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WELCOME

WELCOME. Sunday 9 June 2013. Yellow Card Reporting & What it means for Pharmacy Technicians. Anthony R Cox, Lecturer in Clinical Pharmacy, University of Birmingham and Pharmacovigilance Pharmacist, Yellow Card Centre, West Midlands. Yellow Card Centre West Midlands.

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WELCOME

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  1. WELCOME Sunday 9 June 2013

  2. Yellow Card Reporting & What it means for Pharmacy Technicians Anthony R Cox, Lecturer in Clinical Pharmacy, University of Birmingham and Pharmacovigilance Pharmacist, Yellow Card Centre, West Midlands

  3. Yellow Card Centre West Midlands Yellow Card Reporting and what it means for Pharmacy Technicians Dr Anthony R Cox

  4. Harms Benefits

  5. Regulation (EU) No 1235/2010 and Directive 2010/84/EU

  6. ADR DefinitionDirective 2010/84/EU A response to a medicinal product which is noxious and unintended and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease or for the restoration, correction, or modification of physiological function.

  7. Directive 2010/84/EU New to ADR definition: “not only from the authorised use of a medicinal product at normal doses, but also from medication errors and uses outside of the marketing authorisation, including misuse and abuse of the medicinal product.”

  8. Admissions In-patients £637 million

  9. 1955 neurological reports passed to company, 1960 Company stated “non toxic” • 1961 withdrawn, 90,000 miscarriages, thousands deformed

  10. Lessons • Need for adequate testing • Need for regulation • Need for pharmacovigilance systems (spontaneous reporting) • Avoidance of unnecessary use of drugs in pregnancy • Some risks cannot be minimised

  11. The Black Symbol – article 23 • list of medicinal products that are subject to additional monitoring • All medicines with a new active substance and all biologicals • Medicines which require further information after authorisation • Medicines subject to conditions or restrictions on safe and effective use

  12. Black Symbol (Triangle) “This medicinal product is subject to additional monitoring"

  13. The mean number of people in phase three trials for an NSAID in Europe, in 1994, was 2128 patients. Homma. Drug Inj J 1994

  14. Time

  15. Patient Reporting • Different types of reports • New signals

  16. Technicians?

  17. “Pharmacists lack the knowledge of clinical medicine necessary to recognise adverse drug reactions. However, their knowledge of pharmacology and toxicology should ensure a role for them in the prediction and prevention of adverse drug reactions” 1986

  18. Some ADRs are easy to spot…

  19. Where do reports come from

  20. F R A N C I S

  21. Pharmacy should be the main source of Yellow Card Reports. What is stopping us?

  22. Email: a.r.cox@bham.ac.uk

  23. Poster prize awards Supported by

  24. Parallel Workshops Session E Please go to the designated rooms

  25. WELCOMEBACK

  26. Please switch off your mobile phones

  27. My role as a Pharmacy Technician Specialist in Homecare Diane Meech, Pharmacy Technician Specialist- Homecare & High Cost Drugs, Ealing Hospital NHS Trust

  28. My Role in Homecare Diane Meech Pharmacy Technician Specialist Homecare and High Cost Drugs

  29. Homecare Aim to support patients with chronic and acute illness in the community Definition A homecare medicine service delivers ongoing medicine supplies, and where necessary, associated care initiated by hospital prescriber direct to the patients home with the patients consent.

  30. Background • Market: £1.5 billion + • Growth: 23% per annum • Number of homecare providers: 15+ • Often high cost meds / excluded from PbR • Low tech: tablets and capsules via post or courier • Medium tech: injections self administered or with nursing training, cold chain delivery • High tech: aseptic preparation, nurse administration and monitoring

  31. PAST (2004 to 2011) • <10 patients increasing to >500 patients, • 1 drug increasing to 5 drugs/specialities: rheumatology, dermatology, gastroenterology, growth, oncology, HIV • Prescription management by band 7/8 pharmacist • Prescriptions on standard outpatient scripts • Some service level agreements place • Service levels not monitored • By 2010, purchase orders sent with scripts and use of spreadsheets to track approvals, orders & deliveries

  32. PRESENT (2012 to 2013) • Fulltime Pharmacy Technician Specialist post • Homecare company prescription templates in use • All repeat scripts reviewed for compliance with NICE where applicable • Liaison with clinical nurse specialists • Service level agreements reviewed • Development of IG data security agreement template • Standard operating procedures in place • Medication incidents reported via Datix

  33. MARK HACKETT REPORT A review of the homecare medicines supply and associated services in England to establish what are the current challenges and issues and what should occur in the future.

  34. Recommendations forChief pharmacists • Set a strategy for homecare medicines • Work with clinical directors to agree patient cohorts and set realistic demand projections • Ensure development of shared governance • Ensure effective operational control of procurement, ordering and invoicing • Implement changes to enable direct inter-change with trusts finance system for ordering, invoicing and patient tracking • Review services with Medicine & Nurse providers

  35. 2013 and the future • Develop 3 year strategy • Set up Trust wide homecare group • Agree strategy • Homecare policy and framework • Develop robust governance framework • All service level agreements reviewed and updated • Implementation of new therapies onto homecare, Hep B, new biologics • Development of IT system & upgrade of Ascribe • Complete patient audits & develop patient charter

  36. 3 year strategy • Where are we now? • Form trust homecare group • Priority – implement Hackett report recommendations • Identify strengths, weaknesses, opportunities and threats! • Our vision for homecare and implementation of new services - the next 3 years!

  37. Homecare policy and framework • Responsibilities of prescribers, nurses, chief pharmacist, pharmacy support team • Homecare governance – clinical /information • Monitoring of arrangements & annual report • Patient involvement and charter • Implementation template for new services

  38. Develop robust governance framework • Compliance with all relevant regulatory conditions as would be required by Care Quality Commission for an Acute Trust • Set service standards – monitor by KPIs • Training & development of staff to secure standards • Reporting of complaints, incidents, service failures, medicine compliance • Effectiveness of the service to the patient

  39. Service level agreements • Patient access scheme/Pharma agreement • Delivery and Service • Product Prescribing and Dispensing • Equipment , refrigeration, ancillaries • Training and Education of staff/ patients • Nursing Services • Key performance indicators • Complaints and adverse incidents

  40. Implementation of new services • Identify drugs & patient no.s (current /future) • Risk assessment – financial /health & safety • Obtain agreement from consultants, CCG, trust drugs and therapeutics group • Check if regional contract in place if not negotiate trust tender (complex) • Patient access schemes & Pharma agreements • Agree service level agreement • Develop inclusion criteria to recruit suitable patients

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