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ADVERSE DRUG REACTIONS. Dr Megha Rani N Dept of Pharmacology. Definition- ADVERSE DRUG REACTIONS.
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ADVERSE DRUG REACTIONS Dr MeghaRani N Dept of Pharmacology
Definition- ADVERSE DRUG REACTIONS • WHO definition- “ADR’’ Is defined as any response to a drug that is noxious and unintended and that occurs at doses used in man for prophylaxis, diagnosis or therapy for modification of physiological function.
INCIDENCE OF ADRs • ADRs are always under reported. • ADRs are the 4th-6th largest cause for mortality. • ADRs account for approximately 10% of hospital admissions. • ADRs increase the length of hospital stay and medical costs.
Type A (Augmented ) reactions • Side Effects: unavoidable, predictable Eg. Atropine as antisecretory in preanesthetic medication dry mouth b) Secondary effects: Indirect effect of therapy Eg. Intestinal microflora killed by tetracycline superinfection Corticosteroids immunity oral candidiasis
c) Toxic effects: [Overdose or prolonged use] Atropine - delirium ; Paracetamol -hepatic necrosis Barbiturates - coma; Morphine - respiratory failure
Type B (Bizarre) reactions Unexpected undesirable effects • Cannot be predicted from the pharmacology of the drug • Not dose dependent, host dependent factors important in pre-disposition
Type – B (bizzare) A) Drug allergy ( hypersensitivity reaction) • Type I • Type II • Type III • Type IV B) Idiosyncratic drug responses∕ Genetically determined
Severity of ADR • Minor: no need of therapy, antidote, or hospitalization. • Moderate: requires drug change , specific treatment, hospitalization. • Severe: Potentially life threatening; permanent damage, and prolonged hospitalization. • Lethal: Directly or indirectly leads to death
Prevention of ADR: [1] Avoid inappropriate drugs in the context of clinical condition. [2] Use right dose, route, frequency based on patient variables. [3] Elicit medication history; consider untoward incidents
[4] Elicit history of allergies [in patients with allergic diseases] . [5] Rule out drug interactions. [6] Adopt right technique: Eg slow iv injection of aminophylline . [7] Carry out appropriate monitoring [Eg PT with warfarin; Li levels].
Pharmacovigilance • It is defined by the WHO as the science and activities relating to the Detection, assessment, understanding and prevention of adverse effects or any other drug Related problems.' • The information generated is useful in educating doctors about ADRs and in the official regulation of drug use.