1 / 14

Dr Clive Ondari Essential Drugs and Medicines Policy Roll Back Malaria World Health Organization

Quality of Antimalarials Study. Dr Clive Ondari Essential Drugs and Medicines Policy Roll Back Malaria World Health Organization Presented by Richard Laing. Pilot Project on Quality of Antimalarial Products. Project initiated in 2000 in 8 African Countries : Countries selected:

kacia
Download Presentation

Dr Clive Ondari Essential Drugs and Medicines Policy Roll Back Malaria World Health Organization

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Quality of Antimalarials Study Dr Clive Ondari Essential Drugs and Medicines Policy Roll Back Malaria World Health Organization Presented by Richard Laing

  2. Pilot Project on Quality of Antimalarial Products • Project initiated in 2000 in 8 African Countries: • Countries selected: • Gabon, Ghana, Kenya, Mali, Mozambique, Sudan, Tanzania, Zimbabwe • Products selected in the study: • CQ (tablets), CQ (syrup), SP (tablets) • Countries that have completed study: • Gabon, Ghana, Kenya, Mali, Mozambique, Sudan and Zimbabwe • Countries in the 2nd phase of the study: • Tanzania (starting sample collection in 07/03)

  3. Pilot Project on Quality of Antimalarial Products • Project Objectives: • Provide answers/insight to the following questions: • Is there a problem of poor quality chloroquine (CQ) and/or Sulphadoxine/pyrimethamine (SP) products in countries where they are used? • If there is a problem of quality of CQ and SP products, what is the magnitude of the problem? • If there is a problem of quality of CQ and SP products, is it limited to a particular level of the distribution channel?

  4. Pilot Project on Quality of Antimalarial Products • Project Design : • Country selection criteria: “spot light countries” in AFRO and EMRO • Evaluation of the most widely used antimalarials products in the regions • Sampling from various levels of the distribution chain- (household, private sector pharmacy, peripheral health units, district hospital, teaching/referral hospital and district and/or central medical store) • Evaluation of samples at a central laboratory (pharmacopeal tests) in Centre for Quality Evaluation for Medicines (CENQAM), South Africa

  5. Standards for Assessing Quality • Chloroquin: Samples were judged to have “failed” if content was <93% or >107%, and dissolution <80% in 45 minutes. • Sulphadoxine/Pyramthamine: Samples were judged to have “failed” if content was <90% or >110%, and dissolution <65% in 30 minutes.

  6. Percent Failure - Chloroquine Syrup

  7. Percent Failure - Chloroquine Tablets (Content) Percent Failure - Chloroquine Tablets (Dissolution)

  8. Percent Failure - SP Tablets (Dissolution) Percent Failure - SP Tablets (Content)

  9. Content (%) - CQ Tablets Standard 93% to 107%

  10. SP Tablets - Pyrimethamine Dissolution (%) Standard <65% in 30 mins

  11. Failure rates (%) - Content

  12. Failure Rates (%) - Dissolution

  13. Conclusions: • There are significant problems of substandard antimalarial products exist within the drug distribution chains. • Percentage failure of samples (ingredient content ranging from 20% to 67% for CQT and 5% to 28% for SPT, and in dissolution failures ranging from 5% to 33% for CQT and 75% to 100% for SPT). • Substandard antimalarials circulating in international commerce are a major threat to public health and a challenge to the fight against malaria. • Quality surveillance within drug regulatory authorities in the malaria-endemic regions needs strengthening and enforcement • Manufacturers of antimalarials need to work closely with regulatory agencies to improve GMP compliance.

More Related