ADR Reporting Exercises for Undergraduate students

1. PH 3.4 ADVERSE DRUG REACTIONS

2. OBJECTIVE
 To recognize & report Adverse drug reactions in the
given case
 Perform causality assessment of the identified ADR
using WHO & Naranjo’s scale
 Fill the ADR reporting form (CDSCO form)
 Explain the management of the ADR
 Explain the methods to prevent the occurrence of
ADR
 Report the ADR to the Pharmacovigilance center
 Describe the importance of reporting ADRs
 Describe the various levels of reporting National &
International centers

3. INTRODUCTION
Adverse Drug Reactions
A response to a drug which is noxious and unintended, which
occurs at dose normally used in man for prophylaxis, diagnosis, or
therapy of disease, or for modification of physiological function.
Adverse Drug Event
Any untoward medical occurrence that may appear during
treatment with a pharmaceutical product but which does not
necessarily have a causal relationship with the treatment.

4. DIFFERENCE BETWEEN ADES & ADRS

5. TYPES OFADR
1. Predictable ADRs (Type-A, Augmented, Expected, Mechanism based ADRs)
⚫ Side effects
⚫ Secondary effects
⚫ Toxic effects (Toxicity)
2. Unpredictable ADRs (Type-B, Unexpected, Bizarre reactions)
⚫ Drug allergy (Hypersensitivity reactions)
⚫ Genetically determined abnormal responses of a drug
⚫ Idiosyncratic drug responses (Idiosyncrasy) 3.Type-C ADRs (Chronic
effects)
4.Type-D ADRs (Delayed effects)
5.Type-E ADRs (End of treatment effects)

6. SEVERITY OF ADVERSE DRUG REACTIONS
⚫Minor: No therapy, antidote or prolongation of
hospitalization is required.
⚫Moderate: Requires change in drug therapy, specific
treatment or prolongs hospital stay by atleast one day.
⚫Severe: Potentially life-threatening, causes permanent
damage or requires intensive medical treatment.
⚫Lethal: Directly or indirectly contributes to death of the
patient.

7. PHARMACOVIGILANCE
Pharmacovigilance is “The science and activities
relating to detection, assessment, understanding and
prevention of adverse effects or any other drug related
problems.”
- WHO 2002

8. PHARMACOVIGILANCE PROGRAMME OF INDIA (PVPI)
 The Central Drugs Standard Control Organization (CDSCO),
Directorate General of Health Services under the aegis of Ministry of
Health & Family Welfare, Government of India in association with
Indian Pharmacopeia commission, Ghaziabad initiated a nation-wide
Pharmacovigilance Programme for protecting the health of the patients
by promising drug safety.

9. CONTD..,
 The Pharmacovigilance Programme of India (PvPI) was started
by the Government of India on 14th July 2010 with the All
India Institute of Medical Sciences (AIIMS), New Delhi as the
National Coordination Centre for monitoring Adverse Drug
Reactions.
 To safeguard implementation of this programme in a more
effective way, the National Coordination Centre was shifted
from the All India Institute of Medical Sciences (AIIMS),
New Delhi to the Indian Pharmacopoeia Commission,
Ghaziabad, Uttar Pradesh on 15th April 2011

10. OBJECTIVES OF THE PHARMACOVIGILANCE
PROGRAMME OF INDIA
1. To create a nation-wide system for patient safety reporting
2. To identify and analyze the new signal (ADR) from the
reported cases
3. To analyze the benefit - risk ratio of marketed medications
4. To generate the evidence-based information on safety of
medicines
5. To support regulatory agencies in the decision- making
process on use of medications

11. 6. To communicate the safety information on use of
medicines to various stakeholders to minimize the
risk
7. To emerge as a national centre of excellence for
pharmacovigilance activities
8.To collaborate with other national centres for the
exchange of information and data management
9. To provide training and consultancy support to other
national pharmacovigilance centres located across
globe.

12. PHARMCOVIGILANCE PROCESS
Detecting and reporting an ADR
ADR form is filled out with the patient and reaction details.
 Spontaneous reporting:
Most common form
Healthcare professionals detect and report any SADR to their
NPC or manufacturers
 Mandatory reporting:
Manufacturers are required to submit reports received from health
care providers to the national authority in the form of PSUR

13. LEVELS OF REPORTING
Uppsala Monitoring Centre
National
Pharmacovigilance
Centre
Zonal Centre
Regional Centre
Peripheral Centre

18. IMPORTANCE OF REPORTING
 Causality—The probability that a particular medicine or
substance is responsible for an isolated effect or ADR.
 Signal—Reported information on a possible causal
relationship between an adverse event and a medicine, the
relationship being previously unknown or incompletely
documented. Usually more than one signal report is
required to generate a signal, depending on the
seriousness of the event and the quality of the information.

20. NARANJO’S ALGORITHM

21. NARANJO’S SCALE
1. Definite: Causality is proven.
2. Probable: Though not proven, drug is the likely cause
of the event.
3. Possible: Drug as well as other causes could be
responsible for the event.
4. Doubtful: Drug unlikely to be the cause, but cannot be
ruled out.

22. WHO-UMC CAUSALITY CATEGORIES

23. CONTD..,

24. ASSESSMENT OF ADRS
1. Evaluate the nature of the event
 Obtain a detailed history of the patient including current health status, current
pharmaceutical therapy, and past medical history. (ADR reporting form)
 Identify and document the clinical reaction. Look up suspected medicines and
known ADRs in the literature, and match them with the reactions described by
the patient.
 Classify severity of the reaction
 Severe- Fatal or life threatening
 Moderate—requires antidote, medical procedure, or hospitalization
 Mild—Obvious symptoms that require only the discontinuation of
pharmaceutical therapy Incidental—Mild symptoms; patient given the option to
continue or discontinue medication.

25. 2. ESTABLISH THE CAUSE
 Use the Naranjo algorithm (or other system) for assessing the
reaction and establishing the cause.
 The scores for all items are added to give a probability of causality
of the adverse event.
 Evaluate the quality of the product from the manufacturer to rule out
any adverse event occurring from a poor-quality product.
 This investigation should include the possibility of pharmaceutical
counterfeiting and overt contamination of the product.
 Finally, check for a medication error.

26. 3. TAKE CORRECTIVE AND FOLLOW-UP ACTION
With information obtained through this process, make a
definitive decision based upon the facts as presented.
Determine if the reaction is an ADR, adverse drug event
(including medication error), or a quality defect.
All significant ADRs must be recorded on the patient’s
medical record.

27. PREVENTION OF ADVERSE EFFECTS TO DRUGS
1. Avoid all inappropriate use of drugs in the context of patient’s
clinical condition.
2. Use appropriate dose, route and frequency of drug administration
based on patient’s specific variables.
3. Elicit and take into consideration previous history of drug
reactions.
4. Elicit history of allergic diseases and exercise caution (drug
allergy is more common in patients with allergic diseases).
5. Rule out possibility of drug interactions when more than one drug
is prescribed.
6. Adopt correct drug administration technique (e.g. intravenous
injection of vancomycin must be slow).
7. Carry out appropriate laboratory monitoring (e.g. prothrombin
time with warfarin, serum drug levels with lithium).

34. THANK YOU