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Surveillance and monitoring for substandard and falsified medical products

Substandard and falsified (SF) medical products correspond to the following definitions:

  • Substandard also called “out of specification”, these are authorized medical products that fail to meet either their quality standards or specifications, or both.
  • Falsified medical products that deliberately/fraudulently misrepresent their identity, composition or source.

SF medical products from all main therapeutic categories and from every region of the world have been reported to WHO, including medicines, vaccines and in vitro diagnostics; however, anti-malarials and antibiotics are amongst the most commonly reported SF medical products. Both generic and innovator medical products can be falsified, ranging from very expensive products for cancer to very inexpensive products for management of pain.

Substandard and falsified medical products contribute to antimicrobial resistance and drug-resistant infections. They may cause harm to patients and fail to treat the diseases for which they were intended and they lead to loss of confidence in medicines, healthcare providers and health systems.

To facilitate the reporting and sharing of information on SF medical products, in 2013, WHO launched a Global Surveillance and Monitoring system for SF medical products. The system allows reporting, coordination and technical support and sharing of information between Member States. The system is designed for use by a trained focal point in the NRA.

If UNDP COs discovers or is informed of a suspected or confirmed SF medical products (at reception of supplies or during supervision visits in the field for instance), it should inform the NRA focal point of the Surveillance system and facilitate the transmission of a report to rapidalert[@]who[dot]int. WHO will then contact the NRA focal point and provide the adequate support.

It is also advised that one person (who is part of the PSM team in the UNDP CO) is made responsible for receiving the alerts published by the Global Reporting Mechanism, and each time an alert is posted to check if the product concerned has been supplied to UNDP. If the product has been supplied to UNDP, the CO should immediately inform the QAS team for further instructions.

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