Role of Pharmacovigilance Signal Detection
Role of Pharmacovigilance Signal Detection in Ensuring Drug Safety
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 or IDMP. 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 services 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.
The world of medicines and drugs can indeed be quite interesting and exciting with new life saving and other drugs being invented by science. While this can be life saving and disease annihilating, there is also the possibility of many side effects resulting on account of the consumption of these drugs. There have been many instances of loss of life as well as severe complications due to patients being administered drugs that have reacted with their systems and caused many after effects. It is with a view to analyzing these effects that drug safety pharmacovigilance has been brought into effect as a field of medico-scientific enquiry.
The specific emphasis in medical writing services is studying the short term, medium term and long term after effects of various drugs. Drug safety is of great concern to doctors, patients and their families as well as the whole medical community and even the government. Nothing can be as devastating as a drug disaster and in the US, the Food and Drug Administration (FDA) takes great pains to ensure that improper drugs are not released into the market. Clinical trials of drugs are generally limited and restricted in their scope as testing involves only a few thousand human beings. That's the reason why even very severe adverse drug reactions like liver damage are often not noticed because the study populations are small. Post marketing pharmacovigilance makes use of tools like gathering data and investigation of case reports to recognize the association between drugs and their adverse drug reactions.