Pharmacovigilance ....
“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem”
Pharmacovigilance scope include:
• •Adverse reactions
• •Lack of efficacy
• -Resistance
• -Interaction
• -counterfeiting
• •Quality problems
• •Dependence & abuse
• •Poisoning
• •Medication errors
Who could report:
• Physicians
• Pharmacists
• Nurses
• Traditional healers
• Other health workers
• Patients
• Manufacturers
Definitions
• Adverse Drug Reaction
▫ A noxious and unintended response to a medicine which occurs at doses normally used in man for treatment, prophylaxis, diagnosis or modification of physiological function.
• Adverse Event:
▫ untoward medical occurrence which does not necessarily have to have a causal relationship with the treatment
▫ Side Effect (SE) Response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease or for modification of physiological function.
Serious Adverse Event
• Any untoward medical occurrence that at any dose results in:
▫ Death
▫ Is life-threatening
▫ Requires or prolongs patient hospitalization
▫ Results in permanent disability/incapacity or is
▫ A congenital anomaly/ birth defect
▫ Other medically significant event (e.g. blood dyscrasias, seizures)
Medication Error:
• They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreading or miswriting a prescription.
• Not all medication errors lead to adverse outcomes.
• Medication errors are more common than adverse events, but result in harm less than 1% of the time. About 25% of adverse events are due to medication errors.
WHAT SHOUD BE REPORTED
• All suspected drug-drug, drug-food, drug-food supplement interactions
• - Statement highlighting marine source of supplements such as glucosamine so that can be avoided by those with allergy to sea food
• ADRs associated with drug withdrawals
• ADRs due to medication errors
• ADRs due to lack of efficacy or suspected pharmaceutical defects
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