Egypt Pharmacovigilance, describing the pharmacovigilance system in Egypt. How it works, challenges they face and prposed solutions to overcome the bottle necks.

1. Pharmacovigilance

2. Adverse drug reactions(ADR)
• ADR is defined as any harm associated with the
use of given drugs at a normal dosage during
normal use.
• ADRs may occur following a single dose or
prolonged administration of a drug or result
from the combination of two or more drugs.
• The meaning of ADR differs from the meaning of
"side effect ", as side effects might also imply
that the effects can be beneficial.

3. Possible causes of ADRS
1. Intrinsic
Idiosyncrasy Mutagenicity
Carcinogenicity Teratogenicity
2. Extrinsic
Adulterations, contamination
3. Underlying medical conditions
4. Interactions
5. Wrong use

4. Serious and severe
Serious ADR: when it meets one of the following
criteria:
1. Results in death
2. Life-threatening
3. Requires inpatient hospitalization or prolongation of
hospitalization
4. Results in disability - or permanent change, impairment,
damage or disruption in the patient's body
function/structure, physical activities or quality of life
5. Results in congenital abnormalities
6. Requires intervention to prevent permanent damage
Severity: intensity of the adverse effect

5. Economic impact of ADRs
• The cost to the country of ADRs
may exceed the cost of the
medications themselves
• 30-60 % of ADRs may be
preventable

6. Before drugs become available to the
patients, they are subjected to rigorous
clinical studies.
However, some adverse drug reactions
(ADRs) are often detected ONLY after
marketing.
Pre-
clinical
Research
Post-
marketing
Surveillance
in real life
patients

7. Limitations of clinical trials
1. Number of patients is limited: ~ 5000
2. Narrow population: Specific age and
sex
3. Narrow indications: only those having
the specific disease studied
4. Short duration: often no longer than a
few weeks

8. Pharmaco - Vigilance
Pharmaco (Greek): drug
Vigilance (Latin):
–to keep awake or alert
–to keep watch
–the process of paying close and
continuous attention

9. Definition of Pharmacovigilance
PV is the science and activities dealing
with the detection, assessment,
understanding and prevention of
adverse effects of drugs.
It has been widened to include biological
products, herbals, traditional and
complementary medicines.

10. Why do we need
pharmacovigilance?
Reason 1: Insufficient evidence of safety
–Animal experiments
–Clinical trials prior to marketing
Reason 2: Dying from a disease may be
inevitable, dying from a medicine is
unacceptable
Reason 3: ADR are expensive

11. Aims of pharmacovigilance
1. Identify previously unrecognized adverse
effects or changes in the patterns of adverse
effects
2. Assess the risks and benefits of medicines in
order to determine what action, if any, is
necessary to improve their safe use
3. Provide information to healthcare
professionals and patients to optimize safe
and effective use of medicines

12. – Thus, the ultimate purpose of ADR
reporting and monitoring is to reduce risks
associated with drug prescribing and
administration
– Improve patient care and patient safety
– Communication with international
institutions working in pharmacovigilance

13. A lesson from history
1959 – 1961 thalidomide 4,000 - 10, 000 cases of
phocomelia (congenital limb defects)
This lead to withdrawal of the drug from the market

14. Pharmacovigilance is
gaining importance as
the number of stories
of drug recalls
increases

15. Actions taken from the PV findings
include
1. Restriction in use
2. Changes in the specified dose of the medicine
3. Introduction of specific warnings in the
product information
4. Changing the legal status of a medicine, e.g.,
from over-the-counter to prescription only
5. Product recall: In rare cases, removal of the
medicine from the market, if the risks of a
medicine are found to outweigh the benefits

16. Why is it important for countries to
support their own PV programs?
1. Citizens may have unique traditions and diets
influencing reactions to medications
2. ADRs may be associated with traditional or
herbal remedies unique to each country
3. In some cases, ADRs to certain drugs may
only occur in particular ethnic groups
4. Alternate brands of therapy may be imported
or manufactured & differ in ingredients or
production processes

17. Thank you for your attention