Incidence of drug-related adverse events related to the use of high-alert drugs: A systematic review of randomized controlled trials.

Background: High-alert medication (HAM) is more predictable to cause significant harm to the patient, even when used as intended. The damage related to the HAM lead not only suffering to the patient, but also raise the additional costs associated with care. Objective: Evaluate the incidence of drug-related adverse events related to the use of high-alert medications. Methods: It was conducted an active search for information through COCHRANE databases, LILACS, SciELO, SCOPUS, PubMed/MEDLINE and WEB OF SCIENCE. The search strategy included the following terms: "Patient safety", "Medication errors" and "Hospital" and "High Alert Medications" or "Dangerous Drugs" in different combinations. Then two reviewers independently conducted a preliminary evaluation of relevant titles, abstracts and finally full-text. Studies quality was evaluated according to PRISMA declaration. Results: The systematic review evaluated seven articles, which showed that only 11 HAM identified in the literature could have serious events. The most frequently cited were warfarin (22.2%) which progressed from deep vein thrombosis to gangrene, suggesting lower initial doses, followed by cyclophosphamide (22.2%) and cyclosporine (22.2%) which presented invasive fungal infection and death. In addition to these, morphine was compared with its active metabolite (M6G), with M6G causing fewer serious clinical events related to nausea and vomiting, reducing the need for concomitant use of antiemetics. Conclusions: The most reported drug classes in the articles included that were related to incidence of drug-related adverse events in use of high-alert medications: morphine, M6G-glucuronide, haloperidol, promethazine, ivabradine, digoxin, warfarin, ximelagatran, cyclophosphamide, cyclosporine, and ATG. The formulate protocols for the use of these medications, with importance placed on evaluating, among the classes, the medication that causes the least harm.

[Consumption of non-standard medication in indigenous health: rational usage?] / Consumo de medicamentos não padronizados na saúde indígena: uso racional?

The study analyzed the consumption of non-standard medication in the health of indigenous peoples, emphasizing the rationality of pharmacotherapy, by conducting a cross-sectional study of secondary data from 2018 and 2019 in the Minas Gerais/Espírito Santo Special Sanitary Indigenous Health Districts. These medicines were classified by Anatomical Therapeutic Chemical Classification. Non-parametric tests were applied to compare the origin of prescription and the form of acquisition, assessing access to medication. Rationality was verified through the consumption profile and the therapeutic option in the list of standardized medicines. A total of 104,928 pharmaceutical presentations were consumed, 66,967 (66%) for the alimentary tract and metabolism, 17,705 (17%) for the nervous system, and 12,961 (12%) for the cardiovascular system. With respect to medicines consumed per region, 171 (90%) out of 190 had a therapeutic option. Prescriptions were more from the SUS. Differences were found in the way the medicines were acquired. The study pointed to significant consumption of non-standard medicines, and there may be failings in therapeutic rationality. In indigenous health, ethnocultural and social issues are challenges to access to medicines with rational use.

O estudo analisou o consumo de medicamentos não padronizados na saúde indígena, enfatizando a racionalidade da farmacoterapia, por meio de um estudo transversal dos dados secundários, de 2018 e 2019, no Distrito Especial Sanitário de Saúde Indígena Minas Gerais/Espírito Santo. Esses medicamentos foram classificados pela Anatomical Therapeutic Chemical Classification. Para a comparação da origem de prescrição e da forma de aquisição, empregaram-se testes não paramétricos, avaliando o acesso a medicamentos. Verificou-se a racionalidade por meio do perfil de consumo e da opção terapêutica na lista de medicamentos padronizados. Foram consumidas 104.928 apresentações farmacêuticas, 66.967 (66%) eram para o trato alimentar e o metabolismo; 17.705 (17%) para o sistema nervoso; 12.961 (12%) para o sistema cardiovascular. Quanto aos medicamentos mais consumidos por regiões, 171 (90%) dos 190 apresentavam opção terapêutica. As prescrições foram mais provenientes do SUS. Encontraram-se diferenças na forma de aquisição dos medicamentos. O estudo apontou importante consumo de medicamentos não padronizados, podendo existir falhas na racionalidade terapêutica. Na saúde indígena, questões etnoculturais e sociais constituem desafios para o acesso aos medicamentos com uso racional.

Consumo de medicamentos não padronizados na saúde indígena: uso racional? / Consumption of non-standard medication in indigenous health: rational usage?

Resumo O estudo analisou o consumo de medicamentos não padronizados na saúde indígena, enfatizando a racionalidade da farmacoterapia, por meio de um estudo transversal dos dados secundários, de 2018 e 2019, no Distrito Especial Sanitário de Saúde Indígena Minas Gerais/Espírito Santo. Esses medicamentos foram classificados pela Anatomical Therapeutic Chemical Classification. Para a comparação da origem de prescrição e da forma de aquisição, empregaram-se testes não paramétricos, avaliando o acesso a medicamentos. Verificou-se a racionalidade por meio do perfil de consumo e da opção terapêutica na lista de medicamentos padronizados. Foram consumidas 104.928 apresentações farmacêuticas, 66.967 (66%) eram para o trato alimentar e o metabolismo; 17.705 (17%) para o sistema nervoso; 12.961 (12%) para o sistema cardiovascular. Quanto aos medicamentos mais consumidos por regiões, 171 (90%) dos 190 apresentavam opção terapêutica. As prescrições foram mais provenientes do SUS. Encontraram-se diferenças na forma de aquisição dos medicamentos. O estudo apontou importante consumo de medicamentos não padronizados, podendo existir falhas na racionalidade terapêutica. Na saúde indígena, questões etnoculturais e sociais constituem desafios para o acesso aos medicamentos com uso racional.

Abstract The study analyzed the consumption of non-standard medication in the health of indigenous peoples, emphasizing the rationality of pharmacotherapy, by conducting a cross-sectional study of secondary data from 2018 and 2019 in the Minas Gerais/Espírito Santo Special Sanitary Indigenous Health Districts. These medicines were classified by Anatomical Therapeutic Chemical Classification. Non-parametric tests were applied to compare the origin of prescription and the form of acquisition, assessing access to medication. Rationality was verified through the consumption profile and the therapeutic option in the list of standardized medicines. A total of 104,928 pharmaceutical presentations were consumed, 66,967 (66%) for the alimentary tract and metabolism, 17,705 (17%) for the nervous system, and 12,961 (12%) for the cardiovascular system. With respect to medicines consumed per region, 171 (90%) out of 190 had a therapeutic option. Prescriptions were more from the SUS. Differences were found in the way the medicines were acquired. The study pointed to significant consumption of non-standard medicines, and there may be failings in therapeutic rationality. In indigenous health, ethnocultural and social issues are challenges to access to medicines with rational use.

Quality indicators of hospitalized children influenced by clinical pharmacist services: A systematic review.

BACKGROUND: Care for children who are hospitalized can be optimized if the pharmacist, in conjunction with the multidisciplinary team, promotes the rational use of medicines. In this sense, the evaluation of the quality of these clinical services through indicators is important in the planning, decision making of pharmacists and managers of these services. OBJECTIVE: To characterize which health indicators were influenced by the pharmaceutical clinical services for the care of children in hospitals. METHODS: A systematic review was performed. The search for data was made on the bases: Cochrane, Embase, Lilacs, Pubmed and Web of Science. Then, the search included studies in which evaluated the impact of pharmaceutical clinical services on clinical, economic and humanistic outcomes. RESULTS: The search resulted in 11 included studies. In this review, four pharmaceutical clinical services were found: pharmacotherapy review, multiprofessional team interventions, antimicrobial stewardship program and pharmaceutical services at discharge hospital. The most influenced outcome indicators were length of hospital stay, with average time in the group that received the pharmacotherapy review service, and interventions multiprofessional team with a 6.45-day vs. 10.83 days in the control group; hospital readmissions with a significant reduction of non-scheduled readmission of 30 days in the ntimicrobial stewardship program; reduction of hospital costs and caregiver satisfaction. CONCLUSION: In this study, we can highlight that pharmacotherapy review, multiprofessional team interventions and Antimicrobial Stewardship Program that significantly reduced the clinical results of length of hospital stay and hospital readmission, as well as a significant reduction of hospital costs.

As percepções de estudantes de Farmácia e de Medicina sobre o desenvolvimento de competências clínicas / The perceptions of Pharmacy and Medicine students about the development of clinical competencies

Resumo: Introdução: A atuação ativa do profissional médico em conjunto com o farmacêutico pode auxiliar na garantia de uma efetiva, segura e conveniente farmacoterapia. Para que esses profissionais atuem de maneira colaborativa, é necessário que, durante o processo formativo, os estudantes de Farmácia e Medicina desenvolvam competências clínicas para assegurar um serviço clínico de qualidade, com respeito pela atuação e adequada convivência com outros profissionais. Objetivo: Este estudo teve como objetivos descrever a autoavaliação dos discentes de Medicina e Farmácia em relação às suas competências clínicas, compreendendo suas diferenças e similaridades, e avaliar o desenvolvimento destas durante a graduação. Método: Trata-se de um estudo educacional realizado de maneira remota entre agosto de 2020 e agosto de 2021. Os participantes eram discentes de Farmácia e Medicina de uma instituição pública de ensino. Realizaram-se entrevistas individuais, e aplicaram-se instrumentos de autoavaliação de competências clínicas. Resultado: Participaram da pesquisa 39 discentes: 18 (46,2%) de Farmácia e 21 (53,8%) de Medicina. Os estudantes de Farmácia avaliaram-se positivamente quanto às atividades relacionadas às competências clínicas, salvo a implementação de um plano de cuidado e a identificação de pacientes em risco de doenças prevalentes. Quanto ao currículo, o curso avaliado possui três disciplinas que abordam o desenvolvimento de competências clínicas. Dessas, os discentes relataram ter desenvolvido conhecimento científico, atualização do conhecimento científico e comunicação efetiva. Os estudantes de Medicina avaliaram-se positivamente em relação às suas competências clínicas, com exceção daquelas relacionadas ao diagnostico diferencial, à discussão com equipe de saúde e à identificação de falhas no sistema de saúde. O currículo do curso apresenta 11 disciplinas voltadas para o cuidado, e os alunos associaram disciplinas de cunhos sociais ao cuidado centrado na pessoa. As competências desenvolvidas destacadas foram empatia, compaixão, integridade e respeito, comunicação efetiva e anamnese, e obtenção de informações socioculturais. Ademais, os estudantes de ambos os cursos relataram contato escasso com outros profissionais de saúde. Conclusão: Os discentes avaliados apresentam diversas inseguranças, principalmente relacionadas às habilidades clínicas que exigem prática. Apesar disso, os estudantes de Medicina demonstraram maior apreensão de soft skills, o que pode facilitar a criação de vínculos com os pacientes e resultar na qualidade do cuidado.

Abstract: Introduction: The active role of the medical professional together with the pharmacist can help to guarantee an effective, safe, and convenient pharmacotherapy. For these professionals to work collaboratively, it is necessary that, during the training process, Pharmacy and Medicine students develop skills to ensure a quality clinical service, with respect for their performance and adequate coexistence with other professionals. Objective: This study aimed to describe a self-assessment of the Medicine and Pharmacy records in relation to their technical skills, their differences and similarities, as well as to assess their development during a program. Method: Educational study carried out remotely between August 2020 and August 2021. The participants were Pharmacy and Medicine students from a public teaching institution. Individual interviews were carried out and instruments for self-assessment of clinical competences were applied. Result: A total of 39 students participated in the research: 18 (46.2%) from Pharmacy and 21 (53.8%) from Medicine. Pharmacy students evaluated themselves positively regarding activities related to clinical competences, except for the implementation of a care plan and the identification of patients at risk of prevalent diseases. As for the curriculum, the evaluated course has three subjects that address the development of clinical competences. Of these, the students reported having developed scientific knowledge, updated scientific knowledge and effective communication. Medical students evaluated themselves positively in relation to their clinical competences, apart from those related to differential diagnosis, discussion with the health team and identification of failures in the health system. The course curriculum features 11 disciplines focused on care, and the students' associated disciplines of a social nature with person-centered care. The most outstanding skills developed were empathy, compassion, integrity and respect, effective communication and anamnesis and obtaining sociocultural information. In addition, students from both courses reported little contact with other health professionals. Conclusion: The evaluated students have several insecurities, mainly related to clinical skills that require practice. Despite this, medical students showed greater apprehension of soft skills, which can facilitate the creation of bonds with patients and result in the quality of care.

Effect of pharmacists' interventions on health outcomes of children with asthma: A systematic review.

METHODS: A literature search was performed in January 23, 2018 at the Embase, LILACS, OpenThesis, PubMed, Cochrane Library, and Web of Science databases through January 23, 2018, using keywords related to "asthma," "pharmacist," and "children." This systematic review followed the methodologic standards recommended by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We included intervention studies on the effect of pharmacists' interventions on pediatric patients with asthma, performed in hospital or ambulatory care settings, with presenting process and outcome indicators as a result of pharmacists' interventions. The methodologic quality of the included studies was assessed independently by 2 researchers. The Cohen kappa index was used to measure the degree of agreement between the 2 investigators. RESULTS: The search yielded 3671 records, of which 5 were included in this review. Most of these studies were conducted in the United States (n = 2) and in outpatient clinics (n = 4). All studies described components of pharmacists' interventions. The most reported category concerning pharmacists' work process was the initial assessment of patients' conditions, with the assessment of outcomes (at baseline and follow-up) as the only category present in all studies. The most assessed outcomes at baseline were asthma control, emergency department visits, medication use and technique, and adherence to asthma therapy. At follow-up, emergency department visits were the most evaluated outcome (n = 2), and no study assessed economic outcomes. The average consultation time ranged from 20 to 45 minutes, and the number of encounters ranged from 2 to 3. CONCLUSION: This study highlighted the limited number of studies, most with low quality, on the impact of the pharmacist on pediatric asthma. The most assessed outcome was the number of emergency department visits, with positive results after interventions. Heterogeneity regarding assessed outcomes and work processes was noted, which limited comparison of the results and interventions.

Implementation of clinical pharmacy services using problematization with Maguerez Arc: A quasi-experimental before-after study.

RATIONALE, AIMS, AND OBJECTIVES: The growth of clinical pharmacy services (CPS) has positively impacted clinical, economic, and humanistic health outcomes. However, detailed studies on the process of implementing CPS in healthcare systems are incipient. Thus, the present study aimed to evaluate the CPS implementation in certain public health units in a metropolis in northeast Brazil. METHODS: A quasi-experimental before-and-after study was carried out in Recife City, from July 2015 to March 2016. The study was carried out using the Methodology of Problematization with Maguerez Arc and was divided into: initial evaluation (before), planning, interventions, and preliminary evaluation (after). The participants were pharmacists, patients, health professionals, and local health managers. Descriptive statistics were used to report data. The statistical significance of the comparison between variables was evaluated using the Wilcoxon test (95% CI; P ≤ .05). RESULTS: Initial evaluation: Identified incipient CPS, a lack of structure and work process of pharmacists. Planning: Sixteen brainstorming meetings were held with the different actors resulting in a strategic plan. INTERVENTION: Twenty-two political-administrative meetings were held with managers and health teams and 768 hours of theoretical and practical training with mentoring for pharmacists. Preliminary evaluation: Structure indicators presented a statistically significant difference, differently from the process indicators. Pharmacists attended 842 patients and performed 1465 pharmaceutical consultations in 6 months. Regarding the outcome indicators, it was possible to identify changes in the clinical status of the most prevalent diseases among those patients who attended three pharmaceutical consultations. CONCLUSIONS: It was possible to evaluate the CPS implementation in certain public health units in a metropolis in Brazil, through the Methodology of Problematization with Maguerez Arc. This methodology may be part of models for future implementations of CPS in health systems.

Development and content validation of an instrument to support pharmaceutical counselling for dispensing of prescribed medicines.

RATIONALE, AIMS, AND OBJECTIVES: Counselling is essential in drug dispensing, since it enables patients to receive and understand the information to correctly use their medicines. Although counselling is a quality indicator on drug dispensing, models that guide pharmacists in this practice are scarce. Thus, this study aimed to develop and validate the content of an instrument to support pharmaceutical counselling for dispensing of prescribed medicines. METHOD: A two-stage validation study was conducted out from February to October 2017. The first stage involved the development of the instrument, and the second involved content validation. Instrument development included the following three steps: (1) drafting of the prototype; (2) an academic brainstorming meeting, and (3) a pre-Delphi process. Content validation was then conducted using the Delphi technique. At this stage, 40 pharmacists who were experts in drug dispensing, were invited to assess the instrument. Consensus among experts was calculated according to the content validity index (CVI). RESULTS: The development stage generated three versions of the instrument: the prototype, Version 1 (modified after brainstorming meeting), and Version 2 (modified after the pre-Delphi process). Version 2 underwent the content validation process, in which 29 pharmacists participated during the first round (rate of return: 72.5%) and 23 of these during the second round (rate of return: 79.31%). All items obtained CVI > 0.82 and were thus considered to be validated. The final instrument comprised three components: suggestions for questions, dispensing process reasoning, and suggestions for counselling, and other conduct in 11 stages, each representing a step in the clinical reasoning process. CONCLUSIONS: An instrument was developed to support pharmaceutical counselling for dispensing of prescribed medicines, suggesting main questions, counselling, and conduct to be taken by pharmacists, and its content validity was verified.

Factors influencing the implementation of clinical pharmacy services for hospitalized patients: A mixed-methods systematic review.

BACKGROUND: Despite the evidence of benefits, clinical pharmacy services (CPS) are not uniformly implemented across healthcare institutions. Understanding the influencing factors and identifying the domains in which they act is the first step to a successful implementation. OBJECTIVE: To identify the factors that affect the implementation of CPS for inpatients and to categorize them. METHODS: Cochrane Library, Embase, CINAHL, IPA, Medline/PubMed, and Lilacs databases were researched up until January 2018. The search strategy was developed using text words or MESH terms related to the following four domains: "clinical pharmacy," "influencing factors," "implementation," and "hospital." Two reviewers selected original research articles that reported the factors influencing the implementation of CPS in hospitals, extracted data, and assessed the quality of the studies. After framework synthesis and categorization of the factors, a diagrammatic approach was used to present the results. RESULTS: Fifty-three factors were identified in the 21 studies that were included in this review. The most cited influencing factors were uniformly distributed across the following four domains: Attitudinal, POlitical, TEChnical and Administrative (APOTECA domains). However, in terms of level (pharmacist, healthcare team, patient, institution, and national organization), the "pharmacist" group had the highest concentration of factors. "Clinical skills and knowledge" was the most frequently cited implementation factor, followed by "time to implement CPS." CONCLUSION: Our findings showed the multifactorial nature of CPS implementation process. We suggest that factors from all four APOTECA domains need to be fully considered and strategies need to be addressed for all five groups of interest to successfully implement CPS in hospitals. Future studies on the influence of implementation stages, interrelationships of implementing factors, and strategies to overcome barriers could accelerate the successful adoption of these services. REGISTRATION: PROSPERO register CRD42016050140.

'What is not written does not exist': the importance of proper documentation of medication use history.

Medications are perceived as health risk factors, because they might cause damage if used improperly. In this context, an adequate assessment of medication use history should be encouraged, especially in transitions of care to avoid unintended medication discrepancies (UMDs). In a case-controlled study, we investigated potential risk factors for UMDs at hospital admission and found that 150 (42%) of the 358 patients evaluated had one or more UMDs. We were surprised to find that there was no record of a patient and/or relative interview on previous use of medication in 117 medical charts of adult patients (44.8%). Similarly, in the medical charts of 52 (53.6%) paediatric patients, there was no record of parents and/or relatives interviews about prior use of medications. One hundred thirty-seven medical charts of adult patients (52.4%) and seventy-two medical charts of paediatric patients (74.2%) had no record about medication allergies and intolerances. In other words, there was a lack of basic documentation regarding the patient's medication use history. As patients move between settings in care, there is insufficient tracking of verbal and written information related to medication changes, which results in a progressive and cumulative loss of information, as evidenced by problems associated with clinical transfers and medication orders. Proper documentation of medication information during transfer is a key step in the procedure; hence, it should be rightly performed. It remains unclear whether interviews, and other investigations about medication use history have been performed but have not been recorded as health-care data. Therefore, it is crucial to the improvement of medication use safety that documentation of all drug-related information-even if not directly related to the actual event-become routine practice in health-care organizations, since 'what is not written does not exist'.

Evaluation of the heterogeneity of studies estimating the association between risk factors and the use of potentially inappropriate drug therapy for the elderly: a systematic review with meta-analysis.

PURPOSE: This study was conducted to evaluate the heterogeneity of studies estimating the association between risk factors (age, gender, and polypharmacy) and the use of potentially inappropriate drug therapy for the elderly (PIDT). METHODOLOGY: This study is a systematic review with meta-analysis of observational studies. LILACS, PubMed, Scopus, and the Web of Science databases were reviewed. The following data were extracted from the included studies: country, type of study, characteristics of the sample, practice scenarios, instruments to evaluate potentially inappropriate drug therapy for the older adults, and patient-related variables. RESULTS: Twenty-nine articles (17 cross-sectional and 12 cohort) were included. The majority of the studies were conducted in Europe. Regarding the study durations, 3 to 18 months was necessary to perform the research. As for the sample characteristics, all the studies analyzed involved the older adults and included anywhere from 96 patients to 33,830,599 outpatient consultations. Of the variables analyzed, only polypharmacy presented a positive association with the use of PIDT. All meta-analysis studies showed high heterogeneity, indicating the lack of a methodological standardization of the studies included, among other factors.