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An ABC of Drug-Related Problems

An ABC of Drug-Related Problems. RHB Meyboom, M Lindquist, ACG Egberts Drug Safety 2000;22:415-23. Introduction. The percentage of hospital admissions due to adverse drug reactions in some countries is about or more than 10% Br J Clin Pharmacol 1998, 45(3), 301-308.

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An ABC of Drug-Related Problems

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  1. An ABC of Drug-Related Problems RHB Meyboom, M Lindquist, ACG Egberts Drug Safety 2000;22:415-23

  2. Introduction • The percentage of hospital admissions due to adverse drug reactions in some countries is about or more than 10% • Br J Clin Pharmacol 1998, 45(3), 301-308. • Thèrapie, 1999, 54(1) 21-27. • Ad Drug React Toxico Rev., 1998, 17(1), 19-50. • Norway 11.5%, France 13%, UK 16%

  3. 6.7% of hospital patients have serious adverse drug reactions (medication error excluded)Lazarou J. Pomeranz BH, Corey PN. JAMA 1998;279:1200-5 16.2%of hospital admissions are drug-related Therapeutic failure 54.8% Adverse reactions 32.9% Overdose 12.3% Avoidable 49.3% Nelson KM, Talbert RL. Pharmacotherapy 1996;16:701-7

  4. Some countries spend up to 15-20% of their hospital budget dealing with drug complications. • White T et al. Counting the cost of drug-related adverse events. Pharmacoeconomics, 1999, 15(5). 445-458.

  5. The Zodiac of Drug-Related Problems Type A adverse effects Drug actions Poisoning Organ selective injury Late effects Carcinogenesis Dependence Risk situations Noncompliance Medication error Interactions Type C adverse effects Statistical effects Ineffectiveness Type B adverse effects Patient reactions

  6. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type A adverse effects - Drug actions • Pharmacological side effects • Common (> 1 %) • Dose relationship • Suggestive time relationship (kinetics) • Reproducible

  7. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type A adverse effects - Drug actions • Examples: • Sedation • Constipation • Diarrhoea • Urinary retention • Impotence • Hypoglycaemia (antidiabetics) • Hypokalaemia (diuretics) • Baldness (oncolytics)

  8. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type A adverse effects - Drug actions • Organ selective injury • Long-term use effects • Carcinogenesis • Risk situations, e.g. • - childhood • - elderly • - pregnancy • - lactation • - renal failure • - haemodialysis • Interactions

  9. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type A adverse effects - Drug actions • Methods of study: • Clinical trial / follow-up study • Spontaneous reporting • Prescription event monitoring • Hospital studies • Experiments

  10. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type B adverse effects - Patient reactions • Rare (< 1 %) • No dose relationship • Unexpected • Mechanism uncertain • Causality uncertain • Not reproducible • Characteristic, serious • Suggestive time relationship • Low background frequency

  11. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type B adverse effects - Patient reactions • Immunoallergic reactions • Pseudoallergy • Metabolic intolerance • Idiosyncrasy Examples: • Anaphylaxis • Stevens-Johnson syndrome • Blood dyscrasias • Hepatitis

  12. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type B adverse effects - Patient reactions • Methods of study: • Spontaneous reporting • Prescription event monitoring • Case control surveillance • Large databases / record linkage

  13. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type C adverse effects - 'statistical effects' • Increased frequency of 'spontaneous' disease • High background frequency • Less typical for a drug reaction • No suggestive time relationship • Often long latency • Mechanism unknown • Not reproducible

  14. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type C adverse effects - 'statistical effects' • Examples: • Thromboembolic events • GI haemorrhage • Pancreatitis

  15. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Type C adverse effects - 'statistical effects' Methods of study: • Follow up studies (large scale, long-term) • Case control studies • Large databases / record linkage • Spontaneous Reporting of limited use

  16. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Ineffectiveness • 55% of drug related problems • Limited efficacy • Noncompliance • Pharmaceutical defect • (counterfeit; generic) • Interaction • Resistance • Tolerance

  17. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Inappropriate use • Wrong dose • Wrong duration • Wrong indication • Wrong administration • Wrong patient • Wrong attitude or expectations • - Noncompliance • - Medication error • - Negligence (contraindication) • - Failure of information, counseling • or monitoring

  18. Medication Error > 7000 deaths per year from medication error in the USA To Err is Human: Building a Safer Health System. National Academy Press, 1999

  19. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Inappropriate use • Methods of study: • Spontaneous reporting • Questionnaire • Hospital studies • Follow-up studies

  20. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Dependence • hidden • not only narcotics

  21. Drug actions Type A adverse effects Overdose Dependence Interactions Therapeutic failure Delayed effects Non-compliance Organ selective toxicity Statistical effects Type C adverse effects Special situations Patient reactions Type B adverse effects • Poisoning (overdose) • iatrogenic • accidental • intentional

  22. The Zodiac of Drug-Related Problems Type A adverse effects Drug actions Poisoning Organ selective injury Late effects Carcinogenesis Dependence Risk situations Noncompliance Medication error Interactions Type C adverse effects Statistical effects Ineffectiveness Type B adverse effects Patient reactions

  23. Definitions (WHO) • Side Effect: any unintended effect of a drug occurring at normal doses, which is related to the pharmacological properties of the drug • Adverse Event: any untoward medical occurrence that may present during treatment with a drug but does not necessarily have a causal relationship • Adverse Reaction: any response to a drug which is noxious and unintended and occurs at normal doses • Often only suspicions! Edwards IR, Biriell C. Drug Safety 1994;10:93-102

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