PHARMACOLOGY IS CHALLENGING SUBJECT TO TEACH AND UNDERSTAND ALSO .....THEIR INTERESTING PART IS TO LEARN ABOUT ADR

1. ADR
BY
ASAWE TEJASWINI L
DEPARTMENT OF PHARMACOLOGY
ASSIASTANT PROFESSOR
SIDHHIS INSTITUTE OF PHARMACY
THANE

2. ADVERSE DRUG REACTIONS

3. CONTENTS
Definition of ADR
 Classification of ADR
 Detection of ADR
 Reporting of ADR
 Prevention of ADRs

4. Definition Of Adverse Drug Reactions
• According to WHO (1972)
 “Adverse Drug Reaction is
harmful or undesirable effect of
drug ”.
 All drug are poison until used
legally.
 Ex. Aspirin used for headache also
act on GIT and producing side
effect
 Preventing and detecting adverse
effect from medicine it termed as
pharmacovigilance.
 Adverse effect includes
 Nausea and vomiting
 Deafness (hearing loss)with
gentamycin
 Death with penicillin

5. Classification of ADRs
 Depending upon……..
 Type of reaction:
• Type A
• Type B
• Type C
• Type D
• Type E
• Type F
 Onset of event: Acute (<60 minutes)
 Sub-acute (1-24 hrs)
 Latent (>2 days)
 Severity: Minor, Moderate, Severe, Lethal ADRs.

6. Types of Adverse Drug Reactions
• A (Dose Related)
• Bizzare (Non-Dose Related)
• Chronic (Dose Related and Time
Related)
• Delayed (Time Related)
• End of Use (Withdrawal)
• Failure (Unexpected Failure of
Therapy)

7. Aug Augmented (Dose Related)
 Features
Commonly Related to the pharmacologic action of the
drug –
pharmacologic response is
• Predictable
• Low mortality ( number of death in one period
• of time)
 Example
• Dry mouth with Tricyclic Antidepressants
• Respiratory Depression with Opioids
• Bleeding with Warfarin
 Management
• Reduce Dose
Bleeding with Warfarin

8. Bizzare (Non-Dose Related
Features
• Uncommon
• Not related to the pharmacologic action of the
drug
• Unpredictable
• High mortality
 Example
• Immunologic reactions: anaphylaxis to penicillin.
• Idiosyncratic reactions: malignant hyperthermia
with general anesthetics.

9. Chronic
(Dose Related and Time Related)
 Features
• Uncommon
• Related to the cumulative dose
 Example
• Osteonecrosis of the jaw with bisphosphonates
 Management
• Reduce dose or use an alternate day therapy
• withdrawal may have to be prolonged
Osteonecrosis
of Jaw with
Bisphospho
nates

10. Delayed (Time Related)
 Features
• Uncommon
• Usually dose related
• Occurs or becomes apparent sometime after use of the drug
 Example
• Carcinogenesis
• Tardive dyskinesia
• Leucopenia with lomustine
 Management
• Often intractable
Tardive dyskinesia
tardive dyskinesia is
involuntary repetitive
movements. For example:
Eye blinking

11. End of use (Withdrawal)
 Features
• Uncommon
• Occurs soon after withdrawal of the drug
 Example
• Withdrawal syndrome with benzodiazepines
(e.g., insomnia, anxiety)
 Management
• Reintroduce drug and withdraw slowly
aInsomnia

12. Failure (Unexpected Failure of Therapy)
 Features
• Common
• Dose related
• Often caused by drug interactions
 Example
• Inadequate dosage of an oral contraceptive when used
with an enzyme inducer.
• Resistance to antimicrobial agents
 Management
• Increase dosage

13. Classification of ADRs….
Depending on Severity
1. Minor ADRs: No therapy, antidote or
prolongation of hospitalization is required.
2. Moderate ADRs: Requires change in drug
therapy, specific treatment or prolongs
hospital stay by at least 1 day.
3. Severe ADRs: Potentially life threatening,
causes permanent damage or requires
intensive medical treatment.
4. Lethal ADRs: (causing death)
Directly or indirectly contributes to death
of the patient.

14. Monitoring ADRs
(Detecting adverse drug reaction(ADR).
Documentation of ADR
Reporting serious ADRs to pharmacovigilance
centers
Assessing causality (relationship between a
drug and a drug reaction)

15. Reporting an ADR
 Detecting adverse drug reaction(ADR).
What may happen when
you don’t report?
A) Who can Report?
All healthcare professionals (clinicians, dentists, pharmacists, nurses etc)
and
Non-healthcare professionals including consumers can report suspected
adverse drug reaction.

16. B) Where to report ?
 Duly filled Suspected Adverse Drug Reaction Reporting Form
can be send to the nearest Adverse Drug Reaction Monitoring
Centre (AMC) or directly to the National Coordination Centre
(NCC).
 Call on Helpline (Toll Free) 1800 180 3024 to report ADRs.
 Or can directly mail this filled form to pvpi@ipcindia.net or
pvpi.ipcindia@gmail.com
 A list of nationwide AMCs is available at:
http://www.ipc.gov.in, http://www.ipc.gov.in/PvPI/pv_home.html

17. C) What to report ?
 Report serious adverse drug reactions. A reaction is
serious when the patient outcome is:
• Life-threatening
• Hospitalization (initial or prolonged)
• Disability (significant, persistent or permanent)
• Required intervention to prevent permanent
impairment or damage
 Report non-serious, known or unknown, frequent or
rare adverse drug reactions due to Medicines, Vaccines
and Herbal products.

18. D) Mandatory field
for suspected ADR
reporting form
 Patient initials,
 Age at onset of reaction,
 Reaction term(s),
 Date of onset of reaction,
 Suspected medication(s)
 reporter information.

19. What happens to the submitted information?
ADR reported
by HCP, Patient
or Others
Causality
assessment at
AMCs
Forwaded to NCC-
PvPI through ADR
database
Data is
Analyse
d &
forwarde
d
Reports are
periodically reviewed
by the NCC-PvPI
Global
Pharmacovigilance
Database
(Managed by WHO-
UMC)
Information is
submitted to the
Steering
committee of PvPI
Suggests
required
interventions
Health care
provider
Adverse Drug Reaction
Monitoring Centre (AMC) National Coordinating
Centre (NCC),
PHARMACOVIGILAN
CE PROGRAMME
OF INDIA (PVPI)

20. 70% ADRs are
potentially
avoidable
More
rational
Prescribing
Patient
counselling
Consider
risk factors
for ADRs
Better
monitoring
of treatment
Better
communication
Preventing ADR

21. THANKYOU