July 16, 2024

Jeanne Parisi
Deputy Secretary, Quality Assurance
Pennsylvania Department of Health
Health and Welfare Building
625 Forster Street, 8th Floor West
Harrisburg, PA 17120

Dear Deputy Secretary Parisi:

I am writing on behalf of the Pennsylvania Society of Health-System Pharmacists (PSHP) and The Hospital and Healthsystem Association of Pennsylvania (HAP) to request that the Department of Health clarify the regulatory requirements for DAAC-certified hospital-based retail pharmacies with regards to the pharmacist’s ability to administer vaccinations and injectable medications.

PSHP advocates for pharmacists within Pennsylvania-based health systems across the commonwealth, as well as for the patients and communities they serve. Its mission is to advance patient care by promoting excellence in health-system pharmacy practice.

It has come to our attention that there is some variation in (or restrictions on) pharmacists working in hospital-based retail pharmacies with regard to their ability to administer vaccinations and injectable medications. The distinction seems to be primarily based on whether the hospital-based retail pharmacy is DAAC-certified or not. In short, pharmacists working at DAAC-certified hospital-based retail pharmacies must submit an exception request to administer vaccinations, and at this point are not permitted to administer injectable medications.

This framework unnecessarily creates two standards for hospital-based retail pharmacies in Pennsylvania. Only a small number of hospital-based retail pharmacies are DAAC-certified. Most hospital-based retail pharmacies are governed first and foremost by the Pharmacy Act and applicable Pennsylvania State Board of Pharmacy regulations. In accordance with Section 9.2 of Pharmacy Act, pharmacists authorized by the State Board of Pharmacy are permitted to administer injectable medications, biologicals, and immunizations subject to the standards and conditions set forth by the Board at 49 Pa. Code § 27.401. Therefore, the only hospital-based retail pharmacies that are subject to the restrictions on administration of vaccinations and injectable medications are those that are DAAC-certified.

Restrictions on the scope of practice for pharmacists creates unnecessary barriers to vaccines and medications that have a significant public health impact. Throughout the COVID-19 pandemic, pharmacists were on the front lines of the vaccination effort. They continue to be vital to the vaccination strategy through their work at retail pharmacies across the commonwealth. Any decision or regulatory interpretation by the Department to restrict a pharmacist’s scope of practice at DAAC-certified hospital-based retail pharmacies creates barriers to access at those pharmacies with no clear benefits for patient safety.

The State Board of Pharmacy regulations require that all medications administered by pharmacists are done so only under the order of a treating practitioner. Under the same regulations, there is a framework for ensuring pharmacist competencies with regards to administration of injectable medications, biologicals and immunizations - including an education and certification process. It is important that pharmacists at DAAC-certified hospital-based retail pharmacies not be restricted in their ability to ensure that members of the community maintain access to their medications for HIV prevention, inflammatory diseases, osteoporosis, and opioid use disorder, in addition to scheduled vaccinations.

Restrictions on DAAC-certified hospital retail pharmacies are not in alignment with recent payment changes. As of March 1, 2024, Pennsylvania Medicaid allowed pharmacists to enroll as a mid-level practitioner and be eligible to bill for services. In Pennsylvania, “provider-status” means pharmacists are eligible for payment of services on parity with other health care providers within the existing scope of practice authorized by the Pharmacy Practice Act with amendments per Act 80 of 2020. Pharmacists at DAAC-certified hospital-based retail pharmacies should have access to the same payment mechanisms as their colleagues in the field.

Potential remedies would not require a change in regulation. It is our understanding that for DAAC-certified hospitals, the regulation in question is 28 Pa. Code § 107.64, which states:

“Drugs shall be administered only upon the proper order of a practitioner acting within the scope of his license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training.”

Pharmacists are not included in the FDA’s definition of practitioner which seems to be the limiting factor for DAAC-certified hospitals. However, in light of the evidence presented above, the FDA definition may not be the best definition to use in this scenario nor is it clearly stated in the regulation that the FDA definition is considered the baseline. Sub-regulatory guidance or even a clarifying memo could be issued to reverse this interpretation and bring pharmacists in DAAC-certified hospital-based retail pharmacies into alignment with their colleagues in non- DAAC-certified settings.

We look forward to continued discussion on this important issue.

Jill A. Rebuck, PharmD, MBA, FCCM, FCCP
Executive Director
Pennsylvania Society of Health-System Pharmacists (PSHP)

Nicole Stallings
President and Chief Executive Officer
The Hospital and Healthsystem Association of Pennsylvania