A literature review on pharmacovigilance systems in off-label use of medicines
Problem and significance: Off-label use of medicines is not illegal; however, it can be risky and harmful, or beneficial and innovative. The main problem of this practice is the lack of systems for monitoring adverse drug reactions, since the drugs are used in a manner that is not approved by regulatory agencies. For this reason public health protection is not guaranteed. Purpose: To identify the various systems employed in different regions to monitor/manage the risks and benefits of off-label use; and to ascertain their extent of implementation. Method/search strategy: Electronic and manual literature search was done. Articles referring to off-label medicine use were reviewed. The literature included journal articles, national MRA guidelines, international guidelines, etc. The articles were sourced from databases such as Pubmed and Google Scholar. Data was collected from both developed and emerging markets. There was no limit to publication date. Findings: Pharmacovigilance systems for off-label use do exist although the degree of commitment and advancement differs per country. Explicit off-label laws are present in the developed countries but not in the developing ones. Implications of findings: Stakeholder involvement is very important in monitoring off-label use. Reporting of ADRs can be improved by asserting the role of off-label PV in drug repositioning. The regulator is under pressure to maintain public trust through efficient control of off-label use.