Pharmacovigilance, the MHRA and Yellow Cards

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Pharmacovigilance, the MHRA and Yellow Cards

• http//yellowcard.mhra.gov.uk
• Aileen McKennaSenior Clinical Pharmacist

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Role of the

• 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
  

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A little of the history

• CSD established 1963
• Yellow cards introduced 1964
• CSD became CSM 1970
• 1976 Black triangle scheme introduced

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How many patients with suspected ADRs have you
seen in the last month?

1. None
2. 1-5
3. 6-10
4. 11-15
5. More than 15

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How many of the ADRs would you class as serious?

• None
• 1-5
• 6-10
• 11-15
• More than 15

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How many were recorded in the patients notes or
drug chart?

• None
• 1-5
• 6-10
• 11-15
• More than 15

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How many of these did you report on a Yellow Card?

• None
• 1-5
• 6-10
• 11-15
• More than 15

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Yellow Cards

• Used to report adverse effects (or suspected
  adverse effects) to drugs

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Who can fill in a Yellow Card?

• Any healthcare professional
• A doctor
• A nurse
• A pharmacist
• Any patient

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What information should be given on a report?

• Any information you can
• The more information the better
• As a minimum
• The ADR and the suspected medicine
• Patients initials, age or sex
• Your name and address

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What to do if you suspect a patient has had a
side effect

• 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

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Where can they be found and completed?
In the back of every BNF
Online at http//yellowcard.mhra.gov.uk
OR
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When should you fill one in?

• 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)
• For ANY drug licensed, unlicensed, herbal,
  vaccines, and off-label
• For ANY reaction in a child to any medicine

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Why bother?

• 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

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So, what happens to the information?

• You get a report on what you have filled in
• You may be asked for further information
• Continually analysed by the MHRA
• Its 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)

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• MHRA recommendations since 2008

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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

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Drug Safety Updates

• Published monthly with updated safety data
• Warnings and precautions for use
• Can sign up for alerts and emails

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CPD modules
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• http//www.mhra.gov.uk/ConferencesLearningCentre/L
  earningCentre/Medicineslearningmodules/Pharmacovig
  ilancelearningmodule/pharmacovigilancelearningmodu
  le/index.htm

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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/le
  arningmodule/index.php
• European Medicines Agency - http//www.ema.europa.
  eu

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Quiz time!
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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 treated with IV omeprazole

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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

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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

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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

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What information is not essential on a yellow
card?

• 1. The suspected side effect(s).
• 2. The patients 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 reporters name and address.

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What information is not essential on a yellow
card?

• 1. The suspected side effect(s).
• 2. The patients 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 reporters name and address.

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