Reporting suspected substandard and falsified medicines

Regulatory authorities

• In most countries, there are regulatory authorities responsible for overseeing the safety and quality of medicines. 
• These agencies might have dedicated hotlines or online forms to report SF medicines.
• In the United States, you can report SF medicines through the FDA’s MedWatch program. Use MedWatch to report adverse events and product complaints related to medicines
  • Other countries may have similar programs

Law enforcement

• If you come across SF medicines, you can also report them to your local law enforcement agency. 
• They can investigate and take appropriate action against counterfeiters.
• In the U.S., you can contact the FDA’s Office of Criminal Investigations

Pharmaceutical companies

• Reach out directly to the pharmaceutical company that produces the genuine version of the medicine; often, their official websites have a reporting section to raise any concerns.  

If you suspect an online pharmacy or specific medicines on a website:

• If you encounter SF medicines while shopping online, report the issue to the platform or website where you made the purchase. 
• If you suspect the legitimacy of the entire website, some countries have programs to report online pharmacies. In the U.S., report using FDA’s reporting tool.

It is good practice to report as many details as possible about the suspected medicine. According to the WHO, the following information should be collected at minimum:

• Details of the suspected medicine: name, form, manufacturer or distributor, batch numbers
• Who is reporting the medicine?
• Where and when did you or the patient purchase the medicine?
• What are the symptoms and side effects of the medicine? Or, was there a lack of therapeutic effect?
• If there were visual red flags, what were they? Take pictures of the medicine’s packaging, appearance, leaflets or anything else that raised suspicion.
• Take clear and detailed photographs of the medicine.

Tips for taking pictures of a suspected medicine:

• Capture all information including batch and license numbers, authentication features (holograms, logos, etc), names, expiry date, instructions on the leaflet
• Take photographs of all sides of the product, and internal and external packaging
• Ensure photographs are well-lit and clear

Follow your institution’s risk assessment and management protocols to alert patients or halt the distribution of the medicine.