This document provides an overview of pharmacovigilance and the Pharmacovigilance Program of India (PvPI). It defines pharmacovigilance as the science of detecting, assessing, understanding, and preventing adverse effects of medicines. The document outlines the historical events that led to the development of pharmacovigilance, including the sulfanilamide and thalidomide disasters. It describes the vision, mission, aims, and objectives of PvPI in India to improve patient safety related to medicine use. Key aspects of PvPI covered include adverse drug reaction reporting processes and the expansion of PvPI to include additional medical areas over time.

1. PHARMACOVIGILANCE & PvPI
Presented By,
Mr. Naikwadi Nikhil Kisan
Roll No :- 26
F. Y. M. Pharm (Sem- II)
Dept Of Pharmaceutics
Rajarambapu college of Pharmacy Kasegaon, Sangali

2. CONTENT :-
• 1) What is Pharmacovigilance ?
• 2) Why it is essential ?
• 3) Historical Background.
• 4) Two Important Disaster .
• 5)Terms related to pharmacovigilance .
• 6)Types of advers effect .
• 7) Severity of adverse drug reaction.
• 8) Prevention of adverse effect of drugs.
• 9) Rational use of medicines.
• 10) PvPI (Pharmacovigilance program in india) .
• 11) Vision ,Mission, aim and objectives Of PvPI .
• 12) Performance & Effectiveness Of PV .
• 13) Expansion Of PvPI .

3. What is Pharmacovigilance ?
Pharmacovigilance (PV) Etymological root : Pharmakon
(Greek) means Drug And Vigilar (Latin) mean To keep
awek or alert, or to keep watch .
Pharmacovigilance has been defined by the WHO
(2002) as the ‘Science and activities relating to the
detection, assessment, understanding and prevention
of adverse effect or any other drug related problem.’

4. Why it is essential ?
• It is essential component of patient care and rational use
of medicine .
• It is also referred as adverse drug reaction monitoring,
Drug safety surveillance, side effect monitoring,
spontaneous monitoring, post –marketing surveillance or
variation of these .
• Pharmacovigilance involves the safety monitoring all
medicines including herbal and complementary remedies
,vaccines and biological substance .

5. Claude Bernard :-
(Physiologist and pharmacologist)
“Everything is poisonous
nothing is poisonous.”

6. Dose :-
• Proper dose = Medicine
• Higher dose = Poison

7. Historical Background :-
• This Pharmacovigilance is well developed specially in
USA,UK and other some developed countries .
• There are some major events took place behind the
development of pharmacovigilance .
• There are many historical events which give rise to
this pharmacovigilance .

8. Two important events :-
1) Sulfanilamide Disaster .
2) Thalidomide Disaster .

9. Sulfanilamide Disaster :-
• Sulfanilamide disaster which introduce first basic law of USA .
• S.E.Massengill US company was selling sulfanilamide for the cure of
streptococcul infection.
• That time sulfanilamide sold in the form of tablet & childrens cannot take
the tablets , there was demad to have liq. of this sulfanilamide in the
market .
• Finally chemist found that sulfanilamide soluble in diethylene glycol
popularly known as DEG.

10. • As the chemist found that drug is soluble in DEG it produce liquid from it
and company marketed it with the name of “Elixir Sulfanilamide ”.
• Soon it was available in the market people consumed it and suddenly
poisonous effect of DEG were seen ,and about 107 deaths were reported
the consumption of DEG ,because DEG poisonous product .
• The pharmacist who develop the formula comitted suicide.
• The company Massengill was fined highest possible amount .

12. Why this disaster took place ?
- So, because of there was no law of governing the safety of the medicine .
- At that time Govt of USA introduce the law , the law was known as FDC
act 1938 ,it was at a time .
- Only safety has to be proved at that time .

13. Thalidomide disaster :-
- In 1950 west german pharmaceutical company was very
famous company those introduce sedative drug thalidomide .
- Thalidomide which is induce natural sleep without hangover
the next day the drug become very popular .
- It ultimately means that thalidomide is very safe drug .
- It was very useful in controlling the vomiting in pregnancy that
is what we called “morning sickness”.

14. - In 1960 marketed in 46 countries (hypnotic prevention of
nausea in pregnancy).
- In England, Germany and resulted in high incidence limb
reduction anomalies(phocomelia) in the new born .
- In 1960 first repot of deformed infants (phocomelia) total
more than 20,000 cases .
- Phocomelia means there is short limb like upper and
lower.

15. Phocomelia :-

16. Why thalidomide didn’t entered in US market ?
Dr. Frances Kelsey was a Canadian-American pharmacologist & physiologist . As a reviewer for the U.S.
FDA, she refused to authorized thalidomide for market because she had concern about the lack of
evidence regarding the drug safety Kelsey received the presidents award for distinguished Federal
Civilian Service from president John F. Kennedy, 1962.

17. Terms related to pharmacovigilance :-
Side effect :- Any unintended effect of pharmaceutical product
occuring at dose normally used in man which is related to the
pharmacological properties of drug.
e.g . Sedation with antihistaminics.
Adverse event /Adverse experience :- Any untoward
medical occurrence that may be present during treatment with a
pharmaceutical product at a same time dose not necessarily have a
causal relationship with this treatment .

18. Types Of Advers Effect :-
• Predictable (Type A or Augmented) reaction .
• Unpredictable (Type B or Bizarre)reaction .

19. Predictable (Type A or Augmented)
reaction :-
• It is also called as mechanism based adverse reaction
• These are based on pharmacological properties of the drug ,
which means that they are augmented , but qualitatively
normal response to the drug ; include side effects, toxic effect
and consequences of drug withdrawal.

20. Unpredictable (Type B or
Bizarre)reaction:-
• These are based on peculiarities of the patient and not on
drug’s known action ; include allergy and idiosyncrasy.
• They are less common ,often non-dose related ,generally
more serious and require withdrawal of the drug .
• Some of these reaction can be predicted and prevented if
their genetic basis is known and suitable test to characterized
the individual phenotype is performed .

21. Severity of adverse drug reaction :-
• Minor :- No therapy, antidote and prolongation of
hospitalization is required .
• Moderate :- Requires change in drug therapy , specific
treatment or prolong hospital stay by at least one day .
• Severe:- Potentially life-threatening,causes permanent
damage or requires intensive medical treatment .
• Lethal:- Directly or indirectly contributes to death of the
patient.

22. Prevention of adverse effect of drugs :-
• Avoid all inappropriate use of drug in the context of patient’s
clinical condition .
• Use appropriate dose ,route and frequency of drug
administration based on patient’s specific variables.
• Elicit and take into consideration previous history of drug
reactions.
• Rule out possibility of drug interaction when more drug is
prescribed.
• Elicit history of allergic diseases and exercise caution (drug
allergy is more common in patients with allergic diseases) .

23. Rational use of medicines :-
• It is widely assumed that use of drugs by qualified
doctors of modern medicines would be rational.
• As per WHO – ‘rational use of medicines requires
that the patients receive medication appropriate to
their clinical needs , in doses that meet their own
individual requirements for an adequate period of
time , and at the lowest cost to them and to their
community’.

24. PvPI (Pharmacovigilance program in india):-
• PvPI is conducted by IPC (Indian Pharmacopoeial
commission) & CDSCO (Central Drug Standard
Control Organization) both of these institutes under
Ministry of Health & Family Welfare Government Of
India .
• Mainly PvPI in india is IPC & the head of the program
is DCGI (Drug Control General of India).

26. Vision & Mission Of PvPI :-
• Vision :- To Improve Patient safety and welfare of
indian population by monitoring the drug safety and
thereby reducing the risk associated with use of
medicine .
• Mission :- Safe gaurd the health of the indian
population by ensuring that the benefits of use of
medicine out weight the risks associated with its use.

27. Aim of PvPI :-
• To improve patient care and safety in relation to the use of
medicines and all medical and paramedical intervention.
• To improve public health and safety in relation to the use of
medicines.
• To contribute the assessment of benefit, harm, effectiveness
and risk of medicines, encouraging their safe rational and
more effective (including cost effective) use .
• To Promote understanding , education and clinical training in
PV and its effective communication to the public .

28. Objectives Of PvPI :-
• To create a nation –wide system for patient safety reporting .
• To identify and analyze the new signal ADR from the reported
cases.
• To generate the evidence-base information on safety of medicines.
• To communicate the safety information on use of medicines to
various stakeholders to minimize the risk.
• To emerge as a national center of excellence for PV activities.
• To collaborate with other national centers for the exchange of
Information .

29. Performance & Effectiveness Of PV :-
Who Can Report ?
- HCPs(Healthcare Professionals ),Pharmacists, Nurses can be report suspected
ADR.
- Pharmaceutical Companies can also send ICSRs(case study report is a safety
service ) specific for their product to NCC(National Coordination Centre ).
What To Report ?
- All types of suspected ADRs irrespective of whether they are known or
unknown, serious and non-serious, frequent or rare.
Whom To Report ?
- Use the ‘Suspected ADR Reporting Form’ which is available on the official
website of IPC and CDSCO.

30. How to report of ADR .
Suspected ADR reporting form
PvPI
AMC (ADR Monitoring Center)
NCC (National Coordinating center)
GOVT Of India (Analysis to Causality Assessment )
(Vigiflow)
Vigibase WHO ( WHO UMC Centre, Uppsala Monitoring Center, Swedan )

31. Expansion Of PvPI :-
• HAEMOVIGILANCE on 10th Dec 2012.
• Revised National TB Control Program (RNTPC) Oct 11th,2013
• Participation Of Nursing Professionals : NCC-PvPI organized a
meeting with president Nursing council Of India (NCI), On 16th July
2014
• National AIDS Control Organization (NACO): 15th Sept, 2014.
• ADR Monitoring Centers (AMCs) :-July 2010.
• All MCI approved teaching hospitals established as AMCs under the
PvPI.
• Medical Council Of India (MCI): Mandatory for every medical
college in india to have a PV committee, as per regulation of
medical council of india,2010.

32. References :-
• Essentials Of Medical Pharmacology 8th edition , K.D. Tripathi, Jaypee
brothers medical publishers Adverse Drug Effects , page no. 92-95.
• Textbook of pathology, Fourth edition, Harsh Mohan, Jaypee brothers
medical publishers, Genetic & Paediatric Diseases, page no.239.
• Acuere Life Sciences foundation by Shantanu .R. Joshi,
https://www.youtube.com/watch?v=Jm_NuQgBFzQ&t=624s

33. Thank You !