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.

Real-World Impact of Transferring the Dispensing of Hospital-Only Medicines to Community Pharmacies During the COVID-19 Pandemic.

OBJECTIVES: In Portugal, the dispensing of most outpatient specialty medicines is performed exclusively through hospital pharmacies and totally financed by the National Health Service. During the COVID-19 first wave, the government allowed the transfer of the dispensing of hospital-only medicines (HOMs) to community pharmacies (CPs). This study aimed to measure the value generated by the intervention of CP in the dispensing of HOM. METHODS: A single-arm, before-and-after study with 3-month follow-up was conducted enrolling a randomly selected sample of patients or caregivers with at least 1 dispensation of HOM through CP. Data were collected by telephone interview. Main outcomes were patients' self-reported adherence (Measure Treatment Adherence), health-related quality of life (EQ-5D 3-Level), satisfaction with the service, and costs related to HOM access. RESULTS: Overall 603 subjects were recruited to participate in the study (males 50.6%) with mean 55 years old (SD = 16). The already high mean adherence score to therapy improved significantly (P < .0001), and no statistically significant change (P > .5757) was found in the mean EQ-5D score between baseline (0.7 ± 0.3) and 3-month follow-up (0.8 ± 0.3). Annual savings account for €262.1/person, arising from travel expenses and absenteeism reduction. Participants reported a significant increase in satisfaction levels in all evaluated domains-pharmacist's availability, opening hours, waiting time, privacy conditions, and overall experience. CONCLUSIONS: Changing the dispense setting to CP may promote better access and satisfaction. Moreover, it ensures the persistence of treatments, promotes savings for citizens, and reduces the burden of healthcare services, representing a crucial public health measure.

Monitoring real-life utilization of pembrolizumab in advanced melanoma using the Portuguese National Cancer Registry.

OBJECTIVES: To evaluate the effectiveness and safety of pembrolizumab use in advanced melanoma in a real-life context; and to explore the existence of an efficacy-effectiveness gap, comparing registry data with the reference clinical trial. METHODS: This study followed the guidelines for good pharmacoepidemology practice. An ambispective cohort was constituted, initiating the observation upon drug approval (17/07/2015) and following exposed patients until death or cut-off date (15/11/2019). The primary outcome was overall survival (OS); secondary outcomes comprised progression-free survival (PFS), overall response rate (ORR) and the occurrence of adverse events (AE). For all survival analyses, the Kaplan-Meier estimator was used, considering a 95% confidence interval (CI), aside with one-year survival rates. RESULTS: A total of 125 patients constituted the cohort, originating from 16 hospitals in Portugal. Median OS was estimated to be 16.9 months (CI95% 11.3-25.5) and the probability of survival after 1 year was 57.5% (CI95% 48.4%-65.6%). Median PFS was estimated to be 4.8 months (CI95% 3.9-6.7) and the probability of remaining progression-free after 1 year was 32.8% (CI95% 24.8-41.1). ORR was 30.4% (CI95% 22.5%-39.3%). AEs were experienced by 82% of patients, and 27% experienced AE≥ grade 3. CONCLUSIONS: Our data suggest lower effectiveness in a real-life context than the efficacy reported in the clinical trial. Safety data seems, however, quite comparable to KEYNOTE-006.

Real-world effectiveness of pembrolizumab in previously treated non-small cell lung cancer: A population-based cohort study.

PURPOSE: Immunotherapy is promising for lung cancer treatment, although at significant financial impact. The aim of this study was to evaluate the effectiveness and the efficacy-effectiveness gap of pembrolizumab in previously treated non-small cell lung cancer (NSCLC). METHODS: A population-based ambispective cohort study was conducted. Cases of interest were identified through the National Cancer Registry database and additional data sources. Patients aged ≥18 years, diagnosed with NSCLC and exposed to pembrolizumab, between 23 June 2016 and 31 October 2018, as second or later lines of treatment for advanced disease were included. Patients were followed-up until death or cut-off date (30 April 2019). Primary outcome was overall survival (OS). Secondary outcomes were progression-free survival (PFS), event-free survival (EFS), and adverse events (AEs) leading to treatment discontinuation. The efficacy-effectiveness gap was evaluated comparing results with clinical trial data. RESULTS: A total of 181 patients were included. Median age was 63 years (range 33-94); 74.6% were male. Median treatment duration was 5.6 months (interquartile range: 1.4-10.4) and, at cut-off date, treatment had been discontinued in 141 patients, mainly due to disease progression. Median OS was 13.0 months (95% confidence interval [CI] 9.3-15.9) and 1-year OS was 53.1% (95% CI 45.2%-60.3%). Median PFS was 5.6 months (95% CI 4.6-7.2), median EFS was 4.7 months (95% CI 3.2-6.0), and treatment was discontinued due to AE in 8.3% of cases (n = 15). The efficacy-effectiveness gap seems to favor pembrolizumab use in clinical practice. CONCLUSION: Real-world data suggest the performance of pembrolizumab to reflect the clinical trial outcomes in previously treated NSCLC.

The South Region Cancer Registry: an evaluation of its exhaustiveness in a cohort of lung cancer patients.

The regional cancer registry for Southern Portugal (ROR-Sul) is a population-based registry set up in 1988 to observe and monitor disease incidence, prevalence and survival. Recently, the need to monitor real-life use of early approved and high-priced medicines led to therapeutic effectiveness becoming an emerging area of interest. We aimed to evaluate the exhaustiveness of the ROR-Sul database, covering around 4.8 million inhabitants. We have used a retrospective cohort study comprising 3457 lung cancer cases diagnosed during 2014 and 2015 and extracted from ROR-Sul database. Descriptive analysis of missing data was undertaken using IBM SPSS software, v.24. Exhaustiveness of data registry was classified into high (missing values <1%), medium (missing values {1-15%}) or low (missing values > 15%). High exhaustiveness was found for patients demographic information, date of diagnosis, date of first medical appointment, topography, morphology, cancer differentiation, stage of disease and surgery procedure. Medium exhaustiveness was found for biomarkers (ALK, KRAS, and EGFR) results, and immunotherapy regimens. Low exhaustiveness was found for performance status, chemotherapy regimen, and chemotherapy treatment response. The findings highlight the need to transform treatment variables into compulsory, so that the cancer registry may be used to support effectiveness studies. Education, training and behaviour changes must also be considered to foster the process.

Using a cancer registry to capture signals of adverse events following immune and targeted therapy for melanoma.

Background Toxicity of oncology treatments in real-life patients is frequently disregarded and hence underreported. Objective To characterize adverse events (AEs) of immunotherapy and targeted therapy reported in patients with locally advanced or metastatic melanoma. Setting District Hospital for Cancer treatment (Instituto Português de Oncologia de Lisboa Francisco Gentil). Method A retrospective cohort of melanoma patients was established, comprising adult patients diagnosed with malignant melanoma treated with immunotherapy or targeted therapy. Exposure was characterized by nature, time and intensity of exposure. To account for different exposure periods, person-time was used as unit of analysis. Main outcomes measure Occurrence of AEs. Results Data from 111 patients included in the cohort indicates the majority received immunotherapy regimens (CTLA-4, anti-PD-1 and combination therapy; (n = 70; 63.1%), among which anti-PD-1 were the predominant treatment. Pembrolizumab was the most frequently prescribed drug (n = 30; 45.7%). Three hundred and seventy-one AEs were extracted. The incidence of AEs was lower in the anti-PD-1 mAc group (54 AEs per 1000 person.months) and the number of AEs/patient was also lower (3.1 ± 2.0). Grade 3 to 4 AEs occurred in 15.3% (n = 17) of the cohort, being more common in the targeted therapy group. Forty-two (11.6%) of the extracted AEs were not described in the Summary of Product Characteristics of the drugs under study. Conclusion This study suggests various known and unknown AEs of immunotherapy and targeted therapy may be identified using the Cancer Registry database. These events should be considered as signals worth further investigation for assessment of causality as the underreporting of AEs in cancer may have potential implications for the patient's quality of life.