State Board of Pharmacy Proposes Updates to Immunization Regulations

Last Updated: Oct 23, 2020

Pharmacy

The Pennsylvania State Board of Pharmacy (Board) has issued proposed regulations to reflect statutory changes to the Pennsylvania Pharmacy Practice Act by Act 8 of 2015 (Act of Jun. 26, 2015, P.L. 29, No. 8).

Act 8 of 2015 lowered the age of patients (to nine years of age and older, with parental consent) to whom pharmacists may administer flu vaccinations. This Act also established that licensed pharmacy interns are permitted to administer immunizations under the direct, immediate, and personal supervision of a licensed pharmacist (who is actively authorized to administer injectable medication, biologicals, and immunizations by the Board). Under the Act, pharmacists are required to notify a patient’s primary care provider, if known, of administrations.

The proposed regulations can be accessed here. The proposed regulations were published in the October 24, 2020 edition of the Pennsylvania Bulletin.

PAMED Submits Comments Seeking Clarification

The Pennsylvania Medical Society (PAMED) submitted comments asking for clarification on how a patient’s primary care provider is to become known. Specifically, is it the patient’s responsibility to inform the pharmacist as to who their primary care provider is, such as on an intake form, or must the pharmacist actively ask the patient for this information?

Additionally, PAMED also asked the Board to clarify the role of a supervising pharmacist in providing the required notification to a primary care provider when a pharmacy intern was involved in the administration of an injectable medication, biological, or immunization. The proposed regulations permit either the supervising pharmacist or the pharmacy intern who administered the immunization to fulfill notification requirements.

In its comments, PAMED also stressed the importance of adequate communication between pharmacists and primary care providers to not only manage possible adverse events, but to also ensure continuality of care and that patient medical records are accurately maintained. 

The Board will review all comments and questions submitted to it and respond accordingly. The Board has until Nov. 23, 2022 to submit final-form regulations to the Independent Regulatory Review Commission (IRRC) for review and approval.

PAMED will continue to monitor these regulations and provide updates to its members.

How to Submit Comments

Members wishing to submit their own comments must do so by Nov. 23, 2020 to:

Via mail or email:
Juan A. Ruiz, Board Counsel
State Board of Pharmacy
P.O. Box 69523
Harrisburg, PA 17106-9523
RA-STRegulatoryCounsel@pa.gov

And

Via email:
irrc@irrc.state.pa.us

Comments must reference the following:

State Board of Pharmacy
Proposed Regulations:  Administration of Injectable Medication, Biologicals and Immunizations
IRRC # 16A-5429

 

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