Clinical Pharmacy: By: Narendar Kumar
Clinical Pharmacy: By: Narendar Kumar
Clinical Pharmacy: By: Narendar Kumar
Pharm. 612
4th Prof. Pharm. D (1st Semester)
Week No. 16
Aims of Pharmacovigilance
Scope of Pharmacovigilance
Pharmacovigilance Cycle
Pharmacovigilance Cycle
Management of ADRs
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Introduction to
Pharmacovigilance
According to WHO;
Pharmacovigilance (PV) is defined as
the science and activities relating to
the detection, assessment,
understanding and prevention of
adverse effects or any other drug-
related problem.
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Introduction to
Pharmacovigilance
Thalidomide was developed in 1950s.
Sedative
Used for nausea in pregnancy
10000 infants with deformed limbs (Phocomelia), blindness,
deafness and heart problems
>Half of children died
Then WHO started pharmacovigilance
Nowadays, Thalidomide is indicated for certain cancers and
leprosy
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Aims of Pharmacovigilance
To improve patient safety in relation to the
use of medicines, medical and surgical
interventions
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Scope of Pharmacovigilance
The scope of pharmacovigilance includes;
Impact on patient welfare and public health
It gives an outlook on the rules and laws to follow
in Pharmacovigilance practice
It maintains data safety in pharmaceutical industries
It is involved in;
Small molecule medicinal products, usually derived from
chemical synthesis
Herbal medicines and dietary supplements
Traditional and complementary medicines
Blood products
Biological products (medicines or vaccines)
Medical devices
Substandard medicines and counterfeit medicines
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Pharmacovigilance Cycle
Identification
(Data
Collection)
Information Investigation
(Analysis of
to others Data)
Action
( To protect Evaluation
Public Health)
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Adverse Drug Reactions
According to WHO, An ADR is “a response to a drug 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 modification of physiological
function”
An unwanted or unpleasant or unexpected result or
condition that comes along with the desired effects of the
drug is known as Side Effect.
An adverse effect of a drug produced by an exaggeration of
the effect that produce the therapeutic response is known
as Toxic Effect.
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Types of Adverse Drug
Reactions
Type of ADRs Characteristics Example
Type A (Augmented) • Dose Related Nephrotoxicity due to
• Related to Aminoglycoside
pharmacological action
• Predictable
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How to Recognize ADRs
Ensure, medicine received & actually taken by
the patient at the dose advised
Verify the onset of suspected ADR is after
taking the drug
Determine the time interval between drug taken
– onset of event
Evaluate the suspected ADR after discontinuing
the drug / reduced dose, monitor status
Analyze the alternate cause
Use relevant literature & experienced physician
opinion.
Report the ADR
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Role of Pharmacist in ADRs
Management
The pharmacist should facilitate
1. Analysis of each reported ADR.
2. Identification of drugs and patients at high risk for being
involved in ADRs.
3. The development of policies and procedures for the ADR-
monitoring and reporting program.
4. A description of the responsibilities and interactions of
pharmacists, physicians, nurses, risk managers, and other
health professionals in the ADR program.
5. Use of the ADR program for educational purposes.
6. Development, maintenance, and evaluation of ADR records
within the organization.
7. The organizational dissemination and use of information
obtained through the ADR program.
8. Reporting of serious ADRs to the FDA or the manufacturer (or
both).
9. Publication and presentation of important ADRs to the medical
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community.
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