Rachel A. (2013) Protocol for the New Medicine Service study: a randomized controlled trial and economic evaluation with qualitative appraisal comparing the effectiveness and cost effectiveness of the New Medicine Service in community pharmacies in England

Background: Medication non-adherence is considered an important cause of morbidity and mortality in primary care. This study aims to determine the effectiveness, cost effectiveness and acceptability of a complex intervention delivered by community pharmacists, the New Medicine Service (NMS), compared with current practice in reducing non-adherence to, and problems with, newly prescribed medicines for chronic conditions. Methods/design: Research subject group: patients aged 14 years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease (COPD); hypertension; type 2 diabetes or anticoagulant/antiplatelet agents in two geographical regions in England. Design: parallel group patient-level pragmatic randomized controlled trial. Interventions: patients randomized to either: (i) current practice; or (ii) NMS intervention comprising pharmacistdelivered support for a newly prescribed medicine. Primary outcomes: proportion of adherent patients at six, ten and 26 weeks from the date of presenting their prescriptions at the pharmacy; cost effectiveness of the intervention versus current practice at 10 weeks and 26 weeks; in-depth qualitative understanding of the operationalization of NMS in pharmacies. Secondary outcomes: impact of NMS on: patients’ understanding of their medicines, pharmacovigilance, interprofessional and patient-professional relationships and experiences of service users and stakeholders. Economic analysis: Trial-based economic analysis (cost per extra adherent patient) and long-term modeling of costs and health effects (cost per quality-adjusted-life-year) will be conducted from the perspective of National Health Service (NHS) England, comparing NMS with current practice. Qualitative analysis: a qualitative study of NMS implementation in different community settings, how organizational influences affect NMS delivery, patterns of NMS consultations and experiences of professionals and patients participating in NMS, and patients receiving current practice. (Continued on next page) * Correspondence: [email protected] Division for Social Research in Medicines and Health, The School of Pharmacy, University of Nottingham, University Park, Nottingham NG7 2RD, UK Full list of author information is available at the end of the article © 2013 Boyd et al.; licensee BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Boyd et al. Trials 2013, 14:411 Page 2 of 15 http://www.trialsjournal.com/content/14/1/411 (Continued from previous page) Sample size: 250 patients in each treatment arm would provide at least 80% power (two-tailed alpha of 0.05) to demonstrate a reduction in patient-reported non-adherence from 20% to 10% in the NMS arm compared with current practice, assuming a 20% drop-out rate. Discussion: At the time of submission of this article, 58 community pharmacies have been recruited and the interventions are being delivered. Analysis has not yet been undertaken. Trial registration: Current controlled trials: ISRCTN23560818 Clinical Trials US (clinicaltrials.gov): NCT01635361 Background Favorable outcomes in long-term conditions depend on self-management by patients, including appropriate medicines use. About 25% of medicines prescribed for longterm conditions are not taken as directed [1,2], and 15% of people receiving new medicines take few, if any, doses [3]. Many have problems with their medicines and have information needs, but often fail to discuss these concerns with their prescriber. Furthermore, prescribers do not ask about, and so are generally unaware of, patients’ behavior regarding following instructions, experimentation and self-medication with other therapies [4,5]. Prescribers may overestimate adherence [6], and be reluctant to voice suspicions about non-adherence [7]. Harm caused by nonadherence includes poor health-related quality of life, increased hospitalizations and premature mortality [8-11]. Wider burden includes cost to patients, healthcare providers and society. Improving adherence in asthma, type 2 diabetes and hypertension could save the English National Health Service (NHS England) £290 million, annually [12]. Definition of adherence In this study we have taken the definition of adherence from the World Health Organization: ‘the extent to which a person’s medication-taking behavior, following a diet, and/or executing lifestyle changes, corresponds with agreed recommendations from a healthcare provider’ [2]. In this study we operationalize adherence behavior by defining a patient as non-adherent if any scheduled doses were missed at various time points as a result of different adherence measures deployed. Pharmacist-provided interventions to improve medicines use Pharmacist-provided interventions exist to facilitate improved medicines usage and health outcomes [13-26]. They are also viewed by some as a means to enhance pharmacist professional status [27]. Some interventions are effective [13-15,25,26], but not all [20,22-24]. There is little evidence around cost effectiveness of clinical community pharmacy interventions [28-30]. Most studies have methodological limitations: absence of a control, exclusion of pharmacist employment cost, use of intermediate outcomes, exclusion of health benefits, and absence of incremental analysis [28,31]. Interventions to improve medicines adherence have been disappointing in producing sustained behavior change [32], consistent health benefits, [33] or demonstrable cost effectiveness [31,34]. This can be attributed to poor study design, not using evidence on reasons for non-adherence, poor intervention development, lack of understanding of intervention complexity and its effects, and lack of integration into service delivery [35-37]. Implementing clinical services run by community pharmacists has been hampered by insufficient integration into patient pathways; poorly developed relationships between pharmacists and general practitioners (GPs); lack of access to patient information; inadequate methods for targeting services; and pharmacists’ lack of willingness to provide the service [38]. Medicines Use Reviews (MURs) are a recent example of a community pharmacy-based intervention. However, there has been variable uptake of MURs, mostly in chain pharmacies [39-41]. MURs have been carried out to variable standards by pharmacists, [42,43], partly due to variable understanding of what constitutes an MUR [44]. The New Medicine Service The New Medicine Service (NMS) [45] in England is based on evidence derived from our research that studied doctorpatient communication concerning medicines [46-49]. This and subsequent work established that problems with newly prescribed medicines appeared rapidly, were widespread and that a significant proportion of patients on a long-term medication quickly become non-adherent [50]. A pharmacist’s intervention could significantly reduce reported problems and non-adherence in a cost effective manner [51,52]. Within the NHS community pharmacy contract, the NMS is classified as an Advanced Service, whereby community pharmacists can opt to provide the service from their pharmacy [45]. This comes at a time when efficient medicines use could not be more important, in the face of economic pressures on the public sector budget. England’s ageing population now receives 50% more prescriptions items per capita for conditions such as heart disease, stroke, diabetes, COPD and asthma than in 1990 [53]. This proposed study is therefore timely as it is essential to evaluate whether NMS is effective, cost effective and acceptable to patients and healthcare providers. Supplementary policy-relevant Boyd et al. Trials 2013, 14:411 Page 3 of 15 http://www.trialsjournal.com/content/14/1/411 outcomes from this service are opportunities to intervene regarding lifestyle and potential improved tracking of medicines-related adverse events by community pharmacists and patients [54].