Guidelines on the Safety and Vigilance of Health Products and Technologies

The World Health Organization (WHO) defines Pharmacovigilance (PV) as the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems”.

Pharmacovigilance aims at achieving the following:

a. Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions;

b. Improve public health and safety in relation to the use of medicines;

c. Detect problems related to the use of medicines and communicate the findings in a timely manner;

d. Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, leading to the prevention of harm and maximization of benefits;

e. Encourage the safe, rational and more effective (including cost effective) use of medicines;

f. Promote understanding, education and clinical training in Pharmacovigilance and its effective communication to the public.

There is an increasing burden of adverse events from adverse drug reactions (ADRs), poor quality products, adverse events following immunization, therapeutic ineffectiveness, medication errors, and irrational use of medical products and health technologies in addition to increase in antimicrobial resistance (AMR). These medicine-related problems not only contribute to morbidity and mortality but also result in higher treatment costs, loss of confidence in the health system, non-adherence to treatment, and economic losses to the pharmaceutical industry and patients.

Monitoring the safety of medical products including vaccines and health technologies, their quality and effectiveness following market authorization, in addition to providing medicines safety information are essential functions of national healthcare systems. These are responsibilities of the national medicines regulatory authorities (NMRAs), healthcare providers across all levels of the healthcare system as well as other stakeholders, among them, public health programs (PHPs), and the pharmaceutical industry, including marketing authorization holders (MAHs).