Patients in insulin analogues use via judicial litigation: do they use the Brazilian Public Health System (SUS)? / Pacientes em uso de análogos de insulina via ação judicial: eles utilizam o Sistema Único de Saúde (SUS)?

Abstract Background Studies show that among the drugs most commonly used in judicial litigation in Brazil, are those used to treat diabetes mellitus, especially insulin analogues. Objective Evaluate the use of the Unified Health System (SUS) by patients with type 1 diabetes mellitus (T1DM), who receive insulin analogues through judicial action, before and after this process. Method In a retrospective longitudinal observational study, secondary data was used from these patients in Minas Gerais, Brazil, in 2018. Socio-demographic information was collected and related to the follow-up of these patients in the SUS. The McNemar χ2 test was used to compare the proportions of the variables. Results Of the 89 patients analyzed, women (53.9%) were predominant. Most patients were aged between 20 and 39 years (52.8%), and more than half, 55.1%, use only a private health system. After the judicial action, there was a significant increase (p <0.05) in the number of patients who had consultations in primary health care (from 19.1% to 30.3%) and emergency medical appointments (from 1.1% to 9.0%). Conclusion It is observed that the majority of patients with T1DM via judicial action in the SUS are not monitored by this health system through examinations, consultations, and hospitalizations.

Resumo Introdução Estudos mostram que, dentre os medicamentos mais adquiridos via ação judicial, estão os utilizados para o tratamento do Diabetes Mellitus, especialmente os análogos de insulina. Objetivo Avaliar a utilização do Sistema Único de Saúde (SUS) pelos pacientes com Diabetes Mellitus tipo 1 (DM1), que recebem insulina por meio de judicialização, antes e após este processo. Método Em um estudo observacional longitudinal retrospectivo, foram utilizados dados secundários de pacientes com DM1, que adquiriram insulinas por processos judiciais em Divinópolis-MG, Brasil, em 2018. Foram coletadas informações sociodemográficas e referentes ao acompanhamento destes pacientes no SUS Realizou-se o teste χ2 de McNemar para a comparação das proporções das variáveis utilizadas para a avaliação do acompanhamento antes e após a judicialização. Resultados Dos 89 pacientes analisados, predominou-se o sexo feminino (53,9%), com idade entre 20 e 39 anos (52,8%). 55,1% destes utilizam apenas o sistema privado de saúde. Após a judicialização, houve um aumento significativo (p< 0,05) no número de pacientes que realizaram consultas na atenção primária à saúde (de 19,1% para 30,3%) e consultas médicas de emergência (de 1,1% para 9,0%). Conclusão A maioria dos pacientes com DM1 que judicializam medicamentos no SUS não são acompanhados por este sistema de saúde através de realização de exames, consultas e hospitalizações.

Rastreamento da doença renal do diabetes na atenção primária à saúde / Screening for diabetes kidney disease in primary health care

A Doença Renal do Diabetes (DRD) é assintomática nos estágios iniciais da doença, e por esse motivo, a maioria dos pacientes é diagnosticada somente quando já apresenta várias complicações. O objetivo deste estudo foi avaliar se o rastreio da DRD está sendo realizado de maneira adequada em pacientes com diabetes mellitus tipo 2 (DM2) atendidos na atenção primária à saúde (APS) do Sistema Único de Saúde. Foi realizado um estudo transversal, com duração de cinco meses, na APS dos municípios de Bernardino de Campos e Salto Grande, SP. Os critérios de inclusão foram: diagnóstico de DM2, idade > 18 anos, e ser acompanhado nas unidades participantes do estudo. Um total de 1093 atenderam aos critérios de inclusão e aceitaram participar do estudo. Foi verificado que 398 (36,4%) dos pacientes nunca realizaram os exames de albumina urinária e creatinina, e não tiveram calculados a relação albumina/creatinina em amostra de urina com o cálculo da taxa de filtração glomerular (TFG) estimada pela CKD-EPI a partir da creatinina sérica; 401 (36,7%) dos pacientes realizaram estes exames e tiveram estes índices calculados nos últimos 12 meses. Estes 401 pacientes realizaram estes exames e cálculos de rastreio da DRD uma vez a cada 12 meses nos últimos 5 anos. Os demais pacientes (294; 26,9%) realizaram somente exame de creatinina sérica nos últimos 12 meses. Os resultados demonstraram que o rastreamento da DRD não está sendo realizado de maneira adequada na maioria dos pacientes (AU).

Diabetes Kidney Disease (DRD) is asymptomatic in the early stages of the disease, and for this reason, most patients are diagnosed only when they already have several complications. The aim of this study was to assess whether DRD screening is being carried out properly in patients with type 2 diabetes mellitus (DM2) treated in primary health care (PHC) of the Unified Health System. A cross-sectional study was carried out, lasting five months, in the PHC of the municipalities of Bernardino de Campos and Salto Grande, SP. Inclusion criteria were: diagnosis of DM2, age > 18 years, and being monitored in the units participating in the study. A total of 1093 met the inclusion criteria and agreed to participate in the study. It was found that 398 (36.4%) of the patients had never performed urine albumin and creatinine tests, and they did not calculate the albumin/creatinine ratio in a urine sample, together with the calculation of the glomerular filtration rate (GFR) estimated by CKD-EPI from serum creatinine; in contrast, 401 (36.7%) of the patients underwent these exams and had these indexes calculated in the last 12 months. These 401 patients had these DRD screening tests and calculations performed once every 12 months for the last 5 years. Os demais pacientes (294; 26,9%) realizaram somente exame de creatinina sérica nos últimos 12 meses. Os resultados demonstraram que o rastreamento da DRD não está sendo realizado de maneira adequada na maioria dos pacientes (AU).

Sodium alendronate: proposal and reliability of indicators

Abstract The present study proposes and evaluates the test-retest reliability of indicators of the correct use of sodium alendronate in elderly patients. This is a test-retest reliability study for use of sodium alendronate. Six questions to evaluate the correct use of this medicine were elaborated after analysis of information in the literature. Data collection was performed through questionnaires in face-to-face in-home interviews by previously trained interviewers. The participants were initially interviewed (test) when they agreed to participate in the study, and secondly (retest), after a period of 7 to 14 days from the first interview. The reliability of the questions was evaluated by means of the agreement percentage and the Kappa coefficient. Fifty-seven pairs (test-retest) were obtained. The mean age was 69.3 (SD = 6.9) years, the majority (92.5%) completed elementary education, and declared themselves white (50.9%). All the questions presented high concordance ranging from 79.0% to 98.3%. The Kappa values ranged from 0.1 (low) to 0.83 (very good). The agreement percentage and the Kappa values suggest adequate reliability of the proposed questions. We suggest that they can be used as a simple and quick way to evaluate the quality of sodium alendronate use among the elderly.

Irrational use of alendronate sodium by the elderly / Uso irracional de alendronato de sódio por idosos / Uso irracional de alendronato de sodio en los ancianos

Introduction: The effectiveness and safety of alendronate sodium are dependent on patient adherence to very specific guidelines regarding use. This study aims to estimate the rational use of alendronate sodium in the elderly. Methods: This is a cross-sectional study carried out with a structured questionnaire containing form of use and occurrence of adverse events related to alendronate sodium. The patients were recruited in their own homes. Rational use was considered as being the participants who: a) took the tablet in the morning; b) were fasting; c) waited at least 30 minutes before eating; d) ingested with a full glass of water; e) ingested the whole tablet; f) and remained in the orthostatic position for at least 30 minutes after use. Additionally, the odds ratio (OR) was used to analyze the association between the irrational use of alendronate sodium and the independent variables. Results and Discussion: Of the 248 participants in the study, most of the participants administered the medication in the morning (95.2%), with fasting (89.1%), waited at least 30 minutes to eat the first meal of the day (87.9%), and were in the orthostatic position until the time of the first meal (78.6%), but less than half ingested the tablet with a full glass of water (43.6%). Rational use of the medication was observed in only 30.7% of the participants. Regarding possible adverse events, 13.3% of the participants reported some event. Among the most prevalent were dry cough (6.5%), stomach pain (5.2%) and some throat discomfort (4.8%). The irrational use of this medication is associated with age and education level. Conclusion: The prevalence of irrational use of alendronate sodium in the elderly is high, and this use is associated with patients' sociodemographic factors.

Introdução: A efetividade e segurança do alendronato de sódio são dependentes da adesão dos pacientes em relação às orientações específicas sobre o uso. Assim, este trabalho, tem como objetivo estimar a racionalidade de uso do alendronato de sódio em idosos. Metodologia: Trata-se de um estudo transversal realizado através de um questionário estruturado contendo a forma de utilização e a ocorrência de eventos adversos relacionados ao uso do medicamento. Os pacientes foram recrutados em suas próprias casas. Considerou-se uso racional os participantes que: a) tomaram o comprimido pela manhã; b) em jejum; c) esperaram pelo menos 30 minutos para se alimentar; d) ingeriu com um copo cheio de água; e) ingeriu o comprimido inteiro; f) e permaneceu na posição ortostática por pelo menos 30 minutos após o uso. Adicionalmente, o odds ratio (OR) foi utilizado para analisar associação entre o uso irracional do alendronato de sódio e as variáveis independentes. Resultados e Discussão: Dos 248 participantes do estudo a maioria administravam o medicamento pela manhã (95,2%), em jejum (89,1%), aguardavam pelo menos 30 minutos para realizar a primeira refeição do dia (87,9%), ficavam em posição ortostática até o horário da primeira refeição (78,6%), porém menos da metade ingeria o comprimido com um copo cheio de água (43,6%). O uso racional do medicamento foi observado em apenas 30,7% dos participantes. Em relação aos possíveis eventos adversos, 13,3% dos participantes relataram algum evento. Dentre os mais prevalentes, destacaram-se a tosse seca (6,5%), dor de estômago (5,2%) e algum desconforto na garganta (4,8%). O uso irracional deste medicamento está associado à idade e ao nível de escolaridade. Conclusão: É elevada a prevalência de uso irracional do alendronato de sódio em idosos e este uso está associado a fatores sociodemográficos dos pacientes.

Introducción: La eficacia y seguridad del alendronato sódico dependen de la adherencia de los pacientes en relación con directrices específicas sobre el uso. Por lo tanto, este trabajo tiene como objetivo estimar la racionalidad del uso del alendronato sódico en los ancianos. Metodos: Este es un estudio transversal realizado a través de un cuestionario estructurado que contiene la forma de uso y la ocurrencia de eventos adversos relacionados con el uso de la droga. Los pacientes fueron reclutados en sus propios habitación. Se consideró el uso racional como los participantes que: a) tomaron la tableta por la mañana, b) en ayuno, c) esperaron al menos 30 minutos antes de comer; d) Ingerido con un vaso lleno de agua; e) ingirió toda la tableta, f) y permaneció en la posición ortostática durante al menos 30 minutos después de su uso. Además, el odds ratio (OR) se utilizó para analizar la asociación entre el uso irracional de alendronato de sodio y las variables independientes. Resultados y Discusión: De los 248 participantes en el estudio, la mayoría administró el medicamento por la mañana (95,2%), em ayuno (89,1%), esperó al menos 30 minutos para realizar la primera comida del día (87,9%), estaban en posición ortostática hasta el momento de La primera comida (78,6%), pero menos de la mitad ingeriría el comprimido con un vaso lleno de agua (43,6%). El uso racional de la droga se observó en sólo 30.7% de los participantes. En cuanto a los posibles acontecimientos adversos, el 13,3% de los participantes informaron de algún evento. Entre los más frecuentes, tos seca (6,5%), dolor de estómago (5,2%) Y algunas molestias en la garganta (4,8%). El uso irracional del medicamento está asociado a la ida y al nivel de escolaridad. Conclusión: La prevalencia del uso irracional del alendronato de sodio en los ancianos es alta, y este uso está asociado a factores sociodemográficos de los pacientes.

Profile of activities developed by community pharmacists: do they corroborate the precepts of the pharmaceutical profession?

Studies that addressed the profile of pharmaceutical activities and behaviors in community pharmacies in the last decades pointed to a gap between community pharmacy practice and the precepts of the profession. Facing the need to analyze whether the new legislation has impacted this scenario, the objective of this study was to describe the general profile and academic profile of community pharmacists, and the profile of the activities they develop, as well as to know their place of work. This is a descriptive study, to which all pharmacists in charge of community pharmacies in the metropolitan area of ​​Belo Horizonte-MG (n = 1624) were invited. Data collection was performed through a questionnaire validated online, from October to December 2017, via Google Docs®. Responses were obtained from 109 pharmacists, most of them female, aged 31-40 years, being general graduates, and in private institutions. Pharmacotherapeutic follow-up, an activity linked to clinical management, is performed by only 37.60% of pharmacists, evidencing that there is still a lag in relation to the provision of clinical services by community pharmacists. Thus, we emphasize the importance of implementing the precepts established by Brazilian curricular guidelines for undergraduate pharmacy courses which focus on the development of clinical skills, since the insertion of the pharmacist into the health team and the provision of clinical services to the community can add new value to the use of medications, and contribute effectively to their rational use in Brazil.

A Distance-Learning Course to Improve Drug-Dispensing Behaviors Among Brazilian Community Pharmacists.

Objective. To evaluate the effectiveness of a distance-learning course in the training of pharmacists in drug dispensing. Methods. This interventional study was carried out with community pharmacists throughout Brazil. A 12-week distance-learning course was conducted. Pharmacists' knowledge and performance during drug dispensing were evaluated before and after completion of the course. Results. Community pharmacists' knowledge of drug dispensing was greater after completing the distance-learning course than before (mean=5.7, SD=2.8 points vs mean=3.8, SD=1.9 points, respectively). However, no improvement was observed in pharmacists' drug-dispensing practice. Almost all participants (96.5%) considered that they were more qualified to perform the drug dispensing after the course. There were 1492 pharmacists enrolled in the course, of which 1061 were included in the study, and 472 completed the surveys. Only pharmacists from Ribeirão Preto, Brazil, were invited to take the mytery shopper evaluation (n=26). However, 10 pharmacists completed the mystery shopper encounter. Conclusion. A distance-learning course was effective in improving community pharmacists' knowledge. However, the course did not seem to improve overall drug-dispensing performance. Additional educational strategies should be adopted in future studies to address this gap.

Pharmacists in dispensing drugs (PharmDisp): protocol for a clinical trial to test the effectiveness of distance education in training pharmacists for dispensing drugs

ABSTRACT Dispensing drug is a moment in which the pharmacist is able to analyze pharmacotherapy and contribute to its rational use. However, research has shown that some pharmacists lack adequate knowledge to perform this service. This study aims to describe a research protocol for a clinical trial to test the effectiveness of a distance learning program to train pharmacists in dispensing drugs. This is a protocol for an open diagnostic, non-randomized, single group clinical trial. A 12-week duration distance learning course was structured on the Moodle platform for training community pharmacists who are registered in the Regional Board of Pharmacy and work as employees or owners in Brazilian community pharmacies. The course curricula involves concepts and practice of dispensing drugs applied to the treatment of hypertension, diabetes mellitus, dyslipidemia and asthma. Pharmacists are divided randomly into groups, to which previously selected tutors give directions to the discussion and clarify questions. A validated questionnaire is being used before and after the course to measure participants' knowledge. Participant satisfaction with the course is also being measured. Pharmacists who work in the study headquarters municipality receive two visits from a mystery shopper, before and after the course, to evaluate their performance in dispensing drugs. The virtual platform and the content of the course material were evaluated by judges. The study has been approved by the Research Ethics Committee of the School of Pharmaceutical Sciences of Ribeirão Preto, University of São Paulo. The sample size was estimated to provide desired power for testing the significance of the difference between baseline-to-endpoint change scores. Information about the course is being released through channels such as social networks. The results will be submitted for publication in scientific journals, but information enabling the identification of the study subjects will be kept confidential. The trial has been registered in The Brazilian Clinical Trials Registry with number RBR7mbrp3 on January 15th, 2015.

Implementation of Venous Thromboembolism Prophylaxis Guidelines in Clinical Practice: A Retrospective Study in Two Croatian Hospitals.

The aim of this study was to evaluate the implementation of the 9th edition of the American College of Chest Physicians (ACCP9) guidelines for prevention of venous thromboembolism in nonsurgical patients in clinical practice in one university and one general Croatian hospital. A retrospective study was conducted at Zadar General Hospital from Zadar and Dubrava University Hospital from Zagreb. Medical charts of all patients admitted to Medical Departments in two periods, before and after implementation of the ACCP9 guidelines, were analyzed. The ACCP9 guidelines were made available to all physicians through the hospital electronic information system immediately after the publication. The Hospital Drug Committees promoted implementation of the guidelines during their periodical clinical visits. Overall, 850 patients were included in the study in two periods. There was no statistically significant difference in the number of high-risk patients receiving thromboprophylaxis after the guidelines implementation in either hospital. In both periods, a signifi-cantly higher number of high-risk patients received thromboprophylaxis in Dubrava University Hos-pital in comparison with Zadar General Hospital (31.7% vs. 3.8% and 40.3% vs. 7.3%, respectively; p<0.001). This study revealed insufficient implementation of evidence-based thromboprophylaxis guidelines in clinical practice in two Croatian hospitals.

Study of warfarin utilization in hospitalized patients: analysis of possible drug interactions.

Background Drug-drug interactions in patients taking warfarin may contribute to a higher risk of adverse events. Objective To identify and evaluate the prevalence and characteristics of potential DDIs with warfarin. Methods A cross-sectional study was performed in a Brazilian tertiary hospital. The electronic prescriptions of the patients receiving warfarin between January 2004 and December 2010 were analyzed. Socio-demographic, clinical, and therapeutic variables were collected. Warfarin drug-drug interactions were classified as either risk A, B, C, D, or X according to the Lexi-Interact™ Online database. Results A total of 3048 patients were identified who were prescribed warfarin. Of the 154,161 total drug prescriptions issued, 42,120 (27.3 %) were for warfarin. Evaluation of the prescriptions showed that 63.1 and 0.1 % of patients received concomitant drugs classified as having class D or X risk. It was found that 20,539 (48.7 %) prescriptions had at least one drug with a D or X risk. Patients were prescribed an average of 1.4 (±0.4) concomitant medications with a class D or X warfarin-DDI risk, the most frequent being acetylsalicylic acid and amiodarone. Conclusion The results demonstrate a high prevalence of concomitant drug prescriptions with the potential for clinically relevant DDIs with warfarin, the most frequent being acetylsalicylic acid and amiodarone.

A Systematic Review of the Effects of Continuing Education Programs on Providing Clinical Community Pharmacy Services.

Objective. To summarize the effects of media methods used in continuing education (CE) programs on providing clinical community pharmacy services and the methods used to evaluate the effectiveness of these programs. Methods. A systematic review was performed using Medline, SciELO, and Scopus databases. The timeline of the search was 1990 to 2013. Searches were conducted in English, Portuguese, and Spanish. Results. Nineteen articles of 3990 were included. Fourteen studies used only one media method, and the live method (n=11) was the most frequent (alone or in combination). Only two studies found that the CE program was ineffective or partially effective; these studies used only the live method. Most studies used nonrobust, nonvalidated, and nonstandardized methods to measure effectiveness. The majority of studies focused on the effect of the CE program on modifying the knowledge and skills of the pharmacists. One study assessed the CE program's benefits to patients or clients. Conclusion. No evidence was obtained regarding which media methods are the most effective. Robust and validated methods, as well as assessment standardization, are required to clearly determine whether a particular media method is effective.

Evaluation of the effectiveness of an Internet-based continuing education program on pharmacy-based minor ailment management: a randomized controlled clinical trial

ABSTRACT The aim of this work was to evaluate the effectiveness of an internet-based continuing education (CE) program on pharmacy-based minor ailment schemes (PMASs). A controlled randomized clinical trial was conducted in community pharmacies in Brazil. Community pharmacists (CPs) were enrolled in two groups: intervention (n = 61) and control (n = 60). CPs who were enrolled to the intervention group participated in an Internet-based CE program. CPs in the control group received no educational intervention. We evaluated participant perception, learning outcomes, and practice performance. Learner satisfaction with the CE program was high for every point evaluated (mean ± standard deviation = 4.2 ± 0.4). Posttest learner outcome scores and practice performance in the intervention group after the conclusion of the CE program significantly improved compared with pretest scores (p < 0.001) and were significantly better compared with the control group (p < 0.001). The present Internet-based CE program is a viable educational strategy for improving participant perception, learning outcomes, and practice performance in PMASs.

RESUMO O objetivo desse trabalho foi avaliar a efetividade de um programa de educação continuada (EC) à distância, relacionado ao gerenciamento clínico de problemas autolimitados de saúde em farmácias comunitárias. Realizou-se um ensaio clínico controlado randomizado em farmácias comunitárias no Brasil. Os farmacêuticos comunitários foram alocados em dois grupos: intervenção (n = 61) e controle (n = 60). Os farmacêuticos comunitários do grupo intervenção participaram de um programa de EC à distância. Os farmacêuticos comunitários do grupo controle não receberam intervenção educativa. A percepção dos participantes, os resultados de aprendizagem e hábitos de prática foram avaliados. A satisfação dos estudantes com o programa de CE foi elevada em todos os momentos avaliados (média ± desvio padrão = 4,2 ± 0,4). Os escores de aprendizagem e prática aumentaram significativamente ao final do estudo em relação ao início do estudo (p < 0,001) e foram significativamente melhores que os do grupo controle (p < 0,001). O presente programa de EC à distância é uma estratégia educacional viável para melhorar a percepção dos participantes, os resultados da aprendizagem e hábitos de prática relacionados ao gerenciamento clínico de problemas autolimitados de saúde em farmácias comunitárias.

Economic evaluation of a pharmaceutical care program for elderly diabetic and hypertensive patients in primary health care: a 36-month randomized controlled clinical trial.

BACKGROUND: Most diabetic and hypertensive patients, principally the elderly, do not achieve adequate disease control and consume 5%-15% of annual health care budgets. Previous studies verified that pharmaceutical care is useful for achieving adequate disease control in diabetes and hypertension. OBJECTIVE: To evaluate the economic cost and the incremental cost-effectiveness ratio (ICER) per quality-adjusted life-year (QALY) of pharmaceutical care in the management of diabetes and hypertension in elderly patients in a primary public health care system in a developing country. METHODS: A 36-month randomized controlled clinical trial was performed with 200 patients who were divided into a control group (n = 100) and an intervention group (n = 100). The control group received the usual care offered by the Primary Health Care Unit (medical and nurse consultations). The intervention group received the usual care plus a pharmaceutical care intervention. The intervention and control groups were compared with regard to the direct costs of health services (i.e., general practitioner, specialist, nurse, and pharmacist appointments; emergency room visits; and drug therapy costs) and the ICER per QALY. These evaluations used the health system perspective. RESULTS: No statistically significant difference was found between the intervention and control groups in total direct health care costs ($281.97 ± $49.73 per patient vs. $212.28 ± $43.49 per patient, respectively; P = 0.089); pharmaceutical care added incremental costs of $69.60 (± $7.90) per patient. The ICER per QALY was $53.50 (95% CI = $51.60-$54.00; monetary amounts are given in U.S. dollars). Every clinical parameter evaluated improved for the pharmaceutical care group, whereas these clinical parameters remained unchanged in the usual care group. The difference in differences (DID) tests indicated that for each clinical parameter, the patients in the intervention group improved more from pre to post than the control group (P < 0.001). CONCLUSIONS: While pharmaceutical care did not significantly increase total direct health care costs, significantly improved health outcomes were seen. The mean ICER per QALY gained suggests a favorable cost-effectiveness.

Adverse drug reactions in elderly patients following discharge from an internal medicine clinic.

OBJECTIVE: The aim of this study was to evaluate the incidence and type of adverse drug reactions (ADRs) and identify risk factors for ADRs in elderly patients within 30 days following discharge from an internal medicine clinic. METHODS: A prospective observational study was conducted at the Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia, between September 1(st) and November 30(th) 2012. Patients aged ≥ 65 years discharged from the clinic during the study period were eligible for inclusion in the study. The follow-up visit was scheduled ~ 30 days after discharge. During the visit, the patients were assessed for the occurrence of ADRs. Two independent physicians evaluated each possible ADR by using the Naranjo ADR probability scale. Multivariate logistic regression analysis was used to identify predisposing factors for ADRs. RESULTS: There were 209 patients included in this study. A total of 72 ADRs were detected in 63 (30.1%) patients. The most frequent ADRs were bleeding disorders associated with warfarin therapy, followed by hypoglycemia associated with antidiabetics. Five (6.9%) ADRs, which resulted in hospital admission, were classified as serious. Multivariate logistic regression analysis indicated number of prescribed drugs ≥4 and prescription of furosemide and warfarin to be associated with increased risk of ADRs. CONCLUSIONS: Our study showed that ADRs are an important cause of morbidity in elderly patients after hospital discharge. Judicious prescription of drugs and careful and frequent monitoring of drug therapy are necessary to reduce the risk of ADRs.

Peripheral mononeuropathy associated with valproic acid poisoning in an adult patient.

OBJECTIVE: To present the case of axillary nerve neuropathy associated with valproic acid (VPA) poisoning. CASE REPORT: A 26-year-old man was hospitalized because of a suicide attempt with VPA overdose. Toxicology analysis revealed high serum VPA level (2,896 µmol/L; therapeutic range: 350 - 690 µmol/L). Three days after admission, the patient complained of weakness in his right arm. Neurological examination revealed weakness of flexion and abduction of the right arm and loss of sensation in the skin over the lateral upper right arm. A nerve conduction velocity test was normal in the ulnar, radial, median, musculocutaneous, and suprascapular nerves. Compound muscle action potential showed reduced amplitude and prolonged latencies in the right axillary nerve taken from Erb's point and absent taken from distal stimulation point. Right axillary nerve paresis was diagnosed and the patient underwent a physical therapy program, which resulted in gradual recovery. DISCUSSION: In the presented case, other possible causes of neuropathy were excluded by medical history, laboratory and radiological tests, and clinical course of the disease.The temporal relationship between the VPA poisoning and the occurrence of neuropathy supports the hypothesis of a VPA-caused axillary neuropathy. According to the Naranjo's Adverse Drug Reaction (ADR) Probability Scale, VPA-induced neuropathy was rated "probable". CONCLUSION: VPA-induced neuropathy may be a serious ADR, but it is potentially preventable and reversible. Thus, clinicians should be aware of this rare ADR.

Pharmacoepidemiologic study of warfarin prescription in a Brazilian tertiary hospital.

Warfarin is among the ten drugs most commonly involved in adverse drug reactions, has a narrow therapeutic index and complex dosage regimen, exhibits enormous variability dose-response and high risk drug-drug interactions. To analyze the profile of pharmacoepidemiological drug prescriptions for warfarin in patients admitted to a Brazilian tertiary hospital. In the cross sectional study the electronic prescriptions of the January 01, 2004-December 31, 2010 of patients using warfarin of the Clinical Hospital of the Faculty of Medicine of Ribeirao Preto were analyzed. Sociodemographic characteristics, clinical data, laboratory test results, and drug therapy data were collected. We identified 3,048 patients who received 154,161 drug prescriptions, 42,120 of which contained warfarin. The mean age was 55.8 ± 19.3 years, 48.2% were elderly, and 4.3% had specific cerebrovascular disease diagnoses. The average International Normalized Ratio (INR; 2.4 ± 1.7) and warfarin dose (5.1 ± 1.8 mg/day) were within therapeutic protocol recommendations. However, approximately 14.0 and 8.5% of the patients had mean INR greater than 3.0 and 3.5, respectively. In addition, 66.4 and 6.1% of the patients received polypharmacy and clopidogrel, respectively, which can increase the risk of drug-drug interactions and bleeding. The average number of drugs per prescription was 7.2 ± 3.8, and 31,595 drug prescriptions (74.0%) consisted of five or more drugs. The study found a high prevalence of elderly patients, polypharmacy, and concomitant use of anticoagulant and antiplatelet drugs, which may favor the occurrence of adverse events.

Use of simulated patients to evaluate combined oral contraceptive dispensing practices of community pharmacists.

BACKGROUND: Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. OBJECTIVE: To evaluate the COC dispensing practices of CPs in a developing country. METHOD: A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21(®) (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients' medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. RESULTS: Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., "do you smoke?" (n = 2) and "what is your age?" (n = 1). None of the CPs measured the patient's blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. CONCLUSION: The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure.

Actual drug-drug interactions in elderly patients discharged from internal medicine clinic: a prospective observational study.

PURPOSE: The aim of the study was to evaluate the incidence and type of actual drug-drug interactions (DDIs) that result in adverse drug reactions (ADRs) or diminished therapeutic effect in elderly patients within 30 days of discharge from an internal medicine clinic. METHODS: A prospective observational study was conducted at the Internal Medicine Clinic of University Hospital Dubrava, Zagreb, Croatia, between October and December 2011. Patients aged ≥ 65 years discharged from the Internal Medicine Clinic during the study period with a prescription for two or more medications were eligible for inclusion in the study. A total of 222 patients were ultimately enrolled in the study. For each patient, potential DDIs were identified using Lexi-Interact software. The follow-up visit was scheduled approximately 30 days after discharge. Causality between DDIs and ADRs or diminished therapeutic effect of drugs was assessed by two independent clinicians. RESULTS: Potential DDIs were identified in 190 (85.6 %) patients. Actual DDIs were detected in 21 (9.5 %) patients. In 19 patients, DDIs resulted in an ADR. Diminished therapeutic effect resulting from DDIs was detected in two patients. Angiotensin-converting enzyme inhibitors were the drug class most frequently associated with DDI-related ADRs. CONCLUSIONS: A significant incidence of actual DDIs suggests that DDIs play an important role in patient safety. Drug therapy should be initiated if absolutely necessary, and the number of drugs used to treat elderly patients should be minimized to reduce the incidence of DDI-related adverse patient outcomes.

HLA typing in Brazilian boys with aromatic antiepileptic drug-induced DRESS.

CASES DESCRIPTION: We report two cases of drug rash with eosinophilia and systemic symptoms (DRESS) associated with the use of carbamazepine and phenytoin in Brazilian boys tested for human leukocyte antigen (HLA) class I and II alleles. The clinical manifestations were similar: a maculopapular eruption progressing to exfoliative erythroderma, fever, and lymphadenopathy. Leukocytosis, atypical lymphocytes, and liver injury were also observed. Assessment of causality using the Naranjo algorithm established a "probable" relationship (score 6) in both cases. Case 1 patient presented the following results of HLA typing: HLA-A*02,29 B*44,50 C*06,16 DRB1*01,07 DQA1*01,02. Case 2 patient presented the following results of HLA typing: HLAA*23,24 B*39,53 C*04,07 DRB1*04,08 DQA1*03,05 DQB1*03,03. CONCLUSION: Neither of the cases reported here presented HLA typing similar to that strongly associated with the occurrence of DRESS in Asian or European patients.

Pharmacoepidemiological profile and polypharmacy indicators in elderly outpatients

This cross-sectional study was carried out with 1000 elderly outpatients assisted by a Basic Health District Unit (UBDS) from the Brazilian Public Health System (SUS) in the municipality of Ribeirão Preto. We analyzed the clinical, socioeconomic and pharmacoepidemiological profile of the elderly patients in order to identify factors associated with polypharmacy amongst this population. We used a truncated negative binomial model to examine the association of polypharmacy with the independent variables of the study. The software SAS was used for the statistical analysis and the significance level adopted was 0.05. The most prevalent drugs were those for the cardiovascular system (83.4%). There was a mean use of seven drugs per patient and 47.9% of the interviewees used >7 drugs. The variables that showed association with polypharmacy (P value < 0.01) were female gender, age >75 years, self-medication, number of health problems, number of medical appointments, presence of adverse drug events, use of over-the-counter drugs, use of psychotropic drugs, lack of physical exercise and use of sweeteners. The exposition to all these factors justified the high prevalence of polypharmacy amongst the interviewees. These results showed the need to adopt clinical intervention and educational and managerial measures to analyze and promote rationality in the use of drugs amongst the elderly users of SUS.

Este estudo transversal foi realizado por meio de entrevistas com 1000 idosos atendidos em uma Unidade Básica Distrital de Saúde (UBDS) do Sistema Único de Saúde (SUS) no município de Ribeirão Preto. Analisou-se o perfil clínico, socioeconômico e farmacoepidemiológico a fim de identificar os fatores associados à polifarmácia nessa população. Utilizou-se um modelo binomial negativo truncado para análise da associação da polifarmácia com as variáveis independentes do estudo. O software SAS foi utilizado para a análise estatística. O nível de significância adotado foi de 0,05. Os fármacos com maior prevalência de uso foram do sistema cardiovascular (83,4%). Observou-se média de, aproximadamente, sete fármacos por paciente e 47,9% dos entrevistados usavam >7 fármacos. As variáveis que apresentaram associação com a polifarmácia (p< 0,01) foram: mulheres, idade (>75 anos), automedicação, quantidade de problemas de saúde, número de consultas médicas, uso de medicamentos isentos de prescrição médica, uso de psicotrópicos, não realização de exercícios físicos e uso de adoçante. A exposição a todos esses fatores justifica a alta prevalência de polifarmácia entre os entrevistados. Os resultados mostraram a necessidade de adotar medidas de intervenção clínica e educacional e gerencial para analisar e promover a racionalização do uso de fármacos entre os idosos usuários do SUS.

Adverse drug reactions caused by drug-drug interactions in elderly outpatients: a prospective cohort study.

PURPOSE: Although the prevalence of drug-drug interactions (DDIs) in elderly outpatients is high, many potential DDIs do not have any actual clinical effect, and data on the occurrence of DDI-related adverse drug reactions (ADRs) in elderly outpatients are scarce. This study aimed to determine the incidence and characteristics of DDI-related ADRs among elderly outpatients as well as the factors associated with these reactions. METHODS: A prospective cohort study was conducted between 1 November 2010 and 31 November 2011 in the primary public health system of the Ourinhos micro-region, Brazil. Patients aged ≥60 years with at least one potential DDI were eligible for inclusion. Causality, severity, and preventability of the DDI-related ADRs were assessed independently by four clinicians using validated methods; data were analysed using descriptive analysis and multiple logistic regression. RESULTS: A total of 433 patients completed the study. The incidence of DDI-related ADRs was 6 % (n = 30). Warfarin was the most commonly involved drug (37 % cases), followed by acetylsalicylic acid (17 %), digoxin (17 %), and spironolactone (17 %). Gastrointestinal bleeding occurred in 37 % of the DDI-related ADR cases, followed by hyperkalemia (17 %) and myopathy (13 %). The multiple logistic regression showed that age ≥80 years [odds ratio (OR) 4.4; 95 % confidence interval (CI) 3.0-6.1, p < 0.01], a Charlson comorbidity index ≥4 (OR 1.3; 95 % CI 1.1-1.8, p < 0.01), consumption of five or more drugs (OR 2.7; 95 % CI 1.9-3.1, p < 0.01), and the use of warfarin (OR 1.7; 95 % CI1.1-1.9, p < 0.01) were associated with the occurrence of DDI-related ADRs. With regard to severity, approximately 37 % of the DDI-related ADRs detected in our cohort necessitated hospital admission. All DDI-related ADRs could have been avoided (87 % were ameliorable and 13 % were preventable). The incidence of ADRs not related to DDIs was 10 % (n = 44). CONCLUSIONS: The incidence of DDI-related ADRs in elderly outpatients is high; most events presented important clinical consequences and were preventable or ameliorable.