The Virginia Society of Health-System Pharmacists (VSHP) supports the Board’s actions to improve the integrity of the supply chain regarding drugs delivered through the white bagging process. The lack of notification and logistical information of receipt of drugs through this process has been a longstanding point of frustration for our members who have to allocate additional resources to track down shipments and follow the trail of information to connect these drugs with the intended patient.

VSHP would like to ask the Board to consider exemptions to the 4^th proposed regulation prohibiting delivery of drugs that are delivered to the patient’s residence for self-administration that require special storage, reconstitution, or compounding prior to administration. There are some drugs, such as factors for the treatment of hemophilia which requires the patient to bring their drugs to the clinic or the emergency department for assessment of self-administration and/or drawing of labs prior to observation of administration. This process is critical to ensuring positive outcomes for patients as the observation of administration technique or demonstration of administration technique is part of ensuring that the drug is received by the body in the indicated manner. This is very similar to asking a patient to bring their inhaler to a physician’s office to demonstrate their inhalation technique as part of evaluation for efficacy. The way the proposed regulation is written does not account for this unique population.

We recommend the following: “Prohibiting delivery to a patient's residence of any drug that requires special storage, reconstitution, or compounding prior to administration is intended and that will be subsequently transported by the patient for administration. Drugs that may require compounding or reconstitution, but either are self-administered or that the patient must possess because the drugs are for emergent use for rare conditions and are not stocked in the facilities who would treat the patient, are exempted from this prohibition.”

Thank you for your time and consideration.