What is Pharmacovigilance
According to the WHO (World healthcare organization) “Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.”
Pharmacovigilance plays a key role in the development of new drugs and medications to monitor and observe how these substances can have side effects on the human body. Pharmacovigilance ensures that rigorous testing of clinical drugs is carried out to improve patient care and reduce the risk of negative side effects, therefore making the drug safer once it has been brought to market.
Every year there are thousands of accidental overdoses that take place around the world. These overdoses occur due to lack of knowledge about the drug that a patient has been prescribed. When it comes to any type or form of medication, knowledge is everything especially when it’s a new drug being introduced into the market.
It’s important that pharmacovigilance is carried out as early as possible to study the effects that drugs can have on the human body. It’s also important to observe what side effects may occur from taking the drug for a short and long period of time and what other elements of the body the drug may affect.
With this in mind it’s also important to know how much volume of the drug can be safely prescribed and what is the best dosage to take. This is a fine line as drug manufacturers want to make sure that the prescribed dosage is enough to work well and cure/solve the issue but also not too much that it could potentially damage other parts of the body.
Pharmacovigilance in Clinical Research
Pharmacovigilance always begins with clinical trials. This is the best way to test the risk and benefits of a drug to see how they react on a mass scale. The primary aim is to determine if the drug's benefits outweigh the risk so drug manufacturers can take the next steps to bring the drug to market.
Once these initial clinical trials have been completed it is then important to conduct more clinical trials with larger numbers and more varieties thrown into the mix under the investigation of a third party company/individual.
Once the trials are carried out and the results are concluded the investigator shares the data with the drugs R&D departments so that they can analyze the results and then progress to the next stage of trials to bring it closer to market and make any adjustments necessary before presenting it to the regulatory authority for market approval.
Further studies and trials can be carried out once the drug is approved to test how safe and efficient the drug is in a less controlled environment. Ie the general public consuming it.
Pharmacovigilance in Post-Market
Pharmacovigilance is quite limiting in a clinical setting as it’s hard to test every single variant and possibility before a drug goes to market. It’s difficult to test how the drug might interact with every single person or how it might interact with other drugs that are being taken by an individual.
It’s also hard to identify what the long term risks are of a drug and the dangers that might arise from misuse of the drug. This is why it’s so important that after a drug is brought to market that regular contact and feedback from healthcare professionals and consumers is conducted to harvest data to monitor the real world effectiveness and safety of the drug.
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Biologit offers offers Human and Veterinary Pharmacovigilance, Cosmetovigilance and Medical Device Vigilance Consultancy Services, including the provision of European Economic Area (EEA) Qualified Person for Pharmacovigilance (QPPV) and Responsible Person for Pharmacovigilance (RPPV) in Clinical Trials
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