Medicines Information

1. Medicines Information Useful sources Basic enquiry answering October 2017

2. Session aims • Increase awareness of what questions to ask an enquirer • Have practical experience using some resources which will be useful throughout the pre-registration year • Increase awareness of the Medicines Information (MI) services • UK • Wales

3. GPhC Registration Assessment Framework

4. Source of enquiries • GP/hospital doctor • Nurses – community/hospital • Pharmacy colleagues • Other healthcare professionals • Patient • Carer • Own knowledge/CPD

5. Query #1 • A GP rings and asks you: “Are steroids safe in pregnancy?” • What additional information may be required in order for you to answer the query (or for you to refer the query to MI for answering)?

6. Query #1 • Who is calling? • Name, designation, contact details etc. • Patient specific or general? • Prospective or retrospective? • At the end of the call, negotiate when you will provide an answer.

7. Query #1 • Retrospective: • Which steroid did she take? • What dose? Route? Indication? • At what stage of pregnancy was steroid taken? • try & get exact dates if possible • Taking anything else? • Purpose of call? • for reassurance or because something abnormal has been detected on a scan?

8. Query #1 • Prospective: • Stage of pregnancy (weeks) • What is being treated? • Severity of condition? • Which steroid? Dose? Frequency? Route? • What has been tried already? • Is pregnancy currently ‘healthy & normal’? • Any co-morbidities? • Any other drug therapy being taken?

9. Query #2 • A nurse calls you and asks: “Is fluoxetine safe to use in a breastfeeding mother who is depressed?” • What additional information may be required in order for you to answer the query (or for you to refer the query to MI for answering)?

10. Query #2 • Who is calling? • Name, designation, contact details etc. • Patient specific or general? • Prospective or retrospective? • At the end of the call, negotiate when you will provide an answer.

11. Query #2 • Prospective • Was baby born at term & is baby healthy & of normal weight for its age? • Has mum been treated for depression before e.g. while pregnant? If so with what & did it work? • Proposed dose of fluoxetine to be used? • Co-morbidities for mum? • Other drug therapy for either mum or baby? • Is prescriber open to suggestions of possible safer alternatives (if found)?

12. Query #2 • Retrospective: • Establish why nurse is ringing? • e.g. for reassurance, or is the baby showing signs or symptoms thought to be due to fluoxetine? • If so, further details as appropriate... • Was baby born at term & is baby healthy & of normal weight for its age? • Dose of fluoxetine used? • Co-morbidities for mum? • Other drug therapy for either mum or baby?

13. Query #3 • A GP calls you and asks: “Is their an interaction between clarithromycin and citalopram?”

14. Query #3 • Who is calling? • Name, designation, contact details etc. • Patient specific or general? • Prospective or retrospective? • At the end of the call, negotiate when you will provide an answer.

15. Query #3 • Prospective: • Is citalopram a ‘long-term’ therapy & clarithromycin being prescribed ‘new’? • Proposed doses, duration etc. • What infection is being treated? (Why clarithromycin?) • Other drug therapy being taken?

16. Query #3 • Retrospective: • Establish why is GP ringing? • e.g. following a query to the GP from a community pharmacist, or because a patient is exhibiting a new symptom etc.?

17. Enquiry for you... • Patient on the Medical Admissions Unit • admitted with GI bleed • Consultant suggests may be due to citalopram • Junior Dr wants more information on this AE • What further information do you need?

18. Further background information • Enquirer name & how to contact them? • Patient details? • (We know the query is retrospective) • What was the indication & the dose of citalopram? • When was it started/has the dose recently been increased? • Co-morbidities/risk factors? • Taking any other medication? • When is the answer needed?

19. So, the enquiry really is... • Mrs EW is an 83-year old lady who has been admitted to hospital with a GI bleed. The consultant has suggested her citalopram 40mg daily may be a possible cause (she has taken this for 2 months & takes no other regular medication) & has no risk factors for a GI bleed. No relevant PMH.. • The junior doctor (Dr Jones) is not familiar with this adverse effect of citalopram and requests additional information on this as a possible cause of the GI bleed.

20. Where to look for information

21. eMC • Access via www.medicines.org.uk/emc • SPCs and PILs • Only for products registered with the ABPI (members supply ~90% of UK medicines) • Free access – no login required • Useful links, e.g. X-PIL

22. BNF / BNFc • Access via www.medicinescomplete.com/mc • Apps also available to download • Same content and layout as books • Monthly updates

23. Medicines Complete • Access via www.medicinescomplete.com/mc • Subscription required • AHFS • Stockley’s Drug Interactions • Stockley’s Herbal Medicines Interactions • Handbook of Drug Administration via enteral feeding tubes • Trissel’s Handbook on Injectable Drugs • Herbal Medicines • Dietary Supplements

24. MicroMedex • Access via NHS Wales elibrary http://www.wales.nhs.uk/ehl • Basic access with NHS Athens password • Detailed drug monographs (including some complementary medicines) • Quick Answers/In-depth Answers • Martindale • Drug Interaction Checker • Trissel IV compatibility • Reprotox / TERIS / Shepard’s (MI only access)

25. SPS website • Medicines Use & Safety, Procurement, Quality Assurance, Technical Services & UKMi • Access via www.sps.nhs.uk • Fridge stability database • Drugs in lactation database • UKMi Q&As • Medicines compliance aid database

26. NICE Evidence Search • https://www.evidence.nhs.uk/ • Evidence on treatments, medicines and safety • Can search the latest key medicines and prescribing information in one place • Enter a term into the search bar • Use filters to narrow down search results • Register for email updates

27. Review our enquiry

28. Yellow Card Scheme • Run by the MHRA and Commission on Human Medicines • Introduced in 1964 after thalidomide tragedy • Spontaneous reports of suspected ADRs • Acts as an early warning system to identify ADRs and risk factors • Over 780,000 confidential reports received in UK www.yellowcardwales.org

29. Why report ADRs? • Important role in patient safety • Allows continual safety monitoring of drugs • old and new • New drugs – lack of experience on ADRs • exposure in ~1500 people only for short duration • unlikely to detect frequency <1/500 or long latency • lack of experience in special patient groups • elderly, children, pregnancy, >1 disease / drug • Detect rare adverse effects www.yellowcardwales.org

30. What to report? Report all suspected ADRs for: new drugs (marked ▼) – even if not serious • The black triangle  indicates a medicine is being intensively monitored. • It is assigned to :- • new drugs • new combinations of drugs • novel routes or delivery systems for drugs • significant new indications for drugs

31. What to report? Report all serious suspected adverse drug reactions to established drugs (adults and children) • Fatal • Life-threatening • Disabling or incapacitating • Result in or prolong hospitalisation • Congenital abnormalities • Medically significant

32. Completing a Yellow Card • Online www.yellowcard.mhra.gov.uk • simple and fast • drop-down menus • can register to save time in the future • can be saved part way through • App for use via tablets or smartphones • Paper • available in BNF, MIMs, ABPI • available from YCC Wales • download from MHRA website www.yellowcardwales.org

33. Examples of ADRs identified by Yellow Card Scheme • Domperidone – risk of cardiac SEs • use now restricted to N&V indication • limited duration • Mirabegron – risk of severe hypertension • Strontium ranelate – risk of cardiac SEs • C/I in those with cardiac problems • use restricted to severe osteoporosis, last resort • Risk of switching between branded and generic anti-epileptics www.yellowcardwales.org

34. Our enquiry • Should a yellow card be completed regarding our patient with the GI bleed?

35. Applying theory to practice • Complete a yellow card and submit to MHRA OR • Document a basic enquiry (e.g. adverse effects/drug interactions/drug dosing in renal impairment) • Bring a copy of the yellow card/enquiry to next WCPPE MI session and be prepared to discuss it

36. Medicines Information Service • A service that • supports the safe, effective and efficient use of medicines by the provision of evidence-based information and advice on their therapeutic use • UKMi • Local centres • Regional centres • Specialist centres • Virtual national network

37. UKMi Wales

38. Who uses MI services in Wales? • Total enquiries taken in 2016 = 4,585

39. What do they ask? • Total enquiries taken in 2016 = 4,585

40. Thank you for listening

41. Reflective learning • In your own time, consider the following points: • What have I learnt today? • What do I need clarification on? • How am I going to go about clarifying that?