The healthcare sector is extremely concerned regarding the safety of its patients. Once the new drugs hit the markets, there would be an enormous demand to monitor and evaluate the safety of those drugs. And it is at this very point that Pharmacovigilance enters the fray. According to WHO, “Pharmacovigilance is defined as the science and activities related to the early detection, assessment, understanding, and prevention of adverse effects or any other drug-related issues.”
All of us are very much aware of the fact that our patients are at risk from those not-so-safe drugs. Based on the given context, we will discuss the role of pharmacovigilance in ensuring drug safety, how it works, and the reasons that make it an essential part of the healthcare sector now.
Pharmacovigilance Overview
In short, the official title for the term Pharmacovigilance is PV, which involves monitoring and evaluation of drugs in use when in the market as well as after acceptance and approval by an organization like the Food and Drug Administration (FDA) in the USA, European Medicines Agency (EMA) in Europe, and the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. In the latter, it became acceptable to outsource the Pharmacovigilance to a local Saudi QPPV.
To detect adverse drug reactions – ADRs, that is, unintended and unfavorable effects of a medication that are harmful or injurious to the patient, it can offer assessment through pharmacovigilance.
Some of the activities coming under the science of pharmacovigilance include:
- Collection of data from adverse drug reactions by healthcare professionals and patients.
- Analysis of suspicion reports regarding adverse reactions that may indicate its potential effects.
- Implementation of measures to minimize the risk of adverse effects for current and future patients.
- Ensuring that the manufactured drugs comply with the safety guidelines set out by the regulatory authority.
It is not just only the identification of side effects that can cause harm but also studying how drugs work in combination with one another, different populations of people they come into contact with, and how certain conditions can change the effectiveness or safety profiles of medicines. That’s basic for public health and to continue public confidence in the healthcare system.
Why is Pharmacovigilance Important?
Drugs are also tested over such periods as require several years for them to be researched in the lab before even beginning to undergo clinical tests, and after they finally reach the market, it is still hard to predict every side effect or interaction that may be caused by a drug when wider populations use it. Clinical trials are performed in controlled groups, which usually involve small sizes, which may not account for the full spectrum of effects that the drug might elicit if taken by a larger population.
Pharmacovigilance becomes important when such a drug enters the market, used by millions, and its evolution of side effects and reactions may not bear any reflection of clinical trials. A rare yet serious adverse reaction can only come to light through continuous monitoring of the safety of drugs. Thus, this can help the healthcare provider in his informed decision to continue or withdraw a particular medication, always prioritizing patient safety.
How Does Pharmacovigilance Work?
The good news is that the pharmacovigilance program functions by a mix of proactive and reactive methods. Among those, there are some key ways by which pharmacovigilance ensures drug safety through the collection and analysis of reports of adverse drug reactions from healthcare professionals, patients, and regulatory authorities.
Once a drug has received the green light for market use, the makers of the drugs as well as the healthcare providers who prescribe them invite patients to report any effects that seem unusual or reactions that they have not anticipated. These reports are usually filed with the regulatory agencies, or to the respective drug’s manufacturer. After analysis of the data gathered, regulatory agencies decide whether the reaction might be associated with a specific drug.
Besides monitoring on a reactive basis through adverse event reports, proactive studying and analysis of a wide variety of sources such as electronic health records, medical literature, and global databases are conducted by pharmacovigilance teams to help in the identification of trends and potential risks that are associated with individual drugs or classes of drugs.
Regulatory agencies would likely act if there was a trend of adverse effects. Its actions range from drug labels being updated to include new warnings, sending safety alerts to the healthcare community at large, to the extreme step of withdrawing the drug from the market.
Conclusion
It’s due to pharmacovigilance, which plays an indispensable role in bringing the medicines we administer closer to being as safe as possible. It’s a determinant of the continued safety assessment and monitoring of drugs, safeguarding patients against the adverse consequences of side actions, and global improvement in public health.
PharmaKnowl has realized that there exists betterment regarding improvement of drug safety through the patients. The essence of pharmacovigilance cannot be overstated by taking necessary precautions to ensure that medications benefit and do not harm patients who need them.
