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Clinicopathological features and chemotherapy can influence the quality of life (QOL), women with ovarian cancer. This study aimed to evaluate the physical and functional well-being, and ovarian cancer-specific effects scores reported from QOL questionnaire among women with ovarian cancer at the time of in their initial diagnosis and access the scores trajectory of women receiving neoadjuvant and adjuvant chemotherapy. This prospective study used cross-sectional analysis at baseline and longitudinal analysis from baseline to 12-month post-chemotherapy. QOL was evaluated at the baseline, at sixth cycle and 12-month post-chemotherapy using FACT-O questionnaire. Clinicopathological features and chemotherapy regime were evaluated and tested for associations with QOL measures. Of the 38 women enrolled in this study, 27 (80.1%) completed the questionnaire for 12 months. The multivariate linear regression results suggest, at the baseline, women with advance stage and presence of post-surgery residual disease showed lower scores in physical and functional well-being, ovarian cancer-specific effects, and FACT-O TOI domains (p

Variation in drug disposition genes might contribute to susceptibility to toxicities and interindividual differences in clinical management on chemotherapy for epithelial ovarian cancer (EOC). This study was designed to explore the association of GST and ABCB1 genetic variation with hematologic and neurologic toxicity, changes in chemotherapy, and disease prognosis in Brazilian women with EOC. A total of 112 women with a confirmed histological diagnosis of EOC treated with carboplatin/paclitaxel were enrolled (2014–2019). The samples were analyzed by multiplex polymerase chain reaction (PCR) for the deletion of GSTM1 and GSTT1 genes. GSTP1 (c.313A>G/rs1695) and ABCB1 (c.1236C>T/rs1128503; c.3435C>T/rs1045642; c.2677G>T>A/rs2032582) single nucleotide polymorphisms (SNPs) were detected by real‐time PCR. Subjects with the GSTP1 c.313A>G had reduced risk of anemia (odds ratio (OR): 0.17, 95% confidence interval (CI): 0.04–0.69, P = 0.01, dominant model) and for thrombocytopenia (OR: 0.27, 95% CI: 0.12–0.64, P G AG genotype was associated with a lower risk of dose delay (OR: 0.35, 95% CI: 0.13–0.90, P = 0.03). The ABCB1 c.1236C>T was associated with increased risk of thrombocytopenia (OR: 0.15, 95% CI: 0.03–0.82, P = 0.03), whereas ABCB1 c.3435C>T had increased risk of grade 2 and 3 neurotoxicity (OR: 3.61, 95% CI: 1.08–121.01, P = 0.03) in recessive model (CC + CT vs. TT). This study suggests that GSTP1 c.313A>G, ABCB1 c.1236C>T, and c.3435C>T SNP detection is a potential predictor of hematological toxicity and neurotoxicity and could help predict the clinical management of women with EOC.

Objective The objective of the present study was to analyze the reasons that led to hormone therapies (HTs) regimen changes in women with breast cancer. Methods This was a retrospective cross-sectional study from a single-institution Brazilian cancer center with patient records diagnosed with breast cancer between January 2012 and January 2017. Results From 1,555 women who were in treatment with HT, 213 (13.7%) women had HT switched, either tamoxifen to anastrozole or vice-versa. Most women included in the present study who switched HT were > 50 years old, postmenopausal, Caucasian, and had at least one comorbidity. From the group with therapy change, ‘disease progression’ was reason of change in 124 (58.2%) cases, and in 65 (30.5%) patients, ‘presence of side effects’ was the reason. From those women who suffered with side effects, 24 (36.9%) had comorbidities. Conclusion The present study demonstrated a low rate of HT switch of tamoxifen to anastrozole. Among the reasons for changing therapy, the most common was disease progression, which includes cancer recurrence, metastasis or increased tumor. Side effects were second; furthermore, age and comorbidities are risk factors for side effects. Resumo Objetivo O objetivo do presente estudo foi analisar os motivos que levaram às mudanças no esquema hormonioterápico (HT) em mulheres com câncer de mama. Métodos Estudo transversal retrospectivo realizado no Hospital da Mulher de Campinas e consequente pesquisa de prontuários de mulheres diagnosticados com câncer de mama entre janeiro de 2012 e janeiro de 2017. Resultados De 1.555 mulheres em tratamento com HT, 213 (13,7%) mulheres tiveram HT alterado, tamoxifeno para anastrozol ou vice-versa. A maioria das mulheres incluídas no presente estudo que tiveram mudança de HT tinha > 50 anos, estava na pós-menopausa, era caucasiana e tinha pelo menos uma comorbidade. Os principais motivos de troca de HT foram devido a ’progressão da doença’, ocorrendo em 124 (58,2%) casos e a ’presença de efeitos colaterais’ (n = 65; 30,5%). Das mulheres que sofreram efeitos colaterais, 24 (36,9%) apresentaram comorbidades. Conclusão O presente estudo demonstrou uma baixa taxa na alteração de tamoxifeno para anastrozol. Entre as razõesmais comuns para alterar a HT estava a progressão da doença, que inclui recorrência do câncer, metástase ou aumento do tumor. Os efeitos colaterais foram a segunda causa e, além disso, a idade e as comorbidades foram fatores de risco para efeitos colaterais.

Objectives: The pregnancy period, with its peculiarities and specific symptoms that may or may not be physiological, can lead to medication use through prescription or even self-medication. This study aimed to assess self-medication practices among pregnant women, the most used medications, symptoms reported, and factors associated with this practice.Methods: This was a cross-sectional study conducted with pregnant women with an antenatal care (ANC) appointment in a tertiary teaching hospital referral in women’s health. From April 2019 to February 2020, 297 pregnant women were interviewed. Self-medication was considered as the use of any medicine (including medicinal plants (MPs), herbal products, and vitamins) without a medical or dental prescription. The period considered to assess self-medication practice was the last 60 days prior to the study interview.Results: Among the 297 women interviewed, 107 (36.0%) had practiced self-medication in the previous 60 days. Acetaminophen was the most used medication, and headache was the most frequent symptom reported by self-medicated pregnant women. Pregnant women with high-school (73 (68.2%) (OR = 2.52; 95% CI 1.17–5.43; p = 0.018)) or university-level (23 (21.5%) (OR = 2.82; 95% CI 1.15–6.94; p = 0.024)) education had a higher risk of practicing self-medication when compared to women with lower education. Women in the first gestational trimester (35 (32.7%) (OR = 3.61; 95% CI 1.64–7.96; p = 0.002)) and with two or more pregnancies (87 (81.2%) (OR = 1.96; 95% CI 1.07–3.60; p = 0.029)) were more likely to practice self-medication than pregnant women in the second or third gestational trimester and in the first pregnancy, respectively.Conclusion: Self-medication was practiced by a considerable proportion of our sample, with the majority being OTC drugs. The factors associated with self-medication can help to improve prevention strategies regarding self-medication during pregnancy.

The objective of the present study is to observe the frequency and severity of urinary symptoms in women with breast cancer (BC) being treated with oral hormone therapy, associating them to drug adherence. The participants were interviewed once from June to October 2016. The evaluation of urinary symptoms was performed by two questionnaires: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) and International Consultation on Incontinence Questionnaire Overactive Bladder Module (ICIQ-OAB). Adherence was evaluated by the Morisky-Green method. Statistical analysis was performed by the Mann-Whitney test, linear regression, and Spearman correlation. Fifty-eight women were interviewed: 42 treated with tamoxifen and 16 with aromatase inhibitor. Twenty-seven women (46.5%) presented urinary incontinence symptoms and 15 (25.8%) presented stress urinary incontinence (SUI). Fourteen (24.1%) women had symptoms of overactive bladder (OAB). There was no statistical difference in symptoms between both treatments and duration of treatments. Higher scores in the ICIQ-SF questionnaire were associated with low/medium adherence and advanced age. Higher scores in the ICIQ-OAB questionnaire were associated with low/medium adherence. The present study showed a high prevalence of urinary symptoms, such as urinary incontinence and OAB, associated with low/medium adherence and older age in women with BC being treated with oral hormone therapy. Health professionals should be alert to these symptoms since it could influence life quality and adherence to treatment. O objetivo do presente estudo foi observar a frequência e a gravidade dos sintomas urinários em mulheres com câncer de mama em uso de terapia hormonal oral, associando estes com a adesão ao tratamento. MéTODOS: As pacientes foram entrevistadas uma única vez, entre junho e outubro de 2016. A avaliação dos sintomas urinários foi realizada por dois questionários: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF, na sigla em inglês) e o Questionário Sobre Bexiga Hiperativa (ICIQ-OAB, na sigla em inglês). A adesão foi avaliada pelo método Morisky-Green. A análise estatística foi realizada pelo teste de Mann-Whitney, regressão linear e correlação de Spearman. Foram entrevistadas 58 mulheres: 42 tratadas com tamoxifeno e 16 com inibidor de aromatase. Vinte e sete mulheres (46,5%) apresentaram sintomas de incontinência urinária (IU) e 15 (25,8%) apresentaram incontinência urinária por estresse (IUS). Quatorze (24,1%) das mulheres tinham sintomas de bexiga hiperativa. Não houve diferença estatística nos sintomas entre os tratamentos e a duração dos tratamentos. Os escores mais elevados no questionário ICIQ-SF estiveram associados à baixa/média adesão e à idade avançada. Os escores mais elevados no questionário da ICIQ-OAB foram associados à baixa/média adesão. CONCLUSãO: O presente estudo mostrou alta prevalência de sintomas urinários, como IU e bexiga hiperativa, associadas à baixa/média adesão e à idade mais avançada em mulheres com câncer de mama em tratamento com hormonioterapia oral. Os profissionais de saúde devem estar atentos a esses sintomas, pois eles podem influenciar a qualidade de vida e a adesão ao tratamento.

To evaluate adherence to oral hormone therapy (HT) and which factors impact in incomplete adherence and quality of life. This was a cross-sectional study. Setting: Women’s Hospital Prof. Dr. Jose Aristodemo Pinotti. Participants: women with breast cancer under treatment with oral HT. Main outcome measures: interview and performed an adherence questionnaire (Morisky–Green) and two questionnaires of quality of life (EORTC-QLQ30/BR23). The interviews were done once in a 5-month period. Fifty-eight women were interviewed: 42 under treatment with tamoxifen (TX) and 16 under treatment with aromatase inhibitor (AI). Twenty-six women (44%) showed high adherence to the treatment, 31 (54%) medium adherence, and 1 (2%) low adherence. Statistical analysis showed a relation between incomplete adherence and systemic therapy side effects as well as higher stages of disease, with no difference between the two drugs. When treatments were compared, this study showed treatment with AI presented less breast symptoms and better role functioning. Quality of life score was high, compared to the reference value. A low percentage of women with breast cancer were highly adherent to HT treatment. Low/medium adherence was associated with higher stages of disease and systemic side effects. Quality of life had high scores, with better role function and less breast symptoms in women being treated with an AI.

Nature has been a source of medicinal treatments for thousands of years, with the use of plants as prototypes for drug development and for the extraction of active compounds. Skin injuries occur regularly in everyday life, and the human skin has the ability to promote repair spontaneously under healthy conditions. However, some intrinsic and external factors may interfere with skins' natural ability, leading to nonhealing lesions and chronic wounds, which directly affect health and quality of life. Thus, attention should be given to this health problem, using an appropriated management when necessary. In this scenario, phytotherapy may be an option for cutaneous wound treatment, although further high-quality studies are needed to firmly establish the clinical efficacy of plants. This article reviews traditionally used natural actives for wound healing, highlighting their characteristics and mode of action.

Introduction In the pregnancy-puerperal cycle, women may develop complications that require admission to the Intensive Care Unit (ICU). Thus, special attention to pharmacotherapy is necessary, particularly to potential drug interactions (PDIs) and to the effect of the drugs on the fetus and newborn. Objective The aim of this study was to determine the profile of PDIs and the potential risk of drugs used during pregnancy and breastfeeding among patients admitted to the ICU. Methods We conducted an observational, cross-sectional and prospective study, including pregnant and breastfeeding women admitted to the ICU at the Women's Hospital of a university in the city of Campinas, Brazil, for one year. Online databases were used to identify and classify the PDIs and the potential risk of the drugs used during pregnancy and breastfeeding. Results We evaluated 305 prescriptions of 58 women, 31 pregnant and 27 breastfeeding, and 284 (91%) prescriptions presented PDIs. A total of 175 different combinations of PDIs were identified in the prescriptions, and adverse effects caused by the simultaneous use of drugs were not actually observed in the clinical practice. A total of 26 (1.4%) PDIs were classified as contraindicated. We identified 15 (13.8%) drugs prescribed with risk D, and 2 (1.8%) with risk X for pregnant women, as well as 4 (4.9%) drugs prescribed with high risk for breastfeeding women. Conclusions This study demonstrates that there is a high incidence of PDIs in prescriptions. Most drugs used by pregnant and breastfeeding women at the ICU did not present serious risks to their fetus and newborns, but sometimes drugs with risk D or X are necessary in the course of the treatment. Introducao No ciclo gravidico-puerperal, as mulheres podem desenvolver complicacoes que necessitam de internacao na Unidade de Terapia Intensiva (UTI). Assim, e necessaria uma atencao especial a farmacoterapia, particularmente as interacoes medicamentosas potenciais (IMPs) e ao risco dos medicamentos para o feto e o recem-nascido. Objetivo Determinar o perfil das IMPs e o risco potencial dos medicamentos utilizados durante a gravidez e a amamentacao entre as mulheres internadas em UTI. Metodos Foi realizado um corte transversal e prospectivo, observacional, incluindo mulheres gravidas e lactantes internadas na UTI do Hospital da Mulher de uma universidade de Campinas durante um ano. Bases de dados online foram usadas para identificar e classificar as IMPs e o potencial risco de uso de medicamentos durante a gravidez e a amamentacao. Resultados Foram avaliadas 305 prescricoes de 58 mulheres, 31 gravidas e 27 lactantes, e 284 (91%) prescricoes apresentaram IMPs, sendo que 175 combinacoes diferentes de IMPs foram identificadas nas prescricoes, e nao foram observados efeitos nocivos pelo uso concomitante dos medicamentos na pratica clinica. Um total de 26 (1,4%) IMPs foram classificadas como contraindicadas. Foram identificados 15 (13,8%) medicamentos prescritos com risco D, e 2 (1,8%) com risco X para mulheres gravidas, e foram identificados 4 (4,9%) medicamentos prescritos como de alto risco para as mulheres que estavam amamentando. Conclusoes Este estudo demonstra que ha uma alta incidencia de IMPs nas prescricoes. A maioria dos medicamentos utilizados por mulheres gravidas e lactantes em UTI nao apresentou serios riscos para o feto e o recem-nascido, mas as vezes sao necessarios medicamentos categorizados como risco D ou X.

An ideal wound dressing ensures a moist environment around the wound area and absorbs exudates from the wound surface. Topical application of bromelain to incised wounds has been shown to reprogram the wound microenvironment to promote effective tissue repair. Combining the characteristics of hydrogels and bromelain is therefore of great interest. Herein, we describe the development of a hydrogel, formulated using alginate and Arabic gum, for bromelain loading and release. The hydrogel formulation was evaluated using response surface methodology, considering the pH value and the concentration of alginate and Arabic gum. Bromelain loading and release were evaluated based on passive diffusion. Differential scanning calorimetry and Fourier transform infrared spectroscopy were performed to confirm bromelain immobilization in the hydrogel. The final hydrogel formulation had a swelling ratio of 227 % and incorporated 19 % of bromelain from a bromelain solution. Bromelain immobilization in the hydrogel was the result of hydrogen bond formation and was optimal at 4 °C after 4 h of contact. This evidence suggests that bromelain entrapment into a hydrogel is a promising strategy for the development of wound dressings that support the debridement of burns and wounds.

This study examines whether women with breast cancer, who are adherent and non-adherent to tamoxifen, differ in their perceptions of information received during treatment. This cross-sectional study included women receiving tamoxifen as adjuvant treatment for breast cancer recruited from a teaching hospital specialised in women’s health in the state of São Paulo (Brazil). Women were interviewed and their records were reviewed for socio demographic data and clinical characteristics. We assessed tamoxifen adherence using the Morisky-Green Test, and the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire – Information module (EORTC QLQ-INFO25) was used to evaluate the information received by the women. The sample contained 31 women (mean age = 55.4; SD = 11.6 years). According to the Morisky-Green Test, 74.2% of the women had suboptimal tamoxifen adherence. The global score for women’s perceptions of information they received about the treatment and disease was 57.0 ±19.1 on a scale of 0 to 100, and no significant differences in scores were observed between adherents and non-adherents. A high prevalence of suboptimal tamoxifen adherence was observed. We found no significant differences between women with breast cancer who were adherent and non-adherent to tamoxifen.

Permeation of sunscreens agents reduces its effectiveness and safety, leading to systemic circulation and causing unknown adverse effects. In order to maintain the sunscreen efficacy and safety, the filters must stay on the skin surface, with minimum penetration through dermis. Even facing the possibility of filters permeation, the use of sunscreen is important to avoid skin damage as erythema, free-radicals formation, skin ageing and skin cancer, caused by ultraviolet radiation. Aiming potential side effects caused by topical absorption of sunscreens, studies are carried to improve formulation characteristics and stability, reduce skin permeation and evaluate sun protections factor (SPF). Current assays to detect the permeation of sunscreens involve in vivo or in vitro studies, to simulate physiological conditions of use. The aim of this review is to revisit sunscreen skin permeation data over the last decade and the factors that can enhance skin permeation or improve the sunscreen efficacy.

Objectives The objectives of this study were to analyze adverse drug events (ADEs) related to admissions to a pediatric emergency unit and to identify the associated risk factors. Methods This was a prospective study. Demographic data and details of medications were collected for each patient admitted. Case studies were performed by clinical pharmacists and the clinical team to discuss whether the admission was due to an ADE and to characterize the ADE. Multivariate logistic regression was used for statistical analysis. Results In total, 1708 pediatric patients were included in this study. Adverse drug events were the cause of hospital admission in 12.3% of the studied population. The majority of patients presenting with an ADE were in the age group of 0 to 5 years (61.6%), had a mean ± SD age of 4.9 ± 3.9 years, were female (51.2%), were Caucasian (72.0%), and had infectious disorders (49.3%). High frequencies of medication errors (68.8%), use of drugs to treat respiratory disorders (27.7%), and ADEs of mild severity (75.3%) were reported. The risk of being admitted to the pediatric emergency unit for any ADE increased in cases of neurological (odds ratio [OR], 4.63; 95% confidence interval [CI], 2.38-8.99), dermatological (OR, 3.16; 95% CI, 1.93-5.18), and respiratory (OR, 3.02; 95% CI, 1.89-4.83) disorders. Conclusions A high frequency of ADE-related admissions to the pediatric emergency unit was observed. The risk of being admitted to the pediatric emergency unit for any ADE increased in cases of neurological, dermatological, and respiratory disorders. Clinical pharmacists play an important role in the identification of ADEs and the education of child caregivers and health care providers concerning pediatric medication.

Purpose Evaluate the potential Drug–Drug Interactions (pDDI) found in prescription orders of adult Intensive Care Unit (ICU) of a Brazilian public health system hospital; quantify and qualify the pDDI regarding their severity and risks to the critical patient, using the database from Micromedex®. Methods Prospective study (January–December of 2011) collecting and evaluating 369 prescription orders (convenient sampling), one per patient. Results During the study 1844 pDDIs were identified and distributed in 405 pairs (medication A × medication B combination). There was an average of 5.00 ± 5.06 pDDIs per prescription order, the most prevalent being moderate and important interactions, present in 74% and 67% of prescription orders, respectively. In total, there were 9 contraindicated, 129 important and 204 moderate pDDIs. Among them 52 had as management recommendation to “avoid concomitant use” or “suspension of medication”, while 306 had as recommendation “continuous and adequate monitoring”. Conclusion The high number of pDDIs found in the study combined with the evaluation of the clinical relevancy of the most frequent pDDIs in the ICU shows that moderate and important interactions are highly incident. As the majority of them demand monitoring and adequate management, being aware of these interactions is major information for the safe and individualized risk management.

AIM OF THE STUDY To identify predictors of quality of life (QOL) in head and neck cancer patients prior to cisplatin chemotherapy and radiotherapy treatment. MATERIAL AND METHODS A cross-sectional study at a Clinical Oncology department of a teaching hospital in the state of Sao Paulo, Brazil, from September 2011 to October 2012 was performed. QOL was assessed using the University of Washington QOL Questionnaire. Demographic and clinical characteristics were obtained through interviews with patients and collected from medical records. Multivariate linear regression was used to determine the association between QOL scores and patient-related factors. RESULTS We studied 48 head and neck cancer patients, who were mostly white (77.1%), males (83.3%), with pharyngeal cancers (66.7%), cancers with stage T4 (45.8%) and N1 (31.2%) tumours, and classified with a Karnofsky Performance Status (KPS) of 90% (37.5%). Patients had excellent scores for saliva (96.2 ±13.5) and shoulder (93.6 ±17.9), with pain and anxiety being the most affected domains (59.6 ±32.4 and 57.5 ±39.2, respectively). A significant relationship of KPS and T stage with overall QOL score was noted. The population with lowest overall QOL score was those who had low KPS scores and T4 tumours. CONCLUSIONS Head and neck cancer patients prior to cisplatin chemotherapy and radiotherapy treatment, with a low KPS and staged as T4 tumours, have worse overall QOL, and special attention should be given to these patients.

Objectives The aim of this study was to determine the frequency and profile of spontaneous reports of Adverse Drug Reactions (ADRs) and quality deviations in a Brazilian teaching hospital and propose a consistent classification to study quality deviations. Methods This is a descriptive and retrospective study involving the analysis of spontaneous reports of ADRs and quality deviations in 2010. ADRs were classified according to the reaction mechanism, severity, and causality. The drugs were classified according to their therapeutic classes and symptoms according to the affected organ. The quality deviations were classified according to the type of deviation and type of medicine available in the Brazilian market. Results A total of 68 forms were examined; ADRs accounted for 39.7% of the notifications, while quality deviations accounted for 60.3%. ADRs occurred more frequently in men (51.9%) and adults (63.0%). The skin (28.0%) was the most affected organ, while anti-infectives (40.7%) were the therapeutic class that caused the most ADRs. The most common ADRs were type B (74.0%), moderates (37.0%), and probables (55.6%). In relation to quality deviations, the most frequent notifications were breaks, splits and leaks (20.9%) and related to generic drugs (43.9%). Conclusion The classification system to study quality deviations was clear and consistent. This study demonstrated that practices and public policies related to more effective pharmacovigilance need to be implemented so that the number of spontaneous reports increases.

Background Cisplatin is a high-potency anticancer agent; however, it causes significant adverse drug reactions (ADRs). Potential pharmacokinetic markers must be studied to predict or prevent cisplatin-induced ADRs and achieve better prognosis. This study was designed to investigate the relationship between ADRs and kinetics of cisplatin excretion in the urine of patients undergoing high-dose cisplatin chemotherapy and radiotherapy for head and neck cancer. Methods Outpatients with head and neck cancer received a first cycle of high-dose cisplatin chemotherapy (80–100 mg/m2) concurrent to radiotherapy. ADRs (haematological, renal, and gastrointestinal reactions) were classified based on severity by National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4, grade 0–4). The kinetics of cisplatin excretion in urine was evaluated by high-performance liquid chromatography over three time periods: 0–12, 12–24, and 24–48 h after the administration of cisplatin. Spearman Correlation test and regression analysis were performed to assess the relationship between ADRs and cisplatin excretion in the urine. Results In total, 59 patients with a mean age of 55.6 ± 9.4 years were analysed; most patients were male (86.4%), white (79.7%), and with pharyngeal tumours in advanced stages (66.1%). The most frequently observed ADRs were anaemia (81.4%), lymphopenia (78%), and nausea (64.4%); mostly grades 1 and 2 of toxicity. The mean cisplatin excretion was 70.3 ± 64.4, 7.3 ± 6.3, and 5 ± 4 μg/mg creatinine at 0–12, 12–24, and 24–48 h, respectively. Statistical analysis showed that the amount of cisplatin excreted did not influence the severity of ADRs. Conclusions The most frequent ADRs were anaemia, lymphopenia, and nausea. Grades 1 and 2 were the severities for most ADRs. The period over which the highest cisplatin excretion observed was 0–12 h after chemotherapy, and cisplatin excretion could not predict toxicity. Graphical abstract

SUMMARY What is known and objective: Use of cisplatin can induce type I hypersensitivity reactions that may also be linked to the quality of the drug utilized. We observed cases of hypersensitivity that appeared to be associated with the brand of cisplatin used. The aim of this study was to compare two different brands of cisplatin in relation to type I hypersensitivity reactions. Methods: Brand A was used in a tertiary care teaching hospital until 2012, and use of brand B started from January 2013, when the first hypersensitivity cases were observed. Patients were categorized based on symptom. Cisplatin of both brands was analysed by high-performance liquid chromatography (HPLC) and high-resolution electrospray ionization mass spectrometry (ESI-(+)-MS) and characterized according to US Pharmacopeia. Results and discussion: There were no cases of hypersensitivity associated with the use of cisplatin brand A, whereas four of 127 outpatients that used cisplatin brand B were affected. The two brandswereinaccordancewiththeUSPharmacopeiaparameters, andtherewasnosignificantdifferenceinthetotalplatinumlevels betweenthetwobrandswhenanalysedbyHPLC.However,highresolution ESI-(+)-MS analyses show that brand B contains approximately 27 times more hydrolysed cisplatin than brand A. What is new and conclusion: The increase in the hydrolysed form of cisplatin found in brand B may be the cause of the hypersensitivity reaction observed in a subset of patients. We present the first study of the quality of drugs by high-resolution ESI-(+)-MS. Drug regulatory agencies and manufacturers should consider including measurement of hydrolysed cisplatin as a quality criterion for cisplatin formulations.

Estudos de farmacovigilância são imprescindíveis em oncologia, pois os antineoplásicos possuem alta toxicidade e estreita janela terapêutica. Os objetivos deste estudo foram analisar o perfil das notificações espontâneas de reações adversas a medicamentos (RAM) em pacientes oncológicos e a incidência de RAM ao tratamento antineoplásico em um hospital terciário e universitário. Para compor o perfil de RAM, revisaram-se os formulários de notificação de reações em pacientes oncológicos do ano de 2010 e classificaram-se as reações conforme o medicamento envolvido, mecanismo, causalidade e gravidade. Para avaliar a incidência de reações, aplicou-se um questionário no momento da quimioterapia e a gravidade foi classificada pelos Critérios Comuns de Toxicidade. Apenas 10 reações foram notificadas ao Setor de Farmacovigilância, cujo perfil encontrado foi tipo B, grave, possível, e foram principalmente relacionadas aos compostos de platina e taxanos. Na análise da incidência das reações, observou-se que náusea, alopecia, fadiga, diarreia e distúrbio do paladar foram as reações mais frequentes relatadas por pacientes oncológicos, e as reações grau 3 e 4 não foram notificadas. De acordo com essas análises, propõe-se que os profissionais da saúde sejam treinados quanto às notificações e que farmacêuticos clínicos sejam cada vez mais inseridos neste contexto para redução da subnotificação de RAM. The high toxicity and narrow therapeutic window of antineoplastic agents makes pharmacovigilance studies essential in oncology. The objectives of the current study were to analyze the pattern of spontaneous notifications of adverse drug reactions (ADRs) in oncology patients and to analyze the incidence of ADRs reported by outpatients on antineoplastic treatment in a tertiary care teaching hospital. To compose the pattern of ADR, the notification forms of reactions in oncology patients in 2010 were reviewed, and the reactions were classified based on the drug involved, mechanism, causality, and severity. To evaluate the incidence of reactions, a questionnaire at the time of chemotherapy was included, and the severity was classified based on the Common Terminology Criteria. The profiles of the 10 responses reported to the Pharmacovigilance Sector were type B, severe, possible, and they were primarily related to platinum compounds and taxanes. When the incidence of reactions was analyzed, it was observed that nausea, alopecia, fatigue, diarrhea, and taste disturbance were the most frequently reported reactions by oncology patients, and the grade 3 and 4 reactions were not reported. Based on this analysis, it is proposed that health professionals should be trained regarding notifications and clinical pharmacists should increasingly be brought on board to reduce under-reporting of ADRs.

Patients in intensive care unit are prescribed large numbers of drugs, highlighting the need to study potential Drug-Drug Interactions in this environment. The aim of this study was to delineate the prevalence and risk of potential drug-drug interactions between medications administered to patients in an ICU. This cross-sectional observational study was conducted during 12 months, in an adult ICU of a teaching hospital. Inclusion criteria were: prescriptions with 2 or more drugs of patients admitted to the ICU for > 24 hours and age of ≥18 years. Potential Drug-Drug Interactions were quantified and classified through MicromedexTM database. The 369 prescriptions included in this study had 205 different drugs, with an average of 13.04 ± 4.26 (mean ± standard deviation) drugs per prescription. Potential Drug-Drug Interactions were identified in 89% of these, with an average of 5.00 ± 5.06 interactions per prescription. Of the 405 different pairs of potentially interacting drugs identified, moderate and major interactions were present in 74% and 67% of prescriptions, respectively. The most prevalent interaction was between dipyrone and enoxaparin (35.8%), though its clinical occurrence was not observed in this study. The number of potential Drug-Drug Interactions showed significant positive correlations with the length of stay in the intensive care unit, and with the number of prescribed drugs. Acknowledging the high potential for Drug-Drug Interactions in the ICU represents an important step toward improving patient safety and best therapy results.

There is a lack of safety data supporting the use of hormone therapy in women who have had breast cancer and who have complained of genitourinary syndrome of menopause (GSM). The objective was to test the efficacy of two non-hormonal therapies for vaginal dryness.This was a randomized trial with 52 women with breast cancer who were being treated with tamoxifen and who complained of vaginal dryness. The volunteers answered two questionnaires to evaluate sexual function (Female Sexual Function Index, FSFI) and a customized GSM questionnaire. The women were randomized into two groups: 25 (48.1%) in the polyacrylic acid group and 27 (51.9%) in the lubricant group, using either one of the treatments for 30 days, and after they were invited to answer the questionnaires again.There was improvement in the FSFI after both treatments. The polyacrylic acid group showed a decrease in sexual dysfunction from 96% to 24% (p 0.0001) and the lubricant group showed a decrease from 88.9% to 55.6% (p = 0.0027).The results of this study showed that both treatments improved sexual function; however, polyacrylic acid was superior to the lubricant in treating sexual dysfunction.

Background. Phase I of this study was aimed at comparing the profiles of oxidative stress biomarkers in patients with history of nonmelanoma skin cancer (NMSC), previously treated with surgery, to the healthy subjects. Phase II aimed to evaluate the effects of supplementary antioxidant therapy on the levels of biomarkers in the case group.Materials and Methods. In Phase I, oxidative stress biomarkers were measured in blood samples obtained from 24 healthy subjects and 60 patients with history of NMSC previously treated with surgery. In Phase II, the 60 patients with history of NMSC were randomized into two subgroups, one receiving placebo (n=34) and the other (n=26) receiving vitamin C, vitamin E, and zinc supplementation for 8 weeks, followed by reevaluation of biomarkers.Results. In Phase I, patients with history of NMSC showed increased plasma concentrations of all biomarkers, but only 15-F2t-isoprostane was significantly higher than in the healthy subjects. Risk of NMSC increased by 4% for each additional 1 pg/mL increase in 15-F2t-isoprostane. In Phase II, supplementation did not significantly reduce levels of oxidative stress biomarkers.Conclusion. Patients with history of NMSC had significantly high 15-F2t-isoprostane plasma levels; supplementation did not result in significant reduction of oxidative stress biomarkers. This trial was registered with ClinicalTrials.gov (IDNCT02248584).

Oncologic inpatients often require multiple drug therapy. They may be at higher risk of experiencing prescribing errors, which pharmacist interventions may help to avoid. This study aimed to evaluate the types of prescribing errors, pharmaceutical interventions and differences in clinical significance, in prescriptions for hospitalised patients with breast and gynaecological cancer. A cross-sectional, prospective study was conducted at the oncology ward of a clinic specialised in breast and gynaecology cancer. A clinical pharmacist analysed prescriptions, identified errors, performed interventions and classified clinical significance. A total of 1,874 prescriptions of 248 patients were evaluated; 11.5% prescriptions were involved at least in one prescribing error, totalising 283 errors. The most common error was unsafe medication due to drug interaction (89[31.4%]). Drugs for the alimentary tract and metabolism, and nervous system were the most involved in errors with statistical association (p = .0246 and p = .0002 respectively). Of the 294 interventions, 73.5% were accepted. The clinical significance of prescribing errors and interventions were classified as significant and very significant respectively. The pharmacist interventions obtained a good acceptance rate and impact significantly, avoiding prescribing errors classified as significant.

Objective This study aims to evaluate the frequency and severity of nausea and vomiting using two different instruments and relate them to quality of life (QOL) in patients with cancer receiving antineoplastic treatment. Methods Severity of chemotherapy-induced nausea and vomiting (CINV) was measured by Common Terminology Criteria for Adverse Events (CTCAE) and a numerical scale. QOL was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. Key findings Of the 50 patients studied, 60.0% reported nausea (40.0% CTCAE grade 1; 66.7% moderate intensity on numerical scale) and 30.0% reported vomiting (46.7% CTCAE grades 1 and 2, each; 66.7% moderate intensity on numerical scale). CINV did not influence overall QOL. Conclusion The frequency of CINV was high. There was no association between nausea/vomiting and overall QOL.

Caroline de Godoi Rezende Costa Molino, Renata Cavalcanti Carnevale, Aline Teotonio Rodrigues, Marília Berlofa Visacri, Patricia Moriel, Priscila Gava Mazzola Department of Clinical Pathology, Faculty of Medical Sciences (FCM), University of Campinas (UNICAMP), São Paulo, Brazil Background: Substantial complexity has been introduced into treatment regimens for patients with human immunodeficiency virus (HIV) infection. Many drug-related problems (DRPs) are detected in these patients, such as low adherence, therapeutic inefficacy, and safety issues. We evaluated the impact of pharmacist interventions on CD4+ T-lymphocyte count, HIV viral load, and DRPs in patients with HIV infection. Methods: In this 18-month prospective controlled study, 90 outpatients were selected by convenience sampling from the Hospital Dia–University of Campinas Teaching Hospital (Brazil). Forty-five patients comprised the pharmacist intervention group and 45 the control group; all patients had HIV infection with or without acquired immunodeficiency syndrome. Pharmaceutical appointments were conducted based on the Pharmacotherapy Workup method, although DRPs and pharmacist intervention classifications were modified for applicability to institutional service limitations and research requirements. Pharmacist interventions were performed immediately after detection of DRPs. The main outcome measures were DRPs, CD4+ T-lymphocyte count, and HIV viral load. Results: After pharmacist intervention, DRPs decreased from 5.2 (95% confidence interval [CI] =4.1–6.2) to 4.2 (95% CI =3.3–5.1) per patient (P=0.043). A total of 122 pharmacist interventions were proposed, with an average of 2.7 interventions per patient. All the pharmacist interventions were accepted by physicians, and among patients, the interventions were well accepted during the appointments, but compliance with the interventions was not measured. A statistically significant increase in CD4+ T-lymphocyte count in the intervention group was found (260.7 cells/mm3 [95% CI =175.8–345.6] to 312.0 cells/mm3 [95% CI =23.5–40.6], P=0.015), which was not observed in the control group. There was no statistical difference between the groups regarding HIV viral load. Conclusion: This study suggests that pharmacist interventions in patients with HIV infection can cause an increase in CD4+ T-lymphocyte counts and a decrease in DRPs, demonstrating the importance of an optimal pharmaceutical care plan. Keywords: pharmaceutical care, HIV, clinical pharmacy, CD4+ T lymphocyte count, AIDS, pharmacy service

Introdução: Os erros de prescrição são erros de medicação. A prevenção destes erros é um importante instrumento para a segurança das pacientes. Objetivos: Avaliar a frequência, os tipos, a gravidade dos erros de prescrição e a aceitação das intervenções farmacêuticas. Métodos: Estudo transversal, prospectivo e observacional, em unidade de internação obstétrica de alto risco, entre setembro de 2014 e março de 2015. As variáveis foram tipo de erro, significância clínica do erro de prescrição, classe terapêutica, medicamentos potencialmente perigosos envolvidos com erros, impacto e aceitação das intervenções. Resultados: Foram analisadas 1826 prescrições para 549 pacientes e identificados 130 erros (7,0%) de 101 pacientes (18,4%). Os erros mais frequentes foram interações medicamentosas (43,8%), frequência (21,5%), e dose incorreta (13,1%). O maior número de medicamentos em uma única prescrição foi o principal fator de risco relacionado aos erros (p

Recent studies suggest that lecithin-rich diet can modify cholesterol homeostasis and hepatic lipoprotein metabolism. Considering the phytotherapeutic impact of lecithin, this work hypothesizes that lecithin administration in hypercholesterolemic patients may reduce cholesterol concentrations by increasing biliary secretion. Total cholesterol and LDL were evaluated after soy lecithin administration in hypercholesterolemic patients. One soy lecithin capsule (500 mg/RP-Sherer) was administrated daily. One-two months before the treatment beginning, blood samples were collected for total lipids and cholesterol fractions analysis. The results showed a reduction of 40.66% and 42.00% in total cholesterol and of 42.05% and 56.15% in LDL cholesterol after treatment for one and two months, respectively. A significant reduction in total cholesterol and LDL-cholesterol concentrations was observed during the first month of treatment, suggesting that the administration of soy lecithin daily may be used as a supplemental treatment in hypercholesterolemia.

Background The breast cancer mortality rate is high among Brazilian women, a fact probably related to late diagnosis of this condition. Adjuvant endocrine treatment with tamoxifen for 5 years can increase the survival rate of patients with hormone receptor-positive tumours. Because it is an orally administered drug, the patient plays an important role in compliance with the correct treatment (adherence) assuming much of the responsibility for her treatment. Therefore, Pharmaceutical Care has subsidies to influence treatment of these patients, identifying, preventing and resolving drug treatment problems (DTPs). Purpose To evaluate adherence to tamoxifen and to identify the most important DTPs in patients with breast cancer on adjuvant endocrine treatment. Materials and Methods A prospective study was conducted in a university hospital specialising in women’s health. Over 6 months patients with breast cancer were included if they were on adjuvant endocrine treatment for at least 1 month. All were interviewed by the pharmacist (Minnesota model). The instrument used to evaluate adherence was the Morisky-Green test. Results Forty-one patients were included (mean age 55.0 years; ranging from 34–78). In the first visit, the pharmacist identified 82 DTPs (mean: 2.0 ± 1.1 DTPs/patient), 63.4% related to drug safety. The adherence to oral endocrine treatment was 36.6%; according to the Morisky-Green test; among the non-adherent patients 92.3% were non-intentional (mostly by forgetting to take doses of tamoxifen). The patient’s average time on endocrine therapy was 24.9 ± 17.6 months. Conclusions We observed that the DTPs are present in oral endocrine therapy and adherence to this treatment can be considered inappropriate. The results obtained may contribute to the development of strategies in pharmaceutical care to improve adherence to oral endocrine therapy and decrease DTPs in breast cancer patients using tamoxifen. No conflict of interest.

Background Pharmaceutical interventions can prevent drug-related problems and possible prescription errors. They thus contribute to the optimization of pharmacotherapy and to prioritising safety in an Intensive Care Unit (ICU). Purpose To identify and quantify medicines errors observed and interventions made in the ICU in question, drawing a profile of the main actions of the pharmacist in critical care specialising in women’s health. Materials and Methods The study was conducted in a Brazilian ICU of a university hospital specialising in women’s health, from February to May 2012. Interventions were performed after analysis of patient prescriptions (18 years old or over, hospitalised for more than 24 hours in the ICU) and discussions of clinical cases during multidisciplinary meetings. Interventions were classed on whether or not they were accepted by the medical staff. Drug-related errors observed were classed as preventable or not and ranked by an adaptation of the classification of the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP). Results The study involved 82 patients, and 386 prescriptions were evaluated. The mean age was 41.1 ± 19.0 years old and the average hospital stay was 4.7 ± 3.3 days. We identified 45 medicines errors (mean 0.6 ± 3.5/patient), 86.7% of these were preventable and 13.3% were not. The most common error types were: unsafe medicine due to drug interaction (26.7%), higher dose than recommended (15.6%) and unsafe medicine during lactation (13.3%). Fifty-one interventions were made (mean 0.6 ± 4.2/patient), and 84.3% of these were accepted; 3.9% partially accepted; and 11.8% were not accepted. The most common interventions were to recommend an alternative dose (25.5%), identify drug interactions (23.5%), and risk during lactation (11.8%). Conclusions Partial results obtained show the necessity for clinical pharmacy services in the ICU as an important contribution to reducing risks from drug treatment. No conflict of interest.

Background: Highly active antiretroviral therapy (HAART) is complex and many factors contribute to a patient’s response to initial therapy including adherence, drug effectiveness, and tolerance. Close HAART follow-up is needed, particularly when there are concurrent therapies such as prophylactic antibiotics and medications for the treatment of comorbidities. Objective: To assess the effectiveness of pharmacist intervention in reducing drug related problems in HIV/AIDS outpatients (intervention group) and in improving clinical parameters in the intervention group compared to the control group. Methods: We conducted a prospective controlled intervention study with patients paired by gender and initial T CD4+ lymphocyte (CD4) count. HIV-infected patients of a public outpatient service were enrolled for the study by consecutive and convenience sampling. Patients selected for the study were divided into a control group and an intervention group. Both groups were followed for one year; however, only the intervention group received pharmaceutical care. The primary outcome was the drug related problem (DRP) analysis for the intervention group. Secondary outcomes were CD4 count and viral load evaluation for both groups. Results: There was a total of 143 patients enrolled in this study, with 53 (37.06%) patients in the control group and 90 (62.94%) patients in the intervention group. A total of 202 pharmacist interventions with 193 pharmacist-patient and 9 pharmacist-physician interventions were proposed. After one year of pharmaceutical care, a reduction of 38.43% between the initial and final DRP was found (p=0.0001). The most common DRPs found were related to medication safety. The intervention group showed a mean increase of 84% for the CD4 count in comparison with that observed in the control group. The viral load was not significantly different between the final and initial mean values for both groups. Conclusion: Pharmacist appointments enabled identification, prevention, and solving of drug related problems, especially those related to drug safety. Also, pharmacist interventions improved adherence and increased HAART effectiveness as suggested by the higher elevation in the CD4 count seen in the intervention group in comparison with the control group.

Background Studies have shown that pharmaceutical care can result in favorable clinical outcomes in human immunodeficiency virus (HIV)-infected patients, however, few studies have assessed the economic impact. The objective of this study was to evaluate the clinical and economic impact of pharmaceutical care of HIV-infected patients. Methods A controlled ambispective study was conducted in Brazil from January 2009 to June 2012. Patients were allocated to either intervention or control group. The control group was followed according to standard care while the intervention group was also followed by a pharmacist at each physician appointment for one year. Effectiveness outcomes included CD4+ count, viral load, absence of co-infections and optimal immune response, and economic outcomes included expenses of physician and pharmaceutical appointments, laboratory tests, procedures, and hospitalizations, at six months and one year. Results Intervention and control groups included 51 patients each. We observed significant decreases in total pharmacotherapy problems during the study. At six months, the intervention group contained higher percentages of patients without co-infections and of patients with CD4+ >500 cells/mm3. None of the differences between intervention and control group considering clinical outcomes and costs were statistically significant. However, at one year, the intervention group showed higher percentage of better clinical outcomes and generated lower spending (not to procedures). An additional health care system daily investment of US$1.45, 1.09, 2.13, 4.35, 1.09, and 0.87 would be required for each additional outcome of viral load 200, 350, and 500 cells/mm3, and optimal immune response, respectively. Conclusion This work demonstrated that pharmaceutical care of HIV-infected patients, for a one-year period, was able to decrease the number of pharmacotherapy problems. However, the clinical outcomes and the costs did not have statistical difference but showed higher percentage of better clinical outcomes and lower costs for some items.