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Bound by quota: Drug shortage vulnerability for Schedule II medicines
- Drug shortages have been a serious, persistent feature of the U.S. healthcare market for more than two decades, with headline-grabbing examples including a lack of amoxicillin, attention-deficit/hyperactivity disorder (ADHD) medicines, cancer therapies, and saline. It is well recognized that underlying economic forces play a major role in many shortages, and that FDA’s oversight of quality and manufacturing can shape how quickly supply chains recover when shocks occur. What is less understood is how other parts of the federal regulatory framework can make shortages more likely and more severe.
- This paper examines how the Drug Enforcement Administration’s (DEA’s) quota and inventory controls heighten shortages for a subset of medicines: Schedule II controlled substances under the Controlled Substances Act.
- Schedule II medicines are those that have accepted medical uses but also a high potential for misuse and abuse, as determined either in the original Controlled Substances Act or subsequently by DEA under its scheduling authority. For many conditions, they are among the most effective options available. They include oral-dose painkillers and stimulants for treating ADHD that are used by millions of patients. Intravenous opioids-fentanyl, morphine, and hydromorphone-also fall under Schedule II, despite their addictive qualities, appearing on the FDA Essential Medicines List because of their central role in managing pain and providing sedation during surgery, emergencies, and other hospital care.
- Over the past decade, DEA has increasingly used its authority to cap annual production of Schedule II medicines to curb diversion of controlled medicines into illicit channels. This strategy, motivated by skyrocketing addictions and overdose deaths, has produced an exceptionally restrictive system, with little slack for supply chains to absorb shifts in demand or supply. Across all drug classes, Schedule II medicines stand out for how long those shortages persist. Morphine sulphate injection has been listed in in shortage since 2017, for instance, and ADHD stimulants have been in shortage since 2022.
- When a shortage occurs, DEA’s tight production limits leave a fixed, centrally capped supply to cover clinical and illicit uses alike, so that patients with legitimate medical need cannot always obtain the medicines their clinicians would prefer to prescribe. For intravenous opioids, those shortfalls play out in operating rooms, emergency departments, and intensive care units, where hospitals report having to provide care by substituting whatever formulations or concentrations are available-often ones not as well suited to patient needs-creating substantial risk of medication errors and, in some cases, leading to suboptimal pain control or sedation.
- This paper examines how the Drug Enforcement Administration’s (DEA’s) quota and inventory controls heighten shortages for a subset of medicines: Schedule II controlled substances under the Controlled Substances Act.
- Schedule II medicines are those that have accepted medical uses but also a high potential for misuse and abuse, as determined either in the original Controlled Substances Act or subsequently by DEA under its scheduling authority. For many conditions, they are among the most effective options available. They include oral-dose painkillers and stimulants for treating ADHD that are used by millions of patients. Intravenous opioids-fentanyl, morphine, and hydromorphone-also fall under Schedule II, despite their addictive qualities, appearing on the FDA Essential Medicines List because of their central role in managing pain and providing sedation during surgery, emergencies, and other hospital care.
- Over the past decade, DEA has increasingly used its authority to cap annual production of Schedule II medicines to curb diversion of controlled medicines into illicit channels. This strategy, motivated by skyrocketing addictions and overdose deaths, has produced an exceptionally restrictive system, with little slack for supply chains to absorb shifts in demand or supply. Across all drug classes, Schedule II medicines stand out for how long those shortages persist. Morphine sulphate injection has been listed in in shortage since 2017, for instance, and ADHD stimulants have been in shortage since 2022.
- When a shortage occurs, DEA’s tight production limits leave a fixed, centrally capped supply to cover clinical and illicit uses alike, so that patients with legitimate medical need cannot always obtain the medicines their clinicians would prefer to prescribe. For intravenous opioids, those shortfalls play out in operating rooms, emergency departments, and intensive care units, where hospitals report having to provide care by substituting whatever formulations or concentrations are available-often ones not as well suited to patient needs-creating substantial risk of medication errors and, in some cases, leading to suboptimal pain control or sedation.
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