While the intent of the proposed rule is fundamentally solid, it raises several red flags with serious implications for the pharmaceutical supply chain and the patients it serves that must be addressed before EPA finalizes the rule, likely later this year.
On initial review, the requirements detailed in the proposed rule, “Management Standards for Hazardous Waste Pharmaceuticals,” seem reasonable for health care facilities, including pharmacies. EPA proposes a sector-based approach, with unique waste management requirements tailored to the operations of a number of specific health care facilities.
However, as many organizations indicated during the comment period that closed in December 2015, the rule potentially may lead to unintended and extreme consequences for pharmacies, such as increasing costs, limiting inventories, possible product shortages and the need for pharmacists to take on additional back-office services.
What are the red flags?
First, while the intent of the rule is constructive, and EPA’s sector-based approach to managing hazardous wastes is a good step forward from the existing RCRA requirements, one critical supply chain partner is missing: pharmaceutical distributors. This key omission will have a downstream impact on pharmacies and, ultimately, the patients they serve.
Excluding wholesale distributors from the requirements, combined with other requirements proposed in the rule, means that distributors will no longer be allowed to send pharmaceuticals to reverse distributors to determine whether they are eligible for a credit from the product’s manufacturer. Because distributors would now have to perform these complex return evaluations in-house, the process will become inefficient and may lead to more waste. Distributors will likely have to share their higher costs with health care facilities, insurance companies and ultimately patients.
Distributors also may not be able to stock some of the drugs that health care providers and pharmacists have come to rely on because distributors could not be assured they would receive credit for unsold products.
Second, EPA has introduced a new provision that all pharmaceuticals — including unopened, unused and those that have not yet expired — will now be considered “waste” when sent to a reverse distributor. This approach rescinds a more than 30-year-old policy that allows these types of products to be sent to reverse distributors to obtain a credit (if appropriate) from the manufacturer and to coordinate disposal management.
The EPA fails to explain how this current, highly secure, efficient and environmentally sound returns process between wholesale and reverse distributors is endangering public health or the environment to warrant this change. If the EPA’s rule goes into effect as proposed and eliminates this important policy, there would be greater burdens on reverse and wholesale distributors to manage waste, which would emanate throughout the supply chain.
Additionally, many O-T-Cs and supplements are donated to charitable organizations that distribute these products at no, or very low, cost — often to clinics and customers in need. As these products would be deemed “waste,” it is certain that these charities, and their customers, would lose access to these essential and affordable medicines.
What can be done?
The Healthcare Distribution Alliance (HDA, formerly HDMA) is working with a group of interested parties and affected pharmaceutical supply chain companies to advocate for commonsense policies that protect the environment, while preserving the current supply chain efficiencies that control costs and ensure access.
We urge all stakeholders, and especially dispensers, to take the time to learn about this proposal and to work with the EPA to craft a policy that works for each segment of the supply chain while allowing for the safe and secure disposal of hazardous waste pharmaceuticals.
Anita Ducca is senior vice president of regulatory affairs for the Healthcare Distribution Alliance, which represents primary pharmaceutical distributors.