Pharmacovigilance is a term used to describe all functions related to monitoring and improving the safety of medicines. The goal of pharmacovigilance is to maximize the benefits of pharmaceuticals, while minimizing their risks. Specific functions associated with pharmacovigilance include evaluating safety data collected on medicines, identifying specific medications that may be causing potentially harmful side effects, and taking the initiative to improve medicinal safety once a problem has been identified.
Raising public awareness related to safety of medicines and lobbying for changes related to pharmaceutical law are also key aspects of pharmacovigilance.
Who is Responsible for Pharmacovigilance?
Ultimately, pharmacovigilance is a duty of every participant in the pharmaceutical industry. It is up to individual patients to report potentially dangerous side effects to their doctors. It is up to the doctors, pharmacists and other health care practitioners to report such potential problems to pharmaceutical monitoring boards. Finally, it is up to pharmaceutical companies to be vigilant in research and review methods to ensure that only the safest medications are made available for public use.
While all of these links in the chain are important, the legislative responsibility of pharmacovigilance falls on the shoulders of the government entities tasked with improving and maintaining public safety. In the United States, this duty is primarily the responsibility of the Food & Drug Administration (FDA). In Europe, data collection and monitoring is conducted by the European Medicines Agency (EMEA).
Pharmacovigilance Begins With Clinical Trials
The process for drug improvement can vary from one specific drug case to another. However, testing of drug safety always begins in clinical trials. Before a medication can be approved for public use, it must go through several stages of clinical trials to gauge the potential risks and benefits associated with the drug.
In each clinical trial, a sample of patients is administered the drug. Their response to the medication is then compared to a control group, which typically takes a placebo or alternative form of treatment. Depending on how the sample group responds to the drug, it may or may not be approved by the FDA or EMEA for public use.
The Importance of Data Collection
In addition to clinical studies, pharmaceutical companies are also required to present all reports of adverse reactions to the appropriate governing body. It is the job of the governing body to maintain this data and identify any points of concern.
Though the clinical trial system has proven to be a relatively reliable system for drug approval, the system is not full proof. Occasionally, serious safety hazards are identified after medications have gone to market. It is through this data collection and review process that the availability of unsafe drugs are re-evaluated and eliminated if necessary. An example of this occurred in 1997, when the FDA requested the withdrawal of Fen-phen, an anti-obesity medication, from the U.S. market after receiving numerous reports that linked the drug to serious heart conditions and death.
Additional Monitoring Support
It should be noted that the vast majority of reports related to potential adverse drug effects begin at the patient/doctor level. When suspect effects associated with a drug’s use are identified, a report can and should be submitted to either the pharmaceutical manufacturer or the government entity in charge of pharmacovigilance. These reports, sometimes referred to as spontaneous reports, are generally voluntary in nature.
Additional support comes from international organizations such as the World Health Organization (WHO). Specifically, the WHO Programme for International Drug Monitoring serves primarily as a hub for data collection of case reports culled from numerous countries. This database provides cross-country integration of reports, and is easily accessible by all member states.
Further aiding the cause of pharmacovigilance are non-profit and academic organizations. In the U.S., such organizations include the Research on Adverse Drug Events and Reports (RADAR) and Public Citizen. These organizations strive to offer additional unbiased research into drug safety. They also attempt to enforce accountability of drug companies by raising awareness and lobbying for law change.
