WHO Seeks To Prevent Use Of Substandard Medical Products

The World Health Organisation (WHO) calls for action for countries to prevent, detect and respond to incidents of substandard and falsified medical products.

The call was contained in a statement issued by the WHO.

The organisation noted that in the past four months, countries have reported several incidents of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). It said that the cases are from at least seven countries associated with more than 300 fatalities in three of these countries.

According to it, most are young children under the age of five. “These contaminants are toxic chemicals used as industrial solvents and antifreeze agents that can be fatal even when taken in small amounts and should never be found in medicines.”

It said that based on country reports, WHO has issued three global medical alerts addressing these incidents. “The Medical Product Alert N°6/2022 on 5 October 2022 focused on the outbreak in the Gambia, Medical Product Alert N7/2022 on 6 November 2022 focused on Indonesia, and Medical Product Alert No1/2023 on 11 January 2023 focused on Uzbekistan.”

It said that WHO’s medical product alerts were rapidly disseminated to the national health authorities of all 194 WHO Member States. It said that these medical product alerts requested, inter alia: first, the detection and removal of contaminated medicines from circulation in the markets and increased surveillance and diligence within the supply chains of countries and regions likely to be affected, it said immediate notification to WHO if these substandard products are discovered in-country and otherwise inform the public of the dangers and toxic effects of the substandard medicines at issue.

It said that since these are not isolated incidents, WHO calls on various key stakeholders engaged in the medical supply chain to take immediate and coordinated action. It called on relevant stakeholders to detect and remove from circulation in their respective markets and substandard medical products that have been identified in the WHO medical alerts referred to above as potential causes of death and disease.

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The world health organisation urged stakeholders to ensure that all medical products in their respective markets are approved for sale by competent authorities and obtainable from authorized and licensed suppliers. It said they should assign appropriate resources to improve and increase risk-based inspections of manufacturing sites within their jurisdiction in accordance with international norms and standards. It called for increased market surveillance including risk-based targeted testing for medical products released in their respective markets including informal markets.

It also urged them to enact and enforce, where relevant and as appropriate, laws and other relevant legal measures to help combat the manufacture, distribution, and or use of substandard and falsified medicines.

The WHO also called for manufacturers of medicines to only purchase pharmaceutical-grade excipients from qualified and bona fide suppliers. It urged the stakeholders to conduct comprehensive testing upon receipt of supplies and before use in the manufacture of finished products.

The UN organisation urged stakeholders to provide assurance of product quality including through certificates of analyses based on appropriate testing results. Others are to keep accurate, complete, and proper records of the purchase of materials, testing, manufacture, and distribution to facilitate traceability during investigations in case of incidents.

The WHO urged all suppliers and distributors of medical products to always check for signs of falsification and the physical condition of medicines and other health products they distribute and sell. It said that stakeholders should ensure that only distribute or sell medicines authorized by, and from sources approved by competent authorities.

“Keep accurate, complete, and proper records relating to the medicines and their distribution, sale, and engage competent personnel to handle medicines and provide advice to the public on the appropriate use of the medicines.”

WHO will continue to work with the Member State Mechanism on substandard and falsified medical products, to implement its mandate in promoting an effective collaboration in the prevention, detection, and response to substandard and falsified medical products to save lives.