I work for a pharmaceutical firm that provides various services for drug regulation including clinical data management, pharmacovigilance system and adverse event reporting system.
Medical science has grown in leaps and bounds since the days of Hippocrates. Modern day pharmaceutical drugs are really life-savers. They have increased life expectancy and improved the quality of life for millions of people. But there is the other side of the coin as well. These drugs sometimes have very adverse effects that can even be life-threatening. The drug Vioxx is a case in point.
What is pharmacovigilance?
There is a need to monitor the effects of drugs before and after it’s successfully tested and launched in the market. Pharmacovigilance involves monitoring and assessing the quality of drugs; detecting and preventing any adverse effects of drugs. Pharmacovigilance involves evaluating information provided by healthcare providers, pharmaceutical companies and patients in order to understand the risks and benefits involved with a particular drug.
What is the role of pharmacovigilance?
The goal of pharmacovigilance is to:
- Monitor the quality of drugs
- Identify the health risks involved in the administration of certain drugs
- Prevent harm to patients
- Research the efficacy of drugs
How does pharmacovigilance help the public?
Pharmacovigilance helps save thousands of lives each year. By monitoring the adverse effects of drugs right from the lab to the pharmacy and then on for many years, pharmacovigilance keeps track of any drastic effects of drugs. This way, it prevents harm to patients using those drugs.
How does pharmacovigilance help drug manufacturers?
Pharmaceutical companies spend millions of dollars and a considerably long-time in developing new drugs. They again spend a lot of money in conducting clinical trials before the drugs are approved and launched in the market. But after all this, if there are adverse effects to the drugs, the company again loses millions of dollars in sales and litigations. Furthermore, the reputation of the company is also severely damaged. Pharmacovigilance monitors the development of the drug across various stages and assesses its effectiveness after its launch for many years. This way it may reduce the adverse risk from drugs, thereby aiding the drug manufacturers.
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