The Government Accountability Office (GAO) recentlyreleased a new report on shortages of prescription drugs containing controlled substances. The report looked at trends in these types of shortages, potential causes, what effects they may have on patients and providers, the U.S. Drug Enforcement Administration’s (DEA) management of the quota process, and how interaction between the DEA and the U.S. Food and Drug Administration (FDA) can help mitigate the impact shortages and prevent future shortages.
The report notes that prescription drugs containing controlled substances are often used in various clinical settings and are very important for the treatment of patients with genuine medical conditions. The report also explains that it is the responsibility of the DEA to ensure that these substances are not diverted—which the DEA accomplishes in part by setting quotas on manufacturers. The DEA attempts to enact these quotas without inhibiting the supply of controlled substances needed for legitimate medical concerns.
Because the DEA necessarily puts quotas on these controlled substances, management of this system is an exceptionally important matter for public health, as these medications are often critical for patient care. The report notes that there has been a spike in shortages over recent years.
GAO recommended the Administrator of the DEA take five actions “to ensure an adequate and uninterrupted supply of controlled substances for legitimate medical use and respond to shortages of drugs containing controlled substances.” These five actions included:
Establishing controls and data checksso manufacturer quota submissions and DEA decisions are accurate;
Creating DEA performance measures to facilitate the uninterrupted supply of controlled drugs needed for medical use;
Monitoring all data to assess DEA administration of the quotas;
Designing internal policies for processing quota applications;
Instituting policies and procedures to facilitate coordination with FDA in preventing drug shortages.
GAO also suggested the DEA and FDA update their Memorandum of Understanding (MOU) to strengthen their ability to respond to existing and future drug shortages involving controlled substances.
For the full GAO report, “DRUG SHORTAGES: Better Management of the Quota Process for Controlled Substances Needed; Coordination between DEA and FDA Should Be Improved,”click here.
For information on what the healthcare supply chain is doing to help combat drug shortages,click here.