Medication therapy management training using case studies and the MirixaPro platform.

OBJECTIVE: To implement and assess a medication therapy management (MTM) training program for pharmacy students using the MirixaPro (Mirixa Corporation, Reston, VA) platform and case studies. DESIGN: Students received lectures introducing MTM and were given a demonstration of the MirixaPro platform. They were divided into teams and assigned cases and times to interview patients portrayed by faculty members. Using the MirixaPro system, students performed 2 comprehensive medication reviews during the semester, recording the patient's current medications, indications, side effects, allergies, health conditions, and laboratory test recommendations and developed a personal medication record and medication action plan. ASSESSMENT: Based on a rubric with a rating scale of 0-10, campus and distance pathway students received mean scores ranging from 6.3-7.4 for their performance on the second MTM exercise, an increase of 47%-54% over the first MTM exercise. In qualitative assessments, the majority of students believed that their confidence in providing MTM was enhanced by the activity, while faculty members recognized the advantage of using MirixaPro, which allowed students to experience what is required in processing a pharmacist led, billable MTM encounter. CONCLUSIONS: Use of the MirixaPro system and patient cases provides students with a "hands-on" experience that may encourage them to promote MTM during their APPEs and provide MTM services as practicing pharmacists.

Establishing an institutional model for the administration of tositumomab and iodine I 131 tositumomab.

Radioimmunotherapy with radiolabeled anti-CD20 antibodies is a promising new treatment approach for low-grade non-Hodgkin's lymphoma. However, the administration of radiolabeled antibodies presents some added complexity. At the University of Nebraska Medical Center (Omaha, NE), an institutional model has been developed that ensures the efficient and safe delivery of tositumomab and iodine I 131 tositumomab (Bexxar; Corixa Corp, South San Francisco, CA and GlaxoSmithKline, Philadelphia, PA). An integrated, multidisciplinary treatment team is responsible for managing all aspects of treatment. Using this model, it is possible to administer tositumomab and iodine I 131 tositumomab safely and effectively in the outpatient setting. Patients can usually be released immediately after treatment. Guidelines and instructions for patient release have been developed and validated and are provided herein. These instructions ensure that radiation exposure of family members and caregivers who are exposed to the patient is maintained as low as reasonably achievable and well within regulatory limits.

Explanations and unresolved issues pertaining to the development of the Nuclear Pharmacy Compounding Guidelines.

OBJECTIVES: To provide background information related to the development of the Nuclear Pharmacy Compounding Guidelines, to discuss regulatory complexities related to radiopharmaceutical compounding practice, and to summarize the gaps in the current compounding regulations for radiopharmaceuticals. DATA SOURCES: The Guidelines closely follow the provisions of section 503A of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the monographs and chapters related to pharmacy compounding in the United States Pharmacopeia (USP), and the recommended guidelines published by the American Society of Health-System Pharmacists. SUMMARY: The Food and Drug Administration Modernization Act (FDAMA) of 1997 established parameters under which the compounding of drug products is appropriate and lawful, but these criteria expressly do not apply to radiopharmaceuticals. The Nuclear Pharmacy Compounding Practice Committee, a group of nuclear pharmacists convened by the American Pharmaceutical Association, developed the Nuclear Pharmacy Compounding Guidelines to establish a set of principles and guidelines for good radiopharmaceutical compounding practice. The intent of the new document is to provide guidance on radiopharmaceutical compounding practices that have evolved over the last 2 decades and to place them in an appropriate regulatory framework in accordance with previous enforcement policies and guidelines issued by the U.S. Food and Drug Administration (FDA) regarding the exemption of certain pharmacy practices from enforcement of adulteration, misbranding, and new drug requirements. CONCLUSION: The Nuclear Pharmacy Compounding Guidelines, recently released by APhA, is the first official document that provides realistic and practical compounding guidance for nuclear pharmacists. Even though the United States Court of Appeals for the Ninth Circuit recently ruled section 503A of the FD&C Act to be invalid in its entirety, and the Supreme Court upheld that ruling, the compliance policy guides issued by FDA in March 1992 and revised in May 2002 maintain guiding principles on pharmacy compounding similar to those stated in section 503A of the FD&C Act. The Nuclear Pharmacy Compounding Practice Committee is optimistic that the practical information contained in the Guidelines will assist state boards of pharmacy, FDA, and the United States Pharmacopeial Convention in setting appropriate standards for nuclear pharmacy compounding practice that will ensure the continued availability of high-quality compounded radiopharmaceuticals at reasonable cost.

Combination therapy for non-Hodgkin's lymphoma: an opportunity for pharmaceutical care in a specialty practice.

OBJECTIVE: To describe the application of pharmaceutical care practices in the administration of new therapeutic radiopharmaceuticals used in the treatment of non-Hodgkin's lymphoma (NHL). PRACTICE DESCRIPTION: At the Antibody Labeling Facility at the University of Nebraska Medical Center, the nuclear pharmacist provides support in the formulation, preparation, and quality testing of radiopharmaceuticals. The nuclear pharmacist also provides direct patient care by assisting in the administration of radiopharmaceuticals, monitoring patients during their infusions, and counseling patients on radioimmunotherapy and radiation safety. PRACTICE INNOVATION: Expanding the role of the nuclear pharmacist in treating patients with NHL using radiolabeled monoclonal antibodies (MABs). INTERVENTIONS: The nuclear pharmacist provides specialized pharmaceutical care by being involved in planning patient care, administering diagnostic and therapeutic radiopharmaceuticals, performing individualized patient dose calculations, monitoring patients, and counseling patients. MAIN OUTCOME MEASURES: Number of patients treated with radiolabeled MABs. RESULTS: Since January 1996, 85 patients with NHL have been treated using 131I-tositumomab (Corixa, GlaxoSmithKline), an anti-B1 MAB, under various clinical research protocols requiring specialized pharmaceutical care. The nuclear pharmacist on the team provided direct patient care, assisting with the administration of diagnostic and therapeutic radiopharmaceuticals under a collaborative agreement with a nuclear medicine physician or a radiation oncologist. Other pharmaceutical care activities performed include calculating individual patient doses, obtaining medication histories, counseling patients on their therapy and on radiation safety after early release, and monitoring patients for adverse effects during medication infusion. Patients have responded favorably to nontraditional nuclear pharmacy activities. CONCLUSION: The nuclear pharmacist has become an important member of the health care team that provides a new and unique therapy for patients with NHL. To date, the nuclear pharmacist, in collaboration with the nuclear medicine physician or the radiation oncologist, has successfully administered the tositumomab and 131I-tositumomab combination therapy without significant incident.