Pharmacovigilance – also known as PV, PhV, or drug safety – is a vital component of the drug development process, for protecting the health and safety of healthcare consumers and keeping drug makers informed of any adverse drug reactions (ADRs) their products may cause in specific individuals.
PV involves “identifying, tracking, evaluating and preventing negative outcomes” from drug therapies. It has seen “huge growth” over the past few years: According to European Pharmaceutical Manufacturer Magazine, the PV market will surpass US$8 billion by 2024. That’s because of the sheer number of drugs in development or on the market today, along with the requirement that every manufacturer must prove a drug’s efficacy and safety to the U.S Food and Drug Administration (FDA) and similar agencies around the world.
The PV process begins early on in a drug’s development in the form of phased clinical trials designed to generate data on a drug’s efficacy and safety. Following approval by regulatory bodies, PV continues throughout the drug’s lifecycle and is generally composed of two main pillars.
Single case processing of Individual Case Safety Reports (ICSRs) involves manually collecting, assessing, and reporting ADRs. Case processing usually takes up anywhere from 40 to 85 percent of a company’s PV budget and can divert resources that could otherwise work on more critical tasks. With PV data volumes increasing at a rate of 15 to 15% per year, the inflated cost of case processing has become an enormous issue.
Post marketing surveillance (PMS) or signal detection involves ongoing monitoring for ADRs. PMS depends on clinical data from sources such as medical assessments of ADRs, medical literature, health databases, and clinical trial data, along with “real-world evidence” such as electronic health records (EHRs), medical device data, customer surveys, warranty claims, and data from social media and other online sources.
Because PMS involves long-term monitoring, it plays a vital role in discovering rare benefits or problems in a drug that would otherwise go undetected for years. PMS has other advantages over pre-marketing clinical trials: it’s indefinite (whereas clinical trials usually last just a few weeks or months) and involves a much larger population group, including smaller subgroups not represented in a limited clinical trial.
There are three distinct types of PMS: Spontaneous reporting of cases to the FDA or in health literature; Post marketing studies such as observational studies or randomized clinical trials; and active surveillance.