Directive 2010/84/EU - Association of Pharmacy Technicians, UK

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Yellow Card Reporting
and what it means for
Pharmacy Technicians
Dr Anthony R Cox
Yellow Card Centre
West Midlands
Benefits
ADR Definition
Directive 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.”
Admissions
In-patients
 1955
neurological reports passed to
company, 1960 Company stated “non
toxic”
 1961 withdrawn, 90,000 miscarriages,
thousands deformed
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
1
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
.
Time
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
F
R
A
N
C
I
S
100
90
ADR reports per 100,000
admissions
80
70
60
50
40
30
20
10
0
A
B
C
D
E
F
G
H
I
J
K
L
M
NHS Acute Trust
N
O
Pharmacy should be the main
source of Yellow Card Reports.
What is stopping us?
Email: [email protected]
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