establishment of pv center at PV

1. Establishing
Pharmacovigilance Centres
In Hospital
Presented By : Rushikesh S Tidake
M.Pharm Sem II
Pharmacology
RSCP Buldana
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2. What is Pharmacovigilance ?
 The science & activities relating to
- Detection , Assessment ,
Understanding , Prevention of adverse
effects or any other medicine – related
problem
 Pharamkon (Greek) = Medicinal
Substance
 Vigilia (Latin ) = to keep watch
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3. Hospital based PV centre
• Can contribute greatly in generating
the safety data
• Operates through its PMS / holistic /
comprehensive approach
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4. Steps involved in establishing PV
centre
1. Contact relevant authorities to ensure approval for
the centre by outlining the importance of the centre
and its purpose.
2. Design an ADR reporting form and start collecting
data by distributing it to hospital departments,
family practitioners, etc.
3. Produce printed material to inform health
professionals about definitions, aims and methods
of the pharmacovigilance system.
4. Create the centre: staff, accommodation, phone,
word processor, database management capability,
bibliography etc.
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5. 5. Educate pharmacovigilance staff
6. Establish a database for the storage and retrieval of
ADR data
7. Organize routine meetings in hospitals, academia
and professional associations, explaining the principles
of pharmacovigilance and the importance of reporting.
8. Promote the importance of reporting adverse drug
reactions through medical journals, other professional
publications, and communications activities.
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6. Establishing Hospital based
Pharmacovigilance Centre
 New centre can start operating quickly
 But from uncertain stage to become an
established & effective organisation
- time , vision , dedication , expertise &
continuity
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7. Basic Requirements
Effective functioning of PV centre
depends
STAFF
INFRASTRUCTURE
FUNDING
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8. Staff Requirements
 Staff requirements
 Adequate staff
- size of the centre
- Assessment time / case
report
 Secretarial assistance
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9.  Full time / Part time ( initial )
 Minimum / essential qualification
 Basic qualification – MBBS / Pharm D / BDS
o Desirable
- Postgraduate qualification
- Expertise in clinical medicine ,
pharmacology , toxicology & epidemiology
- Experienced / trained personnel
- Communication skills
- Committed & dedicated
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10.  Take care of the education of pharmacovigilance
staff regarding :
 Data collection & verification
 Interpreting & coding of adverse reactions
descriptions
 Coding of drugs
 Case causality assessment
 Signal detection
 Risk Management
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11. Infrastructure
 Location :
- Any department in a hospital
- Ideal : Clinical pharmacy / Clinical
Pharmacology / Clinical toxicology / epidemiology
 Space :
- Adequate to house staff & infrastructural
requirements
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12. Infrastructure of PV Centre
 Communication System :
- computer , internet connection
- telephone & fax
- printer , photocopier
 Information system :
- Standard texts , sources related to
ADR’s
- literature sources related to ADRs
- hospital library ( teaching hospital)
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13.  Office equipment :
- computer chair & table
- office table & chair
- cupboards
- bookshelves & journal racks
 Adequate Ventilation & lighting :
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14. INITIATION PROCESS
 Create awareness amongst HCPs
- seminars , workshops , personnel &
training
meets
• Adopt suitable & feasible method
- spontaneous reporting system
 Design ADR reporting & documentation forms
- Simple yet comprehensive
 Ensure easy access to reporting forms
 Assist HCPs in identifying the event & provide
updates on drug safety issue
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15.  Provide feedback on the reported information
- ‘Thank you’ notes
 Develop a suitable database
- for easy documentation & retrieval of
information
 Communicate & disseminate the information
 Have a contacts with international institutions
working in pharmacovigilance
 WHO Department of Essential Drugs & Medicine
Policy
 Uppsala Monitoring Centre ,Sweden
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16. Reporting of ADRs
 Spontaneous reporting is backbone of
Pharmacovigilance System
 Reporting forms a notification relating to a patient
with an adverse medical event suspected to be
induced by a medicine
 Electronic reporting
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17. Reporting Form – Essential
 Patient Information : Age , sex & brief medical
history
 Adverse event : description , start date , course &
outcome , any relevant data by lab investigations
 Suspected Drugs Information : Name , brand ,
manufacture details , dose , route , start / stop
dates , indication for use
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18.  Details of concomitant drugs
 Risk factors if any ( impaired renal function ,
previous exposure to suspected drug , previous
allergies , social drug use )
 Details of the Reporter
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19. Use of data
 Collected in pharmacovigilance can be used in a
variety of ways
 Hypothesis generation & strengthening
 Drug regulation
 Information ( dissemination )
 Education & feedback
 Limitations regarding the use of data
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20. Funding
 A pharmacovigilance centre should have some
basic , regular source of funding ( in order to
ensure continuity in its work )
 Requires adequate funding to meet the expenses
- recurring cost
- non recurring cost
- maintenance cost
 Cost estimation :
calculated as a function of rate of reporting
required & size of the population
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21. Basic sources of funding
 University departments
 Professional associations
 Governmental departments ( National centre /
projects)
 Non government organisation ( with an interest in
drug safety )
 Health insurance companies & health insurance
funds
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