adr,types of adr,examples of adr,adr reporting,adr reporting form,applications for adr,websites for adr,pvpi communication,amc center in tamilnadu.

2. CONTENTS
1.ADR(ADVERSE DRUG REACTION)
2.REPORTING OF ADR
3.ADR REPORTING FORM
4..CASSUALTY ASSESMENT OF ADR
MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 2

3.  ADR is any response to a drug that is noxious and unintended and that occurs
At normal doses used in humans for prophylaxis, diagnosis for treatment.
 “A harmful or significantly unpleasant effect caused by a drug. which warrants
Reduction of dose or withdrawal of the drug.”
 Source as a error of adverse effects.Moreover, they reactions due to
Contaminants,(eg, in herbal medicines) or supposedly inactive excipients in a
Formulation.
 The safety of patient and the safe use of medicines are crucial for health policy
Development ,To prevent or reduce harm to patient thereby improving public
Health.
 This requires a well organized pharmacovigilance system, which defines as
System used by an organisation to moniter the safety of authorised medicinal
Products and detect any change to their benefit-risk balance.
ADR
MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 3

4. TYPES
TYPE A - DOSE-RELATED –AUGMENTED
TYPE B - NON-DOSE-RELATED –BIZARRE
TYPE C - DOSE-RELATED AND TIME-RELATED – CHRONIC
TYPE D - TIME-RELATED – DELAYED
TYPE E - WITHDRAWAL - END OF USE
TYPE F - UNEXPECTED FAILURE OF THERAPY FAILURE
MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 4

5. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 5
1. Augmented type is very common to all
2. Which is findout by known Pharmacological properties of a drug
Extension effects
•Predictable
•Dose - Related responses
•Prevention - Adjustment of dosage regimen
Examples
•Benzodiazepines - Sedation
•Furosemide - Water and electrolyte imbalance
•Heparin, warfarin - Spontaneous bleeding
•Insulin - Hypoglycemia
A: DOSE-RELATED - AUGMENTED
TYPES OF ADR

6. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 6
B: NON-DOSE-RELATED -BIZARRE
1. Which is uncommon to all
2. Non dose depented
3. Unrelated from the drug’s known pharmacological actions.
4. Idiosyncratic reactions
EXAMPLES OF BIZARRE REACTIONS
•Hypersensitivity reactions
•Stevens-Johnson’s Syndrome
•Hemolytic anemia

7. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 7
C: DOSE-RELATED AND TIME-RELATED - CHRONIC
1. Uncommon to all
2. This is chronic one due to accumlation of doses
3. Long term effects are usually related to the dose and duration of
Treatment
EXAMPLES
•Ethambutol - Retinopathy
•NSAIDs - Nephrotoxicity
D: TIME-RELATED - DELAYED
EXAMPLES
Carcinogenesis
Teratogenesis
Thalidomide
Reaction produced after some days or weeks or months by the administration of drug

8. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 8
E: WITHDRAWAL - END OF USE
● Uncommon to all
● Occurs soon after withdrawal of the dose
EXAMPLES
• Benzodiazepines – Rebound insomnia,
• Clonidine – Rebound hypertension
• Corticosteroids – Acute adrenal insufficiency
● Common to all
● Often caused by drug interactions,underdosing of medication
F: UNEXPECTED FAILURE OF THERAPY FAILURE
DRUG INTERACTION
1.Warfarin which is highly protein bound is displaced by valproic acid leading
To bleeding
2.Aspirin inhibit platelet aggregation together with heparin an anticoagulant
Leads increased risk of bleeding.

9. Omeprazole + Paracetamol + Diclofenac S.O. 720 (E)
Dated
10.03.2016
Nimesulide + Paracetamol injection S.O. 721 (E)
Dated
10.03.2016
Tamsulosin + diclofenac S.O. 722
(E) Dated
10.03.2016
Paracetamol +Phenylephirine +Chlorpheniramine
+Dextromethorphan +Caffeine
S.O. 723
(E) Dated
10.03.2016
Diclofenac +Zinc Carnosine S.O. 724
(E) Dated
10.03.2016
Diclofenac + paracetamol+ chlorpheniraminemaleate + magnesium
trisillicate
S.O. 725
(E) Dated
10.03.2016
Paracetamol + pseudoephedrine + cetrizine S.O. 726
(E) Dated
10.03.2016
MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 9
LIST OF DRUGS PROHIBITED FOR MANUFACTURE AND SALE
THROUGH GAZETTE NOTIFICATIONS UNDER SECTION 26A OF
DRUGS & COSMETICS ACT 1940 BY THE MINISTRY OF HEALTH AND
FAMILY WELFARE

10. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 10
Cetirizine Dihydrochloride +Diethyl Carbamazine S.O. 792 (E)
Dated
10.03.2016
Doxylamine +Pyridoxine +MefenamicAcid+Paracetamol S.O. 793 (E)
Dated
10.03.2016
Drotaverine + Clidinium+ Chlordiazepoxide S.O. 794 (E)
Dated
10.03.2016
Imipramine + Diazepam S.O. 795 (E)
Dated
10.03.2016
Flupentixol +Escitalopram S.O. 796 (E)
Dated
10.03.2016
Paracetamol + Prochloperazine S.O. 797 (E)
Dated
10.03.2016
Gabapentin +Mecobalamin +Pyridoxine +Thiamine S.O. 798 (E)
Dated
10.03.2016
Imipramine +Chlordiazepoxide +Trifluoperazine
+Trihexyphenidyl
S.O. 799 (E)
Dated
10.03.2016
Chlorpromazine +Trihexyphenidyl S.O. 800 (E)
Dated
10.03.2016
https://www.nhp.gov.in/Complete-list-of-344-drugs-banned-by-the-Ministry-of-
Health-Family-welfare_pg

11. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 11
REPORTING OF ADR
 The safety of patient and the safe use of medicines are crucial for health policy
Development ,To prevent or reduce harm to patient thereby improving public
Health.
 This requires a well organized pharmacovigilance system, which defines as
System used by an organisation to moniter the safety of authorised medicinal
Products and detect any change to their benefit-risk balance.
 A protocol is required for reporting adverse reactions associated with drug
Use,therefore NCC(national coordiation centre) aims to ensure the systemic and
Effective functioning of PVPI(pharmacovigillance program india) by
Publishing and implementing its guidence documents for reporting of adverse
Drug reactions.

12. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 12
FOLLOWING STAKEHOLDERS UNDER PVPI

13. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 13
COMMUNICATION UNDER PVPI

14. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 14
CONTACT DETAILS OF AMC UNDER PVPI
Christian medical
college,thorapadi
Dr.supratim datta
supratimdoc@gmail.c
om
09434488126
Govt.kilpauk medical
college
Dr.J.V.Peter
peterjhonvictor@gmail.
com
09944294769
MMC,chennai Dr.R.nanthini
Pvpi.chennai@gmail.co
m
09884286987
PSG institute of medical
sciences
Dr.S.ramalingam drrampsg@gmail.com 09894618450
SRM medical college
hospital&research
center
Dr.jamuna rani jrs_durai@yahoo.co.in 09840279010
Sri Ramakrishna
medical college,chennai
Dr.chellathi David pvpisrmc@gmail.com 09444622698
MMC,madurai Dr.sheik Dawooth
Drsheik.1960@gmail.co
m
09994026056
Tirunelveli medical
college
Dr.B.meenakshi
Meenakshi_b@tvmc.ac.
in
09443496909
CMC,CBE Dr.N.Shanthi
shanthisunderrajan@gm
ail.com
09443113740

15. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 15
Who can report ?
Why to report ?
What to report ?
How and whom to report ?

16. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 16

17. Suspected Adverse Drug Reaction Reporting Form
For HCPs
This form is divided into four sections:
A. Patient Information
B. Suspected Adverse Reaction
C. Suspected Medication(s)
D. Reporter Details

18. A. Patient Information
A. Patient Information
1. Patient
Initials
_____________
2. Age at time of event
or date of birth
__________________
3. M □ F □ Other □
_________________________________
4. Weight __________ Kgs

19. B. Suspected Adverse Reaction
B. Suspected Adverse Reaction
5. Date of reaction started (dd/mm/yy)
6. Date of recovery (dd/mm/yyyy)
7. Describe reaction or problem

20. C. Suspected Medications
C. Suspected medication(s)
S.
No.
8. Name
(Brand
/Generic)
Manufa
cturer
(If
known)
Batch
No./
Lot no.
Exp. Date
(if known)
Dose
used
Route
used
Frequency
(OD,BD,
etc.)
Therapy dates Indica
tion
Causalit
y
assessm
ent
Date
starte
d
Date
stopped
i
ii.

21. C. Suspected Medications
Action taken- Mark the appropriate option for the action taken with Respect to
Suspected drug.
S.No.
as per
C
9. Action Taken ( Please Tick)
Drug
withdrawn
Dose
increased
Dose
reduced
Dose not
changed
Not
applicable
Unknown
i
ii

22. C. Suspected Medications
 Rechallenge/ Reintroduction - The point at which a drug is again Given to a
patient after its previous withdrawal.
 Mark the appropriate option whether the suspected drug reintroduced & Reaction
occurred or not or effect unknown.
10. Reaction reappeared after reintroduction ( Please Tick)
S.No. Yes No Effect Unknown Dose
(If reintroduced)
i
ii

23. Concomitant medications
Concomitant medical product (s) information given in the Following tabs.
11. Concomitant medical product including self medication
and herbal remedies with therapy dates (exclude those
used to treat reaction)
S.No. Name
(Brand
/Generic)
Dose
used
Route
used
Frequency
(OD, BD, etc.)
Therapy dates Indication
Date
started
Date
stopped
i
ii

24. D. Reporter Details
D. Reporter Details
16. Name and professional address ____________________________
Pin ___________________ E - mail___________________________
Tel. No. (With STD code)____________________________________
Occupation__________________________ Signature ___________
17. Date of this Report (dd/mm/yyyy) ___________________________

25. Android Application
ADR Reporting App. can be downloaded from Google play store (free To Download)
NCC-PvPI in technical collaboration
With NSCB Medical College, Jabalpur
In May 2015 developed a Mobile
Application for all healthcare
Professionals to report adverse drug
Reactions.

26. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 26
PVPI and WHO-UMC collaboration
The following softwares tools are provided by WHO-UMC to acheive the objectives of PV
In a more efficiency way.
VIGIFLOW – Based on the ICH E2B standared
VIGIBASE - Containing medical drug classification
VIGIMINE - Give statistical data of all drug-ADR
VIGIMED - For checking regulatory staus,drug information
VIGISEARCH- For report searching across mutiple drugs
VIGILYZE - Include conventional medicine,traditional medicine

27. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 27
CASSUALTY ASSESMENT OF ADR
Causality assessment is defined as “the evaluation of the likelihood that a
Medicine or drug was the causative agent of an observed adverse reaction”.
To detect signals in order to minimise harm to patients through ADRs
Basic terminologies in WHO-UMC Causality Assessment scale
Challenge: Giving of the drug to the patient during the AE or treatment.
Dechallenge: Stopping of the drug, usually after an adverse event (AE) or at The
End of a planned treatment.
Dechallenges may be complete or partial, i.e. the drug is fully stopped or
Decreased in dose and the AE may fully disappear or only partially decrease.
Positive dechallenge: AE disappears after the stopping of the drug.
Negative dechallenge: This refers to the AE dose not disappear after the
Stopping of the drug.

28. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 28
Rechallenge: Restarting of the same drug after having stopped it, usually for An
AE.
Rechallenges may also be complete or partial.
Negative rechallenge: This is the case where the AE does not recur after the Drug
is restarted.
Positive rechallenge: AE recurrs after restarting the drug.
Prechallenge: This is a new term that refers to the use of the same drug at some
point in the past.

29. WHO-UMC Causality Assessment System
This method includes the following 4 criteria:
1. Time relationships between the drug use and the adverse event.
2. Presence/Absence of other competing causes (medications, disease process
itself).
3. Response to drug withdrawal or dose reduction (dechallenge).
4. Response to drug Readministration (rechallenge).

30. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 30

31. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 31
Categories
Time
sequence
Other
Drugs/
Disease
ruled out
De-challenge Re-challenge
Certain Yes Yes Yes Yes
Probable Yes Yes Yes No
Possible Yes No No No
Unlikely No No No No
WHO–UMC Causality Assessment Criteria

32. REFERENCES
1. www.lungindia.com,DOI-10.4103/0970-2113.80343 volume 28,issue 2, APR-
JUN2011.
2. I Ralph Edwards, Jeffrey K Aronson, Adverse drug reactions: definitions,
Diagnosis, and Management ,the lancet • Vol 356 • October 7, 2000,pag
No:1255-1259.
3. k kousalya,Sri Ramachandra University, India , J Pharmacovigilance 2014
Volume 2, Issue5,ISSN: 2329-6887, JP an open access journal.
4. Stephanie N. Schatz,etal.,An review article by Adverse Drug Reactions.
5. List of drugs prohibited for manufacture and sale through gazette notifications
Under Section 26a of drugs & cosmetics act 1940 by the ministry of health
And family Welfare.
6. Ralph Edwards etal., Adverse drug reactions: definitions, diagnosis, and
Management.
MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 32

33. MOHAMED ABUSALIH
DEPARTMENT OF PHARMACOLOGY 33