Adverse Drug Reactions, Power, Harm Reduction, Regulation and the ADRe Profiles

Sue Jordan, Patricia A Logan, Gerwyn Panes, Mojtaba Vaismoradi, David Hughes, Sue Jordan, Patricia A Logan, Gerwyn Panes, Mojtaba Vaismoradi, David Hughes

Abstract

The power and influence of healthcare systems comes largely from the ability to prescribe efficacious medicine. However, medicine can sometimes cause harm rather than bring benefits. Systematically checking patients for the adverse effects of medicines, as listed in manufacturers' literature, would protect patients from iatrogenic harm, but this is rarely undertaken. We argue for the benefits of this approach using the example of the prescription of antipsychotics to older adults. Prescribing antipsychotics to control challenging behaviours associated with dementia is a controversial matter, and regulatory intervention is under discussion. Improved regulatory systems could protect against iatrogenic harm, such as over-sedation, falls, tremor, or drug-induced Parkinsonism. However, measuring the impact and outcomes of regulatory interventions has proved difficult, not least because there are rarely systematic records of all adverse effects of medicines. We indicate how regulatory initiatives to reduce antipsychotic prescribing can be supported by systematic monitoring and documentation of patients' signs and symptoms of putative adverse drug reactions. Monitoring documentation then provides the rationale and support for professionals' responses to identified problems. Longitudinal monitoring records would improve understanding of the impact and outcomes of adverse drug reactions (ADRs) on health and wellbeing, and the many costs of ADRs.

Keywords: adverse drug reactions; long-term care; medicine management; nursing; patient safety.

Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
An illustration of the Adverse Drug Reaction (ADRe) Profile for mental health medicines. These are the first questions on the ADRe Profile. This is accompanied by a ‘How to Use’ sheet, and supporting information (Figure 2). To request a copy of ADRe, visit: http://www.swansea.ac.uk/adre/.
Figure 2
Figure 2
An example of ADRe’s Supporting Information. If a problem is identified, nurses are asked to review the supporting information for that problem, and consider the actions suggested. The suggested aetiologies should be discussed within the multidisciplinary team.
Figure 3
Figure 3
Logic Model for the introduction of regulation to reduce prescribing of antipsychotics to older adults. Real-world changes may follow a logic model of resources/actions/process change/outcome change (The Kellogg Foundation 1998). In any mandated intervention, there is an opportunity cost, and each phase may be associated with unintended consequences.

References

    1. McKinlay J.B., McKinlay S.M. The Questionable Contribution of Medical Measures to the Decline of Mortality in the United States in the 20th Century. The Milbank Memorial Fund Quarterly. Health Soc. 1977;55:405–428.
    1. Weinshilboum R.M. The Therapeutic Revolution. Clin. Pharmacol. Therap. 1987;42:481–484. doi: 10.1038/clpt.1987.184.
    1. Cutler D.M. Your Money or Your Life: Strong Medicine for America’s Health Care System. Oxford University Press; Oxford, UK: 2004.
    1. Lesch J.E. The First Miracle Drugs: How the Sulfa Drugs Transformed Medicine. Oxford University Press; New York, NY, USA: 2007.
    1. Schuman A.J. A Concise History of Antimicrobial Therapy (Serendipity and All) Contemp. Pediatr. 2003;20:66–85.
    1. Jayachandran S., Lleras-Muney A., Lleras-Muney A., Smith K.V. Modern Medicine and the Twentieth Century Decline in Mortality: Evidence on the Impact of Sulfa Drugs. Am. Econ. J. Appl. Econ. 2010;2:118–146. doi: 10.1257/app.2.2.118.
    1. Leucht S., Tardy M., Komossa K., Heres S., Kissling W., Salanti G., Davis J.M. Antipsychotic drugs versus placebo for relapse prevention in schizophrenia: A systematic review and meta-analysis. Lancet. 2012;379:2063–2071. doi: 10.1016/S0140-6736(12)60239-6.
    1. Shen W.W. A history of antipsychotic drug development. Compr. Psychiatry. 1999;40:407–414.
    1. Zhang J.-P. The Benefits of Antipsychotic Drugs: Symptom Control and Improved Quality of Life. In: Manu P., Flanagan R.J., Ronaldson K.J., editors. Life-Threatening Effects of Antipsychotic Drugs. Academic Press; Cambridge, MA, USA: 2016. pp. 295–309.
    1. D’Arcy P.F. Iatrogenic disease: A hazard of multiple drug therapy. R. Soc. Health J. 1976;96:277–283.
    1. Stolley J.M., Buckwalter K.C., Fjordbak B., Bush S. Iatrogenesis in the elderly: Drug-related problems. J. Gerontol. Nurs. 1991;17:12–17.
    1. Gardner D.M., Teehan M.D. Antipsychotics and Their Side Effects. Cambridge University Press; New York, NY, USA: 2011.
    1. Manu P., Flanagan R.J., Ronaldson K.J., editors. Life-Threatening Effects of Antipsychotic Drugs. Academic Press; Cambridge, MA, USA: 2016.
    1. British Broadcasting Corporation (BBC) The New Jerusalem: Safe in Their Hands (Documentary Produced on 50th Anniversary of UK Postwar Welfare State for BBC 2) [(accessed on 13 September 2018)];1995 Available online: .
    1. Szczepura A., Clay D., Nelson S., Wild D., Spilsbury K. Improving Care in Residential Care Homes: A Literature Review. Joseph Rowntree Foundation; York, UK: 2008.
    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. [(accessed on 20 August 2017)];2009 Available online: .
    1. Sherlaw-Johnson C., Crump H., Curry N., Paddison C., Meaker R. Transforming Health Care in Nursing Homes: An Evaluation of a Dedicated Primary Care Service in Outer East London. Nuffield Trust; London, UK: 2018.
    1. Roberts M.L.A., Schiavenato M. Othering in the nursing context: A concept analysis. Nurs. Open. 2017;4:174–181. doi: 10.1002/nop2.82.
    1. Hoffmann T.C., Del Mar C. Clinicians’ Expectations of the Benefits and Harms of Treatments, Screening, and Tests: A Systematic Review. JAMA Intern. Med. 2017;177:407–419. doi: 10.1001/jamainternmed.2016.8254.
    1. Schork N.J. Personalized medicine: Time for one-person trials. Nature. 2015;520:609–611. doi: 10.1038/520609a.
    1. Hakkarainen K.M., Andersson Sundell K., Petzold M., Hägg S. Prevalence and perceived preventability of self-reported adverse drug events—A population-based survey of 7099 adults. PLoS ONE. 2013;8:e73166. doi: 10.1371/journal.pone.0073166.
    1. Kanagaratnam L., Dramé M., Trenque T., Oubaya N., Nazeyrollas P., Novella J.L., Jolly D., Mahmoudi R. Adverse drug reactions in elderly patients with cognitive disorders: A systematic review. Maturitas. 2016;85:56–63. doi: 10.1016/j.maturitas.2015.12.013.
    1. Alhawassi T.M., Krass I., Bajorek B.V., Pont L.G. 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;9:2079–2086. doi: 10.2147/CIA.S71178.
    1. Bouvy J.C., De Bruin M.L., Koopmanschap M.A. Epidemiology of adverse drug reactions in Europe: A review of recent observational studies. Drug Saf. 2015;38:437–453. doi: 10.1007/s40264-015-0281-0.
    1. Deilkås E.T., Risberg M.B., Haugen M., Lindstrøm J.C., Nylén U., Rutberg H., Michael S. Exploring similarities and differences in hospital adverse event rates between Norway and Sweden using Global Trigger Tool. BMJ Open. 2017;7:e012492. doi: 10.1136/bmjopen-2016-012492.
    1. Tangiisuran B., Wright J., Van der Cammen T., Rajkumar C. Adverse drug reactions in elderly: Challenges in identification and improving preventative strategies. Age Ageing. 2009;38:358–359. doi: 10.1093/ageing/afp050.
    1. Jordan S., Gabe-Walters M.E., Watkins A., Humphreys I., Newson L., Snelgrove S., Dennis M.S. Nurse-Led Medicines’ Monitoring for Patients with Dementia in Care Homes: A Pragmatic Cohort Stepped Wedge Cluster Randomised Trial. PLoS ONE. 2015;10:e0140203. doi: 10.1371/journal.pone.0140203.
    1. Jordan S., Vaismoradi M., Griffiths P. Adverse drug reactions, nursing and policy: A narrative review. [(accessed on 13 September 2018)];Ann. Nurs. Pract. 2016 3:1050. Available online: .
    1. Motter F.R., Fritzen J.S., Hilmer S.N., Paniz E.N., Paniz V.M. Potentially inappropriate medication in the elderly: A systematic review of validated explicit criteria. Eur. J. Clin. Pharmacol. 2018;74:679–700. doi: 10.1007/s00228-018-2446-0.
    1. Pirmohamed M., James S., Meakin S., Scott A.K., Walley T.J., Farrer K., Park B.K., Breckenridge A.M. Adverse drug reactions as cause of admission to hospital: Prospective analysis of 18 820 patients. BMJ. 2004;329:15–19. doi: 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 5; NICE; London, UK: 2015. [(accessed on 20 August 2017)]. Available online: .
    1. Kongkaew C., Noyce P.R., Ashcroft D.M. Hospital admissions associated with adverse drug reactions: A systematic review of prospective observational studies. Ann. Pharmacother. 2008;42:1017–1025. doi: 10.1345/aph.1L037.
    1. Frontier Economic Exploring the Costs of Unsafe Care in the NHS: A Report Prepared for the Department of Health. [(accessed on 20 August 2017)];2014 Available online: .
    1. Elliott R., Camacho E., Campbell F., Jankovic D., St. James M.M., Kaltenthaler E., Wong R., Sculpher M., Faria R. Prevalence and Economic Burden of Medication Errors in the NHS in England. Rapid Evidence Synthesis and Economic Analysis of the Prevalence and Burden of Medication Error in the UK. Policy Research Unit in Economic Evaluation of Health and Care Interventions. Universities of Sheffield and York. [(accessed on 18 September 2018)];2018 Available online:
    1. Nair P.N., Chalmers L., Connolley M., Bereznicki B.J., Peterson G.M., Curtain C., Castelino R.L., Bereznicki L.R. Prediction of Hospitalisation due to Adverse Drug Reactions in Elderly Community-Dwelling Patients (The PADR-EC Score) PLoS ONE. 2016 doi: 10.1371/journal.pone.0165757.
    1. Walter S.R., Day R.O., Gallego B., Westbrook J.I. The impact of serious adverse drug reactions: A population based study of a decade of hospital admissions in New South Wales, Australia. Br. J. Pharmacol. 2017;83:416–426. doi: 10.1111/bcp.13124.
    1. WHO Patient Safety Research: WHO. [(accessed on 20 August 2017)];2009 Available online: .
    1. Roulet L., Ballereau F., Hardouin J.B., Chiffoleau A., Potel G., Asseray N. Adverse drug event nonrecognition in emergency departments: An exploratory study on factors related to patients and drugs. J. Emerg. Med. 2014;46:857–864. doi: 10.1016/j.jemermed.2013.11.124.
    1. Lesser G.T., Boockvar K., Polsky I. Underestimation of adverse drug events in nursing home residents. Arch. Intern. Med. 2002;162:609–610. doi: 10.1001/archinte.162.5.609.
    1. Kongkaew C., Hann M., Mandal J., Williams S.D., Metcalfe D., Noyce P.R., Ashcroft D.M. Risk factors for hospital admissions associated with adverse drug events. Pharmacotherapy. 2013;33:827–837. doi: 10.1002/phar.1287.
    1. Rydberg D.M., Holm L., Engqvist I., Fryckstedt J., Lindh J.D., Stiller C.O., Asker-Hagelberg C. Adverse Drug Reactions in a Tertiary Care Emergency Medicine Ward—Prevalence, Preventability and Reporting. PLoS ONE. 2016;11:e0162948. doi: 10.1371/journal.pone.0162948.
    1. Beijer H.J., de Blaey C.J. Hospitalisations caused by adverse drug reactions (ADR): A meta-analysis of observational studies. Pharm. World Sci. 2002;14:46–54. doi: 10.1023/A:1015570104121.
    1. Gabe M.E., Davies G.A., Murphy F., Davies M., Johnstone L., Jordan S. Adverse drug reactions: Treatment burdens and nurse-led medication monitoring. J. Nurs. Manag. 2011;19:377–392. doi: 10.1111/j.1365-2834.2011.01204.x.
    1. Brenner S., Detz A., Lopez A., Horton C., Sarkar U. Signal and noise: Applying a laboratory trigger tool to identify adverse drug events among primary care patients. BMJ Qual. Saf. 2012;21:670–675. doi: 10.1136/bmjqs-2011-000643.
    1. Forster A.J., Murff H.J., Peterson J.F., Gandhi T.K., Bates D.W. Adverse drug events occurring following hospital discharge. J. Gen. Intern. Med. 2005;20:317–323. doi: 10.1111/j.1525-1497.2005.30390.x.
    1. Gurwitz J.H., Field T.S., Judge J., Rochon P., Harrold L.R., Cadoret C., Lee M., White K., LaPrino J., Erramuspe-Mainard J., et al. The incidence of adverse drug events in two large academic long-term care facilities. Am. J. Med. 2005;118:251–258. doi: 10.1016/j.amjmed.2004.09.018.
    1. Steinman M.A., Handler S.M., Gurwitz J.H., Schiff G.D., Covinsky K.E. Beyond the prescription: Medication monitoring and adverse drug events in older adults. J. Am. Geriatr. Soc. 2011;59:1513–1520. doi: 10.1111/j.1532-5415.2011.03500.x.
    1. Aronson J.K., Ferner R.E. The law of mass action and the pharmacological concentration–effect curve: Resolving the paradox of apparently non-dose-related adverse drug reactions. Br. J. Clin. Pharmacol. 2016;81:56–61. doi: 10.1111/bcp.12706.
    1. Stewart R., Hotopf M., Dewey M., Ballard C., Bisla J., Calem M., Fahmy V., Hockley J., Kinley J., Pearce H., 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;43:562–567. doi: 10.1093/ageing/afu062.
    1. Bradley M.C., Motterlini N., Padmanabhan S., Cahir C., Williams T., Fahey T., Hughes C.M. Potentially inappropriate prescribing among older people in the United Kingdom. BMC Geriatr. 2014;12:72. doi: 10.1186/1471-2318-14-72.
    1. Sköldunger A., Fastbom J., Wimo A., Fratiglioni L., Johnell K. 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;32:671–678. doi: 10.1007/s40266-015-0287-4.
    1. Storms H., Marquet K., Aertgeerts B., Claes N. 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. doi: 10.1080/13814788.2017.1288211.
    1. Jordan S. The Prescription Drug Guide for Nurses. Open University Press, McGraw-Hill; Maidenhead, UK: 2008.
    1. Masopust J., Protopopová D., Vališ M., Pavelek Z., Klímová B. Treatment of behavioral and psychological symptoms of dementias with psychopharmaceuticals: A review. Neuropsychiatr. Dis. Treat. 2018;14:1211–1220. doi: 10.2147/NDT.S163842.
    1. Ballard C., Hanney M.L., Theodoulou M., Douglas S., McShane R., Kossakowski K., Gill R., Juszczak E., Yu L.M., Jacoby R. DART-AD investigators. The dementia antipsychotic withdrawal trial (DART-AD): Long-term follow-up of a randomisedplacebo-controlled trial. Lancet Neurol. 2009;8:151–157. doi: 10.1016/S1474-4422(08)70295-3.
    1. Sacchetti E., Turrina C., Valsecchi P. Cerebrovascular accidents in elderly people treated with antipsychotic drugs: A systematic review. Drug Saf. 2013;33:273–288. doi: 10.2165/11319120-000000000-00000.
    1. Schneider L.S., Tariot P.N., Dagerman K.S., Davis S.M., Hsiao J.K., Ismail M.S., Lebowitz B.D., Lyketsos C.G., Ryan J.M., Stroup T.S., et al. CATIE-AD Study Group. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease. N. Engl. J. Med. 2006;355:1525–1538. doi: 10.1056/NEJMoa061240.
    1. Bradley P., Willson A. Achieving prudent healthcare in NHS Wales Wales: Public Health Wales. [(accessed on 20 August 2017)];2014 Available online: .
    1. Older People’s Commissioner for Wales A Place to Call Home. Older People’s Commissioner for Wales. [(accessed on 20 August 2017)];2014 Available online: .
    1. Older People’s Commissioner for Wales 2018. A Place to Call Home: Impact and Analysis. Older people’s Commissioner for Wales. [(accessed on 13 September 2018)]; Available online: .
    1. Thomas S., Banner T. Improving Medicines Use for Care Home Residents. Royal Pharmaceutical Society; Cardiff, UK: 2016. [(accessed on 3 April 2018)]. Available online: .
    1. National Assembly for Wales (NAfW) Health, Social Care and Sport Committee 2018 Use of Antipsychotic Medication in Care Homes. National Assembly; Cardiff, UK: 2018. [(accessed on 21 July 2018)]. Available online: .
    1. Francis R. Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. The Stationery Office; London, UK: 2013. [(accessed on 20 August 2017)]. Available online: .
    1. NICE 2014 Updated 2017 Managing Medicines in Care Homes. NICE GUIDANCE SC1. [(accessed on 13 September 2018)]; Available online: .
    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. Dementia Services Development Centre, The People Organisation. [(accessed on 20 August 2017)];2014 Available online: .
    1. Page A.T., Clifford R.M., Potter K., Schwartz D., Etherton-Beer C.D. 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. doi: 10.1111/bcp.12975.
    1. Respect Trial Team Effectiveness of shared pharmaceutical care for older patients: RESPECT trial findings. Br. J. Gen. Pract. 2010;60:e10–e19. doi: 10.3399/bjgp09X473295.
    1. Forsetlund L., Eike M.C., Gjerberg E., Vist G.E. 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. doi: 10.1186/1471-2318-11-16.
    1. Holland R., Desborough J., Goodyer L., Hall S., Wright D., Loke Y.K. 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;65:303–316. doi: 10.1111/j.1365-2125.2007.03071.x.
    1. Alldred D.P., Kennedy M.C., Hughes C., Chen T.F., Miller P. Interventions to optimise prescribing for older people in care homes. Cochrane Database Syst. Rev. 2016:CD009095. doi: 10.1002/14651858.CD009095.pub3.
    1. Viswanathan M., Kahwati L.C., Golin C.E., Blalock S.J., Coker-Schwimmer E., Posey R., Lohr K.N. Medication therapy management interventions in outpatient settings: A systematic review and meta-analysis. JAMA Intern. Med. 2015;175:76–87. doi: 10.1001/jamainternmed.2014.5841.
    1. Medicines and Healthcare products Regulatory Agency (MHRA) Antipsychotics: Initiative to Reduce Prescribing to Older People with Dementia. [(accessed on 13 September 2018)];2012 Available online: .
    1. Szczepura A., Wild D., Khan A.J., Owen D.W., Palmer T., Muhammad T., Clark M.D., Bowman C. 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. doi: 10.1136/bmjopen-2015-009882.
    1. Marston L., Nazareth I., Petersen I., Walters K., Osborn D.P. Prescribing of antipsychotics in UK primary care: A cohort study. BMJ Open. 2014;4:e006135. doi: 10.1136/bmjopen-2014-006135.
    1. Cooper A., Edwards A., Williams H., Evans H.P., Avery A., Hibbert P., Makeham M., Sheikh A., JDonaldson L., Carson-Stevens A. Sources of unsafe primary care for older adults: A mixed-methods analysis of patient safety incident reports. Age Ageing. 2017;46:833–839. doi: 10.1093/ageing/afx044.
    1. Jordan S., Knight J., Pointon D. Monitoring adverse drug reactions: Scales, profiles, and checklists. Int. Nurs. Rev. 2004;51:208–221. doi: 10.1111/j.1466-7657.2004.00251.x.
    1. Jordan S., Banner TGabe-Walters M., Mikhail J., Round J., Snelgrove S., Storey M., Wilson D.W., Hughes D. 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. BMJ. 2018 doi: 10.1136/bmjopen-2018-023377.
    1. Australian Pharmaceutical Advisory Council . Guidelines for Medication Management in Residential Aged Care Facilities. Commonwealth of Australia; Canberra, Australia: 2002. [(accessed on 13 September 2018)]. Available online: .
    1. Brodaty H., Aerts L., Harrison F., Jessop T., Cations M., Chenoweth L., Shell A., Popovic G.C., Heffernan M., Hilmer S., et al. Antipsychoticm Deprescription for Older Adults in Long-term Care: The HALT Study. J. Am. Med. Dir. Assoc. 2018;19:592.e7–600.e7. doi: 10.1016/j.jamda.2018.05.002.
    1. Gabe M., Murphy F., Davies G., Russell I., Jordan S. 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. doi: 10.1371/journal.pone.0096682.
    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. doi: 10.7748/ns.2016.e10447.
    1. Jordan S., Gabe M., Newson L., Snelgrove S., Panes G., Picek A., Russell I.T., Dennis M. Medication monitoring for people with dementia in care homes: The feasibility and clinical impact of nurse-led monitoring. Sci. World J. 2014;2014:843621. doi: 10.1155/2014/843621.
    1. Gabe M.E., Jordan S.E. Development and clinical gains of nurse-led medication monitoring profiles. J. Nurs. Manag. 2014;22:331–349. doi: 10.1111/jonm.12067.
    1. Jordan S., Tunnicliffe C., Sykes A. Minimising Side Effects: The clinical impact of nurse-administered ‘side effect’ checklists. J. Adv. Nurs. 2002;37:155–165. doi: 10.1046/j.1365-2648.2002.02064.x.
    1. Jordan S. Managing Adverse Drug Reactions: An Orphan Task. Developing Nurse-Administered Evaluation Checklists. J. Adv. Nurs. 2002;38:437–448. doi: 10.1046/j.1365-2648.2002.02205.x.
    1. Jordan S., Philpin S., Davies S., Andrade M. The biological sciences in mental health nursing: stakeholders’ perspectives. J. Adv. Nurs. 2000;32:881–891. doi: 10.1046/j.1365-2648.2000.01552.x.
    1. Jordan S., Hardy B., Coleman M. Medication management: An exploratory study into the role of Community Mental Health Nurses. J. Adv. Nurs. 1999;29:1068–1081. doi: 10.1046/j.1365-2648.1999.01002.x.
    1. Day G. Divided and Dividing Wales? Explorations in Geography and Class. In: Day G., editor. Making Sense of Wales: A Sociological Perspective. University of Wales Press; Cardiff, UK: 2002. pp. 94–115.
    1. World Health Organization (WHO) 2017 WHO Launches Global Effort to Halve Medication-Related Errors in 5 Years. [(accessed on 20 August 2017)];Geneva/Bonn. Available online:
    1. Drug and Therapeutics Bulletin 2018 What Dose of Paracetamol for Older People? Drug and Therapeutics Bulletin Vol. 56|No. 6|June 2018. [(accessed on 13 September 2018)];:68–72. Available online: .
    1. Jordan S., Morris J.K., Davies G.I., Tucker D., Thayer D.S., Luteijn J.M., Morgan M., Garne E., Hansen A.V., Klungsøyr K., et al. Selective Serotonin Reuptake Inhibitor (SSRI) antidepressants in Pregnancy and Congenital Anomalies: Analysis of linked databases in Wales, Norway and Funen, Denmark. PLoS ONE. 2016;11:e0165122. doi: 10.1371/journal.pone.0165122.
    1. Willson A. The problem with eliminating ‘low-value care’. BMJ Qual. Saf. 2015;24:611–614. doi: 10.1136/bmjqs-2015-004518.
    1. Barber C., Gagnon D., Fonda J., Cho K., Hermos J., Miller M. Assessing the impact of prescribing directives on opioid prescribing practices among Veterans Health Administration providers. Pharmacoepidemiol. Drug Saf. 2017;26:40–46. doi: 10.1002/pds.4066.
    1. Sackett D.L., Rosenberg W.M., Gray J.A., Haynes R.B., Richardson W.S. Evidence based medicine: What it is and what it isn’t. BMJ. 1996;13:71–72. doi: 10.1136/bmj.312.7023.71.
    1. Mittal M., Harrison D.L., Miller M.J., Farmer K.C., Thompson D.M., Ng Y.T. Have antiepileptic drug prescription claims changed following the FDA suicidality warning? An evaluation in a state Medicaid program. Epilepsy Behav. 2014;34:109–115. doi: 10.1016/j.yebeh.2014.03.017.
    1. Lu C.Y., Zhang F., Lakoma M.D., Butler M.G., Fung V., Larkin E.K., Kharbanda E.O., Vollmer W.M., Lieu T., Soumerai S.B., et al. Asthma Treatments and Mental Health Visits After a Food and Drug Administration Label Change for Leukotriene Inhibitors. Clin. Ther. 2015;37:1280–1291. doi: 10.1016/j.clinthera.2015.03.027.
    1. Hazell L., Shakir S.A. Under-reporting of adverse drug reactions: A systematic review. Drug Saf. 2006;29:385–396. doi: 10.2165/00002018-200629050-00003.
    1. De Boissieu P., Kanagaratnam L., Abou Taam M., Roux M.P., Dramé M., Trenque T. 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;23:989–992. doi: 10.1002/pds.3622.
    1. Pariente A., Gregoire F., Fourrier-Reglat A., Haramburu F., Moore N. Impact of safety alerts on measures of disproportionality in spontaneous reporting databases: The notoriety bias. Drug Saf. 2007;30:891–898. doi: 10.2165/00002018-200730100-00007.
    1. Parker D., Lawton R. Judging the use of clinical protocols by fellow professionals. Soc. Sci. Med. 2000;51:669–677. doi: 10.1016/S0277-9536(00)00013-7.
    1. Roland M. Linking physicians’ pay to the quality of care—A major experiment in the United kingdom. N. Engl. J. Med. 2004;351:1448–1454. doi: 10.1056/NEJMhpr041294.
    1. BMA and NHS Employers . Revisions to the GMS Contract 2006/07 Delivering Investment in General Practice. BMA; London, UK: 2009. [(accessed on 13 September 2018)]. Available online: .
    1. Kendrick T., Stuart B., Newell C., Geraghty A.W., Moore M. Changes in rates of recorded depression in English primary care 2003–2013: Time trend analyses of effects of the economic recession, and the GP contract quality outcomes framework (QOF) J. Affect. Disord. 2015;180:68–78. doi: 10.1016/j.jad.2015.03.040.
    1. Barnes G.D., Lucas E., Alexander G.C., Goldberger Z.D. National Trends in Ambulatory Oral Anticoagulant Use. Am. J. Med. 2015;128:1300.e2–1305.e2. doi: 10.1016/j.amjmed.2015.05.044.
    1. Mohammad I., Korkis B., Garwood C.L. Incorporating Comprehensive Management of Direct Oral Anticoagulants into Anticoagulation Clinics. Pharmacotherapy. 2017;37:1284–1297. doi: 10.1002/phar.1991.
    1. Odom D.M., Mladsi D.M., Saag K.G., Sherif B.N., Miles L., Ronquest N., Wang J. Relationship between diclofenac dose and risk of gastrointestinal and cardiovascular events: Meta-regression based on two systematic literature reviews. Clin. Ther. 2014;36:906–917. doi: 10.1016/j.clinthera.2014.04.012.
    1. Sukkar E. Risk of heart problems prompts removal of OTC diclofenac from UK pharmacy shelves. Pharm. J. 2015;294:7846. doi: 10.1211/PJ.2015.20067579.
    1. Singh R.R., Nayak R. Impact of FDA Black Box Warning on Psychotropic Drug Use in Noninstitutionalized Elderly Patients Diagnosed with Dementia: A Retrospective Study. J. Pharm. Pract. 2015;29:495–502. doi: 10.1177/0897190015579451.
    1. Ryan A.M., Krinsky S., Kontopantelis E., Doran T. Long-term evidence for the effect of pay-for-performance in primary care on mortality in the UK: A population study. Lancet. 2016;388:268–274. doi: 10.1016/S0140-6736(16)00276-2.
    1. European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Annex 2 to the Guide on Methodological Standards in Pharmacoepidemiology. [(accessed on 13 September 2018)];2018 Available online: .
    1. Hakobyan L., Haaijer-Ruskamp F.M., de Zeeuw D., Dobre D., Denig P. A review of methods used in assessing non-serious adverse drug events in observational studies among type 2 diabetes mellitus patients. Health Qual. Life Outcomes. 2011;9:83. doi: 10.1186/1477-7525-9-83.
    1. Schoenmakers T.W.A., Teichert M., Wensing M., de Smet P.A.G.M. Evaluation of Potentially Drug-Related Patient-Reported Common Symptoms Assessed during Clinical Medication Reviews: A Cross-Sectional Observational Study. Drug Saf. 2017;40:419–430. doi: 10.1007/s40264-017-0504-7.
    1. Talbot J., Keisu M., Stahle L. Clinical trials—Collecting safety data and establishing the ADR Profile. In: Talbot J., Aronson J.K., editors. Stephens’ Detection and Evaluation of Adverse Drug Reactions. 6th ed. Wiley-Blackwell; Chichester, UK: 2012. pp. 215–290.
    1. Gandhi T., Burstin H., Cook F., Puopolo A., Haas J., Brennan T., Bates D. Drug Complications in Outpatients. J. Gen. Intern. Med. 2000;15:149–154. doi: 10.1046/j.1525-1497.2000.04199.x.
    1. Weingart S., Gandhi T., Seger A., Seger D.L., Borus J., Burdick E., Leape L.L., Bates D.W. Patient reported medication symptoms in primary care. Arch. Intern. Med. 2005;165:234–240. doi: 10.1001/archinte.165.2.234.
    1. Lewis G., Cantwell R., Clutton-Brock T., Cooper G., Dawson A., Drife J., Garrod D., Harper A., Hulbert D., Lucas S., et al. Saving Mothers’ Lives: Reviewing maternal deaths to make motherhood safer: 2006–2008. The Eighth Report of the Confidential Enquiries into Maternal Deaths in the United Kingdom. BJOG. 2011;118(Suppl. 1):1–203.
    1. Ballard C., Orrell M., Sun Y., Moniz-Cook E., Stafford J., Whitaker R., Woods B., Corbett A., Garrod L., Khan Z., et al. Impact of antipsychotic review and nonpharmacological intervention on antipsychotic use, neuropsychiatric symptoms, and mortality in people with dementia living in nursing homes: A factorial cluster-randomized controlled trial by the well-being and health for people with dementia (WHELD) Program. Int. J. Geriatr. Psychiatry. 2015;173:252–262. doi: 10.1176/appi.ajp.2015.15010130.
    1. Ballard C., Orrell M., Sun Y., Moniz-Cook E., Stafford J., Whitaker R., Woods B., Corbett A., Banerjee S., Testad I., 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;32:1094–1103. doi: 10.1002/gps.4572.
    1. Iyer S., Naganathan V., McLachlan A.J., Le Couteur D.G. Medication withdrawal trials in people aged 64 years and older: A systematic review. Drugs Aging. 2008;25:1021–1031. doi: 10.2165/0002512-200825120-00004.
    1. Jordan S., Charlton R.A., Tingay K., Thayer D.S., Davies G.I., Morgan M., Tucker D., Watkins A., Gini R., Pierini A., et al. SSRI use in pregnancy: A study in 6 European databases. The International Marcé Society for Perinatal Mental Health Biennial Scientific Conference, Swansea University, Swansea, Wales, UK. Abstracts from the Marce Society Conference. Arch. Womens Ment. Health. 2015;18:269–408. doi: 10.1007/S00737-014-0488-6.
    1. Guthrie B., Makubate B., Hernandez-Santiago V., Dreischulte T. The rising tide of polypharmacy and drug-drug interactions: Population database analysis 1995–2010. BMC Med. 2015;7 doi: 10.1186/s12916-015-0322-7.
    1. Welsh Government Chief Medical Officer for Wales Annual Report 2015–2016. [(accessed on 13 September 2018)];2016 Available online: .
    1. Hart J.T. The inverse care law. Lancet. 1971;1:405–412. doi: 10.1016/S0140-6736(71)92410-X.
    1. Pedersen A.F., Vedsted P. Understanding the inverse care law: A register and survey-based study of patient deprivation and burnout in general practice. Int. J. Equity Health. 2014;13:121. doi: 10.1186/s12939-014-0121-3.

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