Pharmaceutical Care by Clinical Pharmacists can Effectively Improve the Use of Antibacterials and Hepatoprotective Drugs during Perioperative Period in Urology Department: A Retrospective Study.

BACKGROUND: The management of medication for patients undergoing urological surgery is a subject of ongoing controversy, especially in elucidating the effect of clinical pharmacists on medication rationality. This study aims to assess the influence of clinical pharmacist service on the utilization of antibacterial and hepatoprotective drugs in urological surgery patients during the perioperative period. METHODS: Patients undergoing urological surgery in our hospital from January 2020, to January 2023, were consecutively selected. The patients were divided into control group (routine procedure) and observation group (routine procedure + clinical pharmacist service). The baseline data were balanced by 1:1 propensity score matching (PSM). The t test and chi-square test were used to compare the drug use, adverse reactions, and hospitalization-related indicators between the two groups. RESULTS: A total of 292 patients were included, with 100 patients in each group after PSM. No significant difference was found in the baseline data between the two groups (p > 0.05). The rationality of drug use (drug type, administration time, course of treatment, and combination) in the observation group was significantly better than that in the control group (χ2 = 8.489, 10.607, 10.895, 10.666; p = 0.004, 0.001, 0.001, 0.001). The incidence of adverse reactions (6.00%) and postoperative complications (7.00%) was significantly lower (χ2 = 4.903, 5.531; p = 0.027, 0.019). The length of hospital stay and total cost were similar (p > 0.05). The use time and cost of antibacterial and hepatoprotective drugs in the observation group were lower than those in the control group (t = 2.935, 3.450, 3.243, 3.532; p = 0.004, 0.001, 0.001, 0.001). The types and rates of antibacterial and hepatoprotective drugs in the observation group were significantly lower than those in the control group (p < 0.05). CONCLUSIONS: Clinical pharmacist service can effectively improve the rationality of drug use in urological surgery patients and reduce adverse reactions and postoperative complications, hence its clinical promotion value.

Dispensation of outpatient hospital medicines by hospital only versus hospital-community pharmacies collaboration: a cross-sectional study and survey of patient's satisfaction.

Goal: To describe the experience of a dispensing model of outpatient hospital medicines (OHM) via collaboration of hospital and community pharmacies, and to explore patient satisfaction with the strategy as compared with the hospital pharmacy only service. Background: Patient satisfaction is an important component of the quality of health care. Study: A new model of dispensing OHM was conducted in the Outpatients Unit of the Service of Hospital Pharmacy of Hospital del Mar, in Barcelona, Spain. Participants were patients on stable chronic treatment with clinical or social fragility, immunocompromised patients, and those whose residence was located at a distance from the hospital that justified drug delivery through the community pharmacy. A cross sectional study was done using an ad hoc 14-item questionnaire collecting demographic data, duration of treatment, usual mode of collecting medication, and the degree of satisfaction regarding waiting time for the collection of medication, attention received by professionals, information received on treatment, and confidentiality. Results: The study population included a total of 4,057 patients (66.8% men) with a mean age of 53 (15.5) years, of whom 1,286 responded, with a response rate of 31.7%. Variables significantly associated with response to the survey were age over 44 years, particularly the age segment of 55-64 years (odds ratio [OR] 2.51) and receiving OHM via the community pharmacy (OR 12.76). Patients in the community pharmacy group (n = 927) as compared with those in the hospital pharmacy group (n = 359) showed significantly higher percentages of 'satisfied' and 'very satisfied' (p < 0.001) in the waiting time for the collection of OHM (88.1% vs. 66%), attention received by professionals (92.5% vs. 86.1%), and information received on treatment (79.4% vs. 77.4%). In relation to confidentiality, results obtained were similar in both pharmacy settings. Conclusion: Dispensing OHM through the community pharmacy was a strategy associated with greater patient satisfaction as compared with OHM collection at the hospital pharmacy service, with greater accessibility, mainly due to close distance to the patient's home. The participation of community pharmacists could further optimize the care received by patients undergoing OHM treatment.

Evaluation of medication use and polypharmacy in postoperative cardiac patients: The clinical pharmacist's imperative in a public institute of Pakistan.

As a major concern in the healthcare sector, polypharmacy is correlated with an increased risk of potential drug-drug interactions (pDDIs), treatment costs and adverse drug reactions (ADR). To assess the prevalence of polypharmacy and its associated factors among postoperative cardiac patients admitted to the National Institute of Cardiovascular Diseases (NICVD), a hospital-based cross-sectional study was conducted between November 2021 and April 2022. Medication charts of postoperative patients were reviewed for medication utilization and polypharmacy. Data was collected using a form approved by the Ethical Review Committee (ERC) regarding patient's clinical and demographic characteristics and medications administered. Statistical analysis was performed using the SPSS software version 25.0. Patients were taking an average of 10.3±1.7 medications. The minimum number of drugs taken per patient was 5, while the maximum was 15 drugs. Only 114 (29.7%) received polypharmacy (5-9 drugs) and hyper-polypharmacy (≥10 drugs) was 270 (70.3%). The mean±SD cardiovascular drugs used were 5.45±1.18 and the mean±SD non-cardiovascular drugs were 4.83±1.18. The prevalence of hyper-polypharmacy suggests a critical need for optimized medication management strategies in this population. Incorporating clinical pharmacists within public healthcare institutions can address polypharmacy-related challenges and enhance medication safety, adherence and patient outcomes.

Cost-benefit analysis with return on investment of clinical pharmacists in the Military Health System.

BACKGROUND: The Defense Health Agency comprises more than 700 military medical, dental, and veterinary facilities and provides care to more than 9.6 million beneficiaries. As medication experts, pharmacists identify opportunities to optimize medication therapy, reduce cost, and increase readiness to support the Defense Health Agency's mission. The Tripler Pilot Project and the Army Polypharmacy Program were used to establish a staffing model of 1 clinical pharmacist for every 6,500 enrolled beneficiaries. No large-scale cost-benefit study within the military health care system has been done, which documents the number of clinical interventions and uses established cost-avoidance (CA) data, to determine the cost-benefit and return on investment (ROI) for clinical pharmacists working in the medical treatment facilities. OBJECTIVE: To validate the patient-centered medical home staffing model across the military health care system using the Tripler Pilot Project results to provide a cost-benefit analysis with an ROI. The secondary goal is to describe the interventions, staffing levels, and US Department of Defense-specific requirements impacting the provision of clinical pharmacy. METHODS: A retrospective analysis of 3 years of encounters by clinical pharmacists in which an intervention was documented in the Tri-Service Workflow (TSWF) form as part of the electronic health record was completed. The analysis used 6 steps to assign CA intervention types and to prevent duplication and overestimation of the ROI. The absolute number of clinical pharmacists was determined using workload criteria defined as at least 20 encounters per month for at least 3 months of each calendar year. The number of clinical pharmacist full-time employees (FTEs) was determined by dividing the number of total active months by 12 months. Attrition was calculated comparing the presence of a unique provider identification between calendar years. The ROI range was calculated by dividing the CA by the total cost of clinical pharmacists using the variables' raw and extrapolated CA based on percentage of documentation template usage and the active clinical pharmacist calculation (absolute and FTE-based). RESULTS: Between January 1, 2017, and December 31, 2019, a total of 1,069,846 encounters by clinical pharmacists were documented in the electronic health record. The TSWF Alternative Input Method form was used by pharmacists to document 616,942 encounters. Forty-three percent of TSWF documented encounters had at least 1 CA intervention. The absolute number of clinical pharmacists associated with a documented encounter in any medical treatment facility ranged from 404 in 2017 to 374 in 2018 and the clinical pharmacist FTEs ranged from 324 in 2017 to 314 in 2019. Annual attrition rates for clinical pharmacists ranged from 15% to 20% (58 to 81 clinical pharmacists) annually. The total CA range was $329,166,543-$534,014,494. The ROI range was between $2 and $4 per dollar spent. CONCLUSIONS: This analysis demonstrated that ambulatory care clinical pharmacists in the Military Health System bring value through a positive ROI. Our study also identified a potential shortage of clinical pharmacists within the Air Force and Navy branches impacting medication management. This can have a negative impact on the readiness of service members, one of the leading priorities of the US Department of Defense.

Development of the entrustable professional activity 'medication reconciliation' for clinical pharmacy.

BACKGROUND: Entrustable professional activities (EPAs) are observable process descriptions of clinical work units. EPAs support learners and tutors in assessment within healthcare settings. For use amongst our pharmacy students as well as pre-registration pharmacists we wanted to develop and validate an EPA for use in a clinical pharmacy setting at LMU University Hospital. METHODS: The development of the clinical pharmacy EPA followed a set pathway. A rapid literature review informed the first draft, an interprofessional consensus group consisting of pharmacists, nurses, and medical doctors refined this draft. The refined version was then validated via online survey utilising clinical pharmacists from Germany. RESULTS: We designed, refined and validated an EPA regarding medication reconciliation for assessment of pharmacy students and trainees within the pharmacy department at LMU University Hospital in Munich. Along with the EPA description an associated checklist to support the entrustment decision was created. For validation an online survey with 27 clinical pharmacists from all over Germany was conducted. Quality testing with the EQual rubric showed a good EPA quality. CONCLUSIONS: We developed the first clinical pharmacy EPA for use in a German context. Medication reconciliation is a suitable EPA candidate as it describes a clinical activity performed by pharmacists in many clinical settings. The newly developed and validated EPA 'Medication Reconciliation' will be used to assess pharmacy students and trainees.

[A Questionnaire Survey of Nurses on Pharmacist Services in the Emergency Rooms at Tokushukai Medical Group].

We conducted a multicenter survey of emergency room nurses to obtain information that would be useful for the establishment of pharmacist services in emergency rooms. Notably, 199 valid responses were obtained from 12 hospitals. The most common expectation from pharmacists in the emergency room was "drug management" (70.9%), followed by "providing information to physicians regarding the patient's medication history" (59.3%), and "auditing of dosage and interaction" (57.3%). The working arrangements that the survey respondents wanted regarding pharmacists in emergency rooms were: 24 h pharmacist (41.7% wanted this arrangement), day-shift pharmacist (24.6% wanted this arrangement), 24 h on-call (17.1% wanted this arrangement), day-shift on-call (5.0% wanted this arrangement), telephone support (11.1% wanted this arrangement), and 0.5% said that there was no need for pharmacists. In the analysis of factors affecting nurse satisfaction, day-shift pharmacist was a significant factor. We hope that the results of this survey will be used as a guide for the development of emergency room pharmacist services tailored to the unique characteristics and actual working conditions of each hospital.

The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT).

BACKGROUND: Allergic rhinitis is a chronic respiratory disorder that significantly impacts patients' quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient education and pharmaceutical care for managing allergic rhinitis patients. However, local clinical practice guidelines, particularly regarding pharmaceutical care in public healthcare institutions, are lacking. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm. METHOD: This is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value < 0.05 is considered statistically significant. DISCUSSION: This study protocol will provide a framework for conducting a randomized controlled trial (RCT) to evaluate the effectiveness of pharmacist-led education intervention in managing allergic rhinitis within public healthcare settings. The parameters measured in this trial will quantify outcomes associated with improvements in symptoms and QoL. By systematically assessing these outcomes, we aim to contribute valuable insights into the role of pharmacist-led interventions in enhancing the management of allergic rhinitis in public healthcare settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT06027736 . Registered on 9 July 2023-retrospectively registered.

Pharmacist intervention to improve adherence to medication among heart failure patients at North East Ethiopia hospital.

Heart failure (HF) is a major and growing medical problem and its management is still challenging due to the coexistence of complications, co-morbidity, and medication non-adherence. HF patients who are adherent to their medication have fewer HF exacerbations, improved survival, and lower healthcare expenditure. Adherence to HF medication plays a pivotal role in attaining maximal therapeutic outcomes. The aim was to assess the medication adherence of heart failure patients at Debre Berhan Comprehensive Specialized Hospital (DBCSH). A pre-post interventional study was undertaken from July 1, 2022, to December 31, 2022, at the medical referral clinic of DBCSH. The educational interventions were provided for 6 months. Medication adherence was determined using the Morisky Green Levin Medication Adherence Scale (MGLS). The data was entered into Epidata version 4.2.0 and analyzed using SPSS version 25.0 statistical software. Descriptive statistics and binary logistic regression analysis were performed. The strength of the association between predictor variables and outcome variables was determined using a 95% confidence interval and adjusted odd ratio. In the pre-intervention phase, 54.6% of patients had medium medication adherence, while in the post-intervention phase, 36.4% of patients had high medication adherence and 61.9% of patients had medium medication adherence. Following the intervention, medication cost (120, 50%), inadequate availability of drugs (75, 31%), and forgetfulness (30, 13%) were the main reasons for medication non-adherence. The presence of co-morbidity and the number of co-morbidity (p < .05) were significantly associated with the occurrence of decreased medication adherence in the pre-intervention phase. Interventions by pharmacists to educate HF patients about the nature of their disease and providing brochures to increase awareness of their medications have been shown to improve medication adherence.

[Concordance of medication prescription records in the hospitalised surgical patient]. / Concordancia de los registros de prescripción de medicamentos en el paciente quirúrgico hospitalizado.

INTRODUCTION: Electronic prescription is the prescription system that allows healthcare professionals to send medication prescriptions directly to community pharmacies and the outpatient unit of Hospital Pharmacy Services for dispensing. However, there is difficulty in obtaining a reliable pharmacotherapeutic history in chronic patients through electronic prescription upon hospital admission as a critical point for adequate treatment adaptation. Therefore, the pharmacist as a member of the multidisciplinary team must ensure, through medication conciliation, an adequate transition of care through the correct management of the treatment that the chronic patient requires during their hospitalization. OBJECTIVES: To evaluate the quality of electronic prescription records for routine chronic treatment by analyzing the concordance of the electronic prescription. MATERIAL AND METHODS: Observational, cross-sectional and retrospective study at the General University Hospital of Elche. Hospitalized patients in charge of the Orthopedic Surgery and Traumatology, Urology and Neurosurgery Services in which the responsible doctor requested medication reconciliation by the Pharmacy Service between January 2022 - December 2022 were included. RESULTS: 378 patients, 209 (55.3%) women and 169 (44.7%) men, with a mean age±standard deviation of 71.0±11.6 years and 69.0±11.8 years, respectively. The total percentage of patients with discrepancies in the electronic prescription with respect to the usual chronic treatment was 60.6%, reflecting that only 39.4% of the patients had non-discordant electronic prescriptions. CONCLUSIONS: More than half of hospitalized surgical patients present discrepancies in the medications prescribed in the home electronic prescription, which justifies the importance of treatment reconciliation upon admission carried out by hospital pharmacists.

Devices for securing and administering pediatric compounded oral liquids: survey results from French university hospitals.

Oral liquid forms, either commercial or compounded, are preferred in pediatrics due to their suitability for weight-based dosing and acceptability for children. The choice of dosing delivery devices associated with oral liquid forms is important to ensure accurate dosing, ease of administration, and patient safety. Given the prevalence of compounding in pediatric settings, this study aimed to investigate the practices among French university hospitals concerning the selection of dosing delivery devices associated with compounding oral liquid forms for children. An online survey was distributed to pharmacists involved in compounding in French university hospitals. The survey covered aspects such as the presence of child-resistant caps, types of dosing devices, the presence of bottle adapters, and the type of bottle adapters used. Among the 36 hospital pharmacies contacted, 24 responded to the survey. One pharmacy employed child-resistant caps for compounded liquid forms. Enteral syringes emerged as the primary dosing device (71%), with a minority using luer/luer-lock syringes (21%). Spoon and measuring cup usage was reported by none. Approximately two-thirds of the pharmacies (67%) used a bottle adapter in conjunction with the sampling device.   Conclusion: The study highlighted diversity in the practices of French university hospitals regarding dosing delivery devices associated with compounding oral liquid forms for pediatric patients. The findings underscored the need for standardized guidelines to streamline practices and enhance safety and precision in compounded medication administration for children. What is Known: • Administration devices are important to ensure the correct administration of the required dose of oral liquids in pediatrics. • For compounded oral liquid forms, the selection and supply of administration devices are managed by compounding pharmacies from those available on the market. What is New: • The study highlighted the variability of administration devices associated with compounded liquids for oral use in French hospital pharmacies.

Clinical pharmacy key performance indicators for hospital inpatient setting: a systematic review.

BACKGROUND: Key performance indicators (KPIs) are quantifiable measures used to monitor the quality of health services. Implementation guidelines for clinical pharmacy services (CPS) do not specify KPIs. AIM: To assess the quality of the studies that have developed KPIs for CPS in inpatient hospital settings. METHOD: A systematic review was conducted by searching in Web of Science, Scopus, and PubMed, supplemented with citation analyses and grey literature searches, to retrieve studies addressing the development of KPIs in CPS for hospital inpatients. Exclusions comprised drug- or disease-specific studies and those not written in English, French, Portuguese, or Spanish. The Appraisal of Indicators through Research and Evaluation (AIRE) instrument assessed methodological quality. Domain scores and an overall score were calculated using an equal-weight principle. KPIs were classified into structure, process, and outcome categories. The protocol is available at https://doi.org/10.17605/OSF.IO/KS2G3 . RESULTS: We included thirteen studies that collectively developed 225 KPIs. Merely five studies scored over 50% on the AIRE instrument, with domains #3 (scientific evidence) and #4 (formulation and usage) displaying low scores. Among the KPIs, 8.4% were classified as structure, 85.8% as process, and 5.8% as outcome indicators. The overall methodological quality did not exhibit a clear association with a major focus on outcomes. None of the studies provided benchmarking reference values. CONCLUSION: The KPIs formulated for evaluating CPS in hospital settings primarily comprised process measures, predominantly suggested by pharmacists, with inadequate evidence support, lacked piloting or validation, and consequently, were devoid of benchmarking reference values.

Association of the barriers of pharmaceutical care perceived by clinical pharmacists and occupational stress in tertiary hospitals of China.

Objective: As an important member of the healthcare team, clinical pharmacists' occupational stress will lead to a decline in the quality of pharmaceutical care. According to person-environment fit theory, barriers of pharmaceutical care perceived by clinical pharmacists may be a potential factor influencing occupational stress. This study aimed to assess the association between the specific barriers of pharmaceutical care perceived by clinical pharmacists and their occupational stress in China. Method: A field-based questionnaire survey of tertiary hospitals was conducted in 31 provincial administrative regions in mainland China using a multi-stage stratified sampling method. Data on occupational stress, barriers of pharmaceutical care perceived by clinical pharmacists and other factors of job stress were collected using the Brief Job Stress Questionnaire and a self-administered instrument. The instruments have undergone multiple rounds of pilot investigations, and their reliability is acceptable. Ordinary least squares regression was used to evaluate the association of the perceived barriers and other factors with their occupational stress. Result: A total of 625 clinical pharmacists from 311 tertiary hospitals in China (response rate = 84%) participated. Perceived resource dimension barriers (p = 0.00) and self-improvement dimension barriers (p = 0.01) were associated with increased occupational stress of the participants. In addition, clinical pharmacists with senior professional titles and engaged in neurology and ICU have higher occupational stress. Conclusion: By removing barriers to pharmacists' resources and self-improvement, it is possible to better meet the work needs of clinical pharmacists and may effectively reduce occupational stress, thereby improving the quality of pharmaceutical services.

Multifaceted pharmacist-led interventions in secondary care settings between countries of various income levels: a scoping review protocol.

INTRODUCTION: Clinical pharmacy services often involve multifaceted pharmacist-led interventions. However, current pharmacy practice models vary across different countries. Despite the documented benefits of clinical pharmacy services, the characteristics of pharmacist-led interventions in different countries have not yet been adequately explored and described. Therefore, this protocol outlines the methodology for a proposed scoping review aiming to investigate various types of multifaceted pharmacist-led interventions and the outcomes used to evaluate their effectiveness within secondary care settings. Additionally, the scoping review will map the current evidence surrounding the characteristics of interventions and outcomes reported across various countries of socioeconomic status. METHODS AND ANALYSIS: The scoping review will be conducted according to the JBI Methodology for Scoping Reviews and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) Extension for Scoping Reviews. We will systematically search the following electronic databases: MEDLINE (Ovid), CINAHL (EbscoHost), Embase (embase.com), Scopus (scopus.com), Cochrane Library (cochranelibrary.com) and APA PsycInfo (Ovid). Additionally, the reference lists of identified reviews and included full texts will be searched for relevant papers. Grey literature sources, such as International Pharmaceutical Abstracts and the International Pharmaceutical Federation (FIP) website, will be searched. We will include primary studies published in the English language from January 2013 to December 2023, involving secondary care multifaceted pharmacist-led interventions. Two independent reviewers will screen studies against eligibility criteria and use a piloted data extraction form to extract relevant information. We will extract relevant data, complete a tabular summary from each included publication and analyse it. ETHICS AND DISSEMINATION: Ethical approval is not required as we will be using data from publicly available literature sources. Findings will be disseminated in publications and presentations with relevant stakeholders. We aim to map available evidence across the breadth of studies that have reported multifaceted pharmacist-led interventions and their outcomes.

How Should We Draw on Pharmacists' Expertise to Manage Drug Shortages in Hospitals?

This article argues that drug shortages should be addressed as crises that exacerbate already compromised US health care infrastructure. Clinicians, especially pharmacists, can help limit threats that shortages pose to patients. For example, pharmacists can canvass procurement options, consolidate inventory, and prepare medications to prevent need for some clinical interventions. This article describes how pharmacists' preparation and training equip them to help clinical teams navigate shortages by equitably rationing limited medicines, suggesting appropriate therapeutic alternatives, modifying drug administration routes, or delaying interventions. Pharmacists' roles can be key, since good management of supplies during drug shortages can mitigate risk of worse-than-usual clinical outcomes, mitigate risk of medication errors, and reduce some financial burdens on the overall health care system.

Intelligent supervision of PIVAS drug dispensing based on image recognition technology.

Pharmacy Intravenous Admixture Services (PIVAS) are places dedicated to the centralized dispensing of intravenous drugs, usually managed and operated by professional pharmacists and pharmacy technicians, and are an integral part of modern healthcare. However, the workflow of PIVAS has some problems, such as low efficiency and error-prone. This study aims to improve the efficiency of drug dispensing, reduce the rate of manual misjudgment, and minimize drug errors by conducting an in-depth study of the entire workflow of PIVAS and applying image recognition technology to the drug checking and dispensing process. Firstly, through experimental comparison, a target detection model suitable for drug category recognition is selected in the drug-checking process of PIVAS, and it is improved to improve the recognition accuracy and speed of intravenous drug categories. Secondly, a corner detection model for drug dosage recognition was studied in the drug dispensing stage to further increase drug dispensing accuracy. Then the PIVAS drug category recognition system and PIVAS drug dosage recognition system were designed and implemented.

Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol / Risk-sharing agreement based on health outcomes for the treatment of moderate-severe psoriasis with certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)

Risk-sharing agreement based on health outcomes for the treatment of moderate–severe psoriasis with certolizumab pegol / Acuerdo de riesgo compartido basado en resultados de salud para el tratamiento de psoriasis moderada-grave con certolizumab pegol

Objetivo: aportar evidencia de la efectividad de certolizumab pegol (CZP) en la práctica clínica real en pacientes adultos afectados por psoriasis (PsO) en placas moderada-grave, dentro del contexto de un acuerdo de riesgo compartido (ARC). Métodos: estudio observacional retrospectivo a partir de las variables recogidas en un ARC en los pacientes adultos con PsO en placas moderada-grave tratados con CZP. Participaron 10 hospitales españoles donde se estableció el ARC. Se evaluó el porcentaje de pacientes que alcanzaron la respuesta clínica objetivo del ARC en la visita de seguimiento (semana 16): valor de Psoriasis Area and Severity Index (PASI) absoluto ≤3 para la población naive a biológicos, y ≤5 ante el fracaso previo a un único fármaco biológico. Además, se analizó la mejora en la puntuación de otras escalas: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician’s Global Assesment (PGA) y Nail Psoriasis Severity Index (NAPSI). Se realizó un análisis descriptivo del total de la población y por subgrupos de pacientes (naive vs. no naive a biológico, hombre vs. mujer, y con vs. sin interrupción). Resultados: se incluyeron 66 pacientes, 12 hombres y 54 mujeres. El 90,9% alcanzaron la respuesta clínica objetivo, con una reducción media de 8 (−78,4%) puntos de PASI absoluto. Se observó una mejora en BSA, PGA, NAPSI y DLQI, con una reducción de 11,3 (−80,6%), 1,9 (−65,5%), 3,3 (−30,7%) y 9,0 (−66,4%) puntos del valor absoluto, respectivamente. Pese a no alcanzar el objetivo terapéutico establecido en el ARC en 6 pacientes (9%) (el coste del fármaco fue asumido por el laboratorio), solo 2 (3%) interrumpieron el tratamiento. Conclusión: nuestro estudio muestra que CZP resulta efectivo en la práctica clínica real en los pacientes con PsO en placas moderada-grave con una mejora de PASI absoluto y DLQI, así como de otras escalas, tanto para el total de la población como en los subgrupos analizados...(AU)

Objective: To provide evidence of the effectiveness of certolizumab pegol (CZP) in real clinical practice in adult patients with moderate-to-severe plaque psoriasis (PsO) in the context of a risk-sharing agreement (RSA). Methods: Retrospective observational study based on variables collected in the RSA for treatment with CZP of adult patients with moderate-severe plaque PsO. Ten Spanish hospitals where the RSA was implemented participated. The percentage of patients who achieved the target clinical response of the RSA at the follow-up visit (week 16) was evaluated: absolute Psoriasis Area and Severity Index (PASI) value ≤3 for biologic naïve population, and ≤5 in case of previous failure to a single biologic drug. In addition, the improvement in the scores of other scales included in the study was analyzed: Body Surface Area (BSA), Dermatology Life Quality Index (DLQI), Physician's Global Assessment (PGA), and Nail Psoriasis Severity Index (NAPSI). A descriptive analysis was performed for the total population and by patient subgroups (naive vs. non-naive to biologic, male vs. female, and with vs. without discontinuation). Results: Sixty-six patients were included, 12 men and 54 women. 90.9% achieved the target clinical response, with a mean reduction of 8 (−78.4%) absolute PASI points. Improvement was observed in BSA, PGA, NAPSI and DLQI, with a reduction of 11.3 (−80.6%), 1.9 (−65.5%), 3.3 (−30.7%) and 9.0 (−66.4%) absolute value points, respectively. Despite not achieving the therapeutic target set in the RSA in six patients (9%) (the cost of the drug was assumed by the laboratory), only two (3%) discontinued treatment. Conclusion: Our study shows that CZP is effective in real clinical practice in patients with moderate-severe plaque PsO, with an improvement in absolute PASI and DLQI, as well as other scales, both for the total population and in the subgroups analyzed. Nearly 91% of patients reached the therapeutic target fixed in the RSA...(AU)