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Published on: March 11, 2017
Update on tamper-resistant drug formulations.
M K Romach1, K A Schoedel, E M Sellers
1DL Global Partners Inc., Toronto, ON, Canada. m.romach@dlglobalpartners.com
Drug formulation significantly impacts prescription medication abuse risk. Developing abuse-deterrent formulations requires public health support and regulatory encouragement to become the standard of care.
Area of Science:
- Pharmacology
- Public Health
- Drug Development
Background:
- A 2005 expert panel identified drug formulation as key to reducing prescription medication abuse.
- Pharmaceutical companies are developing opioid formulations resistant to tampering (e.g., crushing, dissolving).
- Regulatory bodies like the US FDA require extensive postmarketing data for abuse-deterrent label claims.
Purpose of the Study:
- To review progress in abuse-deterrent opioid formulations since 2005.
- To discuss the impact of these formulations on both abusers and compliant patients.
- To highlight the need for public health and regulatory support for abuse-deterrent products.
Main Methods:
- Literature review using PubMed (2000-2011).
- Inclusion of scientific work presented by authors and colleagues through May 2012.
- Focus on opioid formulations and abuse deterrence strategies.
Main Results:
- Several tamper-resistant opioid formulations have been approved.
- The FDA has not yet approved explicit abuse-deterrent label claims.
- The impact on compliant patients versus those who abuse medication is an ongoing question.
Conclusions:
- Development of abuse-deterrent products needs broad public health support.
- Continued regulatory encouragement is vital for these products to become standard care.
- Abuse-deterrent formulations represent a significant area of advancement in medication safety.
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