1 / 45

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.

garret
Télécharger la présentation

An ABC of Drug-Related Problems

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related