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Disease Prevention and Control / Communicable Diseases / Malaria

Specifications for Prepackaging Antimalarial Medicines:

Report of a WHO Technical Consultation

Specifications for prepackaging antimalarial medicines

Full Text (28 pp, PDF)
- Abbreviations
- Glossary
1. Introduction
2. Background
3. Technical specifications for prepackaging antimalarial medicines in compliance with good manufacturing practice requirements
4. Regulatory requirements
5. Specifications for package labelling, package inserts and information, education and communication materials accompanying the product
6. References
Annex 1: List of participants
Annex 2: Draft framework to guide analysis of the development and testing of information, education and communication materials for prepackaged antimalarial medicines

- More Roll Back Malaria Publications
- WHO Roll Back Malaria Department
- WHO Malaria Page
- PAHO Malaria Page

Held in Geneva, Switzerland, from 2 to 4 September 2003.

Objectives

  1. Define minimum technical specifications for the blister prepackaging of antimalarial medicines.
  2. Define minimum requirements for product labelling, product information inserts, and information, education and communication (IEC) materials for prepackaged antimalarial medicines.
  3. Elaborate and review the regulatory requirements for registering antimalarial medicines as co-packaged and/or prepackaged products.
  4. Highlight issues related to improved access (good distribution, storage and other drug management processes) for end-users in relation to "course of treatment" packaging.

Key Issues

Establishing minimum standards for prepackaging antimalarial medicines, as follows:

  • Ensuring product quality by blister packing in compliance with good manufacturing practice (GMP) requirements, with emphasis on the shelf-life of the finished products.
  • Ensuring product quality by blister packing in compliance with good manufacturing Providing adequate information that is presented in the right format to enhance ease of use and adherence to therapy by patients and providers. Clear information is particularly important when medicines are used by mothers and other caregivers whose literacy is limited, particularly with regard to medicines supplied outside the public sector.
  • Ensuring product quality by blister packing in compliance with good manufacturing Meeting the challenges to in-country distribution and regulatory processes and other aspects of the health structure to provide scope for improving end-users' access to effective antimalarial medicines.

Introduction

Early diagnosis and prompt treatment with effective antimalarial medicines is the only lifesaving intervention for people afflicted with malaria. The effectiveness of treatment with antimalarial medicines is, however, threatened by the growing resistance of falciparum malaria to chloroquine and sulfadoxine-pyrimethamine, which were once effective against the disease.

As part of a global strategy to delay the rapid development of the parasite's resistance to antimalarial medicines and to enhance the efficacy of treatment with antimalarial medicines, the World Health Organization (WHO) recommends that antimalarial medicines should always be used in combination, preferably with an artemisinin partner—a treatment known as artemisinin-based combination therapy (ACT). The Roll Back Malaria (RBM) global initiative has set a target of reducing malaria mortality by 50% by 2010, and the early diagnosis and prompt treatment of the disease with effective antimalarial medicines are fundamental components of this strategy.

Even in settings where effective treatment policies are in place, patients' non-adherence to the prescribed therapeutic dose and to treatment schedules poses a serious challenge to effective disease management. The prepackaging of treatment courses that are stratified into age or weight groups has greatly contributed towards enhancing the rational use of medicines1.

Prepackaged treatment courses are of particular importance in the treatment of malaria, as the disease is commonly managed without contact with a health worker. The strategy of prepackaging treatment courses has even greater relevance to combination therapy for the treatment of malaria, which requires that the individual medicines are co-packaged in a user-friendly way to optimize their use2.

Antimalarial combination medicines are relatively new products with which many manufacturers, regulatory authorities and health-care professionals have limited experience. It is expected that, as the demand for artemisinin-based combination therapies increases, there will be a corresponding increase in the generic sources of these medicines. An overview of existing combination therapies shows that an array of products is already on the market in Africa and Asia, although such products conform to varying standards with regard to their packaging and the patient information provided.

These changes have made it essential to establish minimum required standards for the prepackaging of antimalarial medicines. The main objective of these guidelines is to assist ministries of health and malaria control programmes in their assessment of different prepackaged antimalarial products. The guidelines will, however, also provide guidance to manufacturers in meeting the basic requirements for prepackaging antimalarial medicines. They are not intended to replace the standard guidelines on packaging for pharmaceutical products, published as an annex to the thirty-sixth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations3.

The technical consultation took the form of presentations of prepared papers, followed by plenary and group discussions, on the basis of which specific conclusions were reached and recommendations were made. The proceedings of the meeting and working papers form the basis of this report.


1 Ansah EK et al. Improving adherence to malaria treatment for children: the use of prepacked chloroquine tablets vs. chloroquine syrup. Tropical Medicine and International Health, 2001, 6 (7): 496504.
2 Yeboah-Antwi et al. Impact of prepackaging antimalarial drugs on cost to patients and compliance with treatment. Bulletin of the World Health Organization, 2001, 79 (5): 394399.
3 Guidelines on packaging for pharmaceutical products. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-sixth report. Geneva, World Health Organization, 2002, Annex 9 (WHO Technical Report Series, No. 902). |  More ...