This document defines key terms related to adverse drug reactions such as adverse events, adverse drug reactions, and medication errors. It describes the etiology and various classification systems for adverse drug reactions. The document outlines methods for detecting, reporting, and assessing the severity and seriousness of adverse drug reactions. It also covers predicting and preventing adverse drug reactions, and how to manage adverse drug reactions when they occur. The document emphasizes the importance of reporting all suspected adverse drug reactions to assist in ensuring drug safety.

1. SANTOSHI SAHU
MPh DIPSAR
Pharmacology

2. • Adverse event
• Adverse drug reaction
• Relation among MEs, ADRs and ADEs
• Etiology
• Classification of ADRs
• Detection and reporting methods
• Severity and seriousness assessment
• Predictability and Preventibility assessment
• Management of adverse drug reactions

3. Adverse Event :
Any untoward medical occurence that may present during
treatment with a pharmaceutical product but which does not
necessarily have a casual relationship with this treatment.
Adverse Drug Reaction (ADR) :
Response to a drug which is noxious and unintended, and which
occur at doses normally used for prophylaxis, diagnosis or therapy
of disease, or for the modification of physiological function.

4. Relation among MEs, ADRs and
ADEs
Medication
errors (MEs)
ADEs
ADRs
Preventable ADRs

5. Etiology
• Dose related
• Allergic
• Idiosyncratic
• Idiopathic

6. Classification of ADRs
On basis of pharmacological mechanism:
(Rawlins)
Type A
(PREDICTABLE DOSE RELATED)
OVERDOSE
ADVERSE EFFECT
DRUG DRUG INTERACTION
DRUG DISEASE INTERACTION
Type B
(UNPREDICTABLE)
(AFTER MARKETTING)
INTOLERANCE
ALLERGY
PSEUDO-ALLERGY
IDIOSYNCRASY

7. Classification of ADRs
Based on wills and brown
• Type A (augmented)
• Type B (bizarre)
• Type C (chronic)
• Type D (delayed)
• Type E (end of use)
• Type F (failure)
• Type G (genetic)
• Type H (hypersensitivity)
• Type U (uncontrolled)

8. Detection and reporting methods
• What to report
1. All ADRs are as aresult of prescription and non
prescription.
2. Whether drug used in accordance with drug
information provides by company marketting the
drug or not.
3. Whether there is increase in frequency of given
reaction
4. ADR occuring from overdose or Mes.
5. Whether a serious reaction was expected or not.

9. Patient information
• Patient identity
• Birth dates or ages
• Sex
• Weight

10. Adverse reactions
• Brief description of ADR(s)
• Time/date of onset of adverse reactions
• Other related information

11. Suspected drug(s)
• Name of suspected drug
• Dosage, frequency and route of administration
• Therapy date
• Batch no. and expiry date
• Reason for use
• Particulars of drug(s) or (other treatment)
administered or continued simultaneously
• Relevent information on medical devices are to be
provided

12. Severity and seriousness assessment
Severity is used to describe intensity of medical
event and graded as minor, moderate, severe
and lethal.
Minor ---- no antidote is required (therapy
given)
Moderate----- change medication/or
prolongation of hospitalization is sufficient
Severe---- must treated immediately
Lethal---- do not respond to treatment

13. Severity: adverse experience/events should be
assessed by on-site investigator as to their
severity and/or intensity and must be
recorded as:
 Life threatening
 Severe: incapacitating with inability to work or do
usual activity
 Moderate: enough discomfort to cause interference
with usual activity
 Mild: awareness of sign or symptom, but easily
tolerated.

14. Predictability and Preventibility
assessment
Predictability assessment: The expectedness of
the reaction is assessed in accordance with approved
product information, reaction is defined as expected
if it is included in package insert or the summary of
product characteristics

15. Approach helpful in assessing
possible drug related ADRs
1. Ensure that medicine ordered is medicine recieved and
taken by patient as advised
2. Take proper history and do proper examination of patient
A full medicine and medical history should be taken
3. Establish time relationships--- ADR occur immediately or
take time to develop
4. Carry out thorough physical examination
5. Effect of dechallenge and rechallenge should be determined
6. Check known pharmacology of of medicine
7. Report any suspected ADR

16. Preventibility assessment: In 2002, olivier
proposed a method for preventibilty assessment
include 3 sets of questions
• Related to drug
• Related to patient
• Related to prescription

18. Inference:
• If the sum of scores is les than or equal to -2, ADRs
will be considered as ‘definitely Non- preventable’
• If the sum of scores is within -1 to 8, ADRs will be
considered as ‘potentially preventable’
• If sum of the scores is equal to or more than 9, ADRs
will be considered as ‘definitely preventable’

19. Management of adverse drug
reactions
1. Confirmation of ADRs
2. Mention the criteria (regarding reaction as serious)
3. Mention any treatment given (after experiencing
ADRs)
4. Outcome (indicate outcome of adverse reaction by
marking X in appropriate box with dates in case of
fatal outcome

20. Reporter information
Details of reporter of an ADR
• Name
• Address
• Email
• Signature
• Telephone
• Date of reporting reaction

21. Who should report?
1. All government hospitals
2. Private hospitals
3. Health centres
4. Dispenseries
5. Private clinics

22. Suspected ADRs
Collection of reports from several healthcare providers
in different parts of country assists in making
associations between a paticular drug and adverse
reaction
When to report
Any suspected ADR should be reported as soon as
soon possible. Delay in reporting make reporting
inaccurate and unreliable.

23. How to report
• Send your report in standardised form of reporting ADRs.
• Dully fill in ADRs reporting form when encountering an ADR
to patient.
• Use seperate form for each patient
• A completed ADR s case report form should immediately be
sealed and mailed preferably direct to.
• Report may be sent by email through following email address.
• Adr reports may be faxed in cases of perceived urgency
• Any follow up information for an ADR case that has already
been reported can be sent on another ADR form
1. It is follow up information
2. The date of original report
3. The patient identities

24. Utilisation of ADR data
Data collected used for provision of timely advice to
health careprofessionals and consumer on drug
safety issues at facility level, national and
international level.
Documented adr case report result in one or more of
following
1. Further investigation of signals
2. Drug regulation and dissemination of information of
current importance
3. Education and training initiatives to improve safe
use of medication and other health promotion
interventions as situation may warrant including
change in supply status

25. REFERENCES
• E6(R2) Good Clinical Practice: Integrated Addendum
to ICH E6(R1) Published march, 2018 page no. 33
• Tripathi d.k. Pharmacovigilance Ist edition published
april 2019, page no. 2.1-2.33