQLRQWRKDYHDJHQHUDOSDWWHUQ RIGLVUHJDUGIRUWKHODZZLOOEHUHIHUUHGWRWKH%RDUG $Q\DSSOLFDQW ZKRPVWDIIEHOLHYHV KDVSURYLGHGIDOVHLQIRUPDWLRQRQDQDSSOLFDWLRQ RURWKHUZLVH ZLOOEH UHIHUUHGWRWKH%RDUG
Policy Number:20-4 Title:Purging Incomplete Applications Date Issued:11/16/2006
PURPOSE:7RSURYLGHVWDIIZLWKJXLGDQFHUHJDUGLQJWKHOHQJWKRIWLPHDQDSSOLFDWLRQZLOOUHPDLQRSHQDQGDFWLYH
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
Policy Number: 20-7 Title: Administrative Approval of Other Outlet Protocols Date Issued:11/16/2006
PURPOSE:7RDOORZVWDIIWKHDXWKRULW\WRDGPLQLVWUDWLYHO\DSSURYHSURWRFROVIRURWKHURXWOHWV POLICY: 7KH %RDUG GHOHJDWHV WR WKH 3URJUDP 'LUHFWRU RU KLVKHU GHVLJQHH WKH DXWKRULW\ WR DSSURYH RU GLVDSSURYH SURWRFROVVXEPLWWHGE\RWKHURXWOHWV
Policy Number:
20-11
Title: Date Issued: Date Revised:
Board Criteria to Identify Wholesaler Applications which Require Board Review 8/21/08 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.)
Policy Number:
20-12
Title: Date Issued:
Board Criteria to Identify Nonresident Pharmacy Applications which Require Board Review 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.
Colorado State Board of Pharmacy Policy POLICY NUMBER:
20-13
Title:
Approved Colleges or Schools of Pharmacy
Date Issued: Date(s) Revised:
April 23, 2009
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 ACPEapproved programs, no matter where the program is located, may take an examination before the Board.
Colorado State Board of Pharmacy
Policy Number:
20-15
Title:
Pharmacy Intern Disenrollment from Schools or Colleges of Pharmacy
Date Issued: Date(s) Revised:
PURPOSE: 7RSURYLGH JXLGDQFHWRSKDUPDF\LQWHUQVVFKRROVDQGFROOHJHVRISKDUPDF\DQG%RDUGVWDIIRI SURFHGXUHV WR EH IROORZHG ZKHQ D &RORUDGROLFHQVHG SKDUPDF\ LQWHUQ GLVHQUROOV IURP D VFKRRO RU FROOHJH RI SKDUPDF\
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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: 7RGHOLQHDWHWKHFULWHULDE\ZKLFK%RDUGVWDIIXVHVWRDSSURYHHOHFWURQLFPDLQWHQDQFHRIRUGHUV
Policy:
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Colorado State Board of Pharmacy 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.
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.
Colorado State Board of Pharmacy Policy Number:
30-6
Title:
In-State Prescription Drug Wholesaler Designated Representative Changes
Date Issued:
January 15, 2009
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: th
i)
If the application and fee are received by the Board by the 45 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 46 through the 59 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,
th
th
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:
g)
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 46 through the 59 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.
th
th
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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Colorado State Board of Pharmacy Policy Number:
30-10
Title:
Issuance of Licenses or Registrations to Facilities with Prior Cease and Desist Orders
Date Issued:
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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: x x
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.
Colorado State Board of Pharmacy POLICY NUMBER:
30-12
Title:
Nonresident Prescription Drug Outlet Pharmacist Manager Changes
Date Issued:
7/15/10
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: th
i)
If the application and fee are received by the Board by the 45 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 46 through the 59 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 60 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.
th
th
th
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.
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:
g)
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 46 through the 59 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 60 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.
th
th
th
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.
Colorado State Board of Pharmacy POLICY NUMBER:
30-13
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: th
i)
If the application and fee are received by the Board by the 45 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 46 through the 59 day following the previous designated representative leaving, a Letter of Admonition will be issued.
iii)
If the application and fee are received by the Board on or after the 60 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.
th
th
th
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:
g)
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 46 through the 59 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 60 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.
th
th
th
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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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
Policy for Prescribing and Dispensing Opioids
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.
“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. 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.
i
Policy for Prescribing and Dispensing Opioids
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
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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Policy for Prescribing and Dispensing Opioids
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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Policy for Prescribing and Dispensing Opioids
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, evidencedbased 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.
1. Diagnose 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.
2. Assess Risk 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 drugrelated behavior and follow-up appropriately when aberrant drug-related behavior is presented. See the Appendix for a description of such behaviors. 1
Policy for Prescribing and Dispensing Opioids
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.
3. Assess Pain 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
4. Review PDMP 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 2
Policy for Prescribing and Dispensing Opioids
● 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.
Dosage 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
Formulation In addition to noting and responding to this dosage marker, prescribers and dispensers must use clinical judgment regardless of dose, especially when: x The prescription is considered an outlier to what is normally prescribed, or x Transdermal, extended relief or long-acting preparation is prescribed.
Duration 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.
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3
Policy for Prescribing and Dispensing Opioids
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: x assessing for improved function x rechecking the PDMP, and x 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.
4
Policy for Prescribing and Dispensing Opioids
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.
5
Policy for Prescribing and Dispensing Opioids
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 Appendix Page 1
Policy for Prescribing and Dispensing Opioids
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.
Appendix Page 2
Policy for Prescribing and Dispensing Opioids
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 Appendix Page 3
Policy for Prescribing and Dispensing Opioids
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
Appendix Page 4
Policy Number:
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Colorado State Board of Pharmacy Policy POLICY NUMBER:
40-4
Title:
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Date Issued:
Purpose:
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POLICY: 7KH %RDUG DFNQRZOHGJHV WKH FRQFHUQ DQG GLOHPPD ZKLFK RFFXUV ZKHQ D SKDUPDFLVW HQFRXQWHUV D SDWLHQW ZLWK D VH[XDOO\ WUDQVPLWWHG LQIHFWLRQ DQG WKH SDUWQHU GRHV QRW FRPH WR WKH SK\VLFLDQ¶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¶VSUHVFULSWLRQE\WKHSDWLHQW¶VRZQQDPH /DEHOWKHXQWUHDWHGSDUWQHU¶VSUHVFULSWLRQE\WKHWUHDWHGSDWLHQW¶VQDPHLPPHGLDWHO\IROORZHG E\ WKH ZRUG ³3DUWQHU´ )RU H[DPSOH IRU WKH WUHDWHG SDWLHQW ± ³-RH 6PLWK´ WKHQ IRU WKH XQWUHDWHGSDWLHQW±³-RH6PLWK¶V3DUWQHU´ $VVLJQDVHSDUDWHDQGXQLTXHLGHQWLI\LQJQXPEHUWRHDFKSUHVFULSWLRQDQGFOHDUO\LGHQWLI\WKLV QXPEHURQHDFKFRUUHVSRQGLQJSUHVFULSWLRQODEHO
Colorado State Board of Pharmacy Policy POLICY NUMBER:
40-6
Title:
Pharmacy Technician Certification Boards
Date Issued:
April 17, 2008
Date(s) Revised:
July 1, 2012; July 20, 2017
Purpose:
To clarify the Board’s position on which Pharmacy Technician Certification Boards are “nationally recognized” pursuant to CRS 1242.5-119.
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) or the National Commission of Certifying Agencies (NCCA).
61
Colorado State Board of Pharmacy Policy 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.
Colorado State Board of Pharmacy Policy POLICY NUMBER:
40-8
Title:
3UHVFULSWLRQVEURXJKWLQIURPKRPHLQKRVSLWDOVHWWLQJV
Date Issued:
6HSWHPEHU
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