Continuing Education

Oral Chemotherapy: Not just an ordinary pill

Fran, a triage nurse in a busy primary care office, receives a call from Marla Rodriguez, whose mother is a long-time patient. Marla says her mother has an intense red rash over most of her trunk. Fran asks her standard questions based on her triage symptom-management protocol for rashes: Does the rash itch? Do you see it anywhere else besides the trunk? Do you see pustules? How long has your mother had the rash? Has she started new medication or used new soaps or lotions lately?

Marla replies that her mother just started taking a drug called sorafenib. Fran accesses Mrs. Rodriguez’s file in her electronic health record (EHR) and discovers she was recently diagnosed with renal cell carcinoma and referred to a medical oncologist. When she asks Marla how long her mother has been on the medication, Marla says she began taking it within the last week.

Fran assumes Mrs. Rodriguez is seeing a medical oncologist outside her facility’s EHR system, as she doesn’t see notes from an oncologist and Mrs. Rodriguez’s medication list isn’t up-to-date. To gain more insight into the possible cause of the rash, Fran consults scanned documents in her file and finds a letter from the medical oncologist summarizing her treatment plan and the side effects of sorafenib, an oral medication; skin rash is listed as a serious side effect.

In recent years, the Food and Drug Administration has approved many new anticancer medications that are taken primarily by mouth. In fact, an estimated 30% of cancer drugs in development are oral, and the trend is increasing.

Some practitioners tout oral chemotherapies as more convenient and flexible. But are they really? The change from parenteral to oral cancer medications brings new challenges. Patients taking oral drugs may end up being seen by many different healthcare team members, some of whom may be unaware of the possible toxicities of these therapies—or even that the patient’s taking them.

Benefits of oral therapy

Patients undergoing treatment for cancer are living longer, and cancer increasingly is becoming a chronic illness. Oral chemotherapy has certain obvious benefits.

• Patients don’t need to spend hours in a clinic infusion room receiving therapy. Patient advocates see this as a major quality-of-life improvement because it gives patients more time at home with their families and doing activities they enjoy.

• Patients may not need to take as much time off work during treatment.

• Patients have more flexibility to travel during treatment.

• Oral therapy eliminates some logistic and financial barriers, such as transportation to and from I.V. treatment centers and child-care and parking costs. In rural areas, this can be crucial because the closest treatment center may be hours away and weather may complicate travel. In urban areas, parking costs can pose a hardship to families already struggling with high medical costs.

• Oral therapy eliminates the cost of I.V. supplies and reduces nursing time in infusion suites.

• Oral therapy nearly eliminates the need for venous access and central venous access devices, such as peripherally inserted central catheters and implanted ports—along with the risks and costs of these devices. Many patients find venous access uncomfortable and complain they feel like a pincushion after multiple blood withdrawals and I.V. sessions. And central venous access devices raise the risk of infection and bleeding in already immunocompromised patients, who also may be thrombocytopenic.

Drawbacks of oral therapy

Although most patients appreciate the advantages of oral chemotherapy, the oral route shifts the burden of proper drug administration to them and their family. Cancer treatments—including oral ones—must be given on specific schedules and may require either the presence or absence of food. They may interact with other drugs and certain foods and nutritional supplements, which can lead to toxicity and inefficacy. (See Common drug and food interactions.) Also, some patients on oral chemotherapy complain they feel less supported because they’re not seeing healthcare providers regularly to help them manage treatment and toxicities.

Patient adherence can be a concern for providers, who are accustomed to knowing exactly which drugs their patients have received because they receive them in a clinic or hospital. Providers may find patients don’t always take their medications as ordered, with significant ramifications for treatment and disease outcomes.

What’s more, some patients may decide not to take prescribed therapies because they can’t afford them. Or they may forget to take them or may stop taking them when toxicities set in.

Some healthcare administrators mistakenly believe oral cancer therapies require less nursing staff. (See Myths and facts about oral chemotherapy.) But experience shows oral chemotherapy requires significant nursing time for patient education and telephone consultations. For clinic nurses, determining patients’ insurance coverage, estimating patient costs, and accessing available financial assistance programs can be time consuming. (See Cost considerations.)

Multidisciplinary approach

Supporting patients who take oral chemotherapy at home requires a team approach involving physicians, nurses, pharmacists, financial counselors, and other professionals. Many cancer patients have comorbidities, which increases the need for a multidisciplinary approach.

This underscores the importance of all healthcare team members to identify themselves in the EHR and document their care thoroughly, to make sure everyone knows the patient is receiving oral chemotherapy. Before treating chemotherapy side effects, they should refer patients to their oncology provider or consult with the oncology team. Clinicians should encourage patients receiving oral therapies to contact their prescriber’s office to manage side effects. To help prevent drug-drug and drug-food interactions, medication errors, and untoward effects, all team members must be kept current on what drugs the patient’s taking.

Mrs. Rodriguez has comorbid hypertension and hyper cholesterolemia. Her renal cell carcinoma required resection of one kidney, so she’s being followed by her urologist. The oncologist’s summary of her treatment plan, which Fran found in her file, notes that she’s taking sorafenib at home and lists its potential side effects. So when Fran receives her daughter’s call, she knows to refer Mrs. Rodriguez urgently to her oncologist, who admits her to the intensive care unit to rule out Stevens-Johnson syndrome, a life-threatening skin condition resulting from an allergic drug reaction. The treatment summary proves essential in helping Fran grasp the seriousness of the patient’s rash—and this enabled her to intervene quickly and appropriately.

But keeping multidisciplinary team members informed isn’t enough. The patient’s family and personal caregivers also need to be engaged. With oral chemotherapy, the responsibility of ensuring the “five rights” of medication administration no longer belongs to the care team in the I.V. infusion unit. This responsibility shifts to the patient and home caregivers.

The emotional burden of caring for a loved one with cancer can be overwhelming. Errors can result from family members’ confusion or poor understanding of the correct dosage, dosing schedule, drug or food interactions, and how to handle and store these potentially hazardous medications.

Building strong, supportive relationships with patients is vital to ensuring they communicate with the healthcare team. Some patients with side effects or other concerns about therapy may minimize them or decide not to “bother” clinicians about them. Or they may fear that if they admit they’re having side effects, their dosage may be decreased, which could prevent them from achieving therapeutic goals.

Assessing patients before oral chemotherapy

The success of a patient’s oral chemotherapy depends on regular comprehensive reviews of body systems and side effects throughout treatment. When care providers have a good rapport with patients,  these reviews can be extremely successful in detecting and managing side effects.

Before patients start oral treatment at home, assess them to determine if they’re good candidates— physically and mentally—for oral administration. Patients should:

• be able to swallow and digest oral medication

• understand the importance of adhering to the drug regimen

• have adequate home supervision to help them adhere to the medication schedule.

Metastatic brain disease, forgetfulness, advanced age, or a history of alcohol abuse or mental illness could interfere with the patient’s ability to adhere to the regimen.

Also review the patient’s history for polypharmacy and comorbidities, and determine if the patient’s symptoms are adequately controlled.

Patient education

Before the patient begins chemotherapy, provide education using the teach-back method by having the patient verbally repeat what you’ve taught. After assessing the patient’s reading level and ability to understand

complex instructions, provide easy-to-understand written teaching material. Inform patients what to do if they miss a dose; caution them not to double up on doses. Also, check with the pharmacy on proper medication storage, and convey this information to the patient. (See Teaching patients about oral chemotherapy.)

Medication adherence and persistence

Medication adherence refers to the extent to which the patient takes medication in accordance with the prescribed interval and dose of a dosing regimen. Medication persistence is the duration from the patient’s drug initiation to discontinuation. Both are important in oral chemotherapy.

Nonadherence can mean missing doses or taking them in the wrong amount, at the wrong time, or in the wrong way (such as with food if they should be taken on an empty stomach). Adherence issues aren’t new—or unique to cancer patients. For years, primary care providers have dealt with nonadherent patients with chronic diseases, such as hypertension and asthma. In 2003, the World Health Organization recognized nonadherence as an issue of striking magnitude and predicted it would only get worse as chronic diseases increase in our aging population. Dr. C. Everett Koop, former U.S. surgeon general, pointed out, “Drugs don’t work in people who don’t take them.”

Cancer care providers may assume that because cancer is a frightening disease, patients will show greater medication adherence and persistence than patients with other diseases. But this assumption is false. A study of patients taking oral tamoxifen for breast cancer found that 80% initially filled their prescriptions but by the fourth year, only 50% were filling them. So although medication adherence and persistence with cancer regimens may be better than with other disease regimens, they remain a significant challenge. (See Helping patients adhere to medication regimens.)

Why some patients don’t take their medications

Many theories address why some patients don’t take prescribed medications. Generally, the more complex the regimen (including food restrictions, frequent doses, and dosage days that lack an easy-toremember pattern), the more likely that errors will occur. Also, the more medications the patient takes, the more likely some doses will be missed. And the more side effects a drug has (either anticipated or experienced), the less likely the patient is to take the full dose on schedule.

Patients receiving cancer therapy generally feel better before they start it, but once they begin the regimen and continue to take it, they experience more side effects, including nausea, skin reactions, and fatigue. When they’re in control of their regimen (as with home oral chemotherapy), they may choose to withhold doses as toxicities increase. In our case scenario, if Mrs. Rodriguez had simply stopped taking sorafenib and waited for the rash to disappear without calling the physician, she would have received suboptimal treatment and might have had a poor outcome.

Patients have many reasons for not calling their physician. They might assume clinic staff are too busy to talk to them, reaching a nurse is too difficult, or their side effect is an expected one that they just need to “tough out.” To help patients manage side effects, urge them to call their oncologist’s office (after hours, if necessary) to report fever, chills, uncontrolled diarrhea, nausea, and vomiting. (See Indications and side effects of common oral chemotherapy drugs.)

Many tips and tools have been created to improve adherence, but few have been studied to determine their success. The most effective evidence-based method is for the healthcare team to develop a strong relationship with the patient. In today’s busy clinics, healthcare professionals may think they don’t have time to build a rapport with patients. Yet doing so can be crucial to achieving success with oral chemotherapy, managing side effects, and obtaining the best patient outcomes.

Oral chemotherapy safeguards: An emerging need

Errors associated with chemotherapy have long been a serious concern, prompting healthcare providers to develop a system of checks and balances to prevent dangerous dosages from reaching patients. Oral chemotherapy bypasses many of those checks, underscoring the need to design and implement new safeguards. For instance, for oral chemotherapy drugs, standardized order sets may not exist and dosagecalculations may not be doublechecked. Recently, many clinics have developed formalized processes for monitoring and documenting patients’ medication adherence.

Other concerns

Local pharmacists may be unfamiliar with oral chemotherapy and their dosing schedules. Also, overwhelmed patients may not completely understand all of the instructions provided. What’s more, some EHR systems don’t include documentation tools that carefully follow oral chemotherapy dosing. In some cases, nurses have had to create their own paper tracking tools to remind them which patients are taking oral chemotherapy and which ones to follow up with.

In addition, patient informed consent is just as important for oral chemotherapy as for parental chemo therapy. Make sure patients understand that an oral chemotherapy drug is just as potent as any other drug and carries certain risks.

Nursing’s crucial role

With more patients now using oral chemotherapy, all healthcare team members must stay informed about patients on these regimens. The nurse’s role in patient education, care coordination, and follow-up takes on even greater importance for patients who take these potent and potentially dangerous drugs at home. Empower patients to speak up and tell all of their healthcare providers they are receiving oral chemotherapy. By working with other disciplines as a coordinated healthcare team and developing open, honest communication with patients and their caregivers, nurses can help ensure safe, effectivetreatment.

Nancy Thompson is the director of quality and clinical practice at the Swedish Cancer Institute in Seattle, Washington. Amy Christian is a manager at the Swedish Cancer Institute in Issaquah, Washington.

Selected references

Geynisman DM, Wickersham KE. Adherence to targeted oral anticancer medications. Discovery Medicine.com. April 25, 2013.

Goodin S, Griffith N, Chen B, et al. Safe handling of oral chemotherapeutic agents in clinical practice: recommendations from an international pharmacy panel. J Oncol Pract. 2011;7(1):7-12.

Lombardi C. Patient adherence to oral cancer therapies: a nursing resource guide. OncoLink.org. Last modified May 23, 2014.

Neuss MN, Polovich M, McNiff K, et al. 2013 updated American Society of Clinical Oncology/Oncology Nursing Society chemotherapy administration safety standards including standards for the safe administration and management of oral chemotherapy. Oncol Nurs Forum. 2013;40(3):225-33.

Novartis Oncology. Managing Treatment with Oral Oncology Medications: An Educational Toolkit for Patients and Caregivers. Novartis Pharmaceuticals Corporation. East Hanover, New Jersey: 2013.

Partridge AH, Wang PS, Winer EP, Avorn J. Nonadherence to adjuvant tamoxifen therapy in women with primary breast cancer. J Clin Oncol. 2003;21(4):602-6.

Rudnitzki T, McMahon D. Oral agents for cancer: safety challenges and recommendations. Clin J Oncol Nurs. 2015;19(suppl 3):41-6.

Segal EM, Flood MR, Mancini RS, et al. Oral chemotherapy food and drug interactions: a comprehensive review of the literature. J Oncol Pract. 2014;10(4):e255-e68.

Tipton JM. Overview of the challenges related to oral agents for cancer and their impact on adherence. Clin J Oncol Nurs. 2015;19(suppl 3):37-40.

Weingart SN, Brown E, Bach PB, et al; National Comprehensive Cancer Network Task Force Report. NCCN Task Force Report: Oral chemotherapy. J Natl Compr Canc Netw. 2008;6 (suppl 3):S1-S14.

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