Medication Literacy Test for Older Adults: psychometric analysis and standardization of the new instrument.

BACKGROUND: Low medication literacy is prevalent among older adults and is associated with adverse drug events. The Medication Literacy Test for Older Adults (TELUMI) was developed and content validated in a previously published study. AIM: To evaluate the psychometric properties and provide norms for TELUMI scores. METHOD: This was a cross-sectional methodological study with older adults selected from the community and from two outpatient services. Descriptive item-analysis, exploratory factor analysis (EFA), item response theory (IRT), reliability, and validity analysis with schooling and health literacy were performed to test the psychometric properties of the TELUMI. The classification of the TELUMI scores was performed using percentile norms. RESULTS: A total of 344 participants, with a mean age of 68.7 years (standard deviation = 6.7), were included; most were female (66.6%), black/brown (61.8%), had low schooling level (60.2%) and low income (55.2%). The EFA pointed to the one-dimensional structure of TELUMI. A three-parameter logistic model was adopted for IRT. All items had an adequate difficulty index. One item had discrimination < 0.65, and three items had an unacceptable guessing index (< 0.35) and were excluded. The 29-item version of TELUMI had excellent internal consistency (KR20 = 0.89). There was a positive and strong association between TELUMI scores and health literacy and education level. The scores were classified as inadequate medication literacy (≤ 10.0 points), medium medication literacy (11-20 points), and adequate medication literacy (≥ 21 points). CONCLUSION: The results suggest that the 29-item version of TELUMI is psychometrically adequate for measuring medication literacy in older adults.

Development, content validation and standardization of an adult patient prioritization tool for hospital clinical pharmacy services.

BACKGROUND: Patient prioritization is a effective strategy to identify high risk patients for targeted Clinical Pharmacy Service (CPS) in hospital pharmacy. However, there is a paucity of patient prioritization tool to use in clinical practice. OBJECTIVES: Describe the development, content validation and standardization of an adult patient prioritization tool for hospital CPS named, PrioFarClinH. METHODS: The tool was developed using a stepwise design multi: Scoping Review to identify prioritization criteria/sub-criteria; Delphi technique to obtain consensus under the identified criteria/sub-criteria; Survey with pharmacists evaluating applicability of the criteria/sub-criteria obtained from Delphi; Definition of criteria/sub-criteria to be included in PrioFarClinH attribution of scores. Content validation was performed by a panel of experts evaluating relevance, feasibility, clarity and adequacy of the score. Content Validity Index (CVI) was calculated. Standardization occurred through a retrospective observational study carried out at 24 and 72 h and median of the patient's hospital stay. An intragroup norm was performed, determining percentile ranks of the instrument's total scores. Patients with a P90 score were classified with a high level of prioritization for CPS. RESULTS: PrioFarClinH is divided into three sections, with prioritization criteria for health issues; therapeutic classes; laboratory parameters. It comprises 51 criteria with specific scores with simple total calculation. None of the criteria presented CVI <0.78, maintaining the items from the initial version of PrioFarClinH. The scores were adjusted per suggestions from the panel of judges. Data were collected from 393 patients. The P90 percentile in the three hospitalization stages (24 h, 72 h, and median) was found, respectively, in the following scores: 18.0, 20.0, and 22.6. CONCLUSIONS: PrioFarClinH is a comprehensive tool to target and to prioritize adults patients most likely to benefit from CPS. Evidence for adequate content validity was provided. However, further validation of this tool is necessary to establish tool performance.

Development and content validation of the medication literacy test for older adults (TELUMI).

OBJECTIVES: Medication literacy comprises the skills needed to access, understand, and act on medication information. Low medication literacy is frequent among older adults, making them more susceptible to negative health outcomes. The aim of this study was to develop and evaluate the content validity of an instrument to measure medication literacy in this population. METHOD: Multistage methodological study. Items were generated according to a conceptual model and a literature review. The instrument was submitted to a panel of experts to assess item's relevance, clarity, and theoretical classification. Subsequently, the instrument was applied to the target population to assess its comprehensibility. RESULTS: Content Validity Index results indicated excellent agreement among experts on the instrument's relevance (0.98) and clarity (0.91). Overall agreement between experts regarding the theoretical subdimensions was moderate [Fleiss' kappa=0.57 (p = 0.00)]. Items were reported to be fully understood by most representatives of the target population. The final version of the instrument had 33 items divided into eight scenarios of medication use. CONCLUSION: The instrument seems to have adequate content validity and good suitability for the target population. Therefore, it can help health professionals to identify older adults with low medication literacy, aiming to improve their medication use skills.

Consensus on the criteria for patient prioritization in hospital clinical pharmacy services: a Delphi study.

BACKGROUND: Hospital pharmacists cannot provide extensive clinical pharmacy service to every inpatient because the demand for these services can exceed pharmacists' available work time. A way to solve this issue is hospital pharmacists to prioritize their clinical tasks. Tool prioritization could determine which patients would benefit from clinical pharmacists' input. AIM: Establishing consensus on which criteria are relevant for prioritizing patients for clinical pharmacy services. METHOD: The Delphi method was performed with criteria identified from a previously published Scoping Review. The panel of experts included hospital pharmacists, who evaluated the clinical significance of criteria in a three-round Delphi panel from July to December 2020. They determined the need for sub-criteria and evaluated their clinical significance. The experts also analyzed the criteria/sub-criteria as to their applicability in clinical practice. Consensus criteria were defined as 70% or more participants scoring the criteria as critical and 15% or fewer scoring the criteria as unimportant. RESULTS: A total of 19 criteria and 230 sub-criteria were included for evaluation by panel experts based on scoping review. Twenty-nine, 22, and 17 experts participated per round, respectively. After completing the three rounds, experts suggested the inclusion of one criterion, the exclusion of one criterion, and the inclusion of 29 sub-criteria. The final list consisted of 18 criteria and 177 sub-criteria, divided into 28 groups. CONCLUSION: The result was comprehensive and coherent, potentially contributing to developing an instrument for prioritizing hospitalized patients for clinical pharmacy services.

Medication literacy: A conceptual model.

BACKGROUND: Medication literacy reflects the specific literacy skills necessary to act on medication-related information. A comprehensive and clear conceptual model that reflects medication literacy is lacking. Conceptual models describe the components that represent a construct, allowing for its understanding and providing a rationale for its measurement. OBJECTIVES: To propose a conceptual model to support the development of an instrument to measure medication literacy. METHODS: This is a three-phase methodological study. A literature review was conducted to identify the components that should be part of the preliminary conceptual model. Subsequently, the importance of its components was judged on a Likert-5 scale. Then, the model was refined, and the dimensions and subdimensions of medication literacy were defined. RESULTS: Forty-five experts were included, with a mean age of 39.9 (SD = 10.5) years, most of them females (86.7%) and pharmacists (80%). All components of the preliminary conceptual model were considered important to extremely important by most experts. "Dosing information", "medication name", and "processing the information received about their medication and acting upon medication instructions" were the components considered most important. In the refinement phase, we identified that the construct has four dimensions - functional literacy, communicative literacy, critical literacy, and numeracy, which include the subdimensions to access, understand, evaluate, calculate, and communicate medication-related information. CONCLUSIONS: The conceptual model allowed identifying the components that represent medication literacy, which will support the development of an instrument for measuring the construct in Brazil.

Prognostic prediction models and clinical tools based on consensus to support patient prioritization for clinical pharmacy services in hospitals: A scoping review.

BACKGROUND: Identifying patients at high risk of adverse medication-related outcomes for targeted clinical pharmacy services is essential in hospital pharmacy. Models and predictive tools to prioritize patients are available to the clinical pharmacy services for hospital use. OBJECTIVE: To describe and assess prognostic models and predictive tools used to identify inpatients at risk of adverse medication-related outcomes. METHODS: We searched in Medline, Lilacs, Cochrane, CINAHL, Embase, Scopus and Web of Science, databases of theses and dissertations, and the references of the selected studies. The screening was carried out by two independent researchers. Cross-sectional studies, prospective or retrospective cohort studies, and case-control studies were eligible for inclusion. The studies addressed the development or validation of predictive models and clinical prioritization tools based on expert opinion to identify inpatients at risk of adverse medication-related outcomes. RESULTS: 25 studies were included, 13 of which were prognostic prediction models, seven were instrument development using the consensus method, and five were validation. The outcome events were drug-related problems (9), adverse drug reactions (8), adverse drug events (6), and medication errors (2). Most studies targeted adult patients (14), eight had older adult patients, one had obstetric patients, and others had pediatric patients. External validation was performed after the development study in three studies. The predictive model with a low risk of bias was the Medicines Optimisation Assessment Tool. Limited details on the method of expert involvement and the number of experts were identified in four studies. CONCLUSION: The development of patient prioritization tools to optimize pharmacotherapy by clinical pharmacy services is a complex process. The predictive models and tools analyzed are limited in their development and validation process, hindering their effective use in prioritizing patients by the clinical pharmacy services. The development of additional prognostic prediction models for drug-related problems is a priority.

New drugs registered in Brazil from 2003 to 2013: analysis from the perspective of child health

This study aims to analyze the new drugs registered in Brazil from 2003 to 2013 from the perspective of childcare needs, drug safety and considering the disease burden of the country. This is a retrospective cohort study including new drugs registered in Brazil between 2003 and 2013. Drug indications were related to the Disability-Adjusted Life Year (DALY) of the 2015 Global Burden of Disease Study. Association between the number of new drugs and DALY was determined by Spearman's coefficient. Post-marketing safety alerts specific to the pediatric population have been identified in the WHO Drug Information Bulletin and on websites of drug regulatory agencies. A total of 134 new drugs were included in the cohort and 46 (34.3%) had a pediatric indication. There was no evidence of an association between the disease burden in children in Brazil and the number of pediatric drugs. The safety alert data associated with the pediatric population published after registration of the new drugs were scarce. The number of new drugs launched in Brazil with a pediatric indication was small, reflecting the international challenges of developing effective and safe medicines for children. No association was found between the number of new drugs and the disease burden.

Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups.

OBJECTIVE: To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups. METHODS: A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions. RESULTS: Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups. CONCLUSION: Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.

Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença / Analysis of new drugs registered in Brazil in view of the Unified Health System and the disease burden

Resumo Para a saúde pública, a importância de um medicamento novo está no valor terapêutico e no benefício que produz para o paciente e para a sociedade. O objetivo do estudo foi analisar medicamentos novos registrados no Brasil de 2003 a 2013, sob a perspectiva da carga de doenças e da assistência farmacêutica no SUS. Estudo de coorte retrospectiva. Identificou-se os medicamentos novos registrados no Brasil por análise documental dos registros publicados pela Agência Nacional de Vigilância Sanitária. Os dados sobre carga de doença no Brasil foram obtidos do Global Burden of Disease Study, publicado em 2012 pela Organização Mundial de Saúde. O grau de inovação terapêutica foi determinado pelo Algoritmo de Motola. Identificou-se 159 medicamentos novos e somente 28 foram classificados como inovação terapêutica importante. Evidenciou-se uma relação desproporcional entre a porcentagem de medicamentos novos e a carga de doenças, com sub-representação de medicamentos para doenças respiratórias infecciosas, doenças cardíacas e doenças digestivas. Estratégias de incentivo à pesquisa e desenvolvimento de medicamentos devem ser priorizadas, para diminuir a desproporção em relação à carga de doença e contribuir para o desenvolvimento de medicamentos inovadores necessários ao quadro sanitário do país.

Abstract The most important aspect of a new drug in terms of public health is its therapeutic value and benefit it provides for the patient and for the society. The aim of this study was to analyze new drugs registered in Brazil between 2003 and 2013 with respect to Pharmaceutical Assistance programs within the Brazilian health system and to the disease burden in the country. In our retrospective cohort study, new drugs registered in Brazil were identified through document analysis of databases and publicly available documents from National Health Surveillance Agency. The data on disease burden in Brazil was obtained from the Global Burden of Disease Study 2012, published by the World Health Organization. The level of therapeutic innovation was determined using the Motola algorithm. Although a total of 159 new medicines were used in the cohort, only 28 (17.6%) were classified as important therapeutic innovations. There is a disproportionate relationship between the percentage of new drugs and the burden of disease, with an under-representation of drugs for infectious respiratory diseases, heart disease, and digestive diseases. Incentive strategies for research and development of medicines should be prioritized to reduce the disparity regarding the burden of disease and to help develop innovative medicines necessary to improve health throughout the country.

Analysis of new drugs registered in Brazil in view of the Unified Health System and the disease burden. / Análise de medicamentos novos registrados no Brasil na perspectiva do Sistema Único de Saúde e da carga de doença.

The most important aspect of a new drug in terms of public health is its therapeutic value and benefit it provides for the patient and for the society. The aim of this study was to analyze new drugs registered in Brazil between 2003 and 2013 with respect to Pharmaceutical Assistance programs within the Brazilian health system and to the disease burden in the country. In our retrospective cohort study, new drugs registered in Brazil were identified through document analysis of databases and publicly available documents from National Health Surveillance Agency. The data on disease burden in Brazil was obtained from the Global Burden of Disease Study 2012, published by the World Health Organization. The level of therapeutic innovation was determined using the Motola algorithm. Although a total of 159 new medicines were used in the cohort, only 28 (17.6%) were classified as important therapeutic innovations. There is a disproportionate relationship between the percentage of new drugs and the burden of disease, with an under-representation of drugs for infectious respiratory diseases, heart disease, and digestive diseases. Incentive strategies for research and development of medicines should be prioritized to reduce the disparity regarding the burden of disease and to help develop innovative medicines necessary to improve health throughout the country.

Para a saúde pública, a importância de um medicamento novo está no valor terapêutico e no benefício que produz para o paciente e para a sociedade. O objetivo do estudo foi analisar medicamentos novos registrados no Brasil de 2003 a 2013, sob a perspectiva da carga de doenças e da assistência farmacêutica no SUS. Estudo de coorte retrospectiva. Identificou-se os medicamentos novos registrados no Brasil por análise documental dos registros publicados pela Agência Nacional de Vigilância Sanitária. Os dados sobre carga de doença no Brasil foram obtidos do Global Burden of Disease Study, publicado em 2012 pela Organização Mundial de Saúde. O grau de inovação terapêutica foi determinado pelo Algoritmo de Motola. Identificou-se 159 medicamentos novos e somente 28 foram classificados como inovação terapêutica importante. Evidenciou-se uma relação desproporcional entre a porcentagem de medicamentos novos e a carga de doenças, com sub-representação de medicamentos para doenças respiratórias infecciosas, doenças cardíacas e doenças digestivas. Estratégias de incentivo à pesquisa e desenvolvimento de medicamentos devem ser priorizadas, para diminuir a desproporção em relação à carga de doença e contribuir para o desenvolvimento de medicamentos inovadores necessários ao quadro sanitário do país.

Suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups / Adequação às faixas etárias pediátricas de medicamentos novos registrados no Brasil de 2003 a 2013

ABSTRACT Objective To analyze suitability of new drugs registered in Brazil from 2003 to 2013 for pediatric age groups. Methods A descriptive study of drugs with pediatric indication included in a retrospective cohort of new drugs registered in Brazil. The evaluation of drug suitability for the pediatric age group was performed using the following criteria: suitability of dosage form and capacity to deliver the recommended dose. The drugs were considered adequate for the pediatric age groups when they met both criteria. The statistical analysis included calculation of frequencies and proportions. Results Suitability due to the drug capacity to deliver the recommended dose was greater than 80% across all age groups. Regarding suitability of the dosage form, we identified that the older the age group, the greater suitability for pediatric use. Concerning the drugs presented in solid dosage form, we showed that half were classified as inadequate for one or more pediatric age groups to whom they were indicated. The adequacy of drugs to the pediatric age group was 64.3% for preschool children, 66.7% for full-term newborns, 66.7% for premature newborns, and over 70% for other age groups. Conclusion Drugs for children aged under 6 years were less often adequate, considering the dosage form and capacity to provide the recommended dose. The availability and proportional suitability of medicines for pediatric use are greater for older age groups, according to age groups the drug is registered for.

RESUMO Objetivo Analisar a adequação às faixas etárias pediátricas dos medicamentos novos registrados no Brasil no período de 2003 a 2013. Métodos Estudo descritivo dos medicamentos com indicação pediátrica incluídos em uma coorte retrospectiva de medicamentos novos registrados no Brasil. A avaliação da adequação do medicamento à faixa etária pediátrica foi realizada empregando os seguintes critérios: adequação da forma farmacêutica e capacidade de fornecer a dose recomendada. Os medicamentos foram considerados adequados às faixas etárias pediátricas quando preencheram os dois critérios. A análise estatística compreendeu cálculo de frequências e proporções. Resultados A adequação devido à capacidade do medicamento fornecer a dose recomendada foi superior a 80% em todas as faixas etárias. Em relação à adequação da forma farmacêutica, identificou-se que quanto maior a faixa etária, maior a proporção de adequação para uso pediátrico. Em relação aos medicamentos que se apresentavam em formas farmacêuticas sólidas, evidenciou-se que metade foi classificada como inadequada para uma ou mais faixas etárias pediátricas para as quais estavam indicados. A adequação dos medicamentos à faixa etária pediátrica foi 64,3% para pré-escolares, 66,7% para recém-nascidos a termo, 66,7% para recém-nascidos prematuros e superior a 70% para as demais faixas etárias. Conclusão Os medicamentos destinados às crianças menores de 6 anos apresentaram menor frequência de adequação, considerando a forma farmacêutica e a capacidade de fornecer a dose recomendada. A disponibilidade e a proporção de adequação dos medicamentos para uso pediátrico aumentam com a elevação da faixa etária para a qual o medicamento é registrado.

Postmarketing Safety Events Relating to New Drugs Approved in Brazil Between 2003 and 2013: A Retrospective Cohort Study.

This study investigated postmarketing safety events (PMSEs) for new drugs approved in Brazil and evaluated whether a range of drug characteristics influenced the time between approval and the first PMSE. This retrospective study included new drugs registered between 2003 and 2013 by the National Health Surveillance Agency (ANVISA), which is responsible for medicines approval in Brazil. PMSEs were defined as any drug safety alert or drug withdrawal from the market. The existence of risk evaluation and mitigation strategies (REMS) by the US Food and Drug Administration (FDA) and Brazil were recorded. A Kaplan-Meier survival curve of the period between the date of ANVISA registration and the PMSE was calculated. We found a statistically significant difference between the time to PMSE for drugs with an FDA REMS compared with those without a REMS, with a log rank value (Mantel Cox) of 0.002. There was no association between the time to PMSE and the other drug characteristics investigated. This study demonstrated that the frequency of PMSEs for new drugs approved by ANVISA was statistically associated with the existence of an FDA REMS. The time between approval and first PMSE was shorter for drugs with an FDA REMS, and this finding may contribute to improved awareness of the risk/benefit balance required to ensure continued safe and effective use of new drugs.

Pharmacovigilance risk mitigation plans: action in public health to promote the safe use of medication.

Risk mitigation plans (RMP) are an innovative and important strategy for monitoring the sanitary risks of medication. The scope of the study was to identify RMPs for drugs registered with the Food and Drug Administration (FDA) and the actions to minimize risks established by the Brazilian Health Surveillance Agency (Anvisa) and the manufacturers of these drugs. This is a quantitative and descriptive study including a survey together with the pharmaceutical industries and research on sites and databases of Anvisa, the FDA and pharmaceutical industries. Forty drugs with RMPs filed with the FDA were also registered with Anvisa. Only 4 laboratories (10f%) reported RMPs developed in Brazil. Safety information for 15 drugs (37.5%) were located on the Anvisa site. In 91.4% of Brazilian user package leaflets there is safety information equivalent to actions to promote safe use described in RMPs available on the FDA website. The actions of communication on drug safety and sanitary risk of drugs needs to be expanded by Anvisa. The RMP is an important strategy in public health for managing new risks, monitoring known risks and, especially, for promoting the safe use of medication.

Planos de minimização de riscos em farmacovigilância: uma ação de saúde pública para promoção da segurança de medicamentos / Pharmacovigilance risk mitigation plans: action in public health to promote the safe use of medication

Resumo O plano de minimização de risco (PMR) é uma estratégia inovadora e importante de monitoramento de medicamentos. O estudo visou identificar os PMR de medicamentos registrados na Food and Drug Administration (FDA), e as ações instituídas no Brasil pela Agência Nacional de Vigilância Sanitária (Anvisa) e pelos fabricantes do setor. Estudo descritivo, de natureza quantitativa, que incluiu inquérito com indústrias farmacêuticas, e pesquisa em sites e bases de dados destas, da Anvisa e da FDA. Identificaram-se 40 medicamentos com PMR na FDA e cadastrados no site da Anvisa. Apenas quatro (10,0%) laboratórios informaram desenvolver PMR no Brasil. No site da Anvisa foram identificadas informações de segurança para 15 dos medicamentos (37,5%) com PMR no FDA. Em 91,4% das bulas brasileiras constavam informações de segurança equivalentes às ações de promoção do uso seguro descritas nos PMR disponíveis no site da FDA. As ações de comunicação sobre segurança e risco sanitário de medicamentos precisam ser ampliadas pela Anvisa. O PMR é uma estratégia importante em saúde pública no gerenciamento de novos riscos, no acompanhamento dos conhecidos e para a promoção do uso seguro dos medicamentos.

Abstract Risk mitigation plans (RMP) are an innovative and important strategy for monitoring the sanitary risks of medication. The scope of the study was to identify RMPs for drugs registered with the Food and Drug Administration (FDA) and the actions to minimize risks established by the Brazilian Health Surveillance Agency (Anvisa) and the manufacturers of these drugs. This is a quantitative and descriptive study including a survey together with the pharmaceutical industries and research on sites and databases of Anvisa, the FDA and pharmaceutical industries. Forty drugs with RMPs filed with the FDA were also registered with Anvisa. Only 4 laboratories (10f%) reported RMPs developed in Brazil. Safety information for 15 drugs (37.5%) were located on the Anvisa site. In 91.4% of Brazilian user package leaflets there is safety information equivalent to actions to promote safe use described in RMPs available on the FDA website. The actions of communication on drug safety and sanitary risk of drugs needs to be expanded by Anvisa. The RMP is an important strategy in public health for managing new risks, monitoring known risks and, especially, for promoting the safe use of medication.