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Adverse drug reactions

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DRUG ADVERS REACTIONS

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Adverse drug reactions

  1. 1. Adverse Drug Reactions By Yousra Ashraf (PHMH-D)
  2. 2. Introduction  Adverse drug reaction (ADR or adverse drug effect) is a broad term referring to unwanted, uncomfortable, or dangerous effects that a drug may have. Adverse reactions may arise from use of the product within or outside the terms of the marketing authorization or from occupational exposure. Conditions of use outside the marketing authorization include off-label use, overdose, misuse, abuse and medication errors. The reaction may be a known side effect of the drug or it may be new and previously unrecognized. It is any undesirable experience that has happened to the patient while taking a drug that is suspected to be caused by the drug or drugs. An example of an ADR could be a patient experiencing anaphylaxis shortly after taking the drug.
  3. 3. Definition  An adverse drug reaction (ADR) is a response to a medicinal product which is noxious and unintended.
  4. 4. Incidence and severity of ADRs vary by…….  Patient characteristics (e.g., age, sex, ethnicity, coexisting disorders, genetic or geographic factors)  Drug factors (e.g., type of drug, administration route, treatment duration, dosage, and bioavailability). Incidence is probably higher and ADRs are more severe among the elderly although age per se may not be the primary cause. The contribution of prescribing and adherence errors to the incidence of ADRs is unclear.
  5. 5. Types of ADR’S  Dose related  Allergic  Idiosyncratic
  6. 6. Dose related  Dose-related ADRs are predictable and are particularly a concern when drugs have a narrow therapeutic index (e.g., hemorrhage with oral anticoagulants). ADRs may result from decreased drug clearance in patients with impaired renal or hepatic function or from drug-drug interactions.
  7. 7. Allergic  Allergic ADRs are not dose-related and require prior exposure. Allergies develop when a drug acts as an antigen or allergen. After a patient is sensitized, subsequent exposure to the drug produces one of several different types of allergic reaction
  8. 8. Idiosyncratic  These are not dose-related or allergic. They occur in a small percentage of patients given a drug. Idiosyncrasy has been defined as a genetically determined abnormal response to a drug, but not all idiosyncratic reactions have a pharmacogenetic cause.
  9. 9. Classification of ADR’S Severity Description Example Mild No antidote or treatment is required; hospitalization is not prolonged Antihistamines (some): DrowsinessOpioids: Constipation Moderate A change in treatment (e.g., modified dosage, addition of a drug), but not necessarily discontinuation of the drug, is required; hospitalization may be prolonged, or specific treatment may be required. Hormonal contraceptives: Venous thrombosis NSAIDs: Hypertension and edema Severe An ADR is potentially life threatening and requires discontinuation of the drug and specific treatment of the ADR. ACE inhibitors: Angioedema Phenothiazines: Abnormal heart rhythm Lethal An ADR directly or indirectly contributes to a patient's death Acetaminophen over dosage: Liver failureAnticoagulants: Hemorrhage
  10. 10. Signs and symptoms  Symptoms and signs may manifest soon after the first dose or only after chronic use. They may obviously result from drug use or be too subtle to identify as drug-related. In the elderly, subtle ADRs can cause functional deterioration, changes in mental status, failure to thrive, loss of appetite, confusion, and depression.  Allergic ADRs typically occur soon after a drug is taken but generally do not occur after the first dose; typically, they occur when the drug is given after an initial exposure.  Symptoms include itching, rash, fixed-drug eruption, upper or lower airway edema with difficulty breathing, and hypotension.  Idiosyncratic ADRs can produce almost any symptom or sign and usually cannot be predicted.
  11. 11. References  Text book of pharmacology by Lippincott  Clinical pharmacology by Goodman Gillman  Pharmacy overview by V.Serin David
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DRUG ADVERS REACTIONS

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