The experience at one institution by Ketan Patel, RPh, MBA, and Patrick Grusenmeyer, ScD, FACHE

Transcription

1 The experience at one institution by Ketan Patel, RPh, MBA, and Patrick Grusenmeyer, ScD, FACHE T he primary function of pharmacy is to prepare medications and to improve patient safety by advising physicians, nurses, and patients on the use of medication. The role of a pharmacist in the oncology practice is especially important due to the nature of the medication. While chemotherapy is a critical component of cancer therapy and of community medical oncology practices, mixing and administration of chemotherapy provide unique patient safety challenges. Nurses mix the chemotherapy in many community oncology practices. It has been suggested that patient safety can be improved by using pharmacists to mix chemotherapy drugs. This article explores the implementation of hospital cancer center-based pharmacists in a community medical oncology practice. In October 2002 the Helen F. Graham Cancer Center collaborated with Medical Oncology Hematology Consultants, P.A., (MOHC) to develop a cancer pharmacy that works directly with the private practice oncologists and nurses to ensure proper mixture and administration of medication. MOHC, the largest private oncology and hematology practice in the state of Delaware, includes seven medical oncologists/hematologists and seven nurse practitioners. In addition to its role with MOHC, the Cancer Center pharmacy services a hospital-based gynecologic oncology practice, the cancer research program, and the Cancer Center s own ambulatory infusion suite. Staff and Location The pharmacy is staffed by two registered pharmacists and two pharmacy technicians, all of whom are employed by the hospital, and one nurse who is employed by MOHC. To provide the best service, the pharmacy has to be easily accessible. Accordingly, the pharmacy is located in the Helen F. Graham Cancer Center adjacent to and connected with MOHC s chemotherapy infusion suite. This location provides direct access for physicians, infusion nurses, and research nurses. The pharmacy s proximity to the infusion unit is also convenient for patients, allowing them easy access to the pharmacists who are available to provide information on the patients therapy, chemotherapy, and other medications. When the pharmacy first began working with MOHC, one of the biggest challenges was being accepted as part of the practice. Earning the trust of the practice physicians and nurses took time. Like most private practices, MOHC staff was not accustomed to having a pharmacist and pharmacy staff located in its chemotherapy infusion suite. Prior to this collaborative arrangement with the Cancer Center-based pharmacy, MOHC staff nurses checked and clarified orders, and then mixed the chemotherapy medication. Typically, one nurse carried out these responsibilities on a rotating basis. Today, working directly with the Cancer Center pharmacy, the practice benefits from the pharmacy s services which contribute to and improve the process, free up nursing time, and improve patient safety. Standard Chemo Regimens One of the most important steps taken to improve patient safety was to change the way the physicians ordered chemotherapy medications. Pharmacy staff worked collaboratively with MOHC nurses and physicians to accomplish this task. After evaluating each discipline s needs, pharmacy staff developed chemotherapy orders that would most effectively communicate the therapy. These forms were then submitted for review to the physicians and nursing staff for comments, revisions, and approval. Prior to the development of the new chemotherapy order sheet, the physician and the nursing flow sheets were on one page. The physician wrote in the name of the patient, the drug ordered, and the administration instructions. Nurses had a section on the same order form to document their patient assessment and services provided to the patient. Unfortunately, the forms were not always fully completed. Pharmacy staff developed two different forms one for the nursing staff and one for physicians. The nursing flow sheet can be found on pages The new physician order form contains much more information than the earlier version. The forms are pre-printed to improve legibility. Physicians check a box to indicate the medication ordered, thus eliminating illegible handwriting. On the same line is a preprinted set of administration instructions that include the 30 Oncology Issues May/June 2009

2 Illustration/Theispot/Jane Sterrett route of administration, volume of administration, type of fluid, and the rate of administration. Physicians must indicate the basis of the dose (i.e., body surface area), the total dose to be administered, and, for some medications, fluid volume and rate at which to infuse the medication. Located at the top of the order form is an area for the patient s height, weight, body surface area, allergies, diagnosis, regimen, and hematologic labs that include WBC/ANC, Hgb, HCT, platelet, and creatinine. The physician must also indicate if the patient is currently on a clinical trial and, if so, which trial. At the bottom of the order form is a section that indicates if a dose was adjusted and a space for any additional information that would affect the patient s treatment. All this information allows the pharmacy to calculate and verify orders. Once the MOHC physician has seen the patient and completed the chemotherapy orders, the treating nurse delivers the physician order to the pharmacy, indicating that that patient is in the chemotherapy infusion suite and awaiting treatment. The infusion nurse ensures that the patient is seated and has IV access. The MOHC pharmacy nurse enters the patient s name and medication into a logbook and is responsible for setting up the IV administration set. The pharmacist then checks the orders. Three-part Safety Check Pharmacy and nursing staff developed and implemented a three-part safety check system that has improved patient safety. Step 1 the pharmacist completes the first check. The pharmacist ensures that the physician accurately filled out the chemotherapy order sheet in its entirety. The pharmacist calculates the dose for correctness according to the chemotherapy regimen. If the pharmacist finds an error with the physician s order, he or she confers with the physician for clarification. To document that the pharmacist verified the dose, he or she initials next to each medication. Step 2 the pharmacy technician conducts the second check prior to reconstituting the medication. The technician checks the label and the medication against the order and then recalculates the doses to verify correctness. The pharmacy technician verifies the medication at the bottom of the chemotherapy order form by initialing. Step 3 two nurses simultaneously complete the third check. This check occurs after the chemotherapy is mixed and before the medication is administered to the patient. The nurses check to verify that the regimen ordered by the physician on the order form reflects the medication label. Both nurses then initial that they have verified the medication. Hospital-based Infusion Services As mentioned previously, the Cancer Center Pharmacy also services the infusion suite at the Helen F. Graham Cancer Center. Located down the hall from the pharmacy, the infusion suite is part of Regional Hematology Oncology, PA, another private practice contracted by the hospital. This ambulatory infusion suite provides care for patients referred by other private practices. Typically, these patients are uninsured or underinsured. The Cancer Center pharmacy mixes chemotherapy and related drugs for this chemo infusion suite. Chemotherapy orders are provided by the patient s oncologist prior to treatment. Medication is prepared for patients when they arrive and have IV access. The Cancer Center pharmacy also provides services for a hospital-based Gynecologic (GYN) Oncology practice. The workflow process for the GYN Oncology practice differs from the MOHC workflow. For the GYN Oncology practice, we fax orders to the pharmacy and verify the orders one week prior to the patient s treatment date. The verification of medication doses is conducted by a pharmacist in a process similar to that followed by MOHC. The drugs Oncology Issues May/June

3 Patient s Name ID Bracelet check : o INFUSION Date IV Access Supervising MD: Medical Oncology Hematology Consultants, PA nursing Flow Sheet o Peripheral o Port o Hickman o PICC o Other: Needle / Catheter size: Blood Return o Yes o No Edema o Yes o No Pain at site o Yes o No Redness o Yes o No Flush w/o Diff o Yes o No Labs: o Blood Draw / Policy and Procedure o Port Flush / Policy and Procedure sig. Drug / Dose / Fluid/ Administration Chemo 3/ 3 Time UP Time Down Vital Signs: Bp pulse resp Lung Sounds temp Initial Pre Chemo Post Chemo Post Treatment Total Input Total Output Pre WT End WT Taxol / Rituximab Time rate Bp pulse Temp (Start then PRN) 15 Min. ml/hr 30 Min. ml/hr 60 Min. ml/hr 90 Min. ml/hr 120 Min. ml/hr 150 Min. ml/hr 180 Min. ml/hr 210 Min. ml/hr 32 Oncology Issues May/June 2009

4 Side Effects Nausea o YES ono o MD Aware Vomiting o YES ono o MD Aware Diarrhea o YES ono o MD Aware Mouth Soreness o YES ono o MD Aware Fatigue o YES ono o MD Aware Constipation o YES ono o MD Aware Loss of appetite o YES ono o MD Aware Hair Loss o YES ono o MD Aware Fever o YES ono o MD Aware Infection o YES ono o MD Aware Numbness/tingling o YES ono o MD Aware Skin changes o YES ono o MD Aware Pain o YES ono o MD Aware Other SE : Explanation Blood Return present during administration o Yes o No Explain: IV access flushed per Policy & Procedure o Yes o No Explain: Access removed o Yes o No Explain: Site w/o complications o Yes o No Explain: Tegaderm Dressing applied o Yes o No Explain: Cap applied o Yes o No Explain: Misc./Comments: Nurses Signature/ Date: are prepared by the pharmacy technicians and checked by a pharmacist on the day of treatment. Medications are prepared between 8:00 am and 9:00 am and delivered to the GYN Oncology practice, which is currently located across the parking lot from the Cancer Center. Transportation picks up and delivers the medication daily. If additional medication needs to be mixed throughout the day, a staff person from the GYN Oncology practice will pick up the medication. The GYN Oncology practice is scheduled to relocate into the Cancer Center in May 2009, as part of the Center s expansion, which will greatly simplify the process. Clinical Trials The Helen F. Graham Cancer Center is a leader in cancer research. Participation in multiple clinical trials requires mixing and dispensing of complex research medications including Phase I trial drugs. The Cancer Center pharmacy is responsible for the ordering, accountability, proper storage, reconstitution, and education of nursing staff on appropriate administration of research drugs. The pharmacy must communicate with research nurses to coordinate research activity. Medication Inventory and Purchasing A separate inventory of medication and supplies is maintained for each program for which the pharmacy provides service, i.e., the Cancer Center, MOHC, the GYN Oncology private practice, and the Cancer Center s clinical trials program. MOHC inventory is ordered by the practice s nurse manager. Medication billing is triggered when the pharmacist removes the medication from the MOHC PYXIS machine. Medication in the PYXIS machine is only available for MOHC use. The hospital-based GYN Oncology practice inventory and the Cancer Center ambulatory infusion suite inventory are ordered through the Christiana Care Health System Oncology Issues May/June

5 The Helen F. Graham Cancer Center T he Helen F. Graham Cancer Center at Christiana Care is a technologically advanced, comprehensive cancer program following the best practices in cancer care, based on the latest medical knowledge, including: State-of-the-science, multidisciplinary treatment plans involving chemotherapy, radiation treatment, surgery, and a full spectrum of cancer-related treatments and therapies Access to research trials through our National Cancer Institute (NCI) sponsored Community Clinical Oncology Program A broad range of programs and services dedicated to cancer prevention and early detection. The Helen F. Graham Cancer Center is one of only 10 cancer centers in the United States selected by the National Cancer Institute to participate in the NCI Community Cancer Centers Program (For more on this program, see the article on page 24). To enhance and strengthen our ability to organize high-quality, coordinated, cost-efficient cancer care, a state-of-the-science, 124,000-square-foot addition to the 60,000-square-foot outpatient cancer center will be completed in May The Helen F. Graham Cancer Center centralizes a vast array of outpatient services under one roof, making care more convenient, efficient, and effective. The Center features unique multidisciplinary medical services that include teams of specialists that patients can see all in one visit including a surgeon, a medical oncologist or hematologist, pharmacy-purchasing program. Medications are billed to each program s cost center and each inventory is kept separately. The GYN Oncology Department is billed directly for all medications ordered by the pharmacy. The department, in turn, bills the patients and/or insurers for medication administered. The Cancer Center ambulatory infusion suite billing is completed when the medication is reconstituted for the patient. Christiana Hospital pharmacy receives payment for medication provided by the ambulatory infusion suite. Research medications are provided by the National Cancer Institute or the pharmaceutical company sponsoring the clinical trial. These organizations have strict rules governing the storage, dispensing, and billing of medication. Legal and Business Implications Relationships between hospitals and physician practices that refer patients to the hospital are governed by several important laws, most notably, the Stark law and the anti-kickback law. These laws and regulations prohibit anyone from providing anything of value in exchange for the referral of patients for designated health services. Failure to adhere to the requirements of these laws can result in severe civil and criminal penalties. Consequently, and a radiation oncologist. Together, these three cancer specialists, in consultation with primary care physicians, and in conjunction with the Cancer Care Management team work to create the most appropriate and effective plan of treatment for cancer. Most of these physicians are members of private physician practices and are not employed by the Cancer Center. Two of the large private practice medical oncology practices lease space from and are located in the hospital-owned cancer center. In addition, the center offers a full complement of associated support services, including: Genetic counseling Nutrition assessment and counseling Psychological counseling Pastoral care Social services Financial counseling Cancer resource library. Translational research studies are extending the boundaries of what we know about cancer. The Helen F. Graham Cancer Center is collecting human tissue samples to help scientists in their laboratories learn more about the growth and development of cancer. The Helen F. Graham Cancer Center is one of two community cancer centers in the country selected to participate in the National Institutes of Health/ National Cancer Institute Cancer Genome Atlas Project. Increased tissue procurement will enhance the resources available for translational research studies that involve the application of basic science toward potential therapies. the business arrangement for hospital pharmacy services provided to a private practice must be carefully structured to assure that all transactions are at fair market value. As stated above, pharmacists and pharmacy technicians working in the Helen F. Graham Cancer Center pharmacy are employees of the hospital-based Cancer Center. Given the complexity of the various programs using the Cancer Center pharmacy, pharmacy staff is required to complete a time-allocation sheet covering one week each month. The Cancer Center charges the medical oncology practice for the time spent by the pharmacy staff, based on their salaries (assessed for fair market value), fringe benefits, and the organization s federally approved overhead cost rate to account for expenses such as space, utilities, and equipment. While complex, partnerships between hospital cancer center-based pharmacists and private medical oncology practices can clearly benefit both care settings. Ketan Patel, RPh, MBA, is a pharmacist and Patrick Grusenmeyer, ScD, FACHE, is senior vice president of Cancer and Imaging Services, Christiana Care Health System, Newark, Del. 34 Oncology Issues May/June 2009