adverse drug effects bds

8/14/2019 Adverse Drug Effects BDS

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Dr.U.P.RathnakarDr.U.P.RathnakarMD.DIH.PGDHMMD.DIH.PGDHM


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Adverse Drug EffectsAny undesirable or unintended consequence

of drug administration

Any response to a drug that is noxious andunintended and that occurs at doses usedin man for the prophylaxis, diagnosis, or

therapy of disease or for modification ofphysiological function WHO

Adverse event: Any untoward event thatoccurs during treatment not necessarilywith causal relation ship to treatment


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ADE: Predictable and Unpredictable

Predictable: Type A : Augmented

Augmented pharmacological properties

Side effects, toxic effects, Drug withdrawaleffects

Common, dose related, Reversible

Unpredictable: Type B: Bizarre Reactions

Not known action of drug

Idiosyncracy, AllergyLess common, Non dose related


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ADE: SeverityMinor:No tt requiredModerate: Requires change in tt, change of drug

Severe:Potentially life threatening,permanent damage

Lethal: Directly or indirectly contributes to

death


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ADE1. Side effects:

Unwanted ,unavoidable pharmacodynamic effectsat therapeutic doses

Eg. Antihistaminics cause sedation2. Secondary effects:

Indirect consequence of primary action of a drug

Eg. Tetracyclines cause superinfection3. Toxic effects:

Due to overdose or prolonged use

Eg. Respiratory failure by morphineComa by barbiturates


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ADE4. Intolerance:

Low threshold to the action of drug

Eg. EPS with single dose of Metoclopromide

5. Idiosyncrasy:

A genetically determined reaction

An unusual individual reaction to food or a drugEg. Barbiturates cause excitement and mentalconfusion

Chloramphenicol causes aplastic anemia


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6. ADE:Drug allergy (drug hypersensitivity)

Immunologically mediated reaction

Types of drug allergy

1.Anaphylactic- -Type I

2.Cytolytic -Type II

3.Immune complex mediated[Arthus]:-Type III

4.Delayed hypersensitivity-Type IV


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Type 1


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Drug allergy-Type I [Anaphylaxis]

Exposure todrug

Eg.Penicillin

IgE ABFixed tomast cells

Reexposure AG+AB

Release ofmediators:

Histamine, 5-HT,PGs, LTs, PAF

Anaphylactic shock:Hypotension,

Bronchospasm,

Urticaria Etc.

Treatment:Medical emergencyInj.Adrenaline[1:1000] .3 to .5 ml

i.m.Inj.Hydrocortisone 100 mgi.v.Inj.Diphenhydramine 25mg i.v.Oxygeni.v. fluids


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Type 2


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Drug allergy-Type II [Cytolytic]

Exposure todrug

Eg.Quinine

Drug+Tissue=AG

IgG, IgM- AB

Reexposure

Tissue+AB

Complement

Celldestruction

Eg. Hemolysis byQuinine, Quinidine


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Type 3


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Drug allergy-Type III[Immune mediated]AG+ABIgG

Complementfixation

Destructive inflammatoryresponse

Eg. Serum sicknes[Fever, urticaria,

joint pain,lymphadenopathy]Penicillin, SulfaNSAIDs

Deposited onvascular

endothelium


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Type 4


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Drug allergy-Type IV[Delayed]

Inflammatory responeDelayed by 2-3 daysContact dermatitis with LA creamsNot AB relatedCell mediated


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7. Photosensitivity

Sensitization of the skin by drugs UV radiation Cutaneous reaction-Photosensitivity

8. Carcinogenicity & mutagenicity: Ability of the drug to cause cancer and genetic

defects respectively

Eg. Tobacco, anticancer drugs9. Iatrogenic diseases:iatros= physician

(physician induced diseases):

Parkinsonism PhenothiazinesPeptic ulcer Aspirin,corticosteroidsHepatitis - Isoniazid


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Drugs frequently cause allergic reactions

Penicillins

Cephalosporins

Sulfonamides

Tetracyclines

Quinolones

Antitubercular

drugsSalicylates

Carbamazapine

ACE inhibitors

Localanesthetics


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10. Teratogenicity: terataos= monster

Capacity of the drug to cause fetal abnormalitieswhen administered to pregnant mother

I. Preimplantation:conception to 17 days-Abortionii.Organogenesis:18-55 days-Deformitiesiii.Growth and development:56 days onwards

Thalidomide PhocomeliaCorticosteroids Cleft lipTC-Discolouration of teeth, retarded bone growth


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17 D 17-55 D >56D

ImplantationOrganogen Growth&Dev

DeathFetus Malform

Growthretard


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Cleft Palate HydrocephalusAnticancer drugs

PhocomeliaThalidomide

Neural tubeDefects

Valproate

Hand defects

Warfarin

Fetal alcoholsyndrome

AlcoholHydantoin syndrome

Phenytoin

Human teratogenic drugs


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Tetracycline

Staining

After Tt


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11.Organ toxicity Hepatotoxicity: INH, Rifampicin

Nephrotoxicity: Aminoglycosides Ototoxicity: Aminoglycosides,

Frusemide Ocular toxicity: Ethambutol,

Chloroquine


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12. Drug dependence A state

Psychological or physical

Due to interaction - living organism+Drug

Characterised by behavioral and other responses

Always includes a compulsion to take the drugcontinuously or periodically

Psychological: Intense desire to take drug andimmense satisfaction later

Physical: Physiological equilibrium is maintained bydrug


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Poisoning

Poisons in small doses are the best medicines; anduseful medicines in too large doses are poisonous

William Withering 1789


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Poisoning Large enough dose of a drug Sub.which endagers life

Accidental or suicidal

TreatmentHospitalization

Gastric lavage

Airway-Suction, Endotracheal tube

Breathing-Mechanical ventilation

Circulation-i.v.Fluids

Diuretics or Dialysis

Antidote-OP poisoning-Atropine


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Poisoning

1. Resuscitation and maintainance of vital functions

Airway, BP, Body temp., Blood sugar

2. Termination of exposure

Fresh air, remove wet clothes, wash,

3. Prevention of absorption

Gastric lavage, Activated charcoal,4. Hastening elimination

Diuresis, Altering urine pH, Hemodialysis


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Prevention of adverse effectsRight dose, route, frequency

Previous history drug allergy andallergic diseases

Rule out drug interactions

Correct technique ofadministration

TDM if appropriate


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Pharmacovigilance

Actively look for adverse drug effects Activities relating to detection, assessment,

understanding and prevention of adverse effects or

any other drug related problem Information collected by

Regional centers to

Zonal centers toNational centers to

Uppsala monitoring center(Sweden)

Uses

Educating doctors about ADE

Assessing safety of drugs


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adverse drug effects bds

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