Code of Maine Rules › 02 - DEPARTMENT OF PROFESSIONAL AND FINANCIAL REGULATION › 392 - MAINE BOARD OF PHARMACY › Part 2 - LICENSES AND REGISTRATIONS › Chapter 4-A - ADMINISTRATION OF DRUGS AND VACCINES AND OPERATION OF A DRUG OR VACCINE ADMINISTRATION CLINIC INSIDE, OUTSIDE OR OFF THE PREMISES OF A LICENSED RETAIL PHARMACY, RURAL HEALTH CLINIC OR FREE CLINIC › Section 392-2-4-A-3 - Operation of Drug or Vaccine Administration Clinics; One-Time Approval by Board for a Drug Administration Clinic

Current through 2024-29, July 17, 2024
1.
Site Suitability
A drug or vaccine administration clinic must be located in
					 a sanitary, well-maintained, adequately equipped space that is appropriately
					 sized for the expected patient volume and facilitates interaction among clinic
					 staff and patients.
2.
Written Plan of Operation
The pharmacist holding a certificate of administration or
					 pharmacy that operates a drug or vaccine administration clinic shall develop a
					 written plan of operation prior to conducting the clinic, and shall ensure that
					 the plan is complied with during operation. The plan may cover multiple
					 pharmacies under common ownership, provided that each such pharmacy adheres to
					 the plan. A drug administration clinic may not be conducted until the written
					 plan of operation has been approved by the board pursuant to subsection
					 5 of this Section. The plan must, at
					 a minimum:
A. Require that any
				  non-health care personnel who assist at the clinic have no contact whatsoever
				  with drugs, vaccines, needles or syringes;
B. Include a specific protocol for prevention
				  of administration errors (e.g., administration of incorrect drug or incorrect
				  dose to patient; administration of drug to wrong patient);
C. Include procedures for the orderly
				  management and flow of patients through the clinic both pre- and
				  post-administration;
D. Include a
				  specific protocol for performing the following procedures
(1) Verification (Section
				  2(1)) ;
(2) Assessment (Section
				  2(2)) ;
(3) Provision of drug or vaccine information
				  and discussion of possible adverse reactions (Section
				  2(3)) ;
(4) Obtaining written informed consent
				  (Section 2(4)) ;
				  and
(5) Issuance of certificate of
				  vaccination (Section
				  2(5)) ;
E. Incorporate the protocol for
				  observing patients following administration required by Section
				  1(5) of this
				  chapter. Clinic staff shall strongly recommend that all patients remain in the
				  immediate vicinity of the drug orvaccination site for the post-administration
				  observation period specified in the treatment protocol. To facilitate patient
				  compliance, the operator of the clinic shall make a comfortable sitting area
				  available in the immediate vicinity of the administration site. The sitting
				  area must be of adequate size and must be suitably equipped to accommodate the
				  flow of patients for the full duration of the post-administration observation
				  period;
F. Include a protocol for
				  the safe storage and transportation of drugs and vaccines to ensure that the
				  drug or vaccine remains viable until the point of administration;
G. Include procedures to ensure that an
				  adequate number of epinephrine and diphenhydramine syringes and other emergency
				  medical supplies will be available for use in case a patient has an adverse
				  reaction to the drug or vaccine administered; and H. Include a protocol for
				  infection control. Standard precautions to minimize the risks of spreading
				  disease during drug or vaccine administration must be in place. The protocol
				  must include, at a minimum, the following provisions:
(1)
Handwashing
. Hands must
				  be washed thoroughly with soap and water or cleansed with an alcohol-based
				  waterless antiseptic between patients, before vaccine preparation or any time
				  hands become soiled;
(2)
Gloving
. Gloves are not required to be worn when administering
				  drugs or vaccines unless the person administering the vaccine is likely to come
				  into contact with potentially infectious body fluids or has open lesions on the
				  hands. It is important to remember that gloves cannot prevent needlestick
				  injuries;
(3)
Needlestick
				  Injuries
. Needlestick injuries must be reported immediately to a lead
				  person, with appropriate care and follow-up given. Safety needles or
				  needle-free injection devices should be used if available to reduce the risk of
				  injury;
(4)
Equipment
				  Disposal
. Used needles may not be detached from syringes, recapped or
				  cut before disposal. All used syringe/needle devices must be placed in
				  puncture-proof containers to prevent accidental needlesticks and reuse. Empty
				  or expired vaccine vials are considered medical waste and are subject to
				  Chapter 900 of the rules of the Department of Environmental Protection,
				  "Biomedical Waste Management Rules;" and
(5)
Drug or Vaccine
				  Preparation
. Proper drug or vaccine handling and preparation is
				  critical in maintaining the integrity of the drug or vaccine during transfer
				  from the manufacturer's vial to the syringe and ultimately to the
				  patient.