Download Egyptian Pharmacovigilance Center (EPVC) Who should report

Who should report
Pharmacovigilance
What is Pharmacovigilance?
 Healthcare Professionals
 Nurses
 Patients & their relatives.
 Marketing authorization holder (MAH)
according to the WHO, Pharmacovigilance is the science What should be reported
and activities relating to the detection, assessment, If it is suspected that a patient has experienced an adverse
understanding and prevention of adverse effects or any drug reaction (ADR ) it should be reported using a Yellow
Card.
other medicine related problem.
 For new medicines report all the suspected reactions,
Importance of Pharmacovigilance
Pharmacovigilance provides Information about rare but including minor ones. (medicines are still considered
serious adverse reactions, chronic toxicity, use of drugs “new” up to five years after marketing authorization)
in special groups (such as children, the elderly or
 For established medicines or well-known medicines
pregnant women) or drug interactions This knowledge
report all serious or unusual unexpected suspected
can not be acquired from pre marketing phases as
adverse reactions.
Patients used in clinical trials are limited in number In
 Report all suspected ADRs associated with drug-drug,
addition to, limited duration of drug use.
drug food or drug-food supplements (including herbal and
complementary products) interactions.
Egyptian Pharmacovigilance Center
(EPVC) has been established in the Egyptian Drug  Report when suspected ADRs are associated with medicine
(EPVC)
Authority (EDA), Ministry of Health to be responsible for withdrawals.
the collection and evaluation of information on
 Report ADRs occurring from overdose or medication error.
pharmaceutical products marketed in Egypt with
particular concern to adverse reactions. EPVC is taking  Report ADRs in special fields of interest such as medicine
all appropriate measures to:
abuse and medicine use in pregnancy (teratogenicity) and
a) Encourage physicians and other healthcare during lactation.
professionals to report the suspected adverse reactions
 In children under the age of 18, all suspected ADRs
to EPVC and
occurring, should be reported regardless of whether the
b) Oblige marketing authorization holders to medicine is licensed for use in children.
systematically collect information on risks related to
their medical products and to transmit them to EPVC.
c) Provide information to end-users through adverse
drug reaction news bulletins, drug alerts and seminars.
How to recognize ADRs in patients??
ADRs are difficult and sometimes impossible to
distinguish from the disease being treated since they may
act through the same physiological and pathological
pathways. However, the following approach is helpful in
assessing possible drug-related ADRs:
 Ensure that the medicine ordered is the medicine
received and actually taken by the patient at the dose
advised.
 Take a proper history and do a proper examination of
patient
 Establish time relationships by answering the
following question: Did the ADR occur immediately
following the medicine administration?
Some reactions occur immediately after the medicine
has been given while others take time to develop. The
time from start of therapy to the time of onset of the
suspected reaction must be logical.
 Carry out a thorough physical examination with
appropriate laboratory investigations if necessary:
 Effect of Dechallenge and Rechallenge should be
determined.Dechallenge (withdrawal of the suspected
medicine):Positive dechallenge is the improvement of
ADR when the suspected medicine is withdrawn in a
strong, though not conclusive indication of medicinei
nduced reaction. Rechallenge (re-introducing the
suspected medicine after a dechallenge). Rechallenge
is only justifiable when the benefit of reintroducing the
suspected medicine to the patient overweighs the risk
of recurrence of the reaction, which is rare. In some
cases the reaction may be more severe on repeated
exposure. Rechallenge requires serious ethical
considerations.