Reporting a Human Medicine Side Effect
Most of us will not experience any problems when using medicines. However, while medicines provide many health benefits, all medicines have some risks associated with their use and so a small number of people may develop side effects (also known as adverse reactions).
What is a side effect?
A side effect or adverse reaction is an unwanted or unintentional reaction that a person may experience after taking a medicine. In many cases, side effects to medicines are mild and do not mean that you have to stop taking the medicine. However, for some people, the side effects can sometimes be more serious and may require a change in treatment or, in rare cases, some additional medical treatment.
What should I do if I think I have had a side effect?
If you are concerned that you have had a side effect to a medicine, contact your doctor or pharmacist who will advise on any treatment you may need. They may also report the suspected side effect to the Irish Medicines Board (IMB).
Should you wish, you can also report side effects directly to the IMB. While a report of a side effect does not necessarily mean that it is has been caused by the medicine you took, the IMB encourages people to report all suspected side effects.
How do I report a side effect?
You can report a suspected side effect in a number of ways:
1. To your doctor, pharmacist or nurse who can then notify the IMB.
2. By using the IMB’s online form. A downloadable version of the form is also available, which can be filled in manually and sent to the IMB by freepost.
3. By calling the IMB on (01) 676 4971
Why is it important for me to report side effects?
As highly regulated healthcare products, medicines are authorised (i.e. licensed) only when it is considered that the product is of high quality and that the benefits outweigh the risks. Once a product is authorised and placed on the market, the monitoring of benefits and risks continues throughout the usage of the product through a system known as pharmacovigilance.
Pharmacovigilance is important because the tests and studies conducted before a medicine is first approved for use are mainly designed to show that the medicine works for the condition it is intended to treat and is safe to take. However, these studies are generally not carried out for a sufficiently long period of time, or in enough people, to identify all of a medicine's potential risks, which can only be detected when the medicine is used across wider groups of people and over prolonged periods of time. Reporting of suspected adverse reactions (unwanted side effects) to medicines is a very important aspect of pharmacovigilance.
The IMB has published a medicines and side effects consumer information leaflet. This leaflet provides more information about side effects and why it is important that they are reported to the IMB.
Information for Patients on Safety Monitoring of Medicines
This document explains the updated legislation for monitoring the safety of medicines (Pharmacovigilance) which came into effect in Ireland and across the EU in July 2012 and the impact of this legislation for patients and consumers. A key aspect of the new legislation is the important role of patients and consumers in contributing to the strengthened system of pharmacovigilance. This document explains the changes to the reporting of side effects (also known as adverse reactions) and the steps a patient or consumer can take to report them.