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Oral chemotherapy: a shifting paradigm affecting patient safety
The health care industry must make adjustments to accommodate this emerging chemotherapy modality.
Oral chemotherapy drug development has significantly increased during the past several years and is anticipated to continue to grow, with an estimated one quarter of the 400 antineoplastics in the pipeline planned as oral drugs. Cancer patients currently have increasingly diverse treatment options comprised of oral therapy, intravenous therapy or both. This new treatment paradigm is shifting treatment responsibility from the medical infusion facilities and physician’s offices into the patient’s home. Many institutions and prescribers are realizing our health care system is unprepared to handle the challenges associated with oral treatment regimens and incorporating these agents into regimens, both alone and with intravenous therapies poses numerous risks to the patients.
In 2005, Weingart et al surveyed 54 NCI-designated Cancer Centers regarding their safety practices for oral chemotherapy. As anticipated by the investigators, because oral chemotherapies are relatively new to oncology, the survey revealed variable prescribing practices and a lack of consensus within the health care system regarding standards for prescribing, dispensing, educating or assessing adherence, among other issues. Forty-two completed questionnaires were returned, reviewed and analyzed. The survey results are outlined in table 2.
Some results are encouraging and some problematic. For example, more than half of the surveyed centers documented that they were using handwritten prescriptions, and that the required elements on prescriptions varied, including diagnosis, protocol number (when appropriate), cycle number, double checking by a second health care team member, patient body surface area and dose per body surface area. Many other centers had no requirements. Clearly, there is room for improvement regarding how oral chemotherapy is prescribed, and the use of electronic systems (among other efforts) to facilitate safer practices in this area is paramount to improving the quality of care patients receive. Based on these survey results, care also was variable in the practice of informed consent, the method used to coordinate care with oral and IV chemotherapy, and whether (and how) adherence monitoring took place. Pharmacy involvement in educating patients also was variable and possibly related to whether patients declined the service at the dispensing pharmacy where they had their prescriptions filled and whether the communication between the dispensing pharmacy and the cancer center was adequate or of high quality. As a result of these variabilities, 10 centers reported that at least one serious adverse event related to oral chemotherapy had occurred in the prior year.
The National Comprehensive Cancer Network organized a multidisciplinary task force to look at various aspects of oral chemotherapy and what increased usage could mean for the patient and the physician or health care team. The task force was made up of oncologists, nurses, pharmacists and payer representatives. They published a very comprehensive review on the topic with suggested solutions, but ultimately realized that drug development is happening at a faster rate than our ability to put safe systems in place. Patients should continue to be selected for their ability to follow their dosing schedule and to be able to recognize when toxic side effects need direct medical attention.
Many patients have misconceptions regarding oral agents, including the concepts of increased convenience and improved tolerability. Convenience may actually be lost when there is a need for increased monitoring and complex dosing schedules. Secondly, perceived convenience of an oral regimen is lost if the treatment is given in combination with an IV agent or the oral regimen must be taken daily. Also, the perception of increased tolerability of an oral agent vs. the intravenous counterpart is often not an accurate one.
Currently, there are no data to guide best practices with oral chemotherapy. Many of these agents are just as toxic as IV chemotherapy agents and should be treated in a similar manner. Until specific practice guidelines are established for safe administration of oral chemotherapies, prescribing offices may need to implement varying strategies to prescribe and monitor oral chemotherapy safely (see table 3). Improving strategies to address diminishing adherence and the effect this may have on patient outcomes is also of utmost importance. Data in patients with chronic myelogenous leukemia and breast cancer indicate that even when facing a life-threatening disease, adherence falls short with chronic therapies and may contribute to disease progression or relapses. These “failures” may be inaccurately attributed to drug resistance if adherence is not questioned.
Obtaining oral chemotherapy drugs also can pose challenges for patients because of the high copays associated with many of these oral agents, and requirements by many insurance companies to use mail-order or specialty pharmacies. Fortunately, many Medicare Part D plans provide coverage for oral chemotherapies to elderly patients. However, some patients find themselves in the donut hole with high out-of-pocket costs. Physician offices have the potential for lost revenue caused by fewer infusion appointments, a lack of quality control in terms of drug administration and a lost opportunity to further educate patients on their treatment regimen during their IV treatments. In addition, these shifting demands on physician offices require staffing to remain unchanged because of the need for detailed patient education, monitoring and adherence support. Patient-physician relationships also may change because of fewer office visits and the need for more coordination of care with outside laboratories, pharmacies and specialty care facilities closer to the patients’ home or in a virtual world via the internet.
Currently, resources for patients who are prescribed oral chemotherapy are also available beyond the physician office. Drug manufacturers are attempting to develop packaging to aide patients with adhering to their prescribed medication. AstraZeneca Pharmaceuticals provided their patients anastrozole (Arimidex) as an Arimidex Pack. The tablets are in a child-proof calendar blister pack with a day of the week aligned with each tablet (similar to oral contraceptives). The goal of this packaging change was to enhance adherence by clearly showing whether each day’s dose was taken. Although this idea has been shown to improve adherence with oral contraceptives, the child-proof packaging has proven to be quite impenetrable for breast cancer patients experiencing arthritic pains, a common adverse effect with the aromatase inhibitors. Despite the best intentions of the manufacturer, this “advance” has proven to be a disadvantage to many patients. AstraZeneca is aware of this issue and will begin providing anastrozole in a traditional bottle. The manufacturer may readdress the packaging issues to determine whether the idea can be salvaged or not, but for now it will be discontinued. Additional resources provided by drug manufacturers can be found on their individual websites. Many offer printable medication dosing diaries, a hotline phone number for patient questions as well as detailed patient education in both text and video forms. Drug manufacturers recognize the importance for patient safety and are taking action to assist their patients with adherence to their oral chemotherapy regimens.
Another vital resource for drug information and assistance for oncology patients taking oral chemotherapy is their pharmacist. Whether the patients get their prescriptions filled at the local community pharmacy or a specialty mail-order pharmacy or the hospital pharmacy, pharmacists are always available to answer questions, review the medication profile for drug interactions and assist patients with knowing when to contact their oncologist. Unfortunately, community pharmacists often are not adequately trained to handle detailed questions regarding these complex medications. This is an area of much needed improvement in pharmacy education. Fortunately, there are a growing number of oncology specialty pharmacists who are appropriately trained and experienced and are working through both local and national efforts to improve the knowledge base of community pharmacists. Medication Therapy Management is a covered service required by Medicare Part D and is a service provided by trained pharmacists as part of the prescription benefit. Medication Therapy Management allows pharmacists to document and bill for consultations with patients regarding medication review, compliance, education and monitoring as well as contacting the prescriber for consultation. Many oncology patients are taking advantage of this service and stand to benefit from the additional education and monitoring with potentially toxic medications that require close monitoring for adverse effects and interventions. Pharmacists can provide additional care to such oncology patients through Medication Therapy Management services in person, by mail or via telephone. Many mail-order pharmacies also are expanding services to provide disease state management services, including services like phone consultations, medication checks to assess for adverse events, refill reminders and other measures that may improve adherence to their planned treatment regimen.
Clearly the health care system has a long way to go to ensure patient safety for those receiving oral chemotherapy. Hopefully, incorporating safe practices that have been successfully implemented with IV chemotherapy agents may prove to be successful in this arena as well. However, the unique nature of the problems encountered with oral chemotherapy also lends itself to novel solutions that strive to improve the overall quality of patient care, at home or in the office. Through continued research and dedication to the problems at hand, we will find solutions that address these myriad concerns. Stay tuned!
Shauna Choi, PharmD, is a Clinical Pharmacist and Laura Boehnke Michaud, PharmD, BCOP, is Manager of Clinical Pharmacy Services at The University of Texas M.D. Anderson Cancer Center.
For more information:
- Feng W, Henk J, Thomas S, et al. Compliance and persistency with imatinib. J Clin Oncol. 2006;24:6038.
- Medicare Part D Medication Therapy Management (MTM) Programs 2008 FACT SHEET. Centers for Medicare and Medicaid Services website. www.cms.hhs.gov/PrescriptionDrugCovContra/Downloads/MTMFactSheet.pdf. Accessed Oct. 23, 2008.
- Partridge AH, LaFountain A, Mayer E, et al. Adherence to initial adjuvant anastrozole therapy among women with early-stage breast cancer. J Clin Oncol. 2008;26:556-562.
- Weingart SN, Brown E, Bach PB, et al. NCCN Task Force report: oral chemotherapy. J Natl Compr Canc Netw. 2008;6:S1–S14.
- Weingart SN, Flug J, Brouillard D, et al. Oral chemotherapy safety practices at US cancer centres: questionnaire survey. BMJ. 2007;334:407-409.