This document outlines the course structure and contents for a Practice School pharmacovigilance course. It includes an introduction to pharmacovigilance, definitions, clinical research principles, good clinical practices, adverse drug reaction identification and assessment. It also discusses ICH E2E guidelines, selection of the antifungal drug Amphotericin B for analysis, identification of its adverse effects through patient interviews and hospital visits.

1. PRACTICE SCHOOL
1

2. Course Structure And Contents For
PRACTICE SCHOOL (BP706PS)
B.Pharmacy Final Year (sem VII)
Domain – 18
PHARMACOVIGILANCE
2

3. A Review Article By :
More Vaishnavi Ramrao .
2052811823015
Final Year B. Pharmacy.
Guided By :
Prof . Unmesh Bhamare.
3

4. INDEX
• ABSTRACT
• INTRODUCTION.
• DEFINATION.
• CLINICAL RESEARCH.
• GOOD CLINICAL PRACTICES.
• CONCEPT OF PHARMACOVIGILANCE.
• ICH E2E GUIDELINES .
• SELECTION OF DRUG CLASS .
• IDENTIFICATION OF ADVERSE EFFECT OF SELECTED DRUG.
• HOSPITAL VISIT.
• PATIENT INTERVIEW .
• ASSESMENT OF ADR.
• BIBLIOGRAPHY.
4

5. ABSTRACT
• In include pharmacovigilance is study in which we study about the drug use ,its mechanism of action
, adverse effect and how to overcome these effect . and in these we study about the use of a
Amphotericine B drug in treatment of MUCORMYCOSIS. Took a look on mechanisam of action
side effect , adverse effect .And patient interview in that how they suffer when they are suspect of
these disease.
5

6. INTRODUCTION TO PHARMACOVIGILANCE
• The role of pharmacovigilance is to ensure the safety and efficacy of drugs by monitoring their
effects on patients.
• Pharmacovigilance involves the collection, analysis, and interpretation of data on the
adverse effects of drugs.
• It also involves the identification of new safety information and the assessment of the risk-
benefit balance of medicines.(1)
6

7. DEFINATION OF PHARMACOVIGILANCE
• Pharmacovigilance has been defined by the world health organisation as “the science and activities
relating to the detection, assessment, understanding and prevention of adverse effects or any other
possible drug-related problem”. (14)
7

8. CLINICAL TRIALS
8
Preclinical
involves
laboratory
studies
Phase 1
Safety
Phase 2
Safety and
Dosing
Phase 3
Safety and
Efficacy
Phase 4
Post Marketing
Safety And
Efficacy (2)

9. FUNCTIONS OF DRUG CONTROLLER GENERAL OF
INDIA (DCGI)
9
Heads The Central Drugs Standard Control
Organization.
Establishes Standards For Manufacturing , Sales
,Import And Distribution Of Drug In India.
Prepare And Maintain The National Reference Standard
For Drugs. (6)

10. TYPES OF REGULATORYAPPLICATION
• Investigational new drug (IND)
• It is an application to FDA to get the permition for drug to use on humans .
• It is unique because it allows companies to bypass pre marketing study and approval
process in order to bring product in market quickly.
• New drug application :
• New drug application (FDA) is the vehicle in the united states through which drug
sponsors formally propose that the FDA approve a new pharmaceutical for sale and
marketing.(12)
10

11. ABBREVIATED NEW DRUG APPLICATION :
• An abbreviated new drug application (ANDA) contains data which is submitted to
FDA for the review and potential approval of a generic drug product. Once
approved, an applicant may manufacture and market the generic drug product to
provide a safe, effective, lower cost alternative to the brand-name drug it
references. (12)
11

12. FUNCTION OF CDSCO
•
12
.
Head Quarter : New drug CLLA
Imports DTAB/DCC
Port Office : Import Export
Zonal and Sub Zonal Office : GMP Audits
Coordinates with States
+
Laboratory : Testing Of Drug Samples Validation
of Test Protocol

13. GOOD CLINICAL PRACTICES
Assuring and unholding
the welfare , rights
,privacy and safety of the
trial subjects .
Safeguard the integrity ,
accuracy and quality of
clinical trials .
Minimizing the
exposure of humans to
investigational products
and risks associated
with them .
A guided approach to
accelerate the marketing
of new products .
Trial and product cost
reduction to benefit
both sponsor and
consumers .
13

14. SCOPE OF ICH –GOOD CLINICAL PRACTICES
It gives methodologies and procedures to be used to monitor and ensure the safety, quality
and efficacy of medicines intended to treat humans.
14

15. PROTOCOL DESIGNING FOR CLINICAL TRIALS
15
Protocol
General and
background
information
Objective
and Clinical
trials
Selection
and
withdrawal
of subject
Treatment
and safety
assesment
Quality
control
Record
Keeping

16. PROCESS OF CLINICAL TRIAL APPLICATION IN PHARMACOVIGILANCE
16
Information from
already known
safety risk .
Collection of safety
data from clinical
trials
Safety data
processing
Evaluation of
collected data
Analysis for benefit
risk balance in a
product

17. CONCEPT OF PHARMCOVIGILANCE
• DEFINE
• Pharmacovigilance has been defined by the world health organisation as “the
science and activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other possible drug-related problem” . (1)
17

18. OBJECTIVES OF IT
Improve Patient Care And Safety In Relation To Use Of
Medicals .
Improve Public Health And Safety .
Prevent Adverse Effect Or Any Other Drug Related
Problems.
18

19. TYPES AND COMPONENTS OF PHARMACOVIGILANCE
19

20. COMPONENTS
The four main elements are
1)Detection.
2)Assessment.
3)Understanding .
4)Prevention of adverse drug effects.
20

21. CONSTITUTION AND OBJECTIVES OF
PHARMACOVIGILANCE PROGRAM OF INDIA :
21
• The national pharmacovigilance program is coordinated at central drug standard control
organization office .
• Aims
• Monitoring adrs.
• Review psurs.
• Recomondations regarding label , amendements and withdrawal .
• Provides information through bulleteins , drug alerts and seminars .

22. FUNCTION OF NATIONAL ADVERSE DRUG MONITORING CENTERS :
22
COMMUNICATION
ANALYSIS
STORAGE
AWARENESS
DOCUMENTATIO
N
TIME
CONSUMPTIO
N
DATA
RETRIEVAL

23. LIST OF NATIONAL ADVERSE DRUG
MONITORING CENTERS AND THEIR FUNCTIONS
23
• IGIMS ,
Patna
(3)
• CMC,
Vallore
• RIMS ,
Ranchi
• JSS,
Mysore
PGIMER,
Chandigarh
KEM,
Mumbai
IMS,
Varanasi
AIMS,New
Delhi

24. FUNCTIONS OF THE WHO PROGRAMME FOR
INTERNATIONAL DRUG MONITORING INCLUDE
24
Identification and analysis of new adverse reaction signals from case report
Information exchange between WHO and National Centres mainly through an
Email .
Publication of periodical Newsletters , Guidwlines and Books in
pharmacovigilance and risk management area.
Providing Training and Consultancy Support to National Centres and Countries

25. INTERNATIONAL CONFERENCE ON HARMONIZATION
E2E GUIDELINES
• ELEMENTS OF NON CLINICAL AND CLINICAL SAFETY SPECIFICATION
:
• SAFETY SPECIFICATION CAN INCLUDE
1. Identified risks .
2. Important potential risk .
3. Important missing information .(7)
25

26. NON CLINICAL SAFETY
SPECIFICATION
• Non clinical safety findings that have not been adequately addressed by clinical data .For
example
• Toxicity
• General pharmacology
• Drug interaction
• Other toxicity related information and data .
• CLINICAL SAFETY SPECIFICATION
• Limitation of the human safety database
• Population not studied in the pre – approval phase
• Adverse drug reaction
• identified and potential interactions , including food -drug and drug-drug interaction
• Epidermology . (7) 26

27. IDENTIFICATION AND EVALUATION OF RISK INCLUDING DRUG -
DRUG INTERACTION AND DRUG -FOOD INTERACTION
27
What is the time course of the interaction ?
What is class of the given drug ?
Is the interaction clinically significant ? (13)

28. DRUG - FOOD INTERACTION
28
Actions For Drugs
Actions For Drugs
Adverse Effect (9)

29. DESIGN AND CONDUCT OF OBSERVATION STUDIES
• AN OBSERVATIONAL STUDY IS A FORM OF QUALITATIVE RESEARCH
IN WHICH THE RESEARCHER OBSERVES PARTICIPANTS’ BEHAVIOUR.
THERE ARE DIFFERENT TYPES OF OBSERVATIONAL STUDIES, SUCH AS
CONTROLLED, NATURALISTIC, AND PARTICIPANT STUDIES.
•
THIS SECOND EDITION OF DESIGN OF OBSERVATIONAL STUDIES IS
BOTH AN INTRODUCTION TO STATISTICAL INFERENCE IN
OBSERVATIONAL STUDIES AND A DETAILED DISCUSSION OF THE
PRINCIPLES THAT GUIDE THE DESIGN OF OBSERVATIONAL STUDIES.
(9)
29

30. SELECTION OF DRUG CLASS
• SELECTED CLASS OF DRUG :
• ANTIFUNGAL CLASS
• DRUG NAME IS AMPHOTERICINE – B .
• ANTIFUNGAL DRUG DEFINE
• The drug which are used to treat fungal pathogen / infection that drug
called as antifungal drug .
EG : AMPHOTERICINE B .
(10)
30

31. AMPHOTERICINE B
• Amphotericin B is for serious, life-threatening fungal infections. It is not
for use in treating a minor fungal infection .
• It used to treat infection like mucormycosis fungal infection .
• Amphotericin B given to patient by oral or by intravenous route .
• Some available medicines
• Ampholip
• Amphomul
• Amfy v
• Fungizone ,etc .
31

32. PROFILING OF SELECTED DRUG CLASS
MECHANISM OF ACTION (AMPHOTERICIN –B )
32
Binds Ergosterol In Fungal Cell Membrane
Form Pores In Cell Membrane
Cell Contents Leak Out

33. PHARMACOLOGICAL EFFECT
33
Produced By
•Streptomycine
Nodosus .
Pharmacological
activity
•Broadspectrum
Activity .
Mechanism of
action
•Bind To
Ergosterol in
fungi to form
pores .

34. INDICATIONS
34
Systemic Fungal Infections.
Infection Of The G.I. Tract Caused By
Candida Albicans.
Oral And Perioral Candida Infection.

35. DRUG INTERACTION
35
Flucytosine
increases toxicity
.
Diuretics or
cisplatin increase
renal toxicity and
risk of
hypokalemia.
Corticosteroids
increase risk of
hypokalemia.
In general
combination with
nephrotoxic
drugs increases
the risk of serious
renal damage.

36. CONTRAINDICATION AND SIDE EFFECTS.
36
Contraindications :
Contraindicated in patients
hypersensitive to drug (14)

37. SIDE EFFECTS
Gastrointestinal
disturbances
Renal damage
Hypokalemia
Myopathy and
neuropathy
Dependance
Respiratory
depression
37

38. SYMPTOMS :
One-sided Facial
Swelling And
Numbness,
Headache,
Nasal Or Sinus
Congestion,
Black Lesions
Fever
Abdominal Pain
Nausea
Gastrointestinal
Bleeding.
38

39. IDENTIFICATION OF ADVERSE EFFECTS
(15)
In a diabetic
woman who
developed
renal failure
Fever
Chills
Kidney failure
Hypotension
anemia
39

40. ADVERSE DRUG REACTION (ADR) MONITORING FORM
40

41. ASSESMENT OF ADR
• Naranjo adverse drug reaction probability scale score was 5, the world health organization-uppsala monitoring centre
criteria: probable, indicating a probable adverse reaction to amphotericin B liposome. Keywords: acrocyanosis,
amphotericin B liposome, histoplasmosis, impaired renal function. (15)
41

42. CONCLUSION
• It observes that because of antifungal property Amphotericine B will be very useful in the
treatment of Mucormycosis but some time it shows some adverse effect too .so we need to study
pharmacovigilance term to find out some another medicament which conquare these effect .
42

43. BIBLIOGRAPHY.
1. Https://primevigilance.Com/resources/what-is-pharmacovigilance/
Byjus.Com › drug-controller-general-of-india-dcgidrug controller general of india (DCGI) -
BYJUS
2. Https://primevigilance.Com/resources/what-is-
pharmacovigilance/pharmacovigilance-in-clinical-trials/
3. International drug monitoring: the role of national centers (WHO technical report series
no .498) WHO
4. Https://primevigilance.Com/resources/what-is-
pharmacovigilance/pharmacovigilance-in-clinical-trials/byjus.Com ›
drug-controller-general-of-india-dcgidrug controller general of
india (DCGI) - BYJUS
5. Byjus.Com › drug-controller-general-of-india-dcgidrug controller
general of india (DCGI) – BYJUS
/
43

44. 6. Https://byjus.Com/free-ias-prep/drug-controller-general-of-india-dcgi/
7. Https://cdsco.Gov.In/opencms/opencms/en/about-us/functions/
8. Https://byjusexamprep.Com/
9. Https://www.Medindia.Net/drugs/drugs-interactions/amphotericin-b.Htm
10. Https://www.Wikidoc.Org/index.Php/amphotericin_b_drug_interactions.
11. WHO, safety of medicines in public health programmes : pharmacovigilance
an essential tool, WHO 2006
44

45. 12 .Https://www.Pharmaguideline.Com/2022/09/investigational-new-drug-ind-
application.Html
13 .Www.Glocaluniversity.Edu.In › files › econtent
14 .Www.Globalpharmatek.Com/blog/what-is-the-aim-of-pharmacovigilance
15 .Www.Studysmarter.Us › observational-designwho, safety of medicines: A guide to
decting and reporting adverse drug reactions, geneva: WHO, 2002.
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46. .
THANK YOU …..
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