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Case histories in pharmaceutical risk management.
Cynthia G McCormick1, Jack E Henningfield, J David Haddox
1McCormick Consultation, LLC, Bethesda, MD 20817, USA.
Drug and Alcohol Dependence
|September 22, 2009
Summary
This study examines four pharmaceutical risk management programs for medications like OxyContin and ADHD treatments. It highlights their success in managing serious drug risks while noting challenges in controlling unintended consequences and ensuring patient access.
Area of Science:
- Pharmacovigilance
- Drug Safety
- Regulatory Science
Background:
- The U.S. Food and Drug Administration (FDA) has increasingly mandated risk management programs for new medications since the mid-1990s.
- These programs aim to minimize risks and assess unintended consequences of pharmaceutical products.
- Formalized and enforceable Risk Evaluation and Mitigation Strategies (REMS) are becoming standard requirements.
Observation:
- Four case histories of post-marketing surveillance and risk management programs are presented.
- Programs addressed potential abuse, dependence, and diversion for drugs including analgesics, ADHD medications, narcolepsy treatments, and opioid dependence therapies.
- Pharmaceutical sponsors presented their programs using a standardized template.
Findings:
- Risk management programs show promise for drug market approval and continued availability, especially for drugs with significant risks.
- These programs offer real-world examples of managing serious drug-related issues.
- Limitations exist in effectively controlling unintended consequences and balancing risk reduction with patient access.
Implications:
- The case studies provide valuable insights into the practical application and effectiveness of drug risk management strategies.
- Understanding these programs is crucial for pharmaceutical sponsors navigating FDA requirements.
- Balancing risk mitigation with patient access remains a key challenge in post-marketing drug surveillance.
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