Yellow Card Reporting and what it means for Pharmacy Technicians
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Yellow Card Reporting and what it means for Pharmacy Technicians Dr Anthony R Cox Yellow Card Centre West Midlands
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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. - PowerPoint PPT Presentation
Transcript of Yellow Card Reporting and what it means for Pharmacy Technicians
Yellow Card Reporting and what it means for Pharmacy Technicians
Dr Anthony R CoxYellow Card CentreWest Midlands
BenefitsBenefits
Regulation (E
U) No 1235/2010
and Dire
ctive 2010/84/EU
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.
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.”
£637 milli
onAdmissions In-patients
1955 neurological reports passed to company, 1960 Company stated “non toxic”
1961 withdrawn, 90,000 miscarriages, thousands deformed
LessonsNeed for adequate testingNeed for regulationNeed for pharmacovigilance systems
(spontaneous reporting)Avoidance of unnecessary use of drugs
in pregnancySome risks cannot be minimised
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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
Black Symbol (Triangle)
“This medicinal product is subject to additional monitoring"
The mean number of people in phase three trials for an NSAID in Europe, in 1994,
was 2128 patients.
Homma. Drug Inj J 1994
Tim
e
Patient Reporting
•Different types of reports
•New signals
“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
Some ADRs are easy to spot…
Where do reports come from
FRANCIS
Pharmacy should be the main source of Yellow Card Reports.
What is stopping us?
Email: [email protected]
