Tertiary drug information sources for treatment and prevention of COVID-19.

Objective: To evaluate tertiary drug information databases in terms of scope, consistency of content, and completeness of COVID-19 drug information. Methods: Five electronic drug information databases: Clinical Pharmacology, Lexi-Drugs, AHFS DI (American Hospital Formulary Service Drug Information), eFacts and Comparisons, and Micromedex In-Depth Answers, were evaluated in this cross-sectional evaluation study, with data gathered from October 2021 through February 2022. Two study investigators independently extracted data (parallel extraction) from each resource. Descriptive statistics were primarily used to evaluate scope (i.e., whether the resource addresses use of the medication for treatment or prevention of COVID-19) and completeness of content (i.e., whether full information is provided related to the use of the medication for treatment or prevention of COVID-19) based on a 10-point scale. To analyze consistency among resources for scope, the Fleiss multi-rater kappa was used. To analyze consistency among resources for type of recommendation (i.e., in favor, insufficient evidence, against), a two-way mixed effects intraclass coefficient was calculated. Results: A total of 46 drug monographs, including 3 vaccination monographs, were evaluated. Use of the agents for treatment of COVID-19 was most frequently addressed in Lexi-Drugs (73.9%), followed by eFacts and Comparisons (71.7%), and Micromedex (54.3%). The highest overall median completeness score was held by AHFS DI followed by Micromedex, and Clinical Pharmacology. There was moderate consistency in terms of scope (kappa 0.490, 95% CI 0.399-0.581, p<0.001) and recommendations (intraclass correlation coefficient 0.518, 95% CI 0.385-0.651, p<0.001). Conclusion: Scope and completeness results varied by resource, with moderate consistency of content among resources.

Exploring the training of chinese medical staff oriented to the need for clinical drug information services: from the perspective of drug information patients obtained and need.

BACKGROUND: There are some gaps between the training of drug information service competencies for medical staff and drug information patients need in China. OBJECTIVE: To investigate drug information patients obtained and need for further providing directions for the training of drug information service competencies among medical staff in China from patients' perspectives. METHODS: A face-to-face nationwide survey was conducted using a stratified sampling method. Data were analyzed descriptively using frequencies, percentages and mean. Several subgroup analyses using Chi-square tests were conducted to identify patients' need for drug information in China. RESULTS: A total of 1994 questionnaires from medical institutions in China were returned. Most of the drug information obtained by patients came from physicians, and different types of drug information were important to patients. Additionally, patients had different needs for drug information due to age, gender, diagnosis and treatment status, and education level. CONCLUSIONS: The training of medical staff needs to increase the presence of nurses and pharmacists in drug information services, enhance the awareness of "patient-centered" services, and improve the ability to provide information services specific to the characteristics of patients.

COVID-19: como informações baseadas em evidências auxiliaram um hospital terciário durante o primeiro ano pandêmico / COVID-19: how evidence-based information supported a tertiary hospital during the first pandemic year

Introdução: Durante a pandemia de COVID-19, a necessidade por uma informação confiável, rápida e precisa desafiou os profissionais de saúde de todo o mundo. O objetivo deste trabalho foi avaliar e comparar as solicitações dos profissionais da saúde realizadas a um Centro de Informação Sobre Medicamentos (CIM) em um ano pré-pandêmico e durante o primeiro ano pandêmico. Métodos: Trata-se de um estudo quantitativo e retrospectivo, que analisou as perguntas realizadas ao CIM do Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHCFMUSP) quanto ao seu assunto, classificação ATC dos medicamentos envolvidos e profissionais solicitantes. Resultados: Os resultados demonstram que, de maneira geral, durante o primeiro ano pandêmico houve um aumento de 454 perguntas (66,13%; p < 0,01). As dúvidas se referiam principalmente a questões de administração, estabilidade/compatibilidade e padronização do medicamento na instituição, sendo o farmacêutico o profissional que realizou maior número de questionamentos. Ao seccionar as perguntas, verificou-se que a maioria das informações solicitadas se referiram a agentes infecciosos, agentes que atuam no sangue/órgãos hematopoiéticos e sistema nervoso. Conclusão: Considerando o cenário pandêmico, com sobrecarga dos serviços de saúde, contratação em massa de novos profissionais e pouca disponibilidade de informações com embasamento científico, as evidências fornecidas pelo CIM, aliadas ao entendimento do quadro clínico de cada paciente, com certeza auxiliaram em um melhor desfecho clínico, bem como foram essenciais no uso racional de medicamentos no combate a pandemia de COVID-19.

Introduction: During the COVID-19 pandemic the need for reliable, fast and accurate information challenged healthcare professionals around the world. The aim of this study was to evaluate and compare the requests made by health professionals to a Drug Information Center (DIC) in a pre-pandemic year and during the first year of the pandemic. Methods: This is a quantitative and retrospective study that analyzed the solicitations made to the DIC of the Instituto Central do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (ICHCFMUSP) regarding its subject, ATC classification of drugs involved and requesting professionals. Results: The results show that, in general, during the first pandemic year there was an increase of 454 questions (66.13%; p < 0.01). The questions referred mainly to issues of administration, stability/compatibility and standardization of the medicines in the institution, being the pharmacist the professional who asked the most number of questions. When sectioning the questions, it was found that most of the information requested referred to infectious agents, agents that act on the blood/hematopoietic organs and the nervous system. Conclusion: Considering the pandemic scenario, with an overload of health services, large number of hires of new professionals and lack of availability of scientifically based information, the evidence provided by the DIC, combined with the understanding of clinical condition of each patient, certainly helped in a better outcome for each patient, as well as being essential in the rational use of medicines in the fight against the COVID-19 pandemic.

US drug shortages compared to the World Health Organization's Model List of Essential Medicines for Children: A cross-sectional study.

PURPOSE: To describe US drug shortages affecting medications on the 2019 World Health Organization (WHO) Model List of Essential Medicines for Children (EMLc). METHODS: Drug shortage data from January 2014 to December 2019 were obtained from the University of Utah Drug Information Service. Shortage data for drugs on the EMLc were analyzed for the type of drug, American Hospital Formulary Service category, reason for the shortage, duration of the shortage, marketing status (generic vs brand name), and whether the agent was a single- or multisource drug. RESULTS: From 2014 to 2019, a total of 209 drug shortages impacted medications on the EMLc, of which 77 (36.8%) remained unresolved by 2019. Of all active shortages, 13 (6.2%) began before 2014. Resolved shortages had a median duration of 5.9 months (interquartile range [IQR], 3.6-13.2 months) while active shortages had a median duration of 18.3 months (IQR, 10.9-33.5 months; P ≤ 0.0001). The therapeutic categories most impacted by drug shortages were anti-infective agents (27.3%), central nervous system agents (12.9%), and antineoplastic agents (11.0%). The reason for the shortage was not reported in 46.4% of cases. When a reason was provided, the most common reason was manufacturing problems (29.2%) followed by supply/demand mismatch (15.8%). CONCLUSION: US drug shortages affected many medications on the WHO EMLc. Future studies should examine the global shortage climate and implications for patient care.

Queries on medication use during pregnancy: characterisation of the Swiss Teratogen Information Service database.

AIMS OF THE STUDY: Limited information on medication safety may result in concerns on how to treat pregnant and breast-feeding patients. The Swiss Teratogen Information Service (STIS) provides information to healthcare professionals about medications during pregnancy and breast feeding. Our objective was to describe the queries addressed to the STIS over the past two decades. METHODS: The STIS maintains a database of queries on pregnancy outcomes after exposure to various substances, which may be a valuable source of information. We initially analysed the general characteristics of all queries. Thereafter, we focused on exposure to medications during singleton pregnancies and associated health-related aspects. RESULTS: From 2000 to 2019, 7148 queries were entered into the database. An increasing number of queries was recorded over the study period, with an average of 357 queries entered into the database per year. Most of the enquirers were physicians; more specifically, gynaecologists/obstetricians (2389/7148; 33.4%) and psychiatrists (1007/7148; 14.1%). Two thirds (4747/7148; 66.4%) of the queries addressed medication intake during pregnancy; the next most frequent queries concerned planned medication in the context of pregnancy (928/7148; 13.0%) or medication use during breast-feeding (873/7148; 12.2%). In more than 50% (3611/7148) of cases, women were treated with more than one drug; altogether, 15193 medications (taken alone or in combination) were identified. The most frequent queries concerned medicines for the nervous system (ATC group N, n = 7042), with selective serotonin reuptake inhibitors (n = 1271) in the leading position, followed by benzodiazepine derivatives (n = 1102) and other antidepressants (n = 780). The next most frequently mentioned drug classes were anti-infectives for systemic use (J, n = 1586) and drugs for the alimentary tract and metabolism (A, n = 1205). Analysis of follow-up information on cases of medication exposure during singleton pregnancies (n = 2672) revealed an offspring malformation rate of 4.2%. The organ system most often affected was the musculoskeletal system, followed by the circulatory system; congenital malformations of the nervous system and chromosomal abnormalities were also seen. The three most frequently documented congenital diagnoses were malformations of cardiac septa, the brain and major arteries. CONCLUSIONS: Healthcare professionals often have concerns regarding the treatment of pregnant women with medication, and require professional counselling in this area. A variety of drugs are mentioned in queries addressed to the STIS, of which psycholeptics and psychoanaleptics are the most frequent. Proper guidelines on their use during pregnancy appear particularly urgent.

Desarrollo y protocolización de un modelo de optimización de respuestas a las consultas en los centros de información del medicamento / Development and protocolisation of a model for optimising responses to queries at the medicines information centres

INTRODUCCIÓN: los Centros de Información de Medicamento (CIM) tienen como objetivo servir a los farmacéuticos como fuente de información técnica, científica y actualizada de los medicamentos y productos sanitarios para promover el uso racional de estos y mejorar el cuidado y la salud del paciente. El farmacéutico ha de disponer de la mejor información sobre el medicamento para dar un buen servicio profesional.OBJETIVO: elaboración, implantación y validación de un protocolo de respuestas a las consultas recibidas en el CIM que permita el registro normalizado de las preguntas recibidas, así como un modelo optimizado de respuestas basado en la recuperación eficiente de información en las bases de datos especializadas.MATERIALES Y MÉTODOS: estudio observacional retrospectivo de las consultas recibidas y desarrollo de una base de datos propia para el registro de las consultas generadas (CAC). Las consultas se clasificaron siguiendo criterios de categorización a través de 25 ejes (comercialización, indicación, seguridad, posología, etc.), fármaco consultado y grupo ATC al que pertenece. Una vez procesadas las consultas de 7 meses, se procedió a la implantación del protocolo normalizado de resolución de consultas para evaluar su eficiencia.RESULTADOS Y DISCUSIÓN: durante el periodo de tiempo comprendido entre junio de 2021 y enero de 2022 se han registrado 248 consultas, que se han categorizado en base al tipo de consulta y fármaco consultado. En febrero, tras iniciar la validación, se recibieron 38 consultas de las cuales se repitieron 9 fármacos consultados (3,21 %), 10 grupos ATC (3,57 %) y se repitieron las mismas consultas 4 veces (1,43 %). Estos resultados permitieron responder de forma rápida y efectiva a las consultas que se repitieron durante el primer mes de validación. (AU)

The Quality and Reliability of Information in the Summaries of Product Characteristics.

The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals. A necessary condition for this is to ensure that the SmPC is clear and precise. However, neither European nor national legislation obliges marketing authorization holders to review the SmPC in terms of its readability and understandability prior to the registration of a medicine. To date, research on SmPCs has focused on accuracy and completeness; however, the literature lacks information on the extent to which SmPCs meet the needs of healthcare professionals concerning the readability of the information they contain. The main objective of this article is to point out the lack of precision in the legal provisions for the preparation of SmPCs concerning the comprehensibility of the provisions. The article points to the lack of testing of the SmPC in terms of accessibility and transparency for healthcare professionals, highlighting that the document does not meet the needs of healthcare professionals in providing adequate information about medicines. It shows that the current rules and guidelines for the preparation of the registration dossier for a medicinal product are not entirely precise and contain numerous shortcomings.

[Comparison in the Recognition about Medication Education between People with Prelingual Hearing Loss and Pharmacists].

Providing medication information according to a patient's health literacy and communication ability is needed for safe and effective healthcare. Communication barriers due to hearing loss prevent pharmacists from providing medication information to patients with hearing loss. A questionnaire about the difficulty in understanding medication information and the feeling of inconvenience during medication education was conducted from September to October 2020 with 84 people with prelingual hearing loss and 346 pharmacists. The 84 hearing loss participants were divided into low- and high-scoring groups based on their understanding of medication use. Pharmacists did not realize that low-scoring group participants did not understand items with homonyms, abstract expressions about medication use and medical terminology. Pharmacists were also unaware that the low-scoring group felt the inconvenience in medication education because of the difficulty to communicate, inform not understanding medication information and consult about medication use with a pharmacist. Prior learning about hearing loss led to higher responses in recognition of the aforementioned issues. However, even pharmacists with prior experience of learning did not fully recognize that speaking out loud is not useful for effective communication and that hearing loss patients need contact methods other than the phone. This indicates the need to learn about hearing loss to improve provision of medication information and effective communication in medication education to people with hearing loss.

Off-label use information in electronic drug information resources.

Objective: To compare electronic drug information resources for scope, completeness, and consistency of off-label uses information, and to group resources into tiers based on these endpoints. Methods: An evaluation study of six electronic drug information resources (Clinical Pharmacology, Lexi-Drugs, American Hospital Formulary Service Drug Information, Facts and Comparisons Off-Label, Micromedex Quick Answers, and Micromedex In-Depth Answers) was conducted. All off-label uses for the top 50 prescribed medications, by volume, were extracted from all resources and used to determine scope (i.e., whether the resource listed the use). Fifty randomly selected uses were then evaluated for completeness (i.e., whether the entry cited clinical practice guidelines, cited clinical studies, provided a dose, described statistical significance, and described clinical significance) and consistency (i.e., whether the resource provided the same dose as the majority). Results: A sample of 584 uses was generated. The largest number of listed uses was in Micromedex In-Depth Answers (67%), followed by Micromedex Quick Answers (43%), Clinical Pharmacology (34%), and Lexi-Drugs (32%). The highest scoring resources for completeness were Facts and Comparisons Off-Label (median score 4/5), Micromedex In-Depth Answers (median score 3.5/5), and Lexi-Drugs (median score 3/5). Consistency with the majority in terms of dosing was highest for Lexi-Drugs (82%), Clinical Pharmacology (62%), Micromedex In-Depth Answers (58%), and Facts and Comparisons Off-Label (50%). Conclusion: The top-tiered resources for scope were Micromedex In-Depth and Quick Answers. For completeness, the top-tiered resources were Facts and Comparisons Off-Label and Micromedex In-Depth Answers. Lexi-Drugs and Clinical Pharmacology were the most consistent in dosing.

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.

Identifying Training Needs and Active Information Opportunities in Primary Care Through the Analysis of Drug Information Requests.

INTRODUCTION: Drug information (DI) services should work toward efficiency by identifying knowledge gaps and actively creating resources to address those needs. The aim was to identify training needs and active information opportunities in primary care by analyzing DI requests and to calculate labor cost associated with DI requests addressable with training or active information. METHODS: DI requests received in 2016 and 2017 by ambulatory care pharmacists were independently classified by 2 authors into: training (i.e., delivery of content meant to be retained as knowledge and used when needed); active information (i.e., resources created preemptively and consulted when needed); or passive information (i.e., not addressable with training or active information). Inter-rater reliability was calculated using Cohen's Kappa. Median time spent by category and across practice settings/professional types was compared using bivariate analysis. Thematic analysis categorized specific training and active DI requests and labor costs were calculated. RESULTS: Of 2,041 DI requests, 330 (16.2%) were classified as training, 454 (22.2%) active information, and 1257 (61.6%) passive information (kappa = 0.769). Median (IQR) time to resolve requests was 5 (2-10) mins for training, 5 (3-11) active information, and 10 (4-15) passive information. Pharmacists spent 132.1 hrs = $8,956.98 answering questions addressable with training or active information. Areas warranting training or active information included: controlled substances, immunizations, patient assistance programs, policy/regulations, medication preparation/administration, storage/stability, disposal, availability/ordering medications, and patient-related resources. CONCLUSION: Several opportunities for training and active information were identified. Despite the single-institution nature, the method described can serve as an example for other institutions.