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Sleep News Blog

Prescription Sleep Medicine

Effective Pharmacovigilance Systems to Ensure Drug Safety

Posted by sleepyguy in Prescription Sleep Medicine on September 27th, 2009

Following the incessant health troubles evoked by pharmaceutical drugs, a major emphasis has been placed on ensuring drug safety. Pharmacovigilance has a major role to play in doing so. It helps in detection, assessment, research and prevention of adverse side effects by drugs. Since it has such an important function in ensuring drug safety, an effective methodology that optimally recognizes the damage causing factor in a particular drug and helps eliminate that factor should be designed. Different pharmaceutical firms use different Pharmacovigilance methods. The comprehensiveness of the system is very important in detecting the problem causing element in the drug quickly and most precisely.

Over the past decade there has been a shift in the drug safety standards, driven by the regulatory authorities. The policies on risk management and the standards of pre marketing and post marketing techniques have been made stringent. This has created a need to constantly document every detail of manufacture, pre marketing and post marketing aspects of each drug. It has become important for drug manufacturers to increase the transparency of their activities and maintain intra industry, inter industry and consumer communication about various aspects about the drug. While choosing a pharmacovigilance system, the following aspects should be borne in mind:

Techno savvy: the system should use advanced software capabilities that is easy to use and elaborate enough to manage adverse drug event reaction reporting effectively.
Global reporting compliance: since drugs are generally marketed globally, the system should adhere to international adverse drug event reporting obligations.
Streamlined case processing: Since adverse event management involves a lot of data, an advanced workflow that is in sync with differing case processing and one that is complaint with the reporting of all major regulatory agencies is important.

Optimal risk management: Risk management should be at the core of the system. It should allow the companies to monitor their products regularly and provide early identification of product risks.