This document discusses pharmacovigilance, which refers to the monitoring of medicines to detect and prevent adverse effects. The objectives of pharmacovigilance include improving patient safety, public health, and rational drug use. It is important due to limitations of clinical trials and the need to ensure drugs are used safely. Governing bodies that oversee pharmacovigilance include regulatory authorities and the WHO. Methods of monitoring include individual case reports, cohort studies, and periodic safety reports submitted by drug companies. Major adverse drug reactions that prompted increased pharmacovigilance include those from sulphanilamide and thalidomide. The scope of pharmacovigilance aims to improve understanding and safe use of medicines.

1. PHARMACOVIGILANCE
AND ITS IMPORTANCE
UNDER GUIDANCE OF –
DEEP SHIKHA
BY- SHUBHAM KUMAR SINHA
M. PHARMACY (QA)
REG- 11600914

2. CONTENTS
• INTRODUCTION
• OBJECTIVES
• RESPONSIBILITY
• NEED OF PHARMACOVIGILANCE
• GOVERNING BODIES
• METHOD OF PHARMACOVIGILANCE
• ADVERSE DRUG REACTIONS
• SCOPE OF PHARMACOVIGILANCE
• REFERENCE

3. INTRODUCTION
Pharmacovigilance (PV) also called as drug safety
Pharmakon --- in Greek -- drug
Vigilance --- in Latin -- to keep watch
The science and activities relating to the
detection, assessment, understanding and
prevention of adverse affects or any other
possible drug-related problems
:

4. OBJECTIVES
• 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 education and clinical training
• To promote rational and safe use of
medicines
• Tracking any drastic effects of drugs

5. RESPONSIBILITIES
• Time to time collection of data, recording and
notification
• Appropriate assessments (data completeness,
seriousness)
• Expedited and periodic reporting
• Creates appropriate structures for
communication

6. WHY PHARMACOVIGILANCE IS
NEEDED

7. 1. Humanitarian concern
• Animal toxicology is often not a good predictor for human effects
• Evidence of safety from clinical trials is insufficient due to some
limitations
2. Safe use of medicines
Dying from a disease is sometimes unavoidable; dying from a
medicine is unacceptable - Lepakhin V. Geneva 2005
• It has been suggested that ADRs may cause 5700 deaths
per year in UK
• ADRs were 4th-6th commonest cause of death in the US in 1994

8. Continue..
3. To reduce healthcare expenses - ADRs are
huge burden
4. Ensuring the public confidence
5. Ethical concern
• To know something which is harmful to
another person who does not know, and not
telling is unethical

9. GOVERNING BODIES
• The pharmaceutical industry
• Regulatory authorities
• WHO collaborating centre for international drug
monitoring
• CIOMS(Council for International
Organization of Medical Sciences )

10. METHOD OF
PHARMACOVIGILANCE
1. Individual case safety reports
2. Clinical review of case reports
3. Cohort event monitoring
4. Longitudinal electronic patient records
5. Periodic Safety Update Reports (PSUR)
6. Expedited report
7. Record linkage

11. Individual case safety reports
• Like Yellow card system which is used in UK in
pharmacovigilance
• By this scheme they collect information on
suspected ADRs to medicines & the scheme
allow the safety to the medicines & vaccines
that are on the market to be monitored

12. YELLOW CARD SCHEME
• This scheme was founded in 1964 after the
thalidomide disaster was developed & also
run by medicines and healthcare product
regulatory agency (MHRA) or the commission
of human medicines
• It also include all herbal preparation or these
ADRs can be reported by pharmacist, doctor,
nurse or even patients also

14. CLINICAL REVIEW OF CASE
REPORT
• The quality of report is variable through
nation to nation or international organization
collect hundreds or thousands of report each
year and this is not possible to review all
report by the available experts
• Even if each report could be reviewed,
important reporting pattern would
be missed

15. COHORT EVENT MONITORING
Cohort Event Monitoring (CEM) systems for
intensified follow up of selected medicinal
products
The main limitations are its restriction to small
subset of medicinal products, the relatively
small fraction of the population covered

16. LONGITUDINAL ELECTRONIC
PATIENT RECORDS
• It is extremely valuable but still in used
• They cover large population, provide detailed
information on both exposed and unexposed
patients
• Information is extracted directly from the
computer systems in which physicians store
patient’s data

17. PERIODIC SAFETY UPDATE
REPORTS (PSUR)
• Pre marketing clinical trials may not be
sufficient to reflect the product safety profile
• Therefore medically advanced countries
impose the “post marketing drug safety
monitoring period ” on new drugs
• License holders shall proactively collect post
marketing safety data, prepare PSUR and submit
them to the health authority

18. CONTINUE..
•According to the “regulation of medical products under
safety monitoring”, if pharmaceutical companies fail to
submit PSUR as required, then the health authority may
consider the safety of the concerned product
• The last PSUR should be submitted before the
expiration of the drug safety monitoring period
•The “summary bridging report” provides summarized
information of the PSURs

19. EXPEDITED REPORT
• If there has been spontaneous reporting of a
suspected ADR to a pharmaceutical company,
there are legal obligations on the company to
report serious reactions within a specified time
frame to the regulatory authority
• Based on the results of drug safety assessment,
license holders shall report to the health
authorities in an expedited manner

20. ADVERSE DRUG REACTIONS
• In year 1932 it was
introduced for treatment
of streptococcal
infections in a elixir or
syrup dosages form
• But, in year 1937
sulphanilamide is
withdrawal from market
because it was
responsible for death of
105 individuals

21. THALIDOMIDE DISASTERS
• In year 1957
thalidomide was
introduced in market
for treatment of
morning sickness &
nausea
• And in year 1961 it was
withdrawal from the
market due to massive
pressure from press and
public

22. Continue..
• 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- are response to the
drug which is noxious & unintended which occurs
due to doses normally used in man for the
prophylaxis, diagnosis or therapy of disease.
There is causal link between a drug & an adverse
drug reaction

23. Continue..
•Side effects
undesirable and unavoidable effects of drugs due to
their pharmacological property at recommended doses
Ex-dry mouth from atropine therapy
•Toxic effect
It is a pharmacological action due to over dosage or
prolonged usage.
Ex-coma with barbiturates

24. 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
• Promote understanding, education and clinical training
in pharmacovigilance and its effective communication
with the public

25. REFERENCE
https://www.google.co.in/search?q=cerivastatin+drug+or+dosages
https://www.linkedin.com/pulse/all-pharmacovigilance-must-read-
garima-srivastava
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC59524/
https://www.google.co.in/#q=pharmacovigilance+from+medicine.net
www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/
en/
who-umc.org/Graphics/24729.pdf
www.who-umc.org/graphics/28550