Drug interaction screening in SWOG clinical trials.

PURPOSE: The frequency and process for drug interaction (DI) screening at sites enrolling patients into SWOG clinical trials were studied. METHODS: Survey invitations were e-mailed to 180 SWOG head clinical research associates to determine the frequency of and personnel involved in DI assessment in subjects who were screened for and enrolled in clinical trials at their sites. Descriptive statistics were performed to evaluate the data. RESULTS: A total of 83 surveys recorded a response to at least 1 question, yielding an overall response rate of 46.1%. At least 72 completed surveys were submitted, for a completion rate of 40.0%. The majority of sites (51%) reported that DI screening only occurred during eligibility assessment when a DI was included in the protocol exclusion criteria. The pharmacist was "always" involved in DI screening during eligibility assessment at 17% of sites. Clinical research coordinators (56%) and research nurses (45%) were the predominant personnel who performed DI screening to assess eligibility for trial enrollment. A subset of sites (3-6%) reported not having access to a pharmacist. Fewer than 10% of sites reported that they "always" use drug information services, websites, resources, or literature searches, though many tools were used "often" or "sometimes" by more than 20% of sites. CONCLUSION: A survey revealed that DI screening was not being systematically conducted within SWOG clinical trials. When DI screening did occur, it was primarily conducted by clinical research coordinators or study nurses. Pharmacist-led DI screening was not the current practice within SWOG sites surveyed and was precluded by a lack of pharmacists' availability or involvement.

Survey to assess the role of pharmacy technicians and nonpharmacist staff in the operation of research pharmacies.

PURPOSE: Results of a survey assessing trends and innovations in the use of pharmacy technicians and other nonpharmacist staff in the research pharmacy setting are reported. METHODS: A Web-based survey was distributed to Internet communities of members of the American Society of Health-System Pharmacists and the University Health-System Consortium involved in investigational drug research and related practice areas. The survey collected data on the characteristics of institutions with pharmacy department staff dedicated to such research activities and the participation of pharmacists, technicians, and other staff in key areas of research pharmacy operations. RESULTS: Survey responses from 51 institutions were included in the data analysis. Overall, the reported distribution of assigned responsibility for most evaluated research pharmacy tasks reflected traditional divisions of pharmacist and technician duties, with technicians performing tasks subject to a pharmacist check or pharmacists completing tasks alone. However, some institutions reported allowing technicians to perform a number of key tasks without direct pharmacist supervision, primarily in the areas of inventory management and sponsor monitoring and auditing; almost half of the surveyed institutions reported technician involvement in teaching activities. In general, the reported use of "tech-check-tech" arrangements in research pharmacies was very limited. Some responding institutions reported the innovative use of nonpharmacist staff (e.g., paid interns, students and residents on rotation). CONCLUSION: Although the majority of research pharmacy tasks related to direct patient care are performed by or under the direct supervision of pharmacists, a variety of other essential tasks are typically assigned to pharmacy technicians and other nonpharmacist staff.

Templates of patient brochures for the preparation, administration and safe-handling of oral chemotherapy.

PURPOSE: The increased use of oral chemotherapy for the treatment of cancer introduces new challenges for patients and caregivers. Among them are the ability to swallow oral solid dosage forms, the proper administration of the agents and the safe-handling of chemotherapeutic drugs in the home. Since these drugs are hazardous, proper preparation, administration, and disposition introduces a variety of safety issues. The increased toxicity of these drugs coupled with complicated dosing regimens and the occasional need to dilute the drug or measure a liquid dosage form require careful instruction of the patient and/or caregivers. The purpose of this project was to create templates for writing patient instruction brochures. METHODS: A group of clinicians specializing in oncology from several institutions in the United States and Canada met through a series of conference calls. The group included pharmacists with a specialty in pediatric oncology, investigational drug pharmacists, and an oncology nurse practitioner. National guidelines and practices at each institution were used for the creation of templates to be used in developing templates for medication and formulation-specific instruction brochures. RESULTS: The group developed six templates. The templates ranged in scope from instructions on the administration of intact tablets or capsules to directions on opening capsules or crushing tablets and mixing the content with foods or liquids. Thirty-three drug-specific brochures were developed using the templates. CONCLUSION: Templates of patient brochures and drug-specific brochures on the safe handling of chemotherapy in the home can be created using a collaborative, multi-institutional approach.

Disintegration of chemotherapy tablets for oral administration in patients with swallowing difficulties.

PURPOSE: The administration of oral chemotherapeutic drugs can be problematic in patients with swallowing difficulties. Inability to swallow solid dosage forms can compromise compliance and may lead to poor clinical outcome. The current technique of tablet crushing to aid in administration is considered an unsafe practice. By developing a technique to disintegrate tablets in an oral syringe, the risk associated with tablet crushing can be avoided. The purpose of this study was to determine the feasibility of using disintegration in an oral syringe for the administration of oral chemotherapeutic tablets. Eight commonly used oral chemotherapeutic drugs were tested. METHODS: Tablets were placed in an oral syringe and allowed to disintegrate in tap water. Various volumes and temperatures were tested to identify which combination allows for complete disintegration of the tablet in the shortest amount of time. The oral syringe disintegration method was considered feasible if disintegration occurred in ≤15 min and in ≤20 mL of water and the dispersion passed through an oral syringe tip. RESULTS: The following tablets were shown to disintegrate within 15 min and in <20 mL of water: busulfan, cyclophosphamide 50 mg, dasatinib, imatinib, methotrexate, and thioguanine. For these drugs, drug-specific information pamphlets can be prepared for patient or caregiver use. Mercaptopurine, cyclophosphamide 25 mg, and mitotane tablets did not pass the disintegration test. CONCLUSION: Disintegrating oral chemotherapeutic tablets in a syringe provides a closed system to administer hazardous drugs and allows for the safe administration of oral chemotherapeutic drugs in a tablet form to patients with swallowing difficulties.

Phase II trial of encapsulated ginger as a treatment for chemotherapy-induced nausea and vomiting.

GOALS OF WORK: Ginger has been used to treat numerous types of nausea and vomiting. Ginger has also been studied for its efficacy for acute chemotherapy-induced nausea and vomiting (CINV). However, its efficacy for delayed CINV in a diverse oncology population is unknown. MATERIALS AND METHODS: We performed a randomized, double-blind, placebo-controlled trial in 162 patients with cancer who were receiving chemotherapy and had experienced CINV during at least one previous round of chemotherapy. All participants were receiving a 5-HT3 receptor antagonists and/or aprepitant. Participants were randomized to receive either 1.0 g ginger, 2.0 g ginger daily, or matching placebo for 3 days. The primary outcome was change in the prevalence of delayed CINV. Secondary outcomes included acute prevalence of CINV, acute and delayed severity of CINV, and assessment of blinding. MAIN RESULTS: There were no differences between groups in the prevalence of delayed nausea or vomiting, prevalence of acute CINV, or severity of delayed vomiting or acute nausea and vomiting. Participants who took both ginger and aprepitant had more severe acute nausea than participants who took only aprepitant. Participants were able to accurately guess which treatment they had received. Ginger appeared well tolerated, with no difference in all adverse events (AEs) and significantly less fatigue and miscellaneous AEs in the ginger group. CONCLUSIONS: Ginger provides no additional benefit for reduction of the prevalence or severity of acute or delayed CINV when given with 5-HT3 receptor antagonists and/or aprepitant.

Improving investigational drug service operations through development of an innovative computer system.

PURPOSE: The development of a computerized system for protocol management, dispensing, inventory accountability, and billing by the investigational drug service (IDS) of a university health system is described. SUMMARY: After an unsuccessful search for a commercial system that would accommodate the variation among investigational protocols and meet regulatory requirements, the IDS worked with the health-system pharmacy's information technology staff and informatics pharmacists to develop its own system. The informatics pharmacists observed work-flow and information capture in the IDS and identified opportunities for improved efficiency with an automated system. An iterative build-test-design process was used to provide the flexibility needed for individual protocols. The intent was to design a system that would support most IDS processes, using components that would allow automated backup and redundancies. A browser-based system was chosen to allow remote access. Servers, bar-code scanners, and printers were integrated into the final system design. Initial implementation involved 10 investigational protocols chosen on the basis of dispensing volume and complexity of study design. Other protocols were added over a two-year period; all studies whose drugs were dispensed from the IDS were added, followed by those for which the drugs were dispensed from decentralized pharmacy areas. The IDS briefly used temporary staff to free pharmacist and technician time for system implementation. Decentralized pharmacy areas that rarely dispense investigational drugs continue to use manual processes, with subsequent data transcription into the system. Through the university's technology transfer division, the system was licensed by an external company for sale to other IDSs. CONCLUSION: The WebIDS system has improved daily operations, enhanced safety and efficiency, and helped meet regulatory requirements for investigational drugs.

Stability of a flavored formulation of acetylcysteine for oral administration.

PURPOSE: The chemical and physical stability of a flavored solution of acetylcysteine stored at room temperature or under refrigeration for up to 35 days in amber plastic prescription bottles were studied. METHODS: The flavored acetylcysteine solution was prepared by adding a sweetener and a strawberry creamsicle flavoring to acetylcysteine solution 10% to a final nominal acetylcysteine concentration of 86.5 mg/mL. Six identical samples of the formulation were prepared in amber plastic prescription bottles. Three bottles were stored at room temperature (23-25 degrees C) and the other three were stored in the refrigerator (3-5 degrees C). Immediately after preparation and at 7, 14, 21, 28, and 35 days, each sample was assayed in duplicate by high- performance liquid chromatography. Stability was defined as the retention of at least 90% of the initial drug concentration. RESULTS: On day 35, the refrigerated acetylcysteine samples retained 96.7% of their initial concentration. The samples stored at room temperature retained 92.5% of their initial concentration. CONCLUSION: A flavored oral formulation of acetylcysteine 86.5 mg/mL was stable for at least 35 days when stored at room temperature and in the refrigerator in amber plastic bottles.