Pharmocovigilance is the science of monitoring, assessing and preventing the side effects or adverse reactions of drugs in the market. It’s a systematic approach to identifying, recording and analyzing safety issues related to medicines or medical devices. It involves collecting, monitoring, researching, assessing and evaluating information from healthcare professionals and patients using the medications or devices. The goal of pharmocovigilance is to protect public health by ensuring that all medications have been studied for their safety and efficacy before they are made available to consumers.
The Three Stages of Pharmacovigilance
Pharmacovigilance has three stages: pre-marketing surveillance, post-marketing surveillance and risk management. Pre-marketing surveillance includes clinical trials that are conducted before a drug can be approved for sale. During these trials, researchers observe how the drug affects volunteers who take it. They also study how well the drug works in treating various conditions. Post-marketing surveillance involves monitoring any adverse reactions that occur after a drug is released on the market for sale. This includes tracking reports from healthcare providers about any negative reactions experienced by people taking the drug. Risk management involves developing strategies for reducing any risks associated with taking a particular medication or device.
This could include educating healthcare professionals about the proper use of a drug and warning patients about possible side effects. Additionally, risk management can involve monitoring for any rare but serious adverse reactions that may occur after a drug is released on the market. The goal of pharmacovigilance is to ensure that all drugs are safe and effective for their intended use. By collecting data on how drugs work in real-world settings, pharmacovigilance helps ensure that patients get the best possible outcomes when taking their medications.
Types of Adverse Reactions Monitored by Pharmacovigilance Programs
Adverse reactions monitored by pharmacovigilance programs can range from mild side effects such as headache or nausea to more serious complications such as anaphylactic shock or organ failure. Depending on the type of reaction being investigated, different methods may be used to collect data about it. For example, if an allergic reaction is being investigated, skin tests might be done on volunteers who take the medication in question; if liver toxicity is suspected, blood tests might be done to monitor liver enzyme levels over time; if renal toxicity is suspected, urine samples might be analyzed for signs of kidney damage; etc. In addition to these types of assessments, pharmacovigilance programs also involve collecting patient reports about their experiences with medications or devices in order to identify any patterns that may indicate a potential problem with them.
In summary, pharmacovigilance is an important part of protecting public health by ensuring that all medications have been thoroughly studied before they become available for sale on the market. By monitoring pre-marketing and post-marketing data about potential adverse reactions associated with drugs or medical devices, pharmacovigilance programs help healthcare professionals better understand how these products work in practice so they can make more informed decisions when prescribing them to their patients.
