Pharmacovigilance Guidelines. Second Edition, November 2009 - Botswana
(2009; 10 pages)


Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Pharmacovigilance is closely linked to drug regulation. The major aims of pharmacovigilance are:

  • Early detection of unknown adverse reactions and interactions.
  • Detection of increases in frequency of known adverse reactions.
  • Identification of risk factors and possible mechanisms
  • Estimation of quantitative aspects of benefit/risk analysis and dissemination of information needed to improve medicine prescribing and regulation.

The specific aims of pharmacovigilance are to:

  • Improve patient care and safety in relation to the use of medicines and all medical and paramedical interventions,
  • Improve public health and safety in relation to the use of medicines,
  • Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and
  • Promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public.

It is important to achieve the development of a positive attitude towards pharmacovigilance among healthcare professionals so that adverse reaction reporting becomes an accepted and understood routine. The following may stimulate reporting:

  • Easy access to reporting forms and other means of reporting
  • Acknowledging the receipt of adverse drug reaction reports by personal letter or phone call
  • Providing feed-back to reporters in the form of articles in journals, adverse drug reactions bulletins or newsletters
  • Participation of the centres staff in pre- and postgraduate education and scientific meetings
  • Collaboration with local drug or pharmacovigilance committees
  • Collaboration with professional associations
  • Integration of pharmacovigilance in the (further) development of clinical pharmacy and clinical pharmacology in a country.

Under reporting is a common phenomenon in all countries. Under-reporting may delay signal detection and cause underestimation of the size of the problem. However, in signal detection not only the quantity but also the relevance of case reports and quality of data are important.

Sometimes healthcare professionals fear that the acknowledgement of adverse reactions may reflect negatively on their competence or put them at risk of litigation. Some are reluctant to report adverse reactions because of doubts regarding the causal role of the drug. Under-reporting is both a technical and a psychological issue. Clarity of criteria for reporting, simple procedures and good motivational practice are all influential in addressing the problem.

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