Impact of formulation on the abuse liability, safety and regulation of medications: the expert panel report.
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.
Grudzinskas
Charles
C
NDA Partners LLC, 720 Riverview Terrace, Annapolis, MD 21401, USA. cgrudzinskas@compuserve.com
Balster
Robert L
RL
Gorodetzky
Charles W
CW
Griffiths
Roland R
RR
Henningfield
Jack E
JE
Johanson
Chris-Ellyn
CE
Mansbach
Robert S
RS
McCormick
Cynthia G
CG
Schnoll
Sidney H
SH
Strain
Eric C
EC
Wright
C
C
D002626:Chemistry, Pharmaceutical; D004339:Drug Compounding / Q000379:methods*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D005104:Expert Testimony; D006801:Humans; D016365:Liability, Legal; D009294:Narcotics / Q000009:adverse effects*; D019966:Substance-Related Disorders / Q000517:prevention & control*
D009294:Narcotics