Survival Outcomes in Older Women with Oestrogen-Receptor-Positive Early-Stage Breast Cancer: Primary Endocrine Therapy vs. Surgery by Comorbidity and Frailty Levels.

Primary endocrine therapy (PET) offers non-surgical treatment for older women with early-stage breast cancer who are unsuitable for surgery due to frailty or comorbidity. This research assessed all-cause and breast cancer-specific mortality of PET vs. surgery in older women (≥70 years) with oestrogen-receptor-positive early-stage breast cancer by frailty and comorbidity levels. This study used UK secondary data to analyse older female patients from 2000 to 2016. Patients were censored until 31 May 2019 and grouped by the Charlson comorbidity index (CCI) and hospital frailty risk score (HFRS). Cox regression models compared all-cause and breast cancer-specific mortality between PET and surgery within each group, adjusting for patient preferences and covariates. Sensitivity analyses accounted for competing risks. There were 23,109 patients included. The hazard ratio (HR) comparing PET to surgery for overall survival decreased significantly from 2.1 (95%CI: 2.0, 2.2) to 1.2 (95%CI: 1.1, 1.5) with increasing HFRS and from 2.1 (95%CI: 2.0, 2.2) to 1.4 (95%CI 1.2, 1.7) with rising CCI. However, there was no difference in BCSM for frail older women (HR: 1.2; 0.9, 1.9). There were no differences in competing risk profiles between other causes of death and breast cancer-specific mortality with PET versus surgery, with a subdistribution hazard ratio of 1.1 (0.9, 1.4) for high-level HFRS (p = 0.261) and CCI (p = 0.093). Given limited survival gains from surgery for older patients, PET shows potential as an effective option for frail older women with early-stage breast cancer. Despite surgery outperforming PET, surgery loses its edge as frailty increases, with negligible differences in the very frail.

What do emergency department pharmacist practitioners know and understand about patient safeguarding? A qualitative study.

BACKGROUND: Pharmacists with additional clinical skills now work in UK emergency departments. Known as Emergency Department Pharmacist Practitioners, the role was developed in response to a shortage of physicians and nurses. They carry out activities typical of traditional hospital pharmacists, but also novel 'practitioner' activities such as examining patients, and acting as designated care provider. The role includes a responsibility to safeguard patients from harm. Professional competence, i.e. to safeguard patients, is underpinned by knowledge of the subject, but also knowledge application. AIM: To investigate what Emergency Department Pharmacist Practitioners know and understand about safeguarding vulnerable children and adults. METHOD: Thirteen Emergency Department Pharmacist Practitioners were interviewed to explore their knowledge and understanding of safeguarding. Interview questions were developed from review of relevant literature, as were vignettes with variables identified and altered to produce different scenarios. Template analysis was used to code data to a priori themes for each of the stages of the initial safeguarding process, and new themes that emerged throughout the process. RESULTS: Six themes were identified in addition to the four a priori themes. Overall, participants frequently described how safeguarding concerns are both recognised and responded to, but seemed more comfortable when responding to medicines related concerns. Factors thought to influence the safeguarding process included: resources and setting; and education, training and experiential learning; and culture. CONCLUSION: While Emergency Department Pharmacist Practitioners interviewed were aware of the safeguarding process, there were some misconceptions as to the roles of different healthcare workers in this process.

A Multi-method Exploratory Evaluation of a Service Designed to Improve Medication Safety for Patients with Monitored Dosage Systems Following Hospital Discharge.

BACKGROUND AND OBJECTIVE: Medication safety problems are common post-hospital discharge, and an important global healthcare improvement target. The Transfers of Care Around Medicines (TCAM) service was launched by a National Health Service Trust in the North-West of England, initially focusing on patients with new or existing Monitored Dosage Systems (MDS). The TCAM service is designed to enable the prompt transfer of medication information, with referrals made by hospitals at discharge to a named community pharmacy. This study aimed to explore the utilisation and impact of the TCAM service on medication safety. METHODS: The evaluation included a descriptive analysis of 3033 anonymised patient referrals to 71 community pharmacies over a 1-year period alongside an assessment of the impact of the TCAM service on unintentional medication discrepancies and adverse drug events using a retrospective before-and-after study design. Impact data were collected across 18 general practices by 16 trained clinical pharmacists. RESULTS: Most patient referrals (70%, 2126/3033) were marked as 'completed' by community pharmacies, with 15% of completed referrals delayed beyond 30 days. Screening of 411 patient records by clinical pharmacists yielded no statistically significant difference in unintentional medication discrepancies or adverse drug event rates following TCAM implementation using a multivariable regression analysis (unintentional medication discrepancies adjusted odds ratio = 0.79 [95% confidence interval 0.44-1.44, p = 0.46]; and adverse drug events adjusted odds ratio = 1.19 [95% confidence interval 0.57-2.45, p = 0.63]), although there remained considerable uncertainty. CONCLUSIONS: The TCAM service facilitated a number of community pharmacy services offered to patients with monitored dosage systems; but the impact of the intervention on unintentional medication discrepancies and adverse drug event rates post-hospital discharge for this patient group was uncertain. The results of this exploratory study can inform the ongoing implementation of the TCAM service at hospital discharge and highlight the need to understand service implementation in different contexts, which may influence its impact on medication safety.

Comorbidity clusters and in-hospital outcomes in patients admitted with acute myocardial infarction in the USA: A national population-based study.

BACKGROUND: The prevalence of multimorbidity in patients with acute myocardial infarction (AMI) is increasing. It is unclear whether comorbidities cluster into distinct phenogroups and whether are associated with clinical trajectories. METHODS: Survey-weighted analysis of the United States Nationwide Inpatient Sample (NIS) for patients admitted with a primary diagnosis of AMI in 2018. In-hospital outcomes included mortality, stroke, bleeding, and coronary revascularisation. Latent class analysis of 21 chronic conditions was used to identify comorbidity classes. Multivariable logistic and linear regressions were fitted for associations between comorbidity classes and outcomes. RESULTS: Among 416,655 AMI admissions included in the analysis, mean (±SD) age was 67 (±13) years, 38% were females, and 76% White ethnicity. Overall, hypertension, coronary heart disease (CHD), dyslipidaemia, and diabetes were common comorbidities, but each of the identified five classes (C) included ≥1 predominant comorbidities defining distinct phenogroups: cancer/coagulopathy/liver disease class (C1); least burdened (C2); CHD/dyslipidaemia (largest/referent group, (C3)); pulmonary/valvular/peripheral vascular disease (C4); diabetes/kidney disease/heart failure class (C5). Odds ratio (95% confidence interval [CI]) for mortality ranged between 2.11 (1.89-2.37) in C2 to 5.57 (4.99-6.21) in C1. For major bleeding, OR for C1 was 4.48 (3.78; 5.31); for acute stroke, ORs ranged between 0.75 (0.60; 0.94) in C2 to 2.76 (2.27; 3.35) in C1; for coronary revascularization, ORs ranged between 0.34 (0.32; 0.36) in C1 to 1.41 (1.30; 1.53) in C4. CONCLUSIONS: We identified distinct comorbidity phenogroups that predicted in-hospital outcomes in patients admitted with AMI. Some conditions overlapped across classes, driven by the high comorbidity burden. Our findings demonstrate the predictive value and potential clinical utility of identifying patients with AMI with specific comorbidity clustering.

Development, Feasibility, Impact and Acceptability of a Community Pharmacy-Based Diabetes Care Plan in a Low-Middle-Income Country.

Informed by existing research, mostly from high-income countries, this study aimed to develop and test the feasibility of a community pharmacy person-centred goal-setting intervention for people living with type 2 diabetes in a low-middle-income country-Nigeria. The Medical Research Council (MRC) guidance for developing complex interventions framed the intervention development. Patients participated in monthly community pharmacist consultations over six months. Self-reported and clinical outcome measures were collected at baseline and study completion and analysed in STATA V.14. Twenty pharmacists in 20 pharmacies completed the research and enrolled 104 patients. Of these, 89 patients had complete study data, and 70 patients also completed a post-study evaluation questionnaire. In addition, 15 patients and 10 pharmacists were interviewed. All outcome measures showed statistically significant improvements (p < 0.05). Clinical outcomes (BMI, waist circumference, and fasting plasma glucose) improved significantly. Mean patient activation measure (PAM©), quality of life (EQ-VAS©), and medication adherence improved from baseline to study completion. Eighty-eight per cent of questionnaire respondents were satisfied with the service. Interviews indicated care plan acceptability, patient satisfaction, empowerment, and service enthusiasm. Identified barriers to the consultations included time and technology. This study developed a feasible, effective, well-perceived community pharmacy diabetes care plan in Nigeria.

Feasibility and validity of using healthcare databases to conduct cross-national comparative studies of opioid use, its determinants and consequences.

PURPOSE: A cross-national comparative (CNC) study about opioid utilization would allow the identification of strategies to improve pain management and mitigate risk. However, little is known about the accessibility and validity of information in healthcare databases internationally. This study aimed to identify the feasibility of using healthcare databases to conduct a CNC study of opioid utilization and its associated consequences. METHODS: A cross-sectional survey was launched in March 2018, including experts interested in CNC studies comparing opioid utilization by purposeful sampling. An electronic survey was used to collect database characteristics, medicine information, and linkage information of each aggregate-level dataset (AD) and individual patient-level dataset (IPD). RESULTS: Overall, participants from 21 geographical regions reported 18 ADs and 19 IPDs. Information on dispensed medications is available from 17 ADs and 17 IPDs. Of the 16 ADs that include primary care settings, only 9 ADs can obtain information from secondary care settings. Fourteen IPDs included patients' characteristics or could be retrieved from linkage databases. Although most ADs are publicly accessible (n = 13), only five IPDs can be accessed without extra cost. CONCLUSION: Most ADs could be used to report opioid utilization in a primary care setting. IPDs with linkage databases should be applied to identify potential determinants, clinical outcomes, and policy impact. Data access restrictions and governance policies across jurisdictions can be challenging for timely analysis and require further collaboration.

Analysis of the nature and contributory factors of medication safety incidents following hospital discharge using National Reporting and Learning System (NRLS) data from England and Wales: a multi-method study.

Introduction: Improving medication safety during transition of care is an international healthcare priority. While existing research reveals that medication-related incidents and associated harms may be common following hospital discharge, there is limited information about their nature and contributory factors at a national level which is crucial to inform improvement strategy. Aim: To characterise the nature and contributory factors of medication-related incidents during transition of care from secondary to primary care. Method: A retrospective analysis of medication incidents reported to the National Reporting and Learning System (NRLS) in England and Wales between 2015 and 2019. Descriptive analysis identified the frequency and nature of incidents and content analysis of free text data, coded using the Patient Safety Research Group (PISA) classification, examined the contributory factors and outcome of incidents. Results: A total of 1121 medication-related incident reports underwent analysis. Most incidents involved patients over 65 years old (55%, n = 626/1121). More than one in 10 (12.6%, n = 142/1121) incidents were associated with patient harm. The drug monitoring (17%) and administration stages (15%) were associated with a higher proportion of harmful incidents than any other drug use stages. Common medication classes associated with incidents were the cardiovascular (n = 734) and central nervous (n = 273) systems. Among 408 incidents reporting 467 contributory factors, the most common contributory factors were organisation factors (82%, n = 383/467) (mostly related to continuity of care which is the delivery of a seamless service through integration, co-ordination, and the sharing of information between different providers), followed by staff factors (16%, n = 75/467). Conclusion: Medication incidents after hospital discharge are associated with patient harm. Several targets were identified for future research that could support the development of remedial interventions, including commonly observed medication classes, older adults, increase patient engagement, and improve shared care agreement for medication monitoring post hospital discharge. Plain language summary: Study using reports about unsafe or substandard care mainly written by healthcare professionals to better understand the type and causes of medication safety problems following hospital discharge Why was the study done? The safe use of medicines after hospital discharge has been highlighted by the World Health Organization as an important target for improvement in patient care. Yet, the type of medication problems which occur, and their causes are poorly understood across England and Wales, which may hamper our efforts to create ways to improve care as they may not be based on what we know causes the problem in the first place.What did the researchers do? The research team studied medication safety incident reports collected across England and Wales over a 5-year period to better understand what kind of medication safety problems occur after hospital discharge and why they happen, so we can find ways to prevent them from happening in future.What did the researchers find? The total number of incident reports studied was 1121, and the majority (n = 626) involved older people. More than one in ten of these incidents caused harm to patients. The most common medications involved in the medication safety incidents were for cardiovascular diseases such as high blood pressure, conditions such as mental illness, pain and neurological conditions (e.g., epilepsy) and other illnesses such as diabetes. The most common causes of these incidents were because of the organisation rules, such as information sharing, followed by staff issues, such as not following protocols, individual mistakes and not having the right skills for the task.What do the findings mean? This study has identified some important targets that can be a focus of future efforts to improve the safe use of medicines after hospital discharge. These include concentrating attention on medication for the cardiovascular and central nervous systems (e.g., via incorporating them in prescribing safety indicators and pharmaceutical prioritisation tools), staff skill mix (e.g., embedding clinical pharmacist roles at key parts of the care pathway where greatest risk is suspected), and implementation of electronic interventions to improve timely communication of medication and other information between healthcare providers.

Reliability and validity testing of the medicines related - consultation assessment tool for assessing pharmacists' consultations.

BACKGROUND: Demonstrating a person-centred approach in a consultation is a key component of delivering high-quality healthcare. To support development of such an approach requires training underpinned by valid assessment tools. Given the lack of a suitable pharmacy-specific tool, a new global consultation skills assessment tool: the medicines related-consultation assessment tool (MR-CAT) was designed and tested. AIM: This study aimed to test the validity and reliability of the MR-CAT using psychometric methods. METHOD: Psychometric testing involved analysis of participants' (n = 13) assessment of fifteen pre-recorded simulated consultations using the MR-CAT. Analysis included discriminant validity testing, intrarater and interrater reliability testing for each of the five sections of the MR-CAT and for the overall global assessment of the consultation. Analysis also included internal consistency testing for the whole tool. RESULTS: Internal consistency for the overall global assessment of the consultation was good (Cronbach's alpha = 0.97). The MR-CAT discriminated well for the overall global assessment of the consultation (p < 0.001). Moderate to high intrarater reliability was observed for the overall global assessment of the consultation and for all five sections of the MR-CAT (rho = 0.64-0.84) in the test-retest analysis. Moderate to good interrater reliability (Kendall's W = 0.68-0.90) was observed for the overall global assessment of the consultation and for all five sections of the MR-CAT. CONCLUSION: The MR-CAT is a valid and reliable tool for assessing person-centred pharmacist's consultations. Moreover, its unique design means that the MR-CAT can be used in both formative and summative assessment.

The impact of age on health utility values for older women with early-stage breast cancer: a systematic review and meta-regression.

INTRODUCTION: An increasing number of postmenopausal women are diagnosed with breast cancer at an older age (≥ 70 years). There is a lack of synthesised health utility data to support decision-making for managing breast cancer in this older population. This study aimed to identify the availability of, and the subsequent impact of age on, health state utility values (HSUVs) measured by the EQ-5D for older women with early-stage breast cancer. METHOD: This systematic review identified EQ-5D (3L or 5L version) HSUVs for postmenopausal women with early-stage breast cancer. Studies were identified from a previous systematic review (inception to 2009) and an electronic database search (Medline and Embase; 2009 to September 2021). Mean HSUVs were summarised by health state. Quality appraisal was performed on studies reporting HSUVs for older ages (≥ 70 years). Multivariable meta-regression assessed the association between HSUVs and age, health state, treatments received, and time of measuring the utility values (greater or less than one year post-treatment). RESULTS: Fifty EQ-5D HSUVs were identified from 13 studies. Mean HSUVs decreased as health state worsened: from the stable (mean=0.83) to progression (mean=0.79) and advanced (mean=0.68) states. Two studies reported six HSUVs estimated from the sample of women with a mean age ≥ 70. Meta-regression model fit improved by including age as an independent variable and attenuated the estimated utility decrements associated with worse health states. Utility decrements for the progression and advanced states were -0.052 (95%CI: -0.097, -0.007) and -0.143 (95%CI: -0.264, -0.022) respectively. The breast cancer-specific utility decrement associated with a one-year increase in age was -0.001 (95%CI: -0.004, 0.002). CONCLUSION: Relevant and accurate HSUVs are essential to help support decision-making about the most effective and cost-effective ways to manage early-stage breast cancer in older women. Age has a vital role in determining health utility values in this population. This study provides analysts and decision-makers with HSUVs and utility decrements that reflect the disease process in this older population.

Core concepts in pharmacoepidemiology: Measures of drug utilization based on individual-level drug dispensing data.

BACKGROUND: Drug utilization studies are essential to facilitate rational drug use in the society. AIM: In this review, we provide an overview of drug utilization measures that can be used with individual-level drug dispensing data, referencing additional reading on the individual analysis. This is intended to serve as a primer for those new to drug utilization research and a shortlist from which researchers can identify useful analytical approaches when designing their drug utilization study. RESULTS AND DISCUSSION: We provide an overview of: (1) basic measures of drug utilization which are used to describe changes in drug use over time or compare drug use in different populations; (2) treatment adherence measures with specific focus on persistence and implementation; (3) how to measure drug combinations which is useful when assessing drug-drug interactions, concomitant treatment, and polypharmacy; (4) prescribing quality indicators and measures to assess variations in drug use which are useful tools to assess appropriate use of drugs; (5) proxies of prescription drug misuse and skewness in drug use; and (6) considerations when describing the characteristics of drug users or prescribers.

A Systematic Review of Pharmacovigilance Systems in Developing Countries Using the WHO Pharmacovigilance Indicators.

BACKGROUND: In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries' PV systems' performance. METHODS: EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries' PV performance. RESULTS: Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0-26). Higher average scores were obtained in the 'Core' (9.27/27) compared to 'Complementary' (5.59/36) indicators. Overall performance for 'Process' and 'Outcome' indicators was lower than that of 'Structural'. CONCLUSION: This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance.

Systematic review of the evidence sources applied to cost-effectiveness analyses for older women with primary breast cancer.

OBJECTIVE: To appraise the sources of evidence and methods to estimate input parameter values in decision-analytic model-based cost-effectiveness analyses of treatments for primary breast cancer (PBC) in older patients (≥ 70 years old). METHODS: Two electronic databases (Ovid Medline, Ovid EMBASE) were searched (inception until 5 September-2021) to identify model-based full economic evaluations of treatments for older women with PBC as part of their base-case target population or age-subgroup analysis. Data sources and methods to estimate four types of input parameters including health-related quality of life (HRQoL); natural history; treatment effect; resource use were extracted and appraised. Quality assessment was completed by reference to the Consolidated Health Economic Evaluation Reporting Standards. RESULTS: Seven model-based economic evaluations were included (older patients as part of their base-case (n = 3) or subgroup (n = 4) analysis). Data from younger patients (< 70 years) were used frequently to estimate input parameters. Different methods were adopted to adjust these estimates for an older population (HRQoL: disutility multipliers, additive utility decrements; Natural history: calibration of absolute values, one-way sensitivity analyses; Treatment effect: observational data analysis, age-specific behavioural parameters, plausible scenario analyses; Resource use: matched control observational data analysis, age-dependent follow-up costs). CONCLUSION: Improving estimated input parameters for older PBC patients will improve estimates of cost-effectiveness, decision uncertainty, and the value of further research. The methods reported in this review can inform future cost-effectiveness analyses to overcome data challenges for this population. A better understanding of the value of treatments for these patients will improve population health outcomes, clinical decision-making, and resource allocation decisions.

Strengths and Weaknesses of the Pharmacovigilance Systems in Three Arab Countries: A Mixed-Methods Study Using the WHO Pharmacovigilance Indicators.

Using the WHO pharmacovigilance (PV) indicators as a framework, this study aimed to explore the structures, processes, and outcomes of three Arab countries' (Jordan, Oman, and Kuwait) PV systems to inform recommendations for countries with nascent PV systems. A mixed-methods design involving document review, semi-structured interviews, and a questionnaire was employed. Fifty-six key informants from the three countries' national PV centres (NPVCs) and pharmaceutical industry were interviewed. The questionnaire collecting quantitative measures was only completed by Oman and Kuwait's NPVCs. Using the framework, system strengths were attributed to the presence of "core" structural indicators, including a dedicated and officially recognised NPVC, PV legislation, and a national PV advisory committee, as well as "complementary" structural indicators, e.g., a computerised case-report management system. Contrastingly, weaknesses were attributed to the absence of these indicators plus other "core" structural indicators, namely, regular financial provision and adequate staff. Other weaknesses were attributed to low performance in "core" process and outcome indicators including reporting rates, reporter awareness, and signal detection. Greater governmental prioritisation through the provision of legislative enforcements, resources, and expertise as part of a well-structured system is required. More regional coordination efforts are needed to allow for sharing of expertise in order to bolster nascent systems.

Evaluating the safety of mental health-related prescribing in UK primary care: a cross-sectional study using the Clinical Practice Research Datalink (CPRD).

BACKGROUND: Most patients with mental illness are managed in primary care, yet there is a lack of data exploring potential prescribing safety issues in this setting for this population. OBJECTIVES: Examine the prevalence of, between-practice variation in, and patient and practice-level risk factors for, 18 mental health-related potentially hazardous prescribing indicators and four inadequate medication monitoring indicators in UK primary care. METHOD: Cross-sectional analyses of routinely collected electronic health records from 361 practices contributing to Clinical Practice Research Datalink GOLD database. The proportion of patients 'at risk' (based on an existing diagnosis, medication, age and/or sex) triggering each indicator and composite indicator was calculated. To examine between-practice variation, intraclass correlation coefficient (ICC) and median OR (MOR) were estimated using two-level logistic regression models. The relationship between patient and practice characteristics and risk of triggering composites including 16 of the 18 prescribing indicators and four monitoring indicators were assessed using multilevel logistic regression. RESULTS: 9.4% of patients 'at risk' (151 469 of 1 611 129) triggered at least one potentially hazardous prescribing indicator; between practices this ranged from 3.2% to 24.1% (ICC 0.03, MOR 1.22). For inadequate monitoring, 90.2% of patients 'at risk' (38 671 of 42 879) triggered at least one indicator; between practices this ranged from 33.3% to 100% (ICC 0.26, MOR 2.86). Patients aged 35-44, females and those receiving more than 10 repeat prescriptions were at greatest risk of triggering a prescribing indicator. Patients aged less than 25, females and those with one or no repeat prescription were at greatest risk of triggering a monitoring indicator. CONCLUSION: Potentially hazardous prescribing and inadequate medication monitoring commonly affect patients with mental illness in primary care, with marked between-practice variation for some indicators. These findings support health providers to identify improvement targets and inform development of improvement efforts to reduce medication-related harm.

A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland's ambiguity-conflict model.

BACKGROUND: As Arab countries seek to implement the 'Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries', understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). RESULTS: Matland's ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between "experimental implementation" and "symbolic implementation". Factors reducing policy ambiguity in Jordan and Oman included: decision-makers' guidance to implementors, stakeholder involvement in the policy's development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy's compliance with internationally recognised standards and the policy's fit with local capabilities (all three countries), decision-makers' cooperation with and support of the national centre as well as stakeholders' agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan). CONCLUSIONS: Using Matland's model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

Development of the adult complexity tool for pharmaceutical care (ACTPC) in hospital: A modified Delphi study.

BACKGROUND: Hospital pharmacists play an essential role in patient care; however, a lack of resources means pharmacists are unable to review all patients daily. Consequently, there is a demand for reliable screening tools to allocate care to patients with urgent and/or complex pharmaceutical needs. Several tools have been developed, but no broad consensus exists on the design of a screening tool to be used in the adult hospital setting. OBJECTIVE: To obtain expert consensus on the design of a pharmaceutical care complexity screening tool for use on admission to hospital. METHODS: Two Delphi studies were conducted: the first sought to gain consensus from experts including pharmacists, academics and physicians on the components of a pharmaceutical complexity tool, the second to achieve consensus from UK chief pharmacists and clinical service pharmacy managers on the clinical appropriateness and practicality of the tool. Tool components and Delphi statements were identified and refined from our previous systematic review, UK survey and interview study of prioritisation tools. A valid definition for consensus was used. RESULTS: Over 300 components were extracted from the interview data and systematic review and then refined for inclusion in the first Delphi study. Thirty-three experts completed Delphi One and consensus was reached on 92 components. Components were grouped into demographic, clinical and medication components and condensed to 33 items, which were included in the first draft of the Adult Complexity Tool for Pharmaceutical Care (ACTPC). The tool stratified patients into highly, moderately or least complex. Forty expert panellists completed Delphi Two and consensus was reached on review frequency and experience of pharmacy practitioner at each level. These decisions were incorporated into the final version of the ACTPC. CONCLUSIONS: The ACTPC is the first systematically designed and internationally agreed tool for use on medical admission to hospital. It has potential to enable the delivery of targeted patient-centred pharmaceutical care.

Investigating the prescribing trajectory and geographical drug utilisation patterns of gabapentinoids in primary care in England: An ecological study.

AIMS: This study aimed to investigate the prescribing trajectory, geographical variation and population factors, including socioeconomic status (SES), related to prescribing gabapentinoids in primary care in England. METHODS: This ecological study applied practice-level dispensing data and statistics from the UK National Health Service Digital and Office for National Statistics from 2013 to 2019. The prescribing of gabapentinoids (in defined daily doses [DDDs]/1000 people) was measured annually and quarterly. General practices were categorised according to the quarterly prescribing in a group-based trajectory model. The one-year prescribing in 2018/19 was associated with practice-level covariates in a mixed-effects multilevel regression, adjusted for the cluster-effects of Clinical Commissioning Groups (CCGs) and mapped geographically. RESULTS: The annual national prescription rate increased by 70% from 2800 to 4773 DDDs/1000 people in the time period 2013/14 to 2018/19. General practices were stratified into six trajectory groups. Practices with the highest level and the greatest increase in prescribing (n = 789; 9.8%) are mainly located in the north of England and along the east and south coastline. Socioeconomic status, demographic characteristics and relevant disease conditions were significantly associated with the prescribing. For every decrease in the Index of Multiple Deprivation decile (becoming less affluent), prescribing of gabapentinoids increased significantly by 203 (95% CI: 183-222) DDDs/1000 registrants. CONCLUSIONS: Gabapentinoid prescribing trajectories varied across geographical regions and are associated with socioeconomic status, CCG locality (geography) and other population characteristics. These factors should be considered in future studies investigating the determinants of gabapentinoid prescribing and the risk of harms associated with gabapentinoids.

Development of prescribing safety indicators related to mental health disorders and medications: Modified e-Delphi study.

AIM: To develop a set of prescribing safety indicators related to mental health disorders and medications, and to estimate the risk of harm associated with each indicator. METHOD: A modified two-stage electronic Delphi. The first stage consisted of two rounds in which 31 experts rated their agreement with a set of 101 potential mental health related prescribing safety indicators using a five-point scale and given the opportunity to suggest other indicators. Indicators that achieved 80% agreement were accepted. The second stage comprised a single round in which 29 members estimated the risk of harm for each accepted indicator by assessing the occurrence likelihood and outcome severity using two five-point scales. Indicators were considered high or extreme risk when at least 80% of participants rated each indicator as high or extreme. RESULTS: Seventy-five indicators were accepted in the first stage. Following the second stage, 42 (56%) were considered to be high or extreme risk for patient care. The 42 indicators comprised different types of hazardous prescribing, including drug-disease interactions (n = 12), drug-drug interactions (n = 9), inadequate monitoring (n = 5), inappropriate duration (n = 4), inappropriate dose (n = 4), omissions (n = 4), potentially inappropriate medications (n = 3) and polypharmacy (n = 1). These indicators also covered different mental health related medication classes, including antipsychotics (n = 14), mood stabilisers (n = 8), antidepressants (n = 6), sedative, hypnotics and anxiolytics (n = 6), anticholinergic (n = 6) and nonspecific psychotropics (n = 2). CONCLUSION: This study has developed the first suite of prescribing safety indicators related to mental health disorders and medications, which could inform the development of future safety improvement initiatives and interventional studies.

Patient prioritisation for hospital pharmacy services: current approaches in the UK.

OBJECTIVES: To survey and explore current approaches to deployment of pharmaceutical care prioritisation tools in acute hospitals in the UK. METHODS: A national online survey was circulated electronically to chief pharmacists of hospitals to determine if they use a prioritisation tool or process. Where such mechanisms exist, respondents were invited to participate in a semistructured telephone interview to explore the development, evaluation and application of their tool and share relevant documentation. Interviews were transcribed and thematically analysed. RESULTS: Seventy hospitals (70/130) used a tool or process to prioritise clinical pharmacy services. Thirty-six interviews were conducted, and two were excluded. The majority of tools had been developed in-house. Few hospitals had undertaken formal evaluations of their prioritisation tool. Pharmacy prioritisation tools ranged in complexity and often included a combination of pharmacy service prioritisation, such as medicines reconciliation, and a section to assign an individual patient prioritisation level. Determining the priority of a patient based on the identification of set indicators instilled confidence in pharmacists by ensuring they were not missing high-risk patients. Electronic prioritisation tools were especially useful at retrieving real-time data to prioritise workload, improving workflow and ensuring continuity in patient care. Drawbacks of using prioritisation tools included lack of tool sensitivity across certain specialties and time spent using the tool if not all information was accessible. CONCLUSIONS: Prioritisation tools were seen to be useful for prioritising workload and ensuring the right patients are seen at the right time. As few hospitals had formally evaluated their tools, it is important to rigorously and systematically develop an evidence-based prioritisation tool that is both useable and acceptable. Further research to evaluate such tools would be needed to ensure it improves patient health outcomes and efficiency in pharmacy services.