02-392-2 Me. Code R. § 4-A-1

Current through 2024-51, December 18, 2024

Section 392-2-4-A-1 - Minimum Requirements for Treatment Protocol Issued Pursuant to 32 M.R.S. Section 13833

For purposes of this section, a treatment protocol is a written collaborative agreement between a practitioner as described in 32 M.R.S. §13833 and a pharmacist who holds a certificate of administration or pharmacy as described in this section. A treatment protocol authorizes the administration and injection of drugs and vaccines by a pharmacist who holds a certificate of administration pursuant to 32 M.R.S. §§13831-13835 and must include, at a minimum, the following provisions:

1.Authorized Practitioner

The treatment protocol must state the name, professional title, license number and contact information of the authorized practitioner issuing the protocol.

2.Time Period

The treatment protocol must state the beginning and ending dates of the period of time during which the protocol will be in effect, and the date on which the treatment protocol was issued. The treatment protocol may not have a beginning date prior to the date of issuance.

3.Scope of Coverage - Pharmacists

The treatment protocol may cover specific, named pharmacists who hold a certificate of administration, or may cover on a blanket basis all pharmacists holding a certificate of administration who are employed by or under contract to a specific pharmacy or pharmacies. Thus, the protocol must either:

A. State the name and contact information of the individual pharmacists holding a certificate of administration who are covered by the treatment protocol; or

B. State the name and physical address of the pharmacy or pharmacies whose employee or contract certified pharmacists holding a certificate of administration will be covered by the treatment protocol without further identification.

A treatment protocol that covers on a blanket basis all pharmacists who hold a certificate of administration and are employed by or under contract to a specific pharmacy or pharmacies only applies to the administration and injection of drugs and vaccines by such pharmacists in the course of the pharmacists' employment or performance of contractual duties for a pharmacy identified in the treatment protocol.

4.Scope of Coverage - Drugs and Vaccines

The treatment protocol must identify the drugs and vaccines that may be administered pursuant to the protocol. For each drug and vaccine named, the protocol must specify the maximum permitted dose and the route of administration.

5.Standards for Observation

The treatment protocol must include standards for observation of the person receiving the drug or vaccine to determine whether the person has an adverse reaction. The treatment protocol must specify a minimum post-administration patient retention period.

6.Adverse Reactions

The treatment protocol must include procedures to be followed by the pharmacist who holds a certificate of administration when administering epinephrine, diphenhydramine, or both, to a person who has an adverse reaction to a drug or vaccine administered by the pharmacist. The treatment protocol must include guidelines as to when contact with the local emergency services system or other follow-up health care providers is necessary or recommended.

7.Notification

A. The treatment protocol must require a pharmacist holding a certificate of administration who administers a drug or vaccine pursuant to this treatment protocol to provide notice of the administration within 3 business days to the authorized practitioner who issued a prescription, treatment protocol or written standing order pursuant to 32 M.R.S. §13831(2) which authorized administration to the patient or to the patient population of which the patient is a member.

B. Where the Maine Immunization Information System (ImmPact) or a successor system allows for entry of administration of a vaccine, reporting the administration of a vaccine through that system satisfies the requirements of this section.

C. The treatment protocol must require a pharmacist who holds a certificate of administration to provide notice of an adverse reaction to a drug or vaccine administered by the pharmacist of which the pharmacist is aware, including a statement as to whether epinephrine or diphenhydramine was administered, within 3 business days to:

(1) The authorized practitioner who issued the prescription, treatment protocol or written standing order which authorized administration to the patient or to the patient population of which the patient is a member;

(2) The Vaccine Adverse Event Reporting System co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration; and

(3) The Maine Center for Disease Control and Prevention.

[NOTE: A prescription, treatment protocol or written standing order from an authorized practitioner is not required for administration of influenza vaccines.]

02-392 C.M.R. ch. 2, § 4-A-1