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Yellow Card Reporting and what it means for Pharmacy Technicians

Yellow Card Centre West Midlands. Yellow Card Reporting and what it means for Pharmacy Technicians. Dr Anthony R Cox. Harms. Benefits. Regulation (EU) No 1235/2010 and Directive 2010/84/EU. ADR Definition Directive 2010/84/EU.

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Yellow Card Reporting and what it means for Pharmacy Technicians

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

  2. Harms Benefits

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

  4. 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.

  5. 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.”

  6. Admissions In-patients £637 million

  7. 1955 neurological reports passed to company, 1960 Company stated “non toxic” • 1961 withdrawn, 90,000 miscarriages, thousands deformed

  8. 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

  9. 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

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

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

  12. Time

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

  14. Technicians?

  15. “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

  16. Some ADRs are easy to spot…

  17. Where do reports come from

  18. F R A N C I S

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

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

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