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Toolbox  –  Measure

Quality of antibiotics

The use of poor quality antibiotics has many consequences for public and animal health. Here, you can find resources to help determine the quality of antibiotics. You can also access selected relevant data on the quality of antibiotics.

Use of poor quality antibiotics has serious consequences. Treatment failures, risk of resistance development, toxicity or other side effects are some examples. Poor quality of medicines has been linked to for example falsifications, poor quality control during manufacture and to improper storage. Learn more in UNDERSTAND: How did we end up here? – Problems related to quality of antibiotics.

Each cause for poor drug quality requires a different solution, but detecting the reason for poor drug quality is often challenging. The selected resources below provide examples and tools to determine the quality of antibiotics.

How can data on the quality of antibiotics be used?

Data on the quality of antibiotics can be used to inform stakeholders on the current situation and assist in developing interventions. Policy makers may use quality data to push for stronger regulations. Civil society organizations may be interested in conducting public health awareness campaigns to educate consumers about the possible presence of poor-quality medicines on the market and ways to inspect their medicine’s package. See RAISE AWARENESS: Civil society for inspiration.

Unfortunately, there is a lack of data on the magnitude and geographical burden of poor quality antibiotics. Most countries have national medicines regulations authorities in charge of assuring the quality of medicines and establishing surveillance systems that comply with harmonized standards. These mechanisms can be utilized to obtain information on the quality of medicines, but whether it is due to the involvement of organized criminal activity facilitating illegal imports of sub-standard or fake drugs, or under-investments in medicines regulatory strengthening, is difficult to know.

A legal and technical approach to improving the quality of medicines – Rwanda

  • Late 1990’s – Rwanda mandated that all drug contracts awarded by the Ministry of Health must be to manufacturers with WHO-approved certificates of Good Manufacturing Practices.
  • 2011 – Formed pharmacovigilance sub-committees at all 469 health centers that are overseen by the country’s 42 district hospitals. 2,400 health workers and more have been trained in the implementation of the guidelines.
  • Accredited private sector integrated with public sector supply chain on medicines for high priority diseases.
  • Agencies involved for inspection, testing and legal actions – Bureau of Standards, Customs Services Department, Ministry of Health, Rwandan police force and Interpol.
  • Working with East African Community in drafting regional law.

Selected Resources

Resource Description
Guidelines on the conduct of surveys of the quality of medicines Methodology, tools and templates: Annex 7 of the 50th report of the WHO Expert Committee on specifications for pharmaceutical preparations provides guidance and tools for designing surveys on the quality of medicines. Contains e.g. a sample collection form and an outline of a survey report.
Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries Review that examines available technologies for quality testing. Bearing in mind the need for cost-effective solutions in resource-poor settings, it discusses suitability of individual technologies based on the need for electricity, need for sample preparation, need for reagents, portability, level of training required, and speed of analysis.
Guidelines for Field Surveys of the Quality of Medicines: A Proposal Methodology/guideline: A proposed guideline targeting post-marketing quality surveillance. Authors propose methodologies to be used during sampling and assessing the market burden with poor quality medical products.
Survey of the quality of selected antimalarial medicines circulating in six countries of sub-Saharan Africa Methodology: This study aimed to survey the quality of selected medicines based on a structured sampling strategy agreed between WHO and national authorities. Samples were screened with GPHF-Minilab and some were subsequently selected for full quality control.

Access data on the quality of antibiotics: Databases and reports

Resource Description
Medicines Quality Database Database: Managed by US Pharmacopoeia, this searchable database provides an overview on the magnitude and a geographical burden of poor quality medical products, including antibiotics, on selected markets mainly in low and middle-income countries.
Full List of WHO Medical Product Alerts Database: Up-to-date list of alerts on medical products, including antibiotics. Possibility to sign up to receive/follow alerts.
WHO Global Surveillance and Monitoring System for substandard and falsified medical products Report (from 2017) based on the data/case studies collected by the WHO Global Surveillance and Monitoring System (GSMS) for substandard and falsified medicines. Antibiotics are among the most reported medicines in the database. Puts forth “prevent, detect, respond” strategy to tackle the issue.
A study on the public health and socioeconomic impact of substandard and falsified medical products Review (from 2017) of literature of the impact of poor quality medicinal products with impact models for childhood pneumonia and malaria. Lays out key areas for further investigation. Annex 5 provides sources of data on substandard and falsified medicines.
WHO Prequalification of medicines The WHO Prequalification of medicines program works to ensure access to quality medicines. The portal has information for manufacturers, regulatory agencies, quality control laboratories and procurement agencies. Provides for example lists of prequalified:

  • Finished pharmaceutical products
  • Active pharmaceutical ingredients
  • Medicines quality control laboratories