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Nehal V. Trambadiya Asst. professor Department of Pharmacology Smt. N. M. Padalia Pharmacy College
Any noxious change which is (^) Suspected to be due to a drug
May requires treatment or decrease in dose or Caution in the future use of the same drug
(^) Incidence of ADR more (^) Polypharmacy (^) Elderly (^) Children (^) Patient with multiple diseases (^) Pregnancy (^) Malnourished (^) Immunosuppression (^) Drug Abusers and addicts Develop (^) Immediately or
GRADING OF SEVERITY OF ADVERSE DRUG REACTIONS : Minor : No therapy, antidote or prolongation of hospitalization is required. Moderate : Requires change in drug therapy, specific treatment or prolongs hospital stay. (^) Severe : Potentially life-threatening, causes permanent damage or requires intensive medical treatment. (^) Lethal : Directly or indirectly contributes to death of the patient.
These are based on the pharmacological properties of the drug so can be predicted. (^) They are common and account for 75% of ADRs Dose related and preventable mostly reversible. Examples:- (^) Anticoagulants (e.g., warfarin, heparin) – bleeding (^) Anti-hypertensives (e.g.. α1-antagonists) – hypotension (^) Anti-diabetics (e.g. insulin) - hypoglycemia Predictable
(^) Have no direct relationship to the dose of the drug or the pharmacological mechanism of drug action. (^) Develop on the basis of:
(^) More serious clinical outcomes with higher mortality and morbidity. (^) Mostly require immediate withdrawal of the drug. Un-predictable
TYPE D – DELAYED They manifest themselves with significant delay (^) Teratogenesis - Thalidomide – Phocomelia (flipper-like fore limbs) (^) Mutagenesis/Cancerogenesis Predictable
TYPE E – END OF USE
Predictable
Various activities involved in pharmacovigilance are : (^) Postmarketing surveillance and other methods of ADR monitoring such as voluntary reporting by doctors prescription event monitoring. (^) Dissemination of ADR data through 'drug alerts', 'medical letters,' advisories sent to doctors by pharmaceuticals and regulatory agencies. (^) Changes in the labelling of medicines indicating restrictions in use or statuary warnings, precautions, or even withdrawal of the drug.
The Uppsala Monitoring Centre (Sweden) is the international collaborating centre. (^) In India, (^) National centre is located at Ghaziabad (^) Peripheral Centres at Medical college levels and tertiary and above hospitals (^) Reports generated by doctors, paramedical staff--to peripheral centre...National centre...Uppsala Monitoring Centre...Compilation of data..analysis of data..causal association is confirmed..guidelines issued regarding the safe use of medicine or (restricted use or withdrawal from the market)
Categorized into : (^) Side effects- (^) Secondary effects Toxic effects Intolerance (^) Idiosyncrasy (^) Drug allergy Photosensitivity Drug dependence Drug withdrawal reactions (^) Teratogenicity (^) Mutagenicity and Carcinogenicity Drug induced diseases (Iatrogenic disorders or Iatrogenicity) Beware of – Iatrogenic, Idiosyncrasy, Idiopathic, Intolerance
Unwanted often unavoidable Pharmaco-dynamic effects. Occur at therapeutic doses. Predictable Examples. Benzodiazepines- Motor in coordination H1 Anti-histaminics- Sedation An effect may be therapeutic in one context but side effect in another context (^) Depression of A-V conduction is the desired effect of digoxin in atrial fibrillation, but the same may be undesirable when it is used for CHF. Constipation by codeine is side effect but can be used as therapeutic effect in patient with loose motions
TOXIC EFFECTS (Poisonous effect) It is the dose and duration which makes a poison.... Over dose or prolonged use. The effects are predictable and dose related. (^) The CNS, CVS, kidney, liver, lung, skin and bone marrow are most commonly involved in drug toxicity.
(^) Toxicity may result from extension of the therapeutic effect itself, e.g. complete A-V block by digoxin, bleeding due to heparin. Poisoning : Poison is a substance which endangers life by severely affecting one or more vital functions.