From Inception to ConcePTION: Genesis of a Network to Support Better Monitoring and Communication of Medication Safety During Pregnancy and Breastfeeding.

In 2019, the Innovative Medicines Initiative (IMI) funded the ConcePTION project-Building an ecosystem for better monitoring and communicating safety of medicines use in pregnancy and breastfeeding: validated and regulatory endorsed workflows for fast, optimised evidence generation-with the vision that there is a societal obligation to rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding. The present paper introduces the set of concepts used to describe the European data sources involved in the ConcePTION project and illustrates the ConcePTION Common Data Model (CDM), which serves as the keystone of the federated ConcePTION network. Based on data availability and content analysis of 21 European data sources, the ConcePTION CDM has been structured with six tables designed to capture data from routine healthcare, three tables for data from public health surveillance activities, three curated tables for derived data on population (e.g., observation time and mother-child linkage), plus four metadata tables. By its first anniversary, the ConcePTION CDM has enabled 13 data sources to run common scripts to contribute to major European projects, demonstrating its capacity to facilitate effective and transparent deployment of distributed analytics, and its potential to address questions about utilization, effectiveness, and safety of medicines in special populations, including during pregnancy and breastfeeding, and, more broadly, in the general population.

Online information discrepancies regarding safety of medicine use during pregnancy and lactation: an IMI ConcePTION study.

Background: Inconsistencies in information on safety of medicine use during pregnancy and lactation can result in sub-optimal treatment for pregnant and lactating women, risks to the fetus or child and unnecessary weaning off breastfeeding. The objective of this study was to analyze information discrepancies regarding medicine use during pregnancy and lactation between on-line sources for patients and health care professionals (HCPs) in four European languages.Research design and methods: The medicines analyzed were ibuprofen, ondansetron, olanzapine, fingolimod, methylphenidate and adalimumab. Recommendations were classified into different data source categories, for patients and for HCPs, and compared between the data source categories for each medicine and language.Results: For patients, 11/24 (46%) and 4/24 (17%) comparisons of the pregnancy and lactation recommendations, respectively, were consistent between all sources. The corresponding figures for HCP-sources were 13/24 (54%) and 5/24 (21%). Regulatory sources had generally more restrictive recommendations. Teratology Information Services (TIS) centers' recommendations for medicine use during pregnancy and lactation were consistent in 25/27 (93%) and 15/22 (68%) of cases respectively.Conclusion: Discrepancies between online information sources regarding medicine use during pregnancy and lactation are common, especially for lactation. TIS centers recommendations were more aligned. Additional work is needed to harmonize information within and between countries to avoid conflicting messages.

Informes de posicionamiento terapéutico: experiencia en España en el periodo 2013-2019 / Therapeutic positioning reports: Experience in Spain during the period 2013-2019

OBJETIVO: Describir las características de los informes de posicionamiento terapéutico (IPT) publicados en España en el periodo 2013-2019. Diseño y fuente de datos: Revisión sistemática de todos los IPT publicados en la página web de la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Selección de estudios: Se incluyeron todos los IPT realizados desde mayo de 2013, hasta marzo de 2019. Extracción de datos: Las principales variables recogidas fueron los grupos terapéuticos evaluados, el número de IPT, el tiempo de elaboración, la existencia de restricciones a las indicaciones autorizadas y la información sobre la eficiencia. RESULTADOS: En el periodo evaluado se realizaron 214 IPT, con un tiempo medio de elaboración de 8,8 meses, casi tres veces el objetivo de 3 meses planteado inicialmente. El 57% de los IPT establecieron restricciones de uso respecto a las indicaciones de sus fichas técnicas. El 26% de los IPT hicieron referencia a la existencia de datos económicos, aunque ninguno incluyó detalles sobre la eficiencia. Se actualizaron el 10% de los IPT. CONCLUSIONES: Para que los IPT puedan cumplir su objetivo de mejorar la eficiencia del proceso de evaluación y la coherencia en las decisiones sobre precio, reembolso y financiación de medicamentos por parte del SNS es preciso que se cumplan los plazos establecidos para su publicación, se incorpore sistemáticamente información sobre la eficiencia de los fármacos y se actualicen los informes con la nueva información generada

OBJECTIVE: Describe the characteristics of the therapeutic positioning reports (TPRs) published in Spain in the period 2013-2019. Design and data source: Systematic review of all TPRs published in the website of the Spanish Agency of Medicines and Health Products (AEMPS). Selection of studies: All TPRs published since May 2013, until March 2019 Data extraction: The main variables collected were the therapeutic groups assessed, the number of TPRs, the time of elaboration, the existence of restrictions versus the authorized indications and the information on the efficiency of medicines. RESULTS: During the period under review, 214 TPRs were carried out, with an average production time of 8.8 months, almost three times the objective of 3-month initially set. 57% of the TPRs established restrictions of use with respect to the approved indications. 26% of TPRs referred to the existence of economic data, although none included details on the efficiency. 10% of TPRs were updated. CONCLUSIONS: For TPRs to meet their objective of improving the efficiency of the assessment process and the consistency in the decisions on price, reimbursement and financing of medicines by the SNS, the deadlines established for publication must be met, incorporating systematically information on the efficiency of the drugs and including periodic updates with the new information generated

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study.

OBJECTIVE: To characterize the therapeutic value of new drugs approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and the association between these ratings and regulatory approval through expedited programs. DESIGN: Retrospective cohort study. SETTING: New drugs approved by the FDA and EMA between 2007 and 2017, with follow-up through 1 April 2020. DATA SOURCES: Therapeutic value was measured using ratings of new drugs by five independent organizations (Prescrire and health authorities of Canada, France, Germany, and Italy). MAIN OUTCOME MEASURES: Proportion of new drugs rated as having high therapeutic value; association between high therapeutic value rating and expedited status. RESULTS: From 2007 through 2017, the FDA and EMA approved 320 and 268 new drugs, respectively, of which 181 (57%) and 39 (15%) qualified for least one expedited program. Among 267 new drugs with a therapeutic value rating, 84 (31%) were rated as having high therapeutic value by at least one organization. Compared with non-expedited drugs, a greater proportion of expedited drugs were rated as having high therapeutic value among both FDA approvals (45% (69/153) v 13% (15/114); P<0.001) and EMA approvals (67% (18/27) v 27% (65/240); P<0.001). The sensitivity and specificity of expedited program for a drug being independently rated as having high therapeutic value were 82% (95% confidence interval 72% to 90%) and 54% (47% to 62%), respectively, for the FDA, compared with 25.3% (16.4% to 36.0%) and 90.2% (85.0% to 94.1%) for the EMA. CONCLUSIONS: Less than a third of new drugs approved by the FDA and EMA over the past decade were rated as having high therapeutic value by at least one of five independent organizations. Although expedited drugs were more likely than non-expedited drugs to be highly rated, most expedited drugs approved by the FDA but not the EMA were rated as having low therapeutic value.

Routine Health Information System (RHIS) improvements for strengthened health system management.

BACKGROUND: A well-functioning routine health information system (RHIS) can provide the information needed for health system management, for governance, accountability, planning, policy making, surveillance and quality improvement, but poor information support has been identified as a major obstacle for improving health system management. OBJECTIVES: To assess the effects of interventions to improve routine health information systems in terms of RHIS performance, and also, in terms of improved health system management performance, and improved patient and population health outcomes. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE Ovid and Embase Ovid in May 2019. We searched Global Health, Ovid and PsycInfo in April 2016. In January 2020 we searched for grey literature in the Grey Literature Report and in OpenGrey, and for ongoing trials using the International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov. In October 2019 we also did a cited reference search using Web of Science, and a 'similar articles' search in PubMed. SELECTION CRITERIA: Randomised and non-randomised trials, controlled before-after studies and time-series studies comparing routine health information system interventions, with controls, in primary, hospital or community health care settings. Participants included clinical staff and management, district management and community health workers using routine information systems. DATA COLLECTION AND ANALYSIS: Two authors independently reviewed records to identify studies for inclusion, extracted data from the included studies and assessed the risk of bias. Interventions and outcomes were too varied across studies to allow for pooled risk analysis. We present a 'Summary of findings' table for each intervention comparisons broadly categorised into Technical and Organisational (or a combination), and report outcomes on data quality and service quality. We used the GRADE approach to assess the certainty of the evidence. MAIN RESULTS: We included six studies: four cluster randomised trials and two controlled before-after studies, from Africa and South America. Three studies evaluated technical interventions, one study evaluated an organisational intervention, and two studies evaluated a combination of technical and organisational interventions. Four studies reported on data quality and six studies reported on service quality. In terms of data quality, a web-based electronic TB laboratory information system probably reduces the length of time to reporting of TB test results, and probably reduces the overall rate of recording errors of TB test results, compared to a paper-based system (moderate certainty evidence). We are uncertain about the effect of the electronic laboratory information system on the recording rate of serious (misidentification) errors for TB test results compared to a paper-based system (very low certainty evidence). Misidentification errors are inaccuracies in transferring test results between an electronic register and patients' clinical charts. We are also uncertain about the effect of the intervention on service quality (timeliness of starting or changing a patient's TB treatment) (very low certainty evidence). A hand-held electronic device probably improves the length of time to report TB test results, and probably reduces the total frequency of recording errors in TB test results between the laboratory notebook and the electronic information record system, compared to a paper-based system (moderate-certainty evidence). We are, however, uncertain about the effect of the intervention on the frequency of serious (misidentification) errors in recording between the laboratory notebook and the electronic information record, compared to a paper-based system (very low certainty evidence). We are uncertain about the effect of a hospital electronic health information system on service quality (length of time outpatients spend at hospital, length of hospital stay, and hospital revenue collection), compared to a paper-based system (very low certainty evidence). High-intensity brief text messaging (SMS) may make little or no difference to data quality (in terms of completeness of documentation of pregnancy outcomes), compared to low-intensity brief text messaging (low-certainty evidence). We are uncertain about the effect of electronic drug stock notification (with either data management support or product transfer support) on service quality (in terms of transporting stock and stock levels), compared to paper-based stock notification (very low certainty evidence). We are uncertain about the effect of health information strengthening (where it is part of comprehensive service quality improvement intervention) on service quality (health worker motivation, receipt of training by health workers, health information index scores, quality of clinical observation of children and adults) (very low certainty evidence). AUTHORS' CONCLUSIONS: The review indicates mixed effects of mainly technical interventions to improve data quality, with gaps in evidence on interventions aimed at enhancing data-informed health system management. There is a gap in interventions studying information support beyond clinical management, such as for human resources, finances, drug supply and governance. We need to have a better understanding of the causal mechanisms by which information support may affect change in management decision-making, to inform robust intervention design and evaluation methods.

Evaluation of the experiences and needs of users of a drug information resources website.

OBJECTIVE: This article describes the evaluation of the experiences and needs of users of the Drug Information Resources (DIR) website. The DIR website attracts traffic and use from around the world, with the highest number of users in Canada and the United States. METHODS: An online questionnaire was developed through use of a literature review and Google Analytics data. Face validity testing and test-retest reliability were completed prior to releasing the questionnaire. RESULTS: Although the Google Analytics data showed that the site is used internationally, most respondents were Canadian students. They used the site for academic and clinical purposes and reported it was easy to use, was well organized, and included required resources, and they would recommend it to others. CONCLUSION: The DIR website was found to be a valuable resource for educational and clinical use. Future studies will aim to obtain input from international users.

Incorporation of a mock drug information telephone call exercise in a health-systems pharmacy laboratory.

BACKGROUND AND PURPOSE: Hospital pharmacists routinely receive and answer drug information questions via telephone while performing order verification. This report describes the development, implementation, and evaluation of a mock learning experience for student performance of these tasks in a health-systems pharmacy laboratory course. EDUCATIONAL ACTIVITY AND SETTING: An active learning skills-based exercise involving students receiving and answering a standardized drug information question via telephone during an order verification activity, referred to as a cold-call exercise, was developed and implemented. Data collected included student grades on a baseline assessment, the cold call exercise, order verification exercises, and student perceptions from a voluntary post-exercise survey. Student performance on the cold-call exercise was further evaluated via individual sections of the cold-call rubric. Data were summarized using descriptive statistics. Thematic analysis of student opinion and an estimate of faculty time were also executed. FINDINGS: Student grades on the cold call and order verification exercises were 86.14% and 88.8%, respectively. Students often failed to ask category-specific questions because they did not categorize the ultimate question appropriately. Students found the activity organized and applicable. Time dedicated to creation was extensive, but execution and grading were reasonable. SUMMARY: Students performed well on the drug information exercise as well as the order verification component. Students and faculty enjoyed the experience, and students found the exercise relevant and challenging. This exercise could be implemented into any pharmacy curriculum in order to prepare students using authentic learning experiences.

Medicine package inserts from the users' perspective: are they read and understood?

INTRODUCTION: The written information on medicines has been acknowledged as an important tool for health education. OBJECTIVE: To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. METHOD: Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. RESULTS: A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. CONCLUSION: The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

[Use of antidepressants during breastfeeding: evaluating drug package inserts conformity with science-based bibliographical sources]. / Uso de medicamentos antidepressivos na amamentação: avaliação da conformidade das bulas com fontes bibliográficas baseadas em evidências científicas.

This article sought to evaluate the conformity between recommendations regarding antidepressant use during breastfeeding found in drug package inserts with recommendations from science-based bibliographic sources. We evaluated the standard drug package inserts of 23 antidepressants with active registration in Brazil. The presence of contraindications of antidepressant use during breastfeeding was compared with information present in the Brazilian Ministry of Health technical manual, the book Medications and Mothers' Milk and on the databases LactMed, Micromedex and UpToDate. In most drug package inserts (62.5%), antidepressants are contraindicated during breastfeeding. Among bibliographical sources, that percentage varied between 0% and 25%. The study shows a low conformity between drug package inserts and bibliographical sources, alerting to the need for revising the content and presentation of information present in antidepressant drug package inserts in Brazil.

O objetivo deste artigo foi avaliar a conformidade entre as recomendações de uso de medicamentos antidepressivos durante a amamentação, presentes em bulas, e as recomendações de fontes bibliográficas baseadas em evidências científicas. Foram avaliadas as bulas padrão de 23 antidepressivos com registro ativo no Brasil. A presença de contraindicação do uso do antidepressivo durante a amamentação foi comparada com as informações presentes no manual técnico do Ministério da Saúde, no livro Medications and Mothers' Milk e nas bases de dados LactMed, Micromedex e UpToDate. Na maioria das bulas (62,5%), o antidepressivo é contraindicado na amamentação. Entre as fontes bibliográficas, esse percentual variou de 0% a 25%. O estudo aponta para baixa conformidade entre bulas e fontes bibliográficas, alertando sobre a necessidade de revisão do conteúdo e forma de apresentação das informações presentes nas bulas dos antidepressivos no Brasil.

El objetivo de este artículo fue evaluar la conformidad entre las recomendaciones de uso de medicamentos antidepresivos durante la lactancia, presentes en prospectos, y las recomendaciones de fuentes bibliográficas, basadas en evidencias científicas. Se evaluaron los prospectos estándar de 23 antidepresivos con registro activo en Brasil. La presencia de contraindicaciones en el consumo de antidepresivos durante la lactancia se comparó con la información presente en el manual técnico del Ministerio de la Salud, en el libro Medications and Mothers' Milk, y en las bases de datos LactMed, Micromedex y UpToDate. En la mayoría de los prospectos (62,5%), el antidepresivo está contraindicado durante la lactancia. Entre las fuentes bibliográficas el porcentaje varió de 0% a 25%. El estudio señala la escasa conformidad entre prospectos y fuentes bibliográficas, alertando sobre la necesidad de revisión del contenido, así como de la forma de presentación de la información que aparece en los prospectos de los antidepresivos en Brasil.

Evaluation of drug information resources for drug-ethanol and drug-tobacco interactions.

OBJECTIVE: The research evaluated point-of-care drug interaction resources for scope, completeness, and consistency in drug-ethanol and drug-tobacco content. METHODS: In a cross-sectional analysis, 2 independent reviewers extracted data for 108 clinically relevant interactions using 7 drug information resources (Clinical Pharmacology Drug Interaction Report, Facts & Comparisons eAnswers, Lexicomp Interactions, Micromedex Drug Interactions, Drug Interactions Analysis and Management, Drug Interaction Facts, and Stockley's Drug Interactions). Scope (presence of an entry), completeness (content describing mechanism, clinical effects, severity, level of certainty, and course of action for each present interaction; up to 1 point per assessed item for a total possible score of 5 points), and consistency (similarity among resources) were evaluated. RESULTS: Fifty-three drug-ethanol and 55 drug-tobacco interactions were analyzed. Drug-ethanol interaction entries were most commonly present in Lexicomp (84.9%), Clinical Pharmacology (83.0%), and Stockley's Drug Interactions (73.6%), compared to other resources (p<0.05). Drug-tobacco interactions were more often covered in Micromedex (56.4%), Stockley's Drug Interactions (56.4%), Drug Interaction Facts (43.6%), and Clinical Pharmacology (41.8%) (p<0.001). Overall completeness scores were higher for Lexicomp, Micromedex, Drug Interaction Facts, and Facts & Comparisons (median 5/5 points, interquartile range [IQR] 5 to 5, p<0.001) for drug-ethanol and for Micromedex (median 5/5 points, IQR 5 to 5, p<0.05) for drug-tobacco, compared to other resources. Drug Interaction Facts and Micromedex were among the highest scoring resources for both drug-ethanol (73.7%, 68.6%) and drug-tobacco (75.0%, 32.3%) consistency. CONCLUSIONS: Scope and completeness were high for drug-ethanol interactions, but low for drug-tobacco interactions. Consistency was highly variable across both interaction types.

Sources of drug information in neonatal guidelines of low- and middle-income countries.

OBJECTIVE: Identify drug information (DI) resources used in neonatal practice guidelines in low- and middle-income countries. METHODS: Individuals with knowledge of national neonatal guideline development completed a descriptive, cross-sectional survey. KEY FINDINGS: Eighty-five per cent (33/39) of respondents fully completed the survey. Physicians from university hospitals in Africa were primary respondents. Forty-five per cent (15/33) used a single national neonatal guideline. Primary neonatal resources for drug dosing and preparation were as follows: (1) World Health Organization Pocketbook of Hospital Care for Children, (2) Pediatric & Neonatal Dosage Handbook and (3) National Institute for Health and Care Excellence for Infants and Neonatal pathways. CONCLUSION: Low- and middle-income countries with single national neonatal guidelines cite a finite range of DI resources.

User-centered design of a mobile medication management.

BACKGROUND: The use of a nationwide medication plan has been promoted as an effective strategy to improve patient safety in Germany. However, the medication plan only exists as a paper-based version, which is related to several problems, that could be circumvented by an electronic alternative. OBJECTIVE: The main objective of this study was to report on the development of a mobile interface concept to support the management of medication information. METHODS: The human-centered design (UCD) process was chosen. First the context of use was analyzed, and personas and an interaction concept were designed. Next, a paper prototype was developed and evaluated by experts. Based on those results, a medium-fidelity prototype was created and assessed by seven end-users who performed a thinking-aloud test in combination with a questionnaire based on the System Usability Scale (SUS). RESULTS: Initially for one persona/user type, an interface design concept was developed, which received an average SUS-Score of 92.1 in the user test. Usability problems have been solved so that the design concept could be fixed for a future implementation. Contribution: The approach of the UCD process and the methods involved can be applied by other researchers as a framework for the development of similar applications.

Implementation and evaluation of medicine and therapeutic information service by clinical pharmacists in oncology care setting.

BACKGROUND: This study was conducted to explore the role of clinical pharmacists in providing medicine and therapeutic information service in oncology care setting. METHODS: It was a prospective study conducted for a period of three years after implementation of medicine and therapeutic information service as an integral part of oncology pharmacy services. The medicine and therapeutic information queries were received during ward rounds, at ambulatory care and via telephone by clinical pharmacists. All the medicine and therapeutic information requests were reviewed and answered to the concerned requester(s). Answered medicine and therapeutic information requests were electronically documented in the hospital drug information database and analyzed further. RESULTS: A total of 484 medicine and therapeutic information requests were received by clinical pharmacists during period of August 2013 to June 2016. Majority of medicine and therapeutic information queries were requested by radiation oncologists (27.2%) followed by medical oncologists (26.4%), general physicians (14.04%), resident medical officers (11.7%), ambulatory care nurses (8.6%), in-patient nurses (5.1%) and patients and care takers (6.6%). Majority of the medicine and therapeutic information queries were asked for the purpose of improving patient care (48.3%) followed by to update knowledge (30.9%) and training sessions to nurses (6.6%). The most common categories of medicine and therapeutic information were adverse drug reactions and its management (21.4%) followed by dosage adjustments of chemotherapy and biologicals (15.5%), supportive care related (14.6%), contraindications (14%), drug-drug interactions (11.9%), management of co-morbidities (7.8%), chemotherapy selection in special populations (4.5%). CONCLUSION: The provision of medicine and therapeutic information was found to be useful in providing medicine information to improve patient care and to update knowledge of health care professionals at the study hospital.

Uso de medicamentos antidepressivos na amamentação: avaliação da conformidade das bulas com fontes bibliográficas baseadas em evidências científicas / Use of antidepressants during breastfeeding: evaluating drug package inserts conformity with science-based bibliographical sources / Uso de medicamentos antidepresivos durante la lactancia: evaluación de la conformidad de los prospectos, respecto a fuentes bibliográficas basadas en evidencias científicas

O objetivo deste artigo foi avaliar a conformidade entre as recomendações de uso de medicamentos antidepressivos durante a amamentação, presentes em bulas, e as recomendações de fontes bibliográficas baseadas em evidências científicas. Foram avaliadas as bulas padrão de 23 antidepressivos com registro ativo no Brasil. A presença de contraindicação do uso do antidepressivo durante a amamentação foi comparada com as informações presentes no manual técnico do Ministério da Saúde, no livro Medications and Mothers' Milk e nas bases de dados LactMed, Micromedex e UpToDate. Na maioria das bulas (62,5%), o antidepressivo é contraindicado na amamentação. Entre as fontes bibliográficas, esse percentual variou de 0% a 25%. O estudo aponta para baixa conformidade entre bulas e fontes bibliográficas, alertando sobre a necessidade de revisão do conteúdo e forma de apresentação das informações presentes nas bulas dos antidepressivos no Brasil.

This article sought to evaluate the conformity between recommendations regarding antidepressant use during breastfeeding found in drug package inserts with recommendations from science-based bibliographic sources. We evaluated the standard drug package inserts of 23 antidepressants with active registration in Brazil. The presence of contraindications of antidepressant use during breastfeeding was compared with information present in the Brazilian Ministry of Health technical manual, the book Medications and Mothers' Milk and on the databases LactMed, Micromedex and UpToDate. In most drug package inserts (62.5%), antidepressants are contraindicated during breastfeeding. Among bibliographical sources, that percentage varied between 0% and 25%. The study shows a low conformity between drug package inserts and bibliographical sources, alerting to the need for revising the content and presentation of information present in antidepressant drug package inserts in Brazil.

El objetivo de este artículo fue evaluar la conformidad entre las recomendaciones de uso de medicamentos antidepresivos durante la lactancia, presentes en prospectos, y las recomendaciones de fuentes bibliográficas, basadas en evidencias científicas. Se evaluaron los prospectos estándar de 23 antidepresivos con registro activo en Brasil. La presencia de contraindicaciones en el consumo de antidepresivos durante la lactancia se comparó con la información presente en el manual técnico del Ministerio de la Salud, en el libro Medications and Mothers' Milk, y en las bases de datos LactMed, Micromedex y UpToDate. En la mayoría de los prospectos (62,5%), el antidepresivo está contraindicado durante la lactancia. Entre las fuentes bibliográficas el porcentaje varió de 0% a 25%. El estudio señala la escasa conformidad entre prospectos y fuentes bibliográficas, alertando sobre la necesidad de revisión del contenido, así como de la forma de presentación de la información que aparece en los prospectos de los antidepresivos en Brasil.

Medicine package inserts from the users' perspective: are they read and understood? / Bulas de medicamentos sob a perspectiva dos usuários: elas são lidas e compreendidas?

ABSTRACT: Introduction: The written information on medicines has been acknowledged as an important tool for health education. Objective: To analyze the use and understanding of medicine package inserts by users and assess sociodemographic and medical factors associated with their comprehension. Method: Data in this analysis are part of the PNAUM National Survey - a cross-sectional population-based study conducted in Brazil. Descriptive statistics and the Pearson χ2 tests were performed to compare proportions between sociodemographic and medical characteristics, as well as use and understanding of medicine package inserts. Results: A total of 28.427 individuals responded to questions related to medicine package inserts. From these, 59.6% (95%CI 57.7 - 61.5) said they usually read the inserts, and 98.4% (95%CI 98.0 - 98.8) considered them necessary. Among people who read the medicine package inserts, more than half indicated difficulties with legibility (57.4%; 95%CI 55,2 - 59,6) and readability (54.1%; 95%CI 52.1 - 56.1). People from a lower education level reported greater difficulty in understanding them. Conclusion: The larger portion of the population usually read medicine package inserts. Nevertheless, people have difficulty in reading and understanding them.

RESUMO: Introdução: A informação escrita sobre medicamentos tem sido reconhecida como uma ferramenta importante para a educação em saúde. Objetivo: Analisar o uso e compreensão de bulas de medicamentos pelos usuários e avaliar fatores sociodemográficos e médicos associados ao seu uso e compreensão. Método: Osdados nesta análise fazem parte da PNAUM - um estudo transversal de base populacional realizado nas cinco regiões brasileiras. Estatísticas descritivas e teste de χ2 de Pearson foram utilizados para comparar proporções entre características sociodemográficas e médicas, uso e compreensão das bulas. Resultados: Um total de 28.427 indivíduos responderam a questões relativas a bulas. Desse total, 59,6% (IC95% 57,7 - 61,5) responderam que geralmente leem as bulas e 98,4% (IC95% 98,0 - 98,8) as consideraram necessárias. Entre as pessoas que leram as bulas, mais da metade indicou dificuldades de legibilidade (57,4%; IC95% 55,2 - 59,6) e de leiturabilidade (54,1%; IC95% 52,1 - 56,1) das bulas. As pessoas com menos educação relataram maior dificuldade em compreendê-las. Conclusões: A maioria da população tem o costume de ler as bulas, no entanto as pessoas consideram-nas difíceis de ler e compreender.

Evaluation of student pharmacists' ability and confidence using drug information resources to analyze drug-drug interactions.

BACKGROUND AND PURPOSE: Drug interaction management is essential in pharmacy practice. The purpose of this study was to evaluate student pharmacists' ability and confidence using drug information databases to investigate a drug-drug interaction previously unencountered in the curriculum. EDUCATIONAL ACTIVITY AND SETTING: A cross-sectional study was conducted where didactic students were presented with three cases, each containing an interaction. Students were asked to select a drug information resource and determine the mechanism, clinical effects, severity, level of documentation, and course of action for each interaction. Overall performance was assessed on a 15-point scale (one point for each assessment item for each interaction), and students were asked to rate their confidence on a five-point scale for each interaction, yielding a 15-point confidence scale. FINDINGS: For the 187 participants (90.8% response rate) who completed each interaction assessment, overall median performance score was 14 out of 15 possible points (IQR 12-15); 58 (31.0%) earned the maximum score of 15 points. Median confidence score was 13 out of 15 possible points (IQR 12-14). DISCUSSION: This study uniquely assessed students' competency in interactions by focusing on analysis, as opposed to recall of basic facts. Although most students performed well, a significant minority earned an overall performance score of 80% or less, suggesting need for continued practice and improvement. SUMMARY: This cross-section of student pharmacists earned generally high performance scores when assessed on their ability to use a drug information resource to analyze interactions, and were mostly highly confident.

A comparison of the content and primary literature support for online medication information provided by Lexicomp and Wikipedia.

OBJECTIVES: The research compared the comprehensiveness and accuracy of two online resources that provide drug information: Lexicomp and Wikipedia. METHODS: Medication information on five commonly prescribed medications was identified and comparisons were made between resources and the relevant literature. An initial content comparison of the following three categories of medication information was performed: dose and instructions, uses, and adverse effects or warnings. The content comparison included sixteen points of comparison for each of the five investigated medications, totaling eighty content comparisons. For each of the medications, adverse reactions that appeared in only one of the resources were identified. When primary, peer-reviewed literature was not referenced supporting the discrepant adverse reactions, a literature search was performed to determine whether or not evidence existed to support the listed claims. RESULTS: Lexicomp consistently provided more medication information, with information provided in 95.0% (76/80) of the content, compared to Wikipedia's 42.5% (34/80). Lexicomp and Wikipedia had information present in 91.4% (32/35) and 20.0% (7/35) of dosing and instructions content, respectively. Adverse effects or warning content was provided in 97.5% (39/40) of Lexicomp content and 55.0% (22/40) of Wikipedia content. The "uses" category was present in both Lexicomp and Wikipedia for the 5 medications considered. Of adverse reactions listed solely in Lexicomp, 191/302 (63.2%) were supported by primary, peer-reviewed literature in contrast to 7/7 (100.0%) of adverse reactions listed only in Wikipedia. A review of US Food and Drug Administration Prescribing Information and the Adverse Event Reporting System dashboard found support for a respective 17/102 (16.7%) and 92/102 (90.2%) of Lexicomp's adverse reactions that were not supported in the literature. CONCLUSION: Lexicomp is a comprehensive medication information tool that contains lists of adverse reactions that are not entirely supported by primary-peer reviewed literature.

Online drug information platform for the public in Hong Kong-Review of local drug information use and needs.

INTRODUCTION: In view of the popularity of Internet usage in Hong Kong, an interactive web-based drug information platform entitled "Ask My Pharmacist - Online University Led drug Enquiry Platform" (AMPOULE) was launched in 2009 to better serve the needs of drug information in Hong Kong. This paper aimed to evaluate the utility of AMPOULE in improving drug-related knowledge among the public and to reassess the needs of the general public in Hong Kong. METHODS: All enquiries sent via AMPOULE were reviewed. Demographic data, nature of questions and types of drug class covered were analyzed. The workload of pharmacists was examined with respect to the preparation time needed for the enquiry, the lag days to reply and also the timing of enquiry recipient. RESULTS: 2122 enquiries were received from 2009 to 2017. Most enquirers were from Hong Kong (56.6%) and female gender (49.2%). 13% of the concerned subjects were aged over 61-year-old. The most frequent types of questions and medications covered were "Drug Ingredients and Indications" (28.0%) and Adverse Drug Reactions (26.8%) and "Cardiovascular Medication" (21.9%) respectively but these varied in different age groups or enquirer groups. The median time for preparation was 40.0 min (IQR: 25-65 min) while the median time lag was found to be 2.5 days (IQR: 1.0-5.0 days). The number of enquiries received was evenly distributed throughout the day except during 1:00 am to 9:00 am and 7:00 pm to 8:00 pm. CONCLUSION: AMPOULE has demonstrated that an online platform providing patient-oriented drug information service through the Internet is promising and further promotion is warranted. Current data suggested that the need of different age groups and enquirer groups are different and should therefore be individualized.