Pharmacovigilance, or PV, has a critical role involving all aspects of a medical product. It is the collecting, researching and assessing of information received from both patients and healthcare professionals concerning any adverse side effects from medications.
Expertise in several different areas including medicine and technology are required in order to create a strong pharmacovigilance strategy. An ideal strategy includes risk management, continuous detection and assessment, processing individual case studies, screening of literature pertaining to products and a safety database.
The Pharmacovigilance System
Pharmacovigilance is a crucial system used to revise labeling of drug products. It detects possible adverse reactions caused by inappropriate use, counterfeit or substandard medications. This, in turn, helps create guidelines for treatment as well as inform the public and healthcare professionals of any reinforced or new information.
In the past several years there has been an increase in publicized issues of safety concerning medicinal products which, consequently, has increased political pressure for implementation of stronger regulations pertaining to pharmacovigilance through the FDA and similar companies throughout the world.
One major change calls for a more proactive approach to risk management strategies. This would aid in characterizing and minimizing both known and potential safety concerns. At the same time there needs to be a more comprehensive surveillance system implemented that would not just identify a possible adverse drug reaction, but confirm it as well. This means that a larger pharmacovigilance data base would need to be available to everyone.
Pharmacovigilance As A Regulatory Agency
The role of pharmacovigilance is very similar to that of regulatory agencies; the goal is to help reduce the risk of harm to patients. This is done by identifying drug hazards that may have been previously unrecognized and making any pre-disposed factors clearer. It will help refute “false” safety readings and quantify any risks in relation to the drugs benefits.
There are times during what is considered a health crisis when decisions need to be made within a relatively short period of time. The threat of a hazard to patients or even a mass media frenzy requires quick decisive actions. However, there is still a need to analyze available data, to consult with experts and to provide this information to other parties. A situation such as this usually gets handled by a “task force” of which pharmacovigilance expertise plays a very important part. This task force has to consider all information gathered, make a risk-benefit judgment call, and propose any action that needs to be taken. Again, this type of situation tests the expertise of pharmacovigilance.
Previously, pharmacovigilance units spent a substantial amount of their time reporting individual cases to many different regulatory authorities. New developments promise to simplify that particular aspect. It is believed that a more uniform harmonious international system of requirements will follow due to the ever increasing developments in electronic communications. This would allow case reports to be automatically distributed within not just the companies themselves but to the various task forces and regulatory authorities as well.
All of this combined means more accurate and comprehensive information concerning risks and benefits of medicine and medical products will be available to everyone in a much more timely fashion. Learn more about Pharmacovigilance or drug lawsuits here.