Revista Brasileira de Farmácia Hospitalar e Serviços de Saúde

Simulation of the economic impact of introducing rivaroxaban in a high-complexity hospital for venous thromboembolism prophylaxis

Diovanna Santos DE CARVALHO — 2024-07-11

Objective: this work aims to simulate the economic impact of the introduction of rivaroxaban for venous thromboembolism (VTE) prophylaxis, when compared to the therapeutic options used in the institution (unfractionated heparin and enoxaparin), in the period from January to February 2022. Methods: In a retrospective study, we analyzed the possibility of replacing the prophylaxis used in the institution with prophylaxis with rivaroxaban based on the analysis of data from the electronic medical record system, taking into account the length of stay, the medications prescribed and compliance with the institutional protocol. Patients prescribed medication for VTE prophylaxis and indicated according to progress in the medical record were included, excluding those using non-pharmacological prophylaxis. Patients with contraindications to the use of rivaroxaban, such as pregnancy and liver impairment, were also excluded. Monte Carlo Simulation was used to calculate the cost of treatment with DOACs (Direct Oral Anticoagulants), using the medicines acquisition values during the study period, and a decision tree was constructed. Results: A total of 157 patients who were prescribed one of the heparins were evaluated. Of these patients, 98 (62.4%) could undergo prophylaxis with rivaroxaban as they had no contraindication to this treatment (price recorded in January/February 2022: R$ 0.23). This new prophylaxis would generate savings of up to 98.4% for enoxaparin 40 mg (price recorded in January/February: R$ 14.26), the item that had the highest consumption, corresponding to 71.4% of patients who could use it rivaroxaban. Conclusion: The implementation of rivaroxaban for venous thromboembolism prophylaxis replacing enoxaparin proved to be beneficial in terms of costs for the hospital, which suggests that more studies should be carried out in order to increase the robustness of results and support the incorporation of this technology in the institution.

Implementation of strategies to reduce medication separation errors in a tertiary public hospital in Brazil

Gabriella Bacelar MOREIRA — 2024-09-29

Objective: To implement and evaluate strategies aimed at reducing errors in the medication dispensing process, with the goal of enhancing safety and quality of care for hospitalized patients. Method: Prospective and transversal study carried out at the Individualized Dose Service Center of the Pharmacy Division of the Central Institute of the Hospital das Clínicas of the Faculty of Medicine of the University of São Paulo, from October 1, 2022, to September 30, 2023. The approach involved identifying the most recurrent dispensing errors, conducting detailed analysis, and implementing process improvements to minimize these errors Results: The most frequent errors observed included medication mix-ups, incorrect dosages, and incorrect pharmaceutical forms. Implementation of strategies led to a significant reduction in dispensing errors: there was a 60.9% decrease in specific error types targeted by interventions and an overall reduction of 60.3% in all types of dispensing errors. These results demonstrate the effectiveness of the adopted strategies and highlight their positive impact on process enhancement. Conclusion: Data analysis confirms the efficacy of the interventions, underscoring the importance of a strategic approach based on studying identified errors and their potential causes. Effective communication and staff participation are crucial for the continuous improvement of outcomes achieved. In addition to enhancing patient safety, the implemented measures significantly contribute to resource optimization and operational process improvement. This study not only mitigates risks associated with medication administration but also enhances the quality of services provided, ensuring safer and more efficient care for hospitalized patients.

Fluid stewardship in intensive care: clinical pharmacist’s actions analysis

Elivelton Jesus CERQUEIRA — 2024-08-30

Objective: To describe and analyze the pharmaceutical interventions performed by clinical intensivist pharmacists in the management of fluid therapy. Methods: This is an observational, retrospective, descriptive study conducted in a clinical ICU of a tertiary teaching hospital from January 2018 to December 2022. The study evaluated the classification according to the “four rights of fluid therapy” adapted from Hawkins14 (right drug, right dose, right route, and right patient); the acceptability of pharmaceutical interventions; the classification of interventions involving hidden fluids, and the medications involved in this classification. Results: The study included 415 patients, the majority of whom were male, 51% (213). The mean age was 57.4 ± 17.2 years. A total of 993 pharmaceutical interventions related to fluids were performed, comprising 12.2% of the interventions during the study period and corresponding to 2.4 per patient. The acceptability rate was 90% (894). Of the cited interventions, the majority (591) were related to the “right dose” (59.4%). The other interventions were: 167 (16.9%) related to the “right drug,” 163 (16.4%) to the “right route,” and 72 (7.2%) to the “right patient.” The management of hidden fluids was present in 722 (72.7%) interventions, with a focus on antimicrobials, totaling 256 (35.4%); followed by electrolytes and vitamins with 229 (31.7%), and antiulcer agents with 124 (17.2%). Conclusion: The pharmaceutical interventions analyzed were related to the “four rights of fluid therapy” and had high acceptability from the team. There was significant demand for pharmaceutical intervention in fluid management. The findings indicate the potential role of the clinical intensivist pharmacist as a key player in the fluid therapy management of critically ill patients.

Budget impact analysis of the incorporating of biosimilars in a cancer institute of a philanthropic hospital

Maria Luísa BRODT-LEMES — 2024-09-28

Objective: Global healthcare costs continue to rise annually, and this is a major challenge given the scarce resources and growing prices of innovative drugs. An interesting alternative for reducing costs is the use of biosimilars. This study aimed to assess the financial impact of introducing biosimilars of the drugs adalimumab, rituximab and trastuzumab in a Cancer Institute of a Philanthropic Hospital in the South of the country. Method: This is a retrospective, descriptive study in which a budgetary impact analysis was used to assess the savings generated by the biosimilars standardized at the institution between January 2020 and December 2023. Information on the average cost and monthly consumption of the three biosimilars: adalimumab, rituximab and trastuzumab was used to assess the financial impact. The economic analysis was carried out using the difference between the cost of the biosimilar and the cost of the reference drug, multiplied by annual consumption. Results: It was evidenced during the study period the cost reduction after switching the reference biological with the corresponding biosimilar was R$ 1.540.701,18 (U$ 279.077,14) for adalimumab, R$ 129.824,93 (U$ 23.516,03) for rituximab and R$ 1.604.319,28 (U$ 290.600,70) for trastuzumab. The analysis identified that the standardization of biosimilars at the institution resulted in a global economy of R$ 3.274.845,39 (U$ 593.193,87). Conclusion: The use of biosimilars proved to be a more economical option when compared to the use of the reference biological. In conclusion, the use of biosimilars allows for a considerable reduction in overall treatment costs, especially in the case of innovative and expensive therapies. Therefore, the incorporation of biosimilars is considered an interesting option in the search for the sustainability of health systems.

Organizational conditions and patient safety practices observed in a Hospital Detoxification Service in Ceará (Brazil)

Francisca Sabrina SIQUEIRA-LIMA — 2024-09-28

Objective: Analyzing the detoxification service offered by a mental health referral hospital from a patient safety perspective, based on the assessment of organizational conditions, identification of patient safety practices and description of strengths and weaknesses. Method: A descriptive, cross-sectional and quantitative study was carried out, with data obtained from primary and secondary sources and through a structured data collection instrument based on the specifications of the Ministry of Health protocols relating to the National Patient Safety Program, using non-participant observation techniques associated with documentary analysis. Results: The results show that the practices of hand hygiene (20%), fall prevention (41.7%), patient identification (42.9%) and safety in the prescription, use and administration of medicines (66.7%) had the lowest percentages of compliance with the recommendations of the protocols recommended by the Ministry of Health. On the other hand, effective communication (92.9%), aspects related to the functioning of the service, human resources (81.8%) and infrastructure (70%), were those with the highest percentage of compliance. Conclusion: The analysis of the Detoxification Service, from the perspective of patient safety, pointed out institutional weaknesses and strengths, which can be used by managers to plan actions to improve the quality offered to patients there, making a relevant contribution to the development of an organizational safety culture.

Bioequivalence of two oral formulations of nitazoxanide in healthy volunteers

Vinícius Marcondes REZENDE — 2024-09-24

Objective: This study evaluated the bioequivalence (BE) between two Nitazoxanide 20mg/ml oral suspension formulations. Methods: We carried out a single-center, open-label, randomized, single-dose, two-sequence, two-period. Subjects received single oral doses of 500 mg Nitazoxanide oral suspension. Whole blood samples were collected pre-dose and at specified intervals up to 12 h post-dose to assess pharmacokinetic parameters. Results: Thirty healthy adult subjects completed the study. We found the 90% confidence intervals for the geometric mean ratios for the Tixozanide area under the curve AUC0‐t and AUC0‐∞ and maximum plasma concentration (Cmax) were within the established limits of 80% to 125 % of BE. Conclusion: The criteria for BE were met for the nitazoxanide formulations from Eurofarma Laboratórios S.A.

Potential drug interactions among people living with HIV on antiretroviral therapy in Belo Horizonte, Brazil

Alícia Moreira COSTA — 2024-09-26

Objective: To characterize the medication use profile and evaluate the factors associated with serious and contraindicated potential drug-drug interactions (DDIs) in pharmacotherapy of people living with HIV (PLHIV). Method: This is a cross-sectional study, comprising two moments in the trajectory of PLHIV treatment - baseline and reevaluation. Sociodemographic, clinical and therapeutic variables were obtained from medical records and interviews. The medications used were classified using the Anatomical Therapeutic Chemical (ATC) system and potential DDIs were identified and classified according to the severity and quality of documentation using Micromedex®. Descriptive analyses were carried out to characterize the selected variables and the logistic regression method was used for univariate and multivariate analyses. Results: At baseline (n=247), the mean age was 36.8 years, with 60.3% being male. Potential DDIs were observed in 84.2% of participants. Upon the reevaluation (n=100), the mean age was 53.0 years, with a male majority (54.0%). Potential DDIs were observed in 63.8% of participants. There was a reduction in the proportion of anti-infectives and an increase in cardiovascular medications, when comparing the baseline and reevaluation. The number of medications (> 3) and the antiretroviral regimen remained associated with the occurrence of potential serious and contraindicated DDIs. Conclusion: The profile of medications used reflected the pattern of the most prevalent diseases in the periods evaluated. There was a reduction in the mean number of medications used and, consequently, a reduction in the number of DDIs at both moments, including those of greater severity.

Pharmacotherapeutic monitoring of oncological patients in palliative care during hospitalization

Victoria Mendes LIMA — 2024-09-26

of cancer patients admitted to an exclusive palliative care unit at a reference institute in Rio de Janeiro. Method: An observational, descriptive, retrospective study with a quantitative approach was conducted. The population consisted of patients admitted and under pharmaceutical care monitoring from June 2022 to May 2023. Data were collected from physical medical records, institutional electronic systems, and specific spreadsheets. Sociodemographic, clinical, and pharmacotherapeutic variables were analyzed. Results: A total of 283 patients were evaluated, ranging in age from 21 to 85 years, with the majority being 60 years or older (n=153; 54.1%; mean age = 60.1; standard deviation = 8.2) and predominantly female (n=186; 65.7%). The most frequent primary tumor site was the digestive system (n=56; 19.8%) followed by breast and gynecological sites (n=55; 19.4%). Regarding comorbidities, most patients had at least one (n=166; 58.7%), with the circulatory system (n=121; 42.7%) being predominant. The percentage of patients with DRP was 50.9% (n=144). A total of 298 DRP were observed, among which the non-use of the necessary medication for the patient was highlighted (n=106; 35.6%). A total of 302 interventions were performed, mainly regarding the inclusion of a new medication (n=87; 28.8%). There was a 93% acceptance rate of the interventions performed. Conclusion: The clinical role of the pharmacist within a multidisciplinary team enables the identification of Drug-Related Problems (DRPs), thereby contributing to the rational and safe use of medications through the optimization of prescriptions and rationalization of pharmacotherapy.

Bioequivalence study between two formulations of betamethasone dipropionate and betamethasone disodium phosphate injectable suspension in healthy adults

Carlos SVERDLOFF — 2024-09-29

Objective: To evaluate bioequivalence between two formulations of 5,0 mg/mL betamethasone dipropionate + 2,0 mg/mL betamethasone disodium phosphate injectable suspension in healthy adults under fasting condition. Methods: The study was an open label, randomized, single dose, 2x2 crossover study in 36 healthy adult subjects under fasting conditions. Betamethasone concentrations in human plasma were determined using a validated liquid chromatography coupled to a tandem mass spectrometer detector method. Results: Statistical analysis has determined confidence intervals, power of the test and p-value for sequence effect to the pharmacokinetic parameters Cmax, AUC0-t and AUC0-∞. The geometric mean ratio (90%CI) of the test drug/reference drug for betamethasone were 87.74% to 92.23% for Cmax, 93.95% to 98.91% for AUC0-t and 94.36% to 99.95% for AUC0-∞. Power of the test was 100% for all parameters and p-value for sequence effect were 33.39% for Cmax, 19.98% AUC0-t, and 24.32% for AUC0-∞. Conclusion: Reference and test formulations are statistically bioequivalent and, therefore, interchangeable, according to the local and international criteria, since confidence intervals for Cmax and AUC0-t ratios were within 80% and 125%, according to Anvisa resolution RE nº 1170/2006.

Analysis of discharge prescriptions in a high-complexity public hospital in Santa Catarina

Gustavo Fortes VOLKART — 2024-09-30

Objectives: Assess, based on the World Health Organization (WHO) prescription indicators, discharge prescriptions in public, general, high-complexity hospital in Santa Catarina. Methods: A retrospective descriptive exploratory study with a quantitative approach, for sample analysis by convenience of discharge prescriptions at a public, general, high-complexity hospital from the State of Santa Catarina in 2023. Data was retrieved from a prescription attached to the patient’s records. The indicators analyzed recommended by WHO, they were average number of prescribed medications per patient; percentage of medications prescribed by generic name; percentage of prescriptions including antimicrobials; percentage of prescriptions including injectables; percentage of prescribed medications present in the National List of Essential Medicines (RENAME); percentage of prescribed medications present in the Municipal List of Essential Medicines (REMUME). Results: A total of 1.199 hospital discharges were analyzed in the study with 4.695 prescribed medications (average = 3,92 medications/patients). The percentage of medications prescribed by generic name was 80.3%. 37.5% contained the same antimicrobials, while 5.8% contained the same injectable medications. The proportion of medications belonging to RENAME was 62.4%, and 50.9% for REMUME. Duration of treatment, dose/concentration, and medication name were the most observed prescription errors. Conclusion: The hospital discharge prescriptions do not meet the requirements for rational drug use. Inconsistencies in the prescriptions were identified and may compromise access and safety in medication use.

Construction and validation of educational booklets regarding oral antineoplastics

Andrieli Meira COSTA — 2024-09-28

Objective: To construct and validate educational pamphlets on oral antineoplastic therapy for patients with oncologic or hematologic diseases treated on an outpatient basis. Method: We carried out this research on two stages: a) Elaboration of educational pamphlets by the researchers, containing information regarding indication, administration mode, adverse effects, storage, and other precautions for the listed oral antineoplastics: Anagrelide, Cyclophosphamide, Chlorambucil, Melphalan, Lomustine, Mercaptopurine, Methotrexate, Mitotane, Pazopanib, Sorafenib, Temozolomide, Thioguanine, Ruxolitinib, and Tretinoin; b) Validation of the developed materials through a median grade among experts in the field (oncology and/or hematology pharmacists), using the Delphi Method, evaluating layout and content through a Likert scale. Data dispersion was assessed through the interquartile range (IQR), and adequate grade was defined as a median above 3. Results: The educational pamphlets were developed using national and international references, encompassing necessary information for the adequate and safe use of medications by patients. The initial validation involved 19 pharmacists specialized in oncology and/or hematology, spread across the national territory. In the first evaluation round, there was disagreement among experts on two issues, both related to the material’s content (highlighted sections and language used). After addressing points of disagreement, the pamphlets were validated by adequate grade among eight experts who remained in the study for the second round. Conclusion: It was possible to validate by experts the educational content of booklets containing written guidance on pharmacotherapy that will be delivered to the patient/caregiver, covering topics relevant to different medications, containing information with assertive scientific evidence, combining illustrations and language that is easy to understand by the population.

Microbiological characteristics and clinical profile of Stenotrophomonas maltophilia infections in a teaching hospital in northeastern Brazil

João Antonio SOUSA — 2024-09-28

Objective: This study aimed to elucidate the microbiological and clinical characteristics of patients affected by infection caused by S.maltophilia in a tertiary hospital in the north-east of Brazil. Methodology: The study consisted of a retrospective analysis of microbiological samples from January 2022 to September 2023 from the microbiology department of the Walter Cantídio University Hospital, Fortaleza, Ceará. The prevalence of these infections was determined, along with the epidemiology and antimicrobial sensitivity profile to sulphamethoxazole/trimethoprim (SMX-TMP) and levofloxacin. Clinical characteristics of the affected patients were identified, such as the use of mechanical ventilation (MV), hemodialysis (HD), previous use of antimicrobials and the outcome of these patients. Results: The prevalence of S.maltophilia infections was 1.79% in the period (35 positive samples and 26 affected patients). Of the positive clinical isolates, there was a predominance from the respiratory tract, with 23 samples (61.43%) from tracheal aspirates and 5 samples from bronchoalveolar lavage (14.57%). The highest number of positive samples was identified in the clinical ICU (23 isolates). About SMX-TMP, 65.71% of the strains were sensitive to increased exposure, 5.71% were fully sensitive and 28.57% were resistant. A profile of strains predominantly sensitive to levofloxacin was observed (91.49%), with 5.71% of the isolates proving sensitive by increasing exposure and 2.85% proving resistant. Women were more affected (57.69%). The average age was 54.33 years. Patients undergoing HD during the infection accounted for 53.84% of the profile obtained, while the use of MV occurred in around 69.23% of those infected. All patients had previously used antimicrobials. 19 patients (69.23%) died and only 7 were discharged from hospital (30.76%). Conclusion: With the findings, it was possible to determine a predominant profile of critically ill patients, with greater involvement of the respiratory tract. We also identified considerable rates of resistance to SMX-TMP, as well as an association between S. maltophilia infection and death.

Use of medication in patients with mental disorders treated at a hospital in Roraima: a cross-sectional study

Soraya Kuyat VICENZI — 2024-09-26

Objectives: To analyze the profile of medications prescribed for patients with mental disorders treated at a hospital in Roraima. Methods: This is a descriptive, cross-sectional and quantitative study, collecting retrospective data from prescriptions and medical records of patients treated in the psychiatry unit of a hospital in Roraima from February 2018 to February 2020. The study was developed in accordance with with the recommendations of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement for observational studies. For data analysis, it was the IBM Statistical Package for the Social Sciences 23.0 was used. The research was approved by the Research Ethics Committee under opinion 4,614,305. Results: A total of 156 patients were included in the research and the analysis of their medical records and prescriptions revealed that the majority of these patients were male (n = 88, 56.4%), aged between 30 and 39 years ( n = 51, 32.7%), mixed ethnicity (n = 136, 87.2%), single marital status (n = 76, 48.7%), diagnosed with 1 mental disorder (n = 119, 76.3%), classified within the Spectrum of Schizophrenia and Other Psychotic Disorders (n = 80, 51.3%). The prescriptions contained a total of 5 or more medications (n = 105, 67.3%), with 2 or more antipsychotics (n = 116, 74.4%), hospital stay length of 6 to 16 days (n = 61, 39.1%). With regard to prescribed drugs, the main classes were antipsychotics, anxiolytics and antiepileptics. The most frequent drugs were haloperidol (n = 110, 70.5%), promethazine (n = 97, 62.2%), levomepromazine (n = 85, 54.5%), diazepam (n = 83, 53.2%), clonazepam (n = 79, 50.6%), biperiden (n = 52, 33.3%), midazolam (n = 41, 26.3%), risperidone (n = 39, 25.0%), and lithium carbonate (n = 37, 23.7%). Conclusion: The presence of polypharmacy, the high frequency of drugs with the potential to produce adverse effects, highlights the need for greater care with the pharmacotherapy of patients with mental disorders, whether in acute or thermal treatment, increasing patient adherence, improving their quality of life.

Proceedings of Congress SOBRAFO 2024

. . — 2024-09-14

Climate change demands preparedness of pharmaceutical services for disasters

Elaine Silva MIRANDA — 2024-07-15