The World Health Organization (WHO) released a statement where it called for action by countries to prevent, detect and respond to incidents of substandard and falsified medical products, by directing countries to take three actions.
The organization put out alerts to all 194 WHO member states wherein it requested:
- The detection and removal of contaminated medicines from circulation in the markets
- Increased surveillance and diligence within the supply chains of countries and regions likely to be affected
- 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
This decision to increase awareness of the potential for the supply chain to be contaminated with substandard products was brought about by various incidents of the sale of certain cough syrup products leading to the deaths of young children.
In particular, across three countries, Gambia, Indonesia, and Uzbekistan, there have been more than 300 reported fatalities due to the contamination of over-the-counter (OTC) cough syrup with high levels of diethylene glycol (DEG) and ethylene glycol (EG). In total, cases have been found of these contaminated products in seven different countries.
The two contaminants are toxic chemicals that are used as industrial solvents and antifreeze agents that can be fatal even in small amounts, and should never be found in medicines, the WHO stated.
The organization also called on the wider pharma manufacturing industry to take action. In particular, the WHO stated that manufacturers should only purchase pharmaceutical grade excipients from qualified and bona fide suppliers; they should provide assurance of product quality, through certificates of analyses based on appropriate testing results; and, keep accurate, complete and proper records of purchase of materials, testing manufacture, and distribution to facilitate traceability during investigation, in case of incidents.
The WHO also urged suppliers and distributors of medical products to be vigilant in their role within the supply chain, such as through checking for signs of falsification and the physical condition of medicines, among others measures.
Due to the severity of the problem, the US Food and Drug Administration (FDA) has begun working with the WHO and the relevant regulatory authorities to support an investigation into the cause of the contamination.
“The FDA is taking the international tragedy seriously and is making every effort to prevent contaminated product from entering the U.S. market and to identify dangerous products that may have been brought into the US,” the agency said in a statement.