Use of potentially inappropriate medications and medications of concern in older adults with multiple myeloma / Utilização de medicamentos potencialmente inapropriados e medicamentos que requerem cautela em idosos com mieloma múltiplo

Objetivo: Analisar o uso de medicamentos potencialmente inapropriados (MPIs) e o uso de medicamentos usados em terapia de suporte que requerem cautela em idosos com câncer (MTSRCICs), determinando os fatores associados. Visou-se também determinar a concordância entre os critérios explícitos empregados na identificação de MPI. Metodologia: Estudo transversal com indivíduos com mieloma múltiplo (MM), idade ≥ 60 anos em tratamento ambulatorial. Os MPI foram identificados de acordo com os critérios AGS Beers 2019, PRISCUS 2.0 e o Consenso Brasileiro de Medicamentos Potencialmente Inapropriados (CBMPI). Os MTSRCIC foram definidos de acordo com a National Comprehensive Cancer Network. Os fatores associados ao uso de MPI e MTSRCIC foram identificados por regressão logística múltipla. O grau de concordância entre os três critérios explícitos empregados no estudo foi mensurado pelo coeficiente kappa Cohen. Resultados: As frequências de MPI foram 52,29% (AGS Beers 2019), 62,74% (CBMPI), 65,36% (PRISCUS 2.0) e 52,29% (MTSRCICs). As concordâncias entre AGS Beers 2019 com PRISCUS 2,0 e com CBMPI foram altas, enquanto a concordância entre CBMPI e PRISCUS 2.0 foi excelente. No modelo final de regressão logística polifarmácia foi associada positivamente ao uso de MPI por idosos para os três critérios explícitos utilizados, além de associado à utilização de MTSRCICs. Conclusões: A frequência do uso de MPI e de MTSRCIC foi elevada. A concordância em relação ao uso de MPI entre os critérios AGS Beers 2019, CBMPI e PRISCUS 2.0 foi alta ou excelente. A polifarmácia apresentou associação independente e positiva com uso de MPIs e de MTSRCICs por pacientes idosos com MM. (AU)

Objectives: To analyze the use of potentially inappropriate medications (PIMs) and medications used in supportive therapy that require caution in older adults with cancer, in addition to determining associated factors the agreement between criteria sets used to identify PIMs. Methods: This cross-sectional study included individuals with multiple myeloma aged ≥ 60 years who were undergoing outpatient treatment. PIMs were identified according to American Geriatric Society Beers 2019, PRISCUS 2.0, and Brazilian Consensus on Potentially Inappropriate Medicines criteria. Medications of concern were defined according to National Comprehensive Cancer Network criteria. Factors associated with the use of PIMs and medications of concern were identified using multiple logistic regression. The degree of agreement between the 3 criteria sets was measured using Cohen's kappa coefficient. Results: The frequency of PIM use was 52.29% according to American Geriatric Society Beers criteria, 62.74% according to Brazilian Consensus criteria, and 65.36% according to PRISCUS criteria, while 52.29% of the patients were using medications of concern. Agreement between American Geriatric Society Beers, PRISCUS, and Brazilian Consensus criteria was high, while it was excellent between Brazilian Consensus and PRISCUS criteria. In the final logistic regression model, polypharmacy was associated with PIM use according to each criteria set, as well as the use of medications of concern. Conclusions: The frequency of PIMs and medications of concern was high. Agreement about PIM use between the American Geriatric Society Beers, Brazilian Consensus, and PRISCUS criteria was high or excellent. There was an independent association between polypharmacy and the use of PIMs and medications of concern by older patients with multiple myeloma. (AU)

Insights from Japan’s cost-effectiveness analysis policy on pricing for China’s NRDL access / 中国药房

The cost-effectiveness analysis policy for drugs was institutionalized in Japan since 2019， realizing quantitative adjustment of price across varieties. A hierarchical categorization approach was adopted to select medicines with high expected annual sales. For selected medicines， adjustments were made to the premium and profit components within the existing price structure based on a pre-defined incremental cost-effectiveness ratio （ICER） threshold， effectively resolving the issue of inconsistent criteria and magnitudes caused by subjective judgment. Meanwhile， incentive measures like evaluation exemption or threshold enhancement were granted for specific medicines. Besides， a price adjustment mechanism， which was allowed for upward and downward adjustments， involving tiered ICER threshold and quantified formulas， had been established for the premium and profit components of drug price. In China’s National Reimbursement Drug List （NRDL） access， certain issues remained to be addressed： insufficient clarity in the quantitative mechanism of price formation， incomplete price adjustment measures， and lagging in the communication channels. It is recommended that the following measures could be referred to when further improving the scientificity and fairness of drug pricing during China’s NRDL access， such as enhancing the ICER threshold for medicines catering to special populations， quantifying criteria and extents for price adjustment， granting preferential pricing policies to pharmaceutical companies that present high-quality evidence of effectiveness， preceding communication channels with pharmaceutical companies， as well as exploring a price floor mechanism for the drugs with excessive price reduction.

Lists of potentially inappropriate medications for older people in primary care: a systematic review of health outcomes / Listas de medicamentos potencialmente inapropriados para idosos em atenção primária: uma revisão sistemática sobre desfechos de saúde / Listas de medicamentos potencialmente inapropiados para adultos mayores en la atención primaria: una revisión sistemática de los resultados de salud

Abstract: This study is a systematic literature review of the association between lists of potentially inappropriate medications (PIM) in clinical practice and health outcomes of older adults followed up in primary health care. For this purpose, the PRISMA protocol was used to systematize the search for articles in the PubMed, Web of Science, Scopus, Cochrane Central, LIVIVO and LILACS databases, in addition to the gray literature. Studies with randomized clinical trials were selected, using explicit criteria (lists) for the identification and management of PIM in prescriptions of older patients in primary care. Of the 2,400 articles found, six were used for data extraction. The interventions resulted in significant reductions in the number of PIM and adverse drug events and, consequently, in potentially inappropriate prescriptions (PIP) in polymedicated older adults. However, there were no significant effects of the interventions on negative clinical outcomes, such as emergency room visits, hospitalizations and death, or on improving the health status of the older adults. The use of PIM lists promotes adequate medication prescriptions for older adults in primary health care, but further studies are needed to determine the impact of reducing PIM on primary clinical outcomes.

Resumo: Este estudo revisou sistematicamente a literatura sobre a associação de listas de medicamentos potencialmente inapropriados (MPI) na prática clínica e desfechos de saúde na população idosa acompanhada na atenção primária à saúde. Para tanto, o protocolo PRISMA foi usado para sistematizar a busca de artigos nas bases de dados PubMed, Web of Science, Scopus, Cochrane Central, LIVIVO e LILACS, além da literatura cinzenta. Foram selecionados estudos com ensaios clínicos randomizados, incluindo a utilização de critérios explícitos (listas) para identificar e manejar MPI em prescrições para idosos atendidos na atenção primária. Dos 2.400 artigos encontrados, seis foram utilizados para extração de dados. As intervenções reduziram significativamente o número de MPI e eventos adversos a medicamentos e, consequentemente, nas prescrições potencialmente inadequadas em idosos polimedicados. No entanto, não houve efeitos significativos das intervenções sobre desfechos clínicos negativos (como visitas a serviços de emergência, hospitalizações e óbito) ou melhora das condições de saúde dos idosos. O uso de listas de MPI pode promover a adequação da prescrição de medicamentos para idosos na atenção primária à saúde, mas mais estudos são necessários para determinar os impactos da redução de MPI em desfechos clínicos primários.

Resumen: Este estudio realizó una revisión sistemática en la literatura sobre la asociación de listas de medicamentos potencialmente inapropiados (MPI) en la práctica clínica y los resultados de salud en la población de edad avanzada monitoreada en atención primaria de salud. Para ello, se utilizó el protocolo PRISMA para sistematizar la búsqueda de artículos en las bases de datos PubMed, Web of Science, Scopus, Cochrane Central, LIVIVO y LILACS, además de la literatura gris. Se seleccionaron estudios con ensayos clínicos aleatorizados, incluyendo el uso de criterios explícitos (listas) para identificar y manejar MPI en prescripciones para adultos mayores atendidos en atención primaria. De los 2.400 artículos encontrados, seis se utilizaron para la recolección de datos. Las intervenciones tuvieron una significativa disminución en la cantidad de MPI y eventos adversos de medicamentos y, en consecuencia, en prescripciones potencialmente inapropiadas en adultos mayores polimedicados. Sin embargo, no hubo efectos significativos de las intervenciones en los resultados clínicos negativos (como consultas a servicios de urgencias, hospitalizaciones o muerte) o mejora en las condiciones de salud de los adultos mayores. El uso de listas de MPI puede promover una adecuada prescripción de medicamentos a los adultos mayores en la atención primaria de salud, si bien se necesitan más estudios para determinar los impactos de la reducción de MPI en los resultados clínicos primarios.

Potentially inappropriate medications with older people in intensive care and associated factors: a historic cohort study

ABSTRACT BACKGROUND: The epidemiology of potentially inappropriate medications (PIMs) in critical care units remains limited, especially in terms of the factors associated with their use. OBJECTIVE: To estimate the incidence and factors associated with PIMs use in intensive care units. DESIGN AND SETTING: Historical cohort study was conducted in a high-complexity hospital in Brazil. METHODS: A retrospective chart review was conducted on 314 patients aged ≥ 60 years who were admitted to intensive care units (ICUs) at a high-complexity hospital in Brazil. The dates were extracted from a "Patient Safety Project" database. A Chi-square test, Student's t-test, and multivariable logistic regression analyses were performed to assess which factors were associated with PIMs. The statistical significance was set at 5%. RESULTS: According to Beers' criteria, 12.8% of the identified drugs were considered inappropriate for the elderly population. The incidence rate of PIMs use was 45.8%. The most frequently used PIMs were metoclopramide, insulin, antipsychotics, non-steroidal anti-inflammatory drugs, and benzodiazepines. Factors associated with PIMs use were the number of medications (odds ratio [OR] = 1.17), length of hospital stay (OR = 1.07), and excessive potential drug interactions (OR = 2.43). CONCLUSIONS: Approximately half of the older adults in ICUs received PIM. Patients taking PIMs had a longer length of stay in the ICU, higher numbers of medications, and higher numbers of potential drug interactions. In ICUs, the use of explicit methods combined with clinical judgment can contribute to the safety and quality of medication prescriptions.

Política industrial farmacéutica, un requisito clave para la autonomía sanitaria de Colombia / Pharmaceutical industrial policy, a key requirement for health autonomy in Colombia

Colombia depende de la importación de medicamentos, así como de gran parte de los materiales (principios activos y excipientes) requeridos para su elaboración; problemática que genera consecuencias sanitarias y macroeconómicas, las cuales se agudizan en el contexto de desindustrialización nacional y de disrupción tecnológica. De esta manera, se acepta que la disponibilidad y acceso a medicamentos y otras tecnologías sanitarias esenciales son un requisito fundamental para alcanzar la autonomía sanitaria de un país. Por lo tanto, resulta imprescindible coordinar esfuerzos entre diversos sectores sociales para desarrollar una agenda pública enfocada a la creación de condiciones que fortalezcan las capacidades científicas y tecnológicas de la industria farmacéutica local, y con ello, mejorar el suministro farmacéutico del país. En el presente documento se presentan conceptos teóricos y prácticos que deberían ser considerados en la definición y materialización de una política pública encaminada a fortalecer la industria farmacéutica y favorecer la autonomía sanitaria de Colombia.

Colombia has a notorious dependency on the importation of medicines, as well as a large part of the materials (active ingredients and excipients) required for their manufacture. This problem generates health and macroeconomic consequences, which are exacerbated in the context of national deindustrialization and technological disruption. In this way, it is accepted that the availability and access to medicines and other essential health technologies are a fundamental requirement to achieve the health autonomy of a country. Therefore, it is crucial to coordinate efforts between several social sectors to develop a public agenda focused on creating conditions that allow strengthening the scientific and technological capabilities of the local pharmaceutical industry, thereby, improving the country's pharmaceutical supply. This document presents conceptual and practical topics that should be considered to defining and materializing a public policy aimed at strengthening the local pharmaceutical industry and favoring Colombia's sanitary autonomy.

Construction of pharmacogenomics-guided individualized medication list for elderly patients / 中国药房

OBJECTIVE To develop an individualized medication list for elderly patients by evidence-based pharmacy method， and to support clinical decisions on rational use of METHODS　Firstly， drugs with risk genetic information were screened out by systematically reviewing evidence-based pharmacy information. Secondly， researchers investigated the included drugs in lists from different data E- sources. Drugs included in three or more data sources and drugs proposed by the expert committee were then included in the medication list. Thirdly， for the drugs included in two data sources， researchers designed questionnaires to investigate the necessity of drug-related gene testing. According to the scoring results of the expert questionnaire， drugs with higher scores were included in the list. Data sources included real-world data （list of high frequency medication in hospitals， high frequency medication for elderly outpatients and inpatients in National Health Care Claims Data， drugs related to frequent medication errors and so on） and evidence-based pharmacy evidence （the websites of Clinical Pharmacogenomics Implementation Consortium， Dutch Pharmacogenetics Working Group， Food and Drug Administration and so on）. RESULTS　The study obtain 68 drugs with risk genetic information which were included in three data sources. Combined with 23 drugs proposed by the expert committee， a list containing 74 drugs was preliminarily formed after de-duplication. A total of 37 drugs included in two databases with risk genetic information were scored through the questionnaire survey to form a supplementary list of 26 drugs. This is the final composition of the list of 100 drugs developed in this study. Among them， there are 43 drugs for the central nervous system， 15 drugs for the cardiovascular system， 12 anti-tumor drugs and so on. Twelve drugs were included in six or more data sources， which mainly consisted of drugs for digestive system， all proton pump inhibitors. CONCLUSION　In this study， a list of 100 commonly used drugs which require individualized medication for the elderly was developed by evidence-based pharmacy method. The drug list will be updated in time as available evidence changes， and can provide guidance for rational use of medicines for elderly patients.

Study on the varieties included in the List of Overseas New Drugs Urgently Needed in Clinic in China and the optimization strategy / 中国药房

OBJECTIVE To study the variety included in the List of Overseas New Drugs Urgently Needed in Clinic in China and optimization strategy， in order to better meet the needs of patients. METHODS The release process of List of Overseas New Drugs Urgently Needed in Clinic， the characteristics and attributes of the new drugs urgently needed abroad， and the problems in the implementation process were all analyzed to put forward some suggestions for optimizing the List of Overseas New Drugs Urgently Needed in Clinic. RESULTS & CONCLUSIONS The release process of the List of Overseas New Drugs Urgently Needed in Clinic was roughly divided into incubation stage， preparation stage and implementation stage. The treatment fields of 3 batches of overseas new drugs urgently needed in clinic were relatively concentrated on endocrine and metabolic diseases，tumor and skin diseases. Of included 73 varieties， 50 varieties have been approved for market，and 26 varieties have been included in the medical insurance， 4 varieties were included in the Catalogue of Encouraged Generic Drugs. At present， there are still some problems in our country， such as the shortage monitoring system needs to be established and improved； the linkage with medical insurance is weakened； the encouragement of generic drugs is insufficient. It is necessary to strengthen the cooperation of monitored departments in the shortage of new overseas drugs，establish a medical insurance payment system oriented by clinical value， and improve the incentive mechanism to encourage the imitation of overseas new drugs urgently needed in clinic.

Assessing Countries’ Deceased Organ Donation and Transplantation Performance

@#Introduction: Donors per million population and transplantations per million population are standardized, widely used indicators to assess and compare countries’ performance in organ donation and transplantation. This study aims to investigate these two particular metrics of organ donation and transplantation performance, and to introduce a new index, namely, ‘transplantations per patients on the waiting list’. Methods: Secondary analyses of data on 23 countries in 2016 were used to construct the transplantations per patients on the waiting list indicator for kidney, liver, pancreas, heart, and lung transplantation, as well as for the transplantation of any of the five aforementioned organs. Results: According to the transplantations per patients on the waiting list, the best-performing countries in terms of organ donation and transplantation are Belarus for kidney transplantation, Finland for liver and pancreas transplantation, Australia for heart transplantation, and France for lung transplantation. Considering all five organs together, Sweden, Australia, Finland, Austria, and Poland were the top five best-performing countries, followed by Spain in the sixth position. Conclusion: The deceased transplantations per patients on the waiting list can be an alternative indicator to assess performance, along with the widely-used donors and transplantations per million population, but still has its limitations in certain scenarios.

Application analysis of checklist nursing management combined with different artificial liver treatment modes in patients with liver failure / 中国实用护理杂志

Objective:To explore the application of list nursing management combined with different artificial liver treatment modes in patients with liver failure.Methods:Fifty-three patients with liver failure hospitalized in Bethune Hospital of Shanxi Province from July 2020 to July 2021 were selected as the control group, 63 patients with liver failure hospitalized in Bethune Hospital of Shanxi Province from July 2021 to July 2022 were selected as the intervention group. According to the different treatment modes of artificial liver for patients, plasma exchange (PE), double plasma molecular adsorption system (DPMAS) and PE + DPMAS treatment were set up in the two groups. The control group received routine nursing care, while the intervention group received checklist nursing care in addition. The changes of albumin (ALB) and prothrombin time (PT) indexes before and after the different treatment modes were compared, together with the occurrence of complications between the two groups after the intervention.Results:The baseline data between the two groups was balanced, the difference had no statistical significant ( P>0.05). After the therapy, the level of ALB of patients who had accepted DPMAS and PE + DPMAS in the intervention group were 25.3(24.0, 27.9) and 23.2(22.4, 26.3) g/L, which were lower than the 28.2(26.3, 29.7) and 29.4(27.2, 30.0) g/L in the control group, the differences were significant ( Z = 2.47, 3.55, both P<0.05). After the therapy, the level of PT of patients in the intervention group under all three treatment modes were 15.8(14.8, 16.8), 22.7(19.2, 26.2) and 6.0(14.6, 20.0) s, which were lower than the 17.4(15.9, 20.9), 26.3(21.4, 36.4) and 21.2(16.9, 23.4) s in the control group, the differences were significant ( Z = 2.10, 2.07, 2.21, all P<0.05). In the intervention group, there were 6 cases of hypotension, anaphylaxis, bleeding, coagulation and infection under the DPMAS treatment mode, which was significant lower than the 11 cases in the control group ( χ2 = 4.97, P<0.05). There were 4 cases in the intervention group with the PE + DPMAS treatment mode occurred complications in above, which were significant lower than the 11 cases in the control group ( χ2 = 6.87, P<0.01). Conclusions:Artificial liver treatment can improve patients′ liver function and coagulation, and list nursing management may help to improve the effect of artificial liver treatment. It can improve nurses′ awareness of risk prejudgement, reduce various risks in the treatment process, reduce the incidence of adverse reactions, and enhance health care and patient satisfaction.

Application of daily target list of patients with mechanical ventilation in ICU in multidisciplinary ward round / 中国实用护理杂志

Objective:To explore the clinical effect of daily target list of ICU patients with mechanical ventilation (hereinafter referred to as target list) for patients with mechanical ventilation in ICU based on multidisciplinary ward round design.Methods:A non contemporaneous controlled study with a quasi experimental design was conducted. One thousand and seventy-one patients with mechanical ventilation admitted to the comprehensive care unit of the First Affiliated Hospital of Medical College of Zhejiang University from January to December 2019 were selected as the experimental group. The target list was used to standardize the communication of multidisciplinary ward rounds and guide the clinical nursing process. Nine hundred and fifty patients with mechanical ventilation admitted from January to December 2018 were selected as the control group. Routine medical communication, ward rounds and nursing shift handover were used. The duration of mechanical ventilation and the length of stay in ICU, the utilization rate of catheter and related infection rate, the implementation rate of daily nursing measures, the incidence of nursing adverse events and the satisfaction of medical staff with multidisciplinary cooperation were compared.Results:Before the intervention, there was no significant difference in the basic data between the two groups ( P>0.05). After the intervention, the duration of mechanical ventilation and the length of stay in ICU were 4 (2, 9) h and 3 (3, 7) d in the experimental group, which were lower than those in the control group 6 (5, 35) h and 4 (3, 8) d, the differences were statistically significant ( Z=-13.76, -3.62, both P<0.01). The standard rate of sedation, the implementation rate of early activities and the implementation rate of venous thromboembolism preventive measures in the experimental group were 83.10% (4 435/5 337), 80.16% (3 155/3 936) and 93.97% (5 530/5 885) respectively, which were higher than the 81.42% (4 190/5 146), 68.83% (2 197/3 192) and 87.86% (5 839/6 646) in the control group, the differences were statistically significant( χ2=5.05, 120.93, 138.50, all P<0.05). The use rate of physical restraint, the incidence of incontinence-associated dermatitis, medical adhesive related skin injury, deep vein thrombosis and delirium in the experimental group were 39.75% (2 936/7 387), 3.64% (39/1 071), 4.11% (44/1 071), 5.23% (56/1 071), 6.54% (70/1 071), which were lower than the 43.50% (3 180/7 312), 5.90% (56/950), 8.53% (81/950), 9.26% (88/950), 12.42% (118 / 950) in the control group, the differences were statistically significant( χ2 values were 5.71-20.67, all P<0.05). The level of multidisciplinary cooperation was greatly improved, 3.83 ± 0.38 vs. 3.61 ± 0.51 ( t=-3.33, P<0.01). Conclusions:The use of target list can improve the implementation rate of treatment and nursing measures for critical patients, improve the level of multidisciplinary cooperation and team satisfaction, reduce the ICU hospitalization time, mechanical ventilation time, the incidence of nursing adverse events, and improve patient safety.

Interpretation of 2022 World Health Organization fungal priority pathogens list / 中华实用儿科临床杂志

The global morbidity of invasive fungal diseases (IFD) tends to increase, especially in immunocompromised people.Due to the atypical symptoms, unclear etiological mechanism, and emerging antifungal resistance, IFD challenge current clinical diagnosis and treatment.The World Health Organization (WHO) developed the first WHO fungal priority pathogens list in 2022.The most concerning fungal pathogens were listed and summarized to promote further understanding of the epidemiology of IFD and antifungal drug resistance.It is hoped to provide a basis for the prevention and interventions of IFD.

Study on French medical insurance payment policy for innovative medical products paid under DRG / 中国药房

OBJECTIVE To analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products. METHODS Taking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS & CONCLUSIONS The additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.

Comparison and enlightenment of anti-infective medicines between WHO model list of essential medicines for children，essential medicine list of WHO and national essential medicine list / 中国药房

OBJECTIVE To provide suggestions and reference for enriching the selection of anti-infective medicines for children in China and promoting the establishment of the Essential Medicine List for Children in China. METHODS Descriptive analysis method was used to statistically compare the differences and similarities of anti-infective medicines included in the World Health Organization Model List of Essential Medicines for Children （EMLc）， World Health Organization Model List of Essential Medicines （EML） and National Essential Medicine List （NEML） in terms of drug category， variety， dosage form， specification， symbol mark， etc. RESULTS All anti-infective medicines of EMLc were covered by EML （85.3%）. NEML lacked the information of anti-infective medicines relatively， and contained few new categories； for example， the third-generation and above cephalosporins in EMLc were not included， and the drug dosage forms were also relatively limited （mainly tablets， capsules and injections）， but the specifications were relatively rich. CONCLUSIONS With reference to EMLc， the guidance on the use of essential medicines for children in China should be added from the aspects of age， body weight， combined medication， etc.， and the dosage forms suitable for children such as oral liquid preparations and scored tablets should be added to NEML； when updating the NEML the newer drugs suitable for children such as cefixime and dacatavir should be included. Finally， with reference to the continuity of EML and EMLc， the Essential Medicine List for Children in China should be established based on NEML to meet the drug needs of children and promote the safe use of drugs in children.

Framework design of WHO and typical national essential medicine lists and its implications for China / 中国药房

OBJECTIVE To sort out the common presentation forms and components of the framework of domestic and foreign essential medicine lists （EMLs）， in order to provide reference for optimizing the framework of the Chinese EML. METHODS The latest edition of the EMLs of WHO， China， South Africa， India， Malaysia and other typical countries were compared， and the similarities and differences of the presentation form and constituent elements of the list framework were analyzed. RESULTS & CONCLUSIONS The common presentation forms of WHO and typical countries’ EMLs included version， classifications and symbols， of which management ideas， functions， and implementation difficulties varied； common framework elements included target population， hospital levels， drug use conditions， core and supplementary lists and procurement priority. Through comparison， it was found that the information covered by the Chinese EML was relatively thin， and the framework design had not yet fully played the ideal role in guiding clinical rational drug use and optimizing the allocation of health resources， and there was still some room for improvement. It is recommended that China clarify the characteristics and roles of different presentation forms of the EML， and reasonably set the EML framework based on national conditions and development needs； the multi-dimensional drug information should be supplemented， such as clinical use， economy， and policy attributes of drugs in the EML， to ensure the rational use of essential drugs； it is also necessary to add “the level of hospitals” in the framework of the EML， refine the management requirements for the allocation and use of essential medicine， and optimize the resource allocation of hospitals.

Current Status of Studies Measuring Health State Utility for 121 Rare Diseases / 罕见病研究

Pharmacoeconomic evaluation is the essential supporting information for the inclusion of rare disease drugs into medical insurance in China. The accurate measurement of the health state utility of rare diseas is of practical significance to the development of rare disease pharmacoeconomic evaluation. Based on the review of pharmacoeconomic evaluation requirements for rare diseases in some countries/regions, we systematically retrieved the published studies on the measurement of health state utility for 121 rare diseases in China and other countries and regions. We identified 17 591 papers in the initial review, and later selected 230 after screening. We also made a comprehensive analysis of the quality of literature, evaluation content and use of tools for measuring health state utility in rare diseases in China. Finally, we analyzed the challenges in measurement in terms of population, instruments use, and application of results and made recommendations based on analysis, hoping to provide reference for the development of rare disease health state utility measurement studies in China.

Behavioural and emotional problems in Malaysian children and adolescents with type 1 diabetes mellitus: A cross-sectional study in a single centre / Journal of the ASEAN Federation of Endocrine Societies

Introduction@#Type 1 diabetes mellitus (T1DM) is an autoimmune disorder that requires a lifelong treatment regimen which may affect psychosocial development.@*Objective@#To identify behavioural and emotional problems in children and adolescents with T1DM.@*Methodology@#A cross-sectional study using the Child Behaviour Check List (CBCL) was conducted among all T1DM patients receiving treatment at the Paediatric Endocrine Unit, Hospital Tunku Azizah Kuala Lumpur, Malaysia.@*Results@#Forty T1DM patients were included. The mean age of the participants was 12.4 years (SD=2.69), with 52.5% males, and 75% Malay. The average duration of illness was 4.8 years, 9 were pre-pubertal, while mean HbA1c was 9.4%. Thirty-five percent of the respondents had parent-reported internalizing problems and 17.5% had parent-reported externalizing problems. Those >12 years old had more internalizing problems (p=0.004) compared to those ≤12 years old. The differences were in the anxious/depressed syndrome subscale (p=0.001) and withdrawn/depressed syndrome subscale (p=0.015). There were no statistically significant differences in the 3 main global scores by gender, glycaemic control, duration of illness and pubertal status by univariate analysis.@*Conclusion@#T1DM patients >12 years old were at higher risk of developing psychosocial difficulties. This highlighted the benefit of screening of behavioural and emotional issues in children and adolescents with T1DM.

Floristic data to support conservation in the Amazonian canga / Dados florísticos para apoiar a conservação nas cangas amazônicas

Abstract Canga is an environment of great natural and economic value because it harbours a considerable number of endemic species on a substrate that is rich in iron ore. In the Amazon, this open vegetation type grows on top of isolated outcrops in a dense forest matrix found in the Carajás region, in southeastern Pará. Of these outcrops, the Parque Nacional dos Campos Ferruginosos (PNCF) is the only area of Amazonian canga with a strict protection status. Therefore, industrial activity in the region needs to implement mitigation actions to ensure species and habitat conservation. The objective of this study is to complement and review the floristic list of this recently created protected area, enabling us to compare the floristic similarity between it and other 14 Amazonian canga outcrops found outside the conservation units of full protection in the region. This data provides a basis to understand the floristic and phylogenetic complementarity of those patches to support conservation action. For this, six field trips were carried out in the Serra da Bocaina and two in the Serra do Tarzan, respectively, in order to increase the sampling efforts in PNCF and to obtain a more comprehensive plant list. Floristic composition was investigated using multivariate analyses (non-metric multidimensional scaling and unweighted pair group method with arithmetic mean) and phylogenetic structure across studied areas. We added 159 species to the floristic list of the PNCF and the results of the analyses showed that all 16 areas (n.b. PNCF comprises two of these sites) have an overall floristic similarity of 42%, with the least similar areas at 35% and the most similar at 50%. The different micro-habitats found in each study site highlight the high beta diversity of the Amazonian canga sites, making each area unique. Therefore, even if the Parque Nacional dos Campos Ferruginosos does not harbour all the species found in the other Amazonian canga sites, it is strategic for the conservation of the vegetation on ferruginous outcrops in the Amazon, protecting its biodiversity, different habitats, and associated ecosystem services.

Resumo Canga é um ambiente de grande valor natural e econômico por abrigar um número considerável de espécies endêmicas sobre substrato rico em minério de ferro. Na Amazônia, esse tipo de vegetação aberta cresce sobre afloramentos isolados em uma matriz de floresta densa encontrada na região de Carajás, no sudeste do Pará. Dentre esses afloramentos, o Parque Nacional dos Campos Ferruginosos (PNCF) é a única área de canga Amazônica que apresenta o status de proteção integral permanente. Dessa forma, a atividade industrial presente na região necessita implementar ações de mitigação para assegurar a conservação de espécies e habitats relacionados às cangas. O objetivo deste estudo é complementar e revisar a lista florística dessa área protegida, recentemente criada, permitindo comparar a sua similaridade florística com outros 14 afloramentos de cangas Amazônicas localizados fora de unidades de conservação de proteção integral encontradas na região. Tais dados fornecem subsídio para entender a complementaridade florística e filogenética desses fragmentos para apoiar ações de conservação. Para isso, foram realizadas seis viagens de coleta à Serra da Bocaina e à Serra do Tarzan, respectivamente, para aumentar o esforço amostral no PNCF e obter uma lista de plantas mais abrangente. A composição florística foi investigada por meio de análises multivariadas (non-metric multidimensional scaling and unweighted pair group method with arithmetic mean) e estrutura filogenética nas áreas estudadas. Nós adicionamos 159 espécies na lista florística do PNCF e os resultados das análises demonstraram que todas as 16 áreas (n.b. o PNCF compreende duas dessas áreas) têm uma similaridade florística total de 42%, com áreas menos similares de 35% e as mais similares de 50%. Os micro-habitats encontrados em cada área de estudo evidenciam a alta diversidade beta das áreas de cangas Amazônicas, o que as tornam únicas. Portanto, ainda que o Parque Nacional dos Campos Ferruginosos não abrigue todas as espécies encontradas em outras áreas de cangas Amazônicas, ele é estratégico para a conservação dos afloramentos ferruginosos na Amazônia, protegendo a sua biodiversidade, os diferentes habitats e os serviços ecossistêmicos associados.

The butterflies (Lepidoptera, Papilionoidea) of the Parque Estadual Intervales and surroundings, São Paulo, Brazil / As borboletas (Lepidoptera, Papilionoidea) do Parque Estadual Intervales e arredores, São Paulo, Brasil

Abstract The Global South has witnessed increasing sampling of its immense biological diversity during the past century. However, the diversity of many regions remains unknown, even at pristine and highly threatened places, such as in the Atlantic Forest; and for bioindicator, umbrella, and flagship groups. The present study reports the first butterfly list of the Parque Estadual Intervales, São Paulo, Brazil and surroundings, a key protected area in the last massive continuous of the Atlantic Forest. We compiled data from museums and four years of field work, under three sampling methods. We also aimed at providing resources to support conservation efforts by analyzing 27 years of climatic data (detailed in the Supplementary Material, in English and in Portuguese), discussing our results also for non-academics, and producing scientific outreach and educational material. A companion article dealt with the experiences of science outreach and capacity development, and illustrated the butterfly catalogue of the species sampled in the park. We found 312 species that sum to 2,139 records. The museum had 229 species (432 records), and we sampled 142 species (1,682 individuals), in a total effort of 36,679 sampling hours (36,432 trap and 247 net and observation hours). The richest families were Nymphalidae (148 species) and Hesperiidae (100 species). Most species were sampled exclusively by active methods (79.8%), but other sources (passive sampling, citizen science, etc.) also found unique records. We found the highest diversity metrics from January to May, and we demonstrated that winter months had less richness and abundance. We illustrated the 20 species common to all regions, and listed those that were found more than seven months in the year, as well as the most abundant species in trap sampling, with forest dwellers as well as species common to open and fragmented areas. The dominant species in our trap datasets was the iridescent white morpho, Morpho epistrophus (Fabricius, 1796), and we suggest it to become the park butterfly mascot.

Resumo O Sul Global testemunhou crescente amostragem de sua imensa diversidade biológica durante o século passado. Entretanto, a diversidade de muitas regiões permanece desconhecida, mesmo em locais pristinos e altamente ameaçados, como na Mata Atlântica; e para grupos bioindicadores, guarda-chuva e emblemáticos. O presente estudo reporta a primeira lista de borboletas do Parque Estadual Intervales, São Paulo, Brasil e arredores, uma unidade de conservação chave no último maciço contínuo de Mata Atlântica. Compilamos dados de museus e quatro anos de campo, sob três métodos de amostragem. Também visamos oferecer recursos para apoiar os esforços de conservação, analisando 27 anos de dados climáticos (detalhados no Material Suplementar, em inglês e em português), discutindo nossos resultados numa linguagem também para não acadêmicos, e produzindo material de divulgação científica e educativos. Um artigo irmão tratou das experiências de divulgação científica e capacitação, e ilustrou o catálogo de borboletas das espécies amostradas no parque. Encontramos 312 espécies em 2.139 registros. O museu tinha 229 espécies (432 registros), e amostramos 142 espécies (1.682 indivíduos), em um esforço total de 36.679 horas de amostragem (36.432 armadilhas e 247 horas de rede e observação). As famílias mais ricas foram Nymphalidae (148 espécies) e Hesperiidae (100 espécies). A maioria das espécies foi amostrada exclusivamente por métodos ativos (79,8%), mas outras fontes (passiva, ciência cidadã, etc.) também encontraram registros únicos. Encontramos as maiores métricas de diversidade de janeiro a maio, e demonstramos que os meses de inverno tiveram menos riqueza e abundância. Ilustramos as 20 espécies comuns a todas as regiões, e listamos aquelas que foram encontradas em mais de sete meses no ano, bem como as espécies mais abundantes em armadilhas, com espécies florestais e também comuns em áreas abertas e fragmentadas. A espécie dominante em nossas armadilhas foi a morfo branca iridescente, Morpho epistrophus (Fabricius, 1796), e sugerimos que se torne a borboleta mascote do parque.

Medication package inserts do not present adequate information on potential risks for older adults in Brazil / Bulas de medicamentos não apresentam informações adequadas sobre potenciais riscos para idosos no Brasil

OBJECTIVE: To compare information on the risks of potentially inappropriate medications (PIMs) for older adults in the Beers criteria with data in the package inserts made available by the Brazilian Health Regulatory Agency. METHODS: This is an observational, cross-sectional study that compared information on the package inserts of 33 brand-name drugs in the Brazilian market with specific recommendations for older adults contemplated in the Beers criteria, categorizing them into: complete, incomplete, absent, or discrepant. RESULTS: Among the analyzed package inserts, 21.21% did not present a specific section dedicated to the use of these drugs by older adults and data were scattered throughout the text; 63.64% were classified as incomplete; 33.33% lacked data; and 3.03% had discrepant information. CONCLUSION: The analyzed package inserts presented incomplete data or lacked information characterizing the drugs as PIMs for older adults. This study demonstrated that some package inserts of drugs used in Brazil are not satisfactory, warranting higher caution in the medical community when prescribing these medications and guiding patients

OBJETIVO: Comparar as informações sobre os riscos de medicamentos potencialmente inapropriados (MPIs) para idosos contidas nos critérios Beers com as informações presentes nas bulas para profissionais de saúde disponibilizadas pela Agência Nacional de Vigilância Sanitária no Brasil. METODOLOGIA: Estudo observacional e transversal que comparou informações das bulas para profissionais de saúde de 33 medicamentos de referência no mercado brasileiro com recomendações específicas para idosos contempladas nos critérios Beers e que foram categorizadas em: completas, incompletas, ausentes ou discrepantes. RESULTADOS: Dentre as bulas dos MPIs analisadas, 21,21% não apresentam seção específica destinada ao uso desses medicamentos por idosos, nas quais as informações estão dispersas pelo texto; 63,64% delas foram classificadas como incompletas; 33,33% tinham informações ausentes; e 3,03% com informações discrepantes. CONCLUSÃO: As bulas analisadas apresentaram dados incompletos ou não apresentam qualquer informação que caracterizasse o medicamento como MPI para idosos. Este estudo demonstra que algumas bulas de medicamentos utilizados no Brasil não estão satisfatórias, sugerindo maior cautela à comunidade médica na prescrição e na orientação aos seus pacientes

Potentially inappropriate prescribing among older patients and associated factors: comparison of two versions of STOPP/START criteria

Abstract The study aimed to estimate and compare the prevalence and type of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs) between the STOPP/START original (v1) and updated version (v2) among older patients in various settings, as well as associated factors. The study included 440 patients attending a community pharmacy, 200 outpatients and 140 nursing home users. An increase in the prevalence of STOPP v2 (57.9%) compared to v1 (56.2%) was not statistically significant in the total sample and within each setting (p>0.05). A decrease in the prevalence of START v1 (55.8%) to v2 (41.2%) was statistically significant (p<0.001) in the total sample and within each setting (p<0.05). Drug indication (32.9%) and fall-risk medications (32.2%) were most commonly identified for STOPP v2, while cardiovascular system criteria (30.5%) were the most frequently detected for START v2. The number of medications was the strongest predictor for both STOPP v1 and v2, with odds ratio values of 1.35 and 1.34, respectively. Patients' characteristics associated with the occurrence of STOPP and START criteria were identified. According to both STOPP/START versions, the results indicate a substantial rate of potentially inappropriate prescribing among elderly patients. The prevalence of PIMs was slightly higher with the updated version, while the prevalence of PPOs was significantly lower