Ensuring that medications work safely on everyone

In order for drugs to work safely, it is vital to have strong systems in place to report any unwanted side effects or “side effects”.

The most important aspect of drug safety monitoring is reliable real-time information. Healthcare professionals (doctors, pharmacists, nurses, dentists) are in the best position to report suspected side effects as part of patient care. Patients also have a key role to play in providing the right information to the authorities and should consult their doctor as soon as they discover unwanted symptoms or reactions. Both healthcare professionals and patients should report them even if they suspect a precise relationship between a given drug and a reaction.

Most side effects can be prevented

Many adverse drug reactions may be due to drug-independent factors. For example:

• incorrect diagnosis of the patient’s health condition;
• prescribing an inappropriate drug or misdosing an appropriate drug;
• an undetected medical, genetic, or allergic condition that may elicit a patient reaction;
• self-medication with prescription drugs;
• non-compliance with medication instructions;
• interactions with other medicines (including traditional medicines) and certain foods.

But risks can also arise because the composition and ingredients of the drug do not meet the required standards, leading to them being ineffective and even dangerous; or because the drug is counterfeit, with no active ingredients or inappropriate ingredients.

Evaluation of medications before and after they reach patients

Before drugs or vaccines become widely available in countries, they are rigorously tested on patients and healthy volunteers to find out how well they work on a particular disease and how safe they are. To get a comprehensive picture of product safety, it is important to constantly monitor how it works, once it is widely used in the population.

This requires careful patient monitoring and further collection of scientific data by organized local, national and international agencies.

Drug safety during the COVID-19 pandemic

International drug safety monitoring is particularly important during global epidemics such as the current COVID-19 pandemic, and even more so when there are no proven vaccines or drugs for the disease. As new vaccines and treatments against COVID-19 become available, healthcare professionals and patients will need to be actively involved in monitoring the effects of these new products and reporting any potential side effects. By analyzing the reported reactions, national medicines authorities can take the necessary measures to use medicines more safely, scientists can assess the data and, if necessary, international problem-solving networks can be activated.

The role of the WHO in making medicines safer

The WHO promotes global drug safety through its International Drug Monitoring Program, which supports countries in developing healthy pharmacovigilance policies, organizes hands-on training and workshops, and establishes information exchange networks.

An important role of the program is to strengthen national reporting systems and their contribution to VigiBase, the WHO’s global database of adverse reactions, managed by the Uppsala Monitoring Center in Sweden, and to identify possible links between drug use and adverse reactions. When signals of drug safety problems arise through a database or from other sources, the WHO and the Uppsala Monitoring Center share new information on serious side effects with all WHO member states.

A recent key development of the WHO is the introduction of a mobile application called Med Safety, jointly launched in nine countries * with the Uppsala Monitoring Center and the UK Medicines and Healthcare Regulatory Agency. The app allows healthcare professionals and patients to report suspected side effects directly to a government database. TKO is preparing to introduce the application in more countries after the vaccine against COVID-19 becomes available.

* Armenia, Botswana, Burkina Faso, Ivory Coast, Democratic Republic of the Congo, Ethiopia, Ghana, Uganda, Zambia.