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.

A cross-country utilization patterns comparison of high expenditure therapeutic groups between Portugal and six European countries: the two sides of the Portuguese coin.

BACKGROUND: Understanding variability in prescribing patterns through comparative drug utilization studies can contribute to improve an efficient, effective and safe use of medicines. OBJECTIVES: To perform a cross-country comparison of consumption patterns of ambulatory high expenditure therapeutic groups between Portugal and six European countries and simulate potential cost-saving scenarios through the adoption of the different prescribing patterns of studied countries. METHODS: Cross-country comparison of 2019 drug consumption patterns between Portugal, Denmark, England, Finland, the Netherlands, Norway, and Spain. Analysis comprised antihypertensive drugs, glucose lowering drugs (GLD), insulins, lipid lowering drugs (LLD) and oral anticoagulants. Cost-saving analysis were performed using the Portugal average annual cost/daily defined dose and the potential reduction in expenditure simulating other European countries consumption pattern scenarios. RESULTS: Portugal had the lowest consumption uptake of metformin and the highest consumption of GLD (30.1%) and LLD (8.5% vs <3%) fixed-dose combinations. Annual cost-savings scenarios showed that Portugal would have saved between 53 M€ and 305 M€ if it had the same prescribing patterns than Norway or the Netherlands, respectively. CONCLUSIONS: Different utilization patterns across countries were found. Although Portugal has the lowest gross domestic product per capita among the countries studied, it had the highest uptake of newly and costly drugs.

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.

Medicinal Product Regulation: Portugal׳s Framework.

PURPOSE: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). METHODS: From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. FINDINGS: In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. IMPLICATIONS: The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances.

Understanding physician antibiotic prescribing behaviour: a systematic review of qualitative studies.

Inappropriate prescription has been associated with mounting rates of antibiotic resistance worldwide, demanding more detailed studies into physicians' decision-making process. Accordingly, this study sought to explore physicians' perceptions of factors influencing antibiotic prescribing. A systematic search was performed for qualitative studies focused on understanding physicians' perceptions of the factors, attitudes and knowledge influencing antibiotic prescription. Of the total of 35 papers selected for review purposes, 18 solely included physicians and the remaining 17 also included patients and/or other healthcare providers. Data collection was based mainly on interviews, followed by questionnaires and focus groups, and the methodologies mainly used for data analysis were grounded theory and thematic analysis. Factors cited by physicians as having an impact on antibiotic prescribing were grouped into those that were intrinsic (group 1) and those that were extrinsic (group 2) to the healthcare professional. Among the former, physicians' attitudes, such as complacency or fear, were rated as being most influential on antibiotic prescribing, whilst patient-related factors (e.g. signs and symptoms) or healthcare system-related factors (e.g. time pressure and policies/guidelines implemented) were the most commonly reported extrinsic factors. These findings revealed that: (i) antibiotic prescribing is a complex process influenced by factors affecting all the actors involved, including physicians, other healthcare providers, healthcare system, patients and the general public; and (ii) such factors are mutually dependent. Hence, by shedding new light on the process, these findings will hopefully contribute to generating new and more effective strategies for improving antibiotic prescribing and allaying global concern about antibiotic resistance.