Adverse Drug Reactions
Understanding Your Medication and Reporting Side-Effects
The number of adverse drug reactions reported to the Food and Drug Administration tripled between 1998 and 2005. When should you report medication side-effects and how?
An estimated 2 million adverse drug reactions occur each year as a result of taking prescription medications, according to a study in the Journal of the American Medical Association.
What is an adverse drug reaction?
An adverse drug reaction is an unwanted side-effect experienced as a suspected result of taking prescription medications. Most common side-effects are mild but in rare instances a prescribed drug can trigger a serious adverse drug reaction, resulting in hospitalisation, disability or death.
However it is important to keep things in perspective - all prescription medications go through rigorous testing prior to being made available to patients, and most side-effects are mild.
Is there anything I can do to reduce the likelihood of experiencing serious side-effects?
Read the patient information leaflet given with your medication. It is important to be aware of factors which may increase your risk of experiencing side-effects, such as alcohol consumption. Even herbal and complementary medicines can impact on your prescription medication.
Follow the advice of your health professional, ensuring you take the correct dosages at the correct time.
Staying informed is the best way to reduce unwanted side-effects. It is important to feel able to discuss your medication and any concerns with your health professional.
Questions you may want to ask:
- What does this medicine do?
- Why do I need to take it?
- Are there any other treatment options?
- How and when should I take it, and for how long?
- What are the possible side-effects and what should I do if I experience any?
- Where can I go for more information?
(Adapted from Ask About Medicines, a UK-based campaign aimed at increasing patient awareness about medicines and promoting better communication between patients and health professionals.)
How are medicines monitored?
Many side-effects are already known when a drug is licensed, but the limitations of early drug trials mean that rarer side-effects may remain undetected. Continual monitoring of a licensed medicine is therefore essential in order to ensure the drug's safety and efficacy.
Although drug companies are legally obliged to report any newly discovered or severe side-effects, much information is obtained through voluntary reporting by patients and health professionals.
But studies indicate that voluntary reporting levels remain low. One study estimated that 96% of adverse drug reactions go unreported. Doctors may be reluctant to report due to fear of reprisals, fear of legal action or for fear of being blamed. Some health professionals may not know how to report an incident, while others may simply not have the time.
How can I report serious side-effects?
Serious side-effects can be reported to MedWatch, the Food and Drug Administration's reporting programme. Patients are encouraged to ask their doctor for assistance with completing the reporting form, which can be downloaded from the MedWatch website, but an online version is also available for patients who wish to report independently.
In the UK, the Medicines and Healthcare products Regulatory Agency and Committee on Human Medicines jointly run the Yellow Card Scheme to allow voluntary reporting by patients and health professionals. Forms can be completed online or by contacting the Yellow Card hotline on 0808 100 3352.
