Trends in chemotherapy administration

Trends in Chemotherapy

Administration

Joyce M. Yasko and Deborah Rust

tient services, becauseof the dramatic increase in their use, especially in cancer care, are being closely scrutinized to ensurehealth care at the lowest possible cost to the consumer and third-party payer.2 Some third-party payers have refused to reimburse for the costs of unlabeled drug use.3,4However, physicians have traditionally exercised their medical judgment to prescribe a drug regardlessof the Food and Drug Administration (FDA)approved indication. The FDA must enforce this regulation but doesagreethat the indication should only serve as a guideline for medical practice. A recent survey indicates that more than 50% of all chemotherapeutic agents used as conventional therapy by today’s standards are not FDA approved.5 Therefore, if this trend of third-party payers is maintained, it will dramatically affect cancercare, as treatmentdecisions are often based on reimbursementpatterns rather than on medical judgment.6-8 The oncology nurse, as the health professionalmost in touch with personsattempting to live with the diagnosis of cancer (and the financial constraints that it causes), must work with other health care professionalsto ensure appropriate reimbursementfor outpatient services. This becomeseven more important when chemotherapeutic agents are used in combination with biologic responsemodifier agents, which are classified as experimental agents.97lo Today, chemotherapyadministration is basedon the principles of cost containment, consumerism, advanced technology, competition, and nursing competence.These principles are responsible for the rapid increase in outpatient chemotherapy administration, use of vascular access devices such as cathetersand ports, as well as implantable and external pumps for continuous infusion in the home environment, and use of oral chemotherapeutic agents when possible. Furthermore, these

HEMOTHERAPY is presently the curative therapy for 14 types of cancer, which account for 11% of the cancersin the United States.’ In the early 195Os,chemotherapy was administered as a single agent primarily in major cancer centers. Today, it is administered in a variety of combinations in cancer centersas well as in community hospitals, outpatient clinics, and physicians’ offices. Since the inception of chemotherapy as a treatment modality for cancer and the rapid development of chemotherapeutic agents, trends associatedwith chemotherapy administration have challenged oncology nurses to develop new and innovative strategies and approachesto care. As nursesassumedincreasing responsibility for administering chemotherapeuticagents and managing the accompanying patient symptoms, this treatment modality served as the catalyst for the development of oncology nursing as a specialty. Standardsof care for patientsreceiving chemotherapy have been developed, implemented, and evaluated by nursesin most agencies.New challenges basedon presentand anticipated health care trends await resolution by oncology nurses.

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ECONOMICS OF CHEMOTHERAPY ADMINISTRATION

Economicshasbeenthe driving force behind the current revolution in health care. Providing the highest quality care at the lowest possible cost is a resounding theme echoedby all health care agencies. Reimbursementof health care servicesis in a period of change.The federal government, a major purchaserof health care through the Medicare system, changed health care reimbursementpatterns in 1983 from retrospective to prospective reimbursement. Since then, all components of the health care system have begun to function as if prospective reimbursement has been universally implemented. Even though the majority of health care reimbursement remains retrospective in nature, third-party payersnow pay for 80% or less of the health care bill. Outpatient cancer care is less costly than inpatient care and thus has become the focus of cost savings in chemotherapy administration. Outpa.%minarS in Oncology Nursing,

Vol 5, No 2, Suppl

1 (May),

1989:

From the University of Pittsburgh, Pittsburgh Cancer Institute, Nursing and Patient Care Services Division. Address reprint requests to Joyce M. Yasko, PhD, FAAN, University of Pittsburgh, 368 Victoria Eldg, Pittsburgh. PA 15261. 0 1989 W.B. Saunders Company. 0749-2081189/0502-1001$05.0010

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principles have challengedoncology nursesto prepare the patient and family for self care, consistent follow-up care, and compliance with cancer treatment.‘l”* NURSING CHALLENGES FOR OUTPATIENT CARE

The challenges of outpatient care to oncology nurses are numerous. To meet them successfully, the oncology nurse must ponder questions like those in Table 1, and design care strategies that effectively addressboth humaneand practical considerations. PRINCIPLES OF CHEMOTHERAPY ADMINISTRATION

Becauseof current health care trends and challenges, certain principles of chemotherapyadministration must be maintained by health care professionals regardlessof the setting. If at all possible, administration should be on an outpatient basis. Advanced technology, such as vascular accessdeTable 1. Challenaes

for OutDatient

Care

Is chemotherapy being safely mixed, administered, and discarded? Are patients and families comprehensively and effectively assessed and monitored? How can patients be prepared for self-management of symptoms experienced in the home? How can patients gain immediate access to the health care system when necessan/? What amenities need to be provided by the health care system to increase comfort and convenience for the patient and family? How can appropriate psychologic support and access to community-based health care services be provided? How can compliance with the treatment and care plan be assessed? How can qualified nurses be recruited and retained and their level of competence maintained? How can supportive staff be educated? What changes need to be made in oncology nursing practice patterns to ensure individualized, prioritized, convenient, and cost-effective care? What technology is needed to improve effectiveness and efficiency of care? How does one compete internally and externally for resources? How can research be incorporated into practice to validate nursing interventions? How can access to the health care system be assessed for all age groups and for all economic levels? How can more be done, in better ways, and at a lower cost?

vices (intraarterial catheters and ports) and implantable and portable infusion pumps must be used when vascular accessis frequent and/or difficult, or when continuous infusion is desired.I3314 Antineoplastic agents must be mixed, administered, and disposedof using consistent guidelines to protect the health care professional from occupational exposure. Universal precautions must be taken when chemotherapy is administered intravascularly to prevent occupational exposureto human immunodeficiency virus or hepatitis virus. Use of Oral Agents

Oral agents that are self-administered are frequently used in certain cancer treatmentregimens. For example, orally administered etoposide has beenused in the aggressivetreatment of small cell lung cancer (SCLC).15’16Oral use at twice the intravenous (IV) dosagerounded off to the nearest 50 mg has had clinically significant results when combined with cisplatin, cyclophosphamide, doxorubicin, and vincristine. Oral administration of an agent that was previously administered IV has proved to be not only clinically effective, but convenient, safe, and cost effective when administeredon an outpatient basis. Patientsand families are sparedtransportation costs, and the patient experiences milder side effects that are easily and effectively managed.” Maintaining Compliance Patient noncompliancewith a treatmentregimen may be due to a variety of reasons.The combination of complex medication schedules, multiple medications, duration of treatment, and frequent toxic side effects makes noncompliance in the treatmentof canceran especially difficult problem. For example, the patient or family may think that an oral agent is not as potent as the same agent administeredIV or they may be confusedabout the administration schedule. Patients may becomeapathetic or forgetful due to fatigue. Often patients may underestimatethe seriousnessof their illness, and patient denial of the cancereliminates the need for therapy in the patient’s mind. Oncology nurses must ensurecompliance when treatment is administered in the home and develop methodsto determine patient compliance with orally administered chemotherapeuticagentsas well as continuation of the prescribed treatment regimen and follow-up care.18*‘9This is especially true in unique popula-

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tions such as the elderly, the economically and educationally disadvantaged,and those that experience difficulty entering, remaining in, or returning to the health care system.

was administered on an outpatient basis. Given the prognosis of a patient with extensive SCLC, inpatient hospital days needed to be kept to a minimum. This is why oral etoposide was chosen for his treatment regimen.

Consistent Management

Factors to Consider When Initiating Oral Chemotherapy

The patient, physician, and nurse, as well as other health care professionalsand administrators, must collaborate to ensureconsistent management during chemotherapy administration and followup. In such a collaborative practice model, the patient and family play a strong interactive role with the physician and nurse. The nurse becomesthe central and immediate link betweenthe patient and family and the health care system. The physician/nurse team should remain the same throughout the course of treatment and follow-up. The nurse becomesa case managerwho provides direct care, actively coordinatesall aspectsof care regardless of who provides it or when it is provided, and takes an active and primary role to prevent or minimize symptoms that occur from the canceror its treatment.20*21 A major componentof the nurse’s role is patient and family education to prevent or minimize symptomsin the home. Innovations are necessary as chemotherapy becomes more aggressive,complex, and entwined with advanced technology. Pretreatmenteducational sessions and self-learning written and audiovisual modules must be developed to facilitate the educational process. CASE STUDIES

The following case studies demonstratethe incorporation of economic factors into patient care and illustrate the delivery of an optimal level of care at the lowest possible cost and highest possible quality of life. Case Study: Oral Etoposide A 42-year-old white man presented to a Veterans Administration Medical Center in 1987 with weight loss and right flank pain. A bronchoscopy revealed positive findings for SCLC. The tumor was widely metastatic to the thoracic spine, skull, and liver, with negative bone marrow involvement and negative brain computed tomography (CT) scan. The patient was entered in a treatment regimen of six alternating cycles of oral etoposide and IV cisplatin, and CAV (cyclophosphamide, doxorubicin, and vincristine) by IV infusion over 20 minutes. Oral etoposide was given for three days, and then the patient was admitted for cisplatin therapy, decreasing a four- to five-day hospitalization by several days. His CAV

Outpatient

Before initiating therapy, the following factors need to be considered and assessed. Patient compliance with oral chemotherapy agents. A patient may be apathetic or forgetful;

therefore, a calendarof drug schedule,dosage,and frequency should be developed. In this case,oncea-day dosing was well suited to optimize compliance. Cost. The costs of prescription drugs may cause a considerable financial burden. Some patients may not be able to afford their prescriptions and consequentlymay not have their prescriptions filled. Both patients and staff should carefully review insurance coverage, because approximately 60% to 75% of the US population has some level of insurance coverage for prescribed outpatient drugs. Confusion about medication regimen. This may occur with multiple instructions regarding a particular treatment plan. Confusion is compounded when instructions by a health care professional are unclear; therefore, a treatment calendar outlines the particular treatment plan. This method not only personalizesa treatment plan but also clarifies any questions that may arise:. Illiteracy. Inability to read or understand the directions often goes unnoticed, as patients will not admit that they are illiterate. Our method to deal with this is to design a medication log that requires the patient to check off each dose taken. Unit dosing is helpful when the health care professional is unsure of a patient’s mathematicabilities. Oral etoposide capsules are conveniently dispensedin unit-dose packaging. Denial of illness. Often, forgetting the medication helps the patient forget the illness. A patient may be at various stagesof accepting the diagnosis and many times conveniently forgets the need for medication. Drug interaction/side effects. Many times patients will not remain compliant with a medication regimen when it makesthem uncomfortable. Consequently, prophylactic antiemetic therapy may need to be consideredwhen patients are startedon

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an oral chemotherapeuticregimen. If the drug administered has a moderateor high antiemetic potential, provision must be made if a dose is vomited. Physical limitations. This may encompassa number of areassuch as hard-to-open containers, hearing problems, poor eyesight, and impaired self care. All these factors needto be consideredwhen a patient is involved with outpatient oral chemotherapy in order to properly managethe patient and symptomsexperienced. Life-style conflicts. Inconvenient dosing schedulesmany times may cause noncompliance. A daily or twice daily schedulev a four times daily schedule may increase compliance considerably. Writing out the instructions clearly and fitting the medication regimen to the patient’s life-style has facilitated compliance in many patient populations. Case Study: Ambulatory Infusion 5-Fluorouracil A 47-year-old white man with Dukes D adenocarcinoma of the colon presented with metastatic disease to the liver and lung. This patient lived 120 miles from the referral center, and family support was limited. He was placed on a randomized clinical trial evaluating the effectiveness of 5-fluorouracil (5FU) and leucovorin in metastatic colon carcinoma. He was randomized to continuous 5-FU infusion via ambulatory infusion pump until signs of disease progression or dose-limiting toxicities were seen. This plan eliminated hospitalization and decreased the number of visits to the outpatient facility. The pump provided comfort and ease of administration.

Factors to Consider When Using an Outpatient ChemotherapyPump Side effectsand management. Known side effects of 5-FU therapy are diarrhea and stomatitis. Therefore, support medications should be administered and proper instructions given for the early detection of stomatitis. The patient’s oral cavity should be examined before treatment to determine baseline oral hygiene statusand the usual program of hygiene maintenance. Preventative measures that can be taken by the patient include establishing an oral hygiene regimen at the initiation of chemotherapy. This regimen should consist of brushing teeth with a medium-soft toothbrush and a nonabrasive toothpaste, rinsing the mouth, and gargling with a nonirritating solution four times a day. An antidiarrheal agent should be provided for the patient along with instruction on its proper use.

YASKO AND RUST

Dietary restrictions are also effective in the control of diarrhea. Potential for successwith mechanical devices. The family support system needs to be assessed carefully. It is not always easy to determine how well personswith cancerare able to deal with their illness and managedaily care needs. Changing a daily dressing, flushing a device, or changing a cassetteof new medication requires family and/or professional support. Self consciousness. Somepatients do not wish to have others know that they are on medication or are ill. Wearing an ambulatory chemotherapy pump may causeconsiderable distress. The benefits of outpatient therapy need to be stressedas a meansof patient support. Physical limitations. Wearing a continuousinfusion pump may significantly alter an individual’s life-style. Factorsneedto be weighed regarding the number of inpatient days in a hospital over a period of time v outpatient ambulatory care. Teaching a patient how to deal with an infusion pump while participating in physical activity can be done and should be encouraged. Level of commitment.This necessitatesindependent problem solving and is required by the patient in order for treatmentto be successfully delivered. Effective collaboration betweenthe nurse, patient, and the family is essentialfor proper management. When treating cancer, one needs to recognize that one is treating a person as well as the disease. Patients can be taught to successfully selfadminister oral chemotherapy agents or maintain themselves on infusion chemotherapy on an outpatient basis. The task requires an experienced nurse clinician who anticipatespotential and actual areasof concern to provide education and support for the patient and family. CONCLUSION

Oncology nursesmust respondto the challenges provided by the outpatient administration of chemotherapy. They must design and implement cancer care systems for the future that focus on the patient and family and are efficient, effective, and delivered at reasonablecost. REFERENCES 1. Baker L: Curative cancer therapy: Historical ment, new approaches. Issues Oncol .5:1-10, 1988

develop-

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2. Mortenson L: Outpatient growth spurs explosive situation. Hospitals 62(8):54-55, 1988 3. Gargi J: FDA review of new indications is lengthy, costly process. J Cancer Program Manage 3:19, 1988 4. Gargi J: Insurers ask FDA to approve all appropriate cancer drug indications. Cancer Econ 2:1-4, 1987 5. Mortenson L: Audit indicates half of current chemotherapy users lack FDA approval. J Cancer Program Manage 3:2125, 1988 6. Weiss GB: Who pays for clinical research? Clin Res 271297-299, 1979 7. Wittes RE: Paying for patient care in treatment researchwho is responsible? Cancer Treat Rep 71:107-113, 1987 8. Antman K, Schnipper L, Frei E: The crisis in clinical cancer research. N Engl J Med 319:46-48, 1988 9. Gargi J: Reimbursement. Oncoline 1:3-7, 1986 IO. Kahn CR: A proposed new role for the insurance industry in biomedical research funding. N Engl J Med 310:257-258, 1984 11. Burda D: Hospitals’ pricing puzzle. Mod Health Care 2:30-37, 1988

7 12. Easterbrook G: The revolution in Medicare. Newsweek 1:40-70, 1987 13. Lawson M, Finly R: Vascular Access and Drug Administration Systems. Philadelphia, Meniscus, 1987, pp 5-20 14. Lokich I, Phillips N: Practical Considerations in Continuous Infusions. Philadelphia, Meniscus, 1987, pp 5- 15 15. Einhom L: Milestones in the treatment of small cell lung cancer. Oncol Comment l:l-2, 1988 16. Comis R: Oral etoposide in small cell lung cancer. Semin Oncol 13:75-78, 1986 (suppl 3) 17. Smyth RD. Pfeffer, Scalzo A, et al: Bioavailability and pharmacokinetics of etoposide (VP-16). Semin Oncol 12:4851, 1985 (suppl 2) 18. Levine AM, Richardson JL, Marks G, et al: Compliance with oral drug therapy in patients with hematologic malignancy. J Clin Oncol 5:1469-1476, 1987 19. Sharbaro J: Strategies to improve compliance with therapy. Am J Med 79134-37, 1985 20. Morel N: Nurses speak out on patients and drug regimens. Am J Nurs 85:51-54, 1985 21. Carter L: Editorial opinion: About nurses, perceptions and misperceptions. Nurs Manage 18: 1 l- 12, I987