The Virginia Society of Health-System Pharmacists (VSHP) supports the draft Guidance Document 110-3 Guidance on alternative delivery of prescriptions, pharmacy to physician or pharmacy to controlled substance registrant.

We particularly support the following examples stated in the Guidance Document:

Examples: A pharmacy is exempt from subsections B through E of this section when it needs to deliver a drug to a licensed alternate delivery site that does not routinely receive deliveries from the pharmacy and compliance with subsections B through E of this section would create a delay in delivery that may result in potential patient harm.

A pharmacy making regular deliveries of a standardized list of drugs to the same alternate delivery site over time would NOT be exempt from compliance with subsections B through E as this constitutes routine delivery from the pharmacy.

A pharmacy delivering a drug to an alternate delivery site when compliance with subsections B through E of this section would not create a delay that may result in patient harm is NOT exempt from subsections B through E of this section.

The guidance examples above help clarify the intent of current regulations that were developed as a positive first step in setting up guardrails in anticipation of this emerging practice. Payors recently implemented additional, specific white bagging policies that have added to the challenges and burden posed by current white bagging practices that prevent providers from timely and optimized care.

VSHP aligns itself with the American Society of Health System Pharmacists (ASHP) white bagging statement:

ASHP stands opposed to payer-mandated white bagging models that jeopardize optimal, safe, and effective medication use. It is ASHP’s position that payer-mandated distribution models that require clinician-administered drugs to be dispensed exclusively via third-party specialty pharmacies are placing patients at risk and threaten to compromise organizations’ well-established practices intended to ensure patient safety. Additionally, white bagging negatively impacts pharmacists’ ability to validate medication integrity and maintain oversight of storage and handling. Further, by sidestepping well-established supply chain procedures, white bagging disrupts efforts to maintain adherence with protocols designed to ensure patient safety, quality, and continuity of care.

We also associate ourselves with the letter from the Virginia Hospital and Healthcare Association (VHHA) submitted as public comment on this matter, including VHHA's interpretation of "regular" deliveries and recommendations for future steps on new stakeholder meetings or a workgroup, data collection and analysis, and potential regulatory or legislative action to address the patient safety risks of white bagging.

Thank you for your time and consideration.

Virginia Society of Health-System Pharmacists