For the past few years, much attention has been given to the development and US Food and Drug Administration (FDA) approval of targeted oral chemotherapy agents. As our knowledge of cancer and its molecular biology increases, many targeted oral chemotherapy agents have become available for use in clinical practice. The emergence of oral chemotherapy agents has provided alternative treatment options and allowed patients to receive cancer treatment in the convenience of their home. While there are many advantages to oral chemotherapy treatment, there are also many safety concerns. As healthcare professionals, we must educate patients and their caregivers on the use of these oral chemotherapy agents. Education should include but not be limited to: (1) what side effects to expect (both acute and chronic); (2) how to monitor, assess, and manage these side effects (are there over-the-counter products that can be safely used to help minimize these side effects, and which side effects warrant immediate medical attention); (3) what to do for missed doses (take as soon as remembered, or skip dose until next scheduled dose); (4) what to do if patients are not able to swallow (should dose be crushed or do we have any information); (5) what precautions to take in the safe handling of these oral chemo therapy agents (storage information, and proper disposal of these agents); and (6) the importance of oral adherence and compliance to these medications to provide effective treatment (do patients and their caregivers fully understand the treatment schedule, as it can be complicated to follow, etc).
With the emergence of oral chemotherapy, adherence to oral chemotherapy treatment has become a concern for many healthcare professionals. In 2009, the American Society of Clinical Oncology and the Oncology Nursing Society (ONS) published a practice guideline on chemotherapy administration safety standards,1 focusing on the 7 domains of the chemotherapy administration process, which include the following: (1) review of clinical information and selection of a treatment regimen; (2) treatment planning and informed consent; (3) ordering of treatment and prescription writing; (4) drug preparation; (5) assessment of treatment compliance; (6) administration and monitoring of treatment; and (7) assessment of response and toxicity monitoring. The guideline indicates that adherence to standards for safe chemotherapy administration should be the goal of all healthcare providers in any oncology care settings, both inpatient and outpatient. Since its publication, the safety standards have provided a framework for best practice throughout the oncology practice arena, and many of these domains are tasks that pharmacists can assist in providing.
On June 14-15, 2011, the National Coalition for Cancer Survivorship in partnership with the National Association of Social Workers, the ONS, and the Association of Oncology Social Work sponsored an oral chemotherapy adherence train-the-trainer conference in Washington, DC. Representatives included teams of 1 pharmacist, nurse, and social worker each from 11 medical centers. Our medical center was privileged to be one of the team participants. Topics discussed at the conference included: (1) addressing oral chemotherapy adherence through multidisciplinary teams; (2) state of the science: adherence to oral chemotherapeutic agents; (3) barriers to adherence; and (4) motivational interviewing/ active listening to promote oral chemotherapy adherence. Breakout discussions were used to further identify barriers to successful adherence, tools and approaches that might address these barriers, and how barriers to adherence can best be resolved using a multidisciplinary team approach. At the conclusion of the conference, each of the team participants was given the task of developing plans to improve oral chemotherapy adherence in their own institution practice settings and community.
What was interesting for me to learn was that there is no “gold standard” definition of adherence, as most literature examining and evaluating oral adherence offers its own definition of adherence.2 While nonadherence to oral chemotherapy agents is an important concern, overadherence to oral chemotherapy agents is also a major concern, as it poses a risk for increases in unwanted side effects and drug toxicities, something I am seeing more frequently at our institution. As many oral chemotherapy agents have restricted REMS (risk evaluation and mitigation strategies) distribution access and require an FDA-approved medication guide with dispensing, we must be familiar with the use of oral chemotherapy agents and be able to provide education to other healthcare professionals, patients, and their caregivers. See the Table that accompanies the online version of this article for a summary of some targeted oral chemotherapy agents with information on lab monitoring, common side effects, and instructions for patient education.3-16
While our own institution is collaboratively developing a plan of action to improve oral chemotherapy adherence at our practice setting, some of you have already implemented a program at your institution. I ask that you continue to share your developmental process and your success with us through publications or at the Hematology Oncology Pharmacy As sociation annual conference.
- Jacobson JO, Polovich M, McNiff KK, et al. American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards. J Clin Oncol. 2009;27:5469-5475.
- Given BA, Spoelstra SL, Grant M. The challenges of oral agents as antineoplastic treatments. Semin Oncol Nurs. 2011;27:93-103.
- Lam MS. Extemporaneous compounding of oral liquid dosage formulations and alternative drug delivery methods for anticancer drugs. Pharmacotherapy. 2011;31:164-192.
- Crizotinib (Xalkori) full prescribing information [package insert]. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202570s000lbl.pdf. Accessed September 8, 2011.
- Vemurafenib (Zelboraf) full prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf. Accessed September 8, 2011.
- Abiraterone (Zytiga) full prescribing information. http://www.zytiga.com/pdf/prescribing_information.pdf. Accessed September 8, 2011.
- Vandetanib (Caprelsa) full prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022405s000lbl.pdf. Accessed September 9, 2011.
- Sorafenib (Nexavar) full prescribing information. http://www.nexavar.com/html/download/Nexavar_PI.pdf. Accessed September 9, 2011.
- Sunitinib (Sutent) full prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021938s009lbl.pdf. Accessed September 10, 2011.
- Pazopanib (Votrient) full prescribing information. http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022465s002lbl.pdf. Accessed September 10, 2011.
- Everolimus (Afinitor) full prescribing information. http://www.pharma.us.novartis.com/product/pi/pdf/afinitor.pdf. Accessed September 20, 2011.
- Lapatinib (Tykerb) full prescribing information. http://us.gsk.com/products/assets/us_tykerb.pdf. Accessed September 23, 2011.
- Lenalidomide (Revlimid) full prescribing information. http://www.revlimid.com/pdf/REVLIMID_PI.pdf. Accessed September 20, 2011.
- Thalidomide (Thalomid) full prescribing information. http://www.revlimid.com/docs/Revlimid-Full-PI.pdf. Accessed September 20, 2011.
- Erlotinib (Tarceva) full prescribing information. http://www.gene.com/gene/products/information/pdf/tarceva-prescribing.pdf. Accessed September 23, 2011.
- Capecitabine (Xeloda) full prescribing information. http://www.gene.com/gene/products/information/xeloda/pdf/pi.pdf. Accessed September 23, 2011.