PILLS - Adverse drug reactions

How do you report adverse drug reactions?

The main method of post-marketing surveillance in the UK is the Yellow Card Scheme which was started in 1964 (post thalidomide). Reports are accepted from doctors, dentists, coroners, industry, pharmacists, nurses, midwives and health visitors. Recent additions include radiographers, optometrists and patients. The MHRA website useful guidance on the Yellow Card Scheme MRHA: The Yellow Card Scheme

The Yellow Card Scheme has had a major impact on the labelling, warnings and availability of drugs following investigation of reports of suspected ADRs. Drugs can be withdrawn although this is more often as a result of the pharmaceutical company removing the drug from the market voluntarily.

A suspected ADR

Go on to the MHRA website and locate the Yellow Card reporting page. Identify the steps you need to go though in order to report a suspected ADR. The process of reporting is said to be very simple. Was it? What information did it ask you for and how easy was it to obtain that information prior to completing the form? Can you think of any improvements that could be made to encourage you to complete and send in a report?

Reporting ADRs
There are no correct answers here as this is your response to the process. The following paragraphs are intended to show how you would proceed.
No right or wrong answer, it’s your response to the process. The process for reporting an ADR The process should be simple if it to encourage more reports. If you have a BNF there is a form at the back but it is simpler to complete one online at http://yellowcard.mhra.gov.uk/ you need to register once. Think about a patient who has come in complaining of new symptoms following the prescription you gave of a newly marketed drug. After questioning you suspect that this is an adverse reaction to the drug and are considering reporting it. What should you do?
Firstly you do not have to prove causality; a suspicion is all that is necessary particularly for a new drug. If the drug has an inverted triangle next to it in the BNF which shows it is new and under particular surveillance you should report any suspected ADR. It doesn’t matter how inconsequential you think the effect actually is as this is helps build up a post marketing picture of the new drug. Secondly, report any serious adverse drug reaction however established the drug is or for however long it has been on the market. The reason the MHRA continue to request reports for established drugs is they may highlight previously unrecognised effects. For example, Reye's syndrome was associated with aspirin eight decades after it was first marketed. Sending the report may allow advice to be given on risk factors for patients such as age or concurrent disease; or how medicines can be used more safely.
It cannot be stressed enough how important completing the Yellow Card Scheme forms can be. Not everyone who is made aware of an adverse reaction to a drug reports it. Why do you think this is? Some suggestions for this are; complacency – a belief that only ‘safe drugs’ get on the market; a fear that you will be involved in litigation; guilt at prescribing the drug that caused the patient discomfort or harm; ambition to collect a series of cases before reporting; ignorance of how/what to report; fear of reporting a mere suspicion; lethargy – lack of interest or time. Make sure this isn’t you.