3. WHO-
The science & activities relating to the
Detection
Assessment
Understanding and
Prevention of adverse effects or any other drug related problems
5. DIRECT RESULT- THALIDOMIDE INCIDENT
• USA - 1962 amendment to Federal Food, drug & Cosmetic Act -
required both safety & efficacy data
• UK - 1964 Yellow card scheme
• WHO - 1968 Program for International Drug Monitoring
6. TERMINOLOGIES IN PHARMACOVIGILANCE
Adverse effect-
‘any undesirable or unintended consequence of drug
administration’.
Adverse drug event
‘any untoward medical occurrence that may present during
treatment with a medicine, but which does not necessarily have a
causal relationship with the treatment’.
7. TERMINOLOGIES IN PHARMACOVIGILANCE
• Adverse drug reaction (ADR)
‘any noxious change which is suspected to be due to a drug,
occurs at doses normally used in man, requires treatment or decrease
in dose or indicates caution in the future use of the same drug’
8. TERMINOLOGIES IN PHARMACOVIGILANCE
• Signal
-” Reported information on a possible causal relationship
between an adverse event and a drug, the relationship being unknown
or incompletely documented previously".
Medication error
any preventable event that may cause or lead to inappropriate
medication use or patient harm while the medication is in control of
the health care professional, patient or consumers
9. Serious adverse drug reaction
• Death
• Life- threatening
• Hospitalization
• Disability (significant ,persistent, permanent)
• Congenital anomaly
• Required intervention to prevent permanent impairment/damage
10. Need of pharmacovigilance?
1: Humanitarian concern
- Insufficient evidence of safety from clinical trials
- Tests in animals are insufficient to predict human safety
- Safety profile in special groups inadequate / Incomplete
11. Need of pharmacovigilance?
2. Medicines are supposed to save lives
“Dying from a disease is sometimes unavoidable; dying from a
medicine is unacceptable”
3. ADRs are expensive
4. Promoting rational use of medicines and adherence
12. AIMS-
• To improve patient care & safety
• To improve public health & safety
• To contribute to the assessment of benefit, harm, effectiveness and risk of
medicines
• To promote education and clinical training
• To promote rational and safe use of medicines
13. • Who can report?
-Medical specialist
-Pharmacists
- Dentists
- Midwives
- patient
- patient’s relatives
14. Reporting time frame
• Expedited reporting is required as soon as possible
• Day 0 - date when any of the MAH receive a case report
• Non –serious ADR
-not reported on an expedited basis
-included in the periodic safety update report
15. • Serious unexpected – 15 calendar days
• Serious death/life threatening unexpected -7 calendar days
16. Periodic safety update report
• MAH submit to regulatory authority to evaluate medicinal products
safety data for a particular interval of time
• PSUR- PREPARATION
-every 6 month from authorization until product placed on the
market
-every 6 month x first 2 years
17. Periodic safety update report….
-annually for the next 2 years
-thereafter every 3 years
18. INDIVIDUAL CASE SAFETY REPORT
• Adverse event report for an individual patient
• Source of data in pharmacovigilance
unsolicited solicited
Spontaneous reports Clinical trial
patients registries
Regulatory authorities Disease management programs
internet survey
19. INDIVIDUAL CASE SAFETY REPORT
• Identifiable patient
• Identifiable reporter
• A suspected drug
• An adverse event
20. VIGIFLOW
-WEB based individual case safety reports management system
-used by national pharmacovigilance centres
-supports collection ,processing , and sharing of ICSR data
VIGIBASE:
- WHO global individual case safety report database.
22. CAUSALITY ASSESSMENT
• assessment of relationship between a drug treatment and the
occurrence of an adverse event.
• It is used to evaluate and to check that the particular treatment is the
cause of an observed adverse event or not.
• It is an essential part of ADR report and important task, conducted by
National Pharmacovigilance Programme in each country.
23. Causality is assessed on the basis of-
• Temporal relationship
• Previous knowledge
• Dechallenge
• Rechallenge
28. WHO - International drug monitoring
• Started 1978
• Located in Uppsala, Sweden
• Collaborating centre for maintaining global ADR database - Vigibase
29. Roles of WHO Collaborating Centre
• • Identify early warning signals of serious adverse reactions to
medicines
• Evaluate the hazard
• Undertake research into the mechanisms of action to aid the
development of safer and more effective medicines
31. • 1997- WHO Programme for international drug monitoring.
• 2004- Central Drugs Standard Control Organization (CDSCO)
National Pharmacovigilance Programme (NPVP).
• 2010- PvPI Ministry of Health & Family Welfare of the
Government of India
34. Capacity building
• Four regional resource centers - training and technical support to AMCs of
their respective regions
• NCC -national and regional programms
(training, consumer awareness and Continuing Medical Education)
• 2014- A Guidance document for spontaneous ADR reporting
• January 2017 - skills development programme.
41. Collaboration with public health programmes
• Universal Immunization Programme (UIP)
• HIV and tuberculosis programmes
• Vector-borne diseases programme
• Deworming programme
42. Collaboration with medical organizations
• Aims : To synergize experience in pharmacovigilance and
pharmacoepidemiology to booster the country’s PvPI initiative.
• National AIDS Research Institution (NARI), Pune
• Institute of Research in Reproductive Health (IRRH), Mumbai
• National Institute of Cholera & Enteric Diseases (NICED), Kolkata
• National Institute of Nutrition (NIN), Hyderabad
• National Institute of Epidemiology (NIE), Chennai
• National Institute of Malaria Research (NIMR), New Delhi
(hypnotic, prevention of nausea in pregnancy)
Dr William Mcbride
GERMAN COMPANY- 1957-CONTERGAN-CHEMIE GRUNENTHAL-CLAIMED TO CURE ANXIETY
for Collecting information on adverse drug reactions-
It introduced a requirement for drug manufactures to provide proof of the effectiveness and safety of their drugs before approval
(elderly, parous women,childern)
ROFECOXIB-2004-CVS EFFECTS
TERFINADINE -1997-TORSADE DE POINTES
LEPAKHIN V GENEVA 2005
in relation to medicines & all medical & para-medical interventions
in relation to the use of medicines Public Health
Risk Benefit Assessment
To promote understanding, clinical training & effective communication to health professionals & the public
EXPEDITED REPORTING- SINGLE CASES OF SERIOUS UNEXPECTED REACTION
MARKETING AUTHORISATION HOLDER- responsible for quality, efficacy and safety of the products
MARKETING AUTHORISATION HOLDER
TRY TO OBTAIN FROM SOMEONE
If one or more of this is missing ,the case is not a valid icsr
For international drug monitoring
1. How the time-sequence of the event is related to drug administration.2. Whether the drug is known to produce the event in earlier recipients with a certain degree of consistency. 3. Whether the event subsided on stopping the drug. 4Whether the event reappeared when the drug was administered again after a gap during which the event had subsided
SEEMING REASONABLE,PROBABLE
BRADFORD HILL CRITERIA –STRENGTH, CONSISTENCY,SPECIFICITY,TEMPORALITY,BIOLOGICAL GRADIENT,
APRIL 2015 VIGIACESS
123 COUNTRIES JOINED
In 1997, India joined the WHO Programme for International Drug Monitoring.
In 2004, the Central Drugs Standard Control Organization (CDSCO) established the National Pharmacovigilance Programme (NPVP); however in mid-2009 the World Bank funding for the NPVP ended and the programme was suspended.
The Pharmacovigilance Programme for India (PvPI) was launched on a national footing in 2010 by the Ministry of Health & Family Welfare (MoHFW) of the Government of India
Quality Review Panel reviews the quality and completeness of ICSRs. The Signal Review Panel identifies and evaluates signals from the ICSRs submitted to NCC, defines biostatistical methods for analysis and actionable indicators, and proposes appropriate regulatory interventions to CDSCO
The Core Training Panel identifies trainers, training needs and training content, and interacts with international agencies on participation and implementation of pharmacovigilance training programmes.
JSS Medical College, Mysore (south), Seth GS Medical College & KEM Hospital, Mumbai (west), Post Graduate Institute of Medical Education and Research, Chandigarh (north), and Institute of Post Graduate Medical Education and Research, Kolkata (east)
training and technical support to AMCs of their respective regions
