Pharmacovigilance, the MHRA and Yellow Cards

http://yellowcard.mhra.gov.uk

Aileen McKennaSenior Clinical Pharmacist

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

http://www.mhra.gov.uk/Aboutus/Whoweare/index.htm

Role of the

1. None2. 1-53. 6-104. 11-155. More than 15

How many patients with suspected ADRs have you seen

in the last month?

1. None2. 1-53. 6-104. 11-155. More than 15

How many of the ADRs would you class as serious?

1. None2. 1-53. 6-104. 11-155. More than 15

How many were recorded in the patient’s notes or drug

chart?

1. None2. 1-53. 6-104. 11-155. 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 http://yellowcard.mhra.gov.uk

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 ( rus)

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 emails

Drug Safety Updates

CPD modules

http://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/Pharmacovigilancelearningmodule/pharmacovigilancelearningmodule/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’

Drug Safety Research Unit - http://www.dsru.org/learningmodule/index.php

European Medicines Agency - http://www.ema.europa.eu

Quiz time!

1. Skin reaction from betamethasone 0.0025% 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 0.0025% 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?