- Identify previously unknown adverse effects
- Recognize changes in the frequency or severity of known adverse effects
- Assess a drugs risk/benefit to determine if action is required to improve safety
- Ensure the accuracy of information communicated to healthcare professionals and patients, and to ensure information contained in patient information leaflets (PILs) is up to date
Pharmacovigilance in clinical research
Pharmacovigilance outside of clinical research
- Potential drug interactions
- Long-term risks
- Risks that come from higher doses
- Dangers that come from drug misuse or abuse
Importance of Pharmacovigilance
Adverse drug reactions (ADRs): Any “noxious and unintended responses” attributed to a drug. ADRs are side effects that are directly caused by the use or discontinuation of a medicine.
Serious adverse events (SAEs): Adverse drug events that are particularly serious, including those that are life-threatening, lead to congenital abnormalities, result in extended or unexpected inpatient hospitalization, or cause disability. Newly discovered SAEs for drugs on the market require expedited reporting by pharma companies to regulatory authorities.
Suspected adverse drug reactions: An adverse event that is suspected to be caused by a drug. If research confirms the correlation, it would become a confirmed adverse drug reaction.
Suspected unexpected serious adverse reactions (SUSARs): Adverse reactions that occur which do not line up with the adverse reactions currently outlined in the investigator brochure (before marketing) or product information including the SmPC and PIL (after marketing). Also called unexpected drug reactions.
Good pharmacovigilance practice
Good pharmacovigilance practices (GVP) vary slightly from one country to the next and are determined by the country’s regulatory authorities.
Regulatory authorities worldwide
There are a variety of drug authorities that oversee pharmacovigilance. These vary by country and include:
- The European Medicines Agency (EMA) for countries in the European Union (EU)
- The Food and Drug Administration (FDA) for the United States
- Pharmaceuticals and Medical Devices Agency (PMDA) for Japan