Concordance analysis of two databases to search for potential drug interactions in onco-hematologic patients.

INTRODUCTION: Potential drug interactions exert a significant impact on patient safety, especially within intricate onco-hematological treatments, potentially resulting in toxicity or treatment failures. Despite the availability of databases for potential drug interaction investigation, persistent heterogeneity in concordance rates and classifications exists. The additional variability in database agreement poses further complexity, notably in critical contexts like onco-hematology. AIM: To analyze the concordance of two databases for researching potential drug interaction in prescriptions for hematological patients at a University Hospital in the Midwest region of Brazil. METHOD: Cross-sectional study developed in a Brazilian hospital. The search for potential drug interaction was conducted in Micromedex® and UpToDate®. The variables were: the presence of potential drug interaction, severity, mechanism, management, and documentation. Data was analyzed in terms of frequency (absolute and relative), Cohen's kappa, and Fleiss kappa. RESULTS: The presence of potential drug interaction, showed a lack of concordance between the databases (k = -0.115 [95% CI: 0.361-0.532], p = 0.003). Regarding the mechanism, a strong agreement was observed (k = 0.805, p < 0.001 [95% CI: 0.550-0.941]). The management concordance showed a fair agreement, 46.8% (k = 0.22, p < 0.001 [95% CI: 0.099-0.341]). Stratifying the categories, significant concordance was observed in "Adjustment of dose + Monitoring" (k = 0.302, p = 0.018) and "Monitoring" (k = 0.417, p = 0.001), while other categories did not reach statistical significance. CONCLUSION: Our study emphasizes the variability in potential drug interaction research, revealing disparities in severity classification, management recommendations, and documentation practices across databases.

Hospitalizations and deaths related to adverse drug events worldwide: Systematic review of studies with national coverage.

PURPOSE: Adverse drug events are related to negative outcomes in healthcare, including hospitalization, increased duration of hospital stay and death. The aim of this study was to conduct a systematic review to evaluate hospitalizations and deaths related to adverse drug events worldwide, reported in studies with national coverage. METHODS: The protocol was registered in PROSPERO (CRD42020157008). We performed a systematic search on Medline, Embase, CINAHL, LILACS, and the Cochrane Library (until March 2020) using pre-specified terms. We included published studies that reported data on hospitalizations and/or deaths related to adverse drug events from a national perspective and the use of secondary data as a source of information. Two reviewers independently extracted and synthesized data. The quality of the studies was assessed using an adapted version of the Joanna Briggs Institute critical appraisal checklist for prevalence studies. Narrative summaries of findings were undertaken. RESULTS: Among 59,336 citations, 62 studies were included for data extraction and synthesis. Among these studies, 41 studies included the outcome of hospitalization, 16 included the death outcome, and five included both outcomes. Administrative databases regarding discharges and registries of vital statistics were the most common sources of information. The relative frequency of hospitalizations ranged from 0.03% to 7.3%, and from 9.7 to 383.0/100,000 population, whereas mortality rate ranged from 0.1 to 7.88/100,000 population. CONCLUSION: Our study highlights information about adverse drug events using large administrative databases in a national scenario and provides an overview of databases and methods implemented to detect adverse drug events.

Institutional strategies as a mechanism to rationalize the negative effects of the judicialization of access to medicine in Brazil.

BACKGROUND: Recently, the Executive Branch and Judiciary in Brazil increased spending due to larger numbers of lawsuits that forced the State to provide health goods and services. This phenomenon, known as health judicialization, has created challenges and required the Executive Branch and Judiciary to create institutional strategies such as technical chambers and departments to reduce the social, economic and political distortions caused by this phenomenon. This study aims to evaluate the effects of two institutional strategies deployed by a Brazilian municipality in order to cope with the economic, social and political distortions caused by the phenomenon of health judicialization regarding access to medicines. METHODS: A longitudinal study was carried out in a capital in the Central-West Region of Brazil. A sample of 511 lawsuits was analyzed. The variables were placed into three groups: the sociodemographic characteristics and the plaintiffs' disease, the characteristics of the claimed medical products and the institutional strategies. To analyze the effect of the interventions on the total cost of the medicines in the lawsuits, bivariate and multivariate linear regressions with variance were performed. For the categorical outcomes, Poisson regressions were performed with robust variance, using a significance level of 5%. RESULTS: A reduction in the costs of medicines in the lawsuits and of the requests for medicines within the SUS formulary was verified after the deployment of the Department of Assessment of Nonstandardized Medicines (DAMNP) and the Technical Chamber of Health Assessment (CATS); an increase in processed prescriptions from the Brazilian Universal Health System was observed after the deployment of the CATS; and an increase in medicines outside the SUS formulary without a therapeutic alternative was verified after the CATS. CONCLUSION: The institutional strategies deployed were important tools to reduce the high costs of the medicines in the lawsuits. In addition, they represented a step forward for the State, provided a benefit to society and indicated a potential path for the health and justice systems of other countries that also face problems caused by the judicialization of health.

Administrative cases: an effective alternative to lawsuits in assuring access to medicines?

BACKGROUND: Although public policy in Brazil supports access to essential medicines, the health system cannot meet all demand. Increasingly, the population has used legal demands to seek access to medicines, an approach that can undermine equitable access by creating policy inconsistencies (e.g., granting access to medicines outside the SUS formulary). In response, the Executive Branch has signed institutional agreements to create an administrative case for submitting requests for medicines directly to the Executive Branch. The objective of this study was to assess the degree to which the administrative cases for requests are in accordance with public policies and guidelines, e.g., if administrative cases results in fewer decisions to purchase outside the SUS formulary. METHODS: This descriptive study used secondary data from lawsuits filed against the Executive Branch from 2003 to 2015 and from administrative cases granted by the Executive Branch from 2010 to 2015 in the capital of a state located in the central-western region of Brazil. The variables included plaintiffs' sociodemographic characteristics and diseases as well as the characteristics of the medical products sought via the processes. RESULTS: Comparing the requests submitted through lawsuits and the administrative cases revealed differences in the incomes of plaintiffs and the costs of medicines. Both methods for submission recorded requests for medicines for diseases of endocrine and circulatory systems; the only difference was the prevalence of diseases of the genitourinary system in the lawsuits. A higher proportion of lawsuits sought medicines outside the SUS formulary with therapeutic alternatives, while medicines outside the SUS formulary without an alternative were more commonly requested in administrative cases. CONCLUSION: Administrative cases adhere to the public policies and guidelines of the SUS. The administrative cases results in fewer decisions to purchase outside the SUS formulary with alternative, and more decisions to purchase drugs for which there is a formulary alternative. In addition, administrative cases provide greater equity by favoring lower income applicants. However, administrative cases also reveal deficiencies in the State's implementation of existing pharmaceutical policies. The public pressure for effective implementation of existing policies may help expand access to medicines.

Internal quality control for cervical cytopathology: comparison of potential false-negatives detected at rapid prescreening and at 100% rapid review.

OBJECTIVE: To evaluate the performance of rapid prescreening (RPS) and 100% rapid review (RR-100%) as internal quality control (IQC) methods assessed by outcome at colposcopy, histopathology and repeat cytopathology for cases with false-negative results on cervical cytopathology at routine screening (RS). STUDY DESIGN: Out of 12,208 cytology smears analyzed, 900 were abnormal. Of these, 656 were identified at RS, and 244 were false-negative, with 90.2% identified at RPS and 57.4% at RR-100%. Of the 900 abnormal cases, 436 were submitted for additional testing. RESULTS: Of the 244 women with cytopathological abnormalities identified only by the IQC methods, 114 had supplementary examinations: 35 were submitted for colposcopy, 22 for biopsy and 99 for repeat cytopathology. The sensitivity of RPS for the detection of abnormalities identified on colposcopy, histopathology and repeat cytopathology was 87.5% (95% CI 67.6-97.3), 82.4% (95% CI 56.6-96.2) and 95.7% (95% CI 85.2-99.5), respectively. The sensitivity of RR-100% was 54.2% (95% CI 32.8-74.4), 52.9% (95% CI 27.8-77.0) and 47.8% (95% CI 32.9-63.1), respectively. RPS was more sensitive than RR-100% when compared to the findings on colposcopy (p = 0.011) and repeat cytopathology (p = 0.000). When compared to colposcopy, histopathology and repeat cytopathology, the sensitivity of RS was 83.2% (95% CI 76.1-88.9), 85.7% (95% CI 78.1-91.5) and 73.3% (95% CI 66.0-79.7), respectively. CONCLUSION: RPS performed better than RR-100% when compared to the results of colposcopy and repeat cytopathology.

Mortality and years of life lost related to adverse drug events in Brazil.

OBJECTIVE: To assess regional and national mortality and years of life lost (YLL) related to adverse drug events in Brazil. METHODS: This is an ecological study in which death records from 2009 to 2018 from the Mortality Information System were analyzed. Codes from the International Classification of Diseases 10th revision (ICD-10) that indicated drugs as the cause of death were identified. The number of deaths and the YLL due to adverse drug events were obtained. Crude, age- and gender-specific, and age-adjusted mortality rates and YLL rates per 100,000 inhabitants were formed by year, age group, gender, and Brazilian Federative Unit. Rate ratios were calculated by comparing rates from 2009 to 2018. A joinpoint regression model was applied for temporal analysis. RESULTS: For the selected ICD-10 codes, a total of 95,231 deaths and 2,843,413 YLL were recorded. Mortality rates from adverse drug events increased by a mean of 2.5% per year, and YLL rates increased by 3.7%. Increases in rates were observed in almost all age groups for both genders. Variations in rates were found between Federative Units, with the highest age-adjusted mortality and YLL rates occurring in the Distrito Federal. CONCLUSIONS: The numbers and rates of deaths and YLL increased during the study period, and variations in rates of deaths and YLL were observed between Brazilian Federative Units. Information on multiple causes of death from death certificates can be useful for quantifying adverse drug events and analyzing them geographically, by age and by gender.

External quality control of cervical cytopathology: interlaboratory variability.

OBJECTIVE: To compare the variability of screening tests held at laboratories with the Unit for External Quality Control (UEQC), checking the frequency of cases that were discordant, false-positive, false-negative, unsatisfactory or that had a delay in clinical management and diagnostic agreement. MATERIALS AND METHODS: The study analyzed 10,053 screening tests from January 2007 to December 2008, including all positive cases, all those that fall under unsatisfactory and at least 10% of negative screening tests. The magnitude of the agreement was analyzed using the kappa coefficient. RESULTS: Out of the 10,053 cases analyzed, 7.59% were considered disagreeing, and it was estimated that 1.1% were false-negative. There was a delay in the clinical procedure regarding 2.44% cases. There were 2.82% of cases identified as false-positive and 1.24% as unsatisfactory. The diagnostic agreement was excellent (kappa = 0.81). The agreement of most laboratories concerning screening tests was classified as very good. The agreement of the sample adequacy was reasonable (kappa = 0.30) and the agreement regarding the representation of epithelia was considered excellent. CONCLUSION: Most laboratories showed very good agreement; however, it is worthy of note that to establish the standardization of diagnostic criteria, and enhance the accuracy of screening and improve the quality of cytopathology test results, it is necessary to perform external quality control.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data.

OBJECTIVE: To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS: Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS: Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS: The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

"A lack of information keeps us from medicine, well-being, harmony ": a mixed method study with plaintiffs requesting medicines in administrative cases. / "A falta de informação nos afasta do remédio, do bem-estar, da harmonia...": estudo de método misto com demandantes de medicamentos pela via administrativa.

The need to request public health managers to ensure the right of access to medicines characterizes an administrative case and the method to do so is called the administrative route. This mixed method study aimed to analyze the perceptions of plaintiffs requesting medications by the administrative route about barriers to access medicines in the Brazilian public health sector. Data were gathered through focus groups and questionnaires. The results point to the interdependence of pharmaceutical services with the interfacing areas to ensure access. The barriers related to individuals reflect the commitment to develop citizenship, justifying the cost of the medicine to motivate the demand. Barriers to service provision include irregular availability of medicines, insufficient resources, and unsatisfactory quality of services. The difficulty in obtaining medical consultations and prescriptions originating in the public sector are barriers to the health sector. The barriers above the health sector are compliance with administrative procedures, corruption, and clientelism. The administrative route intensifies inequities in access to healthcare in Brazil.

A necessidade de recorrer ao gestor público de saúde para efetivar o direito ao acesso a medicamentos caracteriza a via administrativa. O estudo analisou as percepções dos usuários que acionaram a via administrativa sobre as barreiras para o acesso a medicamentos no setor público de saúde de uma capital brasileira. Foi realizado estudo de método misto com grupo focal, questionário com demandantes e descrição dos medicamentos demandados pela via administrativa. Os resultados apontam a interdependência da assistência farmacêutica com as áreas de interfaceamento para a garantia do acesso. As barreiras relativas aos indivíduos refletem o comprometimento do desenvolvimento da cidadania, justificando o custo do medicamento motivar a demanda. As barreiras à prestação dos serviços contemplam disponibilidade irregular dos medicamentos, insuficiência de recursos e qualidade insatisfatória dos serviços. A dificuldade para conseguir consultas médicas e a exigência da prescrição originada no setor público são barreiras ao setor saúde. As barreiras acima do setor saúde são cumprimento dos procedimentos administrativos, corrupção e clientelismo. A via administrativa intensifica as iniquidades no acesso à saúde no Brasil.

Pharmaceutical intervention in the rational use of intravenous omeprazole.

OBJECTIVE: To describe the pharmaceutical interventions of a vertical clinical pharmacy service to promote the rational use of intravenous omeprazole. METHODS: A prospective and descriptive study carried out at a university hospital in the Midwestern Region of Brazil, from November 2014 to May 2015. The service consisted of the analysis of adequacy of the route of administration of omeprazole in relation to the clinical conditions of the patient, as well as the use of the appropriate diluent. Interventions were recorded in medical records and subsequently evaluated for acceptance. RESULTS: A total of 770 prescriptions were evaluated. Interventions related to diluent replacement were more accepted (p<0.001), and surgeons were the specialty that used the intravenous route inappropriately (p<0.001). CONCLUSION: Although partially accepted, pharmaceutical interventions could contribute to improve patient safety, since they allowed the use of a safer route of administration.

Evaluation of a method for drug-related problems identification and classification in hospital setting: applicability and reliability.

Background Prescription evaluation by pharmacists has potential to improve pharmacotherapy management. It requires the use of robust methods to identify drug-related problems (DRP), which are important issues in pharmacotherapy. Objective To evaluate the applicability and reliability of Grupo de Investigação em Cuidados Farmacêuticos (GIGUF) method for prescription analysis, identification and classification of drug-related problems in inpatients prescriptions. Setting Department of Medical Clinic of a tertiary and teaching Brazilian hospital. Method An observational and retrospective study of identification and classification of drug-related problems. GIGUF method was used to evaluate prescriptions of hematological patients hospitalized between August and October 2015. The problems were categorized using GICUF-method classification. Three pharmacists performed inter-rater agreement analysis of the method using Kappa. Differences in prevalence of DRP was calculated by age, sex, pharmacotherapy complexity, length of stay and number of drugs. Main outcome measure (a) frequency and characteristics and (b) inter-rater agreement in identification and classification of the drug-related problems. Results A total of 211 problems were identified and 'inadequate dosing' was the most common problem. There was an association between the occurence of a drug-reklated problem and complexity of pharmacotherapy (p = 0.001) and number of drugs used (p = 0.010). The overall inter-rater agreement was moderate (k = 0.44 IC 95% 0.34-0.55) and the problem 'not suitable drug' (k = 0.55 IC 95% 0.44-0.66) had greater inter-rater agreement. Conclusion The method "Evaluation Drug Use Process" was useful for prescription analysis since it made the identification and classification of DRPs possible. The method demonstrated a moderate inter-rater agreement, and can contribute to pharmacotherapy management by hospital pharmacists.

Performance of Laboratories after 10 Years of Participating in External Quality Monitoring in Cervical Cytology.

OBJECTIVE: To evaluate the performance of laboratories accredited by the National Health System that perform cytopathology examination of the uterine cervix after 10 years of participation in external quality monitoring (eQM). STUDY DESIGN: Seven laboratories were assessed in this study. To assess the concordance of the representation of epithelia and results, 6,536 examinations (3,433 in 2007 and 3,103 in 2017) were reviewed. Statistical analysis was performed using the κ coefficient as well as the χ2 and the Fisher exact test (p < 0.05). RESULTS: All laboratories showed adequate infrastructure and internal quality monitoring. Regarding the representation of the epithelia, the concordance remained excellent (κ between 0.84 and 0.94). In 2007, 26 false-negative results (FN), 157 false-positive results (FP), and 79 delays in clinical conduct (DCC) were identified (κ = 0.80). In 2017, 24 FN, 42 FP, and 38 DCC were identified (κ = 0.90). Five laboratories showed improvement in concordance from 2007 to 2017. We observed significant improvement in cytomorphological criteria of the results: atypical squamous cells of undetermined significance (p < 0.001), atypical squamous cells cannot exclude high-grade squamous intraepithelial lesion (p < 0.016), and low-grade squamous intraepithelial lesion (p < 0.001). We also observed a considerable improvement in the results of cellular abnormalities in glandular epithelium (p < 0.0504). CONCLUSIONS: Ten years after the implementation of eQM, improvements in the concordance of results were observed as well as reductions in FN, FP, and DCC in all laboratories monitored.

Mortality and years of life lost related to adverse drug events in Brazil

ABSTRACT OBJECTIVE To assess regional and national mortality and years of life lost (YLL) related to adverse drug events in Brazil. METHODS This is an ecological study in which death records from 2009 to 2018 from the Mortality Information System were analyzed. Codes from the International Classification of Diseases 10th revision (ICD-10) that indicated drugs as the cause of death were identified. The number of deaths and the YLL due to adverse drug events were obtained. Crude, age- and gender-specific, and age-adjusted mortality rates and YLL rates per 100,000 inhabitants were formed by year, age group, gender, and Brazilian Federative Unit. Rate ratios were calculated by comparing rates from 2009 to 2018. A joinpoint regression model was applied for temporal analysis. RESULTS For the selected ICD-10 codes, a total of 95,231 deaths and 2,843,413 YLL were recorded. Mortality rates from adverse drug events increased by a mean of 2.5% per year, and YLL rates increased by 3.7%. Increases in rates were observed in almost all age groups for both genders. Variations in rates were found between Federative Units, with the highest age-adjusted mortality and YLL rates occurring in the Distrito Federal. CONCLUSIONS The numbers and rates of deaths and YLL increased during the study period, and variations in rates of deaths and YLL were observed between Brazilian Federative Units. Information on multiple causes of death from death certificates can be useful for quantifying adverse drug events and analyzing them geographically, by age and by gender.

Impact of Implementing 100% Rapid Review as a Quality Control Tool in Cervical Cytology.

OBJECTIVE: We aimed to evaluate the impact of implementing 100% rapid review (100% RR) as a quality control tool in cervical smear cytology. DESIGN: A cross-sectional study was conducted in which cytology findings, false-negative results, and quality indicators were evaluated. The variables were analyzed in 2004, the year in which 100% RR was implemented, and again in 2013, i.e., 10 years on. RESULTS: Detection of atypical squamous cells of undetermined significance (ASC-US) increased from 0.90% in 2004 to 2.47% in 2013 by routine screening. Detection of atypical squamous cells, cannot exclude a high-grade squamous intraepithelial lesion (ASC-H) increased from 13.33% in 2004 to 36.27% in 2013 by 100% RR. Detection of high-grade squamous intraepithelial lesion (HSIL) increased from 0.64% in 2004 to 4.29% in 2013 by routine screening, and increased from 0% in 2004 to 19.61% in 2013 by 100% RR. There was a significant increase (p = 0.00001) in the identification of false-negative results of ASC-US, low-grade squamous intraepithelial lesion, ASC-H, HSIL, and atypical glandular cells. All quality indicators had increased in 2013 when compared to 2004 results. CONCLUSIONS: Ten years after the implementation of the 100% RR method, improvements were found in the detection of atypia and precursor lesions and in quality indicators.

Whole, Turret and step methods of rapid rescreening: is there any difference in performance?

We compared the performance of the Whole, Turret and Step techniques of 100% rapid rescreening (RR) in detection of false-negatives in cervical cytology. We tested RR performance with cytologists trained and among those without training. We revised 1,000 consecutive slides from women participating in an ongoing international screening trial. Two teams of experienced cytologists performed the RR techniques: one trained in RR procedures and the other not trained. The sensitivities in the trained group were Whole 46.6%, Turret 47.4% and Step 50.9%; and in the non-trained group were 38.6, 31.6 and 47.4%, respectively. The kappa coefficient showed a weak agreement between the two groups of cytologists and between the three RR techniques. The RR techniques are more valuable if used by trained cytologists. In the trained group, we did not observe significant differences between the RR techniques used, whereas in the non-trained group, the Step technique had the best sensitivity.

Hospitalizations and adverse drug events in the Brazilian unified health system: a ten-year retrospective analysis of routine data

ABSTRACT OBJECTIVE To describe the frequency and characteristics of hospitalizations for/with adverse drug events in the Brazilian unified health system routine data. METHODS Nationwide retrospective study using data obtained from a period of ten years from the Brazil Hospital Information System (SIH-SUS), an administrative database that registers hospitalizations in the unified health system. We selected hospitalizations with primary and/or secondary diagnosis related to adverse drug events according to a list of validated International Classification Disease 10th edition (ICD-10) codes. These events were described according to year, age group, sex, length of hospital stay, mortality, hospital costs, Brazilian geographical region, and category of ICD-10 codes. Crude hospitalization rates of adverse drug events per 100,000 inhabitants were obtained and Joinpoint Regression was used to analyze temporal changes in these rates along the years. The most frequent ICD-10 codes were also identified. RESULTS Over ten years, 603,663 hospitalizations in Brazil were found in the database, out of which 2.5% of the patients died. Though 2009 had the highest prevalence of hospitalization per 100,000 inhabitants (32.57), no significant annual change in rates was found for the entire period. All age groups and sexes presented a jointpoint in temporal series; however, only women had a significative increase trend. The most frequent codes were from the chapter of mental and behavioral disorders (F19.2, F19.0, and F19.5 codes). CONCLUSIONS The database methodology can be useful to estimate frequencies of adverse drug events and perform characterization nationwide and to help monitor morbidity along the years.

Potential drug-drug interactions in older adults: A population-based study.

AIM: To evaluate the potential drug-drug interactions (PDDI) between drugs used by older adults, any associated factors and recommended clinical management. METHODS: A cross-sectional, population-based study was carried out through a home survey of 934 older adults (from December 2009 to April 2010). A questionnaire was applied, and the participants were asked to show all the drugs used and their respective prescriptions, thus providing data to identify polypharmacy, self-medication and PDDI. PDDI, their consequences, severity and clinical management were identified using Micromedex. RESULTS: Overall, 2846 drugs and 665 PDDI were identified, 71.0% of which were moderate and 22.4% serious. The prevalence of PDDI was 36.9%. Drugs with a narrow therapeutic index were involved in 17.0% of the PDDI. The variables female sex (PR = 1.11, 95% CI 1.02-1.20), age ≥80 years (PR = 1.15, 95% CI 1.03-1.28), no polypharmacy (PR = 0.72, 95% CI 0.67-0.78) and no hospitalization in the past year (PR = 0.90, 95% CI 0.82-0.97) remained associated with the presence of three or more PDDI in the final multivariate analysis model. CONCLUSIONS: Most PDDI were related to routinely used drugs (enalapril, hydrochlorothiazide, calcium, captopril, levothyroxine and simvastatin), and more than one-third of the older adults were exposed to PDDI with the possible risk of serious health consequences. Drugs with a narrow therapeutic index were involved in several PDDI, with increased risk of toxicity. The clinical management procedures most recommended are dose adjustment and dosing changes, control of the drugs' serum levels, and monitoring of the clinical conditions. Geriatr Gerontol Int 2017; 17: 2336-2346.

"A falta de informação nos afasta do remédio, do bem-estar, da harmonia... ": estudo de método misto com demandantes de medicamentos pela via administrativa / "A lack of information keeps us from medicine, well-being, harmony... ": a mixed method study with plaintiffs requesting medicines in administrative cases

Resumo A necessidade de recorrer ao gestor público de saúde para efetivar o direito ao acesso a medicamentos caracteriza a via administrativa. O estudo analisou as percepções dos usuários que acionaram a via administrativa sobre as barreiras para o acesso a medicamentos no setor público de saúde de uma capital brasileira. Foi realizado estudo de método misto com grupo focal, questionário com demandantes e descrição dos medicamentos demandados pela via administrativa. Os resultados apontam a interdependência da assistência farmacêutica com as áreas de interfaceamento para a garantia do acesso. As barreiras relativas aos indivíduos refletem o comprometimento do desenvolvimento da cidadania, justificando o custo do medicamento motivar a demanda. As barreiras à prestação dos serviços contemplam disponibilidade irregular dos medicamentos, insuficiência de recursos e qualidade insatisfatória dos serviços. A dificuldade para conseguir consultas médicas e a exigência da prescrição originada no setor público são barreiras ao setor saúde. As barreiras acima do setor saúde são cumprimento dos procedimentos administrativos, corrupção e clientelismo. A via administrativa intensifica as iniquidades no acesso à saúde no Brasil.

Abstract The need to request public health managers to ensure the right of access to medicines characterizes an administrative case and the method to do so is called the administrative route. This mixed method study aimed to analyze the perceptions of plaintiffs requesting medications by the administrative route about barriers to access medicines in the Brazilian public health sector. Data were gathered through focus groups and questionnaires. The results point to the interdependence of pharmaceutical services with the interfacing areas to ensure access. The barriers related to individuals reflect the commitment to develop citizenship, justifying the cost of the medicine to motivate the demand. Barriers to service provision include irregular availability of medicines, insufficient resources, and unsatisfactory quality of services. The difficulty in obtaining medical consultations and prescriptions originating in the public sector are barriers to the health sector. The barriers above the health sector are compliance with administrative procedures, corruption, and clientelism. The administrative route intensifies inequities in access to healthcare in Brazil.

Quality Indicators of Cervical Cytopathology Tests in the Public Service in Minas Gerais, Brazil.

OBJECTIVE: The objective of this study is to assess the performance of cytopathology laboratories providing services to the Brazilian Unified Health System (Sistema Único de Saúde - SUS) in the State of Minas Gerais, Brazil. METHODS: This descriptive study uses data obtained from the Cervical Cancer Information System from January to December 2012. Three quality indicators were analyzed to assess the quality of cervical cytopathology tests: positivity index, percentage of atypical squamous cells (ASCs) in abnormal tests, and percentage of tests compatible with high-grade squamous intraepithelial lesions (HSILs). Laboratories were classified according to their production scale in tests per year ≤ 5,000; from 5,001 to 10,000; from 10,001 to 15,000; and ≥ 15,001. Based on the collection of variables and the classification of laboratories according to production scale, we created and analyzed a database using Microsoft Office Excel 97-2003. RESULTS: In the Brazilian state of Minas Gerais, 146 laboratories provided services to the SUS in 2012 by performing a total of 1,277,018 cervical cytopathology tests. Half of these laboratories had production scales ≤ 5,000 tests/year and accounted for 13.1% of all tests performed in the entire state; in turn, 13.7% of these laboratories presented production scales of > 15,001 tests/year and accounted for 49.2% of the total of tests performed in the entire state. The positivity indexes of most laboratories providing services to the SUS in 2012, regardless of production scale, were below or well below recommended limits. Of the 20 laboratories that performed more than 15,001 tests per year, only three presented percentages of tests compatible with HSILs above the lower limit recommended by the Brazilian Ministry of Health. CONCLUSION: The majority of laboratories providing services to the SUS in Minas Gerais presented quality indicators outside the range recommended by the Brazilian Ministry of Health.

Reproducibility of cervical cytopathology following an intervention by an external quality control laboratory.

BACKGROUND: This study assessed the effects of a continued education program on the agreement between cervical cytopathology exams interpreted by local laboratories and interpretation made by an external quality control laboratory (LabMEQ). METHODS: Overall, 9,798 exams were analyzed between 2007 and 2008, prior to implementation of a continued education program, and 10,028 between 2010 and 2011, following implementation. Continued education consisted of theoretical and practical classes held every two months. The chi-square test and the kappa coefficient were used in the statistical analysis. RESULTS: Following implementation of continued education, the rate of false-negative results, and those leading to delays in clinical management fell in eight laboratories and the rate of false-positive results in five. Agreement between the results reported by the laboratories and the findings of LabMEQ, evaluated according to clinical management, remained excellent in three laboratories (kappa >0.80 and <1.0), went from good (kappa >0.60 and <0.80) to excellent in seven and from excellent to good in two. Agreement regarding the identification of metaplastic epithelium was poor (kappa = 0.25) but progressed to excellent following the implementation of continued education (kappa = 0.950). Agreement between cytopathology results improved significantly following implementation of continued education in cases reported as unsatisfactory (P < 0.001), atypical squamous cells of undetermined significance, cannot exclude high-grade squamous intraepithelial lesion (P < 0.001), low-grade squamous intraepithelial lesion (P < 0.001), and glandular atypia (P < 0.001). CONCLUSION: Continued education contributed towards improving the reproducibility of cervical cytopathology, decreased the rates of false-negative and false-positive results, and reduced delays in clinical management.