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.

Active Pharmacovigilance Project on the safety profile of Dolutegravir in Brazil.

A quantitative descriptive study based on Brazilian Active Pharmacovigilance of Dolutegravir (DTG) Project was performed to describe the adverse drug reactions (ADRs) to DTG reported and to evaluate the noncompleteness of data from DTG active pharmacovigilance in Brazil. ADRs and clinical and individual data were obtained from information from the Pharmacovigilance Questionnaire from April 2017 to August 2019. The reported ADRs were classified using the Medical Dictionary for Regulatory Activities (MedDRA). In the evaluated period, 249,066 individuals using DTG participated in the active pharmacovigilance of DTG, with 3472 (1.39%) reporting ADRs at least once. A total of 6312 ADRs were reported, of which 57.56% were persistent and 81.46% were not serious according to the individuals' reports. Most of the reported ADRs were gastrointestinal, neurological and psychiatric. ADRs related to neural tube defects and serious neuropsychiatric ADRs have been reported. Completion of more than half of the fields in the Pharmacovigilance Questionnaire was excellent. The frequency of ADR was low in relation to the number of people living with HIV (PLHIV) using DTG in Brazil, which suggests good tolerability and safety of DTG. The DTG active pharmacovigilance database in Brazil showed good data completeness.

Instruments to Measure Patient Satisfaction with Comprehensive Medication Management Services: A Scoping Review Protocol.

Comprehensive medication management (CMM) is the service offered within the clinical practice of pharmaceutical care, which has the objective to optimize pharmacotherapeutic outcomes. Patient satisfaction is a multidimensional construct that points to the quality of the health services offered and the degree to which the patients' expectations and needs are met. The evaluation of the level of patient satisfaction is a key indicator to support decisions and to improve the quality of the service provided. This study aims to describe the protocol for a scoping review to map the instruments to measure patient satisfaction with CMM services and compare them according to their development characteristics and the applicability of patient-reported outcome measures. The literature search will be conducted using the scoping review methodology, proposed by the Joanna Briggs Institute and the PRISMA Extension for Scoping Reviews (PRISMA-ScR) method. The results will be presented in two sessions: (1) description of the search strategy; and (2) the characteristics of the satisfaction instruments, number of items and questions related to the conceptual model, content validity, construct validity, reliability, score/interpretation, and respondent burden. This review will shed light on the available satisfaction measurement instruments, allowing existing gaps to be identified for future research.

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.

Integrative Review of Managed Entry Agreements: Chances and Limitations.

BACKGROUND AND OBJECTIVE: Managed entry agreements (MEAs) consist of a set of instruments to reduce the uncertainty and the budget impact of new high-priced medicines; however, there are concerns. There is a need to critically appraise MEAs with their planned introduction in Brazil. Accordingly, the objective of this article is to identify and appraise key attributes and concerns with MEAs among payers and their advisers, with the findings providing critical considerations for Brazil and other high- and middle-income countries. METHODS: An integrative review approach was adopted. This involved a review of MEAs across countries. The review question was 'What are the health technology MEAs that have been applied around the world?' This review was supplemented with studies not retrieved in the search known to the senior-level co-authors including key South American markets. It also involved senior-level decision makers and advisers providing guidance on the potential advantages and disadvantages of MEAs and ways forward. RESULTS: Twenty-five studies were included in the review. Most MEAs included medicines (96.8%), focused on financial arrangements (43%) and included mostly antineoplastic medicines. Most countries kept key information confidential including discounts or had not published such data. Few details were found in the literature regarding South America. Our findings and inputs resulted in both advantages including reimbursement and disadvantages including concerns with data collection for outcome-based schemes. CONCLUSIONS: We are likely to see a growth in MEAs with the continual launch of new high-priced and often complex treatments, coupled with increasing demands on resources. Whilst outcome-based MEAs could be an important tool to improve access to new innovative medicines, there are critical issues to address. Comparing knowledge, experiences, and practices across countries is crucial to guide high- and middle-income countries when designing their future MEAs.

Free access to medicines among older adults in primary care: a cross-sectional study.

BACKGROUND: Access to medicines is an important indicator of healthcare system quality and capacity to resolve problems. The healthcare system needs to ensure free access to medicines for elderly people, in order to provide greater effectiveness of disease control, thus reducing morbidity and mortality, and improving health and quality of life. OBJECTIVES: To analyze the frequency of free access to medication among older adults within primary care and determine the factors associated with free access. DESIGN AND SETTING: Cross-sectional study at two primary care units. METHODS: Free access was defined as provision of all medicines through pharmacies within the Brazilian National Health System and through the Brazilian program for free medicines in private pharmacies. We investigated the sociodemographic, clinical, functional and pharmacotherapeutic characteristics of older adults. Multivariate logistic regression was performed to identify factors associated with free access to medicines. RESULTS: This study included 227 older adults, among whom 91 (40.1%) had free full access to prescription drugs. A direct association with age ≤ 70 years and indirect associations with polypharmacy and multimorbidity (P < 0.05) were found. CONCLUSIONS: Age ≤ 70 years increases the likelihood of having free full access to medicines, and older adults with multimorbidity and polypharmacy use have a lower likelihood of access. Identification of factors associated with free access to medicines among elderly people provides elements to guide the Brazilian National Health System in implementing access improvement actions.

Free access to medicines among older adults in primary care: a cross-sectional study

ABSTRACT BACKGROUND: Access to medicines is an important indicator of healthcare system quality and capacity to resolve problems. The healthcare system needs to ensure free access to medicines for elderly people, in order to provide greater effectiveness of disease control, thus reducing morbidity and mortality, and improving health and quality of life. OBJECTIVES: To analyze the frequency of free access to medication among older adults within primary care and determine the factors associated with free access. DESIGN AND SETTING: Cross-sectional study at two primary care units. METHODS: Free access was defined as provision of all medicines through pharmacies within the Brazilian National Health System and through the Brazilian program for free medicines in private pharmacies. We investigated the sociodemographic, clinical, functional and pharmacotherapeutic characteristics of older adults. Multivariate logistic regression was performed to identify factors associated with free access to medicines. RESULTS: This study included 227 older adults, among whom 91 (40.1%) had free full access to prescription drugs. A direct association with age ≤ 70 years and indirect associations with polypharmacy and multimorbidity (P < 0.05) were found. CONCLUSIONS: Age ≤ 70 years increases the likelihood of having free full access to medicines, and older adults with multimorbidity and polypharmacy use have a lower likelihood of access. Identification of factors associated with free access to medicines among elderly people provides elements to guide the Brazilian National Health System in implementing access improvement actions.

Factors associated with high medication regimen complexity in primary care older adults in Brazil.

PURPOSE: Complex medication regimens are common among older adults and contribute to the occurrence of undesirable health outcomes. This study aims to investigate the factors associated with high medication regimen complexity in older people. METHODS: A cross-sectional study was conducted with older adults selected from two primary healthcare units. Medication regimen complexity was measured using the Brazilian version of the Medication Regimen Complexity Index. The Pearson's Chi square test was used to analyse the individual association of each independent variable with high medication regimen complexity. The backward stepwise method was used to obtain the final multivariate logistic regression model. RESULTS: We included 227 older adults with a median age of 70 years who were mostly females (70.9%). The median total Medication Regimen Complexity Index was 20.8 for high complexity and 10.5 for patients that were not using high complexity regimens. The Medication Regimen Complexity Index section with higher median scores in both groups was dosing frequency, followed by additional instructions. High complexity was associated with diabetes (OR 5.42; p = 0.00 2.69-10.93) and asthma/Chronic Obstructive Pulmonary Disease (OR 2.96(1.22-7.18); p = 0.02). CONCLUSIONS: Older people in primary care with diabetes and respiratory disease were most likely to have complex medication regimens. Dosing frequency and additional instructions were medication regime complexity index components that most contributed to the high complexity in medication regime of older adults.