Nurse-led medicines' monitoring in care homes study protocol: a process evaluation of the impact and sustainability of the adverse drug reaction (ADRe) profile for mental health medicines

Sue Jordan, Timothy Banner, Marie Gabe-Walters, Jane M Mikhail, Jeff Round, Sherrill Snelgrove, Mel Storey, Douglas Wilson, David Hughes, Medicines Management Group, Tom Owen, P Wang, Parkes D, Eryl Z Maunder, Jonathan Bidmead, Alun Toghill, Karen Davies, Kate Mcnamara, Gerwyn Panes, Victoria Warner, Centison S Wong, Victoria Charvis, Tom Owens, Pulin Wang, Sue Jordan, Timothy Banner, Marie Gabe-Walters, Jane M Mikhail, Jeff Round, Sherrill Snelgrove, Mel Storey, Douglas Wilson, David Hughes, Medicines Management Group, Tom Owen, P Wang, Parkes D, Eryl Z Maunder, Jonathan Bidmead, Alun Toghill, Karen Davies, Kate Mcnamara, Gerwyn Panes, Victoria Warner, Centison S Wong, Victoria Charvis, Tom Owens, Pulin Wang

Abstract

Introduction: Improved medicines' management could lead to real and sustainable improvements to the care of older adults. The overuse of mental health medicines has featured in many reports, and insufficient patient monitoring has been identified as an important cause of medicine-related harms. Nurse-led monitoring using the structured adverse drug reaction (ADRe) profile identifies and addresses the adverse effects of mental health medicines. Our study investigates clinical impact and what is needed to sustain utilisation in routine practice in care homes.

Methods and analysis: This process evaluation will use interviews and observations with the participants of all five homes involved in earlier research, and five newly recruited homes caring for people prescribed mental health medicines. The ADRe profile is implemented by nurses, within existing resources, to check for signs and symptoms of ADRs, initiate amelioration and share findings with pharmacists and prescribers for medication review. Outcome measures are the numbers and nature of problems addressed and understanding of changes needed to optimise clinical gain and sustain implementation. Data will be collected by 30 observations and 30 semistructured interviews. Clinical gains will be described and narrated. Interview analysis will be based on the constant comparative method.

Ethics and dissemination: Ethical approval was conferred by the National Health Service Wales Research Ethics Committee. If the ADRe profile can be sustained in routine practice, it has potential to (1) improve the lives of patients, for example, by reducing pain and sedation, and (2) assist in early identification of problems caused by ADRs. Therefore, in addition to peer-reviewed publications and conferences, we shall communicate our findings to healthcare professionals, policy-makers and sector regulators.

Trial registration number: NCT03110471.

Keywords: adult psychiatry; adverse events; organisation of health services; quality in health care.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
The medication chain.
Figure 2
Figure 2
Participant flow diagram. ABMUHB, Abertawe Bro Morgannwg University Health Board.
Figure 3
Figure 3
Logic model for ADRe: resources–actions–outputs–outcomes–goals. ADR, adverse drug reaction. GI, gastro-intestinal; OT, occupational therapist; UTI, urinary tract infenction.

References

    1. WHO. WHO launches global effort to halve medication-related errors in 5 years. Geneva/ Bonn, 2017. (accessed 20 Aug 2017).
    1. Gabe ME, Davies GA, Murphy F, et al. . Adverse drug reactions: treatment burdens and nurse-led medication monitoring. J Nurs Manag 2011;19:377–92. 10.1111/j.1365-2834.2011.01204.x
    1. Brenner S, Detz A, López A, et al. . Signal and noise: applying a laboratory trigger tool to identify adverse drug events among primary care patients. BMJ Qual Saf 2012;21:670–5. 10.1136/bmjqs-2011-000643
    1. Forster AJ, Murff HJ, Peterson JF, et al. . Adverse drug events occurring following hospital discharge. J Gen Intern Med 2005;20:317–23. 10.1111/j.1525-1497.2005.30390.x
    1. Gurwitz JH, Field TS, Judge J, et al. . The incidence of adverse drug events in two large academic long-term care facilities. Am J Med 2005;118:251–8. 10.1016/j.amjmed.2004.09.018
    1. Steinman MA, Handler SM, Gurwitz JH, et al. . Beyond the prescription: medication monitoring and adverse drug events in older adults. J Am Geriatr Soc 2011;59:1513–20. 10.1111/j.1532-5415.2011.03500.x
    1. Pirmohamed M, James S, Meakin S, et al. . Adverse drug reactions as cause of admission to hospital: prospective analysis of 18 820 patients. BMJ 2004;329:15–19. 10.1136/bmj.329.7456.15
    1. NICE Medicines and Prescribing Centre. Medicines optimisation: the safe and effective use of medicines to enable the best possible outcomes. NICE guideline. London: NICE, 2015. (accessed 20 Aug 2017).
    1. Frontier Economic. Exploring the costs of unsafe care in the NHS: a report prepared for The Department of Health. 2014. (accessed 20 Aug 2017).
    1. WHO. WHO Patient Safety Research . 2009. (accessed 20 August 2017).
    1. Hakkarainen KM, Andersson Sundell K, Petzold M, et al. . Prevalence and perceived preventability of self-reported adverse drug events – a population-based survey of 7099 adults. PLoS One 2013;8:e73166 10.1371/journal.pone.0073166
    1. Stewart R, Hotopf M, Dewey M, et al. . Current prevalence of dementia, depression and behavioural problems in the older adult care home sector: the South East London Care Home Survey. Age Ageing 2014;43:562–7. 10.1093/ageing/afu062
    1. Banerjee S. The use of antipsychotic medication for people with dementia:time for action. A report for the Minister of State for Care Services. An Independent Report Commissioned for the Department of Health 2009. (accessed 20 August 2017).
    1. Bradley P, Willson A, Buss P, et al. ; Achieving prudent healthcare in NHS Wales Wales: Public Health Wales, 2014. Available from (accessed 20 August 2017).
    1. Kanagaratnam L, Dramé M, Trenque T, et al. . Adverse drug reactions in elderly patients with cognitive disorders: A systematic review. Maturitas 2016;85:56–63. 10.1016/j.maturitas.2015.12.013
    1. Sköldunger A, Fastbom J, Wimo A, et al. . Impact of Inappropriate Drug Use on Hospitalizations, Mortality, and Costs in Older Persons and Persons with Dementia: findings from the SNAC study. Drugs Aging 2015;32:671–8. 10.1007/s40266-015-0287-4
    1. Storms H, Marquet K, Aertgeerts B, et al. . Prevalence of inappropriate medication use in residential long-term care facilities for the elderly: A systematic review. Eur J Gen Pract 2017;23:69–77. 10.1080/13814788.2017.1288211
    1. Jordan S. The prescription drug guide for nurses. McGraw-Hill: Maidenhead: Open University Press, 2008.
    1. Jordan S, Gabe-Walters ME, Watkins A, et al. . Nurse-Led medicines' monitoring for patients with dementia in care homes: a pragmatic cohort stepped wedge cluster randomised trial. PLoS One 2015;10:e0140203 10.1371/journal.pone.0140203
    1. Carson-Stevens A, Hibbert P, Williams H, et al. . Characterising the nature of primary care patient safety incident reports in the England and Wales National reporting and learning system: a mixed-methods agenda-setting study for general practice. Health Services and Delivery Research 2016;4:1–76. 10.3310/hsdr04270
    1. Jordan S. Managing adverse drug reactions: an orphan task. J Adv Nurs 2002;38:437–48. 10.1046/j.1365-2648.2002.02205.x
    1. Jordan S, Tunnicliffe C, Sykes A. Minimizing side-effects: the clinical impact of nurse-administered ’side-effect' checklists. J Adv Nurs 2002;37:155–65. 10.1046/j.1365-2648.2002.02064.x
    1. Jordan S, Gabe M, Newson L, et al. . Medication monitoring for people with dementia in care homes: the feasibility and clinical impact of nurse-led monitoring. Scientific World Journal 2014;2014:1–11. 10.1155/2014/843621
    1. Jones R, Moyle C, Jordan S. Nurse-led medicines monitoring: a study examining the effects of the West Wales Adverse Drug Reaction Profile. Nurs Stand 2016;31:42–53. 10.7748/ns.2016.e10447
    1. Older people’s Commissioner for Wales. Older People’s Commissioner for Wales. A place to call home. 2014. (accessed 20 Aug 2017).
    1. Thomas S, Banner T. Improving Medicines Use for Care Home Residents. Wales, Cardiff: Royal Pharmaceutical Society; (accessed 03 Apr 2018).
    1. Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. London: The Stationery Office, 2013. (accessed 20 Aug 2017).
    1. Andrews J, Butler M. Trusted to Care. An independent Review of the Princess of Wales Hospital and Neath Port Talbot Hospital at Abertawe Bro Morgannwg University Health Board People: Dementia Services Development Centre, the People Organisation, 2014. (accessed 20 Aug 2017).
    1. Page AT, Potter K, Clifford R, et al. . Medication appropriateness tool for co-morbid health conditions in dementia: consensus recommendations from a multidisciplinary expert panel. Intern Med J 2016;46:1189–97. 10.1111/imj.13215
    1. Richmond S, Morton V, Cross B, et al. . Effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings. Br J Gen Pract 2010;60:e10–19. 10.3399/bjgp09X473295
    1. Fossey J, Masson S, Stafford J, et al. . The disconnect between evidence and practice: a systematic review of person-centred interventions and training manuals for care home staff working with people with dementia. Int J Geriatr Psychiatry 2014;29:797–807. 10.1002/gps.4072
    1. Forsetlund L, Eike MC, Gjerberg E, et al. . Effect of interventions to reduce potentially inappropriate use of drugs in nursing homes: a systematic review of randomised controlled trials. BMC Geriatr 2011;11:16 10.1186/1471-2318-11-16
    1. Holland R, Desborough J, Goodyer L, et al. . Does pharmacist-led medication review help to reduce hospital admissions and deaths in older people? A systematic review and meta-analysis. Br J Clin Pharmacol 2008;65:303–16. 10.1111/j.1365-2125.2007.03071.x
    1. Alldred DP, Raynor DK, Hughes C, et al. . Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev 2013:CD009095 10.1002/14651858.CD009095.pub2
    1. Medicines and Healthcare products Regulatory Agency, 2012. Antipsychotics: initiative to reduce prescribing to older people with dementia. (accessed 20 Aug 2017).
    1. Szczepura A, Wild D, Khan AJ, et al. . Antipsychotic prescribing in care homes before and after launch of a national dementia strategy: an observational study in English institutions over a 4-year period. BMJ Open 2016;6:e009882 10.1136/bmjopen-2015-009882
    1. Flynn M. The Flynn Report: in search of accountability. Cardiff: Welsh Government, 2015. (accessed 20 Aug 2017).
    1. All Wales Medicines Strategy Group, 2015. All Wales policy for medicines administration, recording, review, storage and disposal. (accessed 20 Aug 2017).
    1. Singh RR, Nayak R. Impact of FDA Black box warning on psychotropic drug use in noninstitutionalized elderly patients diagnosed with dementia. J Pharm Pract 2016;29:495–502. 10.1177/0897190015579451
    1. Wilkinson P, Izmeth Z. Continuation and maintenance treatments for depression in older people. Cochrane Database Syst Rev 2016;9:CD006727 10.1002/14651858.CD006727.pub3
    1. Gabe ME, Murphy F, Davies GA, et al. . Medication monitoring in a nurse-led respiratory outpatient clinic: pragmatic randomised trial of the west wales adverse drug reaction profile. PLoS One 2014;9:e96682 10.1371/journal.pone.0096682
    1. Moore GF, Audrey S, Barker M, et al. . Process evaluation of complex interventions: medical research council guidance. BMJ 2015;350:h1258 10.1136/bmj.h1258
    1. Willis CD, Saul J, Bevan H, et al. . Sustaining organizational culture change in health systems. J Health Organ Manag 2016;30:2–30. 10.1108/JHOM-07-2014-0117
    1. European Commission Objective 1. Supporting development in less prosperous regions: European Commission, 2008. (accessed 04 Aug 2012).
    1. Statistics Wales. Population estimates by local health boards and age Wales: Welsh Government, 2015. (accessed 03 Apr 2018).
    1. Regulation and Inspection of Social Care (Wales) Act, 2016. An Act of the National Assembly for Wales (accessed 03 Apr 2018).
    1. 2002. The Care Homes (Wales) Regulations (accessed 03 Apr 2018).
    1. Jordan S, Philpin S, Davies S, et al. . The biological sciences in mental health nursing: stakeholders' perspectives. J Adv Nurs 2000;32:881–91. 10.1046/j.1365-2648.2000.01552.x
    1. Murphy E, Dingwall R, Greatbatch D, et al. . Qualitative research methods in health technology assessment: a review of the literature. Health Technol Assess 1998;2:1-–274.
    1. Higginbottom GMA. Sampling issues in qualitative research. Nurse Res 2004;12:7–19. 10.7748/nr2004.07.12.1.7.c5927
    1. Jordan S, Hughes D. Using bioscience knowledge in nursing: actions, interactions and reactions. J Adv Nurs 1998;27:1060–8. 10.1046/j.1365-2648.1998.00611.x
    1. Jordan S, Hughes D. Community teamwork is key to monitoring the side-effects of medication. Nurs Times 2000;96:39–40.
    1. Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: guided by information power. Qual Health Res 2015;26:1753–60.
    1. Fugard AJB, Potts HWW, Ph FAJ. Supporting thinking on sample sizes for thematic analyses: a quantitative tool. Int J Soc Res Methodol 2015;18:669–84. 10.1080/13645579.2015.1005453
    1. Jordan S, Coleman M, Hardy B, et al. . Assessing educational effectiveness: the impact of a specialist course on the delivery of care. J Adv Nurs 1999;30:796–807. 10.1046/j.1365-2648.1999.01176.x
    1. Jordan S, Knight J, Pointon D. Monitoring adverse drug reactions: scales, profiles, and checklists. Int Nurs Rev 2004;51:208–21. 10.1111/j.1466-7657.2004.00251.x
    1. Talbot J, Keisu M, Stahle L. Clinical trials – Collecting safety data and establishing the ADR Profile : Talbot J, Aronson JK, Stephens’ detection and evaluation of adverse drug reactions. 6th edn Chichester: Wiley-Blackwell, 2012.
    1. Aronson JK. Meyler’s Side Effects of Drugs : The International Encyclopaedia of adverse drug reactions and interactions. 16th edn Amsterdam: Elsevier Science, 2015.
    1. Taylor D, Paton C, Kapur S. The Maudsley prescribing guidelines in psychiatry. 12th edn Oxford: Wiley-Blackwell, 2015.
    1. Welsh Government. Welsh Government Statutory guidance for service providers and responsible individuals on meeting service standard regulations. Cardiff: Welsh Government, 2017. (accessed 20 Aug 2017).
    1. Younas M, Bradley E, Holmes N, et al. . Mental health pharmacists views on shared decision-making for antipsychotics in serious mental illness. Int J Clin Pharm 2016;38:1191–9. 10.1007/s11096-016-0352-z
    1. Joint Formulary Committee. British National Formulary. London: BMJ Group and Pharmaceutical Press; (accessed on 03 Apr 2018).
    1. Uppsala Monitoring Centre. The use of the WHO_UMC system for standardised case causality assessment. (accessed 20 Mar 2018).
    1. Plemons JM, Al-Hashimi I, Marek CL. American Dental Association Council on Scientific Affairs. Managing xerostomia and salivary gland hypofunction: executive summary of a report from the American Dental Association Council on Scientific Affairs. J Am Dent Assoc 2014;145:867–73.
    1. Mouton JP, Mehta U, Rossiter DP, et al. . Interrater agreement of two adverse drug reaction causality assessment methods: a randomised comparison of the liverpool adverse drug reaction causality assessment tool and the world health organization-uppsala monitoring centre system. PLoS One 2017;12:e0172830 10.1371/journal.pone.0172830
    1. Jordan S, Vaismoradi M, Griffiths P. Adverse drug reactions, nursing and policy: a narrative review. Annals of Nursing and Practice 2016;3:1050.
    1. Alldred DP, Kennedy M-C, Hughes C, et al. . Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst Rev 2016;16:CD009095 10.1002/14651858.CD009095.pub3
    1. Patterson SM, Cadogan CA, Kerse N, et al. . Interventions to improve the appropriate use of polypharmacy for older people. Cochrane Database Syst Rev 2014;19:CD008165 CD008165 10.1002/14651858.CD008165.pub3
    1. Ashoorian D, Davidson R, Rock D, et al. . A review of self-report medication side effect questionnaires for mental health patients. Psychiatry Res 2014;219:664–73. 10.1016/j.psychres.2014.05.060
    1. Stomski NJ, Morrison P, Meyer A. Antipsychotic medication side effect assessment tools: a systematic review. Australian & New Zealand Journal of Psychiatry 2016;50:399–409. 10.1177/0004867415608244
    1. Vaismoradi M, Griffiths P, Turunen H, et al. . Transformational leadership in nursing and medication safety education: a discussion paper. J Nurs Manag 2016;24:970–80. 10.1111/jonm.12387
    1. Barnes TRE, Banerjee S, Collins N, et al. . Antipsychotics in dementia: prevalence and quality of antipsychotic drug prescribing in UK mental health services. British Journal of Psychiatry 2012;201:221–6. 10.1192/bjp.bp.111.107631
    1. Yap KZ, Kua EH, Chan SY, et al. . Improving the appropriateness of antipsychotic prescribing for Behavioral and Psychological Symptoms of Dementia (BPSD): a pilot study of the Psychotropic Use Monitoring (PUM) Program. Open J Psychiatr 2014;04:153–62. 10.4236/ojpsych.2014.42020
    1. Mestres Gonzalvo C, de Wit HAJM, van Oijen BPC, et al. . Supporting clinical rules engine in the adjustment of medication (SCREAM): protocol of a multicentre, prospective, randomised study. BMC Geriatr 2017;17:35 10.1186/s12877-017-0426-3
    1. Mahlknecht A, Nestler N, Bauer U, et al. . Effect of training and structured medication review on medication appropriateness in nursing home residents and on cooperation between health care professionals: the InTherAKT study protocol. BMC Geriatr 2017;17:24 10.1186/s12877-017-0418-3
    1. Silverman D. Interpreting qualitative data. 73 4th edn London: Sage Publicatons, 2011.
    1. Colquhoun HL, Squires JE, Kolehmainen N, et al. . Methods for designing interventions to change healthcare professionals’ behaviour: a systematic review. Implement Sci 2017;12:30 10.1186/s13012-017-0560-5
    1. Yang S, Chen Y-C, Nicolini L, et al. . Cut-and-paste manufacture of multiparametric epidermal sensor systems. Adv Mater 2015;27:6423–30. 10.1002/adma.201502386
    1. Smith G, Cantley C. Assessing health care: a study in organisational evaluation. Milton Keynes: Open University Press, 1985.
    1. Glaser B, Strauss A. The discovery of grounded theory. Chicago: Aldine, 1967.
    1. Corbin J, Strauss A. Basics of qualitative research: techniques and procedures for developing grounded theory. 3rd edn Thousand Oaks: Sage Publications, 2008.
    1. Denzin N. Triangulation 2.0. JMMR 2012;6:80–8. 10.1177/1558689812437186
    1. NHS Health Research Authority (HRA). Defining Research. London: HRA, 2016. (accessed 03 Apr 2018).
    1. Campbell MK, Piaggio G, Elbourne DR, et al. . Consort 2010 statement: extension to cluster randomised trials. BMJ 2012;345:e5661 10.1136/bmj.e5661
    1. Weijer C, Grimshaw JM, Eccles MP, et al. . The Ottawa statement on the ethical design and conduct of cluster randomized trials. PLoS Med 2012;9:e1001346 10.1371/journal.pmed.1001346
    1. Taljaard M, Weijer C, Grimshaw JM, et al. . The Ottawa statement on the ethical design and conduct of cluster randomised trials: precis for researchers and research ethics committees. BMJ 2013;346:f2838 10.1136/bmj.f2838
    1. DiazOrdaz K, Slowther A-M, Potter R, et al. . Consent processes in cluster-randomised trials in residential facilities for older adults: a systematic review of reporting practices and proposed guidelines. BMJ Open 2013;3:e003057 10.1136/bmjopen-2013-003057
    1. Council of International Organisations of Medical Sciences (CIOMS)). International ethical guidelines for biomedical research involving human subjects. Geneva, Switzerland: CIOMS, 2002. (accessed 09 Jun 2017).
    1. Department of Health (DoH). An organisation with a memory: report of an expert group on learning from adverse events in the NHS. London: HMSO, 2000.
    1. Department of Health (DoH). Medicines and older people: national service framework. London: HMSO, 2001.
    1. Audit Commission. A spoonful of sugar: medicines management in NHS hospitals. London: Audit Commission, 2001.
    1. National Audit Office (NAO). A Safer place for patients: learning to improve patient safety. London: HMSO, 2005.
    1. Medical Research Council (MRC). Ethics Guide Medical research involving adults who cannot consent. London: MRC, 2007. (accessed 20 Aug 2017).
    1. The Stationery Office, 2005. Mental capacity act. (accessed 20 Aug 2007).
    1. NMC. The code: Professional standards of practice and behaviour for nurses and midwives. London: NMC, 2015. (accessed 20 Aug 2017).
    1. The Stationery Office, 1998. Data protection act. (accessed 20 Aug 2017).
    1. Welsh Assembly Government. Health and Social Care, Wales, Research Governance Framework for Health & Care Research. 2nd edn Wales, Cardiff: Welsh Assembly Government, 2010. (accessed 20 Aug 2017).
    1. Schork NJ. Personalized medicine: Time for one-person trials. Nature 2015;520:609–11. 10.1038/520609a
    1. Alhawassi TM, Krass I, Bajorek BV, et al. . A systematic review of the prevalence and risk factors for adverse drug reactions in the elderly in the acute care setting. Clin Interv Aging 2014;9:2079–86.
    1. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in europe: a review of recent observational studies. Drug Saf 2015;38:437–53. 10.1007/s40264-015-0281-0
    1. Hoffmann TC, Del Mar C. Clinicians’ expectations of the benefits and harms of treatments, screening, and tests. JAMA Intern Med 2017;177:407–19. 10.1001/jamainternmed.2016.8254
    1. Seale C, Chaplin R, Lelliott P, et al. . Antipsychotic medication, sedation and mental clouding: An observational study of psychiatric consultations. Soc Sci Med 2007;65:698–711. 10.1016/j.socscimed.2007.03.047
    1. Quirk A, Chaplin R, Hamilton S, et al. . Communication about adherence to long-term antipsychotic prescribing: an observational study of psychiatric practice. Soc Psychiatry Psychiatr Epidemiol 2013;48:639–47. 10.1007/s00127-012-0581-y
    1. Nosè M, Mazzi MA, Esposito E, et al. . Adverse effects of antipsychotic drugs: survey of doctors’ versus patients’ perspective. Soc Psychiatry Psychiatr Epidemiol 2012;47:157–64. 10.1007/s00127-010-0320-1
    1. van Nieuwenhuizen RC, van Dijk N, van Breda FG, et al. . Assessing the prevalence of modifiable risk factors in older patients visiting an ED due to a fall using the carefall triage instrument. Am J Emerg Med 2010;28:994–1001. 10.1016/j.ajem.2009.06.003
    1. Petrovic M, van der Cammen T, Onder G. Adverse drug reactions in older people: detection and prevention. Drugs Aging 2012;29:453–62.
    1. Gau J-T, Acharya U, Khan S, et al. . Pharmacotherapy and the risk for community-acquired pneumonia. BMC Geriatr 2010;10:45 10.1186/1471-2318-10-45
    1. Paul KJ, Walker RL, Dublin S. Anticholinergic medications and risk of community-acquired pneumonia in elderly adults: a population-based case-control study. J Am Geriatr Soc 2015;63:476–85. 10.1111/jgs.13327
    1. Lampela P, Hartikainen S, Sulkava R, et al. . Adverse drug effects in elderly people – a disparity between clinical examination and adverse effects self-reported by the patient. Eur J Clin Pharmacol 2007;63:509–15. 10.1007/s00228-007-0283-7
    1. Britten N. Adverse Drug Reactions: Societal Considerations : Talbot J, Aronson JK, Stephens’ Detection and Evaluation of Adverse Drug Reactions. 6th edn Chichester: Wiley-Blackwell, 2012:573–84.
    1. Sackett DL. Bias in analytic research. J Chronic Dis 1979;32:51–63. 10.1016/0021-9681(79)90012-2
    1. Morrison-Griffiths S, Snowden MA, Pirmohamed M. Pre-registration nurse education in pharmacology: is it adequate for the roles that nurses are expected to fulfil? Nurse Educ Today 2002;22:447–56. 10.1054/nedt.2002.0756
    1. Care Quality Commission. The State of Health Care and Adult Social Care in England 2013-14: Care Quality Commission, 2014. (accessed 20 Aug 2017).
    1. Care Quality Commission The state of adult social care services 2014 to 2017. Findings from CQC’s initial programme of comprehensive inspections in adult social care. Newcastle: Care Quality Commission, 2017. (accessed 20 Aug 2017).
    1. Keijsers CJPW, Leendertse AJ, Faber A, et al. . Pharmacists' and general practitioners' pharmacology knowledge and pharmacotherapy skills. J Clin Pharmacol 2015;55:936–43. 10.1002/jcph.500
    1. Dilles T, Elseviers MM, Van Rompaey B, et al. . Barriers for nurses to safe medication management in nursing homes. J Nurs Scholarsh 2011;43:171–80. 10.1111/j.1547-5069.2011.01386.x
    1. Bradley MC, Motterlini N, Padmanabhan S, et al. . Potentially inappropriate prescribing among older people in the United Kingdom. BMC Geriatr 2014;14:72 10.1186/1471-2318-14-72
    1. Karlsson SA, Jacobsson I, Boman MD, et al. . The impact of a changed legislation on reporting of adverse drug reactions in Sweden, with focus on nurses’ reporting. Eur J Clin Pharmacol 2015;71:631–6. 10.1007/s00228-015-1839-6
    1. Golder S, Loke YK, Wright K, et al. . Reporting of adverse events in published and unpublished studies of health care interventions: a systematic review. PLoS Med 2016;13:e1002127 10.1371/journal.pmed.1002127
    1. Arnaud M, Bégaud B, Thurin N, et al. . Methods for safety signal detection in healthcare databases: a literature review. Expert Opin Drug Saf 2017;16:721–32. 10.1080/14740338.2017.1325463
    1. Hazell L, Shakir SA. Under-reporting of adverse drug reactions: a systematic review. Drug Saf 2006;29:385–96.
    1. Pariente A, Gregoire F, Fourrier-Reglat A, et al. . Impact of safety alerts on measures of disproportionality in spontaneous reporting databases. Drug Saf 2007;30:891–8. 10.2165/00002018-200730100-00007
    1. de Boissieu P, Kanagaratnam L, Abou Taam M, et al. . Notoriety bias in a database of spontaneous reports: the example of osteonecrosis of the jaw under bisphosphonate therapy in the French national pharmacovigilance database. Pharmacoepidemiol Drug Saf 2014;23:989–92. 10.1002/pds.3622
    1. Raine JWL, Talbot J, Aronson JK. Proactive Pharmacovigilance and risk management : Talbot J, Aronson JK, Stephens’ Detection and Evaluation of Adverse Drug Reactions. 6th edn Chichester: Wiley-Blackwell, 2012:389–410.
    1. The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP). Guide on Methodological Standards in Pharmacoepidemiology. 6: European Medicines Agency, 2017.
    1. Beuscart J-B, Pont LG, Thevelin S, et al. . A systematic review of the outcomes reported in trials of medication review in older patients: the need for a core outcome set. Br J Clin Pharmacol 2017;83:942–52. 10.1111/bcp.13197
    1. Stacey D, Légaré F, Lewis K, et al. . Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2017;19:CD001431 10.1002/14651858.CD001431.pub5
    1. Gyllensten H, Rehnberg C, Jönsson AK, et al. . Cost of illness of patient-reported adverse drug events: a population-based cross-sectional survey. BMJ Open 2013;3:e002574 10.1136/bmjopen-2013-002574
    1. Aitken MV S. Avoidable costs in US Healthcare. Parsippany, NJ, USA: IMS Institute of Healthcare Informatics, 2013. (accessed 20 Aug 2017).
    1. Gyllensten H, Hakkarainen KM, Hägg S, et al. . Economic impact of adverse drug events – a retrospective population-based cohort Study of 4970 Adults. PLoS One 2014;9:e92061 10.1371/journal.pone.0092061
    1. Leendertse AJ, Van Den Bemt PMLA, Poolman JB, et al. . Preventable hospital admissions related to medication (HARM): cost analysis of the HARM study. Value Health 2011;14:34–40. 10.1016/j.jval.2010.10.024
    1. Burns ER, Stevens JA, Lee R. The direct costs of fatal and non-fatal falls among older adults — United States. J Safety Res 2016;58:99–103. 10.1016/j.jsr.2016.05.001
    1. Corbett A, Stevens J, Aarsland D, et al. . Systematic review of services providing information and/or advice to people with dementia and/or their caregivers. Int J Geriatr Psychiatry 2012;27:628–36. 10.1002/gps.2762
    1. Ballard C, Orrell M, Sun Y, et al. . Impact of antipsychotic review and non-pharmacological intervention on health-related quality of life in people with dementia living in care homes: WHELD-a factorial cluster randomised controlled trial. Int J Geriatr Psychiatry 2017;32 10.1002/gps.4572
    1. Mestres Gonzalvo C, Milosevic V, van Oijen BPC, et al. . The use of an electronic clinical rule to discontinue chronically used benzodiazepines and related Z drugs. Eur J Clin Pharmacol 2018;74:227–31. 10.1007/s00228-017-2369-1
    1. Desveaux L, Saragosa M, Rogers J, et al. . Improving the appropriateness of antipsychotic prescribing in nursing homes: a mixed-methods process evaluation of an academic detailing intervention. Implementation Science 2017;12:71 10.1186/s13012-017-0602-z
    1. Page AT, Clifford RM, Potter K, et al. . The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol 2016;82:583–623. 10.1111/bcp.12975
    1. Law S, Haddad PM, Chaudhry IB, et al. . Antipsychotic therapeutic drug monitoring: psychiatrists’ attitudes and factors predicting likely future use. Therapeutic Advances in Psychopharmacology 2015;5:214–23. 10.1177/2045125315588032
    1. Marston L, Nazareth I, Petersen I, et al. . Prescribing of antipsychotics in UK primary care: a cohort study. BMJ Open 2014;4:e006135 10.1136/bmjopen-2014-006135
    1. McGrath K, Hajjar ER, Kumar C, et al. . Deprescribing: a simple method for reducing polypharmacy. J Fam Pract 2017;66:436–45.
    1. Welsh Government. National minimum standards for care home for older people. Cardiff: Welsh Government, 2004. (accessed 20 Aug 2017).
    1. Lawrence V, Fossey J, Ballard C, et al. . Improving quality of life for people with dementia in care homes: making psychosocial interventions work. Br J Psychiatry 2012;201:344–51. 10.1192/bjp.bp.111.101402
    1. Lawrence V, Fossey J, Ballard C, et al. . Helping staff to implement psychosocial interventions in care homes: augmenting existing practices and meeting needs for support. Int J Geriatr Psychiatry 2016;31:284–93. 10.1002/gps.4322
    1. Grant A, Dreischulte T, Guthrie B. Process evaluation of the data-driven quality improvement in primary care (DQIP) trial: active and less active ingredients of a multi-component complex intervention to reduce high-risk primary care prescribing. Implement Sci 2017;12:4 10.1186/s13012-016-0531-2
    1. Jordan S, Watkins A, Storey M, et al. . Volunteer bias in recruitment, retention, and blood sample donation in a randomised controlled trial involving mothers and their children at six months and two years: a longitudinal analysis. PLoS One 2013;8:e67912 10.1371/journal.pone.0067912
    1. Cousins JM, Bereznicki LR, Cooling NB, et al. . Prescribing of psychotropic medication for nursing home residents with dementia: a general practitioner survey. Clin Interv Aging 2017;12:1573–8. 10.2147/CIA.S146613
    1. Mitchell JC. Case and situation analysis. Sociol Rev 1983;31:187–211. 10.1111/j.1467-954X.1983.tb00387.x
    1. Dilles T, Van Rompaey B, Van Bogaert P, et al. . Resident and nurse reports of potential adverse drug reactions. Eur J Clin Pharmacol 2015;71:741–9. 10.1007/s00228-015-1848-5
    1. Crowther GJ, Bennett MI, Holmes JD. How well are the diagnosis and symptoms of dementia recorded in older patients admitted to hospital? Age Ageing 2017;46:112–8. 10.1093/ageing/afw169
    1. WHO, 2017. Medication without harm. (accessed 20 Aug 2017).
    1. de Vries EN, Ramrattan MA, Smorenburg SM, et al. . The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care 2008;17:216–23. 10.1136/qshc.2007.023622
    1. Care Quality Commission, 2016. Regulation 12: Safe care and treatment. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014. (accessed 20 Aug 2017).

Source: PubMed

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

3
Abonnieren