COMAR 10.34.32.06. Approved Protocols

A. A pharmacist shall have and maintain a written protocol for any vaccine to be administered, including influenza vaccination.

B. The pharmacist shall administer vaccinations in accordance with the written protocol.

C. The written protocol for each vaccine shall contain at least the following elements:

(1) Identity and license number of the participating pharmacist;

(2) Vaccine;

(3) Precautions to vaccine use;

(4) Contraindications to vaccine use;

(5) Process to be followed for screening for:

(a) Indications;

(b) Precautions;

(c) Contraindications; and

(d) Allergies;

(6) Process for obtaining and documenting consent;

(7) Process for verification of prescription for patients 11—17 years old for vaccinations other than the influenza vaccine;

(8) Dose or doses of the vaccine that will be administered;

(9) The route or routes and site or sites of administration of the vaccine;

(10) The injection or administration procedures;

(11) Post-vaccination procedures, including waiting requirements;

(12) Process for handling adverse reactions, including but not limited to:

(a) Acute anaphylactic reactions; and

(b) Other acute emergencies; and

(13) Process for documenting and maintaining a vaccination record including at least:

(a) Patient:

(i) Name;

(ii) Date of birth; and

(iii) Address;

(b) Vaccination administration:

(i) Date;

(ii) Dose;

(iii) Site; and

(iv) Route;

(c) Vaccine:

(i) Manufacturer;

(ii) Lot number; and

(iii) Expiration date;

(d) Required Vaccine Information Statement:

(i) Version; and

(ii) Provision date;

(e) Name of the patient’s primary care provider or prescriber;

(f) Documentation:

(i) Of at least one attempt to inform the patient’s primary care provider or prescriber that the vaccination has been administered; or

(ii) That the patient has no primary care provider;

(g) Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and

t one attempt to inform the patient’s primary care provider, and prescriber if the vaccination is administered in accordance with a prescription, that the vaccination has been administered; or

(ii) That the patient has no primary care provider;

(g) Documentation of an attempt to inform the patient’s primary care provider that the influenza vaccination has been administered may not be required; and

(h) The name of the vaccinator.

D. The protocol shall be:

(1) Signed and dated at least annually by the pharmacist;

(2) Available and presented for inspection to the Board of Pharmacy upon request; and

(3) Reviewed and updated as necessary.

Cross References 10.34.32.03B 10.34.32.03C(1) 10.34.32.03D