The reader's ability to judge the validity of pharmacokinetic research can be greatly compromised by the incomplete reporting of study information. Using consensus methods, we have developed a tool to guide transparent and accurate reporting of clinical pharmacokinetic studies. Endorsement and implementation of these guidelines by researchers, clinicians and journals would promote more consistent reporting of these studies and allow for better assessment of utility for clinical applications.

The PI3K/Akt/mTOR (phosphatidylinositol 3 kinase/ Akt/mammalian target of rapamycin) signalling pathway is an established driver of oncogenic activity in human malignancies. Therapeutic targeting of this pathway holds significant promise as a treatment strategy. Everolimus, an mtor inhibitor, is the first of this class of agents approved for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. Everolimus has been associated with significant improvements in progression-free survival; however, it is also associated with increased toxicity related to its specific mechanism of action. Methods: A comprehensive review of the literature conducted using a focused medline search was combined with a search of current trials at http://ClinicalTrials.gov/. Summary tables of the toxicities of the various classes of PI3K/Akt/mTOR inhibitors were created. A broad group of Canadian health care professionals was assembled to review the data and to produce expert opinion and summary recommendations for possible best practices in managing the adverse events associated with these pathway inhibitors. Results: Differing toxicities are associated with the various classes of PI3K/Akt/mTOR pathway inhibitors. The most common unique adverse events observed in everolimus clinical trials in breast cancer include stomatitis (all grades: approximately 60%), noninfectious pneumonitis (15%), rash (40%), hyperglycemia (15%), and immunosuppression (40%). To minimize grades 3 and 4 toxicities and to attempt to attain optimal outcomes, effective management of those adverse events is critical. Management should be interdisciplinary and should use approaches that include education, early recognition, active intervention, and potentially prophylactic strategies. Discussion: Everolimus likely represents the first of many complex oral targeted therapies for the treatment of breast cancer. Using this agent as a template, it is essential to establish best practices involving and integrating multiple disciplines for the management of future PI3K/Akt/mTOR signalling pathway inhibitors.

The primary goal of seamless care is improved patient outcomes and improved standards of care for patients with cancer. The pharmacy service of the Newfoundland Cancer Treatment and Research Foundation conducted a randomized control study that measured clinical and humanistic outcomes of a pharmacist-directed seamless care program in an ambulatory oncology clinic. This article focuses on the intervention group, particularly the identification of drug-related problems (DRPs) and utilization of health care services as well the satisfaction of 3 types of health professionals with the services provided by the pharmacist-directed seamless care program. Overall, the seamless care pharmacist (SCP) identified an average of 3.7 DRPs per intervention patient; the most common DRP reported was a patient not receiving or taking a drug therapy for which there is an indication. The SCP identified more DRPs in patients receiving adjuvant treatment compared to those receiving palliative treatment. On average, family physicians, oncology nurses, and hospital pharmacists were satisfied with the SCP intervention indicating that they agreed the information collected and distributed by the SCP was useful to them. Pharmacist-directed seamless care services in an ambulatory oncology clinic have a significant impact on clinical outcomes and processes of patient care. The presence of a SCP can help identify and resolve DRPs experienced by patients in an outpatient oncology clinic, ensuring that patients are receiving the highest standard of care.

A substantial portion of community pharmacists in Canada lack a solid understanding of oral anticancer agents and thus are poorly equipped to play a major role in ensuring their appropriate use. More education and training on oral anticancer agents are urgently required.

Background: Over the past decade, there has been a sharp rise in the approval of orally administered anti-cancer agents for disease control. The increase in the use of oral anti-cancer agents (OAAs) raises concerns that community pharmacists may not have the training to safely dispense these agents and provide effective patient care. In order to identify the needs of community pharmacists with respect to oral anti-cancer therapy, a survey was conducted in the province of Newfoundland and Labrador. Methods: A structured electronic mailing strategy was used. Standardized data collection forms with a cover letter were electronically mailed to 560 practising pharmacists. Survey items included questions related to demographic information, practice setting, current knowledge related to cancer therapy, education needs, access to resources, patient education, patient and pharmacist safety and required elements of an OAA prescription. Results: The response rate was 39%. Only 9.6% of respondents felt that they had received adequate oncology education at the undergraduate level and approximately 31% had attended a continuing education event related to oncology in the past 2 years. Just 17% of respondents stated that they used protective equipment when dispensing OAAs. Only 28% of the pharmacists who responded were familiar with the common doses of OAAs and approximately 25% felt comfortable educating patients on these medications. Conclusions: A substantial portion of community pharmacists in Newfoundland and Labrador do not have a solid understanding of oral anti-cancer therapy. These educational gaps must be addressed to ensure patient safety as well as the safe handling and dispensing of OAAs by community pharmacists.