Drug Utilization Review of Monitored Parenteral Antimicrobials in a Tertiary Care Private Hospital in Cebu City.

Background: Based on the 2017-2020 annual report of the Department of Health-Antimicrobial Resistance Surveillance Program, significant resistance patterns have been observed for common disease-causing pathogens. In the hospital setting, antimicrobial stewardship programs have been implemented to optimize the use of antimicrobials. Drug utilization review studies provide essential feedback to improve prescribing and use of medications. Objectives: This study aimed to review drug utilization of monitored parenteral antimicrobials among patients admitted from January to December 2019. Methods: The study employed a retrospective, cross-sectional, descriptive research design. A retrospective chart review of drugs administered to patients was conducted. Results: A total of 821 patients charts met the inclusion criteria. The patients' ages ranged from 18 to 98 years old and 52% were females. General Internal Medicine practitioners (28%) were the top prescribers of monitored parenteral antimicrobials primarily for the management of moderate-risk community-acquired pneumonia (39%). They were mostly indicated for empirical treatment of infections (94%) and were given for an average of 5.73 days.Only 58% of the total cases had orders for culture and sensitivity testing. Of which, principally 47% had colony cultures. Blood (29%) and sputum (27%) were the most common specimens taken for culture and sensitivity testing. The microorganisms often isolated were Escherichia coli (19%), Klebsiella pneumoniae (18%), and Staphylococcus aureus (9%). In addition, extended-spectrum beta lactamase-producing gram-negative pathogens (4%) and methicillin-resistant S. aureus (1%) were also isolated. All the microorganisms isolated showed most resistance to ampicillin (81%) and most susceptibility to colistin (100%). There were drug therapy-related problems encountered. There was one case of an adverse drug reaction (0.1%) and two cases of contraindications (0.2%). Therapeutic duplication was also observed in 5% of the cases. Moreover, 39% had instances of drug-drug interactions.Piperacillin-tazobactam had the highest consumption (79.50 defined daily doses/1,000-patient days) among the monitored parenteral antimicrobials.Some prescriptions were deemed inappropriate upon evaluation. 12% of cases were inappropriate based on the justification indicator. As for the critical indicators, duration of therapy (78%) was the main reason. Only four components of the DUE criteria indicators have met or exceeded the established threshold level.The cost analysis indicated that the total actual cost of therapy with the monitored parenteral antimicrobials amounted to ₱17,645,601.73. Considering Department of Health National Antibiotic Guidelines recommendations, ideal total cost of treatment was ₱14,917,214.29. Potential cumulative cost savings of ₱2,728,387.44 could have been achieved for patients admitted last 2019. Conclusion: Consumption of piperacillin-tazobactam was relatively high as compared to the other monitored parenteral antimicrobials covered in this study. Physicians at the study site seldom prescribe monitored parenteral antimicrobials as recommended by the National Antibiotic Guidelines. This is evidenced in the incidence of inappropriate therapy regimens, with inapt duration of therapy as the leading explanation.From the patient's perspective, the main economic implication was on the direct medical costs, particularly the increased cost of the actual antimicrobial therapy prescribed to manage various infections. Adherence of physicians to the established guidelines and selection of the most cost-effective therapy could have resulted in considerable cost savings.

Medication Review: What's in a Name and What Is It about?

BACKGROUND: Medication review is a multifaceted service aimed at optimizing the use of medicines and enhancing the health outcomes of patients. Due to its complexity, it is crucial to clearly describe the service, its variants, and its components to avoid confusion and ensure a better understanding of medication review among healthcare providers. AIM: This study aims to bring clarity to the origins, definitions, abbreviations, and types of medication reviews, together with the primary criteria that delineate key features of this service. METHOD: A narrative review approach was employed to clarify the diverse terminology associated with "medication review" services. Relevant references were initially identified through searches on PubMed and Google Scholar, complementing the existing literature known to the authors. RESULTS: The study uncovers a complicated and sometimes convoluted history of "medication review" in different regions around the world. The initial optimization of medicine use had an economic purpose before evolving subsequently into a more patient-oriented approach. A selection of abbreviations, definitions, and types were outlined to enhance the understanding of the service. CONCLUSIONS: The study underscores the urgent need for comprehensive information and standardization regarding the content and quality of the services, collectively referred to as "medication review".

Adherencia al tratamiento en paciente polimedicado con sistemas personalizados de dosificación (SPD) y su impacto en salud / Adherence to treatment in polymedicated patients using Monitored Dosage Systems (MDS) and their impact on health

Los Sistemas Personalizados de Dosificación (SPD) son una herramienta eficaz, segura y homologada para el reacondicionamiento de fármacos en farmacia comunitaria. Estos implican la revisión del uso del medicamento (RUM) y la colaboración con el médico de atención primaria (MAP). En el presente artículo se describe el caso de una paciente de 57 años intervenida de lumbociatalgia en 2021 y 2022, con dolor crónico mal controlado y aturdimiento derivado del olvido y/o duplicidad de las tomas. Durante la dispensación habitual se detectan estos problemas relacionados con el medicamento (PRM) y se deriva a la paciente al servicio SPD. Tras la implantación del mismo, la paciente mejora a nivel cognitivo, eliminando el aturdimiento y controlando el dolor, lo que supuso un aumento en su calidad de vida. En conclusión, se destaca la importancia de los diferentes servicios disponibles en la farmacia para mejorar la calidad de vida del paciente, la adherencia al tratamiento y la detección de PRM. (AU)

Monitored Dosage Systems (MDS) are an efficient, reliable and approved device for drug reconditioning in pharmacy. These systems imply a review on proper drug use and the collaboration between primary health care and pharmacists. The case study describes a female patient with a surgical intervention due to lumbosciatica in 2021 and 2022. Patient describes uncontrolled chronic pain and confusion related to improper drug use. During regular dispensing of her medication, these medicine-related problems (MRP) were detected and the patient was referred to the MDS service. After its implementation, the patient’s confusion was eliminated and pain management was achieved, increasing her quality of life. As a conclusion, the different health services provided by the pharmacy can improve a patient’s quality of life, treatment adherence and MRP detection. (AU)

Impact of an Educational Intervention on Hospital Pharmacists' Knowledge and Application of Substance Withdrawal Management.

Background: Patients with substance use disorders are often encountered in an acute care setting and withdrawal management is important. Available literature reveals inadequate acute management of substance withdrawal due to lack of experience and knowledge of medications. Methods: A quality improvement project was implemented to improve hospital pharmacists' knowledge, application, and practice of inpatient opioid and alcohol withdrawal management through provision of didactic and case-based education and implementation of practice based prospective drug utilization review (PDUR). Pharmacists' knowledge of the management of alcohol and opioid withdrawal was assessed by a 10-item survey pre-and post-intervention. Results: Twenty-one pharmacists completed the education and pre- and post-surveys. Scores for the 21 pharmacists improved significantly, with pre- and post-intervention scores of 7.33 ± 1.98 and 8.86 ± 0.91, respectively (P = .0035). Most pharmacists completed their required PDUR submission, and several pharmacist interventions were made and accepted post-education. Pharmacists indicated that the education increased their confidence and enabled them to learn new information that could be directly applied to their pharmacy practice. Conclusion: Providing education and requiring a PDUR improved pharmacists' knowledge, application, and practice of inpatient opioid and alcohol withdrawal management. Re-education or expanded education may be warranted to further increase pharmacists' competence.

Clinical decision support systems in community pharmacies: a scoping review.

OBJECTIVE: Clinical decision support systems (CDSS) were implemented in community pharmacies over 40 years ago. However, unlike CDSS studies in other health settings, few studies have been undertaken to evaluate and improve their use in community pharmacies, where billions of prescriptions are filled every year. The aim of this scoping review is to summarize what research has been done surrounding CDSS in community pharmacies and call for rigorous research in this area. MATERIALS AND METHODS: Six databases were searched using a combination of controlled vocabulary and keywords relating to community pharmacy and CDSS. After deduplicating the initial search results, 2 independent reviewers conducted title/abstract screening and full-text review. Then, the selected studies were synthesized in terms of investigational/clinical focuses. RESULTS: The selected 21 studies investigated the perception of and response to CDSS alerts (n = 7), the impact of CDSS alerts (n = 7), and drug-drug interaction (DDI) alerts (n = 8). Three causes of the failures to prevent DDIs of clinical importance have been noted: the perception of and response to a high volume of DDI alerts, a suboptimal performance of CDSS, and a dearth of sociotechnical considerations for managing workload and workflow. Additionally, 7 studies emphasized the importance of utilizing CDSS for a specific clinical focus, ie, antibiotics, diabetes, opioids, and vaccinations. CONCLUSION: Despite the range of topics dealt in the last 30 years, this scoping review confirms that research on CDSS in community pharmacies is limited and disjointed, lacking a comprehensive approach to highlight areas for improvement and ways to optimize CDSS utilization.

Real-world evidence in the use of Bevacizumab in age-related macular degeneration (ArMD): a scoping review.

PURPOSE: Pharmacological treatments for age-related macular degeneration (ArMD) include anti-vascular endothelial growth factor therapies. Bevacizumab is used off-label, as it has no indication for ArMD. This study aims to identify and describe literature on real-world evidence of bevacizumab (originator or biosimilars) use in ArMD. METHODS: A scoping review was conducted in Medline, CINAHL and Embase databases. Studies published in English after September 2017, conducted in USA, including adults (≥ 18 years old) with ArMD who received treatment with bevacizumab for ArMD were included. The review was further limited to peer-reviewed observational studies that quantitatively analyze either clinical or patient-reported outcomes among patients treated with bevacizumab for ArMD. RESULTS: The search strategy retrieved 543 studies. After title and abstract screening, a total of 142 studies were selected for full-text review leading to a total of 12 studies qualifying for data charting. All were retrospective studies. Five (41.6%) of the studies had less than 500 eyes included in the analysis, and the rest had over a thousand eyes. All except one study reported clinical outcomes (visual acuity was the main outcome in 8 (66.6%) studies). There were 3 (25%) studies reporting adverse events of bevacizumab intravitreal injections. None of the studies specified using biosimilars for bevacizumab and none mentioned patient-reported outcomes. CONCLUSION: The lack of studies aiming to study the patient-reported outcomes as well as the use of biosimilars of bevacizumab in ArMD makes this field a potential for future research. The different exposures and times to follow-up make it difficult to compare results among the selected studies.

[Antibiotic stewardship]. / Antibiotic Stewardship.

The spread of antimicrobial resistance (AMR) is one of the greatest threats to global health and causes very many deaths. Also in the context of sepsis-the severest complication of certain infectious diseases-does AMR play a role. Wise use of anti-infectives and application of antibiotic stewardship (AMS) principles can reduce the spread of AMR and improve the quality of management of patients with infectious diseases. Correct use of anti-infective agents includes the correct diagnostic approach and documentation of the (suspected) diagnosis, guideline-conform diagnostic workup and treatment selection, re-evaluation and tailoring during the course of treatment, a focus on treatment de-escalation depending on clinical response and microbiology results, dose optimization, and, if possible, conversion to oral therapy, and early termination of treatment if the suspected diagnosis is not confirmed. Particularly adherence to the guideline-conform treatment duration can reduce unnecessary use of anti-infectives. Prevention of infections via adherence to vaccination recommendations also contributes to a reduction in the use of anti-infectives. Interdisciplinary collaboration with infectious diseases and AMS specialists, as recommended for sepsis, also improves treatment quality and patient outcomes. Particularly for complex infections such as endocarditis cases should be discussed in multidisciplinary teams including specialists in infectious diseases. In this manner, decisive steps against the spread of AMR and towards maintenance of the efficacy of available anti-infective drugs can be taken.

Teaching Independent Decision-Making Through a Computer-Based Drug Utilization Review Simulation.

Background: Drug utilization review (DUR) skills are important for pharmacists across all settings. Computer-based DUR simulations to teach student pharmacists are currently scarce. This article describes a computer-based DUR simulation that required limited faculty and financial resources and was implemented in collaboration among 3 institutions. Objective: To describe the innovation of a computer-based DUR simulation and its impact on pharmacy students' knowledge and confidence of DUR skills. Methods: This pre-post educational study assessed a computer-based DUR simulation that replicated the DUR process in dispensing systems. First- and third-year pharmacy students at 3 institutions were guided through simulated patient cases with various medication-related problems. The self-paced activity provided students with immediate, formative feedback and rationale for each option after an attempt was made in lieu of faculty intervention. Students completed pre-and post-assessments to evaluate changes in knowledge and confidence. Knowledge was assessed by comparing results of multiple choice and matching questions on the pre- and post-assessments. Confidence was assessed by the change in self-reported confidence scale measurements. Results: Students at all institutions (N = 405) had nonsignificant changes in knowledge scores from the pre-assessment to the post-assessment, with the exception of 1 question. All confidence survey questions significantly improved from pre- to post-assessment. Conclusion: The DUR educational innovation had a nonsignificant overall impact on students' knowledge but significantly improved confidence in their abilities. Skills-based instruction provides additional practice to increase student confidence.

Mitigating the Risk of Drug Interactions in Cancer Patients Taking Oral Anticancer Agents: The Role of a Multidisciplinary Team-Based Medication Reconciliation.

PURPOSE: Polypharmacy in cancer patients is a recognized issue and should be an integral part of comprehensive patient assessment and management. Despite this, a systematic review of concomitant drugs or a search for potential drug-drug interactions (DDIs) is not always performed. Here, we present the results of a medication reconciliation model performed by a multidisciplinary team to identify clinically meaningful potential DDIs (defined by the presence of DDI of major severity or contraindication) in cancer patients undergoing oral antineoplastic drugs. METHODS: From June to December 2022, we performed a non-interventional, prospective, cross-sectional, single-center study of adult cancer patients, initiating or undergoing treatment with oral antineoplastic drugs, referred by their oncologists for therapeutic review regarding potential DDIs. DDIs were assessed by a multidisciplinary team of hospital pharmacists and medical oncologists, through research in three different drug databases as well as in the summary of product characteristics. A report detailing all potential DDIs was created for each request and provided to the patient's medical oncologist for further examination. RESULTS: Overall, 142 patients' medications were reviewed. Regardless of the severity or clinical importance, 70.4% of patients had at least one potential DDI. We found 184 combinations of oral anticancer and regular therapy agents with potential DDIs, 55 of whom were considered of major severity by at least one DDI database. As expected, the number of potential DDIs increased with the number of active substances in regular therapy (p < 0.001), but we did not find an increased relation between age and the total number of potential DDIs (p = 0.109). Thirty-nine (27.5%) patients had at least one clinically meaningful DDI identified. After adjustment through multivariable logistic regression, only the female sex (odds ratio (OR) 3.01, p = 0.029), the number of active comorbidities (OR 0.60, p = 0.029), and the presence of proton pump inhibitors in chronic medication (OR 2.99, p = 0.033) remained as predictors of potential meaningful DDI. CONCLUSION: Although drug interactions are a concern in oncology, a systematic DDI review is rarely conducted in medical oncology consultations. The availability of a medication reconciliation service, carried out by a multidisciplinary team with dedicated time for this task, is an added value for safety enhancement in cancer patients.

Evaluation of a multifaceted medication review in older patients in the outpatient setting: a before-and-after study.

BACKGROUND: The prevalence of medication-related emergency department visits and acute hospital admissions in older patients is rising due to the ageing of the population and increasing prevalence of multimorbidity and associated polypharmacy. AIM: To explore whether a combined medication review performed in the outpatient setting reduces the number of medication-related emergency department visits and hospital (re)admissions. METHOD: All consecutive patients visiting the geriatric outpatient clinic underwent a multifaceted medication review (i.e. evaluation by at least a geriatrician, and/or pharmacist and use of clinical decision support system). Subsequently, we analysed the number of, and reason for, emergency department visits, acute hospital admissions and readmissions in the year prior to and the year following the index-date (date of first presentation and medication review). RESULTS: A multifaceted medication review reduced the number of potentially medication-related emergency department visits (38.9% vs. 19.6%, p < 0.01), although the total number of ED visits or acute hospital admissions per patient in the year before and after medication review did not differ. CONCLUSION: A multifaceted medication review performed in the outpatient clinic reduced the number of potentially medication-related emergency department visits and could therefore reduce negative health outcomes and healthcare costs.

[Translated article] Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study.

OBJECTIVE: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription. METHOD: Observational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to seven different days of the week, in seven consecutive weeks. INCLUSION CRITERIA: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by two specialists in emergencies, two pharmacists and one specialist in infectious diseases, all unrelated to prescriptions. RESULTS: 168 patients with 192 prescriptions were evaluated. Seventy-six (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa = 0.71). CONCLUSIONS: A high rate of inappropriate antimicrobial prescriptions was obtained in a hospital emergency department according to local guidelines. The hospital pharmacist has an opportunity to improve the use of antimicrobials in this area.

Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study. / Evaluación de la prescripción de antibióticos en un servicio de urgencias hospitalarias: estudio piloto.

OBJECTIVE: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription. METHOD: Observational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to 7 different days of the week, in 7 consecutive weeks. INCLUSION CRITERIA: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by 2 specialists in emergencies, 2 pharmacists and one specialist in infectious diseases, all unrelated to prescriptions. RESULTS: One hundred sixty eight patients with 192 prescriptions were evaluated. 76 (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa=0.71). CONCLUSIONS: A high rate of inappropriate antimicrobial prescriptions was obtained in a hospital emergency department according to local guidelines. The hospital pharmacist has an opportunity to improve the use of antimicrobials in this area.

Evaluación de la prescripción de antibióticos en un servicio de urgencias hospitalarias: estudio piloto / Evaluation of the antibiotic prescription in a hospital emergency department: Pilot study

Objetivo: describir la adecuación de las prescripciones de antimicrobianos a las guías de tratamiento locales de infecciones, en el área de urgencias hospitalarias, así como conocer las características clínicas y epidemiológicas de los pacientes que reciben dichos tratamientos. Llevar a cabo un estudio de viabilidad para el diseño y la ejecución de investigaciones que aborden aspectos específicos de la inadecuación de prescripción de antimicrobianos.Métodoestudio piloto observacional, descriptivo y transversal, con recogida de datos retrospectiva de prescripción de antimicrobianos en un servicio de urgencias hospitalario. Se realizaron 7 cortes transversales, correspondientes a los 7 días diferentes de la semana, en 7 semanas consecutivas. Criterios de inclusión: paciente mayor de 14 años de edad, con al menos una primera dosis de tratamiento antimicrobiano prescrita el día del estudio. La variable principal fue la prescripción de antimicrobianos inadecuada según las guías locales. Como variables secundarias se recogieron parámetros epidemiológicos y clínicos de los pacientes. La evaluación de la adecuación la realizaron 2 especialistas médicos de urgencias y 2 especialistas en farmacia hospitalaria, más un tercer evaluador, especialista en enfermedades infecciosas, todos ajenos a la prescripción.Resultadosse evaluaron 168 pacientes con 192 prescripciones. Setenta y seis (39,6%) de las prescripciones no se ajustaron a las guías de tratamiento locales, de estas el 55% fueron con cobertura antimicrobiana activa frente al microorganismo, pero no recomendada, el 23,5% con fármacos inactivos, el 13,7% presentaban una dosis inapropiada y el 7,8% eran tratamientos innecesarios. La fuerza de la concordancia en la evaluación de la adecuación del tratamiento entre médicos y farmacéuticos fue alta (kappa=0,71). (AU)

Objective: A study about the adherence of the antimicrobial prescriptions to the local guidelines of treatment of infections was conducted in a hospital emergency department to study the clinical and epidemiological characteristics of the patients who received these treatments. Conducting a feasibility study for supporting the design and execution of future studies, addressing specific aspects of the appropriateness of the antimicrobial prescription.MethodObservational, descriptive and cross-sectional pilot study, with retrospective data collection about the antimicrobial prescription in a hospital emergency department. Seven cross sections were made, corresponding to 7 different days of the week, in 7 consecutive weeks. Inclusion criteria: patient over 14 years of age, with at least one first dose of antimicrobial treatment prescribed on the day of recruitment. The main variable was the inappropriate antimicrobial prescription according to the local guidelines. Epidemiological and clinical parameters of the patients were collected as secondary variables. In order to determine inappropriate prescription a revision was carried out by 2 specialists in emergencies, 2 pharmacists and one specialist in infectious diseases, all unrelated to prescriptions.ResultsOne hundred sixty eight patients with 192 prescriptions were evaluated. 76 (39.6%) of the prescriptions were not conformed to the local treatment guidelines. Of these, 55% were with active antimicrobial coverage against the microorganism but not recommended, 23.5% with inactive drugs, 13.7% presented an inappropriate dose and 7.8% were unnecessary treatment. The strength of agreement in the evaluation of the adequacy of treatment between doctors and pharmacists was high (kappa=0.71). (AU)

Better drug use in advanced disease: an international Delphi study.

Patients with a limited life expectancy use many medications, some of which may be questionable. OBJECTIVES : To identify possible solutions for difficulties concerning medication management and formulate recommendations to improve medication management at the end of life. METHODS : A two-round Delphi study with experts in the field of medication management and end-of-life care (based on ranking in the citation index in Web of Science and relevant publications). We developed a questionnaire with 58 possible solutions for problems regarding medication management at the end of life that were identified in previously performed studies. RESULTS : A total of 42 experts from 13 countries participated. Response rate in the first round was 93%, mean agreement between experts for all solutions was 87 % (range 62%-100%); additional suggestions were given by 51%. The response rate in the second round was 74%. Awareness, education and timely communication about medication management came forward as top priorities for guidelines. In addition, solutions considered crucial by many of the experts were development of a list of inappropriate medications at the end of life and incorporation of recommendations for end-of-life medication management in disease-specific guidelines. CONCLUSIONS : In this international Delphi study, experts reached a high level of consensus on recommendations to improve medication management in end-of-life care. These findings may contribute to the development of clinical practice guidelines for medication management in end-of-life care.

Review of Ruxolitinib in the Treatment of Atopic Dermatitis.

OBJECTIVE: To review the pharmacokinetics, efficacy, and safety of a newly approved topical Janus kinase 1 (JAK) inhibitor, ruxolitinib (RUX), in patients with atopic dermatitis (AD). DATA SOURCES: A literature search was completed May 1, 2022. The term RUX and AD was queried in MEDLINE (PubMed) and EMBASE databases. STUDY SELECTION AND DATA EXTRACTION: Peer-reviewed articles written in English and published prior to May 1, 2022 were included. DATA SYNTHESIS: In the phase II clinical trial, more patients treated with 1.5% topical RUX twice a day had a mean percentage improvement in Eczema Area and Severity Index (EASI) scores from baseline to 4 weeks, when compared to vehicle (71.6% vs 15.5%; P < 0.001). In phase III clinical trials, greater percentage of patients who received 0.75% topical RUX (TRuE-AD1 50.0% and TRuE-AD2 39.0%) or 1.5% topical RUX (TRuE-AD1 53.8% and TRuE-AD2 51.3%) achieved an Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) and had a ≥2-grade improvement from baseline to 8 weeks, when compared to vehicle (TRuE-AD1 15.1% and TRuE-AD2 7.6%; P < 0.001). RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Atopic dermatitis is a highly prevalent long-term inflammatory skin condition. Pruritus is the main contributor of decreased quality of life in patients with AD. Topical RUX inhibits JAK1 and JAK2 producing antiinflammatory and antipruritic effects. Patients experienced a reduction in pruritus within 2 days. This decreased pruritus translated to increased quality of life and less sleep disturbances. CONCLUSION: Data from phase II and III clinical trials in adult patients suggest RUX is an effective and safe therapy for AD.

Japanese Nationwide Comparative Survey of Medication Guidance Provided by Certified and Uncertified Palliative Care Pharmacists.

BACKGROUND: As members of a medical team, pharmacists are expected to provide optimal patient-centered, evidence-based pharmacotherapy. In Japan, in consideration of the importance of palliative care, a system was initiated for certifying palliative care pharmacists in 2010. However, no studies have evaluated the usefulness of board certification in palliative pharmacy. Therefore, we surveyed the status of medication guidance for the physical and psychological symptoms of patients receiving palliative care and compared the medication guidance provided by certified and uncertified pharmacists. METHODS: The survey was conducted in February and March 2022. Pharmacists registered as members of the Japanese Society of Pharmaceutical Palliative Care and Sciences were surveyed by using a web-based questionnaire and 209 pharmacists responded: the certified pharmacist group comprised 123 (58.9%) pharmacists and the uncertified pharmacist group comprised 86 (41.1%) pharmacists. RESULTS: The certified pharmacist group provided better and more frequent medication guidance, according to responses to four of the six items related to pain relief. Three items were related to non-pain symptom relief, and one of the four items was related to psychiatric symptom relief (P < 0.05). The study showed that the certified pharmacist group received a better rating than the uncertified pharmacist group for involvement in palliative pharmacotherapy leading to improvement of patient quality of life (P < 0.05). CONCLUSION: As compared with uncertified pharmacists, certified pharmacists intervened more proactively and provided a broader range of palliative care.

Utilización de antibióticos restringidos en la práctica clínica: ceftolozano/tazobactam, ceftazidima/avibactam, ceftarolina y dalbavancina / Use of restricted antibiotics in clinical practice: ceftolozane/tazobactam, ceftazidime/avibactam, ceftaroline and dalbavancin

Objetivo: Evaluar la utilización en la práctica clínica de cuatro antibióticos de amplio espectro o innovadores: ceftolozano/tazobactam, ceftazidima/avibactam, ceftarolina y dalbavancina. Métodos: Estudio retrospectivo en que se han recogido datos de los pacientes que han recibido dichos antibióticos entre julio de 2018 y junio de 2019 en un hospital terciario. Se recogen las condiciones de uso y los resultados en efectividad a los 30 días para dalbavancina, y para el resto de antimicrobianos a los 3-5 días del inicio, a los 14 y a los 30 días para determinar mortalidad. Resultados: Se recogieron datos de 51 pacientes, con una mediana de edad de 63 años. La infección más comúnmente tratada fue neumonía (41,2%). Tres pacientes (5,9%) recibieron la terapia en estudio como primera línea y 43 (84,3%) recibieron antibióticos concomitantes. En el 66,7% de las infecciones se había aislado previamente un microorganismo sensible. En el 19,6% de los casos el cultivo fue negativo. En el grupo dalbavancina, el 75% de los pacientes se curaron a los 30 días. En el resto de antimicrobianos, el tratamiento resultó efectivo a los 3-5 días en el 65,1%. El 51,2% se curaron a los 14 días y un 30,2% fallecieron a los 30 días. Conclusiones: Los resultados de efectividad resultan comparables a estudios publicados con diseños similares. Se detecta la importancia de fomentar un uso adecuado de los antibióticos, como tratamientos dirigidos o empíricos en casos de riesgo de resistencias, priorizando su desescalada. Es esencial la implantación de equipos multidisciplinares PROA. (AU)

Objective: To evaluate the use in clinical practice of four recently marketed antibiotics: ceftolozane/tazobactam, ceftazidime/avibactam, ceftaroline, and dalbavancin. Methods: Retrospective study in which data have been collected from patients who have received these antibiotics between July 2018 and June 2019, in a third-level hospital. The conditions of use and the results in clinical efficacy measured in three periods have been studied: 3-5 days after the start of treatment, 14 days and 30 days to determine mortality. Results: Data were collected from a total of 51 patients, with a median age of 63 years. The most commonly treated infection was pneumonia (41.2%). Three patients (5.9%) received study therapy as the first line of treatment and 43 (84.3%) received concomitant antibiotics. In 66.7% of the infections, a sensitive microorganism to the antibiotic under study had been previously isolated. In 19.6% of the cases, the culture was negative. In the dalbavancin group, 75% of the pacients cured at day 30. In the other groups, the treatment was effective at 3-5 days in 65.1% of the cases. 51.2% experienced clinical cure at 14 days and 30.2% died at 30 days. Conclusions: The effectiveness results are comparable to published studies with similar designs. The importance of promoting an adequate use of antibiotics is detected, as directed or empirical treatments in cases of risk of resistance, prioritizing their de-escalation. The implementation of multidisciplinary PROA teams is essential. (AU)

The effect of emergency department pharmacists on drug overuse and drug underuse in patients with an ADE-related hospitalisation: a controlled intervention study.

BACKGROUND: Drug overuse or drug underuse are the most common causes of adverse drug events and can lead to hospital admissions. Using clinical pharmacists in the emergency department may improve patient safety as they are specialised in recognising of adverse drug events and tackling drug overuse and drug underuse. This study tested the effect of an emergency department pharmacist on the number of medication changes for drug overuse and drug underuse taking place in patients with an adverse drug event-related hospitalisation following an emergency department visit. METHODS: A multicenter prospective non-randomized controlled intervention study was conducted in a university hospital and a general teaching hospital. Trained emergency department pharmacists included patients in the intervention group with a hospital admission related to an adverse drug event. The interdisciplinary intervention consisted of a pharmacist-led medication review, patient counselling regarding medication, and information transmission to general practitioners and community pharmacies after discharge. The control patients were also admitted after an emergency department visit and received the usual care. The primary outcome was the number of medication changes for drug overuse and drug underuse that took place during hospital admission and persisted 6 months thereafter. Poisson regression analysis was used to estimate the difference in these medication changes between the intervention group and the control group. RESULTS: A total of 216 patients were included (intervention group 104, control group 112). In the intervention group, 156 medication changes for drug overuse and drug underuse persisted 6 months after admission compared to 59 in the control group (adjusted rate ratio 1.22 [95%CI 1.01-1.49] p = 0.039). CONCLUSION: Emergency department pharmacists do contribute to reduction of drug overuse and drug underuse of medication in patients with a hospitalisation related to adverse drug events after an emergency department visit.

Regulatory reliance pathways during health emergencies: enabling timely authorizations for COVID-19 vaccines in Latin America.

Objectives: To map the timing and nature of regulatory reliance pathways used to authorize COVID-19 vaccines in Latin America. Methods: An observational study was conducted assessing the characteristics of all COVID-19 vaccine authorizations in Latin America. For every authorization it was determined whether reliance was used in the authorization process. Subgroups of reference national regulatory authorities (NRAs) and non-reference NRAs were compared. Results: 56 authorizations of 10 different COVID-19 vaccines were identified in 18 countries, of which 25 (44.6%) used reliance and 12 (21.4%) did not. For the remaining 19 (33.0%) it was not possible to determine whether reliance was used. Reference agencies used reliance less often (40% of authorizations with a known pathway) compared to non-reference agencies (100%). The median review time was just 15 days and does not meaningfully differ between reliance and non-reliance authorizations. Conclusions: This study demonstrated that for these vaccines, despite reliance pathways being associated with numerous rapid authorizations, independent authorization review times were not considerably longer than reliance reviews; reliance pathways were not a prerequisite for rapid authorization. Nevertheless, reliance pathways provided rapid authorizations in response to the COVID-19 emergency.