Many medications, ranging from over-the-counter (OTC) and prescription drugs to herbals and supplements, have side effects. Typically, manufacturers have to provide a list of these effects before getting approval from an authoritative entity like the Food and Drug Administration (FDA). Some of these side effects include drowsiness, headache, constipation, and insomnia. If you run a firm in the pharmaceutical industry, you must ensure your products are safe for use and only cause mild permissible side effects. To achieve that, you need pharmacovigilance consulting.
What is Pharmacovigilance?
Pharmacovigilance is the process used to detect, assess, understand, and prevent the adverse effects of pharmaceuticals. Pharmaceuticals, in this case, refers to medication like antibiotics, painkillers, mood stabilizers, vaccines, and anti-inflammatory drugs. Pharmacovigilance is indispensable for every manufacturer because all medicines must be rigorously tested for efficacy and safety before being sent to the market for use by consumers.
How Does Pharmacovigilance Work?
The pharmacovigilance process goes through the following steps:
Step 1: Detection
The detection phase of pharmacovigilance mainly involves data collection and verification. Experts collect data from different sources during clinical trials or reports submitted by caregivers, doctors, patients, or pharmacists. And, since an unexpected adverse event can manifest at any point, the collection of safety data should continue for as long as a product is in use.
Step 2: Assessment
The assessment of individual case study reports (ICSR) comes after collecting safety data. An ICSR is a document filed by consumers. It contains information on the reporting of adverse events and any drug-related problems. During an assessment, the validity of ICSR needs confirmation conducted by checking the identity of the reporter, the adverse event, and the drug in context. Then, if the manufacturer has any queries, they ask the reporter or patient. Afterward, a safety physician conducts a medical review to determine the seriousness of the adverse event.
Step 3: Understanding
Pharmacovigilance specialists review aggregate data to understand a product's safety profile. That means they thoroughly discuss all adverse events that arose spontaneously and in clinical trials. Afterward, they analyze the risk-benefit ratio and find out more about specific adverse reactions using follow-up questionnaires.
Step 4: Prevention
Finally, marketing authorization holders (MAH) take the necessary measures to prevent adverse events. They do that in various ways, including using risk minimization activities like updating: the legal status of medicine, labeling and packaging, and summary or product details. Monitoring patients and educating caregivers are also vital in this stage.
Hire a Pharmacovigilance Consultant
Your biotech or pharmaceutical company needs pharmacovigilance to comply with the law and improve product safety. However, to enjoy the maximum benefits of pharmacovigilance, you need to hire skilled and flexible consultants. Fortunately, by partnering with a reputable pharmacovigilance consulting company, you get a retinue of experts at your disposal.