The American College of Rheumatology (ACR) represents rheumatology professionals across the United States. The College routinely comments on proposed policy changes that could impact our members or the patients that they treat. The Virginia Society of Rheumatologists (VSR) represents rheumatology professionals across the state of Virginia and routinely comments on policy changes that would negatively impact our members and the patients they treat. The ACR and VSR are concerned that the proposed rule will have negative impacts on drug transparency that is vital to patient safety.  The ACR urges the Board of Pharmacy to withdraw this proposed rule.

The drug supply chain is a complex system. When a prescription makes its way into the hands of the consumer it has been touched numerous times by many other people and entities along the way. To ensure adequate pharmacovigilance, the chain of custody once it reaches the pharmacy must be clear and transparent. This proposed rule would allow prescriptions to be filled at a specialty pharmacy then shipped to an alternative site for pickup, without requiring anything on the label to identify the pickup location. This substantially diminishes the drug transparency that patients deserve and that safety demands.  

The ACR and VSR are concerned that this rule would further open the door for “white bagging” and “brown bagging” of pharmaceuticals. “White bagging” policies require providers to purchase medications through a specialty pharmacy, typically owned by the PBM or payer. “Brown bagging” refers to policies that require the dispensing of a medication from a specialty pharmacy directly to a patient, who then transports the medication to the physician’s office for administration.

Our members frequently administer infusions. Increasingly payers are forcing patients to engage in the dubious practice of “brown bagging” to ensure that the payer’s own specialty pharmacy is utilized to fill a prescription, instead of using the “buy and bill” system. The reason “buy and bill” is predominantly used in infusions goes to the heart of patient safety and chain of custody. Once a medication is delivered to a clinic, storage and handling is no longer an issue.  With “brown bagging” handling and storage is especially a concern. Once the patient picks up the medication from a pharmacy, ensuring proper handling and storage is impossible.

It is worth noting that Board of Pharmacy already has a proposed rule on “white bagging” and “brown bagging” in its final stage of consideration. It is also particularly worth noting that the rule would add subsections F-G to the same code sections being modified in this rule. [i] The sections contained in the other proposal prohibit the delivery of a dispensed drug to a patient’s residence that requires special storage, compounding or reconstitution, and is to be subsequently taken by the patient to a clinic for administration. However, it would allow these drugs to be delivered to “alternative delivery sites,” which includes another pharmacy. If this rule is adopted in conjunction with the other proposed rule, the pick-up pharmacy would not be on the drug label and would not just be hidden from the patient, but also from the administering physician.

In a “brown bagging” scenario, a physician must have as much information about the chain of custody as possible. Patient safety depends on the physician knowing how long the patient has had the drug, how it was stored, and where the drug was received from. The ACR and VSR do not endorse or condone “brown bagging.” However, if this rule should move forward, it must exclude “brown bagged’ medications from this label exemption, so that physicians have all the information necessary to determine the safety of the medication. That includes being able to contact the pharmacy where the prescription was picked up by the patient.

Finally, the ACR and VSR are a strong supporters of the rulemaking process and the transparency that it provides for physicians and patients. However, we strongly question the transparency of the rulemaking being undertaken here. While we do not question the Board’s authority, modifying the same code section simultaneously with two different rules effectively hides the ball from interested parties. At a minimum this current proposal should be withdrawn until the other rule has a final disposition and interested parties can submit comments on the full implications of the changes proposed in this rule. We do not believe that the Board has undertaken this new rule with any ill intent. We simply believe it is an oversight driven by a petition for rulemaking that does not take into full account the implications of the proposed rule on patient safety and provider liability.  We respectfully ask the Board to withdraw this rule.

We appreciate the opportunity to comment. If you have any additional questions please reach out to Joseph Cantrell at jcantrell@rheumatology.org.