The Dec. 17 guest commentary, “Tighter rein needed on opioid makers, distributors,” highlights the complexity of treating pain in our country. Unfortunately, it also presents a misleading view of the role of distributors in the supply chain and overlooks the critical factors that affected the country’s response to the opioid epidemic.
As health care logistics experts, distributors deliver all medicines to licensed practitioners and pharmacies. While our members do not manufacture, promote, prescribe or dispense opioids, we do recognize that it will require a commitment from every entity in the supply chain to end this public health emergency. This includes the Drug Enforcement Administration.
During the height of the epidemic, the DEA, the primary federal agency responsible for regulating controlled substances, was regularly increasing the quota levels for an ever-growing supply of opioids in the market. Further, the DEA is the only entity that has the ability to track the full path of controlled substances — insight that is critical to stopping diversion before it occurs, but information, in its aggregate, that is not shared in real-time with distributors and other entities in the supply chain.
The lack of communication between DEA and its registrants has had an impact on enforcement and patient access to care. For this reason, in 2016 Congress passed, without dissent, the bipartisan Ensuring Patient Access and Effective Drug Enforcement Act (S.483) to provide greater regulatory clarity and improve coordination between the DEA and the supply chain it regulates.
Under the act, the DEA remains fully empowered to take immediate action against a registrant if there is “a substantial likelihood of an immediate threat that death, serious bodily harm, or abuse of a controlled substance.” Contrary to the claims made in last week’s commentary, the current DEA leadership recently testified that the law has not stopped the agency “from doing its job” or “hamstrung” its enforcement efforts.
Today, distributors are working closely with enforcement officials and others across the supply chain to make sure that patients with legitimate pain needs can get treatment, while also preventing abuse, misuse and diversion before it begins. Lawmakers, regulators and everyone in the health care system have solutions; we cannot waste any more time in making them a reality.
Healthcare Distribution Alliance