2. WHAT IS PHARMACOVIGILANCE (PV)
The science and activities relating to the
detection, assessment, understanding
and prevention of adverse effects or any
other medicine-related problems -
3. Pharmaco - Vigilance
• Pharmaco = medicine
• Vigilare = to watch
– alert watchfulness
– forbearance of sleep; wakefulness
– watchfulness in respect of danger; care;
caution; circumspection
– the process of paying close and continuous
attention
4. Pharmacovigilance
Aims
• Early detection of unknown safety
problems
• Detection of increases in frequency
• Identification of risk factors
• Quantifying risks
• Preventing patients from being affected
unnecessarily
5. Objectives 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
6. Scope of Pharmacovigilance
• Improve patient care and safety in relation to the use of
medicines, and all medical and paramedical
interventions,
• Improve public health and safety in relation to the use
of medicines,
• Contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging their
safe, rational and more effective (including cost-
effective) use, and
• Promote understanding, education and clinical training
in pharmacovigilance and its effective communication
to the public
7. • ADVERSE Drug Events- ADE, harm caused by the
drug (ADR & overdoses) and harm from the use of the
drug (including dose reductions & discontinuations of
drug therapy).
• ADVERSE Drug Reactions- A response to drug
which is noxious & unintended which occurs at doses at
normally used in man for the prophylaxis, diagnosis or
therapy of disease. There is causal link between a drug
& an adverse drug reaction.
• SIDE Effect- is an expected & known effect of a drug
that is not the intended therapeutic outcome.
8. Adverse Reactions:Possible Causes
• INTRENSIC FACTORS OF THE DRUG
-P’COLOGICAL
-IDIOSYNCRATIC
-CARCINOGENICITY, MUTAGENICITY
-TERATOGENICITY
• EXTRENSIC FACTORS
-ADULTERANTS
-CONTAMINATION
• UNDERLYING MEDICAL CONDITIONS
• INTERACTION
9. NEED FOR PV
Reason 1:
• Humanitarian concern –
– Insufficient evidence of safety from clinical
trials
– Animal experiments
– Phase 1 – 3 studies prior to marketing
authorization
10. CONT…
Reason 2
• Medicines are supposed to save lives
Dying from a disease is sometimes
unavoidable; dying from a medicine is
unacceptable. Lepakhin V. Geneva 2005
11. • UK
It has been suggested that ADRs may cause
5700 deaths per year in UK
• UK
ADRs were 4th-6th commonest cause of
death in the US in 1994
12. Reason 3: ADRs are expensive !!
• Cost £446 million per annum
• 6.5% of admissions are due to ADRs
• Seven 800-bed hospitals are occupied by
ADR patients
13. Reason 4:
Promoting rational use of medicines and
adherence
Reason 5:
Ensuring public confidence
If something can go wrong, it will –
Murphy's law
14. Reason 6: Ethics
To know of something that is harmful to
another person who does not know, and
not telling, is unethical
17. Why Pharmacovigilance?
• Adverse Drug Reactions are the 4th to 6th
largest cause of mortality in the US
• The percentage of hospital admissions
due to drug related events in some countries is
about or more than 10%.
18. Some Examples
Medicine ADR
Thalidomide Congenital malformations
Amidopyrine Agranulocytosis
Clioquinol Myeloneuropathy (SMON)
Statins Rhabdomyolyis
Oral Contraceptives Thromboembolism
19. NEED OF PV IN INDIA
• INDIA RATES BELOW 1% OF PV WHILE WORLD 5%
DUE TO IGNORANCE OF SUBJECT AND LACK OF
TRAINING
• PROBLAM OF A LARGE POPULATION THAT IS
PREDOMINENT RURAL AND EXTENT USE OF
TRADITIONAL MEDICINE
• LACK OF PHYCISIAN AND CONSUMER AWAIRNESS
PROGRAM
20.
21. Pharmacovigilance in WHO
• Exchange of Information
• Policies, guidelines, normative activities
• Country support
• Collaborations
22. CURRENT SCENARIO
• Increased awareness and interest amongst doctors
and pharmacists to report ADRS as they have seen
some benefit in reporting
• GCP training for investigators served to increase
awareness of SAE and ADR reporting amongst health
care professionals and the industry
23. CONT…..
• More hospitals and companies using on-line
reporting system – less hassle than submitting hard
copy reports
• Increasing involvement by hospital pharmacists in
pharmacovigilance – during clinical ward rounds and
when counseling patients
24. Who are the partners?
• Government
• Industry
• Hospitals and academia
• Medical and pharmaceutical associations
• Poisons information centres
• Health professionals
• Patients
• Consumers
• Media
• WHO
25. WHAT TO REPORT?
SERIOUS ADRS
• A serious adverse event (experience) or reaction is any untoward
medical occurrence that at any dose:
– results in death,
– is life-threatening,
– requires inpatient hospitalization of prolongation of existing
hospitalization,
– is a congenital anomaly/birth defect.
NOTE: The term “life-threatening” in the definition of “serious”
refers to an event in which the patient was at risk of death at the
time of the event; it does not refer to an event which
hypothetically might have caused death if it was more severe.
26. 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
27. 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
– eg vincristine given IT
• ADRs due to lack of efficacy or suspected
pharmaceutical defects
28. INNOVATOR PRODUCTS
– Limited information available at time when drug is first
marketed
– Minimal information on use in Asian population,
interactions with indigenous medicines
– Conduct intensive monitoring to identify new, unlabeled
adverse reactions, monitor for “rare” reactions
– Provide updates to prescribers on new findings, labelling
changes, safety issues
29. NON-PRESCRIPTION MEDICATIONS
• Quality defects can also lead to ADRs e.g. Pan
Pharmaceuticals (Australia) case
• Patients can develop ADRs to food supplements,
“health products”
• Overuse of supplements
• Current issue of dioxin contamination in Cod Liver Oil
preparations resulting in product withdrawals in UK
30. TRADITIONAL & COMPLEMENTARY MEDICINES
• Minimal information available on traditional medicines
– ADRs
– Drug interactions
– At risk groups e.g. alfalfa and exacerbation of SLE
• Misnomer of “because it is natural, it is safe
– Association of Black Cohosh with liver problems
• Health professionals should try to get as much
information as possible
– Name of product
– Indication
– Place of purchase (esp for unregistered products)
31. PREGNANCY
– Very little information available on outcome
data for drugs used in pregnancy
• Current issue of association between lamotrigine use
and cleft palate syndrome
• ACE Inhibitors and congenital anomalies
– Should follow-up cases where drugs are
prescribed intentionally or have been used
inadvertently to monitor outcome of
pregnancy, effect to the foetus/baby
33. COMMUNICATING THE OUTCOME OF PV
• Product Alerts – National Health Authorities
• Media statements - National Health
Authorities/Pharmacovigilance Centres
• Newsletters – National Pharmacovigilance Centres
and WHO
• Feedback to reporters – National Pharmacovigilance
Centres
34. SO….WHAT IS OUR ROLE?
• SEND NOT ONLY
QUANTITY BUT….
QUALITY
REPORTS
35. 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
36. REFERANCE
• WHO Safety of medicines. A guide to detecting and
reporting adverse drug Reaction. Geneva WHO 2002
• DRUG ALERT,volume1, issue 1 nov 2005 regional pv
centre (south) JIPMER, Pondicherry INDIA
• http://cdsco.nic.in/pharmacovigilance_intro.htm#Progr
amme Communications
• PROTOCOL FOR NATIONAL PV PROGRAM, CDSCO
Ministry of health &family walfare, gov of INDIA 2004
