reglab/statecodes huggingface dataset:
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-5 - Deployment of Barrier

Current through 2024-29, July 17, 2024
1.
Applicability
This section applies to a self-standing sterile compounding
					 pharmacy or a sterile compounding pharmacy at the same location as a general
					 retail pharmacy. This section does not apply to a sterile compounding pharmacy
					 at the same location as a closed-shop pharmacy.
2.
Barrier
During the absence of a pharmacist or pharmacy technician
					 from the prescription filling area, the prescription filling area shall be
					 secured with a barrier that extends from the floor or counter to the ceiling.
					 The barrier must be constructed of a material of sufficient strength so that
					 the barrier cannot be readily removed, penetrated or bent. If the barrier is
					 constructed of non-solid material, any openings or interstices must be small
					 enough to prevent the removal, by any means, of items from the prescription
					 filling area. If, in addition, there is no authorized person in the
					 prescription filling area, the barrier shall also be locked. The retail
					 pharmacy and pharmacist in charge shall ensure that only a pharmacist or
					 authorized person possesses or has access to the key, combination or activation
					 code to the lock.
As an alternative to the barrier described in the preceding
					 paragraph, the sterile compounding pharmacy may be protected by a restricted
					 admission protocol such as a locked, secured door which is only opened for
					 customers and visitors on an individual basis.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-6 - Alarm

Current through 2024-29, July 17, 2024
The gowning room, clean room, prescription filling area,
					 drug storage areas and shipping area must be protected by an electronic
					 security system. The sterile compounding pharmacy shall activate the electronic
					 security system during the absence of a pharmacist, pharmacy technician or
					 authorized person from the prescription filling area. The pharmacy and
					 pharmacist in charge shall ensure that only a pharmacist or authorized person
					 possesses or has access to the key, combination or activation code to the
					 electronic security system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-7 - Security Cameras

Current through 2024-29, July 17, 2024
A sterile compounding pharmacy shall deploy security
					 cameras sufficient in number to monitor the critical areas of the pharmacy,
					 including, at a minimum, the gowning room, clean room, prescription filling
					 area, self-service customer kiosks, dispensing machines that are part of an
					 automated pharmacy system, controlled drug storage areas, shipping area and
					 checkout area. The cameras shall operate continuously, without interruption, 24
					 hours per day each day of the year. The cameras shall continuously record and
					 store images of the monitored area at a frequency of no less than 15 frames per
					 second. A sterile compounding pharmacy shall retain stored images for no less
					 than 30 days after recordation and shall produce the stored images to the board
					 upon request.
The requirement of security camera coverage of the gowning
					 room, clean room, controlled drug storage areas and shipping area goes into
					 effect on July 1, 2014.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-8 - Alteration of Prescription Filling Area

Current through 2024-29, July 17, 2024
A sterile compounding pharmacy may not alter the physical
					 dimensions of the prescription filling area or add or change the doors, windows
					 or other means of access to the prescription filling area prior to receiving
					 approval from the board. The pharmacy shall provide a scaled drawing of the
					 proposed alteration at the time it requests approval.
[NOTE: Cosmetic changes (e.g., carpet replacement) and
					 changes that are non-structural in nature (e.g., relocation of shelving) do not
					 require board approval.]
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-9 - Deliveries; Closing Procedures

Current through 2024-29, July 17, 2024
A sterile compounding pharmacy shall comply with the
					 following rules of the board applicable to retail pharmacies:
1. Chapter 13, Section
				  6(9), Deliveries and
				  Delivery Logs; and
2. Chapter 13,
				  Section
				  9, Permanent Closing of a Retail
				  Pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-10 - Operational Requirements

Current through 2024-29, July 17, 2024
A sterile compounding pharmacy shall comply in all respects
					 with United States Pharmacopeia USP 36-NF 31, General Chapter <797>,
					 Pharmaceutical Compounding - Sterile Preparations, 2013-14 edition, Vol. 1, p.
					 361 ("Chapter 797"). The board incorporates Chapter 797 into this chapter by
					 reference. Chapter 797 may be obtained from:
National Technical Information Service
5285 Port Royal Road
Springfield, VA 22161
(703) 605-6400
-or-
U.S. Pharmacopeial Convention
www.usp.org
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-11 - Activity Records

Current through 2024-29, July 17, 2024
At the request of the board, a sterile compounding pharmacy
					 shall generate within 3 business days a report showing the number and type of
					 prescriptions dispensed during the period of time specified by the board. The
					 contents and format of the report shall be determined by the board. The
					 reporting period is subject to the record retention requirements contained in
					 Chapter 24 of the board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 37 - LICENSURE OF STERILE COMPOUNDING PHARMACIES › Section 392-5-37-12 - Notice of Potential Contamination

Current through 2024-29, July 17, 2024
Upon discovery of potential contamination, the pharmacist
					 in charge or pharmacist on duty shall immediately notify the board and any
					 patients to whom a potentially contaminated sterile pharmaceutical was
					 dispensed or administered. Positive sterility test results shall prompt a rapid
					 and systematic investigation of aseptic techniques, environmental controls, and
					 other sterility assurance controls to identify sources of contamination and
					 correct problems in the methods or processes.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-1 - Authority

Current through 2024-29, July 17, 2024
A closed-shop pharmacy is a classification of retail
					 pharmacy regulated by the board pursuant to
					  32 MRSA
					 §13751(2)(A) and §
										13751(3).
					 A closed-shop pharmacy must be licensed by the board pursuant to this chapter.
					 For pharmacies that hold or apply for a general retail pharmacy license, the
					 closed-shop pharmacy license may be issued in the form of an endorsement to the
					 general retail pharmacy license.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-2 - Scope of License

Current through 2024-29, July 17, 2024
A closed-shop pharmacy may only serve a limited,
					 institutional patient population such as residents of a long term care
					 facility, assisted living program, residential care facility, residential child
					 care facility, intermediate care facility for persons with mental retardation,
					 or residential mental health facility. A closed-shop pharmacy may not dispense
					 to or be open to the general patient population.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-4 - Pharmacist in Charge

Current through 2024-29, July 17, 2024
The pharmacist in charge is responsible legally and
					 professionally for all activities related to the practice of pharmacy within
					 the closed-shop pharmacy for which the licensee is registered as pharmacist in
					 charge, and for the pharmacy's compliance with the provisions of the Maine
					 Pharmacy Act, the rules of the board, and the federal and state laws and rules
					 and other codes specified in Chapter 29, Section
					 1 of the board's rules. Unless waived
					 by the board for good cause shown, the pharmacist in charge shall practice at
					 the closed-shop pharmacy for a minimum of 30 hours per week or 50% of the hours
					 the pharmacy is open, whichever is less. However, a waiver from the 30 hour/50%
					 requirement will be automatically approved upon request by a pharmacist to the
					 extent authorized by Chapter 13, Section
					 3(4) of the board's
					 rules.
[NOTE: Chapter 13, Section
					 3(4) provides in
					 pertinent part that "[a] request to serve as pharmacist in charge of a retail
					 pharmacy, closed-shop pharmacy and/or sterile compounding pharmacy at the same
					 location will be approved automatically subject to disciplinary
					 review."]
The responsibilities of the pharmacist in charge include,
					 but are not limited to:
1. The
				  pharmacy's procedures for the procurement, storage, compounding and dispensing
				  of drugs;
2. The recordkeeping
				  systems required in the practice of pharmacy for the purchase, sale,
				  possession, storage and repackaging of drugs;
3. Notifying the board of termination of
				  status as pharmacist in charge via letter, fax or email within 7 days of the
				  termination;
4. The supervision of
				  pharmacy technicians and performance of administrative responsibilities
				  relating to pharmacy technicians as required by Chapter 7 of the board's rules;
				  and
5. Ensuring that each
				  pharmacist employed at the pharmacy for which the pharmacist in charge is
				  responsible is licensed with the board.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-5 - Shared Facilities

Current through 2024-29, July 17, 2024
A closed-shop pharmacy may share a physical location with
					 another pharmacy. However, the closed-shop pharmacy may not be accessible to
					 the public; inventory of the closed-shop pharmacy must be physically separated
					 from inventory of the other pharmacy; and all records required by the board's
					 rules must be separately maintained.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-6 - Alarm

Current through 2024-29, July 17, 2024
The prescription filling area, drug storage areas,
					 compounding area (if applicable) and shipping area shall be protected by an
					 electronic security system. The pharmacy shall activate the electronic security
					 system during the absence of a pharmacist, pharmacy technician or authorized
					 person from the prescription filling area. The closed-shop pharmacy and
					 pharmacist in charge shall ensure that only a pharmacist or authorized person
					 possesses or has access to the key, combination or activation code to the
					 electronic security system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-7 - Security Cameras

Current through 2024-29, July 17, 2024
A closed-shop pharmacy shall deploy security cameras
					 sufficient in number to monitor the critical areas of the pharmacy, including,
					 at a minimum, the prescription filling area, dispensing machines that are part
					 of an automated pharmacy system, compounding area (if applicable), controlled
					 drug storage areas and shipping area. The cameras shall operate continuously,
					 without interruption, 24 hours per day each day of the year. The cameras shall
					 continuously record and store images of the monitored area at a frequency of no
					 less than 15 frames per second. A closed-shop pharmacy shall retain stored
					 images for no less than 30 days after recordation and shall produce the stored
					 images to the board upon request.
The requirement of security camera coverage of the
					 compounding area (if applicable), controlled drug storage areas and shipping
					 area goes into effect on July 1, 2014.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-8 - Alteration of Prescription Filling Area

Current through 2024-29, July 17, 2024
A closed-shop pharmacy may not alter the physical
					 dimensions of the prescription filling area or add or change the doors, windows
					 or other means of access to the prescription filling area prior to receiving
					 approval from the board. The pharmacy shall provide a scaled drawing of the
					 proposed alteration at the time it requests approval.
[NOTE: Cosmetic changes (e.g., carpet replacement) and
					 changes that are non-structural in nature (e.g., relocation of shelving) do not
					 require board approval.]
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-9 - Compounding

Current through 2024-29, July 17, 2024
A closed-shop pharmacy that is also a non-sterile
					 compounding pharmacy must comply with Chapter 13, Section
					 7 of the board's rules. A closed-shop
					 pharmacy that is also a sterile compounding pharmacy must be licensed as a
					 sterile compounding pharmacy pursuant to Chapter 37 of the board's
					 rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 38 - LICENSURE OF CLOSED-SHOP PHARMACIES › Section 392-5-38-10 - Deliveries; Closing Procedures

Current through 2024-29, July 17, 2024
A closed-shop pharmacy shall comply with the following
					 rules of the board applicable to retail pharmacies:
1. Chapter 13, Section
				  6(9), Deliveries and
				  Delivery Logs; and
2. Chapter 13,
				  Section
				  9, Permanent Closing of a Retail
				  Pharmacy.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-1 - Definitions

Current through 2024-29, July 17, 2024
1.
Board.
For purposes of this
				  chapter, "Board" means the Maine Board of Pharmacy.
2.
Collaborative drug therapy
				  management.
"Collaborative drug therapy management" is defined in
				  32 MRS
				  §13702-A(2-A). The
				  statutory requirements for collaborative drug therapy management are set forth
				  in
				  32 MRS
				  §§13841 -
				  13847.
3.
Collaborative practice
				  agreement.
"Collaborative practice agreement" is defined in
				  32 MRS
				  §13702-A(2-B).
4.
Practitioner.
"Practitioner"
				  is defined in
				  32 MRS
				  §13702-A(29).
5.
Qualifying condition.
"Qualifying condition" means a condition or disease with generally accepted
				  standards of care, which may include, but is not limited to, the following
				  examples:
A. Anticoagulation
B. Asthma
C. Diabetes
D. Dyslipidemia
E. Hyperlipidemia
F. Hypertension
G. Infectious Disease
H. Cancer
I. Thyroid Disorder
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-2 - Application

Current through 2024-29, July 17, 2024
1.
Pharmacist Qualifications
In order to enter into a collaborative practice agreement
					 with a nurse practitioner, a pharmacist must meet the qualifications set forth
					 in
					 32 MRS
					 §13842. The pharmacist must complete the
					 15 hours of continuing education referred to in
					 32 MRS
					 §13842(2)(A), (B), and
					 (C) within the two-year period preceding the
					 date of application.
[
Note
: A pharmacist who enters into a
					 collaborative practice agreement must agree to complete, in each year of the
					 agreement, continuing education hours as set forth in
					 32 MRS
					 §13735.]
2.
Application Submission
The pharmacist shall submit to the Board an application
					 form supplied by the Board and such other information as the Board may require.
					 Incomplete applications will not be considered and will be returned to the
					 applicant.
3.
Collaborative Practice Agreement Submission
Prior to commencement of the collaborative practice, the
					 pharmacist shall submit to both the Board and the licensing board that licenses
					 the nurse practitioner a copy of the collaborative practice agreement. A copy
					 of the treatment protocol, as established by the practitioner, must be included
					 in the submission.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-3 - Collaborative Practice Agreement Content

Current through 2024-29, July 17, 2024
A collaborative practice agreement may authorize
					 collaborative drug therapy management only for qualifying conditions. A
					 collaborative practice agreement must:
1. Require that activity in the initial 3
				  months of a collaborative practice agreement be limited to monitoring drug
				  therapy, after which, the nurse practitioner and pharmacist shall meet to
				  review the collaborative practice agreement and determine the scope of the
				  agreement, which, only after this meeting, may be expanded to include a
				  pharmacist's initiating, monitoring, modifying, and discontinuing a patient's
				  drug therapy, which actions the pharmacist must report to the nurse
				  practitioner in a timely manner;
2.
				  Identify the parties to the agreement and their dates of execution of the
				  agreement, and specify the effective date and expiration date of the
				  agreement;
3. Permit either party
				  to cancel the collaborative practice agreement by written
				  notification;
4. Specify the site
				  and setting at which the collaborative practice will occur;
5. Specify the qualifications of the
				  participants in the collaborative practice agreement;
6. Describe in detail the types of diseases,
				  drugs or drug categories involved and collaborative drug therapy management
				  allowed in each patient's case;
7.
				  Include a procedure for the referral of each patient to the practitioner that
				  expressly states:
A. No party to the
				  collaborative practice agreement may receive remuneration of any kind for a
				  referral made pursuant to the agreement; and
B. The nurse practitioner is under no
				  obligation to refer patients to the contracting pharmacist;
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-4 - Treatment Protocol Content

Current through 2024-29, July 17, 2024
A treatment protocol shall describe the activities that the
					 pharmacist is authorized to engage in and must, at a minimum, include the
					 requirements set forth below.
1.
Informed Consent Procedures
. The protocol shall specify the
				  procedures for obtaining informed consent from each patient involved in the
				  drug therapy management, which consent shall include the patients' consent to
				  release all relevant medical information to both the nurse practitioner and the
				  pharmacist.
2.
Scope of
				  Activities
. A description of the activities the pharmacist is authorized
				  to engage in, including the procedures, decision criteria, or plan the
				  pharmacist shall follow when providing drug therapy management pursuant to a
				  medical order from the nurse practitioner.
3.
Documentation
. A description
				  of the manner in which the pharmacist shall document all activities involved in
				  providing drug therapy management in collaboration with a nurse
				  practitioner.
4.
Communication
. A description of the procedures the pharmacist
				  shall follow for reporting activities and results to the nurse practitioner,
				  including but not limited to:
A. A description
				  of the timeframe in which the pharmacist must relay normal test results to the
				  nurse practitioner, not to exceed one week for routine results and twenty-four
				  hours for abnormal results; and
B.
				  A description of the timeframe in which the pharmacist must relay adverse drug
				  events, not to exceed twenty-four hours.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-5 - Notifications

Current through 2024-29, July 17, 2024
A pharmacist shall notify both the Board and the board that
					 licenses the nurse practitioner of the occurrence of any of the following
					 changes no later than 10 days after the change:
1. Any modification to a collaborative
				  practice agreement, which notification must include a copy of the amended
				  collaborative practice agreement, which must be signed and dated in accordance
				  with section 3(2) of this rule;
2.
				  Any modification to a treatment protocol, which notification must include a
				  copy of the amended treatment protocol; and
3. Any change in liability insurance, which
				  notification must include proof of existing liability insurance, i.e., a
				  liability insurance policy certificate.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-6 - Recordkeeping Requirements

Current through 2024-29, July 17, 2024
Records received or created by a pharmacist pursuant to
					 this chapter are subject to the record retention and production requirements of
					 Chapter 24 of the Board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-7 - Complaints

Current through 2024-29, July 17, 2024
In the event that the Board or the licensing board that
					 licenses the practitioner receives a complaint related to a collaborative
					 practice agreement, the boards may share the complaint and any investigative
					 information obtained during an investigation of the complaint, as permitted
					 under
					 10 MRS
					 §8003-B(2).
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39-A - COLLABORATIVE DRUG THERAPY MANAGEMENT › Section 392-39-A-8 - Duty to Report Disciplinary Action

Current through 2024-29, July 17, 2024
1. Any party to a
				  collaborative practice agreement who has had disciplinary action taken against
				  any professional license held by that party shall report such disciplinary
				  action to all other parties to the agreement and to the licensing boards of
				  those parties within 10 days of the disciplinary action.
2. The Board and the Maine State Board of
				  Nursing shall notify each other of any disciplinary action against the
				  professional licensees who are party to a collaborative practice agreement as
				  soon as practicable.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-1 - Definitions

Current through 2024-29, July 17, 2024
1.
Board.
For purposes of this
				  chapter, "Board" means the Maine Board of Pharmacy.
2.
Collaborative drug therapy
				  management.
"Collaborative drug therapy management" is defined in
				  32
				  MRS§13702-A(2-A). The
				  statutory requirements for collaborative drug therapy management are set forth
				  in
				  32 MRS
				  §§13841 -
				  13847.
3.
Collaborative practice
				  agreement.
"Collaborative practice agreement" is defined in
				  32 MRS
				  §13702-A(2-B).
4.
Practitioner.
"Practitioner"
				  is defined in
				  32 MRS
				  §13702-A(29).
5.
Qualifying
				  condition.
"Qualifying condition" means a condition or disease with
				  generally accepted standards of care, which may include, but is not limited to,
				  the following examples:
A.
				  Anticoagulation
B. Asthma
C. Diabetes
D. Dyslipidemia
E. Hyperlipidemia
F. Hypertension
G. Infectious Disease
H. Cancer
I. Thyroid Disorder
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-2 - Application

Current through 2024-29, July 17, 2024
1.
Pharmacist
				  Qualifications
In order to enter into a collaborative practice agreement
					 with a practitioner, a pharmacist must meet the qualifications set forth in
					 32 MRS
					 §13842. The pharmacist must complete the
					 15 hours of continuing education referred to in
					 32 MRS
					 §13842(2)(A), (B), and
					 (C) within the two-year period preceding the
					 date of application.
[
Note
: A pharmacist who enters into a
					 collaborative practice agreement must agree to complete, in each year of the
					 agreement, continuing education hours as set forth in
					 32 MRS
					 §13735.]
2.
Application Submission
The pharmacist shall submit to the Board an application
					 form supplied by the Board and such other information as the Board may require.
					 Incomplete applications will not be considered and will be returned to the
					 applicant.
3.
Collaborative Practice Agreement Submission
Prior to commencement of the collaborative practice, the
					 pharmacist shall submit to both the Board and the licensing board that licenses
					 the practitioner a copy of the collaborative practice agreement. A copy of the
					 treatment protocol, as established by the practitioner, must be included in the
					 submission.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-3 - Collaborative Practice Agreement Content

Current through 2024-29, July 17, 2024
A collaborative practice agreement may authorize
					 collaborative drug therapy management only for qualifying conditions. A
					 collaborative practice agreement must:
1. Require that activity in the initial 3
				  months of a collaborative practice agreement be limited to monitoring drug
				  therapy, after which, the practitioner and pharmacist shall meet to review the
				  collaborative practice agreement and determine the scope of the agreement,
				  which, only after this meeting, may be expanded to include a pharmacist's
				  initiating, monitoring, modifying, and discontinuing a patient's drug therapy,
				  which actions the pharmacist must report to the practitioner in a timely
				  manner;
2. Identify the parties to
				  the agreement and their dates of execution of the agreement, and specify the
				  effective date and expiration date of the agreement;
3. Permit either party to cancel the
				  collaborative practice agreement by written notification;
4. Specify the site and setting at which the
				  collaborative practice will occur;
5. Specify the qualifications of the
				  participants in the collaborative practice agreement;
6. Describe in detail the types of diseases,
				  drugs or drug categories involved and collaborative drug therapy management
				  allowed in each patient's case;
7.
				  Include a procedure for the referral of each patient to the practitioner that
				  expressly states:
A. No party to the
				  collaborative practice agreement may receive remuneration of any kind for a
				  referral made pursuant to the agreement; and
B. The practitioner is under no obligation to
				  refer patients to the contracting pharmacist;
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-4 - Treatment Protocol Content

Current through 2024-29, July 17, 2024
A treatment protocol shall describe the activities that the
					 pharmacist is authorized to engage in and must, at a minimum, include the
					 requirements set forth below.
1.
Informed Consent Procedures
.The protocol shall specify the
				  procedures for obtaining informed consent from each patient involved in the
				  drug therapy management, which consent shall include the patients' consent to
				  release all relevant medical information to both the practitioner and the
				  pharmacist.
2.
Scope of
				  Activities
.A description of the activities the pharmacist is authorized
				  to engage in, including the procedures, decision criteria, or plan the
				  pharmacist shall follow when providing drug therapy management pursuant to a
				  medical order from the practitioner.
3.
Documentation
.A description
				  of the manner in which the pharmacist shall document all activities involved in
				  providing drug therapy management in collaboration with a
				  practitioner.
4.
Communication
.A description of the procedures the pharmacist shall
				  follow for reporting activities and results to the practitioner, including but
				  not limited to:
A. A description of the
				  timeframe in which the pharmacist must relay normal test results to the
				  practitioner, not to exceed one week for routine results and twenty-four hours
				  for abnormal results; and
B. A
				  description of the timeframe in which the pharmacist must relay adverse drug
				  events, not to exceed twenty-four hours.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-5 - Notifications

Current through 2024-29, July 17, 2024
A pharmacist shall notify both the Board and the board that
					 licenses the practitioner of the occurrence of any of the following changes no
					 later than 10 days after the change:
1. Any modification to a collaborative
				  practice agreement, which notification must include a copy of the amended
				  collaborative practice agreement, which must be signed and dated in accordance
				  withsection 3(2) of this rule;
2.
				  Any modification to a treatment protocol, which notification must include a
				  copy of the amended treatment protocol; and
3. Any change in liability insurance, which
				  notification must include proof of existing liability insurance, i.e., a
				  liability insurance policy certificate.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-6 - Recordkeeping Requirements

Current through 2024-29, July 17, 2024
Records received or created by a pharmacist pursuant to
					 this chapter are subject to the record retention and production requirements of
					 Chapter 24 of the Board's rules.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-7 - Complaints

Current through 2024-29, July 17, 2024
In the event that the Board or the licensing board that
					 licenses the practitioner receives a complaint related to a collaborative
					 practice agreement, the boards may share the complaint and any investigative
					 information obtained during an investigation of the complaint, as permitted
					 under
					 10 MRS
					 §8003-B(2).
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 39 - COLLABORATIVE DRUG THERAPY MANAGEMENT (Board of Pharmacy) › Section 392-39-8 - Duty to Report Disciplinary Action

Current through 2024-29, July 17, 2024
1. Any party to a
				  collaborative practice agreement who has had disciplinary action taken against
				  any professional license held by that party shall report such disciplinary
				  action to all other parties to the agreement and to the licensing boards of
				  those parties within 10 days of the disciplinary action.
2. The Board and the Board of Licensure in
				  Medicine shall notify each other of any disciplinary action against the
				  professional licensees who are party to a collaborative practice agreement as
				  soon as practicable.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-1 - Purpose

Current through 2024-29, July 17, 2024
These rules establish the procedures and standards by which
					 a pharmacist may dispense naloxone hydrochloride under a prescription order,
					 standing drug order, or collaborative drug therapy management agreement and may
					 prescribe and dispense naloxone hydrochloride to a person of any age without
					 there being a prescription drug order, standing drug order, or collaborative
					 drug therapy management agreement.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-2 - Definitions

Current through 2024-29, July 17, 2024
1.
Caregiver.
"Caregiver" means
				  a family member, friend, or individual in a position to have recurring contact
				  with a person at risk of experiencing an opioid-related overdose.
2.
Emergency opioid antagonist.
"Emergency opioid antagonist" means Naloxone HCl or a similarly acting drug
				  that blocks the effects of opioids administered from outside the body and that
				  is approved by the United States Food and Drug Administration for the treatment
				  of an opioid overdose.
3.
First responder.
"First responder" means any individual or agency
				  that provides emergency on-site care to a person until the arrival of a duly
				  licensed ambulance service. This shall include, but is not limited to,
				  individuals who routinely respond to calls for assistance through an
				  affiliation with law enforcement agencies, fire departments and rescue
				  agencies.
4.
Opioid
				  Antagonist.
"Opioid Antagonist" means Naloxone HCl or other similarly
				  acting drug that is approved by the federal Food and Drug Administration for
				  the treatment of an opioid overdose.
5.
Patient at risk.
"Patient at
				  risk" means a person at risk of experiencing an opioid-related
				  overdose.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-3 - Authorization to Prescribe and Dispense Naloxone Hydrochloride

Current through 2024-29, July 17, 2024
1. A pharmacist may not dispense Naloxone HCl
				  without a prescription drug order, standing order, or collaborative drug
				  therapy management agreement unless authorized to prescribe and dispense
				  Naloxone HCl in accordance with this Chapter.
2. All licensed pharmacists are already
				  authorized and trained to dispense prescription medications, including naloxone
				  hydrochloride, by prescription drug order, standing order, or under a
				  collaborative drug therapy management agreement and, as such, additional Board
				  authorization to dispense naloxone hydrochloride is not required. However, a
				  licensed pharmacist shall, prior to prescribing and dispensing naloxone
				  hydrochloride, obtain 2 hours of training on safe dispensing of an opioid
				  antagonist, counseling, providing instructions to the person receiving the
				  opioid antagonist, and its use as rescue therapy for an opioid overdose as
				  described in Section 4 and shall comply with requirements described in Sections
				  7, 8, 10 and 11. The pharmacist shall retain a record of training and present
				  it to the Board upon request or if subject to a continuing education
				  audit.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-4 - Training Requirement for Pharmacist Authorization to Prescribe and Dispense

Current through 2024-29, July 17, 2024
A pharmacist shall, prior to prescribing and dispensing an
					 opioid antagonist obtain 2 hours of educational training that is approved by
					 the Accreditation Council for Pharmacy Education ("ACPE") related to writing
					 prescription drug orders, the safe dispensing of an opioid antagonist,
					 counseling and providing instructions to the person receiving the opioid
					 antagonist, and its use as rescue therapy for an opioid overdose. Training
					 should address the following topics.
1. Risk factors for opioid abuse and
				  overdose;
2. Opioid overdose
				  prevention;
3. Recognizing and
				  responding to opioid overdoses;
4.
				  Indications for use of Naloxone HCl as rescue therapy;
5. Contraindications for use of an opioid
				  antagonist;
6. Proper storage and
				  expiration of an opioid antagonist product dispensed;
7. Procedures for administration of an opioid
				  antagonist;
8. Adverse effects
				  associated with an opioid antagonist rescue therapy;
9. Identification of a patient who meets the
				  criteria for provision of an opioid antagonist;
10. Required education to provide to persons
				  receiving an opioid antagonist;
11.
				  Required elements of protocol to initiate dispensing of an opioid
				  antagonist;
12. Required
				  documentation when initiating dispensing of an opioid antagonist; and
13.  Actions and interventions to be used
				  upon the occurrence of a clinical event.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-5 - Eligible Recipients

Current through 2024-29, July 17, 2024
Persons eligible to be prescribed Naloxone HCl under this
					 rule include, but are not limited to, the following:
1. Patients at risk;
2. Individuals who are members of a patient
				  at risk's immediate family or a friend of the person or to another person in a
				  position to assist the person if the person is at risk of experiencing an
				  opioid-related drug overdose;
3.
				  Persons with history of receiving emergency medical care for acute opioid
				  poisoning or overdose;
4. Persons
				  with a suspected or confirmed history of substance abuse, dependence or
				  non-medical use of prescription or illegal drugs;
5. Persons receiving high-dose opioid
				  prescriptions (E.g. >100 mg morphine equivalent);
6. Persons who are opioid naïve and
				  receiving a first prescription for methadone for pain;
7. Persons starting buprenorphine or
				  methadone for addiction treatment;
8. Persons on opioid prescriptions in
				  combination with:
A. Smoking, COPD,
				  emphysema, sleep apnea, or other respiratory illness;
B. Renal dysfunction, hepatic disease, or
				  cardiac disease;
C. Known or
				  suspected alcohol use;
D. Anyone
				  who injects opioids, such as heroin or fentanyl;
E. Concurrent benzodiazepine or other
				  sedative prescription; or
F.
				  Concurrent antidepressant prescription;
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-6 - Prescribe and Dispense

Current through 2024-29, July 17, 2024
An authorized pharmacist may prescribe and dispense oral,
					 injectable, intranasal or any other form of opiate antagonist and the necessary
					 medical supplies to administer the naloxone hydrochloride to a person who, the
					 pharmacist determines using his or her clinical judgment, meets the eligible
					 recipient criteria above in order to treat potential opioid overdoses. A
					 pharmacist may write a prescription to meet the need on hand within the
					 pharmacist's current workplace, but not for purposes of providing a
					 prescription to a patient at risk or caregiver to take away and present to
					 another pharmacy for filling.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-7 - Documentation

Current through 2024-29, July 17, 2024
Pharmacists must document in the pharmacy management system
					 each person who receives a Naloxone HCl prescription under this chapter, which
					 documentation shall include:
1. Name
				  of the person to whom the prescription is prescribed;
2. Name of the person at risk, if known and
				  if different than the person to whom the prescription was prescribed;
3. Name of the product;
4. Dose and route of administration and
				  required delivery service;
5. Date
				  dispensed;
6. Name of the
				  prescribing pharmacist or health care provider; and
7. Name of the dispensing pharmacist who
				  reviewed and provided the patient or caregiver receiving an opioid antagonist,
				  educational materials appropriate to the dosage form of the opioid antagonist
				  dispensed as described in Section 10(2) of this chapter.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-8 - Notice to the person's health care provider

Current through 2024-29, July 17, 2024
After prescribing and dispensing Naloxone HCl, the
					 pharmacist may provide to the health care provider of the patient at risk,
					 written notification via fax or other appropriate designated method that
					 Naloxone HCl was provided to the health care provider's patient under this
					 rule. The notification shall include the person's name, the opioid antagonist
					 prescribed and dispensed by the pharmacist and date dispensed. If the health
					 care provider is unknown, it shall be so noted in the pharmacy management
					 system.
Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 5 - LICENSE DENIAL AND PROFESSIONAL DISCIPLINE › Chapter 40 - AUTHORIZATION, TRAINING AND PROCEDURES FOR PRESCRIBING AND DISPENSING NALOXONE HYDROCHLORIDE › Section 392-40-9 - Prescribing Opioid Antagonist Emergency Rescue Kits

Current through 2024-29, July 17, 2024
A pharmacist may prescribe and dispense Naloxone HCl
					 emergency rescue kits or dispense upon a standing order or collaborative drug
					 therapy management agreement. The kit must be labeled and include the
					 expiration date. Prepared patient information must be provided with the kit and
					 the pharmacist must have a complete understanding of the information
					 distributed to the person, caregiver or first responder. A record of
					 prescribing and dispensing rescue kits must be maintained.