Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress
Clinical Collections
Advances in Alzheimer’s

At a glance: The STEP trials

A round-up of the STEP phase 3 clinical trials evaluating semaglutide for weight loss in people with overweight or obesity.
ADVANCED SEARCH
Log in
Top
BMC Health Services Research
Published in: BMC Health Services Research 1/2011

Open Access 01-12-2011 | Study protocol

The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors)

Authors: Joanna E Klopotowska, Peter C Wierenga, Sophia E de Rooij, Clementine C Stuijt, Lambertus Arisz, Paul F Kuks, Marcel G Dijkgraaf, Loraine Lie-A-Huen, Susanne M Smorenburg, the WINGS study group

Published in: BMC Health Services Research | Issue 1/2011

Login to get access

Abstract

Background

The potential of clinical interventions, aiming at reduction of preventable Adverse Drug Events (preventable ADEs) during hospital stay, have been studied extensively. Clinical Pharmacy is a well-established and effective service, usually consisting of full-time on-ward participation of clinical pharmacists in medical teams. Within the current Hospital Pharmacy organisation in the Netherlands, such on-ward service is less feasible and therefore not yet established. However, given the substantial incidence of preventable ADEs in Dutch hospitals found in recent studies, appears warranted. Therefore, "Ward-Oriented Pharmacy", an on-ward service tailored to the Dutch hospital setting, will be developed. This service will consist of multifaceted interventions implemented in the Internal Medicine wards by hospital pharmacists. The effect of this service on preventable ADEs in elderly inpatients will be measured. Elderly patients are at high risk for ADEs due to multi-morbidity, concomitant disabilities and polypharmacy. Most studies on the incidence and preventability of ADEs in elderly patients have been conducted in the outpatient setting or on admission to a hospital, and fewer in the inpatient setting. Moreover, recognition of ADEs by the treating physicians is challenging in elderly patients because their disease presentation is often atypical and complex. Detailed information about the performance of the treating physicians in ADE recognition is scarce.

Methods/Design

The design is a multi-centre, interrupted time series study. Patients of 65 years or older, consecutively admitted to Internal Medicine wards will be included. After a pre-measurement, a Ward-Oriented Pharmacy service will be introduced and the effect of this service will be assessed during a post-measurement. The primary outcome measures are the ADE prevalence on admission and ADE incidence during hospital stay. These outcomes will be assessed using structured retrospective chart review by an independent expert panel. This assessment will include determination of causality, severity and preventability of ADEs. In addition, the extent to which ADEs are recognised and managed by the treating physicians will be considered.

Discussion

The primary goal of the WINGS study is to assess whether a significant reduction in preventable ADEs in elderly inpatients can be achieved by a Ward-Oriented Pharmacy service offered. A comprehensive ADE detection method will be used based on expert opinion and retrospective, trigger-tool enhanced, chart review.

Trial registration

ISRCTN: ISRCTN64974377
Appendix
Available only for authorised users
Literature
1.
Kanjanarat P, Winterstein AG, Johns TE, et al: Nature of preventable adverse drug events in hospitals: a literature review. Am J Health Syst Pharm. 2003, 60: 1750-1759.PubMed
2.
Bates DW, Leape LL, Petrycki S: Incidence and preventability of adverse drug events in hospitalized adults. J Gen Intern Med. 1993, 8: 289-294. 10.1007/BF02600138.CrossRefPubMed
3.
Cano FG, Rozenfeld S: Adverse drug events in hospitals: a systematic review. Cad Saude Publica. 2009, 25 (Suppl 3): S360-S372.PubMed
4.
Thomsen LA, Winterstein AG, Søndergaard B, Haugbølle LS, Melander A: Systematic review of the incidence and characteristics of preventable adverse drug events in ambulatory care. Ann Pharmacother. 2007, 41: 1411-1426. 10.1345/aph.1H658.CrossRefPubMed
5.
Kaushal R, Bates DW, Landrigan C, et al: Medication errors and adverse drug events in pediatric inpatients. JAMA. 2001, 285: 2114-2120. 10.1001/jama.285.16.2114.CrossRefPubMed
6.
Expert Group On Safe Medication Practices: Creation of a better medication safety culture in Europe: Building up safe medication practices. 2006, Strasbourg, France
7.
Kelly WN: Potential risks and prevention, Part 1: Fatal adverse drug events. Am J Health Syst Pharm. 2001, 58: 1317-1324.PubMed
8.
Phillips J, Beam S, Brinker A, et al: Retrospective analysis of mortalities associated with medication errors. Am J Health Syst Pharm. 2001, 58: 1835-1841.PubMed
9.
Rothschild JM: Analysis of Medication-Related Malpractice Claims: Causes, Preventability, and Costs. Arch Intern Med. 2002, 162: 2414-2420. 10.1001/archinte.162.21.2414.CrossRefPubMed
10.
Rommers MK, Teepe-Twiss IM, H-jan Guchelaar: Preventing adverse drug events in hospital practice: an overview. Pharmacoepidemiol Drug Saf. 2007, 16: 1129-1135. 10.1002/pds.1440.CrossRefPubMed
11.
Institute of Medicine: Preventing medication errors: quality chasm series. 2006, Washington, DC
12.
Kucukarslan SN, Peters M, Mlynarek M, Nafziger DA: Pharmacists on rounding teams reduce preventable adverse drug events in hospital general medicine units. Arch Intern Med. 2003, 163: 2014-2018. 10.1001/archinte.163.17.2014.CrossRefPubMed
13.
Leape LL, Cullen DJ, Clapp MD, et al: Pharmacist participation on physician rounds and adverse drug events in the intensive care unit. JAMA. 1999, 282: 267-270. 10.1001/jama.282.3.267.CrossRefPubMed
14.
Sanghera N, Chan PY, Khaki ZF, et al: Interventions of hospital pharmacists in improving drug therapy in children: a systematic literature review. Drug Saf. 2006, 29: 1031-1047. 10.2165/00002018-200629110-00003.CrossRefPubMed
15.
Kaboli PJ, Hoth AB, McClimon BJ, Schnipper JL: Clinical pharmacists and inpatient medical care: a systematic review. Arch Intern Med. 2006, 166: 955-964. 10.1001/archinte.166.9.955.CrossRefPubMed
16.
American College Of Clinical Pharmacy: The definition of clinical pharmacy. Pharmacotherapy. 2008, 28: 816-817.CrossRef
17.
18.
SHPA Committee Of Specialty Practice In Clinical Pharmacy: SHPA Standards of Practice for Clinical Pharmacy. J Pharm Pract Res. 2005, 35: 122-146.CrossRef
19.
Surugue J, Vulto AG: Workforce of EU Hospitals and Pharmacy Services: a direct patientr safety issue. Eur J Hosp Pharm. 2006, 12: 31-33.
20.
Zegers M, Bruijne MC, de Wagner C, et al: Adverse events and potentially preventable deaths in Dutch hospitals: results of a retrospective patient record review study. Qual Saf Health Care. 2009, 18: 297-302. 10.1136/qshc.2007.025924.CrossRefPubMed
21.
Bosma L, Jansman FGA, Franken AM, Harting JW, Van Den Bemt PMLA: Evaluation of pharmacist clinical interventions in a Dutch hospital setting. Pharm World Sci. 2008, 30: 31-38.CrossRefPubMed
22.
Klopotowska JE, Kuiper R, van Kan HJ, et al: On-ward participation of a hospital pharmacist in a Dutch intensive care unit reduces prescribing errors and related patient harm: an intervention study. Crit Care. 2010, 14: R174-10.1186/cc9278.CrossRefPubMedPubMedCentral
23.
Karapinar-Carkit F, Borgsteede SD, Zoer J, et al: Effect of medication reconciliation with and without patient counseling on the number of pharmaceutical interventions among patients discharged from the hospital. Ann Pharmacother. 2009, 43: 1001-1010. 10.1345/aph.1L597.CrossRefPubMed
24.
Merle L, Laroche ML, Dantoine T, Charmes JP: Predicting and preventing adverse drug reactions in the very old. Drugs Aging. 2005, 22: 375-392. 10.2165/00002512-200522050-00003.CrossRefPubMed
25.
Hajjar ER, Cafiero AC, Hanlon JT: Polypharmacy in elderly patients. Am J Geriatr Pharmacother. 2007, 5: 345-351. 10.1016/j.amjopharm.2007.12.002.CrossRefPubMed
26.
27.
Hanlon JT, Schmader KE, Koronkowski MJ, et al: Adverse drug events in high risk older outpatients. J Am Geriatr Soc. 1997, 45: 945-948.CrossRefPubMed
28.
Gurwitz JH, Field TS, Avorn J, et al: Incidence and preventability of adverse drug events in nursing homes. Am J Med. 2000, 109: 87-94. 10.1016/S0002-9343(00)00451-4.CrossRefPubMed
29.
Gurwitz JH, Field TS, Harrold LR, et al: Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA. 2003, 289: 1107-1116. 10.1001/jama.289.9.1107.CrossRefPubMed
30.
Franceschi M, Scarcelli C, Niro V, et al: Prevalence, clinical features and avoidability of adverse drug reactions as cause of admission to a geriatric unit: a prospective study of 1756 patients. Drug Saf. 2008, 31: 545-556. 10.2165/00002018-200831060-00009.CrossRefPubMed
31.
Budnitz DS, Shehab N, Kegler SR, Richards CL: Medication use leading to emergency department visits for adverse drug events in older adults. Ann Intern Med. 2007, 147: 755-765.CrossRefPubMed
32.
Chan M, Nicklason F, Vial JH: Adverse drug events as a cause of hospital admission in the elderly. Intern Med J. 2001, 31: 199-205. 10.1046/j.1445-5994.2001.00044.x.CrossRefPubMed
33.
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: 1962-1968. 10.1046/j.1532-5415.2002.50607.x.CrossRefPubMed
34.
Cecile M, Seux V, Pauly V, et al: [Adverse drug events in hospitalized elderly patients in a geriatric medicine unit: study of prevalence and risk factors]. Rev Med Interne. 2009, 30: 393-400. 10.1016/j.revmed.2009.01.010.CrossRefPubMed
35.
Page RL, Ruscin JM: The risk of adverse drug events and hospital-related morbidity and mortality among older adults with potentially inappropriate medication use. Am J Geriatr Pharmacother. 2006, 4: 297-305. 10.1016/j.amjopharm.2006.12.008.CrossRefPubMed
36.
Gray SL, Sager M, Lestico MR, Jalaluddin M: Adverse drug events in hospitalized elderly. J Gerontol A Biol Med Sci. 1998, 53: M59-M63.CrossRef
37.
Samaras N, Chevalley T, Samaras D, Gold G: Older patients in the emergency department: a review. Ann Emerg Med. 2010, 56: 261-269. 10.1016/j.annemergmed.2010.04.015.CrossRefPubMed
38.
Hohl CM, Robitaille C, Lord V, et al: Emergency physician recognition of adverse drug-related events in elder patients presenting to an emergency department. Acad Emerg Med. 2005, 12: 197-205. 10.1111/j.1553-2712.2005.tb00869.x.CrossRefPubMed
39.
Kaur S, Mitchell G, Vitetta L, Roberts MS: Interventions that can reduce inappropriate prescribing in the elderly: a systematic review. Drugs Aging. 2009, 26: 1013-1028. 10.2165/11318890-000000000-00000.CrossRefPubMed
40.
Spinewine A, Swine C, Dhillon S, et al: Effect of a collaborative approach on the quality of prescribing for geriatric inpatients: a randomized, controlled trial. J Am Geriatr Soc. 2007, 55: 658-665. 10.1111/j.1532-5415.2007.01132.x.CrossRefPubMed
41.
Viktil KK, Blix HS: The impact of clinical pharmacists on drug-related problems and clinical outcomes. Basic Clin Pharmacol Toxicol. 2008, 102: 275-280. 10.1111/j.1742-7843.2007.00206.x.CrossRefPubMed
42.
van Dijk KN, van Asselt DZB, Vogel D, et al: [Effects of a structured medication review by geriatrician and clinical pharmacologist on appropriateness of pharmacotherapy in frail elderly inpatients]. Tijdschr Gerontol Geriatr. 2009, 40: 72-78.CrossRefPubMed
43.
Gillespie U, Alassaad A, Henrohn D, et al: A comprehensive pharmacist intervention to reduce morbidity in patients 80 years or older: a randomized controlled trial. Arch Intern Med. 2009, 169: 894-900. 10.1001/archinternmed.2009.71.CrossRefPubMed
44.
Burns N: Evaluation of warfarin dosing by pharmacists for elderly medical in-patients. Pharm World Sci. 2004, 26: 232-237.CrossRefPubMed
45.
46.
Ramsay CR, Matowe L, Grilli R, Grimshaw JM, Thomas RE: Interrupted time series designs in health technology assessment: lessons from two systematic reviews of behavior change strategies. Int J Technol Assess Health Care. 2003, 19: 613-623.CrossRefPubMed
47.
Grindrod KA, Patel P, Martin JE: What interventions should pharmacists employ to impact health practitioners prescribing practices?. Ann Pharmacother. 2006, 40: 1546-1557. 10.1345/aph.1G300.CrossRefPubMed
48.
Wierenga PC, Lie-A-Huen L, de Rooij SE, et al: Application of the Bow-Tie model in medication safety risk analysis: consecutive experience in two hospitals in the Netherlands. Drug Saf. 2009, 32: 663-673. 10.2165/00002018-200932080-00005.CrossRefPubMed
49.
50.
Nebeker JR: Developing a Taxonomy for Research in Adverse Drug Events: Potholes and Signposts. J Am Med Inform Assoc. 2002, 9 (Suppl 2): 80-85.CrossRef
51.
Morimoto T, Gandhi TK, Seger AC, Hsieh TC, Bates DW: Adverse drug events and medication errors: detection and classification methods. Qual Saf Health Care. 2004, 13: 306-314. 10.1136/qshc.2004.010611.CrossRefPubMedPubMedCentral
52.
Murff HJ, Patel VL, Hripcsak G, Bates DW: Detecting adverse events for patient safety research: a review of current methodologies. J Biomed Inform. 2003, 36: 131-143. 10.1016/j.jbi.2003.08.003.CrossRefPubMed
53.
Resar RK, Rozich JD, Classen D: Methodology and rationale for the measurement of harm with trigger tools. Qual Saf Health Care. 2003, 12 (Suppl 3): 39-45.
54.
Phansalkar S, Hoffman JM, Nebeker JR, Hurdle JF: Pharmacists versus nonpharmacists in adverse drug event detection: a meta-analysis and systematic review. Am J Health Syst Pharm. 2007, 64: 842-849. 10.2146/ajhp060335.CrossRefPubMed
55.
van Doormaal JE, Mol PGM, van Den Bemt PMLA, et al: Reliability of the assessment of preventable adverse drug events in daily clinical practice. Drug Saf. 2008, 17: 645-654.
56.
57.
58.
Charlson ME, Pompei P, Ales KL, MacKenzie CR: A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987, 40: 373-383. 10.1016/0021-9681(87)90171-8.CrossRefPubMed
59.
Kunac DL, Reith DM, Kennedy J, Austin NC, Williams SM: Inter- and intra-rater reliability for classification of medication related events in paediatric inpatients. Qual Saf Health Care. 2006, 15: 196-201. 10.1136/qshc.2005.014407.CrossRefPubMedPubMedCentral
60.
Rozich JD, Haraden CR, Resar RK: Adverse drug event trigger tool: a practical methodology for measuring medication related harm. Qual Saf Health Care. 2003, 12: 194-200. 10.1136/qhc.12.3.194.CrossRefPubMedPubMedCentral
61.
Agbabiaka TB, Savović J, Ernst E: Methods for causality assessment of adverse drug reactions: a systematic review. Drug Saf. 2008, 31: 21-37. 10.2165/00002018-200831010-00003.CrossRefPubMed
Metadata
Title
The effect of an active on-ward participation of hospital pharmacists in Internal Medicine teams on preventable Adverse Drug Events in elderly inpatients: protocol of the WINGS study (Ward-oriented pharmacy in newly admitted geriatric seniors)
Authors
Joanna E Klopotowska
Peter C Wierenga
Sophia E de Rooij
Clementine C Stuijt
Lambertus Arisz
Paul F Kuks
Marcel G Dijkgraaf
Loraine Lie-A-Huen
Susanne M Smorenburg
the WINGS study group
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2011
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-11-124

Other articles of this Issue 1/2011

BMC Health Services Research 1/2011 Go to the issue

Research article

Walk-ins seeking treatment at an emergency department or general practitioner out-of-hours service: a cross-sectional comparison

Research article

Treatment adherence among sputum smear-positive pulmonary tuberculosis patients in mountainous areas in China

Research article

Ten steps or climbing a mountain: A study of Australian health professionals' perceptions of implementing the baby friendly health initiative to protect, promote and support breastfeeding

Research article

Health services performance for TB treatment in Brazil: a cross-sectional study

Research article

Measuring client satisfaction and the quality of family planning services: A comparative analysis of public and private health facilities in Tanzania, Kenya and Ghana

Study protocol

Economic evaluation of three populational screening strategies for cervical cancer in the county of Valles Occidental: CRICERVA clinical trial