Risk management and post-marketing surveillance for the abuse of medications acting on the central nervous system: Expert Panel Report
- 1 December 2009
- journal article
- editorial
- Published by Elsevier BV in Drug and Alcohol Dependence
- Vol. 105 (Suppl 1), S65-S71
- https://doi.org/10.1016/j.drugalcdep.2009.08.006
Abstract
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.Keywords
This publication has 16 references indexed in Scilit:
- Monitoring risk: Post marketing surveillance and signal detectionDrug and Alcohol Dependence, 2009
- Signal detection in post-marketing surveillance for controlled substancesDrug and Alcohol Dependence, 2009
- Risk management and post-marketing surveillance of CNS drugsDrug and Alcohol Dependence, 2009
- Case histories in pharmaceutical risk managementDrug and Alcohol Dependence, 2009
- Introduction to College on Problems of Drug Dependence special conference on risk management and post-marketing surveillance of CNS drugsDrug and Alcohol Dependence, 2009
- Risk management of drug products and the U.S. Food and Drug Administration: Evolution and contextDrug and Alcohol Dependence, 2009
- Principles of laboratory assessment of drug abuse liability and implications for clinical developmentDrug and Alcohol Dependence, 2009
- Conference on drug formulations and abuse liabilityDrug and Alcohol Dependence, 2006
- Impact of formulation on the abuse liability, safety and regulation of medications: The expert panel reportDrug and Alcohol Dependence, 2006
- Research design strategies to evaluate the impact of formulations on abuse liabilityDrug and Alcohol Dependence, 2006