How Pharmacovigilance Helps in Detection of Rare Side Effects
The effectiveness and safety of drugs are accessed through pharmacovigilance to ensure their safety while making sure the manufacturers are adopting the right measures to produce drugs and medications. Most of the time, medicines make us feel better, but sometimes they can harm us, which is not our expectation.
However, the side effects are not easy to assess because they can be rare and only show up in a few people. Hence, pharmacovigilance was introduced to measure the safety of the drugs.
Pharmacovigilance is all about monitoring and studying the safety of medicines after they are sold to people. Scientists and doctors keep note of how well the medicine helps the patient and keep a record of whether it is causing any problems or not. They look at all kinds of information to find out if there are any new side effects not known before. This is especially important for rare side effects which just may happen to a small number of people. SFDA Pharmacovigilance conducts pharmacovigilance activities since 2005 to increase the benefit-risk profile of a drug product.
Here’s how pharmacovigilance helps in detection of rare side effects:
Data Collection
As more people take the new medicine, physicians and patients alike share their accounts. If a patient experiences something unusual after taking the drug, they share that effect. These reports are collected and investigated in detail. By gathering many of these reports, scientists begin to look for patterns: do the reports suggest that an adverse event could be more common than one might otherwise have assumed?
Report Studies
This includes studying reports relating to medicine, which are reported not only by scientists and experts but also by the common man. Experts are very important because they become essential when common people face a problem with a medicine. They compare notes with one another to see if a connection exists between a particular product being marketed and the side effects people report about it. Any problems that people face due to a certain medicine can turn out to be important even if they are experienced by only a few. By understanding these reports, they can identify whether a side effect is rare or a reality.
Data Usage
In the present world, data is easily obtainable. Pharmacovigilance uses large databases where information from many patients and physicians is stored. From analyzing such a large amount of data, the experts find rare side effects that might not be evident in cases where one would look at just a few of them.
Discuss Updated safety information
When a rare side effect is discovered, information about the medicine is updated. This way, a warning alert is given to doctors and patients about new risks. Sometimes, the label on the medicine may change or new pieces of advice on the safe use of the medicine are given.
Conduct More Investigation and Research
If a rare side effect is identified, further study is done for greater understanding. Scientists look at why it occurs and if anything can be done to prevent it. In this way, ongoing research can lead to improved safety in medicines.
Conclusion
Pharmacovigilance is like a safety net for medicines. Its purpose is to capture unforeseen problems and ensure safety. By researching how medicines affect people, experts can find and, in many cases, fix problems that are not apparent at first. So the next time you hear about some new medicine, remember there is a whole team of people working hard to ensure that it is safe for everyone. If a rare side effect is detected, pharmacovigilance helps in understanding it and keeping people updated so that we all can use medicines safely.
