Pharmacovigilance support safe and effective use of drugs.the safety concern of drugs now becoming priority of area.In developing countries drug safety is more focused area. Here is detailed information about role of pharmacist in pharmacovigilance.
According to WHO ” pharmacovigilance is the science and activities relating to detection, assessment, understanding and prevention of adverse effect and any other drug related problem.” Let’s see how pharmacovigilance work? And also the role of pharmacist in pharmacovigilance. It contains various steps such as adverse event Reporting, individual Case Safety Report, medical coding, aggregate reporting, signal detection and risk management.
- Adverse case management- It is the first step where Adverse event is reported in various platforms such as hospital, regulatory agencies, review of manufacturing company. After reporting validation of event is done by using 4 parameters that are – patient, product, report, adverse event.
- Individual Case Safety Report- When the event is validate then individual safety report is created.here special/ separate report of adverse event is made by detail study of patient and product.
- Medical coding- The ICS report come to medical coding to create medical report. The translation of medical report into short code used in healthcare industry is called as medical coding.
- Aggregate reporting- It is the process of compilation and submission of aggregate report to regulatory agencies over the period of the product life cycle.there are various types of aggregate report such as DSUR, PSUR etc.
- Signal detection- the process of actively searching for and identifying safety Signal from wide variety data source. It done in two ways – qualitative and quantitative.
- Risk management- Drug undertaken to promote safe use of medicine and safeguard health of patient. Risk: Benefit ratio is calculated and depending upon that drug given in market or withdraw from market.
In each step of pharmacovigilance there requires good knowledge of drug use , it’s formulation and detailed analysis of Adverse event. The pharmacist know drug in all way so he/she has better understanding ability of adverse event than any other healthcare professionals. There are various drugs developed regularly and they also has some side effects. To avoid that effect and giving better life to patient is most important. pharmacovigilance is essential field for drug safety. That’s why it is new insight in pharma field.