Major Benefits of Dedicated Pharmacovigilance Resources
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Major Benefits of Dedicated Pharmacovigilance Resources

Stacey Smith, Pharma Tech Outlook | Wednesday, January 06, 2021

It is rare for a drug trial to be performed on a group of patients that are close to the same number as those taking the drugs. This occurrence means that unusual adverse effects cannot occur until clinical trials are finished.

FREMONT, CA: Confirming drug safety alone during pharmaceutical product production is still a concern due to data limitations. If the laboratories had unlimited time to sell their drugs, there would be less of a problem. Unfortunately, producers need to start producing as quickly as possible to increase profits.

However, by devoting more time to pharmacovigilance, laboratories will preserve patient safety and public trust for a few reasons.

1. Increase Sample Size

It is rare for a drug trial to be performed on a group of patients that are close to the same number as those taking the drugs. This occurrence means that unusual adverse effects cannot occur until clinical trials are finished.

2. Expand Patient Populations

Analogously, the bulk of research trials are performed with a single population. Patients also come from a specific region and fall into a small age range. As a result, marketers lack knowledge about how patients with diverse ethnicities and particular demographics (such as breastfeeding, pediatric and geriatric patients) react to the medication.

3. Examine the Drug in Natural Settings

The kind of patients studied in clinical trials could respond differently to the treatment in a normal environment. This is because, in a clinical trial, patients must obey stringent protocols that are difficult to execute in the real world. In comparison, individual patients can be more complicated than in the trial. They may have other chronic disorders or other medicines (or pharmaceutical products, herbal products, or nutritional supplements) that may interfere with the medication. There is also a possibility that patients might mistake medicine for the drug.

Finally, there is the fact that it is only possible to identify any adverse symptoms following extended exposure to the drug. Changes could only be evident after several years—far later than is possible in any clinical trial.

4. Monitor for Abuse Potential

Sometimes, it can only be shown that a drug can be exploited or overdosed following commercialization.

 

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