Prospective Assessment of Glucocorticoid Toxicity in Rheumatology Practice: A Focus on the Glucocorticoid Toxicity Index.

OBJECTIVE: The glucocorticoid toxicity index (GTI) is developed to measure glucocorticoid (GC)-related morbidity over time. This study aimed to assess GC-toxicity in patients at a rheumatology outpatient clinic by using the GTI and to identify the factors that interfere with the GTI. METHODS: This prospective study included patients with inflammatory arthritis (IA), connective tissue disease, and vasculitis who were newly prescribed GC-treatment (GC-naive) or have been still on GC-treatment for ≤2 years (GC-experienced). Patient demographics and disease characteristics, aggregate improvement score (GTI-AIS), cumulative worsening score (GTI-CWS), and cumulative GC-doses were recorded at baseline, 3rd month, and 6th month. Generalized estimating equations (GEE) were used to evaluate the GTI scores and associated factors including cumulative GC-doses. RESULTS: The study included 156 (48.7% GC-naive) patients with a mean age of 49.1 ± 17.1 years. More than half of the patients in both groups had a diagnosis of vasculitis. A higher cumulative GC-dose was found to be associated with higher GTI-scores in both groups (p< 0.001). In the GC-naive group, patients with vasculitis showed higher GTI-scores than IA patients (p< 0.001); there was also a significant increase in the GTI-CWS at the 6th month compared with the 3rd month. In the GC-experienced group, GTI-AIS and GTI-CWS were significantly different at 3rd and 6th month (p< 0.05). CONCLUSION: It was shown that GTI scores were associated with cumulative GC-doses and vasculitis patients in the GC-naive patients had higher GTI scores than inflammatory arthritis. The GTI allows individualized assessment and management of adverse effects experienced by patients as a result of GC treatment.

Rituximab-induced leukocytoclastic vasculitis in a patient with low-grade orbital B-cell lymphoma: a case report.

Rituximab is an anti-CD20 chimeric murine/human mAb mainly used to treat certain types of lymphoproliferative malignancies and autoimmune diseases. Although it has been used in the treatment of vasculitis in recent years, it rarely triggers severe vascular skin reactions such as leukocytoclastic vasculitis (LCV). Physicians should be aware of this rare adverse event that requires discontinuation of rituximab, which can occur days or even weeks after rituximab treatment. Here, we report a case of LCV observed in a patient with low-grade orbital B-cell lymphoma treated with weekly rituximab and local radiotherapy. In our case, discontinuation of rituximab and initiation of oral methylprednisolone therapy were sufficient to achieve complete resolution of the LCV.

Impact of pharmacist-led educational intervention on pneumococcal vaccination rates in cancer patients: a randomized controlled study.

PURPOSE: This study aimed to evaluate clinical pharmacist's contribution to the pneumococcal vaccination rate by providing education to cancer patients in hospital settings. METHODS: This study was conducted in 2 tertiary-care hospitals' medical oncology outpatient clinics. Patients over 18 years of age and diagnosed with cancer for less than 2 years, in remission stage, and have not previously received the pneumococcal vaccine were included. Patients were randomized to intervention and control groups. The intervention group was provided vaccination education and recommended to receive the PCV13 vaccine. The control group received routine care. Patients' knowledge about pneumonia/pneumococcal vaccine, Vaccine Attitude Examination Scale (VAX) score, and vaccination rates were evaluated at baseline and 3 months after the education. RESULTS: A total of 235 patients (intervention: 117, control: 118) were included. The mean age ± SD was 57.86 ± 11.88 years in the control and 60.68 ± 11.18 years in the intervention groups. The numbers of correct answers about pneumonia/pneumococcal vaccine (p = 0.482) and VAX scores (p = 0.244) of the groups were similar at baseline. After the intervention, the median (IQR) number of correct answers in intervention group [10(3)] was higher than control group [8(4)] (p < 0.001). After the education, the total VAX score (mean ± SD) was less in intervention group (33.09 ± 7.018) than the control group (36.07 ± 6.548) (p = 0.007). Three months after the education, 20.2% of the patients in the intervention and 6.1% in the control groups were vaccinated with pneumococcal vaccine (p = 0.003). CONCLUSIONS: The pneumococcal vaccination rate in cancer patients has increased significantly by the education provided by a clinical pharmacist in hospital settings.

Oncologists' attitudes towards prophylaxis of cancer associated venous thromboembolism: A prospective, descriptive study.

INTRODUCTION: Cancer-associated venous thromboembolism creates a big burden on both patients and healthcare systems. Clinical guidelines have a consensus on the initiation of prophylactic treatment for hospitalised patients, however a debate still exists for ambulatory cancer patients. Therefore, this study aimed to identify attitudes and practices of medical oncologists on cancer-associated venous thromboembolism management. METHODS: An online survey consisting of 22 questions was developed by researchers in the view of previous studies and delivered to 100 medical oncologists registered to the national society of medical oncology by e-mail between September and October 2018. Descriptive and statistical analyses were performed using Statistical Package for Social Science (SPSS) version 23.0 (ICM Corp. Released 2015. IBM SPSS Statistics for Windows, Version 23.0. Armonk, NY: IBM Corp). RESULTS: A total of 62 medical oncologists (75.8% male) responded to the survey (response rate of 62%). The most critical three risk factors considered for initiating prophylaxis were prior venous thromboembolism history, immobilisation and tumour/cancer type for inpatients and outpatients (χ2 test, p < 0.001). The first choice of drug for prophylaxis was mostly low molecular weight heparins (n = 60, 96.8%). In the absence of contraindications, physicians initiate prophylaxis 'usually' for inpatients (n = 25, 40.3%) and outpatients (n = 5, 8.1%). However routine use of the Khorana score is not incorporated into the risk assessment process of cancer patients. CONCLUSION: Attitudes of oncologists towards thromboprophylaxis in cancer patients are consistent with previous studies in the literature. The respondents are aware of the venous thromboembolism risk of cancer patients, however raising awareness on both cancer-associated venous thromboembolism and current guideline recommendations is needed.

Implementation of Pharmacist-Driven Antifungal Stewardship Program in a Tertiary Care Hospital.

Antifungal stewardship (AFS) is recommended to reduce the inappropriate use of antifungal drugs. In this study, the role of AFS in providing appropriate antifungal therapy was evaluated. This study included three periods, consisting of observation, feedback/education, and daily AFS activities. In the observation period, the use of systemic antifungals was evaluated for a baseline measurement of appropriateness. In the second period, monthly meetings were organized to provide feedback and education to physicians regarding antifungal therapy and the rate of adherence to the clinical guidelines. In the final period, a clinical pharmacist participated in daily ward rounds to evaluate the appropriateness of the antifungal therapy. A scoring system for appropriateness was used for comparison between the three periods. Four hundred eighteen episodes of antifungal therapy were evaluated. Baseline demographics of patients were similar in all three periods for age, gender, and the number of comorbidities. The indications for antifungal use were for prophylaxis in 22.7%, Candida infections in 58.6%, and invasive mold infections in 18.7%. During the third period, 157 (78.9%) recommendations were made and 151 (96.2%) were accepted. The overall appropriateness of antifungal use increased significantly for prophylaxis (30.8%, 17.9%, and 46.3%; P = 0.046) and treatment of fungal diseases (27.8%, 32.4%, and 71.9%; P < 0.001) between the first, second, and third periods, respectively. The 30-day mortality was not significantly changed between the three periods (19%, 15.6%, and 27.5%; P = 0.050). Appropriateness in antifungal therapy can be augmented by the integration of an AFS program. A team-based evaluation of fungal infections and assessment of patients by a clinical pharmacist with a therapeutic perspective may help to increase the quality of antifungal therapy.

Assessment of adherence to cancer-associated venous thromboembolism guideline and pharmacist's impact on anticoagulant therapy.

PURPOSE: Cancer-associated venous thromboembolism (VTE) can cause many unfavorable health outcomes. Many institutions have published guidelines, but implementation of these guidelines in cancer clinics is still under investigation. This study aimed to evaluate the guideline adherence and identify potential gaps between the recommendations and their implications in clinics. METHODS: A prospective study was conducted between September and December 2018 at oncology inpatient and ambulatory settings. The guideline adherence rate was assessed for inpatients during hospital stay by using 8 criteria developed based on the National Comprehensive Cancer Network (NCCN) Guideline on Cancer Associated Venous Thromboembolic Disease Version 1.2018. Guideline-based recommendations were proposed to the consultant physician in case of non-adherence. Khorana risk scores were calculated for each patient at outpatient clinics. In cases where the score was found to be ≥ 3, the consultant physician was informed. RESULTS: A total of 100 inpatients and 200 ambulatory patients were included in the study. The guideline adherence rates ranged between 59 and 100% for 5 out of 8 pre-defined criteria, whereas the rate for others remained at 0-1%. A significant increase was observed in the adherence rates for initiation of prophylaxis at admission and determination of correct dose of an anticoagulant after recommendations being implemented (p < 0.001, McNemar test). Eleven patients were identified as at high-risk of VTE at ambulatory setting; however, an initiation of an anticoagulant was not considered by the consultant physicians. CONCLUSION: There are potential problems in implementation of guideline recommendations, which leads to low adherence rate. Therefore, liason with pharmacists and consultants for individual risk assessment and monitoring of patients will help to increase guideline adherence rates.

International Society of Oncology Pharmacy Practitioners (ISOPP) position statement: Role of the oncology pharmacy team in cancer care.

The Oncology Pharmacy Team (OPT), consisting of specialty-trained pharmacists and/or pharmacy technicians, is an integral component of the multidisciplinary healthcare team (MHT) involved with all aspects of cancer patient care. The OPT fosters quality patient care, safety, and local regulatory compliance. The International Society of Oncology Pharmacy Practitioners (ISOPP) developed this position statement to provide guidance on five key areas: 1) oncology pharmacy practice as a pharmacy specialty; 2) contributions to patient care; 3) oncology pharmacy practice management; 4) education and training; and 5) contributions to oncology research and quality initiatives to involve the OPT. This position statement advocates that: 1) the OPT be fully incorporated into the MHT to optimize patient care; 2) educational and healthcare institutions develop programs to continually educate OPT members; and 3) regulatory authorities develop certification programs to recognize the unique contributions of the OPT in cancer patient care.

Risk assessment of febrile neutropenia and evaluation of G-CSF use in patients with cancer: a real-life study.

PURPOSE: The guidelines suggest using granulocyte-colony stimulating factor (G-CSF) for febrile neutropenia (FN) as prophylaxis in chemotherapy protocols with the risk of 10-20% after assessment of patient's risk factors. Therefore, the aim of this study is to assess the risk of FN by using the Patient Risk Score (PRS) and evaluating G-CSF use and its side effects by a clinical pharmacist at an outpatient clinic. METHODS: The study was conducted from May 2017 until November 2017 at the University Hospital oncology outpatient clinic. Patients who receive chemotherapy protocols with FN risk of 10-20% and > 20% and were initiated G-CSF were included. The patients' risk factors were assessed by the PRS, and the side effects were monitored for 3 months by a clinical pharmacist via a patient self-reported monitoring card. RESULTS: A total of 118 patients were included (286 interviews) in the study. There was a significant increase between the first and third visits on the PRS total scores of patients (p = 0.034). The patterns of G-CSF use showed that 34.7% undertreated, 22.8% overtreated, and 42.3% of patients were correctly treated for the prophylaxis. The severity of G-CSF-related musculoskeletal pain was increased on the second and third days of treatment. CONCLUSIONS: The use of G-CSFs for FN prophylaxis is recommended; however, there may be a group of patients who are inadequately or unnecessarily treated. Therefore, patients should be assessed for the risk of developing FN in each cycle of chemotherapy and a regular risk assessment by using the PRS can be implemented in the monitoring process.

Drug-related problems with targeted/immunotherapies at an oncology outpatient clinic.

BACKGROUND: Some studies in the literature describe drug-related problems in patients with cancer, although few studies focused on patients receiving targeted chemotherapy and/or immunotherapy. To identify the incidence of drug-related problems in patients receiving targeted chemotherapy and/or immunotherapy, and demonstrate the impact of a clinical pharmacist in an outpatient oncology care setting. METHODS: Prospective study was conducted in a hospital outpatient oncology clinic between October 2015 and March 2016. Patients greater than 18 years old receiving cetuximab, nivolumab, ipilimumab, or pembrolizumab were included in the study and monitored over a three-month period by a clinical pharmacist. Drug-related problems were analyzed using the Pharmaceutical Care Network Europe classification system. The main outcome measures were the frequency and causes of drug-related problems and the degree of resolution achieved through the involvement of a clinical pharmacist. RESULTS: A total of 54 patients (mean age: 57 ± 12 years) were included. There were 105 drug-related problems and 159 associated causes. Among the planned interventions (n = 149), 92 interventions were at the patient-level with 88 (96%) being accepted by the doctors. This resulted in 68 (65%) drug-related problems being completely resolved and 9 (8.6%) being partially resolved. The most common drug-related problem identified was "adverse drug event" (n = 38, 36%). Of the 105 drug-related problems, 63 (60%) related to targeted chemotherapy and/or immunotherapy with 34 (54%) classified as an "adverse drug event." CONCLUSION: Adverse drug events were the most common drug-related problems in patients with cancer. The involvement of a clinical pharmacist improved the identification of drug-related problems and helped optimize treatment outcomes in patients receiving targeted chemotherapy/immunotherapy.

An evaluation of chemotherapy drug preparation process in hospitals in Turkey - A pilot study.

OBJECTIVE: To identify the practice differences among chemotherapy units and the opinions of pharmacists on safety precautions for handling antineoplastic drugs in hospitals. METHOD: The survey was administered to hospital pharmacists in Turkey. The pharmacists who work in chemotherapeutic drug preparation units were asked to participate if they are volunteered. The participating pharmacists were asked questions about the type of chemotherapy units, order and verification process of chemotherapy protocols and potential shortcomings of chemotherapy preparation. The questions were initially assessed in a small sample of pharmacists and subsequently revised and refined. The filled and returned questionnaires were accepted as given consent. RESULTS: A total of 97 questionnaires were delivered and 40 (41%) were returned by pharmacists. The median age and practicing years in hospitals of the pharmacists were 38.0 and 6.25 years, respectively. Fully automated chemotherapy units were used by 42.5% of respondents, whereas 30% prepare chemotherapeutics manually; furthermore, 87.5% provide chemotherapeutic drug preparations (admixtures) less than 120 per day. With regard to the drug preparation process, more than half of the respondents 'always' use protective equipment without foot covers (32.3%). Almost 90% of respondents 'always' use a coat, mask and biological safety cabinets; however, 20% of respondents 'often' use closed-system drug transfer sets. More than 50% of pharmacists expressed that they have sufficient knowledge on cytotoxics and the risk of exposure, protective precautions, selection and usage of personal protective equipment and correct storage of cytotoxics. CONCLUSION: Pharmacists acknowledge sufficient understanding of safe preparation and handling of chemotherapeutics, but reported practices by pharmacists in hospitals are not consistent with published recommendations. Providing theoretical and practical educations for pharmacists and developing standard procedures for preparing chemotherapy may be beneficial in improving the preparation and use of antineoplastics in Turkey.