PHARMACOVIGILANCE

PRESENTED TO Mr. M.P. VENKATESH LECTURER DEPT. OF RA JSSCP

PRESENTED BY SHILPI KHATTRI 1ST M.PHARM DEPT. OF RA JSSCP

MEANING
 Pharmaco = medicine  Vigilare = to watch
alert watchfulness wakefulness watchfulness in respect of danger; care; caution; circumspection the process of paying close and continuous attention

What is pharmacovigilance?
WHO definition: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drugrelated problem.

The Aims of Pharmacovigilance

 To improve patient care and safety  To improve public health and safety  To contribute to the assessment of benefit, harm, effectiveness and risk of medicines  To promote understanding, education and clinical training

Why do we need pharmacovigilance?



Humanitarian concern
Insufficient evidence of safety from clinical trials Animal experiments Phase 1 3 studies prior to marketing authorization

 Medicines are supposed to save lives

Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. WHO. Geneva 2005

CONTD
 ADRs are expensive !!  Promoting rational use of medicines and

adherence.
 Ethics:

To know of something that is harmful to another person who does not know, and not telling, is unethical.

DEFINITION
 Adverse Drug Reaction
"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."

 Adverse Event
Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment

 Side Effect
Any unintended effect of a pharmaceutical product occurring at doses normally used in man which is related to the pharmacological properties of the drug

WHAT SHOULD BE REPORTED?

 New drugs
Report all suspected reactions including minor ones

 For established or well known drugs

All serious, unexpected, unusual ADRs

 Change in frequency of a given reaction  ADRs to generics not seen with innovator

products  ADRs to traditional medicines

CONTD
 All suspected drug-drug, drug-food, drug-food

supplement interactions  ADRs associated with drug withdrawals  ADRs due to medication errors  ADRs due to lack of efficacy or suspected pharmaceutical defects

SO.WHAT IS OUR ROLE?

 SEND NOT ONLY

QUANTITY BUT .

QUALITY REPORTS

HOW?
 Monitor clinical status of patients  Identify the correct ADRs not side effects  Get more information  Investigate at hospital level  Help doctors to fill-up the forms  Keep patient s record if more information

needed.