Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: expert panel report.
The abuse and diversion of medications is a significant public health problem. This paper is part of a supplemental issue of Drug and Alcohol Dependence focused on the development of risk management plans and post-marketing surveillance related to minimizing this problem. The issue is based on a conference that was held in October 2008. An Expert Panel was formed to provide a summary of the conclusions and recommendations that emerged from the meeting involving drug abuse experts, regulators and other government agencies, pharmaceutical companies and professional and other non-governmental organizations. This paper provides a written report of this Expert Panel. Eleven conclusions and 11 recommendations emerged concerning the state of the art of this field of research, the regulatory and public health implications and recommendations for future directions. It is concluded that special surveillance tools are needed to detect the emergence of medication abuse in a timely manner and that risk management tools can be implemented to increase the benefit to risk ratio. The scientific basis for both the surveillance and risk management tools is in its infancy, yet progress needs to be made. It is also important that the unintended consequences of increased regulation and the imposition of risk management plans be minimized.
Psychiatry and Behavioral Sciences, Wayne State University, CRS Associates, LLC, Chicago, IL 60616, USA. cjohans@med.wayne.edu
Chris-Ellyn
CE
Johanson
Robert L
RL
Balster
Jack E
JE
Henningfield
Charles R
CR
Schuster
James C
JC
Anthony
Andrea G
AG
Barthwell
John J
JJ
Coleman
Richard C
RC
Dart
Charles W
CW
Gorodetzky
Charles
C
O'Keeffe
Edward M
EM
Sellers
Frank
F
Vocci
Sharon L
SL
Walsh
D002491:Central Nervous System Agents / Q000009:adverse effects*; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000639:trends; D006287:Health Planning Guidelines; D006801:Humans; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D012308:Risk Management / Q000331:legislation & jurisprudence* / Q000379:methods; D019966:Substance-Related Disorders / Q000517:prevention & control
D002491:Central Nervous System Agents