2. PHARMACOVIGILANCE
Pharmacovigilance is “the science and activities
relating to detection , assessment , understanding
and prevention of adverse effect or any other related
problems”
3. ‘‘A response to a drug which is noxious
and unintended, and which occurs at dose
normally used in man for prophylaxis,
diagnosis, or therapy of disease, or for
modification of physiological function’’
(WHO Definition)
4. CAUSES OF ADRS
INTRINSIC FACTORS OF THE DRUG
- Pharmacological
- Idiosyncratic
- Carcinogenicity , Mutagenicity
- Teratogenicity
EXTRINSIC FACTORS
- Adulterants
- Contamination
UNDERLYING MEDICAL CONDITIONS
- Interactions
- Wrong usage
5. TYPES OF ADR
Type A Augmented – Hypoglycemia with insulin
Type B Bizzare – Penicillin hypersensitivity
Type C Chronic – HPA suppression by steroids
Type D Delayed – DES induced vaginal ca. in
offspring
Type E Ending – Clonidine withdrawal
Type F Failure – OCP failure with rifampicin
Type G Genotoxic – Anticancer drugs
6. WHO PROGRAM
FOR
INTERNATIONAL DRUG MONITORING
Started -1968
Located in Uppsala,Sweden
ROLE
1)Identify early warning signals of ADRs
2)Evaluate the hazards
3)Undertake research in to mechanisms of actions to aid the
development of safer & more effective medicines
9. AMC
Collecting ADR
reports
Perform follow up
Assessment of ADRs
Data entry in to
Vigiflow
Training/
sensitization/
feedback
NCC
Preparation of
training manuals
Conduct Training
workshops
Publication
of Newsletter
Reporting to CDSCO
Analysis of PSUR
CDSCO
Regulatory decision &
actions
safety related
decisions to
stakeholders
Collaboration with
WHO-UMC
Provide provisions &
support to
National PvPI
10. Red form will be
checked & signed by
Coordinator / Sub
coordinator ADRs will be entered in
Vigiflow, WHO
database
ADRs reviewed &
analyzed for any
alerts/signals by
signal review
committee
& sent to CDSCO
ADRs will be
reviewed & sent to
UMC.
13. DECHALLENGE AND RECHALLENGE
Dechallenge – The withdrawal of a drug from a
patient the point at which the continuity,
reduction or disappearance of adverse effects
may be observed.
Rechallenge – The point at which a drug is again
given to a patient after its previous withdrawal
(dechallenge).
15. CAUSALITY ASSESSMENT
NARANJO's ALGORITHM
question Yes No Don't know
Are there previous conclusion reports on this reaction? +1 0 0
Did the adverse event appear after the suspect drug was administered? +2 -1 0
Did theARimprove when the drug was discontinued or a specific
antagonist was administered?
+1 0 0
Did theARreappear when drug was readministered? +2 -1 0
Are there alternate causes [other than the drug] that could solely have
caused the reaction?
-1 +2 0
Did the reaction reappear when a placebo was given? -1 +1 0
Was the drug detected in the blood [or other fluids] in a concentration
known to be toxic?
+1 0 0
Was the reaction more severe when the dose was increased, or less
severe when the dose was decreased?
+1 0 0
Did the patient have a similar reaction to the same or similar drugs in any
previous exposure?
+1 0 0
Was the adverse event confirmed by objective evidence? +1 0 0
17. WHO CAUSALITY CLASSIFICATION
1)CERTAIN
-Clinical event ,with plausible time relationship to drug
intake.
-Cannot be explained by concurrent ds or other drugs
2)PROBABLE /LIKELY
-With reasonable time relationship to drug intake
-Unlikely to be due to concurrent ds or drugs
3)POSSIBLE
-With reasonable time relationship to drug intake
-Could also be explained by concurrent ds or drugs
18. 4)Unlikely
-Clinical event or lab test with improbable time
relationship with drug intake
-Other drugs/ds provide plausible explanation
5)Inaccessible/unclassifiable
-Insufficient /contradictory evidence which cannot
be supplemented /verified
6)CONDITIONAL/UNCLASSIFIED
- More data is essential for proper assessment or
additional data are under examination
19. SERIOUS ADR REPORTED IN OUR
HOSPITAL
Stevens Johnson Syndrome –Carbamazepine
Fixed Drug Eruption –Ciprofloxacin, amoxycilin /
clavulanic acid
Erythroderma- Leflunomide
Acute Generalised Exanthematous Pustulosis -
Amikacin and Meropenam
20. RECOMMENDATIONS AND REGULATORY
ACTION –LABEL CHANGE
Drugs ADR
Ranitidine Cardiac arrest
Anti Rabies
Vaccine
Erythema Multiforme
Pulmonary
Surfactant
Pulmonary Hemorrhage
Ceftriaxone Steven Johnson Syndrome
Lamotrigine Steven Johnson Syndrome &
Toxic Epidermal Necrolysis
21. Drug ADR In India Global
Status
Sodium valproate Slurred speech 11 14
Streptokinase Hepatitis 4 18
Liraglutide IHD 2 45
Bupivacaine Confusional state 2 13
Omeprazole Hypokalemia 1 49
Furosemide Breathing
abnormalities
1 33
Nitrofurantoin Lip odema 1 9
Amphoterecin-B Hypernatremia 1 6
Tramadol Renal and urinary
Tract neoplasm
1 5
Metronidazole Thrombophlebitis 1 2
Gentamycin Thrombophlebitis 1 1
Suspected unexpected serious adverse reaction
(Reported SUSAR in India and globally during 2011-2013)
22. SUSPECTED UNEXPECTED SERIOUS ADVERSE DRUG
REACTIONS REPORTED IN 2015
No Name Reported ADR Indian
status
Global status
1 Sildenafil Cyanosis 1 27
2 Vecuronium Cardio respiratory
arrest
1 64
3 Oseltamivir Photophobia 1 5
23. NEW DRUGS APPROVED IN INDIA
(FROM JANUARY 2015 TO MARCH 2015)
Drug Indication
Lixisenatide pre filled solution for
injection
Type 2 Diabeties Mellitus
Bedaquiline Tablet 100mg MDR-TB
Sofosbuvir Tablet 400mg Chronic Hepatitis C
Pazopanib Tablet 200/400 mg
(additional indication)
Advance soft tissue Sarcoma
(STS)
Eribulin mesylate solution for
injection 0.88mg in 2ml vial
Advanced or Metastatic Breast
cancer
Abiraterone acetate Tablet 250 mg
(additional indication)
Metastatic castration resistant
prostrate cancer in adult men
25. ADR MOBILE APP
IPC launched Android mobile application in June 2015.
The reporting app can be used by
Physicians
Nurses
Pharmacists
They can report from anywhere in India to NCC-PvPI
For further queries or suggestions Helpline number-1800-
180-3024 & e-mail @ - pvpi@ipcindia.net.
