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Drug Safety
Published in: Drug Safety 6/2008

01-06-2008 | Original Research Article

Prevalence, Clinical Features and Avoidability of Adverse Drug Reactions as Cause of Admission to a Geriatric Unit

A Prospective Study of 1756 Patients

Authors: Marilisa Franceschi, Carlo Scarcelli, Valeria Niro, Davide Seripa, Anna Maria Pazienza, Giovanni Pepe, Anna Maria Colusso, Luigi Pacilli, Dr Alberto Pilotto

Published in: Drug Safety | Issue 6/2008

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Abstract

Background: Drug use increases with advancing age, and in older patients it is associated with an increase in adverse drug reactions (ADRs). ADRs are a primary cause of morbidity and mortality worldwide.
Objectives: To evaluate the prevalence, clinical characteristics and avoidability of ADR-related hospital admissions in elderly patients.
Methods: From November 2004 to December 2005, all patients aged ≥65 years consecutively admitted to the Geriatric Unit of the Casa Sollievo della Sofferenza Hospital, San Giovanni Rotondo in Italy, were evaluated for enrolment in the study. ADRs were defined according to the WHO Adverse Reaction Terminology system. Drugs were classified according to Anatomical Therapeutic Chemical classification system. The Naranjo algorithm was used to evaluate the relationship between drug use and the ADR (definite, probable, possible or doubtful) and Hallas criteria were used to evaluate the avoidability of the ADR (definitely avoidable, possibly avoidable or unavoidable). All cases of a suspected ADR were discussed by a team trained in drug safety, including three geriatricians, one clinical pharmacologist and one pharmacist. Only cases of an ADR with an agreement ≥80% were included.
Results: Of the 1756 patients observed, 102 (5.8%, 42 males, 60 females, mean age 76.5 ± 7.4 years, range 65–93 years) showed certain (6.8%) or probable (91.2%) ADR-related hospitalization. Gastrointestinal disorders (48 patients, 47.1%); platelet, bleeding and clotting disorders (20 patients, 19.6%); and cardiovascular disorders (13 patients, 12.7%) were the most frequent ADRs. NSAIDs (23.5%), oral anticoagulants (20.6%), low-dose aspirin (acetylsalicylic acid) [13.7%] and digoxin (12.7%) were the drugs most frequently involved in ADRs. Of the ADRs, 45.1% were defined as definitely avoidable, 31.4% as possibly avoidable, 18.6% as unavoidable and 4.9% as unclassifiable. Of 78 patients with definitely or possibly avoidable ADRs, 17 patients (21.8%) had received an inappropriate prescription, 29 patients (37.2%) had not received a prescription for an effective gastroprotective drug concomitantly with NSAID or low-dose aspirin treatment and 32 patients (41%) were not monitored during drug treatment.
Conclusion: In the elderly, almost 6% of hospitalizations are ADR related. Most of these ADRs are potentially avoidable. Strategies that reduce inappropriate prescriptions and monitoring errors, as well as improving active prevention of ADRs, are needed in elderly subjects.
Literature
1.
Pilotto A, Franceschi M, Vitale D, et al. on behalf of FIRI and SOFIA Project Investigators. Drug use by the elderly in general practice: effects on upper gastrointestinal symptoms. Eur J Clin Pharmacol 2006; 62: 65–72PubMedCrossRef
2.
Onder G, Pedone C, Landi F, et al. Adverse drug reactions as cause of hospital admissions: results from the Italian Group of Pharmacoepidemiology in the Elderly (GIFA). J Am Geriatr Soc 2002; 50: 1962–8PubMedCrossRef
3.
Beyth RJ, Shorr RI. Epidemiology of adverse drug reactions in the elderly by drug class. Drugs Aging 1999; 14: 231–9PubMedCrossRef
4.
Mannesse CK, Derkx FH, de Ridder MA, et al. Adverse drug reactions in elderly patients as contributing factor for hospital admission: cross sectional study. BMJ 1997; 315: 1057–8PubMedCrossRef
5.
Cunningham G, Dodd TRP, Grant DJ, et al. Drug-related problems in elderly patients admitted to Tayside hospitals, methods for prevention and subsequent reassessment. Age Ageing 1997; 26: 375–82PubMedCrossRef
6.
Mannesse CK, Derkx FHM, De Ridder MAJ, et al. Contribution of adverse drug reactions to hospital admission of older patients. Age Ageing 2000; 29: 35–9PubMedCrossRef
7.
Doucet J, Chassagne P, Trivalle C, et al. Drug-drug interactions related to hospital admission in older adults: a prospective study of 1000 patients. J Am Geriatr Soc 1996; 44: 944–8PubMed
8.
Pirmohamed M, James S, Meakin S, et al. Adverse drug reactions as cause of admission to hospital: prospective analysis of 18820 patients. BMJ 2004; 329: 15–9PubMedCrossRef
9.
Ghandi TK, Burstin HR, Cook F, et al. Drug complication in outpatients. J Gen Intern Med 2000; 15: 149–54CrossRef
10.
Gurwitz JH, Field TS, Harrold LR, et al. Incidence and prevent-ability of adverse drug events among older persons in the ambulatory setting. JAMA 2003; 289: 1107–16PubMedCrossRef
11.
Gurwitz JH, Field TS, Avorn J, et al. Incidence and preventability of adverse drug events in nursing home. Am J Med 2000; 109: 87–94PubMedCrossRef
12.
Winterstein AG, Sauer BC, Hepler CD, et al. Preventable drug-related hospital admissions. Ann Pharmacother 2002; 36: 1238–48PubMedCrossRef
13.
Rubenstein LZ, Joseph T. Freeman award lecture: comprehensive geriatric assessment: from miracle to reality. J Gerontol A Biol Sci Med Sci 2004; 59: 473–7PubMedCrossRef
14.
L’informatore farmaceutico 2004. OEMF International, Milano 2002. Guidelines for ATC-Classification. Uppsala: NLN-publication No.16 Nordic Council on Medicines, 1985
15.
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356: 1255–9PubMedCrossRef
16.
World Health Organization. International drug monitoring: the role of national centres. WHO technical Report series. 498. Geneva: World Health Organization, 1972
17.
18.
Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239–45PubMedCrossRef
19.
Hallas J, Harvald B, Gram LF, et al. Drug related hospital admissions: the role of definitions and intensity of data collection, and the possibility of prevention. J Intern Med 1990; 228: 83–90PubMedCrossRef
20.
Katz S, Downs TD, Cash HR, et al. Progress in the development of an index of ADL. Gerontologist 1970; 10: 20–30PubMedCrossRef
21.
Lawton MP, Brody EM. Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 1969; 9: 179–86PubMedCrossRef
22.
Pfeiffer E. A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. J Am Geriatr Soc 1975; 23: 433–41PubMed
23.
Linn B, Linn M, Gurel L. The cumulative illness rating scale. J Am Geriatr Soc 1968; 16: 622–6PubMed
24.
Guigoz Y, Vellas B. The Mini Nutritional Assessment (MNA) for grading the nutritional state of elderly patients: presentation of the MNA, history and validation. Nestle Nutr Workshop Ser Clin Perform Programme 1999; 1: 3–11PubMedCrossRef
25.
Lazarou J, Pomeranz BH, Corey PN, et al. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. JAMA 1998; 279: 1200–5PubMedCrossRef
26.
Beijer HJM, Blaey CJ. Hospitalisations caused by adverse drug reactions (ADR): a meta-analysis of observational studies. Pharm World Sci 2002; 24: 46–54PubMedCrossRef
27.
Passarelli MC, Jacob-Filho W, Figueras A. Adverse drug reactions in an elderly hospitalised population: inappropriate prescription is a leading cause. Drugs Aging 2005; 22: 767–77PubMedCrossRef
28.
Vila A, San Jose A, Roure C, et al. Prospective multicenter study of adverse drug in hospitalized elderly patients. Med Clin 2003; 120: 613–8CrossRef
29.
Pilotto A, Franceschi M, Vitale DF, et al. on behalf of F.I.R.I. (Fondazione Italiana Ricerca sull’Invecchiamento and the SOFIA Project Investigators). Upper gastrointestinal symptoms and therapies in elderly out-patients, users of non-selective NSAIDs or coxibs. Aliment Pharmacol Ther 2005; 22: 147–55PubMedCrossRef
30.
Pilotto A, Franceschi M, Leandro G, et al. Proton-pump inhibitors reduce the risk of uncomplicated peptic ulcer in elderly either acute or chronic users of aspirin/non steroidal anti-inflammatory drugs. Aliment Pharmacol Ther 2004; 20: 1091–7PubMedCrossRef
31.
Pilotto A, Franceschi M, Leandro G, et al. The risk of upper gastrointestinal bleeding in elderly acute and chronic users of aspirin and other non-steroidal antiinflammatory drugs: the role of gastroprotective drugs. Aging Clin Exp Res 2003; 15: 494–9PubMed
32.
Torn M, Bollen Ward LEM, van der Meer FJM, et al. Risk of oral anticoagulant therapy with increasing age. Arch Intern Med 2005; 165: 527–32CrossRef
33.
Oden A, Fahlen M. Oral anticoagulation and risk of death: a medical record linkage study. BMJ 2002; 325: 1073–5PubMedCrossRef
34.
Fihn SD, McDonell MB, Vermes D, et al. A computerised intervention to improve timing of outpatient follow-up: a multicenter randomised trial in patients treated with warfarin. J Gen Intern Med 1994; 9: 131–9PubMedCrossRef
35.
Fitzmaurice DA, Hobbs FD, Murray ET, et al. Oral anticoagulation management in primary care with the use of computerized decision support and near-patient testing: a randomised, controlled trial. Arch Intern Med 2000; 160: 2343–8PubMedCrossRef
36.
Sawicki P. A structured teaching and self-management program for patients receiving oral anticoagulation: a randomized controlled 556 trial. Working group for the study of patient self-management of oral anti-coagulation. JAMA 1999; 281: 145–50PubMedCrossRef
37.
Cromheecke M. Oral anticoagulation self management and management by a specialist anticoagulant clinic: a randomized cross-over comparison. Lancet 2000; 356: 97–102PubMedCrossRef
38.
Pilotto A, Franceschi M, Leandro G, et al. Geriatric Gastroenterology Study Group (Societe Italiana Gerontologie Geriatria). NSAID and aspirin use by the elderly in general practice: effect on gastrointestinal symptoms and therapies. Drugs Aging 2003; 20: 701–10PubMedCrossRef
39.
Antiplatelet Trialist’ Collaboration. Collaborative overview of randomised trials of antiplatelet therapy. I. Prevention of death, myocardial infarction, and stroke by prolonged antiplatelet therapy in various categories of patients. BMJ 1994; 308: 81–106CrossRef
40.
The SALT Collaborative Group. Swedish Aspirin Low-dose Trial (SALT) of 75 mgr aspirin as secondary prophylaxis after cerebrovascular events. Lancet 1991; 338: 1345–53CrossRef
41.
Weil J, Colin Jones D, Langman MJS, et al. Prophylactic aspirin and risk of peptic ulcer bleeding. BMJ 1995; 310: 827–30PubMedCrossRef
42.
Serrano P, Lanas A, Arroyo MT, et al. Risk of upper gastrointestinal bleeding in patients taking low-dose aspirin for the prevention of cardiovascular diseases. Aliment Pharmacol Ther 2002; 16: 1945–53PubMedCrossRef
43.
Pilotto A, Franceschi M, Longo MG, et al. Helicobacter pylori infection and the prevention of peptic ulcer with proton pump inhibitors in elderly subjects taking low-dose aspirin. Dig Liver Dis 2004; 36: 666–70PubMedCrossRef
44.
Pilotto A, Franceschi M, Leandro G, et al. Helicobacter pylori infection and the risk of gastro-duodenal damage in symptomatic elderly chronic low-dose aspirin users: effect of antisecretory drugs. Age Ageing 2004; 33: 402–4PubMedCrossRef
45.
46.
Corsonello A, Pedone C, Corica F, et al. Gruppo Italiano di Farmacovigilanza nell’Anziano (GIFA) Investigators. Concealed renal insufficiency and adverse drug reactions in elderly hospitalized patients. Arch Intern Med 2005; 165: 790–5PubMedCrossRef
47.
Pahor M, Guralnik JM, Gambassi G, et al. The impact of age on risk of adverse drug reactions to digoxin. For The Gruppo Italiano di Farmacovigilanza nell’ Anziano. J Clin Epidemiol 1993; 46: 1305–14PubMedCrossRef
48.
Juurlink DN, Mamdani M, Koop A, et al. Drug-drug interactions among elderly patients hospitalized for drug toxicity. JAMA 2003; 289: 1652–8PubMedCrossRef
49.
Howard RL, Avery AJ, Howard PD, et al. Investigation into the reasons for preventable drug related admissions to a medical admissions unit: observational study. Qual Saf Health Care 2003; 12: 280–5PubMedCrossRef
Metadata
Title
Prevalence, Clinical Features and Avoidability of Adverse Drug Reactions as Cause of Admission to a Geriatric Unit
A Prospective Study of 1756 Patients
Authors
Marilisa Franceschi
Carlo Scarcelli
Valeria Niro
Davide Seripa
Anna Maria Pazienza
Giovanni Pepe
Anna Maria Colusso
Luigi Pacilli
Dr Alberto Pilotto
Publication date
01-06-2008
Publisher
Springer International Publishing
Published in
Drug Safety / Issue 6/2008
Print ISSN: 0114-5916
Electronic ISSN: 1179-1942
DOI
https://doi.org/10.2165/00002018-200831060-00009

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