| Following the incessant health troubles evoked by | | | | drug manufacturers to increase the transparency of |
| pharmaceutical drugs, a major emphasis has been | | | | their activities and maintain intra industry, inter |
| placed on ensuring drug safety. Pharmacovigilance has | | | | industry and consumer communication about various |
| a major role to play in doing so. It helps in detection, | | | | aspects about the drug. While choosing a |
| assessment, research and prevention of adverse side | | | | pharmacovigilance system, the following aspects |
| effects by drugs. Since it has such an important | | | | should be borne in mind: |
| function in ensuring drug safety, an effective | | | | - Techno savvy: the system should use advanced |
| methodology that optimally recognizes the damage | | | | software capabilities that is easy to use and |
| causing factor in a particular drug and helps eliminate | | | | elaborate enough to manage adverse drug event |
| that factor should be designed. Different | | | | reaction reporting effectively. |
| pharmaceutical firms use different Pharmacovigilance | | | | - Global reporting compliance: since drugs are generally |
| methods. The comprehensiveness of the system is | | | | marketed globally, the system should adhere to |
| very important in detecting the problem causing | | | | international adverse drug event reporting obligations. |
| element in the drug quickly and most precisely. | | | | - Streamlined case processing: Since adverse event |
| Over the past decade there has been a shift in the | | | | management involves a lot of data, an advanced |
| drug safety standards, driven by the regulatory | | | | workflow that is in sync with differing case |
| authorities. The policies on risk management and the | | | | processing and one that is complaint with the |
| standards of pre marketing and post marketing | | | | reporting of all major regulatory agencies is important. |
| techniques have been made stringent. This has | | | | Optimal risk management: Risk management should |
| created a need to constantly document every detail | | | | be at the core of the system. It should allow the |
| of manufacture, pre marketing and post marketing | | | | companies to monitor their products regularly and |
| aspects of each drug. It has become important for | | | | provide early identification of product risks. |