PVPI is a structured program for controlling drugs and their related effects. It is a rate-limiting step in drug usage in clinical practice, a step towards patient safety.

1. PVPI – A Cost Effective Program for a
Patient(s)
K V GOPINATH
HOSPITAL PHARMACIST
T T D Aswini Hospital Tirumala
Andhrapradesh India-517 504
Mob: 89789 93810
E-mail: gopinath.karnam@gmail.com
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

2. Objectives of the present webinar
• Why Pharmacovigilance?
• Basic elements of Pharmacovigilance?
• Methods of Pharmacovigilance
• Pharmacovigilance of Chronic Diseases – Hospital/
clinical pharmacists
• Case studies
• Basic Steps in Case Process
• Conclusion
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

3. Why Pharmacovigilance??
ILL
NO ILL
PILL ILL
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

4. Definition of Pharmacovigilance
Science and activities relating to the
Detection, Assessment, Understanding
and Prevention of Adverse Drug
Reactions or any other possible drug
related problems’
WHO 2002
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

5. Basic Elements of PVPI
Adverse Drug Reaction –
A response which is noxious
and unintended, and which
occurs at doses normally
used in humans for treatment
WHO, 1972
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

6. Basic Elements of PVPI
Adverse Event –
Any untoward medical
occurrence that may
present during treatment
with a pharmaceutical
product but which does
not necessarily have a
causal relationship with
this treatment
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

7. Methods of Pharmacovigilance
Physician Pharmacist
Nurse Citizen
Patient
Passive
• Spontaneous
• Case Series
• Stimulated
Reporting
Active
• Sentinel Sites
• Medicine Event
Monitoring
• Registries
• Case control, Cohort,
Cross Sectional Study
• Targeted Clinical
Investigations
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

8. Burning Issue of Drugs
SERIOUSNESS
Fatal
Life
Threatening
Prolonged
Hospitalisation
Leads to
Disability
Birth
Defects
Medically
Judged to
Seriousness
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

9. Pharmacovigilance of Chronic Diseases –
Hospital & Community Pharmacists
Hypertension
Diabetes
Asthma
Rheumatoid Arthritis
Epilepsy
Tuberculosis and
Leprosy
Adverse Effects of Drugs & Adverse Events
Poly Pharmacy
Paradoxical Reactions
Vaccination Failure
Irrational Use and Lack of Efficacy
Drug interactions
Poisoning and Over Dose
Abuse and Misuse of Drugs
Medication Errors
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

10. Case Study - 1
Importance of PVPI
Demographic Data
Date 26102007 01112017
Sex M
Age 43 54
Weight 65 kgs 70
BP 140/90 130/80
Diagnos
is
Asthma Asthma -
Coreoretin
opathy
Prescription Profile
Name of the Drug Date
Foracort 400 mcg 26102007
Dloratin
Duolin R/C 1 od 01112017
Levolin R/C , sos
Roflair 1 od
Tab Emlukast FX 1 od
Tab Macphyllin SR , hs
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

11. Symptoms of Retinopathy
• Retinopathy is asymptomatic in early stages of the disease. As
the disease progresses symptoms may include-
• Blurred vision
• Floaters and flashes
• Fluctuating vision
• Distorted vision
• Dark areas in the vision
• Poor night vision
• Impaired color vision
• Partial or total loss of vision
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

12. Case Study : 1
Signs of Retinopathy
Lipid Accumulation with increased
vasopermeability – Hard Exudates
Lesions in nerve fiber - micro infarcts of the
retinal nerve fibre – Cotton Wool Effect
Micro aneurysms and retinal dot and blot
haemorrhage Flame Shaped Haemorrhages
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

13. Case Study
Demographic Data
Date 26102007 01112017
Sex M
Age 43 54
Weight 65 kgs 70
BP 140/90 130/80
Diagnos
is
Asthma Asthma -
Coreoretin
opathy
Prescription Profile
Name of the Drug Date
Foracort 400 mcg 26102007
Dloratin
Duolin R/C 1 od 01112017
Levolin R/C , sos Ophthalmic
opinion: Not to use
any kind of dosage
contain Steroids as
patient developed
Coreo retinopathy
Roflair 1 od
Tab Emlukast FX 1 od
Tab Macphyllin SR , hs
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

14. Macula Thickness - Ocular Coherent
Tomography: Macular Cube
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

15. Macula Thickness - Ocular Coherent
Tomography : Macular Cube
OS Central
Subfield
Thicknes
s (μm)
Cube
Volume
(mm³)
Cube
Average
Thicknes
s (μm)
ILM-RPE 622 12.3 343
OD Central
Subfield
Thicknes
s (μm)
Cube
Volume
(mm³)
Cube
Average
Thicknes
s (μm)
ILM-RPE 218 9.7 269
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

16. Impact of Intervention : Roflumilast
ILM-RPE Central Subfield
Thickness (μm)
Cube Volume
(mm³)
Cube Average
Thickness (μm)
OS
On Steroid
622 12.3 343
OS
On Non - Steroid
214 9.7 270
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

17. Case Study : 2
Steroid Induced Retarded Growth
• 15 year Female patient with
stunted and retarded growth
• Wt :34 kgs
• Ht:140CMs
• BP 129/77 mm/Hg,
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

18. Comparison of Total Cost of Asthma & Cost of Asthma Drug
Complications
13709.33
15000
COA
CADC
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

19. Case Study : 3
Fluconazole Induced Skin Reaction
• Demographic Date
45 M Patient complain with Fungal
Infections treated with Tab : Fluconazole 150 mg
on day one and three. Max. Dose 600 mg
A D R
•Chills
•Light colored stools
•Tachycardia
•Difficulty in breathing
•Swelling on extremities
•Itching and skin rashes
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

20. Case Study 4
Minoxidil Induced Drug Reaction
• Minoxidil – At present time
use in milder decrease in HT
is not recommended
because Risk – Benefit
relations not define
• New indication – Pattern
Hair loss related problems
in either sex
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

21. Basic Steps in Case Process
• Data Collection, Verification & Acknowledgement
• Duplicate Review
• Triage
• Data Entry
• Case Narrative
• Coding of A D R description and Drug Coding
• Case Causality Assessment
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

22. Summary of PVPI
Drug Patient
Upload ADRs
Patient Safety
ADR
Analysis, Processing in
Vigi- Flow
NCC - PVPI
Drug Ban
Reporting
Quality Assessment Signal Detection
AMC, Peripheral,
Regional, Zonal
Regulatory Authority
CDSCO/WHO-UMC
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

23. How to Report ADR
• Toll free number :1 800 180 3024
• Mailing the filled ADR reporting form directly to pvpi@ipcindia.net
• Adverse Drug Reaction Monitoring Centre (AMC)
• VigiAccess™: http://www.vigiaccess.org/
• https://www.who-umc.org/
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

24. Conclusion
“PVPI is a science or micro science dealing with drug
and its effects in biological system where close
monitoring of the patients to ensure safety, efficacy ,
appropriate and economic treatment there by
patients safety to strengthen nations health”
Pharmacovigilance Week 2021 : A Step Towards Patient Safety By ACPI ,CliMed, IPC

25. • Dr N Anantha Nagappa
• Dr N Uduppa
• Dr Hanumanthachar Joshi
• Dr Ajith Singh
• Dr V Gopal
• Dr K S Ganesh Arulkumaran
• Dr Pavan Kumar
• Dr Pranay Wai
• Dr K Karthikeyan
• DR RVS Muralidhar, Dr Narmada and
Dr Kusuma and Mrs Archana, and Mr
Kiran