{"title":"Medication adherence and persistence in heart failure: A protocol for a systematic review and meta-analysis.","authors":"Nerea Baéz-Gutiérrez, Héctor Rodríguez-Ramallo, Susana Sánchez-Fidalgo","doi":"10.1016/j.farma.2024.07.003","DOIUrl":"https://doi.org/10.1016/j.farma.2024.07.003","url":null,"abstract":"<p><strong>Objective: </strong>To study medication adherence and persistence among heart failure patients, assess the methods utilised for estimating medication adherence, and identify optimal adherence thresholds and their impact on clinical outcomes.</p><p><strong>Methods: </strong>A systematic search will be conducted in PubMed, Embase, CINAHL, Web of Science, and Scopus databases. Observational studies assessing medication adherence or persistence among heart failure patients via electronic healthcare databases will be included. A narrative synthesis will describe medication adherence and persistence reported and methods used to measure it. A meta-analysis will be attempted to evaluate the impact of secondary medication adherence (multiple and by drug class) on clinical outcomes, including hospitalisation, emergency visits, and mortality. The I<sup>2</sup> statistic will be employed to study heterogeneity and the GRADE framework to evaluate evidence certainty. This protocol follows the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines and is registered with the Prospective Register of Ongoing Systematic Reviews CRD42024509542.</p><p><strong>Discussion: </strong>This study aims to evaluate medication adherence and persistence in heart failure management through electronic health databases, intending to explore widely used measurement methods and their limitations, and to identify adherence thresholds associated with improved clinical outcomes. By examining these aspects, we anticipate proposing enhancements for future research and establishing desired adherence goals. This approach highlights the expected significance of our findings in advancing patient care and research methodologies.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141983518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F Dámaso Fernández-Ginés, María T Gómez Sánchez, Marina Sánchez Valera, Beatriz Tauste Hernández, Marta Garrido Ortiz, Manuel Cortiñas-Sáenz
{"title":"[Translated article] Safe administration of noradrenaline by the peripheral route: A systematic review.","authors":"F Dámaso Fernández-Ginés, María T Gómez Sánchez, Marina Sánchez Valera, Beatriz Tauste Hernández, Marta Garrido Ortiz, Manuel Cortiñas-Sáenz","doi":"10.1016/j.farma.2024.07.004","DOIUrl":"https://doi.org/10.1016/j.farma.2024.07.004","url":null,"abstract":"<p><strong>Purpose: </strong>To review and analyse the available literature on peripheral administration of noradrenaline (NA) with the aim of providing recommendations to ensure correct use and patient safety.</p><p><strong>Methods: </strong>Systematic review on the databases PubMed, ISI Web of Science, SCOPUS, and Science Direct, using the following search terms: (\"Noradrenaline\" [Mesh]) AND (\"Norepinephrine\" [Mesh]) AND (\"Vasopressors\" [Mesh]) AND (\"Peripheral infusions\" [Mesh]) OR (\"Extravasations\" [Mesh]). A total of 1040 articles were identified. Animal studies and studies written in languages other than English were excluded. Finally, 83 articles were included.</p><p><strong>Results: </strong>NA can be administered peripherally. The risk of extravasation should be taken into account, with phentolamine being the first pharmacological line of treatment. It has also been related to the appearance of thrombophlebitis, cellulitis, tissue necrosis, limb ischaemia, and gangrene, although its incidence seems to be low. The use of peripheral NA in children seems to be carried out without obvious complications. The use of standard concentrations is suggested to reduce the risk of errors. It is recommended to use 0.9% saline as the default diluent for peripheral NA.</p><p><strong>Conclusions: </strong>Peripheral infusions of NA could be a safe and beneficial option in early resuscitation provided that a number of guidelines are followed that reduce the likelihood of complications associated with this route.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141856785","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Patient preference after switching guselkumab from prefilled syringe to an autoinjection pen in psoriasis and psoriatic arthritis patients.","authors":"Joaquin Borrás-Blasco, Rebeca Alcalá García, Silvia Cornejo-Uixeda, Maria Matellanes-Palacios, Elvira Casterá-Melchor","doi":"10.1016/j.farma.2024.07.002","DOIUrl":"https://doi.org/10.1016/j.farma.2024.07.002","url":null,"abstract":"<p><strong>Background: </strong>We assessed pain, acceptability, patient preference, and tolerability of patients with psoriasis and psoriatic arthritis after switching guselkumab from a prefilled syringe to One-Press autoinjector pen.</p><p><strong>Methods: </strong>Patients with psoriasis and psoriatic arthritis treated for at least 6 months with guselkumab syringe were recruited from Jan 2019 to Dec 2022. Gender, age, diagnosis, self-administration, and pain perception of guselkumab prefilled syringe were recorded. At the first visit, patients completed a post-auto-injection syringe questionnaire before starting auto-injection pen administration. After 2 and 6 months of guselkumab self-injection using the One-Press autoinjector pen, patient experience, adherence, preference, pain, and safety of each administration were assessed using post-guselkumab by One-Press autoinjector pen questionnaire.</p><p><strong>Results: </strong>40 patients [psoriasis n=34, psoriatic arthritis n=6] were included. All patients self-administered guselkumab by One-Press autoinjector pen. Pain at the injection site was significantly reduced with the use of the One-Press autoinjector pen. All patients considered that using One-Press autoinjector pen was easier than the syringe, 98% chose the pen as their preferred delivery system.</p><p><strong>Conclusion: </strong>The One-Press autoinjector pen for guselkumab administration is presented as a preferred option, with a high satisfaction and less painful compared to the administration of guselkumab in a prefilled syringe.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789437","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hilario Martínez-Barros, Álvaro Pousada-Fonseca, Jorge Pedreira-Bouzas, Ana Clopés-Estela
{"title":"[Translated article] Characteristics, clinical benefit, and reimbursement of new authorisations for oncohaematology drugs in Spain between 2017 and 2020.","authors":"Hilario Martínez-Barros, Álvaro Pousada-Fonseca, Jorge Pedreira-Bouzas, Ana Clopés-Estela","doi":"10.1016/j.farma.2024.07.006","DOIUrl":"https://doi.org/10.1016/j.farma.2024.07.006","url":null,"abstract":"<p><strong>Objective: </strong>To describe the authorisations and funding resolutions for new onco-haematological drugs in Spain between 2017 and 2020, as well as the results of their main trials.</p><p><strong>Methods: </strong>Observational, cross-sectional, descriptive study conducted between October and December 2022. Onco-haematology drugs approved by the European Medicines Agency between 2017 and 2020 were included, according to EFPIA patients W.A.I.T Indicator 2021 Survey. Authorisation information was obtained from the main study of the European Public Assessment Report. Data were collected on medicines, their authorisation and main study, benefit shown, cost, and status and time to reimbursement.</p><p><strong>Results: </strong>Forty-one new drugs authorised for 49 indications were identified. More than half (58.5%) were targeted therapies, and 61.2% were for the treatment of solid tumours (61.2%). Most had palliative intent (71.4%) and were indicated in relapsed or refractory disease (55.1%). Of the clinical trials, 57.1% were phase III and 63.3% were randomised. The primary endpoint was overall survival in 16.3%, increasing to 25.8% among randomised clinical trials. Regarding licensed drugs based on response rate, the median response rate was 56.4% [IQI 40-66.3]. In those authorised on the basis of surrogate time-to-event endpoints, the median hazard ratio was 0.54 [IQI 0.38-0.57], and among those using overall survival was 0.71 [IQI 0.59-0.77]. Globally, 22.4% had shown benefit in overall survival, with a median gain of 4 months [IQI 3.6-16.7]. One-third (33.3%) of the indications evaluable according to the European Society for Medical Oncology Magnitude of Clinical Benefit Scale showed substantial clinical benefit. Of the indications, 75.5% were funded, half (48.6%; 36.7% of the total) with restrictions. The median time to funding was 19.5 months [IQI 11.4-29.3].</p><p><strong>Conclusions: </strong>Most main clinical trials of new onco-haematology drugs approved in Spain used surrogate primary endpoint and, at the time of authorisation, few had shown to prolong overall survival. More than a third were uncontrolled clinical trials.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141789436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fabiana Angelo Marques Carizio, Isabella do Vale de Souza, Alan Maicon de Oliveira, Maria Madalena Corrêa Melo, Maria Olívia Barbosa Zanetti, Fabiana Rossi Varallo, Leonardo Régis Leira-Pereira
{"title":"Pharmacotherapy assessment and adverse drug reactions in older patients admitted to intensive care.","authors":"Fabiana Angelo Marques Carizio, Isabella do Vale de Souza, Alan Maicon de Oliveira, Maria Madalena Corrêa Melo, Maria Olívia Barbosa Zanetti, Fabiana Rossi Varallo, Leonardo Régis Leira-Pereira","doi":"10.1016/j.farma.2024.06.003","DOIUrl":"https://doi.org/10.1016/j.farma.2024.06.003","url":null,"abstract":"<p><strong>Introduction: </strong>Older patients are more susceptible to medication use, and physiological changes resulting from aging and organic dysfunctions presented by critically ill patients may alter the pharmacokinetic or pharmacodynamic behavior. Thus, critically ill older people present greater vulnerability to the occurrence of pharmacotherapeutic problems.</p><p><strong>Objective: </strong>To evaluate pharmacotherapy and the development of potential adverse drug reactions (ADRs) in older patients admitted to an intensive care unit (ICU).</p><p><strong>Method: </strong>A cohort study was conducted in an ICU for adults of a Brazilian University Hospital during a 12-month period. The patients' pharmacotherapy was evaluated daily, considering the occurrence of ADRs and drug-drug interactions (DDIs), the use of potentially inappropriate medications (PIMs) for older people, and the pharmacotherapy anticholinergic burden (ACB). A trigger tool was used for active search of ADRs, with subsequent causality evaluation. PIM use was evaluated by means of the Beers criteria and the STOPP/START criteria. The ABC scale was employed to estimate ACB. The Micromedex® and Drugs.com® medication databases were employed to evaluate the DDIs.</p><p><strong>Results: </strong>The sample of this study consisted of 41 patients, with a mean age of 66.8 years old (±5.2). The 22 triggers used assisted in identifying 15 potential ADRs, and 26.8% of the patients developed them. The mean estimated ACB score was 3.0 (±1.8), and the patients used 3.1 (±1.4) and 3.3 (±1.6) PIMs according to the Beers and the STOPP criteria, respectively. A total of 672 DDIs were identified, with a mean of 16.8 (±9.5) DDIs/patient during ICU hospitalization. Our findings show an association between occurrence of ADRs in the ICU and polypharmacy (p=.03) and DDIs (p=.007), corroborating efforts for rational medication use as a preventive strategy.</p><p><strong>Conclusions: </strong>Using tools to evaluate the pharmacotherapy for older people in intensive care can assist in the recognition and prevention of pharmacotherapeutic problems, with emphasis on the identification of ADRs through the observation of triggers and subsequent causality analysis.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141753087","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Emilio Jesús Alegre-Del Rey, Silvia Fénix-Caballero, María Dolores Fraga Fuentes, Manuel Jesús Cárdenas Aranzana, Eduardo Lopez-Briz, Francesc Puigventós Latorre, Carmen María Domínguez-Santana
{"title":"The relevance of therapeutic positioning in the post-approval evaluation of new medicines.","authors":"Emilio Jesús Alegre-Del Rey, Silvia Fénix-Caballero, María Dolores Fraga Fuentes, Manuel Jesús Cárdenas Aranzana, Eduardo Lopez-Briz, Francesc Puigventós Latorre, Carmen María Domínguez-Santana","doi":"10.1016/j.farma.2024.06.001","DOIUrl":"https://doi.org/10.1016/j.farma.2024.06.001","url":null,"abstract":"<p><p>The objective of regulatory authorities is to ensure a favorable risk-benefit balance for medicines in their licensed indication, without seeking to establish their place in the therapeutic armamentarium beyond that. The licensed indication covers heterogeneous subpopulations and often does not sufficiently specify the characteristics of the patients who may benefit. The regulatory information does not always show the benefit over the standard treatments; moreover, it only reacts to the conditions specified in the developer's application, and lacks an assessment of the clinical relevance of the benefit and its uncertainties. Many cases highlight the need to establish a more specific therapeutic benefit scenario than the licensed indication. For example, abemaciclib was approved in the adjuvant setting for high-risk patients with early breast cancer, but the appropriate level of risk and how to assess it needs to be specified. Also, pembrolizumab is approved for neoadjuvant plus adjuvant treatment in lung cancer; but it remains to be analyzed whether it is superior to nivolumab in neoadjuvant treatment alone, which involves less treatment and economic burden. As therapeutic positioning is always a necessary decision, whether made at a national, regional, local or individual level, it must be made in the most appropriate way. The absence of a multidisciplinary discussion and consensus, relying only on individual decisions to determine positioning from the outset, underestimates information gaps, inter-individual variability and the influence of drug promotion. It can be harmful and costly. To properly manage the introduction of new medicines, it is essential to establish their benefit scenario in a multidisciplinary way. This, together with consideration of the clinical benefit provided versus the appropriate alternatives and the uncertainties of the benefit, constitutes the objective of the clinical assessment and the basis for designing a well-focused economic analysis. This allows policy makers to make the most appropriate decisions on pricing and funding new treatments. In an ideal situation, the benefit scenario considered for the new medicine would coincide with the one established for funding, but costs that are difficult to bear may lead to restrictions and affect the final positioning after the economic and budgetary impact assessment.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141735267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Fabiana Angelo Marques Carizio, Isabella do Vale de Souza, Thalita Zago Oliveira, Luana Sueli Silva, Natalia Chaguri Alves Rodrigues, Maria Olívia Barbosa Zanetti, Fabiana Rossi Varallo, Leonardo Régis Leira-Pereira
{"title":"Prediction of adverse drug reactions in geriatric patients admitted to intensive care units.","authors":"Fabiana Angelo Marques Carizio, Isabella do Vale de Souza, Thalita Zago Oliveira, Luana Sueli Silva, Natalia Chaguri Alves Rodrigues, Maria Olívia Barbosa Zanetti, Fabiana Rossi Varallo, Leonardo Régis Leira-Pereira","doi":"10.1016/j.farma.2024.05.014","DOIUrl":"https://doi.org/10.1016/j.farma.2024.05.014","url":null,"abstract":"<p><strong>Introduction: </strong>Intensive Care Units (ICUs) pose challenges in managing critically-ill patients with polypharmacy, potentially leading to Adverse Drug Reactions (ADRs), particularly in the elderly.</p><p><strong>Objective: </strong>To evaluate whether the severity and clinical prognosis scores used in ICUs correlate with the prediction of ADRs in aged patients admitted to an ICU.</p><p><strong>Methods: </strong>A cohort study was conducted in a Brazilian University Hospital ICU. APACHE II and SAPS 3 assessed clinical prognosis, while GerontoNet ADR Risk Score and BADRI evaluated ADR risk at ICU admission. Severity of the patients' clinical conditions was evaluated daily based on the SOFA score. Adverse Drug Reaction (ADR) screening was performed daily through the identification of ADR triggers.</p><p><strong>Results: </strong>1295 triggers were identified (median 30 per patient, IQR = 28), with 15 suspected ADRs. No correlation was observed between patient severity and ADRs at admission (p=0.26), during hospitalization (p=0.91), or at follow-up (p=0.77). There was also no association between death and ADRs (p=0.28) or worse prognosis and ADRs (p>0.05). Higher BADRI scores correlated with more ADRs (p=0.001).</p><p><strong>Conclusions: </strong>The data suggest that employing the severity and clinical prognosis scores used in Intensive Care Units is not sufficient to direct active pharmacovigilance efforts, which are therefore indicated for critically ill patients.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141724685","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Cristina Galindo García, Rocío Díaz Acedo, Silvia Artacho Criado, María Rodríguez de la Borbolla Artacho
{"title":"Effectiveness and safety of neoadjuvant therapy in triple-negative breast cancer in a real-world population.","authors":"Cristina Galindo García, Rocío Díaz Acedo, Silvia Artacho Criado, María Rodríguez de la Borbolla Artacho","doi":"10.1016/j.farma.2024.06.007","DOIUrl":"https://doi.org/10.1016/j.farma.2024.06.007","url":null,"abstract":"<p><strong>Objective: </strong>Triple-negative breast cancer is a subtype of aggressive breast cancer. Our aim is to evaluate the effectiveness and safety of neoadjuvant treatment in early-stage triple-negative breast cancer and to identify predictors of pathological complete response.</p><p><strong>Methods: </strong>This is a single-center, retrospective study involving 79 patients with triple-negative breast cancer who initiated neoadjuvant treatment between January 2017 and October 2022. Descriptive analyses were performed as appropriate. Statistical analysis utilized bivariate logistic regression to explore the presence of factors related to pathological complete response, and the Kaplan-Meier method was employed for survival analysis.</p><p><strong>Results: </strong>In the overall population, 27 patients (n = 78; 34.6%) achieved pathological complete response in the breast and axillary lymph nodes, and 31 (n = 73; 42.5%) achieved a grade 5 pathological complete response in the breast, according to the Miller and Payne classification. The addition of platinum to standard therapy improved both breast and axillary lymph node pathological complete response rates. Age less than 40 years was identified as a predictor of pathological complete response in our study population through bivariate analysis, while Ki67 levels lower than 70% were associated with a lower pathological complete response rate. Adverse events were reported in 72 patients (91.1%), with grade 3-5 adverse events observed in 33 (41.8%). There was a particularly notable increase in gastrointestinal and hematological adverse events when platinum was added.</p><p><strong>Conclusions: </strong>In this population, we observed moderate rates of pathological complete response with acceptable chemotherapy tolerance. Platinum-based chemotherapy appears to enhance the likelihood of achieving pathological complete response, albeit with a less favorable safety profile. Therefore, evaluating the benefit-risk balance is crucial when selecting the optimal chemotherapy regimen for individual patients.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141617383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Irene Mangues-Bafalluy, Beatriz Bernárdez, José Manuel Martínez-Sesmero, Andres Navarro-Ruiz, Ana Rosa Rubio-Salvador, Maria Teresa Martín-Conde
{"title":"Treatment adherence to oral chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer: Protocol for a hospital pharmacy-based real-world study.","authors":"Irene Mangues-Bafalluy, Beatriz Bernárdez, José Manuel Martínez-Sesmero, Andres Navarro-Ruiz, Ana Rosa Rubio-Salvador, Maria Teresa Martín-Conde","doi":"10.1016/j.farma.2024.05.016","DOIUrl":"https://doi.org/10.1016/j.farma.2024.05.016","url":null,"abstract":"<p><strong>Objective: </strong>This article describes a study protocol for evaluating adherence to oral chemotherapy (OCT) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in Spain.</p><p><strong>Methods: </strong>This multicenter, observational, prospective study will be conducted by 6 hospital pharmacists from 6 Spanish hospitals. The study will include men and women aged 18 years or older with a diagnosis of locally advanced or metastatic NSCLC who are being treated or have been prescribed OCT. Once included, the patient will be active and prospectively followed up for 3 months, including 4 study visits to record information on sociodemographic variables, antineoplastic treatment and adherence, pharmaceutical care, clinical variables, and patient-reported outcomes (PRO) (the 3-level version of EQ-5D, the EORTC Core Quality of Life Questionnaire, the Brief Illness Perception Questionnaire, the Treatment Satisfaction with Medicines Questionnaire, and the PRO version of Common Terminology Criteria for Adverse Events). Twelve months after patient inclusion, we will record information on the disease progression status and dispensed prescriptions. The primary outcome is the percentage of treatment adherence that will be calculated based on the pill count as follows: the difference between the number of pills dispensed minus the number of unused pills will be divided by the number of days of treatment multiplied by the number of pills/day prescribed by the oncologist; this quotient will be multiplied by 100 to obtain the percentage of adherence. Based on the that pill count reconciliation, those with a percentage adherence >80% will be primarily categorized as adherent. Secondarily, treatment adherence will be also calculated based on the proportion of days covered and the 4-items Morisky Green Levine Medication Adherence Scale. To analyze the impact of patients' and treatment characteristics on adherence, bivariate analyses will be performed using different adherence cut-off points. To evaluate the impact of adherence on treatment efficacy as evaluated by progression-free survival, we will be using the Kaplan-Meier method and compare it with the log-rank test and univariate Cox regression analysis.</p><p><strong>Conclusions: </strong>We expect that our study will provide initial information on key aspects of adherence to OCT (i.e., measurement, facilitators, and barriers) and its relationship with patients' and clinically relevant outcomes in the setting of NSCLC, and that this information will help in designing pharmaceutical interventions to improve adherence.</p>","PeriodicalId":45860,"journal":{"name":"FARMACIA HOSPITALARIA","volume":null,"pages":null},"PeriodicalIF":1.0,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141604341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}