Decreasing the load? Is a Multidisciplinary Multistep Medication Review in older people an effective intervention to reduce a patient's Drug Burden Index? Protocol of a randomised controlled trial
Helene G van der Meer, Hans Wouters, Rolf van Hulten, Niesko Pras, Katja Taxis, Helene G van der Meer, Hans Wouters, Rolf van Hulten, Niesko Pras, Katja Taxis
Abstract
Introduction: Older people often use medications with anticholinergic or sedative side effects which increase the risk of falling and worsen cognitive impairment. The Drug Burden Index (DBI) is a measure of the burden of anticholinergic and sedative medications. Medication reviews are typically done by a pharmacist in collaboration with a general practitioner to optimise the medication use and reduce these adverse drug events. We will evaluate whether a Multidisciplinary Multistep Medication Review (3MR) is an effective intervention to reduce a patient's DBI.
Methods: A randomised controlled trial including 160 patients from 15 community pharmacies will be conducted. Per pharmacy, 1 pharmacist will perform a structured 3MR in close collaboration with the general practitioner, including the objective to reduce the DBI.
Analysis: Primary outcome--the difference in proportion of patients having a decrease in DBI ≥ 0.5 in the intervention and control groups at follow-up. Secondary outcomes--anticholinergic and sedative side effects, falls, cognitive function, activities of daily living, quality of life, hospital admission, and mortality.
Ethics and dissemination: The burden of patients will be kept at a minimum. The 3MR can be considered as usual care by the pharmacist and general practitioner. Medical specialists will be consulted, if necessary. The intervention is specifically aimed at older community-dwelling patients in an attempt to optimise prescribing, in particular, to reduce medication with anticholinergic and sedative properties. Study results will be published in peer-reviewed journals and will be distributed through information channels targeting professionals.
Trial registration number: NCT02317666; Pre-results.
Keywords: aged; drug burden index; medication review; muscarinic antagonists; polypharmacy.
Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Figures
References
- Taxis K, O'Sullivan D, Cullinan S et al. . Drug utilization in older people. In:Elseviers M, Wettermark B, Almarsdottir AB, et al, eds Drug utilization research: methods and applications. Wiley, 2016. Chapter 25).
- Boyd CM, Darer J, Boult C et al. . Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA 2005;294:716–24. 10.1001/jama.294.6.716
- Davies EA, O'Mahony MS. Adverse drug reactions in special populations—the elderly. Br J Clin Pharmacol 2015;80:796–807. 10.1111/bcp.12596
- McLean AJ, Le Couteur DG. Aging biology and geriatric clinical pharmacology. Pharmacol Rev 2004;56:163–84. 10.1124/pr.56.2.4
- Shi S, Morike K, Klotz U. The clinical implications of ageing for rational drug therapy. Eur J Clin Pharmacol 2008;64:183–99. 10.1007/s00228-007-0422-1
- O'Mahony D, O'Sullivan D, Byrne S et al. . STOPP/START criteria for potentially inappropriate prescribing in older people: version 2. Age Ageing 2015;44:213–18. 10.1093/ageing/afu145
- American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults . J Am Geriatr Soc 2012;60:616–31. 10.1111/j.1532-5415.2012.03923.x
- Landi F, Russo A, Liperoti R et al. . Anticholinergic drugs and physical function among frail elderly population. Clin Pharmacol Ther 2007;81:235–41. 10.1038/sj.clpt.6100035
- Mulsant BH, Pollock BG, Kirshner M et al. . Serum anticholinergic activity in a community-based sample of older adults: relationship with cognitive performance. Arch Gen Psychiatry 2003;60:198–203. 10.1001/archpsyc.60.2.198
- Cumming RG, Le Couteur DG. Benzodiazepines and risk of hip fractures in older people: a review of the evidence. CNS Drugs 2003;17:825–37. 10.2165/00023210-200317110-00004
- Huang AR, Mallet L, Rochefort CM et al. . Medication-related falls in the elderly: causative factors and preventive strategies. Drugs Aging 2012;29:359–76. 10.2165/11599460-000000000-00000
- Cancelli I, Gigli GL, Piani A et al. . Drugs with anticholinergic properties as a risk factor for cognitive impairment in elderly people: a population-based study. J Clin Psychopharmacol 2008;28:654–9. 10.1097/JCP.0b013e31818ce849
- Hiitola PK, Enlund H, Sulkava RO et al. . Changes in the use of cardiovascular medicines in the elderly aged 75 years or older—a population-based Kuopio 75+ study. J Clin Pharm Ther 2007;32:253–9. 10.1111/j.1365-2710.2007.00819.x
- Flory JH, Ky B, Haynes K et al. . Observational cohort study of the safety of digoxin use in women with heart failure. BMJ Open 2012;2:e000888 10.1136/bmjopen-2012-000888
- Wastesson JW, Parker MG, Fastbom J et al. . Drug use in centenarians compared with nonagenarians and octogenarians in Sweden: a nationwide register-based study. Age Ageing 2012;41:218–24. 10.1093/ageing/afr144
- Hartikainen S, Rahkonen T, Kautiainen H et al. . Kuopio 75+ study: does advanced age predict more common use of psychotropics among the elderly? Int Clin Psychopharmacol 2003;18:163–7.
- Hilmer SN, Mager DE, Simonsick EM et al. . A drug burden index to define the functional burden of medications in older people. Arch Intern Med 2007;167:781–7. 10.1001/archinte.167.8.781
- Ruxton K, Woodman RJ, Mangoni AA. Drugs with anticholinergic effects and cognitive impairment, falls and all-cause mortality in older adults: a systematic review and meta-analysis. Br J Clin Pharmacol 2015;80:209–20. 10.1111/bcp.12617
- Kouladjian L, Gnjidic D, Chen TF et al. . Drug Burden Index in older adults: theoretical and practical issues. Clin Interv Aging 2014;9:1503–15. 10.2147/CIA.S66660
- Vinks TH, Egberts TC, de Lange TM et al. . Pharmacist-based medication review reduces potential drug-related problems in the elderly: the SMOG controlled trial. Drugs Aging 2009;26:123–33. 10.2165/0002512-200926020-00004
- Teichert M, Luijben SN, Wereldsma A et al. . Implementation of medication reviews in community pharmacies and their effect on potentially inappropriate drug use in elderly patients. Int J Clin Pharm 2013;35:719–26. 10.1007/s11096-013-9794-8
- Hatah E, Braund R, Tordoff J et al. . A systematic review and meta-analysis of pharmacist-led fee-for-services medication review. Br J Clin Pharmacol 2014;77:102–15. 10.1111/bcp.12140
- Blenkinsopp A, Bond C, Raynor DK. Medication reviews . Br J Clin Pharmacol 2012;74:573–80. 10.1111/j.1365-2125.2012.04331.x
- Nederlands Huisartsen Genootschap (NHG). [Multidisciplinary guideline on polypharmacy in older individuals]. Utrecht, 2012. (accessed Jun 2015).
- Cohen J. A power primer. Psychol Bull 1992;112:155–9. 10.1037/0033-2909.112.1.155
- Gnjidic D, Le Couteur DG, Abernethy DR et al. . A pilot randomized clinical trial utilizing the drug burden index to reduce exposure to anticholinergic and sedative medications in older people. Ann Pharmacother 2010;44:1725–32. 10.1345/aph.1P310
- Farmacotherapeutisch Kompas. [Dutch pharmacotherapeutic reference source]. (accessed Aug 2015).
- Expertisecentrum pharmacotherapie bij ouderen (EPHOR). [Dutch reference source for pharmacotherapy in older people]. (accessed Aug 2015).
- KNMP Kennisbank. [Dutch pharmacotherapeutic reference source]. (accessed Aug 2015).
- Duran CE, Azermai M, Vander Stichele RH. Systematic review of anticholinergic risk scales in older adults. Eur J Clin Pharmacol 2013;69:1485–96. 10.1007/s00228-013-1499-3
- Lingjaerde O, Ahlfors UG, Bech P et al. . The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl 1987;334:1–100. 10.1111/j.1600-0447.1987.tb10566.x
- de Vries ST, Haaijer-Ruskamp FM, de Zeeuw D et al. . Construct and concurrent validity of a patient-reported adverse drug event questionnaire: a cross-sectional study. Health Qual Life Outcomes 2014;12:103 10.1186/s12955-014-0103-6
- Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc 1991;39:142–8. 10.1111/j.1532-5415.1991.tb01616.x
- Solomon PR, Hirschoff A, Kelly B et al. . A 7 minute neurocognitive screening battery highly sensitive to Alzheimer's disease. Arch Neurol 1998;55:349–55. 10.1001/archneur.55.3.349
- Reitan RM. The relation of the trail making test to organic brain damage. J Consult Psychol 1955;19:393–4. 10.1037/h0044509
- Wechsler D. Wechsler Adult Intelligence Scale. Third Edition. San Antonio; The Psychological Corporation; 1997.
- Kempen GI, Suurmeijer TP. The development of a hierarchical polychotomous ADL-IADL scale for noninstitutionalized elders . Gerontologist 1990;30:497–502. 10.1093/geront/30.4.497
- Kempen GI, Miedema I, Ormel J et al. . The assessment of disability with the Groningen Activity Restriction Scale. Conceptual framework and psychometric properties. Soc Sci Med 1996;43:1601–10. 10.1016/S0277-9536(96)00057-3
- EuroQol EQ-5D-3L. (accessed Aug 2014).
- Wouters H, Quik EH, Boersma F et al. . Discontinuing Inappropriate Medication in Nursing Home Residents (DIM-NHR Study): protocol of a cluster randomised controlled trial. BMJ Open 2014;4:e006082 10.1136/bmjopen-2014-006082
- Pont LG, Nielen JT, McLachlan AJ et al. . Measuring anticholinergic drug exposure in older community-dwelling Australian men: a comparison of four different measures. Br J Clin Pharmacol 2015;80:1169–75.
Source: PubMed