Term paper presentation 3- Adverse Drug Reactions & Drug Toxicity

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Adverse Drug Reaction

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Term paper presentation 3- Adverse Drug Reactions & Drug Toxicity

  1. 1. DRUG TOXICITY & ADVERSE DRUG REACTIONSUNDER THE PRESENTED BY:GUIDANCE OF: ANSH DEV RAVIDr. Amrish Chandra A4513309001
  2. 2.  ADVERSE DRUG REACTION/ADE/DRUG TOXICITY can be "an appreciably harmful or unpleasant reaction, resulting from an intervention related to the use of a medicinal product, which predicts hazard from future administration and warrants prevention or specific treatment, or alteration of the dosage regimen, or withdrawal of the product.“ Adverse drug reactions are classified into six types: Dose-related (Augmented) Non-dose-related (Bizarre)  Dose-related and time-related (chronic) Time-related (delayed)  Withdrawal (end of use) Failure of therapy (failure) 2
  3. 3. DRUG TOXICITY/ADR/ADE is defined as "manifestations ofthe adverse effects of drugs administered therapeutically orin the course of diagnostic techniques. It does not includeaccidental or intentional poisoning...“It may result when : the dose is too high the liver or kidneys are unable to remove the drug from the bloodstream 3
  4. 4. GIVEN BY WHO• Noxious and unintended response to medicinal product if a medicine is properly prescribed and administered.• Casual reaction between medicinal product and adverse event cannot be ruled out.• Medical errors are not included in this definition.GIVEN BY MHRA• an unwanted or harmful reaction experienced following the administration of a drug or drugs.• suspected to be related to the drug or drugs.• The reaction may be a known side-effect of the drug or it may be new and previously unrecognised. 4
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  6. 6. TYPE A REACTIONS TYPE B REACTIONSCHARACTERISTICS1. Predictable 1. Unpredictable2. Usually dose dependent 2. Rarely dose dependent3. High morbidity 3. Low morbidity4. Low mortality 4. High mortality5. Responds to drug reactions 5. Responds to drug withdrawal6. Identified pre -marketing 6. Identified post- marketingEXAMPLESSulphonylureas- hypoglycaemia Penicillins- anaphylaxisPhenothiazines- orthostatic Chloramphenicol- aplastic anaemiahypotension Carbamazepine- Stevens- JohnsonStilboestrol- vaginal carcinoma syndrome 6
  7. 7.  TYPE C :  Dose-related and time-related  Related to duration and dosage of exposure. Example: hypothalamic-pituitary-adrenal suppression from glucocorticoid therapy. TYPE D :  Time-related  Delayed reaction Example: tardive dyskinesia. 7
  8. 8.  Type E:  Withdrawal  Lend of dose reaction Example: narcotic or beta-blocker withdrawal Type F:  Unexpected failure of therapy  May be caused by drug interactions Example: failure of oral contraceptives due to induction of enzymes by a second drug. 8
  9. 9.  Drug reaction with eosinophilia and systemic symptoms may be caused by medications including:  Allopurinol  Phenytoin  Dapsone  Carbamazepine  Trimethoprim-sulfamethoxazole  Penicillin  Non-steroidal anti-inflammatory agents 9
  10. 10.  Defined as the phenomenon that occurs when the effect of pharmacokinetics of the drugs are altered by prior administration or co administration of second drug. A particularly important type of adverse drug event Complex, involving either increasing or decreasing the activity of a given cytochrome pathway, or preferentially using the pathway rather than other drugs. 10
  11. 11. • Monoamine oxidase inhibitors can cause fatal hypertension in patients who have also consumed food containing high concentrations of tyramine.• The suspect foods form an odd assortment EXAMPLE: Chianti wine, some smoked fish and aged cheese 11
  12. 12.  BY FREQUENCY The recommendations of WHO have been summarized by:  very common (1/10 patients)  common (1/100)  uncommon (1/1000)  rare (1/10,000)  very rare (1/100,000) BY SEVERITY The American Food and Drug Administration defines severe effects as:  Death  Life-Threatening 12
  13. 13.  Hospitalization (initial or prolonged) Disability - significant, persistent, or permanent change, impairment, damage or disruption in the patients body function/structure, physical activities or quality of life. Requires Intervention to Prevent Permanent Impairment or Damage 13
  14. 14.  As research better explains the biochemistry of drug use, less ADRs are Type B and more are Type A Risk factors are:  The number of drugs  History of prior drug toxicity  Presence of heart failure  Presence of liver disease  Presence of renal failure  Presence of 4 or more medical conditions 14
  15. 15. Common Mechanisms……1. ABNORMAL PHARMACOKINETICS due to – Comorbid disease states: Various diseases, especially those that cause renal or hepatic insufficiency, may alter drug metabolism. – Genetic factors: Abnormal drug metabolism may be due to inherited factors of either Phase I oxidation or Phase II conjugation.2. SYNERGISTIC EFFECTS between either – a drug and a disease – two drugs 15
  16. 16. FACTORS INCREASINGADR’s1. POLYPHARMACY― The risk of drug interactions may be increased.― Using 11 or more chronic medications is a risk factor for drug toxicity2. FRAGMENTED HEALTH CARE When controlled for other factors such as the number of prescribing physicians, the number of medications may not be a risk factor for adverse drug reactions. 16
  17. 17. ASSESSING CAUSALITY A scale proposed by the World Health Organization (WHO) is below:a. Certain d. Unlikelyb. Probable/likely e. Conditional/ unclassifiedc. Possible f. Unassessable/ unclassifiable4. INTOLERANCE TO MULTIPLE DRUGS― Amplification may contribute to multiple-drug intolerance.― This is distinct from multiple drug hypersensitivity. 17
  18. 18. SYPMTOMS OF DRUGTOXICITY1.SYMPTOMS OF GHB: i. PALPITATION ii. COMA iii. HYPOTENSION iv. HYPOTHERMIA v. MUSCLE CRAMPS vi. NAUSEA AND VOMITING vii. SLOW BREATHING viii. VOILENT BEHAVIOR 18
  19. 19. 2. SYMPTOMS OF HALLUCINOGEN i. ANXIETY ii. DELUSION iii. DEPRESSION iv. HALUCINATIONS v. PANIC ATTACK vi. PARANOIA vii. RESTLESSNESS viii. VIOLENT BEHAVIOR ix. SEIZURES 19
  20. 20. List of drugs that have been identified asthose with the highest potential for harm:• Warfarin• Aspirin• Metformin• Insulin• Glyburide• Digoxinvalproic Acid 20
  21. 21. To Avoid Drug Toxicity• Keep a careful record of what drugs you are taking including over the counter drugs.• Inform all doctors you see of every medication you are taking and be aware of what the dosage is. Also list supplements, herbs or other OTC medicine you are taking.• If blood tests do not bring your doctor to a diagnosis, ask him to do a specific test for drug toxicity.• Eliminate or reduce the dose of a suspected medication under doctors care. 21
  22. 22. REFERENCES• Essentials of Medical Pharmacology (6th edition) by KD Tripathi• Drug Toxicity Encyclopedia Article- Citizendium• thepharmacist.co.uk• pubmedresult.com• wikipedia 22
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