Adverse Drug Effects Bds

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Dr.U.P.Rathnakar MD.DIH.PGDHM

Adverse Drug Effects  Any undesirable or unintended consequence of drug administration  “Any response to a drug that is noxious and unintended and that occurs at doses used in man for the prophylaxis, diagnosis, or therapy of disease or for modification of physiological function” – WHO  Adverse event: Any untoward event that occurs during treatment not necessarily with causal relation ship to treatment

ADE: Predictable and Unpredictable  Predictable: Type A : Augmented  Augmented pharmacological properties  Side effects, toxic effects, Drug withdrawal effects  Common, dose related, Reversible  Unpredictable: Type B: Bizarre Reactions  Not known action of drug  Idiosyncracy, Allergy  Less common, Non dose related

ADE: Severity  Minor:  No tt required  Moderate:  Requires change in tt, change of drug  Severe:  Potentially life threatening,

permanent damage  Lethal:  Directly or indirectly contributes to death

ADE 1. Side effects: Unwanted ,unavoidable pharmacodynamic effects at therapeutic doses Eg. Antihistaminics cause sedation 2. Secondary effects: Indirect consequence of primary action of a drug Eg. Tetracyclines cause superinfection 3. Toxic effects: Due to overdose or prolonged use Eg. Respiratory failure by morphine Coma by barbiturates

ADE 4. Intolerance:  

5.  

Low threshold to the action of drug Eg. EPS with single dose of Metoclopromide Idiosyncrasy: A genetically determined reaction An unusual individual reaction to food or a drug Eg. Barbiturates cause excitement and mental confusion Chloramphenicol causes aplastic anemia

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

Type 1

Drug allergy-Type I [Anaphylaxis] Exposure to drug Eg.Penicillin

IgE AB Fixed to mast cells

Reexposure

Treatment: •Medical emergency •Inj.Adrenaline[1:1000] .3 to .5 ml i.m. •Inj.Hydrocortisone 100 mgi.v. •Inj.Diphenhydramine 25mg i.v. •Oxygen •i.v. fluids

AG+AB

Release of mediators: Histamine, 5-HT, PGs, LTs, PAF Anaphylactic shock: Hypotension, Bronchospasm, Urticaria Etc.

Type 2

Drug allergy-Type II [Cytolytic] Exposure to drug Eg.Quinine

Drug+Tissue= AG IgG, IgM- AB

Re exposure

Eg. Hemolysis by Quinine, Quinidine

Tissue+AB

Complement Cell destruction

Type 3

Drug allergy-Type III[Immune mediated] AG+AB IgG

Complement fixation

Deposited on vascular endothelium Destructive inflammatory response

Eg. • Serum sicknes [Fever, urticaria, joint pain, lymphadenopathy] •Penicillin, Sulfa •NSAIDs

Type 4

Drug allergy-Type IV [Delayed]

•Inflammatory respone •Delayed by 2-3 days •Contact dermatitis with LA creams •Not AB related •Cell mediated

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 drugs 9. Iatrogenic diseases: iatros = physician (physician induced diseases): Parkinsonism – Phenothiazines Peptic ulcer – Aspirin,corticosteroids Hepatitis Isoniazid

Drugs frequently cause allergic reactions  Penicillins

 Carbamazapine

 Cephalosporins

 ACE inhibitors

 Sulfonamides

 Local anesthetics

 Tetracyclines  Quinolones  Antitubercular drugs  Salicylates

Teratogenicity: terataos = monster Capacity of the drug to cause fetal abnormalities when administered to pregnant mother

10.

I. Preimplantation:conception to 17 days-Abortion ii.Organogenesis:18-55 days-Deformities iii.Growth and development:56 days onwards Thalidomide –Phocomelia Corticosteroids – Cleft lip TC-Discolouration of teeth, retarded bone growth

17 D

17-55 D

Implantation Organogen Death Fetus

Malform

>56D Growth&Dev Growth retard

Human teratogenic drugs

Cleft Palate Hydrocephalus Anticancer drugs

Hand defects Warfarin

Fetal alcohol syndrome Alcohol

Phocomelia Thalidomide

Neural tube Defects Valproate

Hydantoin syndrome Phenytoin

Tetracycline

Staining

After Tt

11.Organ toxicity  Hepatotoxicity: INH, Rifampicin  Nephrotoxicity: Aminoglycosides  Ototoxicity: Aminoglycosides,

Frusemide  Ocular toxicity: Ethambutol, Chloroquine

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 drug continuously or periodically Psychological: Intense desire to take drug and immense satisfaction later Physical: Physiological equilibrium is maintained by drug

Poisoning “Poisons in small doses are the best medicines; and useful medicines in too large doses are poisonous” William Withering 1789

Poisoning  Large enough dose of a drug  Sub.which endagers life  Accidental or suicidal  Treatment  Hospitalization  Gastric lavage  Airway-Suction, Endotracheal tube  Breathing-Mechanical ventilation  Circulation-i.v.Fluids  Diuretics or Dialysis  Antidote-OP poisoning-Atropine

Poisoning 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 1.

Prevention of adverse effects Right dose, route, frequency Previous history drug allergy and

allergic diseases Rule out drug interactions Correct technique of administration TDM if appropriate

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 to National centers to Uppsala monitoring center (Sweden) Uses  Educating doctors about ADE  Assessing safety of drugs

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