| Pharmacovigilance is the practice of maximizing the | | | | necessary if there are unforeseen long-term |
| safety and benefit of drugs and minimizing the risks | | | | consequences of using the medicine or if the |
| and adverse effects. Pharmacovigilance techniques | | | | medicine interacts in unusual or unexpected ways |
| are employed during trials and afterward once a | | | | with other medicines or if the medicine turns out to |
| product is on the market to monitor any adverse | | | | be less suitable for use in certain populations than |
| events and side effects in order to protect the | | | | was previously suspected - for example in the elderly |
| public. Effective pharmacovigilance is a legal | | | | or infirm. Also very rare and potentially serious |
| requirement of any pharmaceutical company and the | | | | side-effects may only be spotted after the drug has |
| penalties for failing to implement good | | | | been taken by a much larger number of people than |
| pharmacovigilance practice are severe. | | | | could have been on the trials. |
| When a pharmaceutical company is granted a license | | | | In order to almost guarantee finding a side effect |
| to release a drug onto the market, the license is | | | | that occurs in 1 in 10 patients, you have to give the |
| granted on the back of several phases of clinical trials | | | | drug to 30 patients just to be sure of finding that |
| where the drug will have been tested firstly on | | | | effect. In order to almost guarantee finding an |
| healthy volunteers and then on patients suffering | | | | adverse effect that is extremely rare and only |
| from the condition that the drug is designed to treat. | | | | affects 1 in 10,000 patients, you need to give it to |
| In many cases the drug will have been tested for | | | | 30,000 patients. No clinical trial would ever be that |
| extensive periods of time on thousands of people | | | | extensive and therefore pharmacovigilance is the |
| the intention being that as many of the adverse | | | | way to detect these rarer events. |
| effects of the drug will have been spotted during the | | | | Pharmacovigilance is the science of drug safety, a |
| clinical trials. | | | | combination of pharmacoepidemiology and |
| The licensing authorities have a balancing act - on the | | | | pharmacology it provides the tools to help assess risk |
| one hand medicines must be as safe as possible, on | | | | vs benefit, to detect signals in data that point to an |
| the other hand they need to make sure that | | | | adverse event and to help assess the significance of |
| diseases are treated. In order to help achieve this | | | | these signals. You can read more about it in other |
| balance there are procedures in place to ensure | | | | articles on here or at the site for the |
| safety once a drug is on the market. This may be | | | | Pharmacovigilance Information Service. |