Ana Carolina Melchiors

Translation and validation into portuguese Language of the Medication Regimen Complexity Index

BACKGROUND The complexity of pharmacotherapy is a result of a multiplicity of prescribed regimen factors, including the number of different drugs in the regimen, the number of dosage units per dose, the total number of prescribed doses per day and administration instructions. The Medication Regimen Complexity Index (MRCI) is a specific, reliable and valid tool used to measure the complexity of pharmacotherapy, originally developed in English language. OBJECTIVE Transcultural translation and validation of this tool into Brazilian Portuguese. METHODS A cross-sectional study was developed with 95 type-2 diabetes patients, receiving multiple medications. The validation process included translation into Portuguese, back-translation and pre-test of the tool, creating a new version called the Pharmacotherapy Complexity Index (PCI). The psychometric parameters were assessed, including convergent validity, discriminant validity and reliability (interclass and test-retest correlation). RESULTS The complexity of pharmacotherapy measured by the MRCI-Brazil had an average score of 15.7 points (SD=8.36). MRCI-Brazil showed significant correlation with the number of medications (r=0.86; p<0.001) and age of patients (r=0.28, p=0.005). Interrater reliability analysis found an intra-class correlation (ICC) of 0.99 (p<0.001) and test-retest correlation was of 0.997 (p<0.001). CONCLUSION The results have shown that the Brazilian version of the MRCI presents adequate validity and reliability, and may be useful in clinical practice and research involving the analysis of the drug regimen complexity.

The effect of isotretinoin on triglycerides and liver aminotransferases

BACKGROUND Isotretinoin has been used to treat the most severe cases of acne; however, it may provoke adverse events in mucocutaneous and hepatic tissues, lead to alterations in lipid levels and cause teratogenicity. OBJECTIVE The objective of this study was to evaluate the profile of changes in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and triglyceride levels in patients who had been treated with oral isotretinoin dispensed by the São Mateus/ES pharmacy for special drugs. METHODS A retrospective, observational, longitudinal study was conducted by carrying out a secondary analysis of each patients data. RESULTS Of the 130 patients who received isotretinoin between January and December 2009, only 70 were actually treated for 3 months or more and handed in the results of their laboratory tests. Of these 70 patients, 39 (55.7%) were female. The mean age of the women (23.9 years) was higher than the mean age of the men (20.1 years). There was a statistically significant increase in the levels of triglycerides (87.01 ± 48.25 versus 105.32 ± 48.76 mg/dL), AST (20.44 ± 6.26 versus 24.38 ± 11.92 U/L) and ALT (18.24 ± 8.31 versus 23.34 ± 20.03 U/L) performed prior to and 3 months or more after oral isotretinoin treatment. After treatment with oral isotretinoin, triglyceride levels had increased beyond the normal range in 11% of the patients, while 8.6% had elevated AST levels and 7.3% had increased ALT levels. CONCLUSION The results in this population show that the use of oral isotretinoin for the treatment of acne may result in altered triglyceride, AST and ALT levels. These findings are in accordance with data published previously in the scientific literature, confirming the need to monitor these patients.

A Tool to Characterize the Components of Pharmacist Interventions in Clinical Pharmacy Services: The DEPICT Project

BACKGROUND The complexity of clinical pharmacy services usually leads to an inconsistent or even poor description of their interventions in scientific reports. To ensure comparability and reproducibility of the evidence, an in-depth description of pharmacist interventions is required. OBJECTIVE To validate a new tool called DEPICT (Descriptive Elements of Pharmacist Intervention Characterization Tool) to characterize clinical pharmacy services. METHODS We developed a 3-phase study. First, to create a theoretical framework, an overview of systematic reviews was performed in PubMed between 2000 and 2010. Then, an in-depth analysis of the included studies was carried out to identify a list of components in order to create the instrument. Finally, 2 independent raters separately applied the tool to a random sample of 28 randomized clinical trials extracted from the systematic reviews. Interrater agreement was evaluated using PABAK (prevalence-adjusted bias-adjusted κ) coefficient or intraclass correlation coefficient (ICC). RESULTS We included 49 systematic reviews in our overview. Analysis of these studies resulted in 58 intervention components, with 57 dichotomous variables and 1 discrete variable. These items resulted in a preliminary version of the instrument. The reliability analysis showed that 8 binary items of this version had a PABAK less than or equal to 0.60. These items were then excluded or modified, resulting in a final version of the tool, with 54 items organized into 12 domains. DEPICT showed an average PABAK of 0.85 (95% CI 0.81 to 0.88) and an ICC of 1.0. Twenty items presented a PABAK value between 0.61 and 0.80 (substantial agreement) and 33 had a value between 0.81 and 1.0 (almost perfect agreement). CONCLUSIONS DEPICT is a reproducible instrument for describing the components of pharmacist interventions performed as part of clinical pharmacy services. It allows retrospective analysis of published studies and can be used as a reference guide to report pharmacist interventions in future studies.

Perfil dos farmacêuticos e farmácias em Santa Catarina: indicadores de estrutura e processo

The present study aimed to assess structure and process quality indicators in community pharmacies in Santa Catarina (Brazil), and also the profile of pharmacists regarding their attitudes and perceptions of pharmaceutical care and professional satisfaction. A cross-sectional study was performed in 10% of Santa Catarina pharmacies randomly chosen. 258 community pharmacies were surveyed. 88.5% pharmacists were in office in the time of the interview. In average, they were 31 years old (SD=8.1) and mainly women (68%). A ratio of 1.4 (SD=0.7) pharmacists per pharmacy and 3.8 (SD=4.5) assistants existed. Only 11.4% pharmacies had an adequate structure for private caring patients. Despite having an average of more than 2 tertiary drug information sources, most of them were low quality. Activities mentioned by the majority of pharmacists were dispensing (98.2%), recording controlled drugs (90.8%), injections administration (85.1%), and helping patients on cash line (84.2%). Most of pharmacies in Santa Catarina (Brazil) do not have the adequate structure for implementing pharmaceutical care services. Barriers identified to implement those services were not different to those communicated in other countries.

Effect of a Pharmaceutical Care Program on quality of life and satisfaction with pharmacy services in patients with type 2 diabetes mellitus

The aim is to evaluate the humanistic outcomes in type 2 diabetic patients by the adoption of pharmacotherapy follow-up in community pharmacies. Controlled, non-randomized, 12-months trial; n=161 patients distributed into control and intervention groups; 6 community pharmacies involved, all in the Curitiba city region, in the state of Parana were used. The health-related quality of life (HRQoL) and the satisfaction index were determined using both the DQOL assessment tool, which measures HRQoL, and the satisfaction evaluation tool (QSSF). Interventions on 119 negative therapeutic outcomes were done (2.3/patient [SD=1.6]); the most commonly found problems were related to ineffectiveness of pharmacotherapy (68.1%). The Intervention-Group showed a significant improvement in HRQoL compared with the Control Group (0.08 vs -0.01, respectively; p=0.036). Satisfaction and impact domains presented the most significant improvement (0.13 vs 0.00 [p=0.030] and 0.07 vs -0.04 [p=0.033], respectively). After adjusting for baseline variables, the difference in improvement scores between groups on the QSSF was attributed to the allocation of patients in the intervention group. Pharmacotherapy follow-up of type 2 diabetic patients in community pharmacies can improve the HRQoL and satisfaction of patients.

Avaliação econômica do seguimento farmacoterapêutico em pacientes com diabetes melito tipo 2 em farmácias comunitárias

OBJECTIVE: Assess economics results of Pharmacotherapeutic Follow-up (PF) in patients with diabetes mellitus type 2 in community pharmacies from additional Health system. METHODS: In a prospective clinic study, 161 patients were divided into two groups, of which only one group received PF for 12 months. From the results, we calculated data of effectiveness and costs. The primary endpoint was the economic evaluation PF by using an indicator of effectiveness (changes in glycated hemoglobin), which was related to the costs of pharmaceutical care. Secondary endpoints were values of blood pressure, waist circumference and body mass index of patients, also related to costs of pharmaceutical care. RESULTS: A real reduction of 1.3% of HbA1 was observed in the PF group, in comparison to control group. The annual cost of the reduction in 1% in HbA1 values in the PF group patients was

Actitudes y conocimientos de los farmacéuticos comunitarios al dispensar medicamentos a embarazadas

45.15. This feature to improve the control of type 2 diabetic patients can be implemented with annual investments of about

Avaliação dos serviços farmacêuticos: indicadores de estrutura e processo em farmácias comunitárias

225.76 per patient, using PF and monitoring of blood glucose test. CONCLUSIONS: It is possible to reduce the HbA1 values to desired levels by using PF. This can be considered an additional resource for the attainment of metabolic control, resulting in this study a cost of

An analysis of quality of systematic reviews on pharmacist health interventions

37.62 per patient, per year, to reduce 1% in the HbA1 values.

Effects of a pharmacotherapy follow-up in community pharmacies on type 2 diabetes patients in Brazil

The present study aimed to assess knowledge and attitudes of the pharmacists on dispensing drugs to pregnant women. Methods: Cross-sectional study in 150 community pharmacies randomly selected in Curitiba (Brazil). A closed end questionnaire with 25 questions were used, including dispensing scenarios containing risk types A, B, D or X and questions on pharmacist interaction with pregnant women, physicians, and information sources availability. Results: Pharmacists performed appropriately in 53% of the encounters. Lower success were associated to prednison and captopril (24.8% in both), end cases producing more doubts were captopril (31.7%) and simvastatin (30.7%). Most of the pharmacists state have advised drugs to pregnant women or contact to the physician to discuss about a prescription related with this issue. A Majority (64.4%) did not feel able to understand FDA risk classification and did not have trustable information sources in pharmacy. Conclusions: Pharmacists dispensing drugs in Curitiba are not able to interpret information on the use of drugs in pregnant women, and they don have reliable information sources on the use of dugs in pregnancy. However, they advice and counsel drugs to pregnant women and discuss with physicians therapeutic strategies.