Pharmacovigilance, the MHRA and Yellow Cards Aileen McKenna Senior Clinical Pharmacist

to enhance and safeguard the health of the public by ensuring that medicines and medical devices work, and are acceptably safe. Role of the

CSD established 1963 Yellow cards introduced 1964 CSD became CSM Black triangle scheme introduced A little of the history

1.None More than 15 How many patients with suspected ADRs have you seen in the last month?

1.None More than 15 How many of the ADRs would you class as serious?

1.None More than 15 How many were recorded in the patients notes or drug chart?

1.None More than 15 How many of these did you report on a Yellow Card?

Used to report adverse effects (or suspected adverse effects) to drugs Yellow Cards

Any healthcare professional A doctor A nurse A pharmacist Any patient Who can fill in a Yellow Card?

Any information you can The more information the better As a minimum: The ADR and the suspected medicine Patient s initials, age or sex Your name and address What information should be given on a report?

Remember to get more than the minimum! Take a full and complete drug history Not just a list of the drugs Take a full and complete reaction history When it started, when it ended, lasting effects etc If possible, get batch numbers of medication especially for biologics and vaccines What to do if you suspect a patient has had a side effect

Where can they be found and completed? Online at In the back of every BNF OR

As soon as you can! Any time the reaction is significant/serious E.g. results in hospital admission, prolongs admission, Is fatal or life threatening. Where the drug is new and still closely monitored by the MHRA ( drugs) drugs For ANY drug – licensed, unlicensed, herbal, vaccines, and off-label For ANY reaction in a child to any medicine When should you fill one in?

Around 6.5% of hospital admissions are ADR related Costs the NHS around £466 million per year More than that – it can cost lives. But less than 10% are reported Revalidation The MHRA website keeps all your Yellow Cards on file Competencies Why bother?

You get a report on what you have filled in You may be asked for further information Continually analysed by the MHRA It s published in the form of Drug Safety Updates Drug Analysis Prints Safety Reports Alerts May result in withdrawal from the market (e.g. rosiglitazone), restrictions on use (e.g. thalidomide) and increased awareness of similar drugs (e.g. COX 2 inhibitors) So, what happens to the information?

MHRA recommendations since 2008

Drug Analysis Prints Available for every licensed drug on the market Includes every report of side effects Total number of reports How long those reports have been gathered over

Published monthly with updated safety data Warnings and precautions for use Can sign up for alerts and s Drug Safety Updates

CPD modules

edicineslearningmodules/Pharmacovigilancelearningmodule/pharmacovi gilancelearningmodule/index.htm edicineslearningmodules/Pharmacovigilancelearningmodule/pharmacovi gilancelearningmodule/index.htm

Other resources that might be useful On MHRA.gov.uk Others Safeprescriber.org (SCRIPT) – Under Managing the Risks of prescribing then Adverse Drug Reactions Safeprescriber.org Drug Safety Research Unit - module/index.php module/index.php European Medicines Agency -

Quiz time!

1.Skin reaction from betamethasone % cream leading to a switch in treatment 2.Constipation with morphine sulphate, treated by the GP with lactulose and senna 3.Drowsiness with chlorphenamine tablets, used PRN to treat hayfever 4.GI bleed with aspirin requiring hospital admission and treated with IV omeprazole Which one of the following must be reported on a yellow card?

1.Skin reaction from betamethasone % cream leading to a switch in treatment 2.Constipation with morphine sulphate, treated by the GP with lactulose and senna 3.Drowsiness with chlorphenamine tablets, used PRN to treat hayfever 4.GI bleed with aspirin requiring hospital admission and treatment with IV omeprazole Which one of the following must be reported on a yellow card?

1.Facial flushing in a 36 year old patient taking amlodipine for hypertension 2.Flu-like symptoms in a 78 year old patient after annual flu vaccination 3.Indigestion in a 56 year old patient taking alendronate for osteoporosis requiring a change in therapy. 4.Oral candidiasis in an 18 year old patient using a Seretide evohaler for asthma Which one of the following must be reported on a yellow card?

1.Facial flushing in a 36 year old patient taking amlodipine for hypertension 2.Flu-like symptoms in a 78 year old patient after annual flu vaccination 3.Indigestion in a 56 year old patient taking alendronate for osteoporosis requiring a change in therapy. 4.Oral candidiasis in an 18 year old patient using a Seretide evohaler for asthma Which one of the following must be reported on a yellow card?

1. The suspected side effect(s). 2. The patient s initials, sex, or age at the time of the side effect. 3. The name of the medicine(s) thought to have caused the side effect(s). 4. The batch number(s) of the medicine(s) thought to have caused the side effect(s). 5. The reporter s name and address. What information is not essential on a yellow card?

1. The suspected side effect(s). 2. The patient s initials, sex, or age at the time of the side effect. 3. The name of the medicine(s) thought to have caused the side effect(s). 4. The batch number(s) of the medicine(s) thought to have caused the side effect(s). 5. The reporter s name and address. What information is not essential on a yellow card?