Adverse Drug Reactions (ADRs) and reporting to The Yellow Card Scheme

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Adverse Drug Reactions (ADRs) and reporting to
The Yellow Card Scheme

• Produced By Christine Randall, CSM Mersey

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What will the session cover?

• What ADRs are, why they are a problem and how to
  recognise them
• What the Yellow Card Scheme is
• What to report and how to fill in a Yellow Card

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What is an Adverse Drug Reaction (ADR)?

• an unwanted or harmful reaction experienced
  following the administration of a drug or
  combination of drugs under normal conditions of
  use and suspected to be related to the drug
• Ref. MCA/CSM Suspected adverse drug reaction
  (ADR) reporting and the Yellow Card Scheme,
  Guidance notes

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Examples of ADRs

• Common ADRs
• Constipation with opioids
• Sedation with antihistamines
• Nausea when starting fluoxetine
• Gastrointestinal upset with non steroidal
  anti-inflammatory drugs

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Examples of ADRs

• Uncommon but well recognised ADRs
• Achilles tendonitis caused by quinolone
  antibiotics
• Visual field defects with vigabatrin

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Why are ADRs a problem?
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Because.

• they account for around 5 of hospital admissions
• they cause death in 1 in 1000 medical inpatients
• they complicate drug therapy
• they decrease compliance and delay cure

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How common are ADRs?

• Up to 40 patients in the community experience
  ADRs
• In the UK Non Steroidal Anti-Inflammatory Drug
  (NSAID) use alone accounts for1
• 65,000 emergency admissions/year
• 12,000 ulcer bleeding episodes/year
• 2,000 deaths/year
• 1Blower et al. Emergency admissions for
  upper gastrointestinal disease and their relation
  to NSAID use. Aliment Pharmacol Ther 1997 11
  283-291

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Are ADRs avoidable?

• 30-50 are preventable
• Obvious interactions
• many drugs interact with warfarin
• Use of contra-indicated drugs
• use of a non-selective beta-blocker in an
  asthmatic ? bronchospasm
• Drug use in an inappropriate clinical indication
  or medically unnecessary
• antibiotics for a viral infection
• antibiotics for viral infections

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How do I recognise ADRs?
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Who might get an ADR?

• Anyone who takes a medicine
• Differential diagnosis should include the
  possibility of an ADR if the patient is taking
  any form of medication

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Who is most at risk from ADRs?

• Patients who
• are young, or old or female
• are taking multiple therapies
• 50 of patients on 5 drugs or more
• have more than one medical problem
• have a history of allergy or a previous reaction
  to drugs

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What should raise my suspicion of an ADR?

• A symptom that
• appears soon after a new drug is started
• appears after a dosage increase
• disappears when the drug is stopped
• reappears when a drug is restarted (do not
  deliberately rechallenge!)

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Listen to the patient!
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What questions should I be asking if I suspect an
ADR?

• Does the patient have a history of other
  drug-induced problems?
• ask the patient
• Does the patient take more than one drug ?
• could an interaction be causing the ADR?
• long term medication is unlikely to cause new
  problems

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What else ...?

• When did the reaction or symptoms begin?
• timings are useful
• Have any of the clinical measurements or lab
  results recently become abnormal?
• Does the patient have any medical problems?
• that could be causing the symptoms?
• some diseases predispose patients to ADRs

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What you might see if an ADR has occurred

• Clinical measurements
• BP, ? by opiates
• weight, ? by carbamzepine, increased appetite
• blood glucose, ? by corticosteroids

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What you might see if an ADR has occurred

• Lab results
• liver function tests, ? by statins and
  methotrexte
• full blood count, deranged by carbimazole
• biopsies, important for assessing liver
  dysfunction
• chest X-rays, pulmonary fibrosis with pergolide

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What conditions are often drug related?

• Anaphylaxis
• antibiotics, iron dextran injection
• Stevens Johnson Syndrome
• associated with carbamazepine, antibiotics
• Blood dyscrasias
• neutropenia with methotrexate and gold salts
• thrombocytopenia with heparin

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The Yellow Card SchemeCollecting information on
ADRs
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Yellow Card Scheme

• The thalidomide tragedy of the the early 1960s
  highlighted the need for drug safety monitoring
• In 1964 the Yellow Card Scheme was introduced
• Collects spontaneous reports of adverse drug
  reactions

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What are the aims of the Yellow Card Scheme?

• The aim of the Yellow Card Scheme is to improve
  patient safety by finding out as much as possible
  about adverse reactions by pooling health
  professionals experience and suspicions

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What are the aims of the Yellow Card Scheme?

• To use this information to
• Provide early warning of unrecognised ADRs
• Identify predisposing factors
• Compare drugs in the same therapeutic class
• Continuously monitor the safety of all drugs

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How many ADRs are reported?

• On average 18,000 reports per year
• over 400,000 reports since 1964
• 33,094 in 2000 due to the national Meningitis C
  vaccination campaign

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Are all ADRs reported?NO

• Only 2-4 of all ADRs are reported
• Only 10 of serious ADRs are reported

Never assume that someone else will report!
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Shouldnt ADRs be picked up before marketing?

• Only 1500 - 3000 patients receive a medicine
  before it is marketed
• Common adverse effects identified in clinical
  trials will be in the Summary of Product
  Characteristics (SPC)
• Unusual adverse effects occurring in only 1 in
  5,000 or 1 in 10,000 patients will not have been
  seen

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How is the information used?

• To improve patient safety by
• Amending the prescribing information in the SPC -
  dose, patient groups
• Current awareness bulletins
• Current Problems in Pharmacovigilance
• CSM Mersey ADR Newsletter
• Dear Health-care professional .. letters
• Drug withdrawal

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Have local reports changed practice?

• Pergolide
• fibrotic reactions highlighted, SPC special
  warnings and precautions strengthened
• High dose pancreatin
• large bowel stricture, additional warnings in SPC
  about use in children with cystic fibrosis
• Metipranolol
• withdrawal of high strength eye drops after 40
  reports of uveitis

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Who can report?

• Doctors
• Dentists
• Coroners
• Pharmacists
• Nurses, midwives and health visitors from October
  2002

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Nurse reportingWhy now?

• 1996-1998 - pilot in CSM Mersey region
• Meningitis C vaccination campaign in 2000 5957
  (18) reports from nurses
• Nurse reports were
• complementary to other HCPs
• equally good in quality and completeness
• gave very detailed descriptions of reactions

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Do I have to be completely certain what I
have seen is an ADR?
NO
The Yellow Card Scheme collects SUSPICIONS
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What should I report on a Yellow Card?

• All suspected reactions for
• herbal medicines
• medicines used in children
• black triangle ? drugs

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What does the ? black triangle mean?

• The Black Triangle ? indicates a medicine is
  being intensively monitored by the CSM
• They are assigned to
• new drugs
• new combinations of drugs
• novel routes or delivery systems for drugs
• significant new indications for drugs

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How do I know which products are Black Triangle
??

• Found against product entries in
• BNF,
• MIMS,
• SPC
• product literature
• The is a full list is on the MCA/CSM website

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Can I report ADRs for older drugs?

• YES, you should report All serious suspected
  reactions for
• established drugs
• vaccines
• intra uterine devices (IUDs)
• dental and surgical materials
• contact lens fluids
• X-ray contrast media

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What is a serious reaction?

• A reaction that
• is fatal
• is life threatening
• is disabling
• is incapacitating
• results in hospitalisation
• prolongs hospitalisation

More details about what a serious reaction is can
be found on the CSM website
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Do I report my suspected ADR?

• Is the patient a child yes
  report
• no
• Is the product herbal yes
  report
• no
• Is the drug a new ?drug yes
  report
• no
• Is the reaction serious yes
  report
• no
• On this occasion you do not need to report

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If in doubt Fill a card out!
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The Yellow Card
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Yellow Cards - Where can I find them?

• In the back of the following books,
• British National Formulary
• Nurse Practitioners Formulary
• Dental Practitioners Formulary
• MIMS
• ABPI Medicines Compendium

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Or..

• On the MCA/CSM and CSM Mersey websites
• Download a copy to complete and post
• Report electronically
• Telephone
• CSM Mersey on 0151 794 8206/8122 if you are in
  Cheshire and Merseyside Strategic HA
• the National Yellow Card Information Service on
  0800 731 6789 if you are outside Cheshire and
  Merseyside Strategic HA

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What information must I have to complete a Yellow
Card?

• Four critical pieces of information are needed,
• . Patient details (anonymised)
• . Suspect drug
• . Suspect reaction
• . Reporter details

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Patient details
Do not include the full name
Weight (if known)
Sex
Use initials only
Age at the time of the reaction
Local identifying number (practice reference
no., Hosp no.)
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Suspect drug
Date the drug started and stopped
Name of the medicine (include batch numbers for
vaccines)
Dose
Reason for use
Route of administration
NB. For an interaction please enter details of
both drugs
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Suspected reaction
Describe the reaction, signs, symptoms and
possible diagnosis, any treatment given?
Outcome, has the reaction finished or is it
resolving?
?
Haematemesis following intermittent dyspepsia
28/11/02
29/11/02
?
Do you consider the reaction serious?
Reaction dates
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Reporter details
Your name, full address and phone number
Your speciality e.g. midwife, practice nurse,
asthma specialist nurse
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Other drugs
List all drugs taken in the last 3 months
including herbal and OTC medicines
Please put NONE if the patient is taking no other
drugs
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Additional information
Please include test results if they have been
performed. You may enclose separate sheets of
results, please anonymise.
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Where do I send my completed Yellow Card?

• If you are
• in Cheshire and Merseyside Strategic Health
  Authority, send to CSM Mersey
• in another Regional Monitoring Centre area, send
  to your local centre
• outside these areas, the CSM in London

Addresses are on the final slide or can be found
in the BNF or on the CSM Mersey and MCA/CSM
websites
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Regional Monitoring Centres
CSM Scotland
CSM Northern and Yorkshire
CSM Mersey
CSM West Midlands
CSM Wales
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What happens after I have sent a Yellow Card?

• You will receive a copy of your card and a letter
  acknowledging your report and quoting its
  individual registration number, file these in the
  patients medical notes
• You may be contacted for further information in
  the future for e.g test results, outcome.

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CSM addresses
CSM Mersey Freepost Liverpool L3 3AB
CSM Wales Freepost Cardiff CF4 1ZZ
Medicines Control Agency CSM Freepost London SW8
5BR
CSM Northern and Yorkshire Freepost
1085 Newcastle upon Tyne NE1 1BR
CSM West Midlands Freepost SW2991 Birmingham B18
7BR
CSM Scotland CARDS Freepost Edinburgh EH3 9YW
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Useful web addresses

• CSM Mersey
• http//www.liv.ac.uk/druginfo/csm/
• MCA
• http//www.mca.gov.uk
• CSM
• http//www.mca.gov.uk/aboutagency/regframework/csm
  /csmhome.htm
• Guidance notes on suspected ADR reporting and the
  Yellow card Scheme
• http//www.mca.gov.uk/ourwork/monitorsafequalmed/y
  ellowcard/ycguidancenotes.pdf

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Remember!

• All health-care professionals have a
  responsibility to inform colleagues about
  clinically important adverse drug reactions that
  they detect, even if a well-recognised or causal
  link is uncertain.
• Edwards IR and Aronson JK. Adverse drug
  reactions definitions, diagnosis, and
  management. Lancet 2000 356 1255-59

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Do not assume someone else will report it!
If you suspect an ADR..
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CAN I MAKE A DIFFERENCE?

• YES !