Rachel Ann Elliott1, Matthew J Boyd2, Nde-Eshimuni Salema2, James Davies3, Nicholas Barber4, Rajnikant Laxmishanker Mehta5, Lukasz Tanajewski6, Justin Waring7, Asam Latif2, Georgios Gkountouras6, A J Avery8, Antony Chuter9, Christopher Craig2. 1. School of Pharmacy, University of Nottingham, Nottingham, UK Division of Social Research in Medicines and Health, University of Nottingham School of Pharmacy, Nottingham, UK. 2. Division of Social Research in Medicines and Health, University of Nottingham School of Pharmacy, Nottingham, UK. 3. Department of Policy and Research, The Company Chemists' Association, London, UK. 4. Health Foundation, London, UK. 5. School of Medicine, University of Nottingham, Nottingham, UK. 6. Division of Social Research in Medicines and Health, University of Nottingham School of Pharmacy, Nottingham, UK School of Pharmacy, University of Nottingham, Nottingham, UK. 7. Nottingham University Business School, University of Nottingham, Nottingham, UK. 8. Division of Primary Care, School of Community Health Sciences, Primary Care, University of Nottingham, Nottingham, UK. 9. School of Pharmacy, University of Nottingham, Nottingham, UK.
Abstract
OBJECTIVE: To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. METHODS: Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7-14 days after presentation of prescription followed by another 14-21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. RESULTS: At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI -£59 to £100, p=0.128) per patient. CONCLUSIONS: The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov trial reference number NCT01635361 (http://clinicaltrials.gov/ct2/show/NCT01635361). Current Controlled trials: trial reference number ISRCTN 23560818 (http://www.controlled-trials.com/ISRCTN23560818/; DOI 10.1186/ISRCTN23560818). UK Clinical Research Network (UKCRN) study 12494 (http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494). 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/
RCT Entities:
OBJECTIVE: To examine the effectiveness of the New Medicine Service (NMS), a national community pharmacy service to support medicines-taking in people starting a new medicine for a long-term condition, compared with normal practice. METHODS: Pragmatic patient-level parallel randomised controlled trial, in 46 community pharmacies in England. Patients 1:1 block randomisation stratified by drug/disease group within each pharmacy. 504 participants (NMS: 251) aged 14 years and over, identified in the pharmacy on presentation of a prescription for asthma/chronic obstructive pulmonary disease, hypertension, type 2 diabetes or an anticoagulant/antiplatelet agent. NMS intervention: One consultation 7-14 days after presentation of prescription followed by another 14-21 days thereafter to identify problems with treatment and provide support if needed. Controls received normal practice. Adherence, defined as missing no doses without the advice of a medical professional in the previous 7 days, was assessed through patient self-report at 10 weeks. Intention-to-treat analysis was employed, with outcome adjusted for recruiting pharmacy, NMS disease category, age, sex and medication count. Cost to the National Health Service (NHS) was collected. RESULTS: At 10 weeks, 53 patients had withdrawn and 443 (85%) patients were contacted successfully by telephone. In the unadjusted analysis of 378 patients still taking the initial medicine, 61% (95% CI 54% to 67%) and 71% (95% CI 64% to 77%) patients were adherent in the normal practice and NMS arms, respectively (p=0.04 for difference). In the adjusted intention-to-treat analysis, the OR for increased adherence was 1.67 (95% CI 1.06 to 2.62; p=0.027) in favour of the NMS arm. There was a general trend to reduced NHS costs, albeit, statistically non-significant, for the NMS intervention: saving £21 (95% CI -£59 to £100, p=0.128) per patient. CONCLUSIONS: The NMS significantly increased the proportion of patients adhering to their new medicine by about 10%, compared with normal practice. TRIAL REGISTRATION NUMBERS: ClinicalTrials.gov trial reference number NCT01635361 (http://clinicaltrials.gov/ct2/show/NCT01635361). Current Controlled trials: trial reference number ISRCTN 23560818 (http://www.controlled-trials.com/ISRCTN23560818/; DOI 10.1186/ISRCTN23560818). UK Clinical Research Network (UKCRN) study 12494 (http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=12494). 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/
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