Risk management


One of the important and new areas of pharmacovigilance is risk management. The latter implies the need and possibility of early identification of risks, factors contributing to their occurrence, as well as the development of measures to study and minimize the risks associated with taking medicines. Our company provides its customers with such a service.

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this is the probability of a consequence of something. The term «risk» is not always, but, as a rule, indicates something negative. In the case of medicines, the concept of «risk» is identified with the concept of «adverse reaction». It is necessary to manage the so-called important risks, that is, those that affect the benefit/risk ratio, increasing the risk component in this ratio

Such risks can be identified, for which there is adequate evidence of an association of an adverse effect with the use of a certain drug, as well as potential, that is, adverse effects in which there is a suspicion, a hypothesis of its connection with a certain drug, but a clear association has not been confirmed.

Missing information is also an important risk. If the risks associated with the use of medicines are not managed, this can lead to a crisis that will affect the health of the population, drug manufacturers and regulatory authorities.

Thus, risk management is the only way to solve the problem after identifying an important risk.

A new approach to risk management is presented in module V of the GVP «Risk management system», according to which the main goal of risk management is to achieve the maximum possible advantage of the benefits of using drugs over the risk for each individual patient of the target group.

A risk managementsystem is a type of pharmacovigilance activity aimed at identifying, characterizing, preventing or minimizing risks associated with the use of a drug, including evaluating the effectiveness of these measures.

According to EU requirements, a risk management plan is mandatory for:

1) all new applications;

2) for applications for changes to the current registration certificate, namely:

  • in the case of the release of a new dosage form;
  • changes regarding the route of administration;
  • when using a new manufacturing process for biotechnological medicines;
  • changes in relation to pediatric indications;
  • other important changes in indications for use;

3) at the request of the regulatory authority, if there is a risk that may affect the benefit/risk ratio;

4) during re-registration, if the drug already has a risk management plan.

The risk management plan should include an assessment of the safety and effectiveness of the drug. At the same time, the risk management plan should be proportional to the risks. Conducting post-registration studies on safety or effectiveness may be a condition for registration, which should also be reflected in the risk management plan, as well as the effectiveness of risk management measures. Given that all pharmacovigilance processes should be transparent, a summary of the risk management plan should be published.

There are 3 stages of risk management:

  • characteristics of the complete safety profile of the drug;
  • planning of pharmacovigilance activities to determine the nature of risks and identify new risks, as well as to replenish knowledge about the safety profile of the drug;
  • planning and implementation of measures to minimize and reduce risks, as well as assessment of their effectiveness.

The main section of the risk management plan, on which all pharmacovigilance and risk minimization activities are based, is the safety specification. Based on what information is presented in this section, pharmacovigilance and risk minimization actions are planned.

The applicant must decide whether routine pharmacovigilance will be sufficient or whether there is a need for additional pharmacovigilance measures. What additional measures are planned by the applicant, in what terms they will be implemented, should also be presented in the relevant part of the risk management plan.

The pharmacovigilance plan helps to investigate, study the safety problems of medicines, get additional information about important risks, including missing information, but it does not minimize the risks.

In terms of risk management, the applicant justifies and presents how he intends to minimize important risks, if any. To minimize risks in certain situations, routine measures are enough, and sometimes additional measures are required to minimize risks.

Routine measures include: labeling, the contents of the leaflet, short characteristics of the drug, limiting the number of finished dosage forms in the package, the corresponding legal status of the drug.

Additional measures should be taken only if necessary, they should be justified, and also developed by qualified specialists. Any additional materials should be clearly focused on minimizing risks and should not be combined with advertising materials for marketing campaigns.

For medicines that are registered according to a centralized procedure, only additional measures recommended by the Pharmacovigilance Risk Assessment Committee —PRAC) will be included in risk minimization plans.

There is a connection between the risk management plan and the regularly updated Safety Reports (PSUR), these are two pharmacovigilance documents that complement each other. Providing them to regulatory authorities depends on what stage of the life cycle the drug is at.