Md. Code Regs. 10.34.32.05

Current through Register Vol. 51, No. 24, December 2, 2024

Section 10.34.32.05 - Record Keeping

A. The pharmacy permit holder shall maintain documentation in the pharmacy from which the vaccine was administered for a minimum of 5 years that includes:

(1) The name, address, and date of birth of the individual receiving the vaccination;

(2) The date of administration and route and site of vaccinations;

(3) The name, dose, manufacturer's lot number, and expiration date of the vaccine;

(4) The name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;

(5) The name of the pharmacist, pharmacy student, physician, or nurse administering the vaccination;

(6) The version of the vaccination information statement provided to the individual receiving the vaccination;

(7) The copy of the signed patient consent form of those individuals to whom the vaccine was administered;

(8) The nature and outcome of an adverse reaction and documentation that the adverse reaction was reported to:

(a) The primary care provider; and

(b) The Vaccine Adverse Event Reporting System.

(9) At least one effort made by the pharmacist to inform the individual's authorized prescriber that the vaccination has been administered; and

(10) If the authorized prescriber is not the individual's primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual's primary care provider or other usual source of care that the vaccination has been administered.

B. The records required in this regulation shall be:

(1) Readily retrievable;

(2) Made available on the request of the Board;

(3) Except for records related to minor patients, maintained for a minimum of 5 years; and

(4) In the case of a minor patient, maintained until the patient attains the age of majority plus 3 years or for 5 years after the record is made, whichever is later.

C. The pharmacist administering a vaccination as an independent provider at a location that is not a pharmacy shall maintain the following documentation for a minimum of 5 years:

(1) Name, address, and date of birth of the individual receiving the vaccination;

(2) Date of administration, and route and site of vaccinations;

(3) Name, dose, manufacturer's lot number, and expiration date of the vaccine;

(4) Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;

(5) Name of the pharmacist or pharmacy student administering the vaccination;

(6) Version of the vaccination information statement provided to the individual receiving the vaccination;

(7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered;

(8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:

(a) The primary care provider; and

(b) The Vaccine Adverse Event Reporting System.

(9) At least one effort made by the pharmacist to inform the individual's authorized prescriber that the vaccination has been administered; and

(10) If the authorized prescriber is not the individual's primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual's primary care provider or other usual source of care that the vaccination has been administered.

D. The pharmacist administering a vaccination on behalf of a permit holder at a location that is not a pharmacy shall maintain the following documentation with the permit holder for a minimum of 5 years:

(1) Name, address, and date of birth of the individual receiving the vaccination;

(2) Date of administration, and route and site of vaccinations;

(3) Name, dose, manufacturer's lot number, and expiration date of the vaccine;

(4) Name and address of the primary health care provider of the individual receiving the vaccination, as identified by that individual;

(5) Name of the pharmacist or pharmacy student administering the vaccination;

(6) Version of the vaccination information statement provided to the individual receiving the vaccination;

(7) Copy of the signed patient consent form of those individuals to whom the vaccine was administered;

(8) Nature and outcome of an adverse reaction, and documentation that the adverse reaction was reported to:

(a) The primary care provider; and

(b) The Vaccine Adverse Event Reporting System.

(9) At least one effort made by the pharmacist to inform the individual's authorized prescriber that the vaccination has been administered; and

(10) If the authorized prescriber is not the individual's primary care provider or if the vaccination has not been administered in accordance with a prescription document, at least one effort made by the pharmacist to inform the individual's primary care provider or other usual source of care that the vaccination has been administered.

Md. Code Regs. 10.34.32.05

Regulations .05 adopted as an emergency provision effective December 16, 2005 (33:1 Md. R. 34); adopted permanently effective April 24, 2006 (33:8 Md. R. 734)