Pharmacovigilance, the MHRA and Yellow Cards

1. Pharmacovigilance, the MHRA and Yellow Cards http://yellowcard.mhra.gov.uk Aileen McKennaSenior Clinical Pharmacist

2. 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

3. How many patients with suspected ADRs have you seen in the last month? None 1-5 6-10 11-15 More than 15

4. How many of the ADRs would you class as serious? None 1-5 6-10 11-15 More than 15

5. How many were recorded in the patient’s notes or drug chart? None 1-5 6-10 11-15 More than 15

6. How many of these did you report on a Yellow Card? None 1-5 6-10 11-15 More than 15

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

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

9. 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 • Patient’s initials, age or sex • Your name and address

10. 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

11. Where can they be found and completed? In the back of every BNF Online at http://yellowcard.mhra.gov.uk OR

12. 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

13. 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

14. 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 • 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)

15. MHRA recommendations since 2008

16. 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

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

18. CPD modules

19. http://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/Pharmacovigilancelearningmodule/pharmacovigilancelearningmodule/index.htmhttp://www.mhra.gov.uk/ConferencesLearningCentre/LearningCentre/Medicineslearningmodules/Pharmacovigilancelearningmodule/pharmacovigilancelearningmodule/index.htm

20. 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

21. Quiz time!

22. Which one of the following must be reported on a yellow card? • Skin reaction from betamethasone 0.0025% cream leading to a switch in treatment • Constipation with morphine sulphate, treated by the GP with lactulose and senna • Drowsiness with chlorphenamine tablets, used PRN to treat hayfever • GI bleed with aspirin requiring hospital admission and treated with IV omeprazole

23. Which one of the following must be reported on a yellow card? • Skin reaction from betamethasone 0.0025% cream leading to a switch in treatment • Constipation with morphine sulphate, treated by the GP with lactulose and senna • Drowsiness with chlorphenamine tablets, used PRN to treat hayfever • GI bleed with aspirin requiring hospital admission and treatment with IV omeprazole

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

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

26. 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.

27. 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.