Research progress in immune checkpoint inhibitors for the treatment of cervical cancer / 国际生物医学工程杂志

Cervical cancer is a common gynecological malignancy. Currently, synchronous radiotherapy and chemotherapy based on the single drug cisplatin are the standard treatment regimen for locally advanced cervical cancer. Compared with simple radiotherapy and chemotherapy, the use of immunosuppressive combination regimens in concurrent radiotherapy and chemotherapy is more likely to improve local control and reduce distant metastasis. In recent years, immune checkpoint inhibitors (ICIs) have been widely studied as potential therapeutic targets for cervical cancer. Immunocheckpoint inhibitors can improve the activation of immune cells and enhance the body’s anti-tumor immunity. In this paper, the mechanism of immune checkpoint inhibitors was summarized, and the therapeutic effects of various monoclonal antibodies were reviewed to provide a new perspective for immunotherapy in patients with cervical cancer.

Mining and analysis of risperidone adverse event signals based on FAERS database / 中国药房

OBJECTIVE To provide reference for safe use of risperidone in clinic. METHODS Data mining and analysis of risperidone-related adverse drug event （ADE） reports from the first quarter of 2017 to the third quarter of 2021 in the United States FAERS database were carried out using reported odds ratio and composite criteria methods from Medicines and Healthcare Products Regulatory Agency. RESULTS There were 101 181 ADE reports with risperidone as the primary suspect drug，involving a total of 33 179 patients. Among those reports，the male-to-female ratio was about 6.21 to 1； most of them were ＜18 years old （15.01%）； ADE was mainly reported by consumers （69.74%） and mainly reported by the United States （79.72%）； oral dosage form was the most used，accounting for 83.71%. A total of 409 ADE signals were obtained，including male breast development， pseudogynecomastia，abnormal increase in body mass，hyperprolactinemia and Wellens syndrome，etc. Twenty-six systems and organs were involved，mainly including reproductive system and breast diseases，various injuries，poisoning and operational complications， mental diseases，metabolic and nutritional diseases，and various nervous system diseases，etc. CONCLUSIONS The common ADE signals of risperidone and the system involved are consistent with the instructions，but we should also be alert to the ADE not recorded in the instruction，such as Wellens syndrome，fibroproliferative endocarditis，cavernous degeneration of portal vein，rabbit syndrome，etc.

Signal mining and analysis of adverse drug events of abatacept based on FAERS database / 中国药房

OBJECTIVE To provide a reference for the safe use of abatacept in clinic. METHODS Based on the United States FDA Adverse Event Reporting System （FAERS） database， the generic name of the drug “abatacept” and the trade name “Orencia” were used as the search keywords to retrieve drug adverse event （ADE） signal of abatacept as primary suspected drug. The reported odds ratio method and proportional reporting ratio method in the proportional imbalance method and Excel 2020 software were used to mine and analyze the signals. RESULTS A total of 93 189 abatacept-induced ADE reports were retrieved， mainly female cases （75.98%）， and the age was mainly concentrated in 18-64 years old （35.17%）； main countries reporting data were the United States （47.41%） and Canada （30.59%）， and the number of reports was generally increasing year by year. A total of 3 092 ADE signals were screened， of which the signals associated with the primary disease were similar to those described in the drug instruction of abatacept， such as rheumatoid arthritis， arthralgia， joint swelling， etc.； followed by ADE signals related to infusion reactions， including pain， fatigue， rash， etc. All selected ADE signals involved 27 system organ classes， mainly involved systemic diseases and drug site conditions， musculoskeletal and connective tissue diseases， injury， poisoning and surgical complications， infections and invasive diseases， gastrointestinal diseases， neurological diseases， respiratory， thoracic and mediastinal diseases， heart diseases， benign， malignant and unspecified tumors and reproductive system and breast diseases， etc. A total of 22 ADE signals were not included in the drug instructions of abatacept among the top 50 ADE signals in the number list of reported cases， including fatigue， drug intolerance， abdominal discomfort， swelling， lupus erythematosus， peripheral swelling， cell sores， diarrhea， elevated liver enzymes and lower respiratory tract infection， etc. CONCLUSIONS In the process of clinical use of abatacept， special attention should be paid to infection and its carcinogenicity， while assessing the risk of respiratory and cardiovascular system diseases in patients； when patients suffer from these two underlying diseases， the pros and cons should be weighed carefully before selecting drug； in addition， the drug-induced ADE in the neurological， gastrointestinal and reproductive system cannot be ignored.

Mining and analysis of adverse drug event signals related to mepolizumab / 中国药房

OBJECTIVE To provide reference for rational clinical use of mepolizumab. METHODS The reporting odds ratio method and Bayesian confidence propagation neural network method were used to conduct signal mining and analysis of adverse drug event （ADE） reports related to mepolizumab in the United States Food and Drug Administration Adverse Event Reporting System from the first quarter of 2016 to the third quarter of 2022. RESULTS A total of 57 501 ADE reports were extracted with mepolizumab as the primary suspect drug， involving 16 358 patients. Among these reports， the proportion of males （23.51%） was lower than females （50.48%）. The reporting countries were primarily the United States （51.91%） and Canada （29.94%）. Consumers （71.18%） constituted the main reporting population. A total of 172 ADE-positive signals were identified， mainly involving 13 system organ classes such as the respiratory， thoracic and mediastinal disorders （41.63%）， as well as infectious and parasitic diseases （14.16%）. There were 60 high-risk signals， including 15 that were explicitly mentioned or related to adverse reactions in the drug instructions of mepolizumab and 45 signals （such as asthmatic crisis， sputum discoloured， purulent sputum， sleep disorder due to a general medical condition） were newly identified high-risk signals. Among them， 11 high-risk signals exhibited gender or age differences. CONCLUSIONS When clinically using mepolizumab， in addition to the adverse reactions mentioned in the drug instruction， special attention should also be given to changes in the nature of sputum， painful respiration， and sleep disorders.

Adverse drug event signal mining of semaglutide based on FDA Adverse Event Reporting System database / 中国药房

OBJECTIVE To exc avate the adverse drug event （ADE）signals of semaglutide and provide reference for its clinical rational use. METHODS The proportional unbalance method was used to mine the signals of all semaglutide ADE reports from FDA Adverse Event Reporting System （FAERS）up to September 2021. The basic situations of the reported cases were analyzed. The corresponding system organ classification （SOC）was mapped and compared with the adverse drug reactions recorded in the drug instructions. Preferred terms （PT）of patients with different indications were analyzed. RESULTS A total of 6 661 semaglutide ADE reports were extracted and 194 valid signals were mined. Among 6 661 cases of ADE ，the proportion of men （43.40％）was lower than women （52.65％）；the age was mainly distributed in ＞40-65 years old （29.00％）and ＞65 years old （22.61％）；the reporting country was mainly the United States （83.88％）；the report year was mainly concentrated in 2021 （40.88％），with an increasing trend year by year ；the main outcome was hospitalization or prolonged hospitalization in serious ADE reports （17.78％）. Semaglutide ADE signal was mapped to the main SOC ，mainly including gastrointestinal diseases ，various injuries，poisoning and operation complications ，metabolic and nutritional diseases ，various examinations. The screening criteria were based on the report odds ratio ＞10 or ADE reported cases ＞50，and 48 new potential adverse drug reactions were added to the drug description. Among the indications with the top two reported cases （type 2 diabetes and obesity ，overweight，weight control），the frequency of gastrointestinal system related ADE reports represented by nausea ，vomiting and diarrhea was higher ， which was similar to the drug instructions. CONCLUSIONS This study supplemented 48 new potential adverse drug reactions based on the drug instructions of semaglutide. At present ，it can be considered that semaglutide is safe.

Polimedicación, prescripción inapropiada y eventos adversos a fármacos en ancianos hospitalizados: un problema de seguridad del paciente / Polymedication, inappropriate prescription and adverse events to drugs in hospitalized elderly: a patient safety problem / Polimedicação, prescrição inadequada e eventos adversos a medicamentos em idosos hospitalizados: um problema para a segurança do paciente

RESUMEN Introducción: La esperanza de vida ha ido en aumento y la posibilidad de padecer una o más patologías crónicas, por ejemplo, diabetes mellitus, hipertensión arterial, etc. es alta. La respuesta a los medicamentos en los adultos mayores es marcadamente diferente que en los adultos no ancianos pues se trata de un organismo donde las consecuencias directas del envejecimiento son de relevancia (reducción de la capacidad metabólica del hígado, reducción de la capacidad de filtrado del riñón, hipoclorhidria, entre otros). Objetivo: Analizar la polifarmacia, la prescripción inapropiada y los eventos adversos en adultos mayores hospitalizados. Materiales y métodos: Estudio descriptivo de corte transversal. Resultados: Se estudiaron 318 pacientes. La frecuencia de pacientes polimedicados fue 89 % (283). La prescripción inapropiada, 18,9 %. Los fármacos mayormente presentes en los esquemas de pacientes polimedicados fueron benzodiacepinas, AINEs, anticoagulantes y antihipertensivos. Los pacientes con eventos adversos han sido 179 (56,3 %), de ese porcentaje un 30,2 % (54) ha recibido tratamiento con otro medicamento para resolver el evento producido por un medicamento, eso es la llamada cascada de prescripción o de medicamentos. Conclusiones: La polimedicación es alta y causa eventos adversos, es necesario insistir en el trabajo integral para reducir este problema sanitario.

SUMMARY Introduction: Life expectancy has been increasing and the possibility of suffering from one or more chronic pathologies, for example, diabetes mellitus, arterial hypertension, etc. is high. The response to medications in older adults is markedly different than in non-elderly adults since it is an organism where the direct consequences of aging are relevant (reduction of the metabolic capacity of the liver, reduction of the filtering capacity of the kidney, hypochlorhydria, among others). Objective: To analyze polypharmacy, inappropriate prescription, and adverse events in hospitalized older adults. Materials and methods: Descriptive cross-sectional study. Results: 318 patients were studied. The frequency of polymedicated patients was 89 % (283). Inappropriate prescription, 18.9 %. The drugs most present in the regimens of polymedicated patients were benzodiazepines, NSAIDs, anticoagulants and antihypertensives. Patients with adverse events have been 179 (56.3 %), of that percentage 30.2 % (54) have received treatment with another drug to resolve the event produced by a drug, which is the so-called prescription or prescription cascade. Conclusions: Polypharmacy is high and causes adverse events, it is necessary to insist on comprehensive work to reduce this health problem.

RESUMO Introdução: A expectativa de vida vem aumentando e a possibilidade de sofrer de uma ou mais patologias crónicas, como por exemplo, diabetes mellitus, hipertensão arterial etc. é alta. A resposta aos medicamentos em idosos é marcadamente diferente da de adultos não idosos, pois é um organismo onde as consequências diretas do envelhecimento são relevantes (redução da capacidade metabólica do fígado, redução da capacidade de filtragem do rim, hipocloridria, entre outros). Objetivo: Analisar polifarmácia, prescrição inadequada e eventos adversos em idosos hospitalizados. Materiais e métodos: Estudo transversal descritivo. Resultados: 318 pacientes foram estudados. A frequência de pacientes polimedicados foi de 89% (283). Prescrição inadequada, 18,9%. Os medicamentos mais presentes nos esquemas dos pacientes polimedicados foram benzodiazepínicos, AINEs, anticoagulantes e anti--hipertensivos. Os pacientes com eventos adversos foram 179 (56,3%), desse percentual 30,2% (54) receberam tratamento com outro medicamento para resolução do evento produzido por um medicamento, que é a chamada prescrição ou receita em cascata. Conclusões: A polifarmácia é elevada e causa eventos adversos, é necessário insistir em um trabalho abrangente para reduzir esse problema de saúde.

Pharmacist intervention can reduce the potential use of inappropriate drugs medications in Indonesian geriatric patients

Intervention study design by pharmacists to doctors using face-to-face interviews conducted in this study aimsto analyze potentially inappropriate medications (PIMs) with prospective data collection in the geriatric ward ofRegional General Hospital Dr.M. M. Dunda Gorontalo, Indonesia in the period from January to March 2018. Thesampling technique was a total sampling design and obtained by the end of the study were 123 patients. Results ofanalysis with Beers and screening tool of older people’s prescriptions (STOPP) from 123 patients found 54 PIMs in48 patients (39.0%) based on Beers criteria and 6 patients (6.3%) based on STOPP criteria. Bivariate analysis showedthat there was a significant relationship between the incidence of adverse drug events (ADEs), with unresolved PIMswith a relative risk value at 1.55 (95% CI 1.26:1.91), p = 0.007 and a correlation coefficient (r) of 0.332. Based on theresults of univariate and bivariate statistical analysis, it can be concluded that there are still many PIMs occurring inthe prescription of geriatric patients based on Beers and STOPP criteria and pharmacists have a large enough role toreduce the incidence of PIMs so that the prevalence of ADEs due to inappropriate use of the drug can be minimized atRegional General Hospital Dr. M. M. Dunda Gorontalo, Indonesia.

A prospective study on drug utilization pattern of anti-diabetic drugs in a tertiary care teaching hospital of eastern Uttar Pradesh, India

Background: Diabetes mellitus is a metabolic disorder with common denominator of hyperglycemia, arising from a variety of pathogenic mechanisms. The aim of the study was to evaluate the drug utilization pattern of anti-diabetic drugs in diabetic patients and observe adverse drug events (ADEs) associated with anti-diabetic therapy in a prospective way.Methods: A prospective study was carried out in diabetic patients visiting the Departments of General Medicine in a tertiary care teaching hospital. Demographic data, drug utilization pattern and ADEs due to Anti-diabetic drugs were summarized.Results: In the present study, 153 (54%) of the 282 diabetic patients were males and 129 (46%) were females. Majority of patients were in the age group of 51-60 years (31.20%) and most of the patients (31.56%) had a diabetic history of 11-15 years. Metformin was the most commonly prescribed drug (64.89%). Majority of the patients (36.87%) were on multidrug therapy. Co-morbid condition was found in 232 patients (82.26%) where hypertension (22.69%) being the most common co-morbid condition. 32 ADRs were observed with Nausea being the most common ADR reported.Conclusions: The present study helps to find out current prescribing pattern of oral diabetic medications with different co-morbidities with respect to diagnosis, cost of treatment and it also highlight the need for comprehensive management of diabetic patients, including life style changes, dietary control, hypoglycemic agents, cardiovascular prevention, treatment of complications and co-morbidity. Therefore, through the existing prescribing patterns, attempts can be made to improve the quality and efficiency of drug therapy.

Qualidade de vida e eventos adversos de pacientes com epilepsia farmacorresistente em uso de lamotrigina / Quality of life and adverse events of patients with drug-resistant epilepsy using lamotrigine

Modelo do estudo: Estudo transversal. Introdução: O tratamento farmacológico é a primeira opção para o tratamento da epilepsia, e cerca de 40% dos pacientes necessitam de politerapia para melhor controle das crises epilépticas, o que pode estar associado ao aumento de eventos adversos e comprometimento da qualidade de vida. Objetivos: Avaliar a qualidade de vida de pacientes com epilepsia farmacoresistente em uso de lamotrigina (LTG), bem como verificar a associação dos eventos adversos dos antiepilépticos com a qualidade de vida. Metodologia: Este estudo transversal foi realizado com 75 pacientes com epilepsia farmacorresistente em uso LTG atendidos em um Ambulatório de Epilepsia de Difícil Controle de Ribeirão Preto-SP, no período de maio/2011 a abril/2012. As variáveis clínicas analisadas foram a qualidade de vida (Quality of Life in Epilepsy - Qolie-31) e o perfil de eventos adversos (AEP ­ Adverse Events Profile Questionnaire). Dados sociodemográficos e farmacoterapêuticos foram coletados através dos prontuários dos pacientes. Este trabalho foi aprovado pelo Comitê de Ética em Pesquisa do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo (HCFMRP-USP), cujo número do processo é 8791/2010. Resultados: Os eventos adversos mais frequentes foram sonolência e dificuldade de concentração. Além disso, observou-se baixos escores em todos os domínios relacionados à qualidade de vida (Qolie-31). Conclusão: A qualidade de vida possui associação inversamente significativa com os eventos adversos, nos pacientes em uso de antiepilépticos (p<0,01). (AU)

Study design: Cross-sectional study. Introduction: Pharmacological treatment is the first option to treat epilepsy, and about 40% of patients require polytherapy to better control epileptic seizures, which may be associated with an increase in adverse events and impairment of quality of life. Objective: To evaluate the quality of life of patients with pharmacoresistant epilepsy using lamotrigine (LTG), as well as to verify the association of adverse events with antiepileptic drugs with quality of life. Methods: This cross-sectional study was carried out with 75 patients with drugresistant epilepsy using LTG, in a Clinic of Epilepsy of Difficult Control of Ribeirão Preto-SP, from May/2011 to April / 2012. The clinical variables analyzed were Quality of Life in Epilepsy (QOLIE31) and the Adverse Events Profile Questionnaire (AEP). Socio-demographic and pharmacotherapeutic data were collected through patient records. This study was approved by the Research Ethics Committee of the General Hospital of the Medical School of Ribeirão Preto of the University of São Paulo (HCFMRP-USP), whose case number is 8791/2010. Results: The most frequent adverse events were somnolence and difficulty concentrating. In addition, low scores were observed in all domains related to quality of life (Qolie-31). Conclusion: Quality of life has an inverse association with adverse events in patients using antiepileptic drugs (p <0.01). (AU)

Assessment of the Latent Adverse Events of Antipsychotic Treatment Using a Subjective Questionnaire in Japanese Patients with Schizophrenia

OBJECTIVE: The adverse effects of antipsychotic agents can have a marked influence on medication adherence. In this study, we investigated the adverse events of antipsychotics that are less likely to be reported by patients and the reasons why such symptoms remain latent. METHODS: Data were collected by interviewing patients using a subjective questionnaire, and the associations between unreported symptoms and background factors were investigated. RESULTS: A total of 306 patients with schizophrenia or schizoaffective disorder were examined. Their major symptoms were daytime sleepiness (50.0%), weight gain (42.2%), and sexual dysfunction (38.9%). Sexual dysfunction was nominal significantly more common among the patients that had been treated with antipsychotic agent polypharmacy (odds ratio [OR], 2.14; 95% confidence interval [CI], 1.07 to 4.30), and was nominal significantly more common among outpatients (OR, 1.78; 95% CI, 1.02 to 3.13). Only approximately 30% of the patients had reported their symptoms to their physicians. CONCLUSION: Patients receiving antipsychotic treatment tolerate some symptoms and do not feel able to report them to their physicians. The most common reason for this is an insufficient patient-physician relationship. Sexual dysfunction is especially hard to identify because it is a delicate problem, and our findings demonstrate that subjective questionnaires are helpful for detecting such symptoms.

Prescripción inapropiada en adultos mayores hospitalizados / Inappropriate prescription in elderly inpatients

Una de las causas prevenibles de los eventos adversos a medicamentos (EAM) en la población adulta mayor es la prescripción inapropiada, (PIM), es decir aquella prescripción donde los riesgos superan los beneficios clínicos. Se propone conocer la incidencia de PIM con los criterios de Beers, los Screening tool of older person´s prescriptions (STOPP), la omisión de prescripción apropiada (PPO) con Screening tool to alert doctors to right treatment (START) y los costos medios de hospitalización. Es un estudio de incidencia de una muestra de pacientes > 64 años, internados en el periodo enero-julio 2014 en un hospital universitario. Se halló una incidencia de PIM de 61.4% con los criterios de Beers, 65.4% con STOPP y 27.6% de PPO con START. Se calculó una tasa de EAM de 15.2 EAM/100 admisiones y 18.6 EAM/1000 días paciente. El OR de EAM con PIM según Beers y STOPP fue 1.49 (IC95% 1.68-4.66) y 1.17 (IC95% 0.62-2.24) respectivamente. El costo de hospitalización en pacientes con EAM fue mayor que sin EAM (p = 0.020). Los resultados de PIM son similares a la mayoría de los estudios publicados, aunque levemente mayores para Beers y STOPP y menores para START. La tasa de EAM es inferior a la encontrada por Kanaan (18.7% vs. 15.2%). Hay una contribución de PIM a la aparición de EAM.

One of the causes of preventable adverse drug events (EAM) in the older adult population is the inappropriate prescription (PIM), i.e. that prescription where risks outweigh clinical benefits. The aim of this study is to determine the incidence of PIM with Beers criteria and Screening Tool of older person´s prescriptions (STOPP), Potentially Prescribing Omissions (PPO) with Screening Tool to alert doctors to Right Treatments (START), and the average costs of hospitalization. This is an incidence study on a sample of patients over 64 years hospitalized, from January to July 2014 at a university hospital. According to Beers criteria, PIM incidence was 61.4%, 65.4% with STOPP and 27.6% PPO with START. The EAM rate calculated was 15.2/100 admissions and 18.6 EAM / 1000 patient days. The OR of EAM with PIM according to Beers and STOPP was 1.49 (IC95% 1.68-4.66) and 1.17 (IC95% 0.62-2.24) respectively. The average cost of hospitalization in patients with EAM were higher than without EAM (p = 0.020). PIM results are in line with most of the studies cited, but slightly higher for Beers and STOPP and lower for START, and the rate of EAM is lower than the data found by Kanaan (18.7% vs. 15.2%). PIM contributes to the appearance of EAM. The costs of hospitalizations with EAM are higher than those without EAM, achieving level of significance.

Uso da vitamina K como rastreador de eventos adversos hemorrágicos por varfarina: um estudo de caso / Use of vitamin K to track hemorrhagic adverse events caused by warfarin: a case study

The medical use of warfarin requires close monitoring because of its narrow therapeutic index. Thus, methods that enable effective monitoring to detect any adverse events (AEs) associated with this drug are necessary to improve the quality of health care. Many authors have proposed the use of triggers to search actively for possibleAEs. The aim of this study was to assess the possible use of vitamin K as a tracker of adverse bleeding events caused by warfarin in a public hospital specialized in cardiology in Rio de Janeiro. We applied the method of trigger tools (Institute for Healthcare Improvement, 2004; Rozichet al., 2003), which retrospectively analyzed the results of the use of vitamin K (phytomenadione), to screen for adverse bleeding events caused by warfarin, from October 2010 to March 2011. From an analysis of 46 medical records, 14 possible AEs were found. In 23 cases, internal bleeding was the cause of hospitalization. Despite difficulties, especially those related to poor access to data and quality of hospital records, the application of vitamin K as a trigger was found to be of great use in detecting hemorrhagic AEs associated with warfarin. This method has potential applications for monitoring the results of interventions, with a view to reducing the incidence of hemorrhagic adverse events...

O uso de varfarina requer monitoramento rigoroso devido a seu índice terapêutico estreito. Da mesma forma, a aplicação de métodos que permitam o monitoramento adequado de eventos adversos a este medicamento é necessária para que se possa contribuir com a qualidade do cuidado em saúde. O uso de marcadores para o processo de busca ativa de eventos adversos tem sido proposto por muitos autores. Neste trabalho, buscou-se avaliar o potencial de utilização do uso da vitamina K como rastreador de eventos adversos hemorrágicos causados por varfarina em um hospital público de alta complexidade em cardiologia do Rio de Janeiro. O método dos rastreadores ou trigger tools foi aplicado para análise retrospectiva da utilização da vitamina K (fitomenadiona) como rastreador de eventos adversos hemorrágicos causados por varfarina, no período de outubro de 2010 a março de 2011. Com base na análise de 46 prontuários, foram encontrados 14 possíveis eventos adversos. Em 23 casos, a hemorragia foi a causa da internação. Apesar das dificuldades, sobretudo relacionadas ao acesso às informações e à qualidade dos registros, a aplicação da vitamina K como rastreador se mostrou bastante útil na detecção de eventos adversos hemorrágicos por varfarina. A aplicação deste método como estratégia de monitoramento de eventos adversos, tem potencial para uso no acompanhamento dos resultados de intervenções visando à redução da incidência dos eventos adversos hemorrágicos...

Polypharmacy and Adverse Drug Events Leading to Acute Care Hospitalization in Japanese Elderly / General Medicine

<b>Background: </b>Elderly patients are considered to be at risk of developing adverse drug events (ADEs) because they tend to receive a greater number of medications. The purpose of our study is to determine the prevalence of ADEs related to polypharmacy and causative admissions of patients in Japanese acute care hospitalization.<br><b>Methods: </b>In retrospective cohort study, we analyzed 700 consecutive elderly patients admitted to the department of medicine of a Japanese community hospital in 2011. ADEs were defined by World Health Organization–Uppsala Monitoring Centre criteria. Polypharmacy was defined as five or more medications.<br><b>Results: </b>The mean age was 79.5 years (men, 54%). The mean number of medications was 6.36 +/− 4.15 (maximum, 26). Polypharmacy was observed in 63% of cases. ADEs were identified in 4.9% (95% CI, 3.5–6.7%). The mean numbers of medications among patients with ADEs and those without ADEs were 9.3 +/− 3.4 and 6.2 +/− 4.1, respectively. A greater number of medications was significantly associated with ADEs (p < 0.001). Polypharmacy was identified in 91% of patients with ADEs, while it was noted in 62% of patients without ADEs (p = 0.001). Using logistic regression analysis, polypharmacy was significantly associated with ADEs (Odds ratio 5.89, 95% CI 1.74–19.9). The highest number of ADEs were identified among patients on antiplatelets or anticoagulants (n = 8), followed by benzodiazepines and NSAIDs (n = 4 for both). The most common ADEs were gastrointestinal bleeding, nausea and congestive heart failure.<br><b>Conclusion: </b>ADEs complicated to about 5% of acute care elderly hospitalizations in Japan. Polypharmacy was significantly associated with these ADEs.

Intervention Effect of “Intelligent Interactive Software for Drug Monitoring Warning” / 中国药师

Objective:To analyze the intervention effect of a successfully created platform“intelligent interactive software for drug monitoring warning” on the decrease of medication errors and adverse drug events,and the increase of the drug treatment level. Meth-ods:The intensive care unit ( ICU) of our hospital was selected as the experiment group, and the ICU of the other two hospitals was used as the contrast group. During the first 18 months, both groups were without intervention. During the latter 18 months, the plat-form was used in the experiment group, and the clinical pharmacists employed alerts of the system in the practice of interaction with doctors to correct the medication errors. No intervention was performed in the contrast group. In addition, all adverse drug events in both groups were surveyed. Results:During the first period, 50 preventable adverse drug events were discovered with the incidence of 6. 8% in the experimental group. During the second period, the correct rate of the alerts was 97. 7%. Through the effective interven-tion,the alerts and their percentage in the prescriptions were from the maximum of 68 and 1. 1% to the minimum of 6 and 0. 1%. To-tally 17 preventable adverse drug events were found with the incidence of 2. 4% after the intervention. The decline was significant, 848 991 yuan of hospitalization expenses was saved, and 294 days of the length of stay were shortened. There was no change in the contrast group, and there was no change in unpreventable adverse drug events in the two groups before and after the intervention. Conclusion:The intelligent interactive software for drug monitoring warning can examine many sorts of medication errors,and decline the inci-dence rate of preventable adverse drug events in ICU. However, it needs to continuously improve the intelligence. Clinical pharmacists need to master the relevant conditions of patients to detect the irrational drug use based on the clinical practice for each patient.

Effect of Clinical Pharmacist Interventions on Prevention of Adverse Drug Events in Surgical Intensive Care Unit / 대한구급학회지

BACKGROUND: A pharmacist's participation in medical rounds in intensive care unit (ICU) is becoming popular nowadays. In this study, we investigated the effect of pharmacologic intervention by a pharmacist's participation in medical round in ICU on prevention of adverse drug events (ADEs). METHODS: From March 2011 to July 2011, the intervention data were obtained by participating in medical round two or three times a week, and by reviewing electronic medical records of patients admitted to surgical ICU. The incidence, cause, and type of ADEs were noted, respectively. Expected cost avoidance was calculated from interventions, which were considered to be preventive of ADEs. The acceptance rate of pharmacologic interventions was noted. RESULTS: Among 2781 patients, a total of 159 intervention data were collected in 90 patients. Recommendation for drug dosage adjustment or monitoring in patients with potential overdose and sub-therapeutic dose made up 82% of the total interventions. In 8% of interventions, initiation of drug therapy was recommended. 83% of the interventions were accepted and the acceptance rate of interventions within 24 hrs was 58%. The rate of the interventions, which were considered to be preventive of ADEs was 62%. Expected cost reduction obtained by preventing ADEs was 25,867,083 Won during a 5-month period. CONCLUSIONS: A pharmacist's participation in physician rounds in ICU was associated with prevention of ADEs and subsequent reduction of the cost in drug therapy.

Comparison Between Beers Criteria and Screening Tool of Older Person's Prescriptions as a Screening Tool for the Detection of Potentially Inappropriate Medicines and Adverse Drug Events in the Elderly Patients

BACKGROUND: Beers criteria are used to identify the potentially inappropriate medications (PIMs) in elderly patients. However, the criteria have limitations such as lacking consideration of drug-drug and duplicated prescriptions. The aim of this study is to compare the efficacy of newly developed screening tool of older person's prescriptions (STOPP) with Beers criteria in identifying PIMs and adverse drug events (ADEs) in elderly patients. METHODS: We included 115 elderly patients older than 65 years who visited the outpatients' clinic or have been hospitalized for medical illness. Comprehensive geriatric assessments including medication review by the pharmacists were performed by the multidisciplinary team. Beers criteria and STOPP were used to find out PIMs. The association between PIMs defined by both criteria with ADEs was also evaluated. RESULTS: A total of 59 patients (50.4%) by Beers criteria and 76 patients (65.0%) by STOPP had been prescribed with PIMs. Compared with Beers criteria, STOPP had advantage in identifying more PIMs. In addition, STOPP could identify more ADEs related medications than Beers criteria. STOPP was also useful to detect duplicate drug class prescription and nonsteroidal anti-inflammatory drugs for renal impaired patients. CONCLUSION: STOPP criteria PIMs can detect more duplicated prescription and are significantly associated with avoidable ADEs in older individuals compared with that of Beers criteria PIMs.

A pilot study on area under curve of mycophenolic acid as a guide for its optimal use in renal transplant recipients.

Background & objectives: The immunosuppressants administered to renal transplant subjects are usually monitored therapeutically to prevent graft rejection and drug toxicity. Mycophenolic acid (MPA) is an immunosuppressant. The present prospective study was undertaken to establish the utility of plasma level monitoring of MPA and to correlate it with clinical outcomes in renal transplant receipients. Methods: MPA plasma level at 2, 4 and 9 h and the area under concentration-time curve (AUC) were estimated using high performance liquid chromatography in 24 renal transplant recipients receiving immunosuppressant MPA plus tacrolimus and steroid. Results: There was wide inter-individual variation in MPA plasma level and the AUC. The incidences of gastrointestinal adverse drug events (diarrhoea and acidity) were significantly more in the high MPA AUC patients. Though biopsy proven acute rejection was not found, of the six subjects with lower MPA AUC (<30 mg.h/l), three were clinically diagnosed to develop tacrolimus nephrotoxicity. The Gastrointestinal Symptom Rating Scale (GSRS) and Gastrointestinal Quality of Life Index (GIQLI) scores represented better health related quality of life in lower MPA AUC than in the higher MPA AUC (>60 mg.h/l). Interpretation & conclusions: The present findings suggest the MPA AUC of 30 - 60 mg.h/l in the maintenance stage of renal transplant patients to have optimum clinical benefit and relegated adverse events profile indicating the usefulness of AUC of MPA with limited sampling strategy in optimizing its use.

Pharmacovigilance: healthcare professionals' role in benefits versus harm analysis of drugs use / La vigilancia farmacológica: el papel de los profesionales del cuidado de la salud en el análisis de los beneficios versus riesgos de los medicamentos: análisis del uso de los medicamentos

Monitoring the negative effect of drugs is a concept that all healthcare professionals would be aware of as part of their professional responsibility. However, since 1968, it has evolved into a structured science called 'Pharmacovigilance'. This review aims to sensitize Caribbean healthcare professionals to the global pharmacovigilance network of the World Health Organization and how their active involvement at the national level is imperative to the benefit versus harm evaluation of drugs.

El monitoreo de los efectos negativos de los medicamentos es un concepto del cual todos los profesionales del cuidado de la salud debían tener conciencia como parte de su responsabilidad profesional. Desde 1968, este monitoreo se ha venido transformando en una ciencia estructurada conocida como "Vigilancia farmacológica", o "farmacovigilancia". El presente examen se dirige a sensibilizar a los profesionales del cuidado de la salud caribeños con la red de vigilancia farmacológica global de la Organización Mundial de la Salud, y a que tomen conciencia de cómo su participación activa a nivel nacional es indispensable para la evaluación de los beneficios y riesgos de los medicamentos.

Imported Malaria in Korea: a 13-Year Experience in a Single Center

The incidence of imported malaria has been increasing in Korea. We reviewed data retrospectively to evaluate the epidemiology, clinical features, and outcomes of imported malaria from 1995 to 2007 in a university hospital. All patients diagnosed with imported malaria were included. Imported malaria was defined as a positive smear for malaria that was acquired in a foreign country. A total of 49 patients (mean age, 35.7 year; M : F = 38 : 11) were enrolled. The predominant malarial species was Plasmodium falciparum (73.5%), and the most frequent area of acquisition was Africa (55.1%), followed by Southeast Asia (22.4%) and South Asia (18.4%). Fourteen-patients (30.6%) suffered from severe malaria caused by P. falciparum and 1 patient (2.0%) died of multiorgan failure. Most of the patients were treated with mefloquine (79.2%) or quinine (10.2%); other antimalarial agents had to be given in 13.2% treated with mefloquine and 44.4% with quinine due to adverse drug events (ADEs). P. falciparum was the most common cause of imported malaria, with the majority of cases acquired from Africa, and a significant number of patients had severe malaria. Alternative antimalarial agents with lower rates of ADEs might be considered for effective treatment instead of mefloquine and quinine.

Reacciones y eventos adversos por medicamentos en ancianos que consultan un servicio de urgencias / Adverse drug reactions and adverse drug events in elderly patients consulting a hospital emergency unit

Objetivo: Determinar eventos adversos y reacciones adversas medicamentosas en ancianos que consultan a un servicio de urgencias. Dise±o: Estudio observacional comparativo de corte transversal. Pacientes y métodos: Se estudiaron 400 pacientes (>60 a±os) que consultaron al servicio de urgencias del Hospital de Caldas (Manizales, Colombia) (marzo-mayo 2004). Se evaluaron variables demogrßficas, diagnóstico primario al ingreso, enfermedades asociadas, uso de medicamentos, el estado funcional (índice de Barthel) y el tipo y severidad de los eventos y reacciones adversas a medicamentos. Se realizo anßlisis bivariado y regresión logística. Resultados: El promedio de edad fue 72.8±8.2 a±os en su mayoría mujeres (52.3%). La frecuencia de eventos y reacciones adversas a medicamentos fue 6.8%. Los sistemas orgßnicos comprometidos mßs frecuentes fueron gastrointestinal (48.1%), endocrino y metabólico (37%). El 28.3% no tomaban medicamentos. El promedio de uso de medicamentos por paciente fue 2.9±1.7. Los grupos de medicamentos mßs utilizados fueron antiplaquetarios, hipoglicemiantes, diuréticos, analgésicos-AINEs y cardiovasculares. En el anßlisis bivariado el estado funcional y el número de medicamentos se asociaron con los eventos y reacciones adversas a medicamentos (OR=3.5 IC 95% 1.58-7.87, OR=3.5, IC 95% 1.6-7.82; respectivamente), sin embargo, en el anßlisis multivariado el número de enfermedades asociadas fue la única variable asociada (OR=3.2, IC 95% 1.95-5.42). Conclusiones: Los eventos y reacciones adversas a medicamentos son una causa frecuente, importante y no bien estudiada de ancianos que consultan los servicios de urgencia. El número de enfermedades fue el principal determinante de riesgo de ingreso al servicio de urgencias.

Objective: To determine adverse drug events (ADE) and adverse drug reactions (ADR) in elderly patients consulting a third level hospital emergency unit (EU). Design: Cross sectional study. Patients and methods: Four hundred patients aged sixty years or older consulting the EU (Caldas Hospital, Manizales, Colombia) (March-May 2004). Data on demographic characteristics, primary diagnosis, associated conditions and evaluation of medications intake were taken from the clinical records. Functional state was measured according with BarthelÆs index. Type and severity of ADE and ADR were categorized. Algorithms were used for ADR operational assessment. Results: The mean of age of patients was 72.8±8.2 years, and 52.3% were females. Frequency of ADE and ADR was 6.8%. Organic systems affected were 48.1% gastrointestinal, 37% endocrine and metabolic. 28.3% of the patients were not on medication. Mean use of medications per patient was 2.9±1.7. Type of medications involved, in order of frequency, was antiplatelet, hypoglicemic, diuretic, NSAIDs and cardiovascular. Intake of medication (Odds Ratio (OR)=3.52, (IC95% =1.58-7.87), and functional status (OR=3.54 (IC95% = 1.6-7.82) were associated factors for emergency unit admission for ADE or ADR. In the logistic regression the presence of an associated illness constituted the only independent associated factor for hospitalization (OR=3.2 IC 95% 1.95-5.42). Conclusions: ADE and ADR are frequent, important and not well studied causes for consultation of elderly patients at the EU. The number of associated illness was the main risk factor for hospitalization by ADE or ADR.