Objectives Explain Pharmacovigilance amp various types of adverse drug reactions List some common adverse effects amp toxicities with examples Discuss drug dependence amp its public health importance ID: 737058
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Adverse Drug Reaction
Slide2
Objectives
Explain
Pharmacovigilance & various types of adverse drug reactions.
List some common adverse effects & toxicities with examples. Discuss drug dependence & its public health importance. Describe principles of toxicology & treatment of poisoning in general. Describe Idiosyncratic reactions.
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Pharmacovigilance
Science of collecting, monitoring, researching, assessing and evaluating information from health care providers and patients on adverse effects of medications
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Adverse drug reaction (ADR) (WHO)
Response to a drug that is noxious & unintended
Occurs at doses normally used in man
For prophylaxis, diagnosis or therapy of disease or for modification of physiological functionsShould require an interventionWarning, Dose adjustment, Stoppage
of
therapy, Intervention
for treatment of ADRs
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Side Effects
Undesirable effects which may accompany beneficial effects of drug
Not so harmful as to stop drug
e.g.Dryness of mouth with atropineTachycardia with ephedrine
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Toxicity
Exaggeration of desired therapeutic effect at higher doses
Dose related
Coma due to barbiturates Delirium, hyperpyrexia in atropine overdose
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Adverse drug reaction: Classification
Types
Type A: Augmented
Type B: BizarreType C: Chronic Type D: Delayed
Type E: End of dose
Type F: Failure of therapy
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Type A: Augmented
Dose related, Predictable & expected
Less mortality, High frequency
Incidence more in elderly, infants, renal & hepatic dysfunction Gastritis with NSAIDsTachyarrhythmias
with adrenaline
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Type B: Bizarre
Not expected from known pharmacological action of drug in usual doses
Unpredictable, Based on patient rather than drug
Occur on 1st exposure, High mortality, Less frequencyHemolysis in G-6-PD deficient individuals:
Primaquine
,
Dapsone
Prolonged apnea with
SCh
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Type C: Chronic
Dose & time related
Uncommon
Related to cumulative doseDrug given for prolonged period of timee.g.SLE with Hydralazine
HPA suppression with Corticosteroids
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Type D: Delayed
Time related
Uncommon
Apparent sometimes after stoppage of druge.g.Vaginal adenocarcinoma with DES
Tardive
dyskinesia
with CPZ
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Type E: End of Dose
Uncommon
Occur after withdrawal of therapy
e.g.Acute adrenal insufficiency on stoppage of corticosteroids
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Type F: Failure of therapy
Common
Dose related
Often caused by drug interactionse.g.Oral contraceptive failure with Rifampicin
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Drug Dependence
Drug dependence
is a state in which use of drugs
for personal satisfaction is accorded a higher priority than other basic needs
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1. Psychological dependence
W
hen
individual believes that optimal state of wellbeing is achieved only through actions of drugMay start as liking for drug effects & may
progress
to compulsive
drug use in some
individuals
E.g
: opioids
,
cocaine
2. Physical
dependence
An
altered
physiological state
Produced
by repeated
administration of
a drug
Need for presence
of
drug
to maintain
physiological equilibrium
Discontinuation
of
drug results in
a characteristic withdrawal (abstinence) syndrome
E.g
: Alcohol
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3. Drug abuseRefers to use of a drug by self medication
Not approved by medical
and social patterns
Coccaine 4.Drug addictionPattern of compulsive drug use characterized by overwhelming involvement with the use of a drugE.g. Amphetamines
, cocaine, cannabis
,
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Toxicology
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Definitions
Toxicology
Science deals with poison with reference to
Source, properties, mode of actionSymptoms, lethal dose, treatment
Poison
Substance which when administered, inhaled/ ingested, capable of acting deleteriously on human body
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Initial management of toxicity
Airway
Breathing
CirculationHistory Physical Examination
Vital signs
Eyes
Mouth
Skin
Abdomen
Nervous system
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Initial management of toxicity
Laboratory reports
Arterial blood gases
ElectrolytesRenal function test
Echocardiogram
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Decontamination
Skin
Gastrointestinal tract
EmesisGastric lavage
Activated charcoal
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Specific Antidote
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Poison
Antidote
Dose
Anticholinesterases
, OPC,
Carbamate
Atropine
1-2 mg IV
, repeated every 5- 10 min till
atropinization
occur
Benzodiazepines
Flumazenil
0.2 mg IV
upto
3 mg
Methanol,
Ethylene Glycol
Ethanol
LD
0.7
mg/kg IV followed by 0.15 mg/kg/h
Methanol,
Ethylene Glycol
Fomepizole
LD 15 mg/kg IV followed by 10 mg/kg
every 12 h
Narcotic drugs
Naloxone
1-2 mg IV/ IM
Anticholinergic
agents
Physostigmine
0.5-
1 mg IV
OPC
Pralidoxime
1-2 g IVSlide23
Idiosyncratic Reactions
Genetically
determined abnormal
response of a drugUnique feature of individual, not found in majority of subjects.Eg.Barbiturates causes excitement and mental confusion in some subjects.
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