Difference between Drug Safety and Pharmacovigilance
Drug Safety & Pharmacovigilance are receiving more attention than any these days. “Drug Safety and Pharmacovigilance” is not a single term. There is a slight difference between “Drug Safety” and “Pharmacovigilance.”
In short, we can say one is reactive, and the other is proactive. One is taking care of compliance and reporting, and the other is focused on interpreting signals. Ultimately, both refer to the same function of reporting, gathering, and adverse drug reactions. The primary difference between Drug Safety and Pharmacovigilance lies in the value of data generation.
| Drug Safety | Pharmacovigilance |
With the Drug Safety design, data collected at clinical trials and in the post-marketing environment is examined and reported. Crucial data is highlighted, and regulatory agencies use this information to decide which drugs will be registered and reimbursement authorities to decide reimbursement. These choices include weighing up the risk vs. benefit of different treatment options, i.e., for the service that the patient receives from the medicine, what are the likely chances in terms of side effects. | The Pharmacovigilance model takes drug safety to the next level. The term ‘vigilance’ links to ‘being vigilant,’ i.e., proactively considering the environment, and identifying signals and trends, with an enhanced focus on the post-marketing environment. The conditions of use have changed. Patient compliance is variable, and inclusion/exclusion criteria are not as tight as in controlled trial settings. Within the Pharmacovigilance model, larger and more complex datasets are being analyzed. It generates considerable insight into how drugs are performing in the real world. Valuable data is being developed on how medicines are completing inpatient sub-populations and across disease states. The Pharmacovigilance model concentrates on establishing signal detection systems and uses advanced data analytics to proactively monitor the entrance of new medicines to large patient populations. Real-world evidence is collected, collated, analyzed, and turned into penetration which is then being used during regulatory, reimbursement, and commercial discussions on strategic competitive benefits. |
The two words Drug Safety and Pharmacovigilance can be used conversely – the same primary role is being performed. But Pharmacovigilance is more encompassing and more strategic.Feel free to share this article with your colleagues.
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