The Richmond Academy of Medicine (RAM) appreciates the opportunity to comment upon the proposed regulations affecting the labeling of prescription medications (18 VAC 110-20). The Academy represents more than 1900 physicians in the greater Richmond region.

While an initial reading of the proposed labeling changes sounds innocuous and could result in a less confusing label, the implications of this proposed change are significant, do not improve the health of Virginians, and have potentially devastating impacts upon not only our patients, but also pharmacies and physician practices. 

First, we do not understand the rationale for the proposal. At a time when both citizens and legislators are asking for more transparency within the drug supply chain, it is inappropriate to decrease the ability of the prescription recipient to ask questions of or hold accountable the actual dispenser of the medication, not the final distribution point.

Second, anyone who has a question about a prescription would naturally call or speak with the person at the site where they picked up the prescription. If the pharmacist at the location did not actually fill the prescription, they may or may not be able to legitimately vouch for the information on the label, whether the prescription was actually filled correctly, or a number of other issues. If there is no data on the label to contact the actual dispenser to confirm the information, this places a potential significant liability on the distribution site employee and/or undue burden upon that person if they must then contact the pharmacy that actually filled the prescription. This creates additional unnecessary waste within our drug distribution system while creating an unfunded mandate upon the prescription distribution site.

Third, this proposed change opens the door for further limitation of prescription fulfillment from neighborhood and independent pharmacies to only chain pharmacies. We have seen in other states (i.e. Ohio) how national corporations have funneled business to their own pharmacies through spread pricing and other techniques. This business model has resulted in the closing of independent pharmacies. These closings are especially prevalent in areas where access to health care is already difficult - rural areas and inner cities. This proposal will allow national organizations to utilize their centralized pharmacies to fill prescriptions and have them delivered through their corporate network pharmacies, thereby cutting out neighborhood and independent pharmacies. We do not believe this will improve access to medications nor same money for the health care system. We fear it will result in profit mongering for these vertically integrated insurer/pharmacy benefit manager/pharmacy businesses at the expense of access to care.

Fourth, there is significant potential impact on physicians and their practices, especially those that prescribe specialty medications and/or infusion services. It will likely have a negative effect on independent infusion providers and hospital systems. This labeling proposal creates a means for insurers and/or pharmacy benefit managers to require that any medication that will be infused come from their national or specialty pharmacy. This so-called "white bagging" comes with a lack of validation by the infuser of how the medication was handled prior to being infused. It also creates an additional financial barrier to the provision by these localized infusion centers and/or a problem for the hospital if the infuser cannot "buy and bill" for these medications. The current financial strain on physician practices as well as hospital/regional health care systems means that this change in drug distribution/payment system could result in the closure of these providers. Again, the potential negative effects of this action would primarily affect the most vulnerable Virginians - those with chronic and/or disabling conditions as well as those who live in rural areas or inner cities.

Lastly, the Academy is concerned that the out-of-state filling of prescriptions could negatively affect to Commonwealth's revenue resulting in the loss of jobs and small businesses as an unintended consequence of this proposed regulation change.

For these reasons, on behalf of the 1,900+ physicians we represent and most importantly, the patients for whom they care, the Richmond Academy of Medicine respectfully opposes the proposed regulation changes to 18 VAC 110-20.