Adverse Drug Reaction (ADR) Pharmacovigilance . Here all about Adverse Drug Reaction and how to Report, Procedure and ADR Reporting form. So You can all see in this slide share.

1. Presented By
Mr. Mukesh Kumar
D.Pharm. 2st Year
PHARMACOVIGILANCE

2. CONTENT
• Adverse Drug Reaction (ADR)
• Types of ADR
• Reporting an ADR.
• Monitering.
• Benefits of ADR.
• Suspected ADR Form.

3. ➢What is adverse drug reaction ?
According to WHO (1972) A response to a drug which is Noxious and
Unintended occurs at doses normally used in man for the prophylaxis ,
diagnosis , or therapy of disease , or for the modification of physiological
function.
➢Types of Adverse Drug Reaction
• TYPE - A (Augmented)
• TYPE - B (Bizarre)
• TYPE - C (Continuous)
• TYPE - D (Delayed)
• TYPE - E (End of Dose)
• TYPE - F (Failure of therapy)

4. ➢ TYPE – A (Augmented) Dose related
Feature:-
• Common related to the pharmacologic action of the drug – exaggerated pharmacologic
response
• Predictable
• Low mortality
Example:-
• Bleeding with warfarin
• Dry mouth with Tricyclic Antidepressants
• Respiratory Depression with Opioids
Management:-
• Reduce Dose or Withhold Drug
• Consider effects of concomitant therapy

5. ➢ TYPE – B (Bizarre) -Non Dose Related.
Feature:-
• Uncommon
• Not related to the pharmacologic action of the drug
• Unpredictable
• High mortality
Example:-
•Immunologic reactions: anaphylaxis to penicillinPenicillin AllergyPenicillin
Allergy
Idiosyncratic reactions: malignant hyperthermia with general anesthetics
Management:-
Withhold and avoid in future

6. ➢ TYPE – C (Chronic)- Dose and Time related
Feature:-
• Uncommon
• Related to the cumulative dose
Example:-
• Hypothalamic-pituitary-adrenal axis suppressionby corticosteroids.
Osteonecrosis of the jaw with bisphosphonates
• Management:-
• Reduce dose or use an alternate day therapy
• withdrawal may have to be prolonged

7. ➢ TYPE – D (Delayed)- Time related.
Feature:-
• Uncommon
• Usually dose related
• Occurs or becomes apparent sometime after use of the drug
Example:-
• Carcinogenesis
• Teratogenesis
• Tardive dyskinesia
• Leucopenia with lomustine
Management:-
• Often intractable

8. ➢ TYPE – E(End of use)-Withdrawal
Feature:-
• Uncommon
• Occurs soon after withdrawal of the drug
Example:-
• Withdrawal syndrome with opiates or benzodiazepines (e.g., insomnia, anxiety)
Management:-
• Reintroduce drug and withdraw slowly

9. ➢ TYPE – F(Failure)-unexpected failure of therapy.
Feature:-
 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
 Consider effects of concomitant therapy

10. ➢ ADR Reporting Procedure:-
A)Who can Report?
 All healthcare professionals (clinicians, dentists, pharmacists, nurses etc).
 Non-healthcare professionals including consumers can report suspected adverse drug reaction.
C) What to report ?
• All types of suspected adverse reaction
 Known or Unknown
 Serious or non-serious.
 Frequent or rare
• Reaction from all types of pharmaceutical products:-
 Allopathy
 Ayurvedic
 Vaccine
 Medical Devices etc

11. ➢ 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
pypi.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
➢ Why to report ?
ADRs are among the leading causes of death in many countries (World
Health Organization, 2008)
Account for 5% of all hospital admissions in India. Source:
htt.achi.nlm.nih.articles/PMC195320.

12. Detecting adverse drug reaction(ADR).
Documentation of ADR
Reporting serious ADRs to pharmacovigilance centers
Assessing causality between drug and suspected reaction
➢Detection ADRs:-
Pre-Marketing Studies Post-Marketing Surveillance
➢Monitoring ADRs
• Phase 1
• Phase 2
• Phase 3
• Spontaneous adverse
reaction reporting
• Epidemiological methods

13.  Assess the safety of drug therapies, especially recently approved drugs.
 Provides updated drug safety information to health care professionals
and other stakeholders
 Measuring the economic impact of ADR prevention as manifested
through reduced hospitalization, optimal and economical drug use, and
minimized organizational liability
➢ Benefits of ADR Reporting

14. ➢ Suspected Adverse Drug Reaction Form For Health Care Professionals
This form is divided into four sections:
A. Patient Information
B. Suspected Adverse Reaction
C. Suspected Medication(s)
D. Reporter Details