This document provides an overview of pharmacovigilance (PV), which is defined as monitoring the safety of medicines. It discusses the need for PV due to limitations of clinical trials and real-world use of medicines. Historical examples are given of drugs that were withdrawn from the market due to safety issues identified through spontaneous reporting. The PV process involves detecting, assessing and preventing adverse drug reactions through both spontaneous and mandatory reporting. India has a national PV program to improve patient safety. Narrative case reports are important for communicating individual safety cases and include details like medical history, events, and causality assessment. Various databases and reporting forms are used to support global PV activities.

1. Wasim Akram Ansari
Medical Services Associate
Accenture Solutions

2. What is pharmacovigilance?
 Pharmakon (Greek)= Medical substance
 Vigilia (Latin)= To keep watch
WHO Definition
 Pharmacovigilance (PV) is defined as the science and
activities relating to the detection, assessment,
understanding and prevention of adverse effects or any
other drug-related problem.

3. Need For Pharmacovigilance
 Limitations to clinical study data
Clinical trials Clinical Practice
Number of patients Hundreds (rarely
thousand)
Thousands to millions
Duration Weeks Years
Population Pregnant, children,
elderly excluded
All
Concomitant medication
and illness
Avoided Usually present
Dose Fixed Variable
Condition Rigorous; more
information
Flexible; less information

4. Withdrawals from the market as a
result of spontaneous reporting
Drugs Reason for
withdrawals
Year of approval Year of withdrawal
Practolol Blindness 1970 1975
Benoxaprofen Onycholysis, renal,
liver, bone marrow
toxicity
1982 1982
Encainide Excessive mortality 1987 1981
Temafloxacin Haemolytic
anaemia
1992 1992
Terfenadine Fatal Cardiac
arrythmia
1985 1998
Bromfenac Serious hepatotoxic
effect
1997 1998

5. Historical Background
Thalidomide disaster:
 1960 marketed in 46 countries (hypnotic, prevention
of nausea in pregnancy).
 Heavily promoted.
 1960 first reports of deformed infants with supressed
limbs. (20000 cases were reported).
 The deformity was known as “Phocomelia”.

6. What is Phocomelia.
 A rare congenital deformity in which the hands or feet
are attached close to the trunk, the limbs being grossly
underdeveloped or absent. This condition was a side
effect of the drug thalidomide taken during early
pregnancy.

7. Aim
 To improve patient care and safety in relation to the
use of medicines, and all medical and paramedical
interventions.
 To improve public health and safety in relation to the
use of medicines.

8. Contd...
 To contribute to the assessment of benefit, harm,
effectiveness and risk of medicines, encouraging their
safe, rational and more effective use.
 To promote understanding, education and clinical
training in pharmacovigilance and its effective
communication to health professionals and the public.

9. Pharmacovigilance process
 Detecting and Reporting ADR,
1. Spontaneous reporting
2. Mandatory reporting

10. Spontaneous reporting
 HCP identify and reports any ADR related to the drug
to their national regulatory bodies.
 Most common ADR form.

11. Mandatory reporting
 Manufacture needs to submit the ADR reports to the
their respective national regulatory bodies in the form
of PSUR (Periodic safety update report).
 Includes information of all types of ADR collected
irrespective of the reporting country.
 Includes scientific evaluation of risk benefit balance.

12. Pharmacovigilance In India
 CDSCO (Central drug standard control organisation)-
DGHS (Ministry of health).
 Legislative requirement of PV in India was done under
schedule Y drug. (drugs under clinical trials).
 PVPI (Pharmacovigilance programe of india).

13. Timelines For ADR Reporting
 Serious ICSR
-Fatal and Life threatening outcome should be reported
in 7 calendar days.
-Hospitalization and IME (15 calendar days).
 No serious ICSR- 30 calendar days (for USA) and 90
days for European country.

14. Narrative writing
 A narrative is a short story about the events in a third
person language. It should be in the past tense.
 Very important in ICSR (Individual case safety report)
case processing.
 Eventually the narrative is the only thing which gets
submitted to regulatory authorities.

15. Parts of Narrative
 It consists of 10 parts.
a. Event verbatim
b. Country of incidence
c. Opening sentence or Lead statement.
d. Medical history details
e. Concomitant medication details.
f. Suspect product details.
g. Event section.
h. Outcome, lab data and treatment section.
i. Causality section.
j. Closing statement

16. Example
PNEUMONIA
(USA)
This case was regarding a 75 year-old, female patient who received Pomalyst for multiple myeloma.
Medical history were not provided. No past medication were reported. Concurrent medical
conditions included chronic atrial fibrillation. Concomitant medication included Benadryl, Eliquis,
Fentanyl, Flonase, Lasix, Levothyroxine Sodium, Lisinopril, Lorazepam, Metoprolol
Succinate Er, Ninlaro, Norco, Pantoprazole Sodium, Potassium, Tramadol Hcl, Tylenol/Codeine and
Vitamin B12 all for an unknown indications.
The patient received oral Pomalyst capsules at 2 mg daily from 14May2019 to an unknown date, at 3
mg daily from Aug2019 to an unknown date, and at 4 mg 21/28 days from Oct2019 to an unknown
date. Lot number was C2293A and expiry date was 31-Aug-2023.
On an unspecified date, the patient experienced pneumonia which led to hospitalization for about six
weeks. Lab data, if any, were not provided. Corrective treatment, if any, was not provided. Action
taken with Pomalyst in response to the event of pneumonia was unknown. At the time of reporting,
outcome of the event of pneumonia was unknown.
The causal relationship was not assessed between Pomalyst therapy and the event of pneumonia. The
company assessed the causal relationship between Pomalyst therapy and the event of pneumonia as
not suspected.
Additional information will be requested.
Initial information was received on 22Jul2020 via contract pharmacy from a patient.

17. Database used in PV
 ARISg, ARGUS, PVNET, LSMV are used for PV
activities.
 Vigibase and Vigiflow are used by WHO for Post
marketing surveillance.

18. Types of reporting forms
 CIOMS- Europe
 Medwatch- USA
 E2B- World

19. Online course - Free of cost
 Uppsala monitoring center website.
 https://www.who-umc.org/

20. THANK YOU