Pharmacovigilance is the practice of maximizing the safety and benefit of drugs and minimizing the risks and adverse effects. Pharmacovigilance techniques are employed during trials and afterward once a product is on the market to monitor any adverse events and side effects in order to protect the public. Effective pharmacovigilance is a legal requirement of any pharmaceutical company and the penalties for failing to implement good pharmacovigilance practice are severe.

When a pharmaceutical company is granted a license to release a drug onto the market, the license is granted on the back of several phases of clinical trials where the drug will have been tested firstly on healthy volunteers and then on patients suffering from the condition that the drug is designed to treat. In many cases the drug will have been tested for extensive periods of time on thousands of people the intention being that as many of the adverse effects of the drug will have been spotted during the clinical trials.

The licensing authorities have a balancing act - on the one hand medicines must be as safe as possible, on the other hand they need to make sure that diseases are treated. In order to help achieve this balance there are procedures in place to ensure safety once a drug is on the market. This may be necessary if there are unforeseen long-term consequences of using the medicine or if the medicine interacts in unusual or unexpected ways with other medicines or if the medicine turns out to be less suitable for use in certain populations than was previously suspected - for example in the elderly or infirm. Also very rare and potentially serious side-effects may only be spotted after the drug has been taken by a much larger number of people than could have been on the trials.

In order to almost guarantee finding a side effect that occurs in 1 in 10 patients, you have to give the drug to 30 patients just to be sure of finding that effect. In order to almost guarantee finding an adverse effect that is extremely rare and only affects 1 in 10,000 patients, you need to give it to 30,000 patients. No clinical trial would ever be that extensive and therefore pharmacovigilance is the way to detect these rarer events.

Pharmacovigilance is the science of drug safety, a combination of pharmacoepidemiology and pharmacology it provides the tools to help assess risk vs benefit, to detect signals in data that point to an adverse event and to help assess the significance of these signals. You can read more about it in other articles on here or at the site for the Pharmacovigilance Information Service.

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