Oral Oncology: New Perspectives on the Role of Pharmacists

Pharmacists have a unique opportunity when working with patients taking oral oncology regimens. Here's a comprehensive guide to these programs and what they can provide.

With the growing number of oral oncology agents approved and on the market in the United States, a new therapeutic option for the treatment of cancer has been established. Many of these oncology agents have been determined to be highly effective.

In today’s marketplace, oral oncology regimens can range in cost from $1000 to $10,000 per month of treatment. This route of administration is attractive because of its convenience, ability to take at home versus the hospital, and ease of administration (oral versus intravenous), particularly in the palliative setting. When comparing the 2 options, the majority of patients (>80%) prefer oral chemotherapy. ^1,2

Pharmacists have a unique opportunity when working with patients taking oral oncology regimens. Typically, patients on oral agents are associated with less physician-patient contact and oversight compared with intravenous regimens. The pharmacist is able to clarify information about the disease state, explain medication administration, and assist in side effect management. The pharmacist is vital to maximizing the treatment’s effectiveness by educating patients on how and when to take the medication, with or without food. Counseling on possible drug interactions is also vital in achieving optimal treatment effectiveness.

Some of the common challenges patients face while on these regimens include lack of understanding of the disease or the medication, possible side effects, and fear and anxiety about affording the medication. All of these challenges contribute to the patient’s adherence. With less direct medical care associated with administering the doses, there is a greater responsibility placed upon the patient to take their medication correctly and when advised.

Maximizing Therapy Outcomes

Traditionally, the majority of cancer regimens have been administered intravenously and in a hospital setting, where the patient is closely monitored by experienced oncologists and nurses. With the development of oral regimens, however, a greater responsibility is placed upon the patient or their caregiver to adhere to the regimen without the close supervision of experienced health care professionals. The oral regimen option is able to provide greater flexibility and convenience, thus increasing the patient’s quality of life. However, the risk associated with utilizing an oral regimen for chemotherapy would include greater chances of overdosing or underdosing due to a multitude of factors. Self-administration, narrow therapeutic indexes, complex dosing regimens, and a high likelihood of medication administration errors can all contribute to this risk. ³

BioScrip has developed a patient management program with a goal to reduce barriers associated with oral oncology medications and provide benefit to the patient, provider, and the payer. The objectives of the program include:

• Assisting in therapy adherence

• Educating regarding medication tolerance concerns

• Actively monitoring regimen compliance

• Providing feedback to the prescriber regarding patient information

Pharmacists can recommend the use of daily pill boxes to help improve patient adherence. According to a study, patient satisfaction with and preference for daily pill boxes were greater than for conventional pill bottles. ⁴ Overall, oral oncology treatment will contribute to a reduced number of hospital visits (in-patient and outpatient), decrease administration costs associated with the visit, cut down on costs of disposables (eg, infusion pumps, tubing), and decrease the pharmacy workload, 5 contributing to lower overall health care costs.

Pharmacist Intervention

Common treatment challenges in specific oncology treatment groups offer some opportunities for the pharmacist to relay possible recommendations to the patient or prescriber.

For example, a known issue with the breast cancer treatments tamoxifen and toremifene is the risk of developing thrombosis. There is increased risk of stroke associated with deep venous thrombosis (DVT). Pharmacists can help educate patients on possible signs of DVT and caution them on medication side effects. Patients on these medications should look for pain, swelling, tenderness of legs or calves, unexplained shortness of breath, changes in vision, sudden chest pain, or coughing up blood. There is also an increased risk for endometrial cancer in these patients, so regular gynecologic examinations should be recommended as well as a caution on menstrual irregularities, change in vaginal discharge, abnormal vaginal bleeding, or pelvic pain.

Hot flashes are also a potential barrier to patient adherence. Possible recommendations to help manage hot flashes are gabapentin 900 mg/day, venlafaxine ER 37.5 to 75 mg/day, or clonidine 0.15 to 0.2 mg/day by mouth. Aromatase inhibitors, such as Arimidex (AstraZeneca), Aromasin (Pfizer), and Femara (Novartis Oncology), are also associated with hot flashes during use. Another valid concern is increased risk of osteoporosis; recommendations of 800 IU of vitamin D per day and 1500 mg of calcium per day have been established.

Pharmacists may be able to assess and educate the patient taking prostate cancer therapies for symptoms of jaundice, such as yellowing of the eyes or darkening of the urine. Prostate cancer regimens require close monitoring of liver function tests, so if the patient notices signs of jaundice, the prescriber should be notified immediately.

Immunomodulators, such as Revlimid (Celgene) and Thalomid (Celgene), can cause thromboembolism, which can be helped or prevented by daily aspirin use. Patients with 2 or more risk factors (eg, obesity and nonambulatory) should use low—molecular weight heparin (Lovenox; sanofi-aventis) or warfarin with a goal of international normalized ratio of around 1.5. 6 Restriction of Revlimid and Thalomid is required due to their teratogenicity effects. Each drug has a specific REMS program to allow for close monitoring. The requirement of patient counseling prior to dispensing is to ensure all possible measures are taken to prevent bearing or fathering a child.

Tyrosine kinase inhibitors are typically dosed once a day and recommendations to patients include to avoid smoking, avoid taking on an empty stomach, and use of loperamide to help control diarrhea. Be sure to inform the patient that potential adverse effects include corneal ulcerations and unexplained cough, fever, or dyspnea. The majority of patients will have dermatologic reactions that can be reduced in severity by avoiding sun exposure and moisturizing. Hydrocortisone cream can be used for mild reactions; moderate reactions may also need metronidazole gel and doxycycline. Severe reactions often require a Medrol dose pack in addition.

Multikinase inhibitors, such as Nexavar (Onyx and Bayer HealthCare) and Sutent (Pfizer Oncology), should be taken on an empty stomach and can cause hypertension. Patients new to therapy should have their blood pressure monitored weekly for the first 6 weeks. Sutent use should be monitored for congestive heart failure and arrhythmias; Nexavar use should be monitored for cardiac ischemia. Liver function tests should be assessed and patients should be notified of handfoot syndrome, which is a side effect that develops 2 to 4 weeks after the start of treatment. It starts out as paresthesias, redness, peeling, hyperkeratosis, and flat blisters on the palms and soles and may progress to large, tense blisters, ulcers, and bleeding. Prophylactic measures include using moisturizing creams, removal of calluses, and using cushioning inserts.

Pharmacists dispensing Xeloda (Genentech) should caution patients on possible side effects of diarrhea, handfoot syndrome, and anemia. Diarrhea over a prolonged period of time can cause dehydration, shock, and cardiac disturbances. Loperamide can be utilized at 2 mg every 4 hours up to every 2 hours until resolved; if unresolved, octreotide use should be recommended and considered by the prescriber.

In summary, oral regimens represent new strategies for improved outcomes in oncology patients. Due to the medications being self-administered, the patient or caregiver must take greater responsibility for understanding the regimen and ensuring that they administer properly. The development of oral oncology agents has given pharmacists an opportunity to work with the patient on the management of side effects as well as proper and safe use of these medications to optimize therapeutic outcomes. SPT

About the Author

Rebecca Nelson is pharmacist in charge and senior clinical pharmacist at BioScrip Pharmacy in Columbus, Ohio. BioScrip is a leading provider of comprehensive, cost-effective pharmaceutical and home care solutions. Dr. Nelson is licensed in 17 states and is actively involved in mentoring pharmacy students. She graduated from Ohio Northern University Raabe College of Pharmacy in 2007 and currently resides in Dublin, Ohio.

References

1. Payne SA. A study of quality of life in cancer patients receiving palliative chemotherapy. Soc Sci Med. 1992;35(12):1505-1509.

2. Bartel S. Safe practices and financial considerations in using oral chemotherapeutic agents. Am J Health-Syst Pharm. 26: 2007;64(suppl 5):S8-S14.

3. Macintosh PW, Pond GR, Pond BJ, Leung V, Siu LL. A comparison of patient adherence and preference of packaging method for oral anticancer agents using convential pill bottles versus daily pill boxes. Eur J Cancer Care (Engl). 2007;16(4):380-386.

4. O’Neill VO, Twelves CJ. Oral cancer treatment: developments in chemotherapy and beyond. Br J Cancer. 2002;87(9):933-937.

5. Farhan SY, Vega J, Hanbali A, Kuriakose P, Janakiraman N. Efficacy and safety of low dose versus full dose anticoagulation for prevention of thalidomide-related venous thromboembolism. J Clin Oncol. 2008;26(May 20 suppl; abstr 19518).

6. Liu G, Franssen E, Fitch MI, Warner E. Patient preferences for oral versus intravenous palliative chemotherapy. J Clin Oncol. 1997;15:110-115.