• 'A response to a drug which is noxious and unintended, and which
occurs at doses normally used in man for the prophylaxis,
diagnosis, or therapy of disease, or for the modifications of
Dr.C.SUHAS REDDY 2
BASED ON INCIDENCE Classification
• VERY COMMON
• VERY RARE
Dr.C.SUHAS REDDY 3
• VERY COMMON ADR- incidence >10% (1 in 10 ppl)
• Ex- drowsiness associated with carbamazepine
• COMMON ADR- incidence is 1-10 to 1-100
• Ex-fluid retention with carbamazepine
Dr.C.SUHAS REDDY 4
• UNCOMMON ADR- incidence 0.1-1.0 % (1-1000 to 1-100)
• Ex- diarrhea associated with carbamazepine
• RARE ADR- incidence 0.01-0.1 % (1-10000 to 1-1000)
• Ex- depression associated with carbamazepine
• VERY RARE- incidence <0.01% (1-10000)
• EX-arrhythmia associated with carbamazepine
Dr.C.SUHAS REDDY 5
BASED ON SEVERITY / INTENSITY
• MILD (minor)
• SEVERE (major)
Dr.C.SUHAS REDDY 6
• MILD (minor)- does not required any therapy / may not notice
• MODERATE – required change in drug therapy
• SEVER (major) – capable of damaging any organ / life threatening,
hospitalization, disability (significant, persistent or permanent, congenital
anomaly, required intervention to prevent permanent impairment or damage
Dr.C.SUHAS REDDY 7
• Commonest (up to 70%) – Dose dependent, severity increases with dose.
• Preventable in most part by slow introduction of low dosages.
• Predictable by the pharmacological mechanisms,
• e.g., hypotension by beta-blockers,
• hypoglycaemia caused by insulins or oral hypoglycaemics,
• NSAID induced gastric ulcers.
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• Rare, idiosyncratic, genetically determined, unpredictable, mechanisms are
unknown, serious, can be fatal; unrelated to the dose,
• e.g. ,hepatitis caused by halothane,
• aplastic anaemia caused by chloramphenicol,
• neuroleptic malignant syndrome caused by some anaesthetics and
Dr.C.SUHAS REDDY 10
• Occurs as a result of continuous drug use.
• May be irreversible, unexpected, unpredictable,
• e.g., tardive dyskinesias by antipsychotics,
• dementia by anticholinergic medications.
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• Delayed occurrence of ADRs, even after the cessation of treatment.
• e.g., corneal opacities after thioridazine,
• ophthalmopathy after chloroquine.
Dr.C.SUHAS REDDY 12
TYPE-E (End of Dose)
• Withdrawal reactions. Occurs typically with the depressant drugs.
• e.g., hypertension and restlessness in opiate abstainer,
• seizures on alcohol or benzodiazepines withdrawal;
• first dose hypotension caused by alpha-blockers (Prazosin) or ACE
Dr.C.SUHAS REDDY 13
TYPE-F (Failure of therapy)
• Results from the ineffective treatment (previously excluded from analysis
according to WHO definition),
• e.g., accelerated hypertension because of inefficient control.
Dr.C.SUHAS REDDY 14
How to recognize ADRs
• Ensure, medicine received & actually taken by the patient at the dose advised
• Verify the onset of suspected ADR is after taking the drug
• Determine the time interval between drug taken – onset of event
• Evaluate the suspected ADR after discontinuing the drug / reduced dose, monitor
• Analyse the alternate cause (other than the drug)
• Use relevant literature & experienced physician opinion & information PV ceneter
• Report the ADR
Dr.C.SUHAS REDDY 16
• WHAT TO REPORT ?
• WHO SHOULD REPORT
• WHEN TO REPORT
• HOW TO REPORT
• WHERE TO REPORT
Dr.C.SUHAS REDDY 17
WHAT TO REPORT ?
• Any undesirable adverse event suspected to be associated with use of drug.
• Include - All ADRs as a result of prescription and non-prescription
• All ADRs – irrespective of the used (acc with PI provided by company)
• Unexpected reactions - regardless of their nature or severity
• ADRs-in special field – drug abuse, drug use – pregnancy / lactation
• ADRs occurring from overdose or medication error
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Information required for ADR case reporting
• Patient information-
- patient identifier
- age at time of event or date of birth
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• Adverse event or product problem-
-description of event or problem
- date of event
- date of this report
- relevant tests/laboratory data (if available)
- other relevant patient information/history
- outcomes attributed to adverse even
Dr.C.SUHAS REDDY 21
Suspected medication (s)
- name (INN and brand name)
- dose, frequency & route used
- therapy date
- diagnosis for use
- event abated after use stopped
or dose reduced
- batch number
- expiration date
- event reappeared after
reintroduction of the treatment
- concomitant medical products
and therapy dates
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• - name, address and telephone number
- speciality and occupation
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WHO SHOULD REPORT
• doctors, dentists, pharmacists, nurses, assistant medical officers,
clinical officers, pharmaceutical technicians, pharmaceutical assistants,
traditional medicine practitioners and others health care providers.
Dr.C.SUHAS REDDY 24
WHEN TO REPORT
• Any suspected ADR should be reported as soon as possible.
• Delay in reporting will make reporting inaccurate and unreliable.
• If possible, report while the patient is still in the health facility this gives a
chance to reporter to clear any ambiguity by re-questioning or examining the
Dr.C.SUHAS REDDY 25
HOW TO REPORT
• CDSCO suspected ADR Reporting Form
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WHERE TO REPORT
• Please return the completed form to the nearest Adverse drug reaction
Monitoring Centre (AMC) or to National Coordinating Centre
• A list of nationwide AMCs is available at:
Dr.C.SUHAS REDDY 28
What happens to the submitted
• Information provided in this form is handled in strict confidence.
• The causality assessment is carried out at (AMCs) by using WHO-UMC.
• The analyzed forms are forwarded to the National Coordinating Centre
through the ADR database.
• Finally the data is analyzed and forwarded to the Global Pharmacovigilance
Database managed by WHO Uppsala Monitoring Center in Sweden.
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• The reports are periodically reviewed by the National Coordinating Centre
(PvPI). The information generated on the basis of these reports helps in
continuous assessment of the benefit-risk ratio of medicines.
• The information is submitted to the Steering Committee of PvPI constituted
by the Ministry of Health and Family Welfare. The Committee is entrusted
with the responsibility to review the data and suggest any interventions that
may be required.
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PREVENTION OF ADR
• Anticipation by patient monitoring
Ex- anemia- due to deficiency of G6PD, check the condition
• Anticipation of dosage reeducation
Ex- impaired renal / liver function – dosage should reduce
• Monitoring the serum levels(drug)
Ex- theophylline, aminoglycosides
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• Monitoring of pharmacological activity (extensive of P’cology activity)
Ex-diuretics- to promote salt & water loss , but causes electrolyte depletion &
dehydration. So therapeutic end point not exceeded.
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• Minimizing of non-preventable- Idiosyncratic / hypersensitivity not
• Can be done by carful observation / monitoring of patient
Ex- patient with meningitis – should be with penicillin (even if pt is allergic).
Chemotherapy – nausea
Dr.C.SUHAS REDDY 37
Management of the adverse reaction
• Confirmation of the ADRs: indicate what assisted in confirming the suspected
adverse reactions. For example:
• i. Drug reactions confirmed by disappearance of the reaction after stopping
administration of the drug or reducing the doses.
• ii. Recovery on withdrawal of suspected drug(s) if no other drug is
withdrawn and no therapy given.
• iii. Recovery follows treatment of the reaction in addition to withdrawal of
Dr.C.SUHAS REDDY 38
• 2. Mention the criteria for regarding the reaction as serious
• 3. Mention any treatment given to the patient after experiencing the ADRs.
• 4. Outcome: indicate the outcome of the adverse reaction by marking X in the
appropriate box with dates in case of fatal outcome.
Dr.C.SUHAS REDDY 39
• CLINICAL PHARMACY TEXT BOOK - G.PARTHASARATHI
• CLINICAL PHARMACY TEXT BOOK - RAVI KUMAR
• WHO website
• Adverse drug reaction-causality assessment-ijrpc 2011, 1(3).
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