WHO calls for action to protect children from contaminated medicines

WHO issues an urgent call to action for countries to prevent, detect and respond to cases of substandard and counterfeit medical products.

Over the past four months, countries have reported several cases of over-the-counter cough syrups for children with confirmed or suspected contamination with high levels of diethylene glycol (DEG) and ethylene glycol (EG). The cases are from at least seven countries, linked to more than 300 deaths in three of those countries. Most are small children under the age of five. These contaminants are toxic chemicals used in industrial solvents and antifreezes that can be fatal even if taken in small amounts, and should never be found in medicines.

Based on country reports, WHO has issued three global medical alerts related to these incidents. The Warning on medical products no. 6/2022 5 October 2022 focused on the Gambia outbreak, Warning on medical products no. 7/2022 November 6, 2022 focused on Indonesia, and Warning on medicinal products N^on1/2023 January 11, 2023 focused on Uzbekistan.

WHO warnings about medicinal products were quickly sent to the national health authorities of all 194 WHO member states. These requested warnings on medicinal products, Among others: (a) detection and removal of contaminated drugs from circulation in markets, (b) increased surveillance and diligence within the supply chains of countries and regions that may be affected, (c) immediate notification to WHO if these substandard products are detected in the country; and in other ways to inform the public about the dangers and toxic effects of questionable medicines that are of poor quality.

As these are not isolated incidents, WHO is calling on the various key stakeholders involved in the medical supply chain to take immediate and coordinated action.

WHO calls on regulators and governments to:

• detect and remove from circulation in their markets all low-quality medical products that are identified in the above-mentioned WHO medical warnings as potential causes of death and disease;
• ensure that all medical products in their markets are approved for sale by competent authorities and can be obtained from authorized/licensed suppliers;
• allocate adequate resources to improve and increase inspections of production sites within their jurisdiction based on risk in accordance with international norms and standards;
• strengthen market surveillance, including targeted risk-based testing for medicinal products placed on their markets, including informal markets; and
• enact and implement, where relevant and appropriate, laws and other relevant legal measures to help combat the production, distribution and/or use of low-quality and counterfeit medicines.

WHO calls on drug manufacturers to:

• purchase only pharmaceutical grade excipients from qualified suppliers in good faith;
• conduct comprehensive testing upon receipt of supplies and prior to use in the production of finished products;
• provide product quality assurance, including through certificates of analysis based on appropriate test results; and
• maintain accurate, complete and correct records of material purchase, testing, production and distribution to facilitate traceability during incident investigations.

WHO calls on all suppliers and distributors of medical products to:

• always check for signs of counterfeiting and the physical condition of medicines and other health products they distribute and/or sell;
• distribute and/or sell only drugs approved and from sources approved by the competent authorities;
• keep accurate, complete and orderly records of medicines and their distribution and/or sale; and
• hire professional staff to handle medicines and give advice to the public on the appropriate use of medicines.

In addition, WHO will continue to work with Mechanism of member states for low-quality and falsified medical products in implementing its mandate to promote effective cooperation in the prevention, detection and response to substandard and counterfeit medical products to save lives.