From the Guidelines
Pharmacovigilance (PhV) is the cornerstone of drug safety monitoring, playing a crucial role in identifying, understanding, and preventing adverse drug reactions, as emphasized by the World Health Organization Program for International Drug Monitoring (VigiAccess) 1. The process of pharmacovigilance involves continuously monitoring medications after they've been approved for use to identify previously unrecognized adverse effects. This process begins during clinical trials but continues throughout a drug's market life, as some adverse effects may only become apparent when medications are used in larger populations or over longer periods. Some key aspects of pharmacovigilance include:
- Detecting adverse effects or any other drug-related problems
- Assessing the severity and impact of these effects
- Understanding the mechanisms behind adverse drug reactions
- Preventing adverse effects through targeted interventions and regulatory actions Pharmacovigilance systems rely on healthcare professionals, patients, and manufacturers to report suspected adverse drug reactions through spontaneous reporting systems. These reports are collected, analyzed for patterns, and may lead to regulatory actions such as adding warnings to drug labels, restricting use, or in severe cases, removing medications from the market, as seen in the management of drug-related pneumonitis in patients receiving molecular targeting agents and immune checkpoint inhibitors 1. The ultimate goal of pharmacovigilance is to improve patient safety by ensuring that the benefits of medications continue to outweigh their risks when used in real-world settings, which is achieved through early diagnosis, cessation of the offending drug, and appropriate treatment, such as glucocorticoids for severe cases 1. Healthcare providers should actively participate in this process by reporting unusual or severe reactions to help maintain medication safety profiles, as highlighted by the National Comprehensive Cancer Network, American Society of Clinical Oncology, Society for Immunotherapy of Cancer, and European Society for Medical Oncology guidelines 1.
From the FDA Drug Label
The FDA drug label does not answer the question.
From the Research
Definition of Pharmacovigilance
Pharmacovigilance (PhV) is defined as the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problem 2, 3, 4, 5.
Key Aspects of Pharmacovigilance
The key aspects of pharmacovigilance include:
- Detection of adverse drug reactions (ADRs)
- Assessment of ADRs
- Understanding of ADRs
- Prevention of ADRs and other drug-related problems Pharmacovigilance plays a crucial role in ensuring that patients receive safe drugs 3.
Methods of Pharmacovigilance
Various methods are used in pharmacovigilance, including:
- Spontaneous reporting
- Intensive monitoring
- Database studies These methods help increase our knowledge of a drug's adverse reactions 3, 6.
Importance of Pharmacovigilance
Pharmacovigilance is essential for:
- Preventing and mitigating adverse drug reactions and medication errors
- Ensuring the safe use of medicines
- Generating knowledge to facilitate the rational use of medicines, especially in vulnerable populations such as pediatric and older patients 2, 4, 5.
Education and Training in Pharmacovigilance
Education and training of healthcare professionals are critical for effective pharmacovigilance 2. The education should focus on:
- Awareness of potential adverse effects
- Knowledge of frequently prescribed drugs and factors that increase susceptibility to harm
- Reporting of adverse drug reactions and their role in regulatory aspects and scientific knowledge.