CPRASU

Pharmacovigilance & ADR reporting

Dr. Sawsan Aboul-Fotouh,
MD; PhD

Faculty of Medicine, Ain Shams University, Cairo, Egypt

Presentation Objectives
Define Pharmacovigilance (PV). Explain why we need PV Present tools for PV (How to detect ADR?) Identify ADRs reporting and its significance Recognize the main domains of ADR reporting Explain how can we report on ADRs

Pharmacovigilance
What is this??

Pharmacovigilance ??
Pharmakon vigilare

Drug
Greek

to be awake or alert, to keep watch Latin

Pharmacovigilance ??
WHO

The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions (ADRs) or any other drug-related problems

Do we need Pharmacovigilance???

Yes

Why

Pharmacovigilance Why?
Information on Drug safety collected during drug development is incomplete: Animal tests insufficient to predict human safety Clinical trials evaluate for limited duration and limited numbers of carefully selected patients in carefully selected settings

Pharmacovigilance Why?
Information often incomplete on:
Rare but serious Adverse drug reactions (ADRs) Risks of long-term, repeated use, interactions Use in vulnerable groups (pregnancy, children, elderly)

Phocomelia

By the time it was withdrawn in 1961, [5000-12,000 deformed babies]

Pharmacovigilance Why?
ADRs occur in 10-20% of all patients prescribed drugs ADRs responsible for 5-10% of all admissions 6.7% of hospital patients suffer a serious ADR 0.1-0.3% of hospital patients suffer a fatal ADR

Pharmacovigilance Why?
Economic impact ADRs related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in 2000
(Ernst & Grizzle, 2001)

Pharmacovigilance Why?
The economic burden of ADRs has been estimated to be in the billions of dollars annually

Pharmacovigilance Why?

An estimated 3060% of ADRs may be preventable

3060% of ADRs may be preventable

How Can We prevent ????

We Should Detect ADR

How Can We Detect ADR ????

Detection of ADR
(Tools for Pharmacovigilance) Spontaneous ADRs reports Post-marketing surveillance studies
Case reports Case series Observational studies (case control, cross sectional, cohort) Experimental studies (clinical trials, meta-analysis)

Spontaneous ADR reporting

It has proven to be an effective way to generate an early signal that a drug may be causing an adverse event.

It is the only practical way to detect : Rare ADRs ADRs that occur after prolonged use of drug ADRs that are delayed in appearance Drug-drug interactions

Reporting Requirements

Documentation and reporting of adverse events are critical steps in ADRs prevention.

How can we do ADR reporting ????

ADR reporting
ADR report ADR reply

ADR report

It is written by the clinicians when they notice

occurrence of a certain adverse effect (suspected reaction) in association with a

certain drug administration (suspected drug)

ADR report
Its contents: 1- Patient details 2- Suspected reaction 3- suspected drug 4- Other drugs taken 5- Outcome events (prognosis & severity of ADR) 6- Lab investigations & Other illness

ADR report
Examples

MHRA

CPRASU

MHRA MHRA
Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. (British)

Yellow Card

CPRASU

Ain Shams University

Rounds done between the pharmacology department and different clinical departments.

www.cprasu.org

Brown Card

ADR reply
It is written by the clinical

Pharmacologist

to detect, evaluate and understand the adverse drug reaction (ADR) and to assess its Causality

ADR reply
Its contents: 1- Patient details 2- Suspected reaction & Suspected drug & Other drugs 3- No. of suspected ADR cases in MHRA 4- Medline search for suspected ADR 5- Risk factors for suspected ADR 6- Causality assessment & Justification 7- References

Causality Assessment

Causation
Certain Probable Possible Unlikely Unclassified

Aims of Pharmacovigilance:
to improve patient care and safety to improve public health and safety to promote education and clinical training to promote effective communication to the public to promote rational and safe use of medicines to contribute to the assessment of : benefit, harm, effectiveness & risk of medicines

Thank you
People who are vigilant do not die; people who are negligent are as if dead.
Shakyamuni Buddha