John Valgus

Knowledge, attitudes and education of pharmacists regarding pharmacogenetic testing

AIM Pharmacists are positioned to provide medication counseling and drug information to patients. This study assessed the knowledge, attitudes and education of over 700 pharmacists concerning pharmacogenetics and pharmacogenetic testing. METHODS A multiquestion, online survey was developed to assess healthcare provider knowledge, attitudes and education concerning pharmacogenetic testing. RESULTS More than 90% of pharmacists were interested in learning more about pharmacogenetics and testing, with those with less than 10 years of experience were more likely to want web-based continuing education programs. The pharmacists were unlikely to have had formalized education regarding pharmacogenetics, were very likely to rate their knowledge accurately, and were more likely to have a positive attitude about pharmacogenetics if they had received education regarding pharmacogenetics. CONCLUSION Most pharmacists were interested in learning more about pharmacogenetic testing.

Fondaparinux and the Management of Heparin-Induced Thrombocytopenia: The Journey Continues

Objective: To review the available literature addressing the role of fondaparinux in the management of heparin-induced thrombocytopenia (HIT). Data Sources: Primary articles were identified by a MEDLINE search (2004–June 2009) of English-language literature using the MeSH headings fondaparinux, heparin, low-molecular-weight heparin, and thrombocytopenia. Relevant consensus guidelines (2006–June 2009) were also identified. Study Selection and Data Extraction: All published studies and case reports, as well as relevant consensus guidelines, evaluating the use of fondaparinux for the management of HIT were included. Data Synthesis: The role of fondaparinux in the management of HIT is a therapeutic controversy challenging clinicians today. An open-label, prospective pilot study of 7 patients with acute HIT supports fondaparinux as an alternative anticoagulant. Additionally, a total of 12 patients with HIT from a larger case study and retrospective cohort were successfully treated with fondaparinux. Much of the supporting data exists in the form of case reports, each demonstrating normalization of platelet counts without any evidence of new thrombosis. The differences in clinical scenarios as well as the role and dose of fondaparinux make interpretation of these reports difficult. Three case reports have been published raising concerns regarding fondaparinux causing or failing to manage HIT appropriately. However, common weaknesses such as small sample sizes and nonuniform definitions of HIT limit the usefulness of these findings. The updated American College of Chest Physicians consensus guidelines now recognize fondaparinux as an option in the management of HIT; however, the level of evidence supporting this is of low quality. The use of fondaparinux as a bridging agent between direct thrombin inhibitor and warfarin therapy has been proposed. A recently published case report gives support to this approach. Conclusions: Controlled clinical trials evaluating the use of fondaparinux in the management of HIT need to be completed before this therapy can be routinely recommended.

Bevacizumab: A Treatment Option for Recurrent Glioblastoma Multiforme

Objective: To review the available literature evaluating the effect of bevacizumab on progression-free survival when used in combination with irinotecan for recurrent glioblastoma multiforme (GBM). Data Sources: Searches of MEDLINE (1966-June 2008), the Cochrane Library. and International Pharmaceutical Abstracts (1970-June 2008) were conducted using the terms bevacizumab. irinotecan, and glioblastoma multiforme. Study Selection And Data Extraction: The search was limited to studies conducted in humans. All articles identified trom the data sources were evaluated. All clinical trials evaluating the efficacy and safety of bevacizumab in the treatment of recurrent GBM were included in the review. Data Synthesis: Hypoxia, mutagenesis, and the secretion of various growth (actors can all lead to production of vascular endothelial growth factor (VEGF), a proangiogenic growth factor, and angiogenesis in GBM. Neoplastic progression is dependent on angiogenesis, and anti-VEGF therapy has been successful in multiple disease states. However, there are currently no available anti-VEGF therapies approved tor treatment of GBM. Bevacizumab is a humanized monoclonal antibody that binds to and inhibits the activity of VEGF. When compared with data from clinical trials that use single chemotherapeutic agents in recurrent GBM, the addition of bevacizumab to cytotoxic chemotherapy, such as irinotecan, appears to improve progression-Iree survival in patients progressing on the standard of care, with a 6-month progression-free survival rate of 46%. Bevacizumab is well tolerated by most patients, with modest risk (11% tn Phase 2 trials) of venous thromboembolism. Conclusions: Although the combination of bevacizumab and irinotecan is producing positive results in patients with recurrent GBM, larger, randomized clinical trials need to be performed to determine the magnitude of the benefit from bevacizumab. Bevacizumab administered biweekly at a dose of 10 mg/kg in combination with irinotecan may improve progression-free survival.

Integration of a clinical pharmacist into the hematology–oncology clinics at an academic medical center

PURPOSE The development, implementation, and early experience with a program providing clinical pharmacist services at the hematology-oncology clinics of a university teaching hospital are described. SUMMARY With funding from a university research grant and other sources, a pharmacist was hired to launch a new program addressing four goals identified in a needs assessment: (1) improved management of supportive care, (2) enhanced education of patients receiving complicated chemotherapy regimens, (3) improved efficiency in the chemotherapy infusion unit, and (4) development of an experiential learning opportunity for pharmacy students and residents. The pharmacist hired to lead the ongoing program was a state-approved clinical pharmacist practitioner (CPP) who had authority to prescribe with physician oversight under established protocols. EXPERIENCE An oncology supportive care consultation service implemented by the CPP in collaboration with a nurse and a physician served 89 new patients in its first 18 months of operation; during that period the CPP made 186 interventions and wrote 136 prescriptions. The CPP also established a chemotherapy counseling service that provided more than 900 bill-able patient education sessions over 18 months. In addition, the CPP launched an effort to increase use of a rituximab rapid-infusion protocol among eligible patients. The creation of the new oncology pharmacist position has given dozens of pharmacy students and residents a new opportunity for interaction with oncology clinic patients and other health care team members. CONCLUSION Integration of the services of a CPP into the hematology-oncology clinics has helped achieve goals set by physician, nursing, and pharmacy leaders.

Randomized double-blind study of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy

GoalsOur goal was to evaluate the efficacy and tolerability of the Reliefband as an adjunct to standard antiemetics in patients receiving moderately-high to highly emetogenic chemotherapy.Patients and methodsForty-nine adult cancer patients receiving moderately-high or highly emetogenic chemotherapy were randomized to receive either the active Reliefband (n=26) or an inactive device (n=23). Patients continued to receive all scheduled and as needed antiemetic agents as prescribed. The device was worn the day of chemotherapy administration for 5 days (days 1–5). Patients maintained a daily dairy of nausea severity, vomiting and retching episodes, and antiemetic medications taken. Each patient completed a Functional Living Index Emesis (FLIE) and a tolerability survey at the conclusion of the study. A Wilcoxon rank sum test was used to compare the number of vomiting episodes, severity of nausea and FLIE scores between the two groups.Main resultsPatients wearing the active Relifband experienced less vomiting (Reliefband 1.9 versus inactive device 4.6 mean episodes; p=0.05), retching (1.4 versus 3.6 mean episodes; p=0.05), and nausea severity (0.91 versus 1.65 mean cm/day; p=0.01) over the 5-day period compared to patients wearing the inactive device. Vomiting was statistically significantly reduced during the delayed period (0.42 versus 1; p=0.032), whereas nausea was significantly reduced during the acute (0.71 versus 2.3; p=0.028) and delayed (1.8 versus 3.3; p=0.020) periods. FLIE scores did not differ between the two treatment groups (91 versus 80; p=0.088).ConclusionsThis study suggests that patients receiving moderately-high to highly emetogenic chemotherapy who experience nausea and vomiting despite scheduled antiemetics may benefit from the use of the Reliefband as an adjunct to antiemetics. Limitations of this study include differences in risk factors for emesis, chemotherapy, and antiemetic regimens. A larger, better, controlled randomized study is needed to better define optimal use of this device.

A desensitization protocol for the mAb cetuximab.

could be somehow regarded as a disease-specific biomarker: this fact also suggests that HVA, which is a pure IgE-mediated disease, differs in its immunologic regulation from other types of allergic diseases. Daniele Saverino, BS Anna Maria Riccio, BS Anthi Rogkakou, MD Marcello Bagnasco, MD Patrizia Bonadonna, MD Rita Simone, BS Alessandra Chiappori, BS Cinzia Gamalero, BS Giovanni Passalacqua, MD Giorgio Walter Canonica, MD Giampaola Pesce, BS From the Human Anatomy Section, Department of Experimental Medicine, University of Genoa, Genoa, Italy; Allergy and Respiratory Diseases, Department of Internal Medicine, University of Genoa, Genoa, Italy; Medical and Radiomethabolic Therapy, University of Genoa, Genoa, Italy; Allergy Service, Verona General Hospital, Verona, Italy; and Internal Medicine, Department of Clinical and Experimental Medicine, University of Verona, Verona, Italy. E-mail: passalacqua@unige.it. Disclosure of potential conflict of interest: The authors have declared that they have no conflict of interest.

Pharmacist-Led, Interdisciplinary Model for Delivery of Supportive Care in the Ambulatory Cancer Clinic Setting

PURPOSE To describe a pharmacist-led, interdisciplinary method of care delivery begun at the University of North Carolina. We describe the characteristics of the population seen and the role of the individual members of the interdisciplinary team, and provide an early analysis of the programs impact on symptom improvement. METHODS A supportive care consultation service was begun at the University of North Carolina Hospitals to serve adult outpatients with cancer undergoing treatment or follow-up. Patients data were entered into an institutional review board-approved database to permit detailed assessments over time. Patient demographics were analyzed using descriptive statistics, medications used and changes made were noted, and symptom scores from a previously described instrument were captured and compared over time. RESULTS Patients were seen from all adult oncology services, including gynecologic, radiation, medical, and surgical. The characteristics of the population seen were similar to those of the hospital population as a whole. Most of the patients were seen for pain management, and many required a medication change. Symptom scores improved by the second visit, and the improvement was maintained. CONCLUSION We are able to demonstrate that the use of a pharmacist-led, interdisciplinary team produced an improvement in symptom scores comparable to what has been seen in the inpatient palliative care service within our institution. Projected shortages of oncology providers may be mitigated by pharmacists working in collaborative practices, with prescriptive authority, in the ambulatory oncology setting.

Converting to Transdermal Fentanyl: Avoidance of Underdosing

BACKGROUND Converting between the various opioid agents continues to be challenge for many practitioners. Specifically, variable recommendations for converting to the transdermal fentanyl patch may lead to confusion among clinicians and errors in dosing. OBJECTIVE Our aim was to describe the inconsistencies among available opioid conversions with regard to transdermal fentanyl and to provide recommendations for safe and effective utilization of this product in patients with chronic pain. RESULTS Available reports support the use of the morphine intravenous to oral ratio of 1:3 during the conversion to transdermal fentanyl product. CONCLUSIONS Underdosing is an often overlooked complication of switching to transdermal fentanyl. Current recommendations for converting to transdermal fentanyl do not reflect contemporary clinical practice and should be reevaluated.

Institutional Profile: UNC Institute for Pharmacogenomics and Individualized Therapy: interdisciplinary research for individual care

The Institute for Pharmacogenomics and Individualized Therapy (IPIT) at the University of North Carolina at Chapel Hill (NC, USA) is a collaborative, multidisciplinary unit that brings together faculty from different disciplines and crosses the traditional departmental/school structure to perform pharmacogenomics research. IPIT investigators work together towards the goal of developing therapies to enable the delivery of individualized medical care. The NIH-supported Comprehensive Research on Expressed Alleles in Therapeutic Evaluation (CREATE) group leads the field in the evaluation of pathways regulating drug activity, and also provides a foundation for future IPIT research. IPIT members perform bench research, clinical cohort analysis and prospective clinical intervention studies, research on the integration of pharmacogenomic therapy into practice and research to foster global health pharmacogenomics application through the Pharmacogenetics for Every Nation Initiative. IPIT Investigators are actively incorporating a pharmacogenomics curriculum into existing teaching programs at all levels.

Patient perspectives on the barriers associated with medication adherence to oral chemotherapy

Purpose Appropriate use of oral chemotherapy is a challenge for patients and clinicians. The purpose of this study was to analyze cancer patients’ use of oral chemotherapies and identify opportunities to improve adherence. Methods We developed a 30-question survey to address frequency and reasons for reducing/skipping doses; sources of information for oral chemotherapy use; perceived importance of food–drug effects; and ease of understanding labeling directions. Results Ninety-three patients taking oral chemotherapies with chronic myeloid leukemia, renal cell carcinoma, breast cancer, and colorectal cancer completed the survey. This was a well-educated population with 69% (n = 62) having completed some college; 51% (n = 47) female and 59% (n = 54) older than 50 years of age. Thirty percent of patients reported forgetting to take their oral chemotherapy at least “sometimes”. Younger patients (<50 vs. ≥50, p = 0.002), shorter treatment duration (<6 vs. ≥6 months p = 0.03), or with chronic myeloid leukemia (vs. other diagnoses, p = 0.015) forget to take their oral chemotherapy at higher rates. Twenty-three percent (n = 21) indicated they intentionally skipped their oral chemotherapies and 38% (n = 8) of those did not inform their physicians. Forty-one percent (n = 28) taking drugs with significant food–drug effects did not think about their last meal before taking their oral chemotherapy and 80% (n = 55) did not understand the potential interactions. Additionally, 39% (n = 36/92) never looked at labeling and 15% (n = 14/91) had difficulty understanding label directions. Conclusion There are three main barriers associated with appropriate use of oral chemotherapies: misunderstanding about the timing of drug with food; stopping drug without informing physicians; and difficulty understanding labeling directions. A multipronged approach is needed to optimize communication of directions for optimal oral chemotherapy use.