NE Oncology Issue – June 2007

Catherine Allison

According to oncology pharmacist Sean Hopkins, the Ottawa Regional Cancer Centre (ORCC) has a one-of-akind anemia monitoring program that is the envy of many oncology clinicians in Canada. The backbone of the program is an electronic tool that enables a team of pharmacists, nurses, and physicians to closely monitor their patients’ responses to erythropoiesis-stimulating agents (ESAs).

Hopkins was instrumental in designing and implementing an electronic tool at the ORCC, and he is now developing a device for commercial distribution.

The electronic tool facilitates regular scrutiny of hemoglobin levels and allows clinicians to see at a glance if the hemoglobin is drifting too high or too low.

The device will consist of a hardware unit that can be plugged in to any hospital computer network and a software program (database) that tracks patients who have been flagged as receiving ESA therapy with either epoetin alfa or darbepoetin alfa. Clinicians can access the database from any hospital computer or Personal Digital Assistant (PDA), through an Internet browser. The system provides up-to-date information for each patient, including current drug dosage, blood transfusion history, blood work results, and other relevant information.

Though simple in design, the system fills a gap in patient care that Hopkins identified at the ORCC four years ago, when the number of oncology outpatients being treated with ESAs rose sharply. More and more patients were receiving the drugs for chemotherapy-related anemia due to a change in the Ontario Drug Benefit Program coverage policy, which streamlined access to the expensive agents under the Individual Clinical Review (Section 8) program. The cost of one month of ESA therapy ranges from $1,600 to $2,700 per person, depending on the drug and dosage.1

“It used to be such a huge fight to get someone on ESA therapy,” says Hopkins. “After they were approved, we tended to monitor patients very closely for hemoglobin, iron levels, blood pressure, etc. That was feasible when we didn’t have a large number of patients to follow.”

Clinical trials have demonstrated that ESA therapy reduces the need for blood transfusions and improves quality of life for patients with chemotherapy-induced anemia.* However, for patients receiving ESAs, hemoglobin levels greater than 120 g/L have been associated with an increased risk of thrombotic vascular events, including death. Health Canada issued an advisory on April 16, 2007, stating that the ESA dose must be adjusted to gradually increase hemoglobin to the lowest level sufficient to avoid blood transfusions, without exceeding 120 g/L.2 Furthermore, ESAs are no longer authorized to treat anemia in patients with cancer who are not being treated with radiation or chemotherapy, because studies have reported a higher risk of death in this group.

Hopkins says that before the ORCC electronic anemia monitoring system was introduced in September 2004, the biggest challenge that clinicians faced was having access to relevant information at the same time that new blood work results were coming in from dozens of external labs where outpatients went for testing. The system meets this challenge by bringing all pertinent data into one centralized location, and allowing information to be readily updated and shared with authorized users around the clock.

Dr. Glen Goss, Head of Systemic Therapy at the ORCC and Division Head of Medical Oncology at the University of Ottawa, confirms that the system has ensured continuous, high-quality monitoring and follow-up of patients on ESA therapy. The electronic tool facilitates regular scrutiny of hemoglobin levels and allows clinicians to see at a glance if the hemoglobin is drifting too high or too low, Goss explains. “Prior to the program, we didn’t have a systematic way of doing this.” In light of the Health Canada recent advisory, Goss acknowledges that close attention to hemoglobin levels is crucial to prevent inappropriate use of ESAs. “We need to monitor patients more effectively and this program is certainly a good way to do that.”

Pascale Plastre, a primary designated nurse for more than 300 patients at the ORCC, says that the tool not only improves the efficiency of her work, it helps prevent patients from falling through the cracks. “I rely on the system to help me keep track of my patients,” says Plastre. “Flipping through the chart for blood work results can be so time-consuming. With the monitoring system, you just click on a button and you can see each patient’s hemoglobin trend. If their hemoglobin is dropping too low, we can respond to that and get them on ESA therapy before they become fatigued.”

The numbers of patients receiving ESA therapy in Ontario could potentially rise. The Ontario Drug Benefit Program no longer requires a case-by-case review of each patient’s eligibility for epoetin alfa or darbepoetin alfa coverage under the Individual Clinical Review (Section 8) program. Since December 2006, both drugs are now included in the general list of covered drugs.3 A strong advocate for shared information, Hopkins has promoted the ORCC’s anemia monitoring program at the National Oncology Pharmacy Symposium (NOPS) and at the Canadian Society of Hospital Pharmacists’ (CSHP) Annual Conference. He has also delivered numerous web conferences and in-service presentations to oncology clinicians in Newfoundland, Calgary, Vancouver, Hamilton, Toronto, Cambridge, and London. Hopkins says that clinicians who learn about the ORCC anemia monitoring program are keen to emulate the model, but technology barriers have prevented them from implementing similar programs.

This provided the impetus for Hopkins to develop a commercial application of the system. With a pilot program set to begin in June 2007, Hopkins says he plans to begin marketing the device toward the end of 2007. “Any centre that deals with oncology patients is a potential market,” says Hopkins. If the device is successful in Canada, Hopkins is already eyeing potential markets in the U.S. and Europe.

The first phase of the commercial development involves setting up a database and web server that can be integrated into any hospital computer network with minimal configuration by an information technology specialist. For the second phase of development, Hopkins plans to introduce an HL7 interface, which is the standard information interface used by health care information systems. With an HL7 interface added to the device, rather than requiring manual input of lab results, the database will automatically receive incoming blood work as it is reported by the labs.

Although a retail price for the device has not yet been established, Hopkins says that some pharmaceutical industry representatives are watching his technology development with keen interest, and could potentially provide some hospitals with educational grants to help purchase the device and cover training costs.

While Hopkins is presently focusing his attention on an ESA monitoring program, his entrepreneurial eye envisions other potential software applications for the device. “This could easily be translated to a thrombosis program to monitor INRs for patients taking warfarin, or monitoring neutrophil levels in patients receiving G-CSF,” he says. “The same concepts are there. If you have an enabler to help you share information in a more efficient and effective way with the people that need to have the information, you can improve patient care.”

* 2007 NCCN’s Clinical practice Guidelines for Cancer- and Treatment-Related Anemia v.3.
References: 1. Ontario Drug Benefit Formulary/Comparative Drug Index. 2007. http://216.176.50.202/formulary/SearchServlet?searchType=noteQuery &phrase=exact&keywords=02206072. 2. Important Safety Information and New Prescribing Information for the Erythropoiesis-Stimulating Agents (ESAs): Aranesp® (darbepoetin alfa) and EPREX® (epoetin alfa) Health Canada. April 16, 2007. http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/ aranesp_eprex_hpc-cps_e.html. 3. McGuinty Government Improves Access to Drugs. News Release. Dec. 20, 2006. http://www.health.gov.on.ca/english/media/news_releases/archives/nr_06/dec/nr_122006_2.html.

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Contributors

dr-hirsh
Vera Hirsh, MD, FRCPC
Chief of the Hematology-Oncology Service, Santa Cabrini Hospital
Associate Professor, Medicine and Oncology, McGill University
Associate Physician, Oncology Service, at the Royal Victoria, Montreal General, and Montreal Chest Hospitals
With a current practice in both hematology and oncology, Dr. Vera Hirsh is an associate professor of medicine and oncology at McGill University. Her research at the Quebec Pulmonary Unit focuses on the treatment of lung cancer, and she continues to chair ongoing international chemotherapy trials. Dr. Hirsh chaired the Quebec Lung Cancer Committee to establish guidelines for the treatment of lung cancer. In addition, she has published abstracts, articles, and book chapters. Dr. Hirsh is a member of advisory boards for many pharmaceutical companies and the Medical Oncology Standing Committee of RTOG.

dr-cripps
Christine Cripps, MD, FRCPC
Medical Oncologist, Director,
Continuing Medical Education,
Ottawa Hospital Regional Cancer Centre
Dr. Christine Cripps is a medical oncologist and director of the Continuing Medical Education Department at the Ottawa Hospital Regional Cancer Centre. She also holds a position of Associate Professor, Medicine at the University of Ottawa. A keen teacher, Dr. Cripps’ main areas of interest include gastrointestinal cancer and head and neck cancer. She also enjoys cycling, skiing, and sailing when time permits.

dr-chia
Stephen K. L. Chia, MD, FRCPC
Assistant Professor of Medicine Department of Medicine
University of British Columbia
British Columbia Cancer Agency
Dr. Chia is a staff oncologist with the British Columbia Cancer Agency (BCCA), Vancouver, Canada. He also serves as physician coordinator for both the breast cancer and head and neck cancer clinical trials at the BCCA – Vancouver Cancer Centre. He is an active researcher in phase I-III trials in breast cancer, head and neck cancer and investigational new drugs. He is currently carrying out studies in breast cancer with grant funded research from the National Cancer Institute of Canada, Canadian Breast Cancer Alliance and Canadian Breast Cancer Foundation – British Columbia/Yukon Chapter. Dr. Chia is an active member of the British Columbia Breast Tumor Group, Breast Cancer Systemic Policy Group and Head and Neck Tumor Group.

dr-chang
José Chang, MD, FRCPC
Head of Medical Oncology, RS
McLaughlin Durham Regional Cancer Centre, Oshawa
Dr. José Chang is the principal investigator and site representative for the National Cancer Institute of Canada Clinical Trials Group, and is an examiner for the Medical Council of Canada. His research interests lie in the areas of breast cancer, melanoma, lymphoma, and quality of life during chemotherapy. Dr Chang has presented at major oncology meetings of the American Society of Clinical Oncology, San Antonio Breast Cancer Symposia, and European Breast Cancer Conference. A member of the editorial board of the journal Current Oncology, Dr. Chang has published in journals such as the Journal of Clinical Oncology, European Journal of Cancer, and Canadian Medical Association Journal.