Effectiveness and cost-effectiveness of a collaborative deprescribing intervention of proton-pump-inhibitors on community-dwelling older adults: Protocol for the C-SENIoR, a pragmatic non-randomized controlled trial.

INTRODUCTION: Worldwide, demographic ageing is a major social, economic and health challenge. Despite the increase in life expectancy, elderly often live with multiple chronic conditions, exposing them to multiple medications. Concerns have been raised about the growing issue of inappropriate long-term usage of proton-pump inhibitors (PPI), which have been associated with adverse outcomes and increased healthcare costs. Deprescribing is a recommended intervention to reduce or withdraw medicines that might be causing harm or might no longer be of benefit. This protocol details a trial to assess the effectiveness and cost-effectiveness of a collaborative deprescribing intervention of PPI among community-dwelling elderly, involving community pharmacists and general practitioners. METHODS AND ANALYSIS: A pragmatic, multicentre, two-arm, non-randomised controlled trial of a structured PPI collaborative deprescribing intervention in the primary care setting with a 6-month follow-up will be conducted. Patients must be 65 years old or older, live in the community and have been using PPI for more than 8 weeks. We hypothesize that the intervention will reduce the PPI usage in the intervention group compared to the control group. The primary outcome is the successful discontinuation or dose decrease of any PPI, defined as a statistically significant absolute 20% reduction in medication use between the intervention and control groups at 3- and 6-month follow-ups. An economic evaluation will be conducted alongside the trial. This study was approved by the Ethics Research Committee of Nova Medical School, NOVA University of Lisbon and by the Ethics Committee from the Local Health Unit Alto Minho, Portugal. DISCUSSION: This pragmatic trial will provide evidence on the effectiveness and cost-effectiveness of a patient-centred collaborative deprescribing intervention in the community setting in Portugal. It will also inform improvements for the development of future multi-faceted interventions that aim to optimise medication for the community-dwelling elderly. CLINICAL TRIAL REGISTRATION: ISRCTN 49637686.

Estimating Type 2 Diabetes Prevalence: A Model of Drug Consumption Data.

Observational, cross-sectional prevalence studies are costly and time-consuming. The development of indirect methods estimating prevalence used to obtain faster, less-expensive, and more robust results would be an advantage for several healthcare applications. This study aimed to use the drug dispensing data from community pharmacies to estimate the prevalence of Type 2 Diabetes mellitus (T2DM) in the Portuguese population. A cross-sectional study was conducted using a database of dispensed medicines with an indication for Diabetes mellitus in 2018 and 2021, stratified by geographic region. The methodology was based on a sequential method of acquiring prevalence estimates obtained through exposure to medicines using the daily doses defined per thousand inhabitants per day and adjusted to the rate of adherence to therapy, prescription patterns, and concomitance of antidiabetic drugs. The estimated overall T2DM prevalence in 2018 was 13.9%, and it was 14.2% for 2021. The results show the increased consumption of antidiabetic drugs, with fixed-dose combination antidiabetics and new antidiabetics being particularly important in 2021. This work allowed for the development of a model to obtain the estimated prevalence of T2DM based on drug consumption, using a simple, fast, and robust method that is in line with the available evidence. However, with the recent expanding indications for new antidiabetics, the inclusion of further data in the model needs to be studied.

Measuring the value of solidarity: The abem financial assistance program for out-of-pocket payments on pharmacy medicines in Portugal.

OBJECTIVE: Out-of-pocket payments for prescribed medicines are still comparatively high in Portugal. The abem program was launched in Portugal in May 2016 to aid vulnerable groups by completely covering out-of-pocket costs of prescribed medicines in community pharmacies. This study assesses the impact of the program on poverty and catastrophic health expenditures. METHODS: A longitudinal study was carried out with the analysis of several program databases (from the beginning of the program in May 2016 to September 2018) covering the cohorts of beneficiaries, daily data on medicines dispensed, social referencing entities, and solidarity pharmacies. The study provides estimates of standard poverty measures (intensity and severity) as well as the incidence of catastrophic health expenditures. RESULTS: More than 6000 beneficiaries were supported (56.8% female, 34.7% aged 65 or over), encompassing 127,510 medicines (mainly nervous system and cardiovascular system) with an average 26.9% co-payment (payments totalling €1.5 million). The program achieved substantial reductions in poverty (3.4% in intensity, 5.6% in severity), and eliminated cases with catastrophic health expenditures in medicines that would have affected 7.5% of the beneficiaries. CONCLUSIONS: Findings confirm a continuous increase in the number of beneficiaries, enabling access to medicines especially for the vulnerable elderly, and a sizable impact on eliminating out-of-pocket payments for medicines in the target population.

Effectiveness of a collaborative diabetes screening campaign between community pharmacies and general practitioners.

AIM: To evaluate the impact of a collaborative screening campaign on the prevalence of pre-diabetes and diabetes among the screened population. METHODS: A Longitudinal, multicentre study was developed. The Finnish Diabetes Risk Score (FINDRISC) was applied to the eligible population in the participating community pharmacies. Individuals with a FINDRISC score ≥ 15, were eligible to measure their glycated haemoglobin (HbA1c) level at the community pharmacy. If HbA1c≥ 5.7%, participants were referred to a general practitioner (GP) appointment for potential diagnosis of Diabetes. RESULTS: Out of 909 screened subjects, 405 (44.6%) presented a FINDRISC score ≥ 15. Among the latter, 94 (23.4%) had HbA1c levels that made them eligible for GP referral, of which 35 (37.2%) completed the scheduled appointments. 24 participants were diagnosed with pre-diabetes, and 11 with diabetes. The prevalence was estimated at 2.5% (CI95% 1.6-3.8%) and 7.8% (CI95% 6.2-9.8%) for diabetes and pre-diabetes, respectively. CONCLUSION: This collaborative model has proved to be effective in the early detection of diabetes and pre-diabetes. Joint initiatives between health professionals can play a pivotal role in the prevention and diagnosis of diabetes, which may lead to a reduction on the burden to health system and society.

COVID-19 pandemic and the quality of antibiotic use in primary care: an interrupted time-series study.

The coronavirus disease-19 pandemic and the related public health mitigation measures have impacted the transmission of infectious diseases; however, their impact on the use of antibacterials has not yet been extensively evaluated. This study evaluated the impact of the pandemic on the consumption patterns of antibacterials for systemic use in primary care in Portugal. An interrupted time-series analysis was performed using the autoregressive integrated moving average model of the antibacterials dispensed in the community pharmacies in Portugal from 1 January 2016 to 30 June 2022. Monthly rates of absolute consumption (all antibacterials for systemic use, and specifically penicillins; cephalosporins; macrolides, lincosamides, and streptogramins; and quinolones) and the relative consumption of antibacterials (penicillins sensitive to ß-lactamase, penicillin combinations including ß-lactamase inhibitors, third- and fourth-generation cephalosporins, fluoroquinolones, and the ratio of broad- to narrow-spectrum antibacterials) were estimated. Antibiotic consumption was expressed in defined daily doses per 1000 inhabitants per day (DID). In Portugal, the consumption of antibacterials (J01) declined sharply immediately after the beginning of the pandemic, having a significant reduction of >5 DID (P < .0001). A similar, short-term impact was found for penicillins (-2.920 DID; P < .0001); cephalosporins (-0.428 DID; P < .0001); macrolides, lincosamides, and streptogramins (-0.681 DID; P = .0021); and quinolones (-0.320 DID; P < .0001). A long-term increase was found for cephalosporins (+0.019 DID per month; P < .0001). Relative consumption changes were only found for third- and fourth-generation cephalosporins (0.0734%). Our study suggests that the coronavirus disease-19 pandemic may have resulted in a decrease in antibiotic use, with no significant changes in the relative dispense. Uncertainties regarding the long-term effects of the pandemic and its impact on the rates of resistance remain.

Drug shortages in community pharmacies: Impact on patients and on the health system.

BACKGROUND: Worldwide, drug shortages are a critical public health concern. Consequences range from inconvenience and distress to more serious concerns related to negative clinical, humanistic and economic outcomes. OBJECTIVE: This study aimed to investigate the impact of drug shortages at the community pharmacies on patients and on the health system in Portugal. METHODS: A national, cross-sectional, multicenter study was conducted in Portuguese community pharmacies during April 2019. The proportion of patients reporting drug shortages, types of drugs affected and consequent economic burden to patients and the health system were estimated. Regional and urban setting stratification was performed. RESULTS: A total of 71.1% of pharmacies participated in the study and 22,830 patient surveys were retrieved. About 52.2% of patients experienced a drug shortage in the past 12 months; 21.5% had to see a physician to change the prescription and 5.7% declared treatment discontinuation because of this shortage. The estimated economic impact of shortages related to additional physician appointments varied between €2.1-€4.4 million for patients and €35.3-€43.8 million for the National Health Service. Drug shortages were mostly felt in rural and inner regions and least felt in the islands. CONCLUSION: This national study showed that community pharmacy drug shortages are a national problem with negative consequences on patients and the health system, which need to be tackled and mitigated.

Overtreatment and undertreatment in a sample of elderly people with diabetes.

AIMS: In older adults with type 2 diabetes (T2D), overtreatment remains prevalent and undertreatment ignored. The main objective is to estimate the prevalence and examine factors associated with potential overtreatment and undertreatment. METHOD: Observational study conducted within an administrative database of older adults with T2D who registered in 2018 at the Portuguese Diabetes Association. Participants were categorized either as potentially overtreated (HbA1c ≤ 7.5%), appropriately on target (HbA1c ≥7.5 to ≤9%), or potentially undertreated (HbA1c > 9%). RESULTS: The study included 444 participants: potential overtreatment and undertreatment were found in 60.5% and 12.6% of the study population. Taking the patients on target as a comparator, the group of potentially overtreated showed to be more men (61.3% vs 52.2%), less-obese (34.1% vs 39.2), higher cardiovascular diseases (13.7% vs 11%), peripheral vascular diseases (16.7% vs 12.8%), diabetic foot (10% vs 4.5%), and severe kidney disease (5.2% vs 4.5%). Conversely, the potentially undertreated participants were more women (64.2% vs 47.7%), obese (49% vs 39.2%), had more dyslipidemia (69% vs 63.1%), peripheral vascular disease (14.2% vs 12.8%), diabetic foot (8.9% vs 4.5%), and infections (14.2% vs 11.9%). The odds of potential overtreatment were mostly decreased by 59% of women, 73.5% in those with retinopathy, and 86.3% in insulin, 65.4% sulfonylureas, and 66.8% in SGLT2 inhibitors users. Contrariwise, an increase in the odds of potential undertreatment was more than 4.8 times higher in insulin, and more than 3.1 times higher in sulfonylureas users. CONCLUSION: Potential overtreatment and undertreatment in older adults with T2D in routine clinical practice should guide the clinicians to balance the use of newer oral antidiabetic agents considering its safety profile regarding hypoglycemia.

Drug-drug interactions and inappropriate medicines impact on glycemic control and kidney function in older adults with diabetes-attending specialty care institution.

PURPOSE: To describe and assess the impact of polypharmacy, and its potential adverse reactions; serious clinically relevant drug-drug interactions (DDIs) and inappropriate medicines (PIMs) on glycemic target, and kidney function in a sample of older adults with type 2 diabetes (T2D). METHODS: Cross-sectional study was performed in a real-world database including 444 elderly people with T2D from the Portuguese Diabetes Association, aged ≥ 65 years, and registered in 2018. DDIs were analyzed using Micromedex drug-interaction platform and PIMs identified using STOPP criteria version-2. RESULTS: Polypharmacy was identified in 43.6% of patients. This group of patients has shown to be more females (50 vs. 39.6%, P=0.0208), higher HbA1c targets (P=0.0275), longer diabetes duration (66.4 vs. 54.4%, P=0.0019), more hypertensive (87 vs. 62.9%, P<0.0001), using more insulin (38.1 vs. 26%, P=0.0062), sulfonylureas (37.1 vs. 15.6%, P<0.0001), GLP-1 receptor-agonists (9.7 vs. 3.6%, P=0.0077), metformin-DPP-4 inhibitors (41.2 vs. 29.2%, P=0.0081), and SGLT2 inhibitors (19 vs. 9.6%, P=0.0040). A total of 8.7% of patients had potentially serious clinically relevant DDIs, mainly due to interacting medicine pairs dexamethasone and fluoroquinolones. Furthermore, 23.4% had PIMs, and cardiovascular medicines accounted for largest therapeutic group associated. Polypharmacy found to be associated with twofold greater odds of having HbA1c ≤8%, whereas PIMs associated with 2.5-fold greater odds of having HbA1c ≤9%, and 5.5-folds greater odds of having severe kidney function. CONCLUSIONS: These findings suggested that there is a potential association between polypharmacy and PIMs and altered glycemic control, and PIMs with the deterioration of kidney function.

Polypharmacy, potentially serious clinically relevant drug-drug interactions, and inappropriate medicines in elderly people with type 2 diabetes and their impact on quality of life.

The aim of the study is to investigate the patterns of polypharmacy, clinical-relevant drug-drug interactions (DDIs), and potentially inappropriate medicines (PIMs), and whether polypharmacy, potential serious clinically-relevant DDIs, or PIMs can be associated with low quality of life (QoL) index scores of older adults with type 2 diabetes (T2D). A cross-sectional study was conducted using data of 670 elderly T2D sub-cohort from a nationwide pharmacy-based intensive monitoring study of inception cohort of T2D in Portugal. 72.09% were found on polypharmacy (≥5 medicines). Participants on polypharmacy were mostly females (P = .0115); more obese (P = .0131); have more comorbid conditions (P < .0001); more diabetes complications (P < .0001); and use more of glucose lowering drugs (P = .0326); insulin (P < .0001); chronic medicines (P < .0001); and have higher diabetes duration (P = .0088) than those without polypharmacy. 10.59% of the participants were found to have potential serious clinically relevant DDIs. The most frequent drug-combinations were angiotensin-converting enzyme (ACE) inhibitors with angiotensin-receptor blockers (ARBs), aspirin with Selective serotonin reuptake inhibitors (SSRIs), and clopidogrel with calcium channel blockers. PIMs are found in 36.11% of the participants. The most common PIMs were benzodiazepines, long-acting sulfonylureas, and iron overdose. The adjusted multivariate models show that Polypharmacy, PIMs, and potential serious clinically relevant DDIs were associated with lower QoL index scores (OR 1.80 95% CI 1.15-2.82), (OR 1.57 95% CI 1.07-2.28), and (OR 1.34 95% CI 0.73-2.48) respectively. The study shows that polypharmacy, potential serious clinical-relevant DDIs, and PIMs may correlate with risk of reduced health related QoL outcome of older adults with T2D.

Costs and consequences of the Portuguese needle-exchange program in community pharmacies.

BACKGROUND: Needle-exchange programs (NEPs) reduce infections in people who inject drugs. This study assesses the impact community pharmacies have had in the Needle-Exchange Program in Portugal since 2015. METHODS: Health gains were measured by the number of human immunodeficiency virus (HIV) and hepatitis C virus (HCV) infections averted, which were estimated, in each scenario, based on a standard model in the literature, calibrated to national data. The costs per infection were taken from national literature; costs of manufacturing, logistics and incineration of injection materials were also considered. The results were presented as net costs (i.e., incremental costs of the program with community pharmacies less the costs of additional infections avoided). RESULTS: Considering a 5-year horizon, the Needle Exchange Program with community pharmacies would account for a 6.8% (n = 25) and a 6.5% reduction (n = 22) of HCV and HIV infections, respectively. The present value of net savings generated by the participation of community pharmacies in the program was estimated at €2,073,347. The average discounted net benefit per syringe exchanged is €3.01, already taking into account a payment to community pharmacies per needle exchanged. INTERPRETATION: We estimate that the participation of community pharmacies in the Needle Exchange Program will lead to a reduction of HIV and HCV infections and will generate over €2 million in savings for the health system. CONCLUSIONS: The intervention is estimated to generate better health outcomes at lower costs, contributing to improving the efficiency of the public health system in Portugal.

Real-world prevalence of mild to moderate hypoglycemic episodes in type 2 diabetes in Portugal: Results from the HIPOS-PHARMA study.

AIMS: This study aimed to characterize and estimate prevalence and frequency of mild to moderate hypoglycemia and potentially associated factors in a population of type 2 diabetes mellitus (T2DM) patients treated at ambulatory care level. METHODS: HIPOS-PHARMA was a nationwide observational, cross-sectional, multicenter study conducted in community pharmacies, which surveyed T2DM patients treated for at least 3 months. RESULTS: Overall, 233 pharmacies recruited 1890 patients (males: 50.6%) with mean 67.1 years. On average, participants reported having diabetes for 11.8 years. A total of 86.9% had at least one chronic illness or complication of diabetes, and 76.8% were usually followed in the primary care setting. Fifty eight percent were treated without a secretagogue or insulin. Overall prevalence of mild to moderate hypoglycemic episodes in the 3 months prior to recruitment was 17.8%. A 3.13% prevalence of severe hypoglycemia was observed in the last 12 months. Results suggested that men and patients on antihyperglycemic therapies excluding secretagogues or insulin were less likely to have mild to moderate hypoglycemic episodes. CONCLUSIONS: Mild to moderate hypoglycemic episodes were commonly reported, and factors like type of antihyperglycemic therapy, duration of disease and due complications may contribute. Almost half of episodes were not reported. Such factors should be considered in T2DM management.

Use of generic and essential medicines for prevention and treatment of cardiovascular diseases in Portugal.

BACKGROUND: The successful control of cardiovascular diseases at the lowest possible cost requires the use of the most effective and affordable medicines. We aimed to describe the trends in the ambulatory use of medicines for prevention and treatment of cardiovascular diseases [Anatomic Therapeutic Chemical classification system (ATC): C and B01A] in Portugal, between 2004 and 2012, and to estimate the potential for expenditure reduction through changes in patterns of use. METHODS: We analysed sell-out data, expressed as defined daily doses (DDD) and pharmacy retail price (€), from a nationwide database. We estimated potential reduction in expenditures through the increase, up to 90% of the volume of DDD, in the use of generic and essential medicines; the latter were defined according to guidelines from Portugal and another European country. RESULTS: Overall consumption increased by approximately 50% from 2004 to 2012, reaching nearly 2400 million DDD, whereas expenditure decreased to 753 million € (-31.3% since 2006). Use of generics and essential medicines increased, representing 43.6 and 39.9% of DDD consumption in 2012, respectively. The 40 most used groups of medicines in 2012 accounted for just over 80% of overall consumption; among these, increase in use of generics and essential medicines would have contributed to a saving of 275 million €. CONCLUSIONS: Changes in patterns of consumption of medicines towards a more frequent use of generics, a preferential use of essential medicines and a more rational use of fixed-dose combinations may contribute to a more efficient use of health resources.

Análisis de la calidad de vida relacionada con la diabetes (ADDQoL) para Portugal: exploración de la validez y la fiabilidad / An Audit of Diabetes Dependent Quality of Life (ADDQoL) for Portugal: exploring validity and reliability

Objetivo: Este artículo describe el proceso realizado para asegurar que un cuestionario de calidad de vida específico para diabetes [el «Audit of Diabetes Dependent Quality of Life» (ADDQoL)] mantiene sus propiedades psicométricas después de una adaptación transcultural del inglés al portugués. Métodos: Usando farmacias comunitarias de Lisboa, se reclutó a 100 pacientes mediante un diseño transversal. Se pidió a los pacientes que respondieran el cuestionario una vez. Se sometió a los datos a un análisis factorial, y se realizaron análisis de consistencia interna y de poder discriminatorio. Resultados: En la muestra portuguesa, 17 ítems se incluyeron en un factor con pesos de más de 0,43. El ítem «preocupaciones sobre el futuro» peso poco en este factor, pero si se retiraba la consistencia interna sufría un muy ligero incremento (alfa de Cronbach=0,89 a 0,90). Se detectó un mayor impacto negativo en 16 de los 18 dominios de calidad de vida para los pacientes tratados con insulina, y también se encontró un mayor impacto negativo en 14 de los 18 dominios en pacientes con complicaciones diabéticas. El dominio «libertad para comer» mostró el mayor impacto negativo en todos los subgrupos de pacientes, tal y como describía la versión original, así que se conservaron las propiedades psicométricas. Además, los pacientes sin complicaciones diabéticas comunicaron peor calidad de vida (mayor impacto negativo) en el primer ítem, calidad de vida actual (Z=-2,25; p=0,024); mientras que los pacientes con insulina comunicaron un mayor impacto negativo de la diabetes en su calidad e vida (Z=-1,94; p=0,053). Conclusión: Generalmente, la versión portuguesa para Portugal del ADDQoL ha demostrado mantener sus propiedades psicométricas originales y podría recomendarse para su uso y posterior evaluación en posteriores estudios (AU)

Objective: This paper describes the processes involved to ensure a diabetes-specific quality of life questionnaire [the «Audit of Diabetes Dependent Quality of Life» (ADDQoL)] retained the psychometric properties following cross-cultural adaptation from English to Portuguese. Methods: One hundred patients were recruited through community pharmacies located in Lisbon through a cross sectional study design. Patients were asked to respond to the questionnaire on one occasion in time. Data were subjected to factor analysis, and internal consistency and discriminatory power analyses were undertaken. Results: In the Portuguese sample, 17 items loaded into one factor, with factor loadings above 0.43. The item «worries about the future» loaded weekly into this factor but if removed its internal consistency estimate increased very slightly (Cronbach's alpha=0.89 to 0.90). A greater negative impact of diabetes on 16 of the 18 quality of life domains was detected for insulin-treated patients, together with a greater negative impact on 14 of the 18 quality of life domains for patients with diabetic complications. The domain «freedom to eat» revealed the greatest negative impact in all patient subgroups, as described in its original version, so the psychometric properties were retained. Additionally, patients without diabetic complications reported a worse quality of life (greater negative impact) on the first overview item, present quality of life (Z=-2.25; p=0.024); whilst patients on insulin reported a greater negative impact of diabetes on their quality of life (Z=-1.94; p=0.053). Conclusion: Generally, the Portuguese version for Portugal of the ADDQoL has shown to maintain its original psychometric properties, and could be recommended for use and further evaluation in subsequent studies (AU)

An Audit of Diabetes Dependent Quality of Life (ADDQoL) for Portugal: exploring validity and reliability.

OBJECTIVE: This paper describes the processes involved to ensure a diabetes-specific quality of life questionnaire [the "Audit of Diabetes Dependent Quality of Life" (ADDQoL)] retained the psychometric properties following cross-cultural adaptation from English to Portuguese. METHODS: One hundred patients were recruited through community pharmacies located in Lisbon through a cross-sectional study design. Patients were asked to respond to the questionnaire on one occasion in time. Data were subjected to factor analysis, and internal consistency and discriminatory power analyses were undertaken. RESULTS: In the Portuguese sample, 17 items loaded into one factor, with factor loadings above 0.43. The item "worries about the future" loaded weekly into this factor but if removed its internal consistency estimate increased very slightly (Cronbach's alpha=0.89 to 0.90). A greater negative impact of diabetes on 16 of the 18 quality of life domains was detected for insulin-treated patients, together with a greater negative impact on 14 of the 18 quality of life domains for patients with diabetic complications. The domain "freedom to eat" revealed the greatest negative impact in all patient subgroups, as described in its original version, so the psychometric properties were retained. Additionally, patients without diabetic complications reported a worse quality of life (greater negative impact) on the first overview item, present quality of life (Z=-2.25; p=0.024); whilst patients on insulin reported a greater negative impact of diabetes on their quality of life (Z=-1.94; p=0.053). CONCLUSION: Generally, the Portuguese version for Portugal of the ADDQoL has shown to maintain its original psychometric properties, and could be recommended for use and further evaluation in subsequent studies.