The FDA and DEA provide an update on the efforts being taken to alleviate the shortages in a joint letter.
Amidst a shortage of prescription stimulant medications, the FDA and DEA have issued a joint letter, urging stakeholders to collaborate and ensure patient access to these crucial drugs.
Key Points:
- The shortage began last fall due to a manufacturing delay from a single pharmaceutical company.
- This issue was exacerbated by record-high prescription rates for stimulant medications.
- The DEA sets annual production quotas for these controlled substances.
- Manufacturers did not produce their full quota in 2022, and 2023 shows a similar trend.
- DEA is urging manufacturers to either increase production to meet their quota or relinquish it for redistribution.
Additional Points:
- The FDA suggests reviewing the appropriateness of stimulant prescriptions and considering alternative treatments.
- Alternatives include an FDA-cleared game-based digital therapeutic for children with ADHD and nonstimulant medications.
- The FDA mandated updates to prescription stimulant labels to address concerns of misuse, addiction, and overdose.
- Medical literature indicates that family and friends are the primary sources of prescription stimulants for nonmedical use.
Conclusion:
- Both the FDA and DEA emphasize the importance of ensuring access to stimulant medications while also promoting thoughtful and responsible prescribing.
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