Patients and methodsA sample of breast cancer patients (n=62 women) were interviewed for the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) in Albanian. Reliability of the questionnaire was considered acceptable if Cronbach’s alpha was ≥0.70. Item convergent-discriminant validity was tested through multitrait scaling analysis. Construct validity was tested under the hypotheses that QLQ-C30 interscale correlations would have an acceptable value of ≥0.40 and as well as by known group comparisons assessing differences of patient subgroups with reference to disease stage and education level.ResultsThe mean age of the patients was 50 years (standard deviation: 10.9 years). Cronbach’s alpha ranged from 0.54 for the cognitive functioning scale to 0.96 for the global health quality of life (GH/QoL) scale. In multitrait scaling analysis, the strength of Spearman’s correlations between an item and its own subscale was ≥0.40, with the exception of item 5 (ρ=0.22); results for item discriminant validity were satisfactory, with the exception of item 5, which showed higher correlation with other subscales than with its own physical functioning. The Spearman’s interscale coefficients generally were correlated with each other. Results of known group comparisons did not show significant differences in terms of disease stage. Regarding education level, patients with high school/university education had better functional scales scores only in certain subscales compared to other subgroups; furthermore, patients with secondary school education had better GH/QoL compared to other subgroups of patients.ConclusionThe EORTC QLQ-C30 (v3.0) in Albanian was found to be valid and reliable for women with breast cancer and could be considered as a starting point for further evaluation study.
Pharmacovigilance (PV) and drug safety monitoring have an essential role in protecting public health. A cross-sectional study evaluated pharmacist knowledge, attitude and practice toward PV and adverse drug reactions (ADRs) reporting. The structured validated questionnaire was distributed to 550 randomly selected pharmacists in the whole Kosovo region. 405 out of 550 pharmacists responded to the questionnaire. Most pharmacists have insufficient knowledge about pharmacovigilance and the ADRs reporting process. The main reasons for under-reporting were little knowledge of pharmacovigilance and adverse reporting process, lack of time, and lack of infrastructure. However, pharmacists showed a positive attitude and stated that they would practice pharmacovigilance if they receive the training. There is a necessity to intensify communication among all stakeholders involved in PV. In addition, continuous training and education are needed to increase pharmacist's awareness and knowledge of PV and their participation in the ADRs reporting process.
Keywords: Pharmacovigilance, adverse drug reaction, knowledge, attitude, practice, pharmacists, Kosovo
Tamoxifen is a selective estrogen receptor modulator (SERM) used for the prevention of breast cancer and for the treatment of metastatic and early stage receptor positive breast cancer. It has been shown than tamoxifen is metabolized by the cytochrome P450 2D6 (CYP2D6) enzymes, especially with the CYP26 isoform. The aim of this study was to examine the prevalence of CYP2D6*4, CYP2D6*9 and CYP2D6*10 variants in patients with breast cancer in Kosovo as well as the association between CYP2D6 polymorphisms and the therapeutic outcome in tamoxifen treated patients. The study included 111 patients who were at the age of 25 to 70 years (45.75 ± 9.50). The overall variant allele frequency of CYP2D6*4 was 0.16. The genotypic frequencies of the CYP2D6*4 polymorphism in all patients were 0.02 for *4/*4, 0.28 for *1/*4 and 0.70 for the *1/*1 genotype. The overall CYP2D6*10 variant allele frequency was 0.30 and the frequency of *10/*10, *1/*10 and *1/*1 genotypes was 0.11, 0.37 and 0.52, respectively. In our study, a population of the CYP2D6∗9 variant allele was not detected. In addition, we did not find any correlation between the evaluated genotypes for CYP2D6 polymorphisms and the therapeutic outcome with tamoxifen therapy. Although our study is a rather small- scale compared to large multicentre studies, we believe that it will contribute to determining the impact of CYP2D6 polymorphisms on the success of tamoxifen therapy in patients with a diagnosed breast cancer. Our results are pointing to the direction of the growing number of claims that there is still no strong evidence of any therapeutic connection between the polymorphisms examined and the outcome of the therapy.
Keywords: Tamoxifen, breast cancer, CY2D6*4, CYP2D6*9, CYP2D6*10
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