The Canadian Association of Pharmacy in Oncology NEWSLETTER SUMMER 2009 Association Canadienne de Pharmacie en Oncologie President’s Message As we all enter into our summers, I’d like to acknowledge all the great work you all do for cancer patients across this great country. I had the opportunity to attend the 7th National Summit on Community Cancer Care which was held here in Prince George, BC. We hosted approximately 400 attendees and discussed innovative strategies for delivery of care. Focuses included utilization of telehealth, human resource challenges, prevention and building healthier communities. As I attended the sessions, I was reminded of the many ways pharmacists and technicians have been instrumental in improving access to services and care. One stream of the conference focused on education needs and programs. Very soon, you will receive a survey from CAPhO which will attempt to capture the education needs of the pharmacists across the country. Participation from members as well as nonmembers will be crucial in giving us the information we need to move forward with education initiatives. Please complete the survey and please forward the survey to anyone you think should complete it. As an incentive, we are offering a random draw for prizes. Most of all, I hope the incentive will be that CAPhO will be able to create education programs that meet the needs of our members. I’d like to recognize the hard work of members, Kimberly Stefaniuk, Larry Broadfield and Jeff Barnett for their work in laying the groundwork for the survey. I’d also like to thank Rhonda Kalyn, our education chair, for her work on this project. I’d like to recognize the hard work of our membership committee. They have been working to develop an information pamphlet to be used for recruitment. We are also working towards development of display materials that could be used for conferences and other events to advertise our association. Thank you to all who submitted requests and ideas for locations for NOPS 2011. We are still discussing possible sites, so additional suggestions are welcome; just send me an email: [email protected] . 1 I wish everyone a very warm and relaxing summer. Remember to mark your calendars for NOPS 2009 in Ottawa: October 23-25, 2009! Warm regards, Dana Cole CAPhO President Oncology Pharmacy Education Needs Survey Update Rhonda Kalyn Education Chair After a short delay, the Oncology Pharmacy Educational Needs Survey is complete. It is currently being tested on Survey Monkey, and will be ready for dissemination at the beginning of July. To allow for summer vacations, the survey will be available until the end of August. To thank you for your patience and the time you spend doing the survey, we are now offering two prizes in the prize raffle: • One iPod • One complimentary registration for the National Oncology Pharmacy Symposium (NOPS), which is being held in Ottawa, October 23-25, 2009. CAPhO values your input. We will use it to determine if a Cancer Oncology Pharmacy Education (COPE) program is needed in Canada, and what format it should take. NOPS 2009 October 23-25, 2009 Fairmount Château Laurier Ottawa, Ontario Hélène Bourget-Letarte NOPS 2009 Co-Chair Although summer has just officially started and all of us are busy with planning vacation time, the National Oncology Pharmacy Symposium (NOPS) is just around the corner! NOPS 2009 will be held in Ottawa October 23-25 at the Fairmount Château Laurier. If you are interested in learning, discussing, sharing and networking with other pharmacy colleagues practicing in oncology, NOPS offers it all. The planning committee is busy with finalizing the program and planning the social event on Saturday evening. Safety in oncology, both from patient and health care provider perspective, is the driving theme of this year’s conference. Medication reconciliation, drug interactions in oncology pharmacy and repetitive strain injuries are some of the topics that will be covered during the symposium. Breakout sessions divided into clinical, technical and administrative themes were much appreciated last year and will have them once again this year. The full program will be posted on the CAPhO website very shortly. The poster display was a huge success at NOPS 2009 and CAPhO invites you to begin preparing your posters now for submission starting at the beginning of July. The famous Canadian Museum of Civilization is the venue for the NOPS social on Saturday night. Surround yourself with the world’s largest indoor collection of totem poles, journey through 1,000 years of Canadian history and culture, and have good time with friends and colleagues from across the country. Stay tuned for entertainment details! 2 Wishing all of you a wonderful summer and looking forward to see you at NOPS 2009 in Ottawa. NCIC Spring Meeting Summaries of CAPhO Grant Winners Vicky Infantino Clinical Trial Pharmacy Technician Juravinski Cancer Centre Hamilton, Ontario This year I was fortunate enough to be one of the successful grant applicants supported by CAPhO to attend my first NCIC Spring 2009 meeting. As a Clinical Trial Pharmacy Technician my goal was to have the opportunity to network with other colleagues to share ideas about the challenges we are encountering with the more complex Clinical Trials that are up and coming. I also wanted to gain a better understanding of the roles and responsibilities of a Clinical Research Associate (CRA). On my first day I attended the Clinical Research Associate orientation and had the opportunity to be introduced to the Trial team at NCIC CTG. I was given an overview of the internal organization at the NCIC CTG, trial team structures and supports as well as the trial team core activities. This orientation also provided a better understanding of the funding process involved in Clinical Trials. That day I also attended a CRA workshop on Electronic Data Entry. We were presented with the abilities of EDC including the ability to provide built-in audit trails therefore reducing all printing, mailing and faxing when preparing for an audit. The next day I attended a Pharmacy Network meeting. I found it very interesting to listen in on the day to day obstacles the Pharmacists are challenged with in Clinical Trials. There was a lengthy discussion regarding the relabelling of Lot numbers and expiry dates on Clinical trial drugs upon arrival to each site as opposed to the time of dispensing. I then attended a GI disease site meeting where seeds were planted for new Clinical Trials. I found it very interesting to hear about a Clinical Trial in its very early planning stage. I had the pleasure of attending the Cosbie Lecture in which Dr. Frances A. Shepherd spoke about Lung disease. I had the privilege to witness this amazing lady be recognized for her many contributions to the field of lung cancer research. To summarize, these positive experiences have helped me become a more informed team member of our Clinical Trial team. In closing I would like to thank the members of CAPhO for their generous contribution that allowed me to attend the NCIC Spring 2009 meeting. Rongrong Karim Clinical Trials Pharmacist BCCA-Vancouver Centre NCIC CTG Pharmacists Network Open Session • Drug Labeling: NCIC CTG cannot assume the label is compliant on site. Some problems with Drug Labelling: o Supplementary labels should NOT only be affixed at the time of dispensing. It should be affixed at time of receiving o Supplementary labels should be in both inner and outside containers. Questions arose regarding container size for supplementary label and what to do with blister pack. NCIC CTG will double check and get back to us o Question regarding what to do with sealed box, i.e., potential for mistake if open sealed box for labeling purpose. • Biologics lot release program effective Jan 09. Canada has more strict guidelines regarding regulating biologics compare to U.S. More tests have to be done to 3 get the biologics lot approved in Canada. PMB will not segregate lot for a study. One lot might be used for multiple studies. When receiving biologics for NCIC CTG study, it is IMPORTANT to check if the lot is approved on NCIC CTG website. If received a lot that is not approved on website, call NCIC CTG Ethics and Regulatory (Alina Sutton). It might be one of the following two situations: o Paper work is in progress or o Process for paper work has not started yet o Bottom line: only use lots that have been approved on NCIC CTG website NCIC Clinical Trials Group Disease Site Committee Meeting • Economics are affecting trial opening. If a trial has very slow accrual, NCIC CTG is quick at cancel the trial. The investigator is asking the audience to have more centres activated for trials so the accrual process can be accelerated Genito-Urinary Trials • PRP.1: Soy protein, Vitamin E, selenium vs. Placebo in high grade prostatic intraepithelial neoplasia. Soy supplement, Vitamin E and selenium does not delay the time to progression. • REC2 trial: Adjuvant sorafenib or sunitinib for unfavourable renal cancer. Toxicity high in first cycle. New major amendment coming to start at lower dose (dose level -1) • IND165: This is a phase 2 study. It showed more fever, rigor and chills with OGX-011. PSA progression is significantly less in combination arm (OGX-011 and docetaxel). A new phase 3 trial is being planned for overall survival. • IND195: new trial coming up. SB939 is an oral histone deacetylase (HDAC) inhibitor. Circulating tumor cell (CTC) will be done for this trial. Breast Trials • MA32. Use metformin 1700 mg po versus placebo as adjunct for early adjuvant Breast Cancer Patient (within 4 years). It has been show insulin might affect cancer prognosis in the first 5 years. Therefore, the study duration is for 5 years. Metformin can reduce insulin usage by 25 to 33% within the first few days. It has potential for cancer treatment in two ways; 1. thru liver to reduce insulin; 2. act in tumor cells via the mTOR pathway. Sample size is 3582. It might be OK to be on this trial if patients are on other clinical trials. • MA27: exemestane versus anastrozole to test two issues. Potency with all the aromatase inhibitors and if there is a difference between steroid AI and non-steroid AI. Futility analysis will be done for this study. A futility analysis is a calculation made during the course of a trial of the probability that the trial will produce helpful results. A trial is judged futile if the probability is too small. • Correlative studies: biomarker may help us better understand how individual cancer might respond to treatment. • Circulating tumour cells: This is not a new concept. It was discovered 100 years ago, but poorly understood. There are questions regarding if CTC has metastatic potential, i.e., breast cancer CTC can circulate for years. There is also evidence that CTC might have prognostic significance. Currently, only one FDA approved system, cell search system, to measure CTC. Dr. Chi in our center had purchased one. However, the test is not as sensitive as some of the other tests. Kathy Lebreux Pharmacy Research Technician The Ottawa Hospital Cancer Centre My position at The Ottawa Hospital Cancer Centre(TOHCC), one of 3 Pharmacy Research Technicians, is an important part of the Clinical Trial team. Attending the NCIC meeting for the 1st time provided me with a more complete picture of the Clinical Trial process and specifically how NCIC trials operate. I attended a variety of disease site meetings and lectures over the 3 days. I found the CTG Pharmacists Network meeting very interesting and I was able to take part in a conversation 4 regarding drug receipt and Lot# procedures. I learned a few helpful tools in the Stress and Time Management workshop which I brought back to work with me and shared with my colleagues. A highlight of my weekend was listening to Dr. Frances Shepherd’s excellent Crosbie Lecture on “Lung Cancer: A Journey from Nihilism to Hope Through Bench to Bedside Research.” Through networking at this meeting and previous Investigator meetings that I have attended, I have come to realize that the role of Pharmacy Research Technicians working in Clinical Trials at TOHCC has been expanded to a wide scope of practice. In the future I would be very interested in becoming a member of the Pharmacist Network Group if there would be an opening for a Pharmacy Research Technician within the group. I would be happy to share any information about the role of Pharmacy Research Technicians at our centre if any other cancer centres are considering expanding the duties of their Pharmacy Technicians. I would like to thank the CAPhO executives and awards chair for selecting my application for the sponsored Travel Grant. I thoroughly enjoyed the Spring NCIC meeting and hope to be able to attend future NCIC meetings as well.