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- Substandard also called "out of specification", these are authorized medical products that fail to meet either their quality standards or specifications, or both.
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Jan 31, 2018 · An estimated 1 in 10 medical products in low- and middle-income countries is substandard or falsified. Substandard and falsified medical products contribute to antimicrobial resistance and drug-resistant infections.
Dec 7, 2023 · Substandard and falsified medical products. Up to two billion people around the world lack access to necessary medicines, vaccines, medical devices including in vitro diagnostics, and other health products, which creates a vacuum that is too often filled by substandard and falsified products.
Nov 29, 2013 · Substandard medicines are widespread and represent a threat to health because they can inadvertently lead to healthcare failures, such as antibiotic resistance and the spread of disease within a community, as well as death or additional illness in individuals.
- Atholl Johnston, David W. Holt
- 10.1111/bcp.12298
- 2014
- 2014/08
May 20, 2013 · Substandard and falsified medicines encourage drug resistance, threatening the health of populations today and in the future.
- Gillian J. Buckley, Lawrence O. Gostin, Counterfeit Medical Products
- 2013/05/20
- 2013
Dec 9, 2019 · Substandard and falsified (SF) medical products are medicines, devices and other products manufactured to imitate or replace similar certified products. They may contain no active ingredient, the wrong active ingredient or the wrong amount of the correct active ingredient.
- How big is the problem of SF medical products?SF medical products are by their very nature difficult to detect. They are often designed to appear identical to the genuine product and may not ca...
- Which medical products are most affected?Reports received by WHO from Member States suggest that all therapeutic categories are affected by SF medical products. Anti-infectives, anti-malar...
- Where do SF medical products come from?SF medical products are manufactured in many different countries and in all WHO regions. Member States and the media frequently report successful o...
- Which countries are affected the most?No countries remain untouched by this issue and work is being done in all WHO Regions. What was once considered a problem suffered by developing an...
- What is the harm caused by SF medical products?Assessing the harm caused by SF medical products is complex and difficult. Most cases involve a medical product that fails to work properly. Often...
- How do SF medical products enter the supply chain?Most commonly, SF medical products enter the legal supply chain at distribution level through hospitals, clinics, pharmacies and wholesalers, who h...
- Are deterrents strong enough?Many countries have started to strengthen their legislation in respect of substandard and falsified (SF) medical products and specifically intentio...
- Is organised crime involved in SF medical products?Some of those involved in the manufacture, distribution and supply of spurious, falsified and counterfeit medical products have access to sophistic...
Aug 16, 2021 · These include substandard medicines, which are made by registered pharmaceutical companies in regulated factories but do not meet the quality standards set out in their market authorization paperwork, either because they were poorly made or because they have degraded since manufacture.
Sep 23, 2021 · Substandard medicines (also called “out of specification”) are legal pharmaceutical products that fail to meet either their quality standards or specifications or both [ 1 ]. The global health challenge of ‘counterfeit’ medicines was first addressed in 1985, at the Conference of Experts on the Rationale use of Drugs in Nairobi.
