This document discusses pharmacovigilance, which involves monitoring medicines to detect and prevent adverse effects. It defines pharmacovigilance and describes its aims to improve patient safety and public health related to medicine use. The document outlines the scope of pharmacovigilance and objectives to improve care, health, assess medicine benefits and risks, and promote education. It also discusses adverse drug reactions, types A-F, factors affecting reactions like patient characteristics and medicine properties, and the role of pharmacists in managing reactions.

1. Dr. Are.Anusha Joel
Assistant professor
PHARMACOVIGILANCE

2. CONTENT:
1. Scope, aims ,definition and scope of pharmacovigilance
2. Adverse drug reactions
3. Reporting, evaluation, monitoring , preventing and management of
pharmacovigilance
4. Role of pharmacist in management of ADR.

3. WHAT IS PHARMACOVIGILANCE (PV)
• The science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other medicine-
related problems -
Pharmaco - Vigilance
 Pharmaco = medicine
 Vigilare = to watch
– alert watchfulness
– forbearance of sleep; wakefulness
– watchfulness in respect of danger; care; caution; circumspection
– the process of paying close and continuous attention

4. PHARMACOVIGILANCE AIMS
• Improve patient care and safety in relation to the use of medicines, and
all medical and paramedical interventions
• Improve public health and safety in relation to the use of medicines
• Contribute to the assessment of benefit, harm, effectiveness and risk of
medicines, encouraging their safe, rational and more effective (including
cost-effective) use
• Promote understanding, education and clinical training in
pharmacovigilance and its effective communication to the public.

5. OBJECTIVES OF PHARMACOVIGILANCE
• To improve patient care and safety
• To improve public health and safety
• To contribute to the assessment of benefit, harm, effectiveness and risk
of medicines
• To promote understanding, education and clinical training

6. SCOPE OF PHARMACOVIGILANCE
• Improve patient care and safety in relation to the use of medicines, and
all medical and paramedical interventions,
• Improve public health and safety in relation to the use of medicines,
• Contribute to the assessment of benefit, harm, effectiveness and risk of
medicines, encouraging their safe, rational and more effective (including
cost- effective) use, and
• Promote understanding, education and clinical training in
pharmacovigilance and its effective communication to the public

8. ROLE OF PHARMACIST IN
MANAGEMENT OF ADR’s
 Avoiding the combination entirely
 Adjusting the dose of the object drug
 Spacing dosing times to avoid the interaction
 Monitoring for early detection
 Provide information on patient risk factors that increases the chance of
an adverse outcome
 Improve computerized screening systems
 Excessive number of drug interactions on the systems
 Drug class differences not handled correctly

9. WHAT ARE ADVERSE DRUG REACTIONS
(ADRS)?
 Any noxious change which is suspected to be due to a drug, occurs at
doses normally used in man , requires treatment or decrease in dose or
indicates caution for in future use of the same drug.
 Adverse drug event – Any untoward medical occurrence that may
present during treatment with medicine , but which may not have causal
relationship with the treatment.

10. STATISTICS
 ADR to drugs are most common cause of iatrogenic disease.
 3-5% hospitalisations due to adverse reactions results in 3,00,000
hospitalisations annually in US.
 Once hospitalised → 30% chance of ADR → Risk of each course is 5%
 3% chance of life threatning reactions → Risk of each course is 0.4 %

11. COMMON CAUSES OF ADRS
 Failing to take the correct dosages at the correct times.
 Overdosing.
 Allergies to chemical components of the medicine.
 Combining the medicine with alcohol.
 Taking other drugs or preparations that interact with the medicine.
 Taking a medicine that was prescribed for someone else.

12. FACTORS AFFECTING ADVERSE DRUG REACTIONS
:
 Patient-related factors
 Age
 Sex
 Genetic influences
 Concurrent diseases (renal ,liver , cardiac)
 Previous adverse drug reactions
 Compliance with dosing regimen
 Total number of medications
 Misc. (diet, smoking, environmental exposure)

13. AGE
• Children are often at risk because their capacity to metabolize drugs is usually
not fully developed
• Children younger than 18 may be at risk of developing Reye’s syndrome if
given acetylsalicylic acid (aspirin) while infected with chickenpox or influenza.
ELDERLY
• ADRs, including drug interactions, are a common cause of admission to
hospitals in the elderly .
• Reasons for ADRs in the elderly: Concomitant use of several medications
Decreased drug ADME activity due to age
• These conditions are exacerbated by malnutrition and dehydration, common in
the elderly

14. PREGNANCY
1. Sulfonamides → Jaundice and brain damage in the fetus
2. Warfarin → Birth defects, and increased risk of bleeding problems in
newborns and mothers
3. Lithium → Defects of the heart (Ebstein’s Anomaly), lethargy, reduced
muscle tone, and underactivity of the thyroid gland
BREAST FEEDING
→ Many drugs can be passed from mother to infant via breast milk
– Amantadine (antiviral)
– Cyclophosphamide (antineoplastic)
– Cocaine (Schedule 2 FDA drug)
– Carisoprodol (skeletal muscle relaxant

15. FACTORS AFFECTING ADVERSE DRUG
REACTIONS :
• Drug-related factors
 Dose
 Duration
 Inherent toxicity of the agent
 Pharmacodynamics properties
 Pharmacokinetic properties

16. TYPES OF ADR’S
 Type A - (Augmented)
 Type B - (Bizarre)
 Type C - (Continuous)
 Type D - (Delayed)
 Type E - (Ending of Use)
 Type F - (Failure of Efficacy)

17. ADR CLASSIFICATION
Type A (Augmented) Predictable Type B (Bizarre) Unpredictable
Expected- Undesirable Unexpected- Undesirable
Based- Pharmacological properties of drug Based- Peculiarities of patient
More common Less common
Dose related Non dose related
Mostly preventable and reversible More serious, requires drug withdrawal
Includes- Side effects , Secondary effects ,
Toxic effects, Consequences of drug
withdrawal
Includes-Hypersensitivity/allergy ,
Idiosyncrasy

18. TYPES BASED ON ONSET
Onset of event:
• Acute - within 60 minutes
• Sub-acute - 1 to 24 hours
• Latent - > 2 days

19. SEVERITY OF ADR
Minor Moderate Severe Lethal
No treatment/
Antidote/
Prolongation of
hospitalization on
Requires
treatment/ Change
in treatment/
Prolongation by at
least 1 day
Requires intensive
treatment , Life
threatening,
Permanent
damage
Directly/
Indirectly
contributes to the
death of the
patient

20. FDA DEFINES SERIOUS ADR AS WHICH
 Results in death
 Life-threatening
 Require hospitalization
 Prolong hospitalization
 Cause disability
 Cause congenital anomalies
 Require intervention to prevent permanent injury

21. TYPE A REACTIONS OR AUGMENTED
• Pharmacological properties of a drug
Extension effects
 Predictable
 Dose - Related responses
 Prevention - Adjustment of dosage regimen
Examples
 Benzodiazepines - Sedation
 Furosemide - Water and electrolyte imbalance
 Heparin, warfarin - Spontaneous bleeding
 Insulin - Hypoglycemia

22. • ADVERSE EFFECTS Predictable, dose-dependent
reactions unrelated to the goal of therapy Often
produced by the same drug-receptor interaction
responsible for the therapeutic effect, differing only
in the tissue/s or organ/s affected

23. EXAMPLES OF ADVERSE EFFECTS
 INH, Rifampicin, PZA – Hepatotoxicity
 Streptomycin -Ototoxicity, nephrotoxicity
 Captopril - Cough
 Simvastatin – Rhabdomyolysis
 Nitrates – Headache
 Propranolol – Bronchial asthma
 Tetracycline – Hypoplasia of the teeth

24. TYPE B REACTIONS OR BIZARRE
 Abnormal effects
 Unrelated from the drug’s known pharmacological actions.
EXAMPLES OF BIZARRE REACTIONS
 Hypersensitivity reactions
 Stevens-Johnson’s Syndrome
 Hemolytic anaemia

25. TYPE C REACTIONS OR CONTINUOUS
Long term effects are usually related to the dose and duration of treatment
Examples
 Ethambutol - Retinopathy
 NSAIDs - Nephrotoxicity

26. TYPE D REACTIONS OR DELAYED
• Carcinogenesis
• Teratogenesis
• Examples: Thalidomide

27. TYPE E REACTIONS OR ENDING OF USE
Withdrawal Syndromes
Examples:
 Benzodiazepines – Rebound insomnia, agitation
 Clonidine – Rebound hypertension
 Corticosteroids – Acute adrenal insufficiency

28. TYPE F REACTIONS OR FAILURE OF EFFICACY
 Counterfeit medicines
 Underdosing of medications
 Drug interactions

29. DRUG INTERACTION
• Warfarin which is highly protein bound is displaced by valproic acid leading to bleeding
• Aspirin inhibit platelet aggregation together with heparin an anticoagulant leads increased
risk of bleeding.
ADVERSE DRUG EFFECTS MAY BE CATEGORISED INTO
1. Side Effects - Undesirable effects at therapeutic doses
e.g a)Atropine → Preanaesthetic medication → (undesirable ) dry mouth
b) Codiene → Suppresses Cough (desirable) → Constipation (undesirable)
Making Use of side effects
 Minoxidil → Antihypertension → Hypertrichosis → Male pattern baldness
 Codeine → used in travellers diarrhoea

30. 2. Secondary Effects- Indirect consequence of primary action of drug
Examples –
a)Corticosteroids → ↓Immunity → Latent T.B. activated
b)Tetracyclines → ↓Bacterial flora → Super-infection.
3. Toxic Effects-Exaggerated form of side effects due to overdosage/prolonged
use
Examples –
a)High dose heparin → Bleeding
b)Prolonged use of streptomycin →Ototoxicity, nephrotoxicity

31. 4. Allergy/Hypersensitivity-Immunologically mediated allergic
responses occurs when sensitised individuals are re-exposed to same
drug again
 Humoral-Type I,II,III
 Cell mediated-Type IV
Type I - Anaphylactic reactions due to IgE antibodies, min→2-3 hours
Examples - urticaria ,angioedema , anaphylactic shock
Type II - Cytolytic reactions due to antigen antibody complex , within 72
hours
Examples - hemolytic anemia , SLE.

32. Type III – Retarded or Arthus reaction - Immune complex mediated reactions,
72 hours→1-2 weeks
Examples - serum sickness (fever, arthralgia, lymphadenopathy),PAN , Steven
Johnson syndrome , procainamide induced systemic lupus erythematous.
Type IV - Delayed hypersensitivity reaction
Examples - Contact dermatitis

33. 5. Idiosyncrasy - Genetically determined abnormal reactivity to a chemical.
Here drug interacts with some unique features of individuals , not found in
majority of subjects , produces uncharacteristic reaction.
Examples –
a) Barbiturates → excitement and mental confusion in some patients.
b) Chloramphenicol → Aplastic anemia in some patients.
c) Quinine/ quinidine → cramps, diarrhoea , purpura , asthma & vascular
collapse.

34. 6. Drug Intolerance –
- Characteristic toxic effects at therapeutic dose
- Converse of tolerance
- ↑ sensitivity to low doses
Examples - Single dose triflupromazine → muscular
dystonia

35. 7. Photosensitivity
- Cutaneous reactions → sensitized skin → UV radiation. Two types:
- a) Phototoxicity
- b) Photoallergicity

36. Phototoxicity Photoallergy
Drug/ metabolite accumulates in skin
→ absorbs light → photochemical and
photobiological reaction → local tissue
damage i.e.erythema,edema,blistering,
hyperpigmentation
Drug/metabolite → cell mediated
immune response → UV light →
papular or eczematous contact
dermatitis like picture
Short wavelengths (290-320nm) UV-B Longer wavelengths (320-400nm) UV-
A
More common e.g. Tetracyclines Less common e.g.
Sulfonamides,Griseofulvin

37. 8. Drug withdrawal reactions
- Sudden interruption of drug → worsens clinical condition for which
previously drug was used.
Examples –
a) Corticosteroids in asthma → precipitates acute attacks , myalgia,
depression
b) b) Beta Blockers → worsening of angina , precipitates myocardial
infarction

38. 9. Teratogenicity
– Drug → pregnant mother → foetal abnormalities
Examples-
 Thalidomide → Phocomelia.
 Diethylstilbesterol → Vaginal adenocarcinoma.
 Valproic acid → Neural tube defects.
 Antithyroid drugs → Foetal goiter, hypothyroidism.
 Phenytoin → Cleft lip , microcephaly.

39. DRUGS CAN AFFECT THE FOETUS AT 3 STAGES
• .
Fertilization & implantation
(blastocyst formation)
Conception to 17 days -
failure of pregnancy -
Cytotoxic drugs , alcohol
Organogenesis - 18-55 days
of gestation - most
vulnerable period -
deformities are produced –
teratogens.
Growth and
development -
Developmental &
functional abnormality
ACE inhibitors -
Hypoplasia of organs
NSAIDS- Premature
closure of ductus
arteriosus

40. RISK CATEGORY OF DRUGS DURING
PREGNANCY
Pregnancy Category Description
No risk : Adequate and well-controlled
human studies - Failed to demonstrate a
risk to the foetus
e.g. inj magnesium sulphate , thyroxine
A

41. Pregnancy Category Description
No evidence of risk in humans : Animal
reproduction studies - Failed to
demonstrate a risk to the foetus & no
adequate and well-controlled studies in
pregnant women OR Animal studies have
shown an adverse effect, but adequate
and well-controlled studies in pregnant
women have failed to demonstrate a risk
to the foetus in any trimester.
E.g. Penicillin V, amoxicillin , cefaclor,
erythromycin paracetamol , lidocaine
B

42. Pregnancy Category Description
Risk cannot be ruled out: Animal
reproduction studies have shown an
adverse effect on the foetus and there are
no adequate and well-controlled studies in
pregnant women, But potential benefits
may warrant use of the drug in pregnant
women despite potential risks.
E.g morphine , codeine , atropine ,
corticosteroids ,adrenaline , thiopentone,
bupivacaine
C

43. Pregnancy Category Description
Benefit may outweigh potential risk:
Positive evidence of human foetal risk
- on adverse reaction data from
investigational or marketing
experience or studies in humans, But
potential benefits may warrant use of
the drug in pregnant women despite
potential risks .
E.g. aspirin , phenytoin ,
carbamazepine, valproate, lorazepam ,
methotrexate
D

44. Pregnancy Category Description
Contraindicated in Pregnancy: Studies in
animals or humans have demonstrated
foetal abnormalities and/or There is
positive evidence of human foetal risk
based on adverse reaction data from
investigational or marketing experience,
and the risks involved in use of the drug in
pregnant women clearly outweigh potential
benefits.
E.g oestrogens , isotretinoin , ergometrine,
thalidomide.
X

45. 10. Carcinogenicity and mutagenicity
Carcinogenicity
- Oxidation → reactive metabolites → structural gene damage
e.g. Anticancer drugs , estrogens .

46. Mutagenicity
 Structural changes in DNA
 Oxidation of the drugs produces reactive metabolites
 Covalent interaction with DNA
 Inheritable
 Takes 10-40 years to develop
 Anti cancer drugs, radioisotopes
 Usually marketed for life threatening conditions

47. 11. Iatrogenic (Drug induced diseases)
- Examples :
• a) NSAID'S → Peptic ulcers
• b) Hydralazine → DLE
• c) Phenothiazine's → Parkinsonism
• d) INH → Hepatitis

48. • 12. Drug Dependence - Use of drug produces a state in which person
believes that continuous use is necessary for state of well being (
psychic dependence) or to avoid withdrawal symptoms ( physical
dependence
Psychological Physical
Here person believes that state of wellbeing
achieved only with action of drugs
Here repeated administration of drug required
to maintain physiological equilibrium
Discontinuation → withdrawl
e.g. Opiods , Benzodiazepins e.g. Alcohol , Barbiturates , Benzodiazepins

49. PREVENTION OF ADR
1. Avoid all inappropriate use of drugs.
2. Use of appropriate dose , route & frequency of drug administration.
3. Elicit & take into consideration previous history of drug reactions.
4. Elicit h/o allergic diseases & exercise caution.
5. Rule out possibility of drug interaction.
6. Adopt correct drug administration technique.
7. Carry out appropriate laboratory investigation.
8. Be aware of interactions with certain foods, alcohol and even with
household chemicals.

50. MANAGEMENT OFADR
Discontinue the offending agent if –
 It can be safely stopped
 The event is life-threatening or intolerable
 There is a reasonable alternative
 Continuing the medication will further exacerbate the patient’s condition
Continue the medication (modified as needed) if –
 It is medically necessary
 There is no reasonable alternative
 The problem is mild and will resolve with time
 Discontinue non-essential medications
 Administer appropriate treatment - e.g., atropine,protamine sulfate ,digibind antibodies, flumazenil.
 Provide supportive or palliative care - e.g., hydration, glucocorticoids, warm / cold compresses,
analgesics or antipruritics
 Consider rechallenge or desensitization

51. CASUALITY ASSESSMENT

52. CAUSALITY ASSESSMENT
 Routine procedure in Pharmacovigilance
 Relationship of cause & effect
 Most outcomes : multiple interacting causes
 Aim : to define contribution due to drugs
Problems:
 ADRs rarely specific
 Diagnostic tests usually absent
 Re challenge rarely ethically justified

53. • Three broad categories of various methods of causality assessment:
1. Expert judgment/global introspection
2. Algorithms
3. Probabilistic methods (Bayesian approaches)
1. Expert judgment/global introspection: Expert judgments are individual assessments
based on previous knowledge and experience in the field using no standardized tool to arrive
at conclusions regarding causality.
2. Algorithms: Algorithms are sets of specific questions with associated scores for
calculating the likelihood of a cause-effect relationship.

54. 3. Probabilistic methods (Bayesian approaches)
 Bayesian approaches use specific findings in a case to transform the
prior estimate of probability into a posterior estimate of probability of
drug causation.
 The prior probability is calculated from epidemiological information
and the posterior probability combines this background information with
the evidence in the individual case to come up with an estimate of
causation.

56. THE NARANJO PROBABILITY SCALE
The score :-
 ≥ 9 = Definite
 5-8 = Probable
 1-4 = Possible
 0 = Doubtful

57.  World Health Organization (WHO) - Uppsala Monitoring Centre
(UMC) causality assessment criteria The WHO–UMC causality
assessment method includes the following four criteria :
a) Time relationships between the drug use and the adverse event.
b) Absence of other competing causes (medications, disease process itself).
c) Response to drug withdrawal or dose reduction (dechallenge).
d) Response to drug readministration (rechallenge).

59. • ADR can also be categorized into
Unclassified/Conditional or Unassessable/Unclassifiable in WHO-UMC
causality assessment.
• The term Unclassified/Conditional is applied when more data is needed
and such data is being sought or is already under examination.
• Finally when the information in a report is incomplete or contradictory
and cannot be complemented or verified, the verdict is Unassessable.

60. CERTAIN
✘ NOT a common causality grading
✘ Event / laboratory test abnormality with PLAUSIBLE TIME
RELATIONSHIP to drug intake
✘ Event CANNOT BE EXPLAINED BY CONCURRENT DISEASE /
OTHER DRUGS / CHEMICALS / NO CONCOMITANT DRUG
✘ PLAUSIBLE RESPONSE TO WITHDRAWAL – usually recover
without any treatment
✘ Confirmed with POSITIVE RECHALLENGE / SPECIFIC
LABORATORY TEST (patch test)
✘ Event DEFINITIVE - no other possible explanation

61. CERTAIN
• Only that particular drug
• No concomitant drug Or specific laboratory test
• Plausible time relationship
• Recover without treatment

62. PROBABLE
✘ COMMON causality grading
✘ Event / laboratory test abnormality with REASONABLE TIME
RELATIONSHIP to drug intake
✘ Event UNLIKELY TO BE ATTRIBUTED TO CONCURRENT
DISEASE / OTHER DRUGS / CHEMICALS
✘ REASONABLE RESPONSE TO WITHDRAWAL – usually recover
without any treatment
✘ RECHALLENGE NOT NECESSARY

63. POSSIBLE
✘ COMMON causality grading
✘ Event / laboratory test abnormality with REASONABLE TIME
RELATIONSHIP to drug intake
✘ Event COULD BE EXPLAINED BY CONCURRENT DISEASE /
OTHER DRUGS / CHEMICALS
✘ LACK OF INFORMATION ON WITHDRAWAL
✘ NO RECHALLENGE

64. UNLIKELY
✘ Event / laboratory test abnormality with IMPROBABLE (BUT NOT
IMPOSSIBLE) TIME RELATIONSHIP to drug intake
✘ Event MORE LIKELY CAN BE EXPLAINED BY CONCURRENT
DISEASE / OTHER DRUGS / CHEMICALS

65. UNCLASSIFIABLE
✘ INSUFFICIENT / CONTRADICTORY INFORMATION
✘ Cannot be supplemented / verified

68. WHY REPORT ADRS?
• To prevent drug-induced human suffering
• To avoid financial risks associated with unexpected risks
GOVERNMENT POLICY ON ADR REPORTING
• June 22, 1963 as amended on May 22, 1987 Republic Act 3720 “Food, Drugs and
Devices and Cosmetics Act”
• Creation of Food and Drug Administration now Bureau of Food and Drugs April
20, 1994
• BFAD Memorandum Circular No. 5 s. 1994 Submission of ADR reports by
pharmaceutical establishments and parties concerned June 30, 1994
• Department Order No. 345 - I s. 1994 Creation of National Adverse Drug Reaction
Advisory Committee (NADRAC)

70. HOW TO WE REPORT ADR
Step:1 Fill out the red alert card

74. Examples of Reported ADRs
COMMON REPORTS
 RASH CAUSED BY OXACILLIN
 RED FACE, FEVER SECONDARY TO VANCOMYCIN
UNCOMMON REPORTS
 HAIR LOSS DUE TO ANTI THYROID AGENTS
 NEUROLEPTIC MALIGNANT SYNDROME WITH RISPERIDONE

75. 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 status.
• Analyze the alternate cause (other than the drug)
• Use relevant literature & experienced physician opinion & information PV
center
• Report the ADR

76.  WHAT TO REPORT ?
 WHO SHOULD REPORT
 WHEN TO REPORT
 HOW TO REPORT
 WHERE TO REPORT

77. 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.
Information required for ADR case reporting
 Patient information-
 patient identifier
 age at time of event or date of birth
 gender
 weight

78. 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.
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

79. WHO SHOULD REPORT
 Doctors,
 Dentists,
 Pharmacists,
 Nurses,
 Assistant Medical Officers,
 Clinical Officers,
 Pharmaceutical Technicians,
 Pharmaceutical Assistants,
 Traditional Medicine Practitioners And Others Health Care Providers.

80. 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 patient

81. HOW TO REPORT
• CDSCO suspected ADR Reporting Form.
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 are available

82. What happens to the submitted information:
• 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.

83. • 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

86. DETECTION OF ADRS
1. Pre- marketing studies
2. Post –marketing surveillance
3. Under reporting
4. Communicating ADRs

98. 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
 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.
 Minimizing of non-preventable- Idiosyncratic / hypersensitivity not preventable.
 Can be done by carful observation / monitoring of patient Ex- patient with
meningitis – should be with penicillin (even if pt is allergic). Chemotherapy –
nausea

99. 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 drug.
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.