Pharmacovigilance is required in order to identify adverse effects that have not been detected in clinical trials .Hence, clinical research courses have been structured to give students a clear understanding of the field of pharmacovigilance . Pharmacovigilance helps in improving health and the chance of survival in the population. Therefore, this article would help you gain an understanding of the different methods used in pharmacovigilance
Given below are the following methods in pharmacovigilance that are covered in clinical research courses.
1. Individual case safety reports
Individual case safety reports are the reports that are sent by pharmacovigilance professionals to regulatory authorities. They mostly warn and raise genuine concerns about real-life suspected adverse drug reactions. They are usually based on information gathered and collated from many independent research sources. Furthermore, these safety report cases give professionals the means to recognize the unexpected cases. Pharmacovigilance courses give one an idea of this method
In addition to this, pharmacovigilance courses help professionals know more about clinical revues
Clinical review of safety reports
There are huge collections of individual case reports in the pharmacovigilance industry. These clinical reviews are not always submitted to pharmacovigilance systems by various health professionals. They are often published in journals or arise as a result of lawsuits. However, there is a hurdle as every case cannot be reviewed. Pharmacovigilance courses help individuals understand how to conduct clinical reviews.
Some countries alsohave cohort-monitoring systems (CEM) in order to strengthen the follow-up of certain medicinal products. . These event monitoring reports give confidence to healthcare professionals to report certain events which may otherwise have gone unnoticed by the healthcare industry. These cohort size monitoring systems usually range from a few thousands to ten thousand patients. Pharmacovigilance courses help professionals to adapt to new systems which detect unexpected events.
Longitudinal electronic patient records
These longitudinal electronic patient records are of great significance to professionals because they analyze real-world use of medicines. These records mostly give the professionals detailed information on extended parts of medical histories and comprise of data of exposed and unexposed patients. The range of data include in these records include prescriptions, laboratory test results, hospital referrals and admissions and notes on symptoms, signs and diagnosis
Pharmacovigilance courses help individuals to maintain these records with high-quality data.
The necessity of screening patient records and case reports
Case studies and reports are of great significance to the pharmacoepidemical industry because of pharma-co-epidemiological studies. In the current times, their utilization has been extended to exploratory analysis and routine drug surveillance. Many methods focus exclusively on a single aspect of drug-event association, It focuses on aspects such as the time from first exposure to the first occurrence of an ADR or difference in frequencies of events in exposed and unexposed patients.. However, it may differ in different situations
To summarize, pharmacovigilance courses give students a clear understanding of the ultra-modern methods of pharmacovigilance.