Pharmacovigilance, also known as drug safety, is a broad term that describes the collection, analysis, monitoring, and prevention of the various side effects of the drugs and treatments. This is completely a scientific and process-oriented pharmaceutical field.
Therefore, it conducts clinical trials that provide data about the risks and benefits of drugs. In clinical trials, pharmacovigilance seeks to determine whether the benefits outweigh the risks. If they do, the drug manufacturer will take the necessary steps to obtain the marketing consent for the new drug.
PVs are important to ensure they are safe for distribution during the clinical trial phase of drug development, but continuous monitoring of the drug is also important. Clinical Research Courses and Training is required for this particular course of study.
Further, the significance of pharmacovigilance is as follows:
- Safety monitoring of medicinal products
- Clinical trials
- Pharmacoepidemiological studies
- Case reports
- Developing case series
- Analysis of case series
- Use of data mining to identify product -event combination
Steps in Pharmacovigilance Program:
- Safety data management
- Signal detection for any new altered safety issue
- Signal evaluation and making decisions with regard to safety issues
- Actions, including regulatory, to protect public health
- Spontaneous reporting
Knowledge of a product’s safety profile may change over time as a result of long-term use. Once a drug is approved for marketing, pharmacovigilance activities continue through the post-marketing phase and as long as the drug remains on the market.
As the core mission of life sciences has always been to improve and save the lives of patients around the world, pharmacovigilance will continue to play an important and influential role in the development of future new drugs and therapies. It is important for drug regulatory authorities to make appropriate decisions to protect public health.
Therefore, this should be seen as a very important obligation, rather than an additional clinical burden, for healthcare professionals to ensure safer drug use worldwide.
