Section 392-2-4-A-2 - Administration RequirementsA pharmacist who holds a certificate of administration shall observe the following administration requirements in addition to requirements contained in:
- An applicable prescription, treatment protocol or written standing order issued pursuant to 32 M.R.S. §13831(2); and
- The applicable treatment protocol issued pursuant to 32 M.R.S. §13833 and Section 1 of this chapter.
1.VerificationA. For the administration of all drugs and vaccines pursuant to a prescription or treatment protocol or standing written order, the pharmacist who holds a certificate of administration shall verify: (1) That the patient is the person to whom the prescription was issued; or(2) That the patient is a member of the patient population (e.g., employee of designated employer, resident of designated municipality) covered by the treatment protocol or standing written order.B. In addition, for the administration of vaccines, the pharmacist who holds a certificate of administration shall verify:(1) For administration of a COVID-19 vaccine pursuant to 32 M.R.S. §13831 (2-A), that the patient is 3 years of age or older;(2) For administration of influenza vaccines, that the patient is 7 years of age or older; or(3) For the administration of all other vaccines pursuant to a prescription or treatment protocol or standing written order, that the patient is 18 years of age or older.2.Assessment Prior to administering a drug or vaccine, a pharmacist who holds a certificate of administration shall assess the patient for contraindications that would preclude vaccination.
3.Drug or Vaccine Information A pharmacist who holds a certificate of administration, prior to administration, shall give each patient or the patient's legal representative the appropriate drug or vaccine information for the drug or vaccine to be administered. The pharmacist shall review with the patient or patient's legal representative the portions of the statement describing the risks of the vaccine and what to look for and what to do in the event of a severe reaction.
4.Informed Consent After providing the drug or vaccine information, but prior to administration, the pharmacist who holds a certificate of administration shall obtain in writing the informed consent of the patient or the patient's legal representative to administration of the drug or vaccine and to emergency administration of epinephrine, diphenhydramine or both if the patient has an adverse reaction to the drug or vaccine administered.
5.Certificate of Vaccination A pharmacist holding a certificate of administration who administers a vaccine shall issue a certificate of vaccination to the patient or patient's representative at the time the vaccine is administered. The certificate shall be signed by the pharmacist and shall include the patient's name, date of vaccination and the location where the vaccine was administered.
6.Record of Individual Administration A pharmacist who holds a certificate of administration shall record the administration of a drug or vaccine in a computerized or non-computerized recordkeeping system that includes, at a minimum, the following information. The recordkeeping system may be a pharmacy's patient profile record system:
A.For drugs and both influenza and non-influenza vaccines(1) The name, date of birth, gender and contact information of the patient;(2) The name of the pharmacist holding a certificate of administration who administered the drug or vaccine;(3) The written informed consent required by Section 2(4) of this chapter, or an electronic copy of the document;(4) The date of administration;(5) The street address or location of the building where the drug or vaccine was administered;(6) The name of the drug or vaccine administered, including the dose, route of administration, expiration date, manufacturer and lot number; and(7) In the event that epinephrine or diphenhydramine is administered pursuant to 32 M.R.S. §13831(3), (a) The name of the pharmacist holding a certificate of administration who administered the drug;(b) The date of administration;(c) The street address or location of the building where the drug was administered; and(d) The name of the drug administered, including the dose, route of administration, expiration date, manufacturer and lot number.B.For drugs and non-influenza vaccines(1) For drugs and vaccinations authorized by prescription, the prescription; and(2) For drugs and vaccinations authorized by a treatment protocol or standing written order, the name of the authorized practitioner who issued the treatment protocol or standing written order and the date of issuance.02-392 C.M.R. ch. 2, § 4-A-2