Postmarketing surveillance for drug abuse.
نویسندگان
چکیده
Assessing actual abuse of prescribed medications requires postmarketing surveillance. In this article we discuss general systems of postmarketing surveillance that exist as of the end of 2002 in the United States and two medication-specific surveillance systems that were devised and tested. The two specific surveillance systems are compared with limitations highlighted. Postmarketing surveillance is in its infancy and requires more research on ways to improve its validity without inducing illicit experimentation. Information on comparator medications is highly recommended both to validate the system and to place the results in context.
منابع مشابه
Monitoring risk: post marketing surveillance and signal detection.
The primary goal of postmarketing surveillance is to provide information for risk assessment of a drug. Drugs affecting the central nervous system form a unique group of products for surveillance because they are often misused, abused, and diverted. These medications include opioid analgesics, stimulants, sedative-hypnotics, muscle relaxants, anticonvulsants and other drug classes. Their advers...
متن کاملRisk identification, risk assessment, and risk management of abusable drug formulations.
There is a demand for pharmaceutical products with reduced abuse liability. These products must meet three tests to be successful. They must be safe for patients, be less likely to injure the abuser, and be less desirable for abuse by established drug abusers relative to existing products on a dose for dose (milligram-equivalent) basis. There is a need for standardization of the evaluation of a...
متن کاملProactive Postmarketing Surveillance: Overview and Lessons Learned from Medication Safety Research in the Veterans Health Administration
This report is an overview of the medication safety studies conducted by the VISN (Veterans Integrated Service Network) 8 Patient Safety Center of Inquiry (PSCI), Tampa, FL, over the past 5 years. The Center has been developing the research capacity to conduct national Veterans Health Administration (VHA) proactive medication safety surveillance studies as part of its research focus on patient ...
متن کاملThe effect of an abuse‐deterrent opioid formulation (OxyContin) on opioid abuse‐related outcomes in the postmarketing setting
An extended-release opioid analgesic (OxyContin, OC) was reformulated with abuse-deterrent properties to deter abuse. This report examines changes in abuse through oral and nonoral routes, doctor-shopping, and fatalities in 10 studies 3.5 years after reformulation. Changes in OC abuse from 1 year before to 3 years after OC reformulation were calculated, adjusted for prescription changes. Abuse ...
متن کاملThe Diversion of Ultram, Ultracet, and generic tramadol HCL.
Ultram (tramadol HCL) was approved by the Food and Drug Administration in 1994 as a non-scheduled drug under the Controlled Substance Act. The non-scheduled status was contingent on the development and implementation of a comprehensive post-marketing surveillance program by an Independent Steering Committee external to Ortho-McNeil Pharmaceutical charged with monitoring abuse and recommending s...
متن کاملذخیره در منابع من
با ذخیره ی این منبع در منابع من، دسترسی به آن را برای استفاده های بعدی آسان تر کنید
برای دانلود متن کامل این مقاله و بیش از 32 میلیون مقاله دیگر ابتدا ثبت نام کنید
ثبت ناماگر عضو سایت هستید لطفا وارد حساب کاربری خود شوید
ورودعنوان ژورنال:
- Drug and alcohol dependence
دوره 70 3 Suppl شماره
صفحات -
تاریخ انتشار 2003