Pharmaceutical policies: effects of policies regulating drug marketing.

BACKGROUND: The costs of developing new treatments and bringing them to the market are substantial. The pharmaceutical industry uses drug promotion to gain a competitive market share, and drive sale volumes and industry profitability. This involves disseminating information about new treatments to relevant targets. However, conflicts of interest can arise when profits are prioritised over patient care and its benefits. Drug promotion regulations are complex interventions that aim to prevent potential harm associated with these activities. OBJECTIVES: To assess the effects of policies that regulate drug promotion on drug utilisation, coverage or access, healthcare utilisation, patient outcomes, adverse events and costs. SEARCH METHODS: We searched Epistemonikos for related reviews and their included studies. To find primary studies we searched MEDLINE, CENTRAL, Embase, EconLit, Global Index Medicus, Virtual Health Library, INRUD Bibliography, two trial registries and two sources of grey literature. All databases and sources were searched in January 2023. SELECTION CRITERIA: We planned to include studies that assessed policies regulating drug promotion to consumers, healthcare professionals or regulators and third-party payers, or any combination of these groups.In this review we defined policies as laws, rules, guidelines, codes of practice, and financial or administrative orders made by governments, non-government organisations or private insurers. One of the following outcomes had to be reported: drug utilisation, coverage or access, healthcare utilisation, patient health outcomes, any adverse effects (unintended consequences), and costs. The study had to be a randomised or non-randomised trial, an interrupted time series analysis (ITS), a repeated measures (RM) study or a controlled before-after (CBA) study. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed eligibility for inclusion of studies. When consensus was not reached, any disagreements were discussed with a third review author.  We planned to use the criteria suggested by Cochrane Effective Practice and Organisation of Care (EPOC) to assess the risk of bias of included studies. For randomised trials, non-randomised trials, and CBA studies, we planned to estimate relative effects, with 95% confidence intervals (CI). For dichotomous outcomes, we planned to report the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For ITS and RM, we planned to compute changes along two dimensions: change in level and change in slope. We planned to undertake a structured synthesis following EPOC guidance.  MAIN RESULTS: The search yielded 4593 citations, and 13 studies were selected for full-text review. No study met the inclusion criteria. AUTHORS' CONCLUSIONS: We sought to assess the effects of policies that regulate drug promotion on drug use, coverage or access, use of health services, patient outcomes, adverse events, and costs, however we did not find studies that met the review's inclusion criteria. As pharmaceutical policies that regulate drug promotion have untested effects, their impact, as well as their positive and negative influences, is currently only a matter of opinion, debate, informal or descriptive reporting. There is an urgent need to assess the effects of pharmaceutical policies that regulate drug promotion using well-conducted studies with high methodological rigour.

Involvement of Human Volunteers in the Development and Evaluation of Wearable Devices Designed to Improve Medication Adherence: A Scoping Review.

Wearable devices designed to improve medication adherence can emit audible and vibrating alerts or send text messages to users. However, there is little information on the validation of these technologies. The aim of this scoping review was to investigate the involvement of human volunteers in the development and evaluation of wearable devices. A literature search was conducted using six databases (MEDLINE, Embase, Scopus, CINAHL, PsycInfo, and Web of Science) up to March 2020. A total of 7087 records were identified, and nine studies were included. The wearable technologies most investigated were smartwatches (n = 3), patches (n = 3), wristbands (n = 2), and neckwear (n = 1). The studies involving human volunteers were categorized into idea validation (n = 4); prototype validation (n = 5); and product validation (n = 1). One of them involved human volunteers in idea and prototype validation. A total of 782 participants, ranging from 6 to 252, were included. Only five articles reported prior approval by a research ethics committee. Most studies revealed fragile methodological designs, a lack of a control group, a small number of volunteers, and a short follow-up time. Product validation is essential for regulatory approval and encompasses the assessment of the effectiveness, safety, and performance of a wearable device. Studies with greater methodological rigor and the involvement of human volunteers can contribute to the improvement of the process before making them available on the market.

Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

[Mobile technologies in healthcare: reflections on development, application, legal aspects, and ethicsTecnologías sanitarias móviles: reflexiones sobre desarrollo, aplicación, legislación y ética]. / Tecnologias móveis em saúde: reflexões sobre desenvolvimento, aplicações, legislação e ética.

The association between fast-growing mobile technologies and increasingly more mobile devices has allowed the introduction of virtual environments into daily activities. That includes the health care domain, where concepts such telemedicine, telehealth, eHealth, and mHealth have emerged. In addition to presenting these new concepts, this article aims to discuss the advancements and challenges of mobile health technologies stemming from considerations regarding development, application, legal aspects, and ethics. Because of their innovative nature, mobile health technologies entail the engagement of many actors in the journey to reach end users, covering conception, technical development, sanitary regulations, and design of clinical guidelines, having raised a great deal or interest in terms of monitoring and care across a variety of clinical conditions. However, assessment of the effectiveness and safety of mobile health technologies does not seem to involve the same methodological rigor imposed for clinical trials of drugs and other health products; still, the enthusiasm produced by this innovation counters some of the regulatory and ethics concerns relating to data protection, privacy, access to mobile devices, and technological or social inequality. Despite possible limitations, mobile technologies, as well as other telehealth resources, have produced promising results. Digital healthcare has great potential for expansion and represents an opportunity for the review of traditional practices with selection of mobile technologies for incorporation into the health care system whenever evidence-based benefits are verified.

El avance de las tecnologías móviles, junto con la creciente movilidad de los dispositivos, permitió incorporar el entorno virtual a diversas actividades cotidianas, incluso en el ámbito de la salud, al introducir conceptos como telemedicina, telesalud, eSalud y mSalud. Además de presentar estos nuevos conceptos, en el presente artículo se pretende debatir los avances y desafíos de las tecnologías sanitarias móviles a partir de reflexiones sobre el desarrollo, las aplicaciones, la legislación y la ética. Por su carácter innovador, las tecnologías sanitarias móviles llevan a muchos actores a recorrer el camino conducente al usuario final, centrándose en el diseño, el desarrollo técnico, la regulación sanitaria y la elaboración de directrices clínicas; además, han despertado un gran interés para fines de seguimiento y atención en diferentes condiciones clínicas. Sin embargo, al evaluar la eficacia y seguridad de las tecnologías sanitarias móviles no se observa el mismo rigor metodológico exigido en los ensayos clínicos de medicamentos y otros productos sanitarios, y el entusiasmo por la innovación se contrapone a las preocupaciones reguladoras y éticas relacionadas con la protección de datos, la privacidad, el acceso a los dispositivos móviles y las disparidades tecnológicas y sociales. A pesar de las posibles limitaciones, las tecnologías móviles, así como otros recursos de telesalud, han dado resultados prometedores. La atención digital en el ámbito de la salud tiene un gran potencial de expansión y representa una oportunidad para revisar las prácticas tradicionales de salud a partir de la selección e incorporación de las tecnologías móviles a los sistemas de salud, siempre que se registren beneficios basados en la mejor evidencia.

Treatment of urinary incontinence: a critical appraisal of clinical practice guidelines with the AGREE II instrument.

INTRODUCTION AND HYPOTHESIS: This systematic review evaluated the rigor of the development of clinical practice guidelines (CPG). METHODS: The searched sources were MEDLINE, EMBASE, Web of Science, Scopus, and specific databases of CPG. Reviewers, organized in triplicate and independently, selected the studies and assessed the quality of the guidelines using the Appraisal of Guidelines Research and Evaluation (AGREE II) instrument, which contains six domains for classification. The classification of the CPGs prioritized the domain 3 (developmental rigor) considering: high (score > 60%), moderate (score 30-60%), or low quality (score < 30%). The results were checked for discrepancies and decided by consensus. The interventions were described. Descriptive statistics presented the results. RESULTS: Of the ten CPGs evaluated, five were of high methodological quality, three were of moderate quality, and two of low quality. Three documents were not recommended for use. The domains with the highest scores were scope and purpose (mean = 90.1%) and clarity of presentation (mean = 88.9%). The domains of editorial independence (mean = 41.4%) and applicability (mean = 29.3%) were those with the lowest score. The most cited interventions in CPGs were the nonpharmacological, such as lifestyle interventions, bladder training, or re-education and pelvic floor muscle training. CONCLUSION: Most guidelines showed rigor in development and were recommended for use; however, editorial independence and applicability were domains that need to be improved in these documents. Our findings can guide the choice of CPG for the treatment of urinary incontinence.

[Methicillin-resistant Staphylococcus aureus in the Americas: systematic review and metanalysis of prevalence in food-producing animalsStaphylococcus aureus resistente a la meticilina en la Región de las Américas: revisión sistemática y metanálisis de la prevalencia en la actividad agropecuaria]. / Staphylococcus aureus resistente à meticilina nas Américas: revisão sistemática e metanálise da prevalência na pecuária.

OBJECTIVE: To determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA) in animals used to produce foods in the Americas. METHOD: A systematic literature review was performed in the following databases: Scopus, Web of Science, MEDLINE, EMBASE, and Virtual Health Library. Articles published in the past 10 years, without language limits, were selected. The outcome of interest was the prevalence of MRSA in food-producing animals. Prevalence rates were meta-analyzed in grouped random effects models using the DerSimonian and Laird method. The geographic distribution of MRSA and the time trend of resistance were also analyzed. RESULTS: Of 19 studies included, 11 were performed in the United States and 11 analyzed pig samples. Five studies were performed in South America. The samples analyzed in the studies were collected in farming, processing, and retail sites. MRSA prevalence in the Americas was 7.6% (95%CI: 5.6-9.5%), and was higher in pigs [12.6% (95%CI: 7.0-18.2%)] followed by bovine cattle [2.4% (95%CI: 1.2-3.7%)] and poultry [1.8% (95CI%: 0.3-3.4%)]. MRSA prevalence was higher in pigs in North America and bovine cattle in Latin America. There was no significant variation in MRSH prevalence along the 10-year period analyzed. CONCLUSIONS: MRSA prevalence in food-producing animals in the Americas was higher in pigs, without significant changes across time.

OBJETIVO: Determinar la prevalencia de Staphylococcus aureus resistente a la meticilina (MRSA por su sigla en inglés) en animales destinados a la producción de alimentos en la Región de las Américas. MÉTODOS: Se realizó una revisión sistemática en las siguientes bases de datos: Scopus, Web of Science, MEDLINE, EMBASE y Biblioteca Virtual de Salud (BVS). Se seleccionaron artículos publicados en los últimos diez años, sin restricción en cuanto al idioma. El resultado de interés fue la prevalencia de MRSA en animales destinados a la producción de alimentos. Las tasas de prevalencia se agruparon en metanálisis de efectos aleatorios por el método de DerSimonian y Laird. También se analizaron la distribución geográfica de los microorganismos resistentes y las tendencias de resistencia con el transcurso del tiempo. RESULTADOS: De los 19 estudios incluidos, 11 se realizaron en Estados Unidos y en 11 se analizaron muestras tomadas de cerdos. Se efectuaron cinco estudios en América del Sur. Las muestras analizadas se recogieron en lugares de cría, sacrificio y venta. La prevalencia de MRSA en la Región de las Américas fue de 7,6% (IC95%: 5,6-9,5%) con una tasa mayor en cerdos [12,6% (IC95%: 7,0-18,2%)], seguidos por bovinos [2,4% (IC95%: 1,2-3,7%)] y aves [1,8% (IC95%: 0,3-3,4%)]. Se observó una mayor prevalencia de MRSA en la población porcina de América del Norte y en la población bovina de América Latina. No hubo variación significativa de la prevalencia de resistencia en los diez años analizados. CONCLUSIONES: La prevalencia de MRSA en animales destinados a la producción de alimentos en la Región de las Américas fue mayor en cerdos, sin variación significativa de la prevalencia con el transcurso del tiempo.

Rapid Tranquilization for Psychiatric Patients with Psychomotor Agitation: What is Known About it?

Rapid tranquilization is an intervention used in control of agitation or aggression in patients with mental disorders. This study synthesized the available evidence regarding efficacy and safety of drugs used for rapid tranquilization in psychiatric patients with psychomotor agitation. It is an overview study of systematic reviews and meta-analysis of randomized controlled trials (RCT) identified in the database MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Library and LILACS until April 2015. A team of reviewers, in pairs and independently, identified eligible studies and assessed methodological quality using AMSTAR. Data were extracted from four studies (61 RCT, 8021 participants). The association of haloperidol with promethazine (H + P) promoted tranquilization and presented better safety profile, with moderate quality evidence. Olanzapine demonstrated benefit towards tranquilization and good safety profile, but needed additional administration to keep tranquilization. There was no benefit in the use of haloperidol alone or associated to another psychotropic to most outcomes evaluated. The evidence was of low quality to most of the interventions. H + P was considered a good option for rapid tranquilization, however, more RCT are necessary to confirm the efficacy and safety of the available interventions.

Antibiotics and Breastfeeding.

During the breastfeeding period, bacterial infections can occur in the nursing mother, requiring the use of antibiotics. A lack of accurate information may lead health care professionals and mothers to suspend breastfeeding, which may be unnecessary. This article provides information on the main antibiotics that are appropriate for clinical use and the interference of these antibiotics with the infant to support medical decisions regarding the discontinuation of breastfeeding. We aim to provide information on the pharmacokinetic factors that interfere with the passage of antibiotics into breast milk and the toxicological implications of absorption by the infant. Publications related to the 20 most frequently employed antibiotics and their transfer into breast milk were evaluated. The results demonstrate that most antibiotics in clinical use are considered suitable during breastfeeding; however, the pharmacokinetic profile of each drug must be observed to ensure the resolution of the maternal infection and the safety of the infant.

Essential psychiatric medicines: wrong selection, high consumption and social problems.

BACKGROUND: The World Health Organization Essential Medicines List (WHO-LIST) and national essential medicines lists differ because many countries face significant challenges, such as product availability, cost, product quality and epidemiological disease profiles. In Brazil, governments pay for drugs that are included on the federal, state and municipal government (REMUME) lists. The extent to which municipal lists differ from state and national lists and from the WHO-LIST is unclear. We investigate the use of the WHO-LISTas a tool with which to evaluate the selection process for the essential psychiatric medicines in the public system coverage list of Brazilian communities (cities) and the use of the target drugs. METHODS: Municipal health secretaries were interviewed regarding the selection process for REMUMEs and the antidepressants and benzodiazepines included in REMUMEs and reference lists. We calculated the use of REMUME drugs that appeared or did not appear on reference lists according to the defined daily dose (DDD) per 10,000 inhabitants. RESULTS: Local physicians and pharmacists without specific training or explicit criteria developed the REMUMEs. Of the 13 drugs and 24 products (i.e., the different dosages of these 13 drugs) in the REMUMEs, 8 drugs and 10 products were included in at least one reference list and in one municipal list; 4 drugs and 6 products were included in at least one reference list but in none of the municipal lists; and 7 drugs and 8 products were included in at least one municipal list but in none of the reference lists. The antidepressants that appeared in at least one municipal list but in none of the reference lists represented 25.1 % (mean 60.9 DDD/10,000 inhabitants-day) of the usage. The benzodiazepines that appeared in at least one of the municipal lists but in none of the reference lists represented 14.7 % mean 18.5 DDD/10,000 inhabitants-day) of the usage. CONCLUSIONS: Brazilian cities have no rigorous processes for selecting the drugs that appear on their lists, and drugs that do not appear on the reference lists represent a significant proportion of antidepressant and benzodiazepine use, resulting in public health and social problems.

Sales trends of psychotropic drugs in the COVID-19 pandemic: A national database study in Brazil.

Background: The social restrictions among coronavirus disease 2019 (COVID-19) pandemic have posed a thoughtful risk to mental health and have implications in the use of drugs, including antidepressants, anxiolytics and other psychotropics. Objective: This study analyzed the sales data of the psychotropics prescribed in Brazil, in order to verify the change in consumption trends of these drugs during the COVID-19 pandemic. Methods: This interrupted time-series analyzed psychotropic sales data, between January 2014 and July 2021, using the National System of Controlled Products Management from The Brazilian Health Regulatory Agency. The monthly mean DDDs per 1,000 inhabitants per day of psychotropic drugs was evaluated by analysis of variance (ANOVA) followed by Dunnett Multiple Comparisons Test. The changes in monthly trends in the use of the psychotropic studied were evaluated by Joinpoint regression. Results: During the period studied, clonazepam, alprazolam, zolpidem and escitalopram were the most sold psychotropic drugs in Brazil. According to Joinpoint regression, an upward trend was observed in sales during the pandemic of pregabalin, escitalopram, lithium, desvenlafaxine, citalopram, buproprion and amitriptyline. An increase in psychotropic consumption was noted throughout the pandemic period, with the maximum consumption (2.61 DDDs) occurring in April 2021, with a downward trend in consumption that accompanied the drop in the number of deaths. Conclusions: The increase in sales, mainly of antidepressants during the COVID-19 pandemic, draws attention to issues related to the mental health of the Brazilian population and on the need for greater monitoring in the dispensing of these drugs.

Critical appraisal and comparison of recommendations of clinical practice guidelines for the treatment of schizophrenia in children and adolescents: a methodological survey.

INTRODUCTION: The production of clinical practice guidelines (CPGs) has grown in the past years. Notwithstanding, the quality of these documents and their recommendations for the treatment of schizophrenia in children and adolescents is still unknown. OBJECTIVE: To assess the quality of the guidelines and recommendations for the treatment of schizophrenia in this population. METHODS: CPGs from 2004 to December 2020 were identified through a systematic search on EMBASE, MEDLINE, PsycINFO, PubMed, Epistemonikos, VHL, Global Index Medicus and specific CPG databases. The CPGs' quality was independently assessed by three reviewers using AGREE II and they were considered of high quality if they scored ≥60% in domains 3 and 6. The evidence classification systems were described, the quality of recommendations was assessed in pairs using AGREE-REX and the recommendations were compared. RESULTS: The database search retrieved 3182 results; 2030 were screened and 29 were selected for full-text reading. Four guidelines were selected for extraction. Two CPGs were considered of high quality in the AGREE II assessment. We described the commonly agreed recommendations for each treatment phase. The pharmacological recommendations were described in all treatment phases. Scores of AGREE-REX were lower for psychosocial recommendations. CONCLUSION: There are still few clinical studies and CPGs regarding schizophrenia in children and adolescents. The quality of the documents was overall low, and the quality of the recommendations report has much to improve. There is also a lack of transparency about the quality of the evidence and the strength of the recommendations. PROTOCOL REGISTRATION NUMBER: CRD42020164899.

Increase in veterinary prescriptions of azithromycin during the COVID-19 pandemic in Brazil.

INTRODUCTION: With the advent of the pandemic in 2020 and the lack of perspectives on the treatment of COVID-19, numerous therapeutic proposals have emerged, including hydroxychloroquine and azithromycin. Therefore, some studies have shown that in many countries, the demand for azithromycin has increased during the pandemic. In Brazil, antibiotics can only be purchased with a medical, dental, or veterinary prescription. This study aimed to determine whether the number of prescriptions made by veterinarians (which could be used by humans) has increased during the pandemic. METHODOLOGY: Data on the purchase of antibiotics made under veterinary prescriptions in Brazilian pharmacies between 2014 and 2021 were collected. To assess the changes in monthly trends in the use of the selected antibiotics, we applied the Joinpoint regression. RESULTS: The most prescribed antibiotic in all years was cephalexin (35%), followed by amoxicillin (24%). During the pandemic, sales of azithromycin substantially increased. Regression analysis showed that since 2014, azithromycin prescriptions grew by an average of 0.67% per month. At the beginning of the pandemic, the monthly growth rate became 12.64%. When comparing azithromycin sales during the pandemic with the historical average (2014-2019), the increase was 41%. CONCLUSIONS: During the pandemic, there was no animal health situation in Brazil that required the use of this antibiotic. Veterinary prescriptions may have been an instrument for human access to azithromycin for the treatment of COVID-19. Stricter enforcement policies are needed to address this problem to avoid antimicrobial resistance.

E-Health technologies for treatment of depression, anxiety and emotional distress in person with diabetes mellitus: A systematic review and meta-analysis.

OBJECTIVE: This systematic review of randomized clinical trials (RCT) summarized the available evidence regarding the use of e-Health technologies for the treatment of depression, anxiety, and emotional distress in person with diabetes mellitus. METHODS: The Cochrane CENTRAL, MEDLINE, EMBASE, Web of Science and LILACS databases searched were up to January 11th, 2023. The primary outcomes were improvement of depression, anxiety, diabetes-related emotional distress and quality of life. Reviewers, in pairs and independently, selected the studies and extracted their data. RESULTS: A total of 10 RCT involving 2,209 participants were analyzed. The methodological quality of the studies reviewed was high. Results showed improvements in depression with the use of Internet-Guided Self-Help (SMD = -0.74, 95%CI = -1.04 to -0.43) or Telephone-Delivered Cognitive Behavioral Therapy (CBT) (SMD = -0.42, 95%CI = -0.65 to -0.19); in anxiety with Internet-Guided Self-Help (SMD = -0.72, 95%CI = -1.02 to -0.42) or Diabetes-specific-CBT (SMD = -0.60, 95%CI = -1.18 to -0.02); and in emotional distress with Internet-Guided Self-Help (SMD = -0.72, 95%CI = -1.02 to -0.41) or Healthy Outcomes through Patient Empowerment (SMD = -0.26, 95%CI = -0.53 to 0.01) compared to usual care. CONCLUSION: Due to heterogeneity in interventions, populations, follow-up time and outcomes, future RCT should be conducted to confirm these findings.

Preemptive use of anti-inflammatories and analgesics in oral surgery: a review of systematic reviews.

Objectives: This review of systematic reviews evaluated the effectiveness and safety of the preemptive use of anti-inflammatory and analgesic drugs in the management of postoperative pain, edema, and trismus in oral surgery. Materials and methods: The databases searched included the Cochrane Library, MEDLINE, EMBASE, Epistemonikos, Scopus, Web of Science, and Virtual Health Library, up to March 2023. Pairs of reviewers independently selected the studies, extracted the data, and rated their methodological quality using the AMSTAR-2 tool. Results: All of the 19 studies reviewed had at least two critical methodological flaws. Third molar surgery was the most common procedure (n = 15) and the oral route the most frequent approach (n = 14). The use of betamethasone (10, 20, and 60 mg), dexamethasone (4 and 8 mg), methylprednisolone (16, 20, 40, 60, 80, and 125 mg), and prednisolone (10 and 20 mg) by different routes and likewise of celecoxib (200 mg), diclofenac (25, 30, 50, 75, and 100 mg), etoricoxib (120 mg), ibuprofen (400 and 600 mg), ketorolac (30 mg), meloxicam (7.5, 10, and 15 mg), nimesulide (100 mg), and rofecoxib (50 mg) administered by oral, intramuscular, and intravenous routes were found to reduce pain, edema, and trismus in patients undergoing third molar surgery. Data on adverse effects were poorly reported. Conclusion: Further randomized clinical trials should be conducted to confirm these findings, given the wide variety of drugs, doses, and routes of administration used.

Improving the adherence to COVID-19 preventive measures in the community: Evidence brief for policy.

Objectives: To identify evidence-based strategies to improve adherence to the preventive measures against the coronavirus disease (COVID-19) at the community level. Method: This is an evidence brief for policy, combining research evidence specific to contextual knowledge from stakeholders. A systematic search was performed in 18 electronic databases, gray literature, and a handle search, including only secondary and tertiary studies that focused on the adherence of the general population to COVID-19 preventive measures in the community. Two reviewers, independently, performed the study selection, data extraction, and assessment of the quality of the studies. Relevant evidence has been synthesized to draft evidence-based strategies to improve adherence. These strategies were circulated for external endorsement by stakeholders and final refinement. Endorsement rates >80%, 60-80% and <60% were considered high, moderate, and low respectively. Results: Eleven studies, with varying methodological qualities were included: high (n = 3), moderate (n = 3), low (n = 1), and critically low (n = 4). Three evidence based strategies were identified: i. Risk communication; ii. Health education to the general public, and iii. Financial support and access to essential supplies and services. The rates of endorsement were: 83% for risk communication, 83% for health education, and 92% for financial support and access to essential supplies and services. The evidence showed that an increase in knowledge, transparent communication, and public awareness about the risks of COVID-19 and the benefits of adopting preventive measures results in changes in people's attitudes and behavior, which can increase adherence. In addition, the guarantee of support and assistance provides conditions for people to adopt and sustain such measures. Conclusions: These strategies can guide future actions and the formulation of public policies to improve adherence to preventive measures in the community during the current COVID-19 pandemic and other epidemics.

Consumption Trends of Antibiotics in Brazil During the COVID-19 Pandemic.

Background: In 2019, a new type of coronavirus emerged and spread to the rest of the world. Numerous drugs were identified as possible treatments. Among the candidates for possible treatment was azithromycin alone or in combination with other drugs. As a result, many clinicians in Brazil have prescribed azithromycin in an attempt to combat or minimize the effects of COVID19. Aim: This study analyzed the sales data of the main antibiotics prescribed in Brazil to verify the change in consumption trends of these drugs during the COVID-19 pandemic. Methods: This is an interrupted time series that analyzed antimicrobial sales data between January 2014 and July 2021, publicly accessible information obtained from the Brazilian government's website. Monthly means of "defined daily doses of DDDs" (DDDs per 1,000 inhabitants per day) of antibiotics were compared by analysis of variance, followed by the Dunnett Multiple Comparisons Test. Monthly trend changes in antibiotic use were verified using Joinpoint regression. Results: Amoxicillin (31.97%), azithromycin (18.33%), and cefalexin (16.61%) were the most sold antibiotics in Brazil during the evaluation period. Azithromycin consumption rose from 1.40 DDDs in February 2020 to 3.53 DDDs in July 2020. Azithromycin sales showed a significant increase in the pandemic period [Monthly Percent Change (MPC) 5.83%, 95% 1.80; 10.00], whereas there was a fall in amoxicillin sales (MPC -9.00%, 95% CI -14.70; -2.90) and cefalexin [MPC-2.70%, 95% (CI -6.30; -1.10)] in this same period. Conclusion: The COVID-19 pandemic changed the pattern of antibiotic consumption in Brazil, with a decrease in the use of amoxicillin and cefalexin and an increase in the consumption of azithromycin.

Public sector implementation strategies to approach the judicialization of health care: a systematic review protocol.

BACKGROUND: The judicialization of health care can be understood as a societal response to pressing healthcare needs, which probably are not being adequately addressed by the current healthcare system. This phenomenon increases the strain on service resources, both in the health sector and in the judiciary system as well, demanding an institutional reorganization to manage judicial actions. It is believed that each institution has developed strategies for coping with the problem in isolation and with little public disclosure. The purpose of this review will be to identify institutional strategies implemented and to investigate their effects in approaching the judicialization of health care. METHODS: Electronic searches will be conducted up to December 2021 on 11 databases, supplemented with gray literature and references lists of secondary studies. The descriptor "judicialization of health" will be the basis for conducting the main research. Studies describing any strategy implemented by public institutions to approach the judicialization of health care will be included. Results related to the quality of services provided by the implemented strategy reported in the studies and those that report accessibility, usability, and potential adverse effects or harms caused by the implemented strategy will be investigated. In addition, it will be explored if there have been changes related to the value or characteristics of health litigation. Two reviewers will independently screen all citations, abstract data, and full-text papers. The risk of bias in each study will be appraised using a tool suggested by Cochrane Effective Practice and Care Organization Group (EPOC). Subsequently, the reviewers will also extract the data of interest and classify the findings of these studies according to their performance at the institutional level. The results obtained will be described as a narrative synthesis. DISCUSSION: This review may provide evidence on the effects of the strategies implemented to approach the judicialization of health care. It will potentially benefit health care and legal professionals, decision-makers, and researchers by identifying the types and characteristics of strategies that have the potential to improve service delivery in the future. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42020160608.

Changes in the Profile of Antibiotic Prescriptions by Dentists in Brazil during the Pandemic.

During the COVID-19 pandemic, people worldwide, including the scientific community, were insecure and fearful. The lack of vaccines at the beginning of the pandemic and the high mortality rate led to a search for alternative treatments for COVID-19. Among these proposals, a postulated activity of azithromycin was frequently studied in early treatment. In view of this, many countries saw an increase in the consumption of this antibiotic. Thus, the objective of this study was to evaluate, in Brazil, whether there was an increase in azithromycin prescriptions made by dentists, as they may have been prescribing this antibiotic as a probable treatment for COVID-19. This is an interrupted time series that analyzed antimicrobial prescriptions data between January 2014 and July 2021. The data were taken from the National System of Controlled Products Management, and pre- and postpandemic periods were compared. To assess changes in azithromycin consumption, Joinpoint regression and analysis of variance, followed by Dunnett's test, were used. More than 38 million prescriptions written during the period were analyzed. Amoxicillin (72.3%), azithromycin (18.0%), cephalexin (6.1%), and metronidazole (3.58%) were the most prescribed antibiotics. At the beginning of the pandemic, there was a drop in amoxicillin prescriptions motivated by a decrease in consultations, but conversely, in less than three months, azithromycin prescriptions grew by more than 100%. The exaggerated use of this antibiotic during the pandemic will certainly have consequences in the short and medium term on indicators of bacterial resistance. The use of guidelines and respect for the therapeutic protocols of government agencies should be fundamental for collective and strategic action in the fight against health emergencies.

ABCDE and ABCDEF care bundles: A systematic review of the implementation process in intensive care units.

BACKGROUND: The ABCDE (Awakening and Breathing Coordination of daily sedation and ventilator removal trials, Delirium monitoring and management, and Early mobility and exercise) and ABCDEF (Assessment, prevent and manage pain, Both spontaneous awakening and spontaneous breathing trials, Choice of analgesia and sedation, assess, prevent and manage Delirium, Early mobility and exercise, Family engagement) care bundles consist of small sets of evidence-based interventions and are part of the science behind Intensive Care Unit (ICU) liberation. This review sought to analyse the process of implementation of ABCDE and ABCDEF care bundles in ICUs, identifying barriers, facilitators and changes in perception and attitudes of healthcare professionals; and to estimate care bundle effectiveness and safety. METHODS: We selected qualitative and quantitative studies addressing the implementation of ABCDE and ABCDEF bundles in the ICU, identified on MEDLINE, Embase, CINAHL, The Cochrane Library, Web of Science, Epistemonikos, PsycINFO, Virtual Health Library and Open Grey, without restriction on language or date of publication, up to June 2018. The outcomes measured were ICU and hospital length of stay; mechanical ventilation time; incidence and prevalence of delirium or coma; level of agitation and sedation; early mobilization; mortality in ICU and hospital; change in perception, attitude or behaviour of the stakeholders; and change in knowledge of health professionals. Two reviewers independently selected the studies, performed data extraction, and assessed risk of bias and methodological quality. A meta-analysis of random effects was performed. RESULTS: Twenty studies were included, 13 of which had a predominantly qualitative and 7 a quantitative design (31,604 participants). The implementation strategies were categorized according to the taxonomy developed by the Cochrane Effective Practice and Organization of Care Group and eighty strategies were identified. The meta-analysis results showed that implementation of the bundles may reduce length of ICU stay, mechanical ventilation time, delirium, ICU and hospital mortality, and promoted early mobilization in critically-ill patients. CONCLUSIONS: : This study can contribute to the planning and execution of the implementation process of ABCDE and ABCDEF care bundles in ICUs. However, the effectiveness and safety of these bundles need to be corroborated by further studies with greater methodological rigor. PROTOCOL REGISTRATION: PROSPERO CRD42019121307.

Antimicrobial resistance of microorganisms present in periodontal diseases: A systematic review and meta-analysis.

Objective: The aim of this study was to estimate the antimicrobial resistance in microorganisms present in periodontal diseases. Methods: A systematic review was conducted according to the PRISMA statement. The MEDLINE (PubMed/Ovid), EMBASE, BVS, CINAHL, and Web of Science databases were searched from January 2011 to December 2021 for observational studies which evaluated the antimicrobial resistance in periodontal diseases in permanent dentition. Studies that allowed the antimicrobial consumption until the time of sample collection, studies that used laboratory acquired strains, studies that only characterized the microbial strain present, assessment of cellular morphological changes, sequencing system validation, and time series were excluded. Six reviewers, working in pairs and independently, selected titles, abstracts, and full texts extracting data from all studies that met the eligibility criteria: characteristics of patients, diagnosis of infection, microbial species assessed, antimicrobial assessed, identification of resistance genes, and virulence factors. "The Joanna Briggs Institute" critical appraisal for case series was adapted to assess the risk of bias in the included studies. Results: Twenty-four studies (N = 2.039 patients) were included. Prevotella and Porphyromonas species were the most cited microorganisms in the included studies, and the virulence factors were related to Staphylococcus aureus. The antimicrobial reported with the highest frequency of resistance in the included studies was ampicillin (39.5%) and ciprofloxacin showed the lowest frequency of resistance (3.4%). The most cited genes were related to macrolides. The quality of the included studies was considered critically low. Conclusion: No evidence was found regarding the profile of antimicrobial resistance in periodontal diseases, requiring further research that should focus on regional population studies to address this issue in the era of increasing antimicrobial resistance. Clinical relevance: The knowledge about the present microorganism in periodontal diseases and their respective antimicrobial resistance profiles should guide dentists in prescribing complementary therapy for these infections. Systematic review registration: [http://dx.doi.org/10.1097/MD.0000000000013158], identifier [CRD42018077810].