The document discusses pharmacovigilance, which is defined as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. It describes the history of pharmacovigilance, including the thalidomide tragedy in the 1960s which led to increased regulation. The document outlines pharmacovigilance in Pakistan, including the establishment of an online reporting system by DRAP in 2018 for healthcare professionals and patients to report adverse drug reactions. It provides key terms related to pharmacovigilance and describes the pharmacovigilance workflow and functions.

1. Pharmacovigilance
Rashid Mureed
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2. The need for Pharmacovigilance….
No medicinal product is entirely or absolutely safe for all
people, in all places, at all times.
Pharmacovigilance can characterize this risk !
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3. Pharmacovigilance – WHO
Definition
WHO defines Pharmacovigilance as:
“The science and activities relating to the
detection, assessment, understanding and
prevention of adverse effects or any other
drug-related problem.”
This applies throughout the life cycle of medicine equally to the
pre-approval stage as to the post-approval
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4. Pharmacovigilance
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5. History of Pharmacovigilance…
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6. History of Pharmacovigilance…
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7. Pharmacovigilance –
Background
► Thalidomide was used as a
sedative agent.
► One out of seven persons used
this drug.
► 1957 over the counter.
► By 1960 marketed in 46
countries.
► Off-label use in pregnant
patients.
► Dr. William McBride, first
suspected a causal link between
serious fetal deformities (phocomelia)
and thalidomide.
► 1961 birth defect in 161 babies.
Many children in the 1960's, like the
kindergartner pictured above, were
born with phocomelia as a side
effect of the drug thalidomide,
resulting in the shortening or
absence of limbs.
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8. PV Scope Today
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 Adverse Reactions
 Inadequate/incorrect use
 Medication error
 Dependence, abuse & poising
 Antibiotic resistance
 Product Quality Problem
 Failing GMP
 Lack of efficacy
 Other Safety Challenges
 Immunization program
 Other public health program
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9. PHARMACOVIGILANCE
IN PAKISTAN
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10. Pharmacovigilance in Pakistan
December ,2011
More than 200 people died and around 1000 became seriously ill in Pakistan after taking
contaminated cardiac medicines.
February, 2012
WHO issued a drug safety alert for the government and pharmaceutical regulators
around the world.
The Drug Regulatory Authority of Pakistan (DRAP) was established under the DRAP
act 2012 to provide effective coordination and enforcement of the Drug Act 1976.
In 2018, The Drug Regulatory Authority of Pakistan (DRAP) created a
Pharmacovigilance reporting system called “Online DRAP MED Vigilance System”.
This system ensures that AE reports are reported by :
• Health Care Professionals
• Pharmaceutical companies
• Patients
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11. DRAP MED vigilancesystem for patients :
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12. DRAP MED vigilance system for Health care professionals :
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13.  DRAP is endeavoring to get full membership for World Health Organization
Program for International Monitoring (WHO-PIDM), Uppsala Monitoring Centre
(UMC),Sweden.
 DRAP has recently subscribed VIGIFLOW from UMC as Pakistan’s National
database for Adverse Drug Reactions (ADRs) and has started collaboration with
UMC on the safety of therapeutic goods.
 DRAP has advised Pharmaceutical Associations to :
 To establish Pharmacovigilance system in every pharmaceutical company.
 To appoint a Qualified Person for Pharmacovigilance(QPPV).
 To submit monthly report for domestic ADRs consisting of Individual Case Safety
Reports (ICSRs) on CIOMS form both in PDF and E2B-R3 format.
Pharmacovigilance in Pakistan
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14. Uppsala Monitoring Centre (UMC)
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 Established as foundation 1978
 Based on agreement Sweden –WHO
 WHO responsible for Policy
 Self Funding
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15. Terms related to Pharmacovigilance
ADR (Adverse Drug Reaction)
Noxious and unintended effect of
a drug occurring at usual
therapeutic doses for the
prophylaxis, diagnosis or therapy
of disease.
Significant Safety Issue
Major changes in product safety
information, safety issues
regarding quality, adulteration and
contamination.
AE(Adverse Experience)
Unfavorable and unintended
medical occurrence that does
not have a causal relationship
with treatment.
Counterfeiting
Unauthorized use of trademark,
trade name, imprint, or device, to
adulterate or represent that the
product was manufactured or
distributed by the identified
manufacturer or distributor.
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16. Diversion
The transfer or sale of products or
materials outside of their intended
distribution channels that result in a
violation of a law or contract
• E.g. a prescription product
being sold at a convenience
store or market
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Tampering
A fraudulent and unauthorized intervention
that alters a product's quality or intended
representation
► E.g. a seal on a bottle of capsules that
is broken with an attempt to glue it
back together
Terms related to Pharmacovigilance
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17. Product Quality Complaint
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A Product Quality Complaint (PQC) is defined as any
communication that describes a potential defect related to the
identity, strength, quality, or purity of an company product
after it is released / distributed for use by a customer.
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18. Product Quality Complaints (PQCs)
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Some PQC examples include:
• Changes in product appearance
• Product contamination
• Missing components
• Product delivery malfunction e.g. a nasal sprayer that does not spray
e.g. an aerosol inhaler missing a mouthpiece
e.g. foreign matter in or on the product (for
example mold)
• Product damage e.g. a cracked nasal applicator
• Product mismatches e.g. has a tube of cream in a carton
labeled for ointment
• Product shortages (i.e. missing
tablets from a packet)
e.g. tablets missing from a bottle
• Product packaging defects e.g. an unreadable expiry date on a packaging
e.g. a creamy product that turned watery
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19. Sources of Adverse Experiences :
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20. Minimum information for a Case
Report ?
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21. Pharmacovigilance workflow
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22. Designated Point of Contact (DPOC)
DPOC – A person or a group designated to receive:
• Adverse Experiences and Other Reportable Information
• Product Quality Complaints
• Medical Inquiries
• Alleged Counterfeit, Diversion and Tampering (CDTs)
• Customer Feedback
• and ensuring that they are consistently reported, documented, and
routed to the appropriate departments.
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Impact of Not Reporting AEs/PQCs
Most importantly: PATIENT SAFETY may be compromised!
Other Impacts:
Product recalls => loss of sales
Loss of consumer/customer
confidence
Damaged company
reputation
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24. Function of PV
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 Signal detection
 Identification of previously unknown drug reactions
 Signal strengthening
 Annual any other relevant document
 Search requests
 Web-based search program
 Adverse reaction profiles
 Comparing national experiences
 identification of risk factors
 Combining ADR figures with other data
 drug utilization statistics
 population statistics
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25. Pharmacovigilance
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