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Evaluation of Drug Sorption to PVC- and Non-PVC-based Tubes in Administration Sets Using a Pump

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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 and Alcohol Dependence

|February 19, 2013

Summary

This summary is machine-generated.

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.

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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.