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Raymond N. Dansereau - One of the best experts on this subject based on the ideXlab platform.
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hospital Nuclear Pharmacy a comparison of physician and pharmacist practice
Annals of Pharmacotherapy, 1992Co-Authors: Raymond N. DansereauAbstract:OBJECTIVE:Nuclear Pharmacy is practiced in every hospital with a Nuclear medicine clinic. Pharmacists control this practice in fewer than four percent of these institutions. The authors wish to bring to the attention of hospital pharmacists an area of practice in which they can make a significant contribution to the state of Pharmacy practice.METHOD:The current state of the physician practice of Nuclear Pharmacy is described and compared with the accepted standards of Pharmacy practice.CONCLUSIONS:Hospital pharmacists can improve pharmaceutical care administered in Nuclear medicine by their participation in Nuclear Pharmacy practice and by the application of hospital Pharmacy practice standards. It is also suggested that Nuclear Pharmacy should be integrated into the Pharmacy curriculum at schools of Pharmacy.
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Hospital Nuclear Pharmacy—A Comparison of Physician and Pharmacist Practice
The Annals of pharmacotherapy, 1992Co-Authors: Raymond N. DansereauAbstract:OBJECTIVE:Nuclear Pharmacy is practiced in every hospital with a Nuclear medicine clinic. Pharmacists control this practice in fewer than four percent of these institutions. The authors wish to bring to the attention of hospital pharmacists an area of practice in which they can make a significant contribution to the state of Pharmacy practice.METHOD:The current state of the physician practice of Nuclear Pharmacy is described and compared with the accepted standards of Pharmacy practice.CONCLUSIONS:Hospital pharmacists can improve pharmaceutical care administered in Nuclear medicine by their participation in Nuclear Pharmacy practice and by the application of hospital Pharmacy practice standards. It is also suggested that Nuclear Pharmacy should be integrated into the Pharmacy curriculum at schools of Pharmacy.
Joseph C. Hung - One of the best experts on this subject based on the ideXlab platform.
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Potential Ways to Address Shortage Situations of 99Mo/99mTc.
Journal of nuclear medicine technology, 2017Co-Authors: Leah M. Filzen, Lacey R. Ellingson, Andrew Paulsen, Joseph C. HungAbstract:99mTc, the most common radioisotope used in Nuclear medicine, is produced in a Nuclear reactor from the decay of 99Mo. There are only a few aging Nuclear reactors around the world that produce 99Mo, and one of the major contributors, the National Research Universal (Canada), ceased production on October 31, 2016. The National Research Universal produced approximately 40% of the world's 99Mo supply, so with its shut down, shortages of 99Mo/99mTc are expected. Methods: Nuclear pharmacies and Nuclear medicine departments throughout the United States were contacted and asked to provide their strategies for coping with a shortage of 99Mo/99mTc. Each of these strategies was evaluated on the basis of its effectiveness for conserving 99mTc while still meeting the needs of the patients. Results: From the responses, the following 6 categories of strategies, in order of importance, were compiled: contractual agreements with commercial Nuclear pharmacies, alternative imaging protocols, changes in imaging schedules, software use, generator management, and reduction of ordered doses or elimination of backup doses. Conclusion: The supply chain of 99Mo/99mTc is quite fragile; therefore, being aware of the most appropriate coping strategies is crucial. It is essential to build a strong collaboration between the Nuclear Pharmacy and Nuclear medicine department during a shortage situation. With both Nuclear medicine departments and Nuclear pharmacies implementing viable strategies, such as the ones proposed, the amount of 99mTc available during a shortage situation can be maximized.
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Minimizing human error in radiopharmaceutical preparation and administration via a bar code-enhanced Nuclear Pharmacy management system.
Journal of nuclear medicine technology, 2012Co-Authors: John L. Hakala, Joseph C. Hung, Elton A. MosmanAbstract:UNLABELLED The objective of this project was to ensure correct radiopharmaceutical administration through the use of a bar code system that links patient and drug profiles with on-site information management systems. This new combined system would minimize the amount of manual human manipulation, which has proven to be a primary source of error. The most common reason for dosing errors is improper patient identification when a dose is obtained from the Nuclear Pharmacy or when a dose is administered. A standardized electronic transfer of information from radiopharmaceutical preparation to injection will further reduce the risk of misadministration. METHODS Value stream maps showing the flow of the patient dose information, as well as potential points of human error, were developed. Next, a future-state map was created that included proposed corrections for the most common critical sites of error. Transitioning the current process to the future state will require solutions that address these sites. To optimize the future-state process, a bar code system that links the on-site radiology management system with the Nuclear Pharmacy management system was proposed. A bar-coded wristband connects the patient directly to the electronic information systems. RESULTS The bar code-enhanced process linking the patient dose with the electronic information reduces the number of crucial points for human error and provides a framework to ensure that the prepared dose reaches the correct patient. Although the proposed flowchart is designed for a site with an in-house central Nuclear Pharmacy, much of the framework could be applied by Nuclear medicine facilities using unit doses. CONCLUSION An electronic connection between information management systems to allow the tracking of a radiopharmaceutical from preparation to administration can be a useful tool in preventing the mistakes that are an unfortunate reality for any facility.
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Mayo Clinic Approaches to Meet United States Pharmacopeia Requirements for Facility Design and Environmental Controls of Nuclear Pharmacy
Journal of nuclear medicine : official publication Society of Nuclear Medicine, 2008Co-Authors: Joseph C. Hung, Michelle M. AndersonAbstract:According to the United States Pharmacopeia (USP) General Chapter ,797. (USP ,797.), ‘‘Pharmaceutical Compounding— Sterile Preparations,’’ the compounding facility must be physically designed and environmentally controlled to minimize airborne contamination from contacting critical sites. The goal of the project was to evaluate the appropriateness and effectiveness of our approaches in meeting ,797. requirements. Methods: USP ,797. standards, radiation safety concerns, and work-flow patterns were the focal points in our assessment of 4 laboratories: 2 Nuclear Pharmacy laboratories that engage in preparing sterile (low-, medium-, and high-risk levels), nonsterile, or possible hazardous radioactive drugs and 2 other laboratories in which only low–risk-level preparations are involved. Results: Each laboratory was constructed with a physically separated International Organization for Standardization Class 7 anteroom and clean room to allow us to maintain an appropriate air quality, a consistent operation, and a desirable flexibility. An isolated area within the laboratory was designated for preparing nonsterile products. Higher air change per hour was used in the areas with higher traffic or smaller space. Lead-lined biological safety cabinets (BSCs) were segregated and used depending on the risk category of the preparations. In 1 laboratory, the exhaust flow for the BSC was too great, and a lead-lined compounding aseptic containment isolator (CACI) was installed. Air in the BSC and CACI was 100% exhausted to the atmosphere. 99 Mo/ 99m Tc generators were placed in the negative-pressure clean room to ensure a more efficient operation and cleaner air environment. Clean-room equipment (i.e., keyboards, printers, and telephones) was installed, and refrigerators or freezers and the central-processing unit of each computer were placed outside clean room. Conclusion: Our wide-range preparations of sterile, nonsterile, or potential hazardous radiopharmaceuticals, coupled with the limited space of each laboratory and existing antiquated mechanical systems, presented a challenge. Nevertheless, we successfully remodeled each Nuclear Pharmacy laboratory to meet USP ,797. requirements for facility design and environmental controls.
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Deficiencies of product labeling directions for the preparation of radiopharmaceuticals.
Journal of the American Pharmacists Association : JAPhA, 2004Co-Authors: Joseph C. Hung, James A. Ponto, Katie R. Gadient, Julia A. Frie, Carolyn M. Aksamit, Cassandra L. Enquist, Katie E. CarrelsAbstract:ABSTRACT Objective To identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals. Methods Preparation instructions, which include both reconstitution and quality control (QC) directions, as stated in the package inserts were evaluated for all commercially available reconstituted radiopharmaceuticals. Reviews of the package inserts were initially performed by each author, and then all identified deficiencies were compiled and evaluated by all authors. The preparation scenario for each package insert evaluated was based on a centralized Nuclear Pharmacy operation assuming typical support personnel, standard operating equipment, and workload. Main Outcome Measure The instructions as stated in each package insert for the preparation (including QC) were rated as inadequate if a satisfactory preparation could not be prepared by a Nuclear pharmacist or physician when instructions were followed exactly. Results Identified deficiencies in package insert instructions for the preparation of radiopharmaceuticals fell into the following five categories: (1) absent or incomplete directions (especially with regard to QC procedures); (2) restrictive directions (e.g., specific requirement to use designated needles, chromatography solvents, counting devices), (3) inconsistent directions (e.g., different reconstituted volumes for the same final drug product, unworkable expiration times); (4) impractical directions (e.g., unrealistically low reconstituted activity limits, dangerously high number of radiolabeled particles); and (5) vague directions (e.g., use of the words "should," "may," "recommend"). Conclusion Manufacturers' directions for the preparation of radiopharmaceuticals often contain deficiencies and should be viewed as standard guidance rather than as requirements. Just as physicians are permitted to use U.S. Food and Drug Administration (FDA)-approved drugs for off-label indications, Nuclear pharmacists should be allowed to use alternative methods for preparing radiopharmaceuticals, provided those methods have been validated to be as good as the stated directions and that the Nuclear pharmacists do not engage in activities that fall outside the normal practice of Pharmacy. Manufacturers, FDA, Nuclear pharmacists, and Nuclear physicians should work together to address identified deficiencies in package insert directions.
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Explanations and Unresolved Issues Pertaining to the Development of the Nuclear Pharmacy Compounding Guidelines
Journal of the American Pharmaceutical Association (Washington D.C. : 1996), 2002Co-Authors: Joseph C. Hung, James A. Ponto, David L. Laven, Kenneth T. Cheng, Neil A. Petry, Samuel C. Augustine, Richard L. Green, Wade M. Hopkins, Brigette R. Nelson, Timothy M. QuintonAbstract: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.
Raymond J. Gibbons - One of the best experts on this subject based on the ideXlab platform.
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Optimal conditions of 99mTc eluate for the radiolabeling of 99mTc-sestamibi
Nuclear medicine and biology, 1996Co-Authors: Joseph C. Hung, Thomas J. Herold, Raymond J. GibbonsAbstract:Abstract Our Nuclear Pharmacy has reported that a failed radiochemical purity (RCP) ( i.e., RCP 99m Tc-sestamibi may be associated with the use of a first elution at later stages from a longingrowth time ( i.e. , ⩾ 72 h) wet-column generator. The primary purpose of this study was to evaluate the effects of 99m Tc eluates from wet- and dry-column generators on the RCP of 99m Tc-sestamibi under the above conditions. RCP values were found to be measurably higher and kit failure rates lower with the use of dry-column generator eluate. Using a dry-column generator eluate, Cardiolite ® kits were prepared with 11.10 GBq of 99m Tc at 3, 4, and 5 h postelution and 5.55 GBq at 6, 10, 11, and 12 h postelution. Our data suggest that when 11.10 GBq of 99m Tc from a dry-column generator with ⩾72-h ingrowth was used to prepare 99m Tc-sestamibi, kit failure started to occur using 99m Tc eluate at approximately 4 h postelution. When 5.55 GBq was used to reconstitute the kit, RCP failure began to occur using 99m Tc eluate ~10 h postelution and was likely to occur by 12 h postelution. Dry-column generator eluates have lower kit failures than do wet-column generators; the failure rate can be reduced even further by avoiding the addition of high activities of 99m Tc and long elution times.
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Generator Eluate Effects on the Labeling Efficiency of 99mTc-Sestamibi
Nuclear medicine and biology, 1995Co-Authors: Joseph C. Hung, Thomas J. Herold, Mark E. Wilson, Raymond J. GibbonsAbstract:Abstract Our Nuclear Pharmacy noted that 99m Tc-sestamibi kits sometimes failed radiochemical purity (RCP) testing (i.e., RCP 99m Tc activity and eluate volume were then investigated to help explain the reason for the low RCP values. Our results demonstrated that higher failure rates of the 99m Tc-sestamibi kits were noted when higher activities of 99m Tc eluates were added, and the higher failure rates of the kits were associated with lower RCP values. In addition, higher kit failure rate and lower RCP values of the 5.55-GBq kits at 12 h postelution in comparison with the 11.1-GBq kits at 6 h (same eluate volume) indicated that the 99m Tc activity and volume had a less detrimental effect on the 99m Tc-sestamibi kit preparation than the 99m Tc eluate age. The kit failures might be explained by the higher amount of 99m Tc and the production of the free radicals during the long ingrowth time prior to generator elution. In conclusion, the use of a first elution from a long-ingrowth time generator at a later stage (i.e., 11.1 GBq at 6 h and 5.55 GBq at 12 h postelution) in preparation of a 99m Tc-sestamibi kit is associated with a high rate of kit failure and should therefore be avoided.
Blaine Smith - One of the best experts on this subject based on the ideXlab platform.
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Comprar Nuclear Pharmacy Concepts and applications in Nuclear Pharmacy | Blaine Smith | 9780853698661 | Pharmaceutical Press
2010Co-Authors: Blaine SmithAbstract:Tienda online donde Comprar Nuclear Pharmacy Concepts and applications in Nuclear Pharmacy al precio 40,83 € de Blaine Smith, tienda de Libros de Medicina, Libros de Farmacia - Farmacia
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comprar Nuclear Pharmacy concepts and applications in Nuclear Pharmacy blaine smith 9780853698661 pharmaceutical press
2010Co-Authors: Blaine SmithAbstract:Tienda online donde Comprar Nuclear Pharmacy Concepts and applications in Nuclear Pharmacy al precio 40,83 € de Blaine Smith, tienda de Libros de Medicina, Libros de Farmacia - Farmacia
Donald C. Mcleod - One of the best experts on this subject based on the ideXlab platform.
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Pharmacotherapy. Part IV. The future of specialization and certification in Pharmacy.
DICP : the annals of pharmacotherapy, 1990Co-Authors: Donald C. McleodAbstract:THE DEVELOPMENT OF Pharmacy SPECIALTIES is not completed with Nuclear Pharmacy, clinical nutrition, and pharmacotherapy. There will be two prominent pressures coming to the forefront. One already exists within pharmacotherapy: the pressure to fractionate pharmacotherapy into pediatrics, geriatrics, oncology, infectious diseases, adult medicine, family medicine, and so forth. The other pressure will be the dissatisfaction of the large number of pharmacists who will not be eligible for specialty status in the three current specialties. A similar dissatisfaction occurred in medicine among the thousands of general practitioners who did not qualify to be internists or pediatricians. This disenfranchisement resulted in the creation of the family medicine specialty, now the largest of medical specialties. Professional organization aspirations and politics will play a key role in the eventual specialty lineup. With the pharmacotherapy specialty now in the hands of the American College of Clinical Pharmacy, the American Society of Hospital Pharmacists (ASHP) will be even more anxious to see narrow clinical specialties approved, i.e., those it can reasonably sponsor. The ASHP has a difficult course ahead. The Board of Pharmaceutical Specialties (BPS) has already declared that specialties will not be based on administrative functions or location of practice. This apparently leaves out hospital Pharmacy directors and supervisory personnel and the thousands of pharmacists working in drug-distribution services and lower-level clinical activities. The old camaraderie within hospital Pharmacy in the pre-1975 era has eroded and will be even more stressed when most practitioners are still left out of a few new specialties to come. This disparity has been widened by the employment of thousands of entry-level pharmacists (those with B.S. or Pharm.D. degrees with no residency) to perform largely technical and low supervisory functions in drug-distribution control. There is no clear way out of this without a quick and thorough dedication to meaningful education and career development for Pharmacy technicians. As long as high school graduates are hired one day and put in the sterile compounding service the next, the university education of pharmacists will be wasted and professional growth thwarted. The American Pharmaceutical Association (APhA), with some 50 000 members, curiously has no strategic plan to encourage specialization. Its flagship group, the Academy of Pharmaceutical Sciences, was badly torpedoed by the new American Association of Pharmaceutical Scientists in 1986. The APhA is in a struggle with NARD for community Pharmacy, has lost hospital Pharmacy, and never had clinical Pharmacy. With thought to this confused background, I will speculate liberally on the future of specialties and certification in Pharmacy. My thoughts are not constrained by the current policies of the BPS, organizations' status quo, or educational shortcomings; this analysis is concerned only with where we could go, not exactly how we can get there. These are my assumptions about the future of specialization in Pharmacy: 1. Practice specialties will be built upon the Pharm.D. degree as the educational base (this can be entrylevel Pharm.D., or Pharm.D. after B.S. in Pharmacy). 2. By implication above, new B.S.-degree pharmacists have no specialization future unless they enter a Pharm.D. program or recognized graduate program in the specialty area, i.e., M.S. program in Nuclear Pharmacy. The five-year B.S. could be reduced to four years to train pharmacists to function as drugcontrol supervisors. These graduates could not be heads of institutional or clinical services, but would have to report to a pharmacist with the Pharm.D. degree or other certified specialist. 3. M.S. programs would still be feasible, but hospital Pharmacy and other practice-oriented programs would be only for pharmacists holding the entry Pharm.D. degree. 4. Current practitioners with B.S. degrees will be needed to do what they now do in the transition period of several decades.
