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Toolbox  –  Measure

Quality of antibiotics

Here you find resources and information to help determine the quality of antibiotics, and selected databases and reports gathering data on the quality of antibiotics.

The use of poor quality antibiotics has serious consequences for public and animal health. 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.

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 for inspiration.

Measuring quality

Most countries have national medicines regulations authorities in charge of assuring the quality of medicines. These mechanisms can be utilized to obtain information on the quality of medicines. However, there are many points in the supply chain where quality can be compromised and systems to monitor distribution are often inadequate.

There are  a number of technologies available to test the quality of medicines (content and purity). Whether the poor quality is due to criminal activity, for example illegal imports of sub-standard or fake drugs, production errors or drug degradation during shipping or storing is however often difficult to find out. It may require backtracking with sampling at different levels of the supply chain and investigating distribution and storage conditions. Each cause for poor drug quality also requires a different solution ranging from improving regulatory systems to storage conditions in individual pharmacies.

Resources below have been separated into the following tables and aims to help work to determine the quality of antibiotics and find available data:

  • Tools and guidelines
  • Databases and reports

Selected Resources

Tools and guidelines

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 for example 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, sample preparation and 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.
Inscrutable medicines and marginal markets: tackling substandard veterinary drugs in Nigeria Journal article with methodology. Interviews and focus groups used to follow substandard veterinary drugs through the supply chain from importers and distributors to vendors and customers, and how different actors work to reduce risks with substandard drugs. Please note that WHO has updated their terminology since the publication of this article (See: Problems related to 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, where antibiotics are among the most reported medicines. 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 Report from 2017 reviewing literature of the impact of poor quality medicinal products. Also includes 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 Information portal. 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
1.
Full List of WHO Medical Product Alerts. WHO: Essential medicines and health products https://www.who.int/our-work/access-to-medicines-and-health-products.
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Fadeyi, I., Lalani, M., Mailk, N., Wyk, A. V. & Kaur, H. Quality of the Antibiotics—Amoxicillin and Co-Trimoxazole from Ghana, Nigeria, and the United Kingdom. Am J Trop Med Hyg 14–0539 (2015) http://doi.org/10.4269/ajtmh.14-0539.
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Newton, P. N. et al. Guidelines for Field Surveys of the Quality of Medicines: A    Proposal. PLoS Med 6, (2009).
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Kovacs, S. et al. Technologies for Detecting Falsified and Substandard Drugs in Low and Middle-Income Countries. PLoS ONE 9, e90601 (2014).
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World Health Organization - WHO. A study on the public health and socioeconomic impact of substandard and falsified medical products. WHO https://www.who.int/publications/i/item/9789241513432 (2017).
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World Health Organization - WHO. WHO Global Surveillance and Monitoring System for substandard and falsified medical products. WHO https://www.who.int/publications/i/item/WHO-MVP-EMP-SAV-2019.04 (2017).
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World Health Organization - WHO. Survey of the quality of selected antimalarial medicines circulating in six countries of Sub-Saharan Africa. https://www.afro.who.int/publications/survey-quality-selected-antimalarial-medicines-circulating-six-countries-sub-saharan (2011).
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World Health Organization - WHO. Annex 7: Guidelines on the conduct of surveys of the quality  of medicines. WHO https://www.who.int/medicines/areas/quality_safety/quality_assurance/Guidelines-on-medicines-quality-surveys-QAS15-630_30062015.pdf?ua=1 (2016).
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Kingsley, P. Inscrutable medicines and marginal markets: tackling substandard veterinary drugs in Nigeria. Pastoralism 5, 2 (2015).
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World Health Organization - WHO. Essential Medicines and Health Products: Prequalification of medicines. https://extranet.who.int/prequal/.
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US Pharmacopeia. Medicines Quality Database. https://www.usp.org/global-health/medicines-quality-database (2015).