World Health Organization : Year 1999 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication, No. 99.1: Counterfeit Drugs

By World Health Organization

Book Id: WPLBN0000121029
Format Type: PDF eBook
File Size: 2.6 MB
Reproduction Date: 2005

Title:	World Health Organization : Year 1999 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication, No. 99.1: Counterfeit Drugs
Author:	World Health Organization
Volume:
Language:	English
Subject:	Health., Public health, Wellness programs
Collections:	Medical Library Collection, World Health Collection
Historic Publication Date:
Publisher:	World Health Organization


Citation APA MLA Chicago Organization, W. H. (n.d.). World Health Organization : Year 1999 ; World Health Organization, Department of Essential Drugs and Other Medicines, Quality of Self-Medication, No. 99.1. Retrieved from http://www.gutenberg.cc/

Description
Medical Reference Publication

Excerpt
Executive Summary In 1988, the World Health Assembly adopted resolution WHA 41.16, which requested the Director-General of WHO to initiate programmes for the prevention and detection of the export, import and smuggling of, inter alia, counterfeit pharmaceutical products. This resolution was reinforced by another WHA resolution in 1994, TjgIHA 47.13, which asked the Director-General to assist Member States in their efforts to ensure that available drugs are good quality, and in combating the use of counterfeit drugs. These guidelines respond to the WHA requests: They are aimed to provide guidance to ember States in developing their own national measures to combat counterfeiting of drugs. The guidelines provide an overview of the problem and factors contributing to the counterfeiting of drugs. They outline also the steps to be followed in developing national strategies as well the specific measures to be considered in combating counterfeit drugs. Issues such as, approaches to country studies, inspection of suspected counterfeit drugs, screening of potentially counterfeit products and training of human resources are also dealt with in the guidelines.

Table of Contents
TABLE OF CONTENTS Page ExecutiveSumma ry ................................................................. 1 . Introduction ................................................................. 1.1 Background . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.2 The DMP-DAP Joint Project on Counterfeit Drugs' . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.3 Structure of the guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 . Ovelviewoftheproblem ....................................................... 3 . -Impact on public health ....................................................... 4 . Factors facilitating counterfeiting ............................................... 5. Developing national strategies .................................................. 5.1 General considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2 Planofaction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 Monitoring and evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6. Specificmeasures ............................................................. 6.1 Strengthening political will and commitment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.2 Promulgating appropriate legislation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.3 Establishing a national drug regulatory authority . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.4 Developing standard operating procedures and guidelines for drug inspectors . . . . . . . . 6.5 Enforcing drug control laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.6 Empowering the judiciary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.7 Fostering partnerships . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6.8 Sharing responsibilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 . Assessment of the problem at the national level .................................... 7.1 Approaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.2 Sampling procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7.3 Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 . Inspection when pharmaceutical products are suspected to be counterfeit, spuriousorsubstandard ........................................................ 8.1 Broadobjective . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.2 Standard operating procedures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8.3 Counterfeit products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 . Testmethods ................................................................. 9.1 Methods based on thin-layer chromatography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.2 Other simple methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.3 Analytical techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9.4 Visualinspection . . . . . . . . . . . . . . . . . . . . . . . . . . . . .