Prescribing differences among older adults with differing health cover and socioeconomic status: a cohort study.

INTRODUCTION: As health reforms move Ireland from a mixed public-private system toward universal healthcare, it is important to understand variations in prescribing practice for patients with differing health cover and socioeconomic status. This study aims to determine how prescribing patterns for patients aged ≥ 65 years in primary care in Ireland differ between patients with public and private health cover. METHODS: This was an observational study using anonymised data collected as part of a larger study from 44 general practices in Ireland (2011-2018). Data were extracted from electronic records relating to demographics and prescribing for patients aged ≥ 65 years. The cohort was divided between those with public health cover (via the General Medical Services (GMS) scheme) and those without. Standardised rates of prescribing were calculated for pre-specified drug classes. We also analysed the number of medications, polypharmacy, and trends over time between groups, using multilevel linear regression adjusting for age and sex, and hospitalisations. RESULTS: Overall, 42,456 individuals were included (56% female). Most were covered by the GMS scheme (62%, n = 26,490). The rate of prescribing in all drug classes was higher for GMS patients compared to non-GMS patients, with the greatest difference in benzodiazepine anxiolytics. The mean number of unique medications prescribed to GMS patients was 10.9 (SD 5.9), and 8.1 (SD 5.8) for non-GMS patients. The number of unique medications prescribed to both GMS and non-GMS cohorts increased over time. The increase was steeper in the GMS group where the mean number of medications prescribed increased by 0.67 medications/year. The rate of increase was 0.13 (95%CI 0.13, 0.14) medications/year lower for non-GMS patients, a statistically significant difference. CONCLUSION: Our study found a significantly larger number of medications were prescribed to patients with public health cover, compared to those without. Increasing medication burden and polypharmacy among older adults may be accelerated for those of lower socioeconomic status. These findings may inform planning for moves towards universal health care, and this would provide an opportunity to evaluate the effect of expanding entitlement on prescribing and medications use.

The impact of lidocaine plaster prescribing reduction strategies: A comparison of two national health services in Europe.

AIMS: In 2017, two distinct interventions were implemented in Ireland and England to reduce prescribing of lidocaine medicated plasters. In Ireland, restrictions on reimbursement were introduced through implementation of an application system for reimbursement. In England, updated guidance on items which should not be routinely prescribed in primary care, including lidocaine plasters, was published. This study aims to compare how the interventions impacted prescribing of lidocaine plasters in these countries. METHODS: We conducted an interrupted time-series study using general practice data. For Ireland, monthly dispensing data (2015-2019) from the means-tested General Medical Services (GMS) scheme was used. For England, data covered all patients. Outcomes were the rate of dispensings, quantity and costs of lidocaine plasters, and we modelled level and trend changes from the first full month of the policy/guidance change. RESULTS: Ireland had higher rates of lidocaine dispensings compared to England throughout the study period; this was 15.22/1000 population immediately pre-intervention, and there was equivalent to a 97.2% immediate reduction following the intervention. In England, the immediate pre-intervention dispensing rate was 0.36/1000, with an immediate reduction of 0.0251/1000 (a 5.8% decrease), followed by a small but significant decrease in the monthly trend relative to the pre-intervention trend of 0.0057 per month. CONCLUSIONS: Among two different interventions aiming to decrease low-value lidocaine plaster prescribing, there was a substantially larger impact in Ireland of reimbursement restriction compared to issuing guidance in England. However, this is in the context of much higher baseline rates of use in Ireland compared to England.

Clinical study reports published by the European Medicines Agency 2016-2018: a cross-sectional analysis.

OBJECTIVES: To describe the characteristics of clinical study report (CSR) documents published by the European Medicines Agency (EMA), and for included pivotal trials, to quantify the timeliness of access to trial results from CSRs compared with conventional published sources. DESIGN: Cross-sectional analysis of CSR documents published by the EMA from 2016 to 2018. METHODS: CSR files and medication summary information were downloaded from the EMA. Individual trials in each submission were identified using document filenames. Number and length of documents and trials were determined. For pivotal trials, trial phase, dates of EMA document publication and matched journal and registry publications were obtained. RESULTS: The EMA published documents on 142 medications that were submitted for regulatory drug approval. Submissions were for initial marketing authorisations in 64.1%. There was a median of 15 (IQR 5-46) documents, 5 (IQR 2-14) trials and 9629 (IQR 2711-26,673) pages per submission, and a median of 1 (IQR 1-4) document and 336 (IQR 21-1192) pages per trial. Of all identified pivotal trials, 60.9% were phase 3 and 18.5% were phase 1. Of 119 unique submissions to the EMA, 46.2% were supported by a single pivotal trial, with 13.4% based on a single pivotal phase 1 trial. No trial registry results were identified for 26.1% trials, no journal publications for 16.7% and 13.5% of trials had neither. EMA publication was the earliest information source for 5.8% of pivotal trials, available a median 523 days (IQR 363-882 days) before the earliest publication. CONCLUSIONS: The EMA Clinical Data website contains lengthy clinical trial documents. Almost half of submissions to the EMA were based on single pivotal trials, many of which were phase 1 trials. CSRs were the only source and a timelier source of information for many trials. Access to unpublished trial information should be open and timely to support decision-making for patients.

Self-monitoring for improving control of blood pressure in patients with hypertension: a Cochrane intervention review.

BACKGROUND: Hypertension is a major risk factor for cardiovascular events with only a minority of people treated to satisfactory levels. There is an increasing body of literature pertaining to the beneficial effect of self-blood pressure monitoring (SBPM) on blood pressure control in hypertensive patients. It is cost-effective, well tolerated, and has been shown to be a better predictor of end organ damage than traditional office blood pressure monitoring (OBPM). The aim of this Cochrane review is to provide an up-to-date assessment on the effectiveness of self-monitoring in the management of hypertension.Is SBPM more efficacious in reducing blood pressure, compared with OBPM or usual care?Is SBPM with additional supports more efficacious in reducing blood pressure, compared with no additional support?Are there any adverse events associated with SBPM, compared with OBPM or usual care? METHODS: All randomised controlled trials of adult patients with a diagnosis of primary hypertension where the intervention of interest is SBPM will be included. Data extraction, analysis and risk of bias assessment will be carried out by two independent authors. Analysis will be based on intention-to-treat (ITT) data from individual trials. RESULTS: Primary outcome measures include change in mean office systolic and/or diastolic BP, change in mean ambulatory blood pressure, the proportion of patients reaching target BP, and adverse events including mortality or cardiovascular morbidity or related to treatment with antihypertensive agents. DISCUSSION: This review will help to determine if self-monitoring of blood pressure, with or without co-interventions, is effective in lowering blood pressure. Results will be available for conference.

Derivation and validation of clinical prediction rules for diagnosis of infectious mononucleosis: a prospective cohort study.

OBJECTIVES: Infectious mononucleosis (IM) is a clinical syndrome that is characterised by lymphadenopathy, fever and sore throat. Although generally not considered a serious illness, IM can lead to significant loss of time from school or work due to profound fatigue, or the development of chronic illness. This study aimed to derive and externally validate clinical prediction rules (CPRs) for IM caused by Epstein-Barr virus (EBV). DESIGN: Prospective cohort study. SETTING AND PARTICIPANTS: 328 participants were recruited prospectively for the derivation cohort, from seven university-affiliated student health centres in Ireland. Participants were young adults (17-39 years old, mean age 20.6 years) with sore throat and one other additional symptom suggestive of IM. The validation cohort was a retrospective cohort of 1498 participants from a student health centre at the University of Georgia, USA. MAIN OUTCOME MEASURES: Regression analyses were used to develop four CPR models, internally validated in the derivation cohort. External validation was carried out in the geographically separate validation cohort. RESULTS: In the derivation cohort, there were 328 participants, of whom 42 (12.8%) had a positive EBV serology test result. Of 1498 participants in the validation cohort, 243 (16.2%) had positive heterophile antibody tests for IM. Four alternative CPR models were developed and compared. There was moderate discrimination and good calibration for all models. The sparsest CPR included presence of enlarged/tender posterior cervical lymph nodes and presence of exudate on the pharynx. This model had moderate discrimination (area under the receiver operating characteristic curve (AUC): 0.70; 95% CI: 0.62-0.79) and good calibration. On external validation, this model demonstrated reasonable discrimination (AUC: 0.69; 95% CI: 0.67-0.72) and good calibration. CONCLUSIONS: The alternative CPRs proposed can provide quantitative probability estimates of IM. Used in conjunction with serological testing for atypical lymphocytosis and immunoglobulin testing for viral capsid antigen, CPRs can enhance diagnostic decision-making for IM in community settings.

Adverse drug reactions and associated patient characteristics in older community-dwelling adults: a 6-year prospective cohort study.

BACKGROUND: To date, research on adverse drug reactions (ADRs) has focused on secondary care, and there is a paucity of studies that have prospectively examined ADRs affecting older adults in general practice. AIM: To examine the cumulative incidence and severity of ADRs and associated patient characteristics in a sample of community-dwelling older adults. DESIGN AND SETTING: Prospective cohort study of older adults (aged ≥70 years, N = 592) recruited from 15 general practices in the Republic of Ireland. METHOD: Manual review of the participant's general practice electronic medical record, linked to the national dispensed prescription medicine database, and a detailed, self-reported patient postal questionnaire. The primary outcomes were ADR occurrence and severity over a 6-year period (2010-2016). Unadjusted and adjusted logistic regression models examined potential associations between patient characteristics and ADR occurrence. RESULTS: A total of 211 ADRs were recorded for 159 participants, resulting in a cumulative incidence of 26.9% over 6 years. The majority of ADRs detected were mild (89.1%), with the remainder classified as moderate (10.9%). Eight moderate ADRs, representing 34.8% of moderate ADRs and 3.8% of all ADRs, required an emergency hospital admission. ADRs were independently associated with female sex (adjusted odds ratio [OR] 1.83, 95% confidence interval [CI] = 1.17 to 2.85; P = 0.008), polypharmacy (5-9 drug classes) (adjusted OR 1.81, 95% CI = 1.17 to 2.82; P = 0.008), and major polypharmacy (≥10 drug classes) (adjusted OR = 3.33, 95% CI = 1.62 to 6.85; P = 0.001). CONCLUSION: This prospective cohort study of ADRs in general practice shows that over one-quarter of older adults experienced an ADR over a 6-year period. Polypharmacy is independently associated with ADR risk in general practice and older adults on ≥10 drug classes should be prioritised for regular medication review.

Evidence for using point-of-care diagnostics in the management of respiratory tract infections in primary care: a scoping review protocol.

Background:  Antimicrobial resistance (AmR) is widely considered a global health threat and is associated with significant morbidity, mortality and costs. Inappropriate antimicrobial use is the most important modifiable risk factor for AmR. Most human antimicrobial medicines use occurs in primary care [prescribed by general practitioners (GPs), dispensed by community pharmacists (CPs)]. However, up to 50% of use is deemed inappropriate. Point-of-care diagnostic tests are used as a basis for antimicrobial stewardship interventions to improve the diagnostic certainty of respiratory tract infections (RTIs), and therefore ensure prudent antimicrobial use. However, there is a lack of guidance on their use, and they are therefore not routinely used in clinical practice. Objective: A scoping review will be conducted to synthesise the available evidence to inform the development of best practice guidance for using point-of-care diagnostics in the management of RTIs in primary care. Methods: A scoping review will be conducted following guidance from the Joanna Briggs Institute (JBI) and reported using the PRISMA-ScR guidelines. Databases including Web of Science, MEDLINE, CINAHL, EMBASE, the International HTA database and the Cochrane Central Register of Controlled Trials, as well as grey literature, will be searched. Screening will be undertaken independently by two reviewers to identify studies and literature reporting the use of point-of-care diagnostics in the management of RTIs in primary care by GPs and/ or CPs. Findings will be described using narrative synthesis. Conclusion:  The findings of this scoping review will be used to produce draft guidance on the use of point-of-care diagnostic tests in primary care, which will undergo further development using a Delphi consensus methodology involving experts in the field of RTIs, antimicrobial stewardship, point-of-care diagnostics and primary care.

An external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care (PolyPrime).

BACKGROUND: For older populations with multimorbidity, polypharmacy (use of multiple medications) is a standard practice. PolyPrime is a theory-based intervention developed to improve appropriate polypharmacy in older people in primary care. This pilot study aims to assess the feasibility of the PolyPrime intervention in primary care in Northern Ireland (NI) and the Republic of Ireland (ROI). METHODS: This external pilot cluster randomised controlled trial (cRCT) aimed to recruit 12 general practitioner (GP) practices (six in NI; six in the ROI counties that border NI) and ten older patients receiving polypharmacy (≥ 4 medications) per GP practice (n = 120). Practices allocated to the intervention arm watched an online video and scheduled medication reviews with patients on two occasions. We assessed the feasibility of collecting GP record (medication appropriateness, health service use) and patient self-reported data [health-related quality of life (HRQoL), health service use)] at baseline, 6 and 9 months. HRQoL was measured using the EuroQol-5 dimension-5 level questionnaire (EQ-5D-5L) and medication-related burden quality-of-life (MRB-QoL) tool. An embedded process evaluation and health economics analysis were also undertaken. Pre-specified progression criteria were used to determine whether to proceed to a definitive cRCT. RESULTS: Twelve GP practices were recruited and randomised. Three GP practices withdrew from the study due to COVID-related factors. Sixty-eight patients were recruited, with 47 (69.1%) being retained until the end of the study. GP record data were available for 47 patients for medication appropriateness analysis at 9 months. EQ-5D-5L and MRB-QoL data were available for 46 and 41 patients, respectively, at 9 months. GP record and patient self-reported health service use data were available for 47 patients at 9 months. Health service use was comparable in terms of overall cost estimated from GP record versus patient self-reported data. The intervention was successfully delivered as intended; it was acceptable to GPs, practice staff, and patients; and potential mechanisms of action have been identified. All five progression criteria were met (two 'Go', three 'Amend'). CONCLUSION: Despite challenges faced during the COVID-19 pandemic, this study has demonstrated that it may be feasible to conduct an intervention to improve appropriate polypharmacy in older people in primary care across two healthcare jurisdictions. TRIAL REGISTRATION: ISRCTN, ISRCTN41009897 . Registered 19 November 2019. CLINICALTRIALS: gov, NCT04181879 . Registered 02 December 2019.

Prescribing cascades in community-dwelling adults: A systematic review.

The misattribution of an adverse drug reaction (ADR) as a symptom or illness can lead to the prescribing of additional medication, referred to as a prescribing cascade. The aim of this systematic review is to identify published prescribing cascades in community-dwelling adults. A systematic review was reported in line with the PRISMA guidelines and pre-registered with PROSPERO. Electronic databases (Medline [Ovid], EMBASE, PsycINFO, CINAHL, Cochrane Library) and grey literature sources were searched. Inclusion criteria: community-dwelling adults; risk-prescription medication; outcomes-initiation of new medicine to "treat" or reduce ADR risk; study type-cohort, cross-sectional, case-control, and case-series studies. Title/abstract screening, full-text screening, data extraction, and methodological quality assessment were conducted independently in duplicate. A narrative synthesis was conducted. A total of 101 studies (reported in 103 publications) were included. Study sample sizes ranged from 126 to 11 593 989 participants and 15 studies examined older adults specifically (≥60 years). Seventy-eight of 101 studies reported a potential prescribing cascade including calcium channel blockers to loop diuretic (n = 5), amiodarone to levothyroxine (n = 5), inhaled corticosteroid to topical antifungal (n = 4), antipsychotic to anti-Parkinson drug (n = 4), and acetylcholinesterase inhibitor to urinary incontinence drugs (n = 4). Identified prescribing cascades occurred within three months to one year following initial medication. Methodological quality varied across included studies. Prescribing cascades occur for a broad range of medications. ADRs should be included in the differential diagnosis for patients presenting with new symptoms, particularly older adults and those who started a new medication in the preceding 12 months.

Anticipatory care planning for community-dwelling older adults at risk of functional decline: a feasibility cluster randomized controlled trial.

OBJECTIVES: To determine the feasibility, implementation and outcomes of an Anticipatory Care Planning (ACP) intervention in primary care to assist older adults at risk of functional decline by developing a personalized support plan. DESIGN: Feasibility cluster randomized control trial. SETTING AND PARTICIPANTS: Eight primary care practices (four in Northern Ireland, United Kingdom and four in the Republic of Ireland) were randomly assigned to either intervention or control arm. Eligible patients were those identified in each practice as 70 years of age or older and assessed as at risk of functional decline. Study participants (intervention n = 34, control n = 31) and research staff were not blinded to group assignment. ANTICIPATORY CARE INTERVENTION: The intervention delivered by a registered nurse including: a) a home-based patient assessment; b) care planning on the basis of a holistic patient assessment, and c) documentation of a support plan. OUTCOME MEASURES: A conceptual framework (RE-AIM) guided the assessment on the potential impact of the ACP intervention on patient quality of life, mental health, healthcare utilisation, costs, perception of person-centred care, and reduction of potentially inappropriate prescribing. Data were collected at baseline and at 10 weeks and six months following delivery of the intervention. RESULTS: All pre-specified feasibility indicators were met. Patients were unanimous in the acceptance of the ACP intervention. Health care providers viewed the ACP intervention as feasible to implement in routine clinical practice with attending community supports. While there were no significant differences on the primary outcomes (EQ-5D-5L: -0.07 (-0.17, 0.04) p = .180; CES-D: 1.2 (-2.5, 4.8) p = .468) and most secondary measures, ancillary analysis on social support showed responsiveness to the intervention. Incremental cost analysis revealed a mean reduction in costs of €320 per patient (95% CI -31 to 25; p = 0.82) for intervention relative to the control. CONCLUSIONS: We successfully tested the ACP intervention in primary care settings and have shown that it is feasible to implement. The ACP intervention deserves further testing in a definitive trial to determine whether its implementation would lead to better outcomes or reduced costs. TRIAL REGISTRATION: Clinicaltrials.gov, ID: NCT03902743 . Registered on 4 April 2019.

Evaluation of policies and practices to support safe and appropriate analgesic and sedative prescribing: The CDRx (controlled drug prescribing) protocol.

Medications provide many therapeutic benefits; however, these must be balanced against the potential for patient harm. Two high-risk medications are benzodiazepine receptor agonists or BZRAs (including benzodiazepines and Z-drugs hypnotics) and opioid analgesics, which carry a risk of dependence, misuse, and abuse. Use of these medications has been growing internationally, along with associated morbidity and mortality. These medications are often classified as 'controlled drugs' and subject to legal restrictions in order to balance therapeutic benefits and risks of misuse. The aim of this project is to evaluate prescribing of analgesic and sedative drugs, in particular opioid and BZRA medications, to characterise time trends, the impact of policy changes, and regional and GP practice variation. This will be addressed across three workpackages, primarily using data on prescriptions dispensed to individuals eligible for the General Medical Services scheme in Ireland, held by the HSE Primary Care Reimbursement Service, along with other national and international data collections. Workpackage 1 will derive volume and patterns of utilisation indicators of controlled drugs and related medications and describe time trends in primary care in Ireland between 2014 and 2021 in two repeated cross-sectional studies. Workpackage 2 will consist of two interrupted time series studies on the impact of recent policy changes on prescribing. Workpackage 3 is a cohort study of GP practices, which will aim to quantify and explain regional and GP practice-level variation in analgesic and sedative prescribing, and, in relation to policy changes. This research will provide data-driven insights to inform policy-makers' decisions and clinical practice to optimise regulation and use of these medications for the benefit of patients and society.

Hospital initiation of benzodiazepines and Z-drugs in older adults and discontinuation in primary care.

OBJECTIVE: To examine factors associated with continuation of hospital-initiated benzodiazepine receptor agonists (BZRAs) among adults aged ≥65 years, specifically instructions on hospital discharge summaries. METHODS: This retrospective cohort study involved anonymised electronic record data on prescribing and hospitalisations for 38,229 patients aged ≥65 from forty-four GP practices in Ireland 2011-2016. BZRA initiations were identified among patients with no BZRA prescription in the previous 12 months. Multivariate regression examined whether instructions on discharge messages for hospital-initiated BZRA prescriptions was associated with continuation after discharge in primary care and time to discontinuation. RESULTS: In total, 418 hospital-initiated BZRAs were identified, 48.8% being to males and mean patient age was 79.0 (SD 8.3) years. Almost 60% of these discharge summarieshad some BZRA instructions (e.g. duration). Approximately 40% (n = 166) were continued in primary care. Lower age, being prescribed a Z-drug or great number of medicines were associated with higher risk of continuation. Of those continued in primary care, in 98 cases (59.6%) the BZRA was discontinued during follow-up (after a mean 184 days). Presence of instructions was associated with higher likelihood of discontinuation (hazard ratio 1.71, 95%CI 1.11-2.62). CONCLUSIONS: Improved communication to GPs after hospital discharge may be important in avoiding long-term BZRA use.

Opioid and analgesic utilization in Ireland in 2000 and 2015: A repeated cross-sectional study.

In recent decades, opioid use has increased internationally and is a major public health concern. This study aims to characterize changes in opioid and other analgesic prescribing in Ireland over a 15-year period (2000-2015). This is a repeated cross-sectional study of administrative pharmacy claims data in 2000 and 2015. Individuals of all ages in Ireland's Eastern Health Board region who were eligible for the General Medical Services (GMS) scheme were included. This scheme covers 40% of the population, mostly those on lower incomes and older people. The primary outcome was dispensing of opioids, both prevalence of any use and rate per 1000 GMS eligible population (standardized to the 2015 population). Logistic regression was used to assess odds of opioid dispensing in 2015 versus 2000, controlling for demographic differences. The eligible study population was 364 436 in 2000 and 523 653 in 2015. In 2000, 19.4% of the eligible population had at least one opioid dispensing compared to 20.8% in 2015. The rate increased from 671 to 1098 dispensings per 1000 population. The increase was highest in the dispensing rates of codeine, tramadol, oxycodone, buprenorphine, and fentanyl. Compared to 2000, there was higher odds in 2015 of being dispensed a strong opioid (adjusted odds ratio 2.0, 95%CI 1.97-2.04) or long-acting formulation (3.75, 95%CI 3.58-3.92). Increased prescribing of opioids, particularly strong opioids, between 2000 and 2015 is evident in Ireland. This is concerning due to the potential for misuse, and opioid-related morbidity/mortality.

Prescribing cascades in community-dwelling adults: protocol for a systematic review.

Introduction: Internationally, health systems face the challenge of managing a growing ageing population living with multimorbidity and polypharmacy. Potentially inappropriate prescribing is common among patients with polypharmacy, increasing the risk for adverse drug reactions (ADRs). Several prescribing indicator sets exist to improve prescribing and reduce potentially inappropriate prescribing, but do not address prescribing cascades. Prescribing cascades occur when a medication is prescribed to treat an ADR to another prescribed medication, whether intentionally or unintentionally, and constitute an important area to consider when characterising problematic polypharmacy. This is a protocol for a systematic review examining prescribing cascades in community-dwelling adults. Methods: The review will be reported adhering to the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. A systematic search of Medline (Ovid), EMBASE, PsycINFO, CINAHL and the Cochrane Library will be conducted from inception to March 2021, using a predetermined strategy. Grey literature will be searched using Open Grey, MedNar, Dart Europe, and the Turning Research Into Practice (TRIP) databases. No restrictions will be placed on language or publication year. Inclusion criteria are: population - community-dwelling adults (≥18 years), including those in residential or nursing homes; risk - prescription medication with the potential to cause side effects; outcomes - initiation of a new medicine to 'treat' or reduce the risk of experiencing an ADR. Prospective and retrospective cohort studies, case control and case series studies will be included. Two reviewers will independently screen titles and abstracts; studies meeting inclusion criteria will undergo independent full-text screening by two reviewers.  A narrative synthesis will be conducted. Study quality will be independently assessed using the relevant Joanna Briggs Institute Critical Appraisal Checklist. Discussion: This systematic review will identify examples of prescribing cascades for community-dwelling adults and contribute to developing an evidence base regarding such cascades. Registration: PROSPERO [ CRD42021243163, 31/03/2021].

Successful implementation of a trans-jurisdictional, primary care, anticipatory care planning intervention for older adults at risk of functional decline: interviews with key health professionals.

BACKGROUND: Aging populations present a challenge to health systems internationally, due to the increasing complexity of care for older adults living with functional decline. This study aimed to elicit expert views of key health professionals on effective and sustainable implementation of a nurse-led, person-centred anticipatory care planning (ACP) intervention for older adults at risk of functional decline in a primary care setting. METHODS: We examined the feasibility of an ACP intervention in a trans-jurisdictional feasibility cluster randomized controlled trial consisting of home visits by research nurses who assessed participants' health, discussed their health goals and devised an anticipatory care plan following consultation with participants' GPs and adjunct clinical pharmacist. As part of the project, we elicited the views and recommendations of experienced key health professionals working with the target population who were recruited using a 'snowballing technique' in cooperation with older people health networks in the Republic of Ireland (ROI) and Northern Ireland (NI), United Kingdom [n = 16: 7 ROI, 9 NI]. Following receipt of written information about the intervention and the provision of informed consent, the health professionals were interviewed to determine their expert views on the feasibility of the ACP intervention and recommendations for successful implementation. Data were analyzed using thematic analysis. RESULTS: The ACP intervention was perceived to be beneficial for most older patients with multimorbidity. Effective and sustainable implementation was said to be facilitated by accurate and timely patient selection, GP buy-in, use of existing structures within health systems, multidisciplinary and integrated working, ACP nurse training, as well as patient health literacy. Barriers emerged as significant work already undertaken, increasing workload, lack of time, funding and resources, fragmented services, and geographical inequalities. CONCLUSIONS: The key health professionals perceived the ACP intervention to be highly beneficial to patients, with significant potential to prevent or avoid functional decline and hospital admissions. They suggested that successful implementation of this primary care based, whole-person approach would involve integrated and multi-disciplinary working, GP buy in, patient health education, and ACP nurse training. The findings have potential implications for a full trial, and patient care and health policy. TRIAL REGISTRATION: Clinicaltrials.gov, ID: NCT03902743 . Registered on 4 April 2019.

Payments reported by the pharmaceutical industry in Ireland from 2015 to 2019: An observational study.

BACKGROUND: The pharmaceutical industry makes large numbers of payments to healthcare organisations (HCOs) and healthcare professionals (HCPs). Ireland has a large pharmaceutical industry presence and national debate on legislating for greater industry payment transparency. This study characterises payments in Ireland to HCPs and HCOs during 2015-2019, and the content, consistency and methodology of the data source. METHODS: An observational study of TransfersOfValue.ie, the disclosure website for the Irish Pharmaceutical Health Association pharmaceutical companies. We conducted a quantitative analysis, summarising payments to HCOs, HCPs and for research and development (R&D). We quantified disclosure rates of names for HCP and HCO payment recipients. We also conducted a content analysis of the methodology notes and website content. RESULTS: Payments totalling €163 million were reported by 47 companies during 2015-2019, €84.6 million for R&D, with non-R&D payments of €45.1 million to HCOs and €33.6 million to HCPs. HCOs were named for 91.2% of payments, and HCPs for 55.1-62.8% across study years. For 2019, ten companies disclosed >€1 million in payments, and three disclosed >€1 million in HCO and HCP payments. Content analysis of 132 data reports and 46 methodology notes indicated substantial variation in methodologies for reporting between companies. CONCLUSIONS: There are substantial payments in Ireland, often the recipient is undisclosed, and companies differ in their reporting. A mandatory disclosure system could enhance transparency.

Protocol for a process evaluation of an external pilot cluster randomised controlled trial of a theory-based intervention to improve appropriate polypharmacy in older people in primary care: the PolyPrime study.

BACKGROUND: The PolyPrime intervention is a theory-based intervention aimed at improving appropriate polypharmacy in older people (aged ≥65 years) in primary care. The intervention consists of an online video which demonstrates how general practitioners (GPs) can prescribe appropriate polypharmacy during a consultation with an older patient and a patient recall process, whereby patients are invited to scheduled medication review consultations with GPs. The aim of the process evaluation is to further examine the implementation of the PolyPrime intervention in primary care. This will involve investigating whether the PolyPrime intervention can be delivered as intended across two healthcare systems, how acceptable the intervention is to GPs, practice staff and patients, and to identify the intervention's likely mechanisms of action. METHODS: The PolyPrime study is an external pilot cluster randomised controlled trial (cRCT) which aims to recruit 12 GP practices across Northern Ireland [NI] (n=6) and the six counties in the Republic of Ireland (ROI) that border NI (n=6). Practices have been randomised to intervention or usual care. An embedded process evaluation will assess intervention fidelity (i.e. was the intervention delivered as intended), acceptability of the intervention to GPs, practice staff and patients and potential mechanisms of action (i.e. what components of the intervention were perceived to be effective). Quantitative data will be collected from data collection forms completed by GPs and practice staff and a feedback questionnaire completed by patients from intervention arm practices, which will be analysed using descriptive statistics. Qualitative data will be collected through semi-structured interviews with GPs and practice staff and audio-recordings of medication review appointments from the intervention arm practices which will be transcribed and analysed using the framework method. Quantitative and qualitative data will be triangulated to provide an overall assessment of intervention fidelity, intervention acceptability, and mechanisms of action. DISCUSSION: This process evaluation will add to feasibility data from the pilot cRCT by providing evidence on the fidelity of implementing the intervention package across two healthcare systems, the acceptability of the intervention and potential mechanisms of action. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN41009897 . Registered on 19 November 2019. ClinicalTrials.gov NCT04181879 . Registered 02 December 2019.

Geographical variation of emergency hospital admissions for ambulatory care sensitive conditions in older adults in Ireland 2012-2016.

OBJECTIVE: Ambulatory care sensitive (ACS) conditions are those for which intensified primary care management could potentially prevent emergency admissions. This study aimed to quantify geographical variation in emergency admissions with ACS conditions in older adults and explore factors influencing variation. DESIGN: Repeated cross-sectional study. SETTING: 34 public hospitals in the Ireland. PARTICIPANTS: Adults aged ≥65 years hospitalised for seven ACS conditions between 2012 and 2016 (chronic obstructive pulmonary disease, congestive heart failure (CHF), diabetes, angina, pyelonephritis/urinary tract infections (UTIs), dehydration and pneumonia). PRIMARY OUTCOME MEASURE: Age and sex standardised emergency admission rates (SARs) per 1000 older adults. ANALYSIS: Age and sex SARs were calculated for 21 geographical areas. Extremal quotients and systematic components of variance (SCV) quantified variation. Spatial regression analyses was conducted for SARs with unemployment, urban population proportion, hospital turnover, supply of general practitioners (GPs), and supply of hospital-based specialists as explanatory variables. RESULTS: Over time, an increase in UTI/pyelonephritis SARs was seen while SARs for angina and CHF decreased. Geographic variation was moderate overall and high for dehydration and angina (SCV=11.7-50.0). For all conditions combined, multivariable analysis showed lower urban population (adjusted coefficient: -2.2 (-3.4 to -0.9, p<0.01)), lower GP supply (adjusted coefficient: -5.5 (-8.2 to -2.9, p<0.01)) and higher geriatrician supply (adjusted coefficient: 3.7 (0.5 to 6.9, p=0.02)) were associated with higher SARs. CONCLUSIONS: Future research should evaluate methods of preventing admissions for ACS conditions among older adults, including how resources are allocated at a local level.

Acceptability of a nurse-led, person-centred, anticipatory care planning intervention for older people at risk of functional decline: A qualitative study.

BACKGROUND: As the population of older adults increases, the complexity of care required to support those who choose to remain in the community amplifies. Anticipatory Care Planning (ACP), through earlier identification of healthcare needs, is evidenced to improve quality of life, decrease aggressive interventions, and prolong life. With patient acceptability of growing importance in the design, implementation, and evaluation of healthcare interventions, this study reports on the acceptability of a primary care based ACP intervention on the island of Ireland. METHODS: As part of the evaluation of a feasibility cluster randomized controlled trial (cRCT) testing an ACP intervention for older people at risk of functional decline, intervention participants [n = 34] were interviewed in their homes at 10-week follow-up to determine acceptability. The intervention consisted of home visits by specifically trained registered nurses who assessed participants' health, discussed their health goals and plans, and devised an anticipatory care plan in collaboration with participants' GPs and adjunct clinical pharmacist. Thematic analysis was employed to analyze interview data. The feasibility cRCT involved eight general practitioner (GP) practices as cluster sites, stratified by jurisdiction, four in Northern Ireland (NI) (two intervention, two control), and four in the Republic of Ireland (ROI) (two intervention, two control). Participants were assessed for risk of functional decline. A total of 34 patients received the intervention and 31 received usual care. FINDINGS: Thematic analysis resulted in five main themes: timing of intervention, understanding of ACP, personality & individual differences, loneliness & social isolation, and views on healthcare provision. These map across the Four Factor Model of Acceptability ('4FMA'), a newly developed conceptual framework comprising four components: intervention factors, personal factors, social support factors, and healthcare provision factors. CONCLUSION: Acceptability of this primary care based ACP intervention was high, with nurses' home visits, GP anchorage, multidisciplinary working, personalized approach, and active listening regarded as beneficial. Appropriate timing, and patient health education emerged as vital.

Persistence with oral bisphosphonates and denosumab among older adults in primary care in Ireland.

Gaps in pharmacological treatment for osteoporosis can reduce effectiveness. Among older adults, we found about half of new users of oral bisphosphonate and denosumab persisted with their treatment at 2 years, with few switching to alternative therapy. Persistence is suboptimal and warrants evaluation of interventions to improve this. PURPOSE: Gaps in pharmacological treatment for osteoporosis can reduce effectiveness. This study aimed to estimate persistence rates for oral bisphosphonates and denosumab in older primary care patients and identify factors associated with discontinuation. METHODS: Older patients newly prescribed oral bisphosphonates or denosumab during 2012-2017 were identified from 44 general practices (GP) in Ireland. Persistence without a coverage gap of >90 days was calculated for both medications from therapy initiation. Factors associated with time to discontinuation were explored using Cox regression analysis. Exposures included age group, osteoporosis diagnosis, fracture history, calcium/vitamin D prescription, number of other medications, health cover, dosing frequency (bisphosphonates) and previous bone-health medication (denosumab). RESULTS: Of 41,901 patients, n=1569 were newly initiated on oral bisphosphonates and n=1615 on denosumab. Two-year persistence was 49.4% for oral bisphosphonates and 53.8% for denosumab and <10% were switched to other medication. Having state-funded health cover was associated with a lower hazard of discontinuation for both oral bisphosphonates (HR=0.49, 95% CI=0.36-0.66, p<0.01) and denosumab (HR=0.71, 95% CI=0.57-0.89, p<0.01). Older age group, number of medications and calcium/vitamin D prescription were also associated with better bisphosphonate persistence, while having osteoporosis diagnosed was associated with better denosumab persistence. CONCLUSION: Persistence for osteoporosis medications is suboptimal. Of concern, few patients are switched to other bone-health treatments when denosumab is stopped which could increase fracture risk. Free access to GP services and medications may have resulted in better medication persistence in this cohort. Future research should explore prescribing choices in primary care osteoporosis management and evaluate cost-effectiveness of interventions for improving persistence.