Risk Management in Pharmacovigilance

It’s important to know that whenever a new medicinal product is authorized based on specified indications at the time of authorization, the benefits of the product for the target population must be shown to outweigh the risks of using the product. Generally,  medicinal products have some adverse reactions that vary in terms of severity, likelihood of occurrence, effect on individual patients, and public health impact. However, not all adverse reactions or other risks are identified at the time of initial marketing authorization. Some will only be discovered and characterized in the post-authorization phase.

Do we need a Risk Management Plan?

A risk management plan (RMP) is an essential part of pharmacovigilance and involves identifying, assessing, and controlling the risks associated with a drug throughout its lifecycle This is conducted to ensure that the benefits of a specific medicinal product outweigh the risks by a significant margin.

What are the different types of risks?

• Potential risk: An untoward (adverse) occurrence for which there is some basis for suspicion of an association with the medicinal product of interest but where this association has not been confirmed.
• Identified risk: An untoward occurrence for which there is adequate evidence of an association with the medicinal product of interest.
• Important identified risk and important potential risk: An identified risk or potential risk that could have an impact on the risk-benefit balance of the product or have implications for public health.

How can we manage or minimize risk?

Risk minimization measures aim to facilitate informed decision-making when prescribing, dispensing, and/or using a medicinal product. Routine measures are applied to every medicinal product and additional risk minimization activities should only be introduced when they’re deemed essential for the safe and effective use of the medicinal product.

There are several methods that can be included in an RMP for pharmacovigilance, including:

1. Adverse Event Reporting: One of the most important methods for identifying potential risks associated with a drug, involves collecting reports of any adverse events that occur after the use of a drug and analyzing them to identify patterns or trends that may indicate a potential risk.
2. Risk Minimization Measures: Once a potential risk has been identified, risk minimization measures can be implemented to reduce the likelihood of harm to patients. Possible measures may include changes to a drug’s labeling or packaging or providing additional information or training to healthcare professionals.
3. Risk-Benefit Analysis: A method used to assess the overall risk and benefit of a drug for a specific patient population. This helps to determine whether the benefits of a drug outweigh the risks and whether a drug should be used in certain patient groups.
4. Signal Detection: The process of identifying potential safety issues by analyzing data from multiple sources, such as adverse event reports, clinical trial data, and observational studies.
5. Post-Authorization Safety Studies (PASS): Studies conducted after a drug has been authorized for sale to assess potential risks that were not identified during pre-authorization testing.

An Effective RMP

An RMP includes information on the risks associated with a drug, the measures that will be taken to minimize these risks, and the methods that will be used to monitor the safety of the drug. It includes several key elements:

• Identification of Risks: A process that identifies the risks associated with a drug, including known adverse events, potential drug interactions, and risks associated with specific patient populations.
• Risk Mitigation: The measures taken to mitigate the identified risks. These may include changes to a drug’s labeling or packaging, providing additional information or training to healthcare professionals, or implementing risk minimization activities such as targeted communication or restricted distribution.
• Monitoring: A plan for monitoring the safety of a drug, including the methods that will be used to collect and analyze data on adverse events.
• Communication: Communicating safety information to healthcare professionals and patients, including developing educational materials and the process for updating the RMP.
• Safety Review: A schedule for regular safety reviews conducted to assess the effectiveness of the risk management measures and to identify any new or emerging risks.

Risk management is an essential part of pharmacovigilance and involves identifying, assessing, and controlling the risks associated with a drug throughout its lifecycle. By implementing an RMP, healthcare providers, regulatory authorities, and pharmaceutical companies can ensure that the benefits of a drug outweigh the risks for the intended patient population by continuously monitoring and adjusting the safety measures accordingly. 

It’s important to regularly review the RMP to identify any new or emerging risks and ensure that the measures implemented are effective. With a comprehensive RMP in place, we can work towards ensuring the safety and well-being of patients who use these drugs.

 

References: 

Good pharmacovigilance practices (GVP) | European Medicines Agency (europa.eu)