Educationally Intervening the Use of Potentially Harmful Medication Among Residents in Institutional Settings
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Department of General Practice and Primary Health Care Faculty of Medicine University of Helsinki Finland EDUCATIONALLY INTERVENING THE USE OF POTENTIALLY HARMFUL MEDICATION AMONG RESIDENTS IN INSTITUTIONAL SETTINGS Anna-Liisa Juola Academic dissertation To be presented, with the permission of the Faculty of Medicine, University of Helsinki, for public examination in Auditorium XII, Fabianinkatu 33, on 2nd February 2018, at 12 noon Helsinki, Finland 2018 Supervisors Professor Kaisu Pitkälä, MD, PhD University of Helsinki, Department of General Practice and Primary Health Care Helsinki, Finland Mikko Björkman, MD, PhD University of Helsinki, Department of Medicine, Division of Geriatrics Helsinki, Finland Reviewers Professor Esa Leinonen, MD, PhD University of Tampere, Department of Psychiatry Tampere, Finland Adjunct Professor Juha Puustinen, MD, PhD University of Helsinki, Division of Pharmacology and Pharmacotherapy Helsinki, Finland Satakunta Hospital District, Unit of Neurology Pori, Finland Opponent Adjunct Professor Raimo Isoaho, MD, MPH, PhD University of Turku, Department of General Practice Turku, Finland City of Vaasa, Social and Health Services Vaasa, Finland Cover graphics Vesa Juola Untitled 2017 ISBN 978-951-51-4032-6 (nid.) ISBN 978-951-51-4033-3 (PDF) Unigrafia Helsinki 2018 To Vesa with love Contents Abbreviations 7 Definitions 8 List of original publications 9 Abstract 10 Tiivistelmä (Finnish Abstract) 13 1 Introduction 17 2 Review of the literature 19 2.1 Ageing and medication 19 2.1.1 Pharmacokinetics and pharmacodynamics 19 2.1.2 Problems related to drug use among older people in institutional settings 20 2.2 Potentially harmful medications (PHMs) for older people 21 2.2.1 Various criteria for inappropriate prescribing 22 2.2.2 Beers’ inappropriate drugs 31 2.2.2.1 Development of Beers’ list over decades 31 2.2.2.2 Prevalence of Beers’ drugs in institutional settings 34 2.2.2.3 Factors associated with use of Beers’ drugs 38 2.2.2.4 Adverse events related to Beers’ drugs 39 2.2.3 Drugs with anticholinergic properties (DAPs) 43 2.2.3.1 Cholinergic transmission 43 2.2.3.2 Definitions of DAPs 44 2.2.3.3 Prevalence of DAPs in institutional settings 46 2.2.3.4 Factors associated with use of DAPs 47 2.2.3.5 Adverse events related to DAPs 49 2.2.4 Psychotropic drugs 56 2.2.4.1 Definitions of psychotropic drugs 56 2.2.4.2 Prevalence of psychotropic drugs in institutional settings 57 2.2.4.3 Factors associated with use of psychotropic drugs 66 2.2.4.4 Adverse events related to psychotropic drugs 67 2.2.5 Proton pump inhibitors (PPIs) 76 2.2.6 Non-steroidal anti-inflammatory drugs (NSAIDs) 77 2.3 Educational intervention studies to reduce harmful drug use in institutional settings 78 2.4 Summary of PHMs 84 3 Aims of the study 87 4 Methods 88 4.1 Participants and setting 88 4.2 Study design and randomization 90 4.3 Measurements 92 4.4 Intervention 95 4.5 Outcome measures 96 4.6 Statistical analyses 97 4.7 Ethical considerations 98 5 Results 99 5.1 Burden of PHMs (Study 1) 99 5.1.1 Predictors of burden of PHMs and associations with participants’ quality of life and mortality 101 5.2 Educational intervention to reduce PHM use among residents in assisted living facilities 101 5.2.1 Baseline findings and feasibility (Study 2) 101 5.2.2 Effect of intervention on use of PHMs (Study 3) 102 5.2.3 Effect of intervention on participants’ quality of life (Study 3) 104 5.2.4 Effect of intervention on participants’ hospitalization and use of health services (Study 3) 105 5.2.5 Effect of intervention on participants’ mortality (Study 3) 105 5.2.6 Effect of intervention on participants’ falls (Study 4) 105 5.2.7 Effect of intervention on participants’ cognition (Study 4) 106 6 Discussion 108 6.1 Main findings 108 6.2 Strengths and limitations of the study 108 6.3 Medication use (Studies 1-4) 110 6.4 Burden of PHMs (Study 1) 112 6.5 Educational intervention to reduce the use of PHMs (Studies 2-4) 113 7 Conclusions 117 8 Implications for clinical practice and for future research 118 9 Acknowledgements 119 10 References 121 11 Appendices 140 12 Original publications 159 Abbreviations A = Anxiolytic ACTRN = Australian New Zealand Clinical Trials Registry AD = Alzheimer’s Disease ADL = Activities of Daily Living ALF = Assisted Living Facility AT = Atypical Antipsychotic ATC = Anatomic Therapeutic Chemical classification CDR = Clinical Dementia Rating CI = Confidence Interval CN = Conventional Neuroleptic CNS = Central Nervous System DAP = Drug with Anticholinergic Properties DBI = Drug Burden Index DDI = Drug-Drug Interaction EP = Extrapyramidal GEE = Generalized Estimating Equation H = Hypnotic HR = Hazard Ratio HRQoL = Health Related Quality of Life IRR = Incidence Rate Ratio LTCF = Long-Term Care Facility LTCW = Long-Term Care Ward MAI = Medication Appropriateness Index MMSE = Mini-Mental State Examination MNA = Mini-Nutritional Assessment NH = Nursing Home NHD = Nursing Home for people with Dementia NNH = Number Needed to Harm NSAID = Non-Steroidal Anti-Inflammatory Drug OR = Odds Ratio PHM = Potentially Harmful Medication PID = Potentially Inappropriate Drug PIM = Potentially Inappropriate Medication PPI = Proton Pump Inhibitor PWB = Psychological Well-Being QoL = Quality of life RAI = Resident Assessment Instrument RCT = Randomized Controlled Trial RR = Relative Risk S = Sedative SAA = Serum Anticholinergic Activity SD =Standard Deviation SSRI = Selective Serotonin Reuptake Inhibitor TCA = Tricyclic Antidepressant WHO = World Health Organization 15D = 15-Dimensional 95% CI = 95% Confidence Interval Definitions Potentially harmful PHMs in this study: 1. Beers’ 2003 Potentially inappropriate drugs medication (PHM) (PIDs), 2. Drugs with anticholinergic properties (DAPS) according to Rudolph’s anticholinergic risk scale (ARS), Beers’ 2003 anticholinergic drugs, and the Svenska Socialstyrelsen 2010 list, 3. Use of >2 psychotropics concomitantly according to Svenska Socialstyrelsen, 4. Proton Pump Inhibitors (PPIs), 5. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Potentially PID is a term first used in Beers’ 1997 updated criteria. PIDs are drugs inappropriate drug that should be avoided among people aged ≥65 years. (PID) Potentially PIM refers to inappropriate drugs according to various international inappropriate criteria. medication (PIM) Older people People aged ≥65 years. Educational An educational intervention seeks to reform an older practice through intervention training. In this study, education is based on constructive learning theory. This means learning with an active process in which learners construct new concepts based upon their previous knowledge to solve problems. Nursing home Institutional settings providing 24-hour care for older people with multimorbidity and need for assistance in activities of daily living (ADL) and instrumental activities of daily living (IADL). Assisted living facility Home-like environment that provides room and board for older people. Level of assistance and costs depend on each resident’s needs according to medical conditions and ADL and IADL skills. Care available around the clock. Nowadays in Finland, an assisted living facility resident’s need for assistance and the level of care are quite similar to those in nursing homes. Defined as an institutional setting in this study. List of original publications This thesis is based on the following original publications: 1. Juola AL, Pylkkanen S, Kautiainen H, Bell JS, Bjorkman MP, Finne-Soveri H, Soini H, Pitkälä KH. Burden of potentially harmful medications and the association with quality of life and mortality among institutionalized older people. J Am Med Dir Assoc 2016;17:276.e9-14. 2. Juola AL, Bjorkman MP, Pylkkanen S, Finne-Soveri H, Soini H, Kautiainen H, Bell JS, Pitkala K. Feasibility and baseline findings of an educational intervention in a randomized trial to optimize drug treatment among residents in assisted living facilities. Eur Geriatr Med 2014;5:195-9. 3. Pitkälä KH, Juola AL, Kautiainen H, Soini H, Finne-Soveri UH, Bell JS, Björkman M. Education to reduce potentially harmful medication use among residents of assisted living facilities: a randomized controlled trial. J Am Med Dir Assoc 2014;15:892-8. 4. Juola AL, Bjorkman MP, Pylkkanen S, Finne-Soveri H, Soini H, Kautiainen H, Bell JS, Pitkala KH. Nurse education to reduce harmful medication use in assisted living facilities: effects of a randomized controlled trial on falls and cognition. Drugs Aging 2015;32:947-55. These publications have been reprinted with the kind permission of their copyright holders. In addition, some unpublished material is presented. Abstract Background: Institutionalized older people are frail and they suffer from a high number of comorbidities. Polypharmacy is also common. In older age, changes in pharmacokinetics often lead to slower metabolism and higher drug concentrations. Thus, older people are prone to adverse effects of drugs and their drug treatment is challenging. Over the last few decades, several criteria have been developed to define potentially inappropriate medication for older people. Beers’ list of inappropriate drugs in 1991 in USA was the first explicit criteria for inappropriate drugs, and it has been updated in 1997, 2003, 2012, and 2015. Many countries have developed their own criteria. There are also some implicit criteria for beneficial medication such as STOPP and START criteria. Drugs with anticholinergic properties (DAPs) are known to be potentially harmful. Their use may lead to many