Beruflich Dokumente
Kultur Dokumente
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
Dependence
Ineffectiveness
Overdose Dependence
Type A adverse effects - Drug actions Pharmacological side effects Common (> 1 %) Dose relationship Suggestive time relationship (kinetics) Reproducible
Overdose Dependence
Type A adverse effects - Drug actions Examples: Sedation Constipation Diarrhoea Urinary retention Impotence Hypoglycaemia (antidiabetics) Hypokalaemia (diuretics) Baldness (oncolytics)
Overdose Dependence
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
Overdose Dependence
Type A adverse effects - Drug actions Methods of study: Clinical trial / follow-up study Spontaneous reporting Prescription event monitoring Hospital studies Experiments
Overdose Dependence
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
Overdose Dependence
Type B adverse effects - Patient reactions Immunoallergic reactions Pseudoallergy Metabolic intolerance Idiosyncrasy Examples: Anaphylaxis Stevens-Johnson syndrome Blood dyscrasias Hepatitis
Overdose Dependence
Type B adverse effects - Patient reactions Methods of study: Spontaneous reporting Prescription event monitoring Case control surveillance Large databases / record linkage
Overdose Dependence
Overdose Dependence
Type C adverse effects - 'statistical effects' Examples: Thromboembolic events GI haemorrhage Pancreatitis
Overdose Dependence
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
Overdose Dependence
Ineffectiveness
55% of drug related problems Limited efficacy Noncompliance Pharmaceutical defect (counterfeit; generic) Interaction Resistance Tolerance
Overdose Dependence
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
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
Overdose Dependence
Inappropriate use
Methods of study: Spontaneous reporting Questionnaire Hospital studies Follow-up studies
Overdose Dependence
Dependence
hidden not only narcotics
Overdose Dependence
Poisoning (overdose)
iatrogenic accidental intentional
Dependence
Ineffectiveness
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