Impact of formulation on the abuse liability, safety and regulation of medications: The expert panel report

Charles Grudzinskas, Robert L. Balster, Charles W. Gorodetzky, Roland R Griffiths, Jack E. Henningfield, Chris Ellyn Johanson, Robert S. Mansbach, Cynthia G. McCormick, Sidney H. Schnoll, Eric C Strain, C. Wright

Research output: Contribution to journalArticle

Abstract

A scientific meeting was held in April 2005 to consider how the formulation of medications might impact on their potential for abuse. The background papers prepared for this meeting, as well as abstracts of volunteered presentations, are published in this supplemental issue of Drug and Alcohol Dependence. This paper is the Expert Panel Report summarizing the discussions held following the formal presentations and including the suggested recommendations for additional research that emerged from these discussions. There was overwhelming consensus that formulation does play a role in prescription drug abuse, i.e., a formulation of an abused substance can be developed that will decrease its abuse potential, and several examples were cited. Nevertheless, it is imperative that new formulations have similar efficacy and in no way compromise medication access to doctors and patients. However, there was also consensus that a great deal of research and discussion was needed to fully implement a program of risk management through reformulation of existing products or tailoring the formulation of new products to retain clinical efficacy and safety while minimizing potential for abuse. Those who need to take part in this discussion include scientific groups, pharmaceutical companies, as well as governmental and regulatory agencies. The areas where more research is needed include development of standards for assessing tamper-resistance, improved animal models that can address formulation-related variables (e.g., onset, duration), the redesign of human laboratory studies providing appropriate models for comparing formulations, and improved post-marketing surveillance. Finally, knowledge and experience are needed to translate scientific work into a predictable, transparent and reliable regulatory process.

Original languageEnglish (US)
JournalDrug and Alcohol Dependence
Volume83
Issue numberSUPPL. 1
DOIs
StatePublished - Jun 2006

Fingerprint

liability
medication
abuse
expert
Safety
regulation
Prescription Drug Misuse
Consensus
Research
Prescription Drugs
Risk Management
drug abuse
Risk management
Marketing
risk management
Pharmaceutical Preparations
pharmaceutical
Alcoholism
compromise
Substance-Related Disorders

Keywords

  • Abuse liability
  • Drug regulation
  • Formulations
  • Tampering

ASJC Scopus subject areas

  • Medicine(all)
  • Behavioral Neuroscience
  • Toxicology
  • Health(social science)

Cite this

Impact of formulation on the abuse liability, safety and regulation of medications : The expert panel report. / Grudzinskas, Charles; Balster, Robert L.; Gorodetzky, Charles W.; Griffiths, Roland R; Henningfield, Jack E.; Johanson, Chris Ellyn; Mansbach, Robert S.; McCormick, Cynthia G.; Schnoll, Sidney H.; Strain, Eric C; Wright, C.

In: Drug and Alcohol Dependence, Vol. 83, No. SUPPL. 1, 06.2006.

Research output: Contribution to journalArticle

Grudzinskas, C, Balster, RL, Gorodetzky, CW, Griffiths, RR, Henningfield, JE, Johanson, CE, Mansbach, RS, McCormick, CG, Schnoll, SH, Strain, EC & Wright, C 2006, 'Impact of formulation on the abuse liability, safety and regulation of medications: The expert panel report', Drug and Alcohol Dependence, vol. 83, no. SUPPL. 1. https://doi.org/10.1016/j.drugalcdep.2006.02.008
Grudzinskas, Charles ; Balster, Robert L. ; Gorodetzky, Charles W. ; Griffiths, Roland R ; Henningfield, Jack E. ; Johanson, Chris Ellyn ; Mansbach, Robert S. ; McCormick, Cynthia G. ; Schnoll, Sidney H. ; Strain, Eric C ; Wright, C. / Impact of formulation on the abuse liability, safety and regulation of medications : The expert panel report. In: Drug and Alcohol Dependence. 2006 ; Vol. 83, No. SUPPL. 1.
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