Risk minimization measures in pharmacovigilance: review of national and international experience

Abstract

The use of risk-based approach in pharmacovigilance management is due to the strategy of preventive measures to ensure the safe administration of medicines. Now, manufacturers of drugs to ensure the functions of pharmacovigilance provide a set of documents registering the safety of products, including a risk management plan. In the process of preparing a risk management plan, risks are identified and assessed, measures to minimize them are developed and the effectiveness of these measures is further evaluated. The article considers risk factors in relation to pharmacovigilance for a drug and examples of their occurrence. Routine and additional measures to minimize risks are used to ensure risk management. In the case of biotechnological drugs, it is not superfluous to conduct post-registration studies with pharmacoepidemiological design with mandatory publication of both positive and negative results. The article analyzes the domestic and foreign experience of measures to minimize risks. If a particular strategy is found to be ineffective, alternative interventions should be developed and implemented. A possible result of ineffective risk minimization measures is the withdrawal of drugs from the market or the restriction of their use only to the subgroup of patients for whom the benefits outweigh the risks. Manufacturers should not neglect the implementation of measures to minimize risks, as this prevents the application of drastic measures of regulatory authorities in relation to them and allows the drug to exist on the market in a safe application, providing quality medical care for patients.

Keywords

• план управления рисками
• меры минимизации рисков
• фармаконадзор