Good Pharmacovigilance Practices for the Americas - PANDRH Technical Document Nº 5 (Pan American Network on Drug Regulatory Harmonization)
(2011; 83 pages) [Portuguese] [Spanish]


The potential toxicity of certain medicines is an issue of particular concern among patients, physicians, prescribers, dispensers, and regulatory authorities, as adverse reactions are a major cause not only of medical consultations but hospital admissions and, occasionally, patient deaths. Moreover, in recent years, many medicines have been withdrawn from the market as a result of an unfavorable benefit/risk ratio not detected when their sale was authorized.

As described in the report of the World Alliance for Patient Safety of the World Health Organization (WHO), some of the main requirements of programs for improving patient safety are quality and the capacity to obtain the most complete information possible on adverse reactions and medication errors, so that these programs become sources of knowledge and serve as the foundation for future preventive action. If appropriate steps are not taken when an adverse reaction to a medicine occurs or when new evidence is obtained in this respect, no lesson is usually learned, the opportunity to make generalizations about the problem is missed, and the capacity to develop broader, more effective and more applicable solutions will not be developed (1). Two key lines of action are therefore essential:

a) proper training in clinical and therapeutic pharmacology at all levels to ensure better use of medicines, and

b) the creation of a pharmacovigilance system.

Health needs and medicine usage varies widely from country to country. There are many reasons for this, among them economics, ethnicity, culture, the burden of disease, and diet, as well as a country’s development level and medicine regulatory system. As a result, decisions concerning safety and efficacy must be considered in the specific context of each country. Thus, monitoring of the safety and efficacy of medicines must be a public health priority.

Pharmacovigilance systems are imperfect. The development of the Pharmacovigilance in Latin America and the Caribbean is still in the early stages of development, suffering from the same shortcomings as it does in developed countries: underreporting, redundant reporting of already known adverse effects, conflicts of interest stemming from prescribers and dispensers’ links both to each other and to the pharmaceutical industry, and lack of reporting incentives among health professionals. However, others compound these shortcomings: inequitable, individualistic health systems, high percentages of the population with no access to the health system or medical care; and little direct interaction between patients and health professionals, which encourages the use of herbal home remedies not subject to industrial manufacturing and control processes. Other shortcomings are the availability of combination medicines in irrational doses, whose efficacy has not been demonstrated; the use of medicines for off-label indications, not to mention greater problems, such as the ability to purchase medicines such as antibiotics without a prescription and the online sale of medicines, etc.

It is within this context that the issue of pharmacovigilance in the 21st century must be addressed. Hence, there is the importance of ensuring its harmonization in the Americas and promoting the development of guidelines for good pharmacovigilance practices and risk management systems. There must be the creation of active pharmacovigilance programs based on pharmacoepidemiology, since planning activities prior to the approval of medicines will benefit public health in the Region.

PAHO/WHO is interested in developing guidelines for good practices used to facilitate and improve the pharmacovigilance reporting system and, thus, patient safety. At the very least, this process will produce feedback from the conclusions of the data analysis. Ideally, it will also yield recommendations for changes in health procedures and health systems—for example, conducting significant in-depth analyses and using the findings, and learning from reports. Disseminating lessons learned, calls for competencies and various other human and financial resources. The authority receiving the reports must be capable of influencing solutions, as well as disseminating the information and making the pertinent recommendations for change.

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