A dverse D rug R eactions (ADRs) and reporting to The Yellow Card Scheme

1. Adverse Drug Reactions(ADRs) andreporting toThe Yellow Card Scheme Produced By: Christine Randall, CSM Mersey

2. 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

3. 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

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

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

6. Why are ADRs a problem?

7. 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

8. 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

9. 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

10. How do I recognise ADRs?

11. 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

12. Who is most at risk from ADRs? Patients who; • are young, or old or female • are taking multiple therapies • 50% of patients on5 drugs or more • have more than one medical problem • have a history of allergy or a previous reaction to drugs

13. 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!)

14. Listen to the patient!

15. 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

16. 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

17. What you might see if an ADR has occurred Clinical measurements • BP,  by opiates • weight,  by carbamzepine, increased appetite • blood glucose,  by corticosteroids

18. 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

19. 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

20. The Yellow Card SchemeCollecting information on ADRs

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

22. 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

23. 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

24. 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

25. 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!

26. Shouldn’t 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

27. 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 How is the information used?

28. 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

29. Who can report? • Doctors • Dentists • Coroners • Pharmacists • Nurses, midwives and health visitors from October 2002

30. 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

31. Do I have to be completely certain what I have seen is an ADR? NO The Yellow Card Scheme collects SUSPICIONS

32. What should I report on a Yellow Card? Allsuspected reactions for • herbal medicines • medicines used in children • black triangle drugs

33. 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

34. 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

35. Can I report ADRs for older drugs? YES, you should report All serioussuspected reactions for • established drugs • vaccines • intra uterine devices (IUDs) • dental and surgical materials • contact lens fluids • X-ray contrast media

36. 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

37. 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

38. If in doubt Fill a card out!

39. The Yellow Card

40. 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

41. 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

42. 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

43. Patient details Do not include the full name Weight (if known) Sex Use initials only Local identifying number (practice reference no., Hosp no.) Age at the time of the reaction

44. 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

45. 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 29/11/02 28/11/02  Do you consider the reaction serious? Reaction dates

46. Reporter details Your name, full address and phone number Your speciality e.g. midwife, practice nurse, asthma specialist nurse

47. 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

48. Additional information Please include test results if they have been performed. You may enclose separate sheets of results, please anonymise.

49. 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

50. Regional Monitoring Centres CSM Scotland CSM Northern and Yorkshire CSM Mersey CSM West Midlands CSM Wales