Nuclear Pharmacists Research Articles

Second Wave of COVID-19 Pandemic in Malaysia and the Impact on Nuclear Cardiology Services: An Institutional Experience

Introduction: Nuclear cardiology applying radioactive tracer and hybrid imaging techniques are able to provide information needed to detect and evaluate ischaemic heart diseases. In our centre, nuclear cardiology services involving stress and rest myocardial perfusion scans and viability studies contribute about 40% of overall scan workload. The second wave of COVID- 19 pandemic in Malaysia announced by the end of February 2020 has affected nuclear cardiology services.Objectives: Our aims were to determine the impact of COVID-19 pandemic second wave on the nuclear cardiology imaging studies performed as well as to ascertain crucial institutional experience especially unavoidable problem and adjustment during the period.Methods: A review of Technetium-99m tetrofosmin radiopharmaceutical dispensing data and scan records for 1st February to 31st August 2019 and 2020 was conducted at Nuclear Medicine Department, Hospital Kuala Lumpur. Figures were compiled and statistical analysis done. Survey and focus discussion conducted involving nuclear medicine physicians, pharmacists and physic officers to identify the main difficulty faced and most important Job-adapting measure taken.Results: A total of 1109 cardiac radiopharmaceutical doses dispensed during the studied period but were less when compared to 1342 doses dispensed last year. Significant reduction was noted in April and May 2020 with only 69 and 67 cases respectively in comparison with monthly average of 192 cases in 2019. Although some scan appointments were postponed to avoid the usual waiting area congestions, the main difficulty faced was Technetium-99m generator supply disruption with limited production in Europe and international transportation restriction. Implementing infection control standard operating procedure (SOP) instructions as part of routine work practice with emphasis of time, distance and shielding concept was the most important Job-adapting measure.Conclusion: Nuclear cardiology services were affected by the second wave of COVID-19 pandemic locally. Main problem ascertained was disruption of radioactive supply. Most important adjustment was infection control SOP implementation.International Journal of Human and Health Sciences Supplementary Issue: 2021 Page: S25

Legacies begun, legacies continued

Legacies begun, legacies continued

In vivo Time-Dependent Radio-Protective Effect of Lycopene Against Whole-Body Gamma Radiation in Mice

Background: Ionizing radiation has become an essential part of modern medicine. However, applying the effective dose of ionizing radiation is compromised by its inevitable radiation-induced damage to normal tissues. Natural products with free radical scavenging, antioxidant activities, and immune stimulatory effects offer suitable radio-protective effects. Objectives: This study was designed to evaluate the in vivo radio-protective activity of lycopene, a naturally dietary carotenoid, against whole-body gamma-irradiation-induced mortality and sickness in mice. Methods: In this animal experimental study, lycopene was extracted from tomato paste, characterized, and then administered to mice. Consecutively, 80 healthy adult male mice were recruited and irradiated individually, and then monitored for irradiation sickness and survival parameters. Results: Pretreatment with 7 mg/kg dose of lycopene 7 days before irradiation was found to reduce the severity of symptoms of radiation sickness in a 30-day post-radiation monitoring. Lycopene treatment increased the survival rate. At the radiation dosage of 8 and 9 Gy, the difference between the survival rates of control and sample groups became significant after day 15 and 25. Lycopene was also shown to have a protective effect on white blood cell count against 8 and 9 Gy gamma radiations. Conclusions: Natural and exhibiting whole-body radio-protective activity, lycopene can be proposed as an effective radio-protector in healthy people who are exposed to radiation, such as radiographers, nuclear pharmacists, and radiologists.

Pharmacists in Action: A minute with …; Joint Federal Pharmacy Seminar; free publications from APhA; nuclear pharmacists

Pharmacists in Action: A minute with …; Joint Federal Pharmacy Seminar; free publications from APhA; nuclear pharmacists

APhA2016; Advanced Preceptor Training; APhA member spotlight; BPS specialty certification

APhA2016; Advanced Preceptor Training; APhA member spotlight; BPS specialty certification

New milestone: More than 20,000 pharmacists hold BPS certification

The Board of Pharmacy Specialties (BPS) has reached new heights, with the total number of board-certified pharmacists now at 21,560 following administration of the fall 2014 examination—an increase of 12% from 2013. Exceeding 20,000 board-certified pharmacists is a very important milestone for BPS, demonstrating that BPS credentials are sought by an increasing number of pharmacists and recognized by employers around the globe.

Knowledge about the availability of the pharmacist in the Nuclear Medicine Department: A questionnaire-based study among health-care professionals.

Objective:The objective of this study was to analyze the knowledge about the availability of the pharmacist in the nuclear medicine department among health-care professionals through a prospective cohort study.Methods:A total of 741 health-care professionals participated in the study by answering 10 simple questions about the role of the pharmacist in the nuclear medicine department and the availability of pharmacist in the nuclear medicine department. An online questionnaire system was used to conduct the study, and participants were invited to participate through personal communications and by promoting the study through social websites including Facebook, LinkedIn and Google (including Gmail and Google+). The study was conducted between April 2013 and March 2014 using the http://www.freeonlinesurveys.com/Webserver. Finally, the data provided by 621 participants was analyzed. Group frequency analysis was performed using Statistical Package for the Social Sciences (SPSS) version 16 (SPSS Inc. USA).Results:The participants were from Malaysia, India, Pakistan, Sri Lanka, Bangladesh, UAE and Nepal. In total, 312 (50.2%) female health-care professionals and 309 (49.8%) male health-care professionals participated in the study. Of the 621 participants, 390 were working in hospitals, and 231 were not working in hospitals. Of the participants who were working in hospitals, 57.6% were pharmacists. The proportion of study participants who were aware of nuclear pharmacists was 55.39%. Awareness about the role of the pharmacist in nuclear medicine was poor.Conclusion:The role of the pharmacist in a nuclear medicine unit needs to be highlighted and promoted among health-care professionals and hence that the nuclear medicine team can provide better pharmaceutical care.

Clinical Pharmacist in Nuclear Medicine: A New Role in Ascendancy

Nuclear pharmacy is a unique branch of pharmacy services that focuses on the proper, safe management and use of radiopharmaceuticals. Most of pharmacist spent their time in traditional services while few renders clinical services in hospital setting even recruitment and regulatory body also demand undergraduate qualification which may find insufficient to render services. It is a matter of question how many provides clinical or pharmaceutical care? But spending a time in clinical activities by pharmacist is an issue of debate. After satisfactory completion of project in this area, attempt has been made by this article to explore our perception on scope, education and functions of pharmacist especially by hospital and by clinical pharmacist. How pharmacist can perform pharmaceutical care in this unique service area is discussed and responsibilities of pharmacist in nuclear pharmacist are proposed.

BPS certifications continue to expand rapidly

The Board of Pharmacy Specialties (BPS) recently reported that a total of 3,247 pharmacists successfully passed the 2013BPS specialty certification and recertification examinations. There are now 19,109BPS board-certified pharmacists, representing an increase of almost 21% from 2012.

The faces of pharmacy: Students and pharmacists stepping forward

The faces of pharmacy: Students and pharmacists stepping forward

Power boost: Nuclear pharmacists essential to the Mass General patient care team

Power boost: Nuclear pharmacists essential to the Mass General patient care team

Nuclear pharmacists cope with isotope shortage

A long-standing shortage of technetium 99m (99mTc) generators has nuclear pharmacists changing their methods so that patients can receive critical imaging studies. “We’ve done things like reducing the dosages that we’re providing for the studies, which means that oftentimes the imaging procedure takes a little bit longer,” said George Hinkle, professor of pharmacy and director of nuclear pharmacy at Ohio State University Medical Center in Columbus. In addition, he said, “we’ve shifted some of our diagnostic studies that would typically use a technetium 99 product to using another radionuclide, one that’s not in critical shortage because it’s not made by a nuclear reactor.” According to FDA, 99mTc is used in about 80% of all nuclear imaging studies done in the United States. Until last year, nearly all of the U.S. supply of molybdenum 99, the parent nuclide of 99mTc, was produced by two nuclear reactors—one in Chalk River, Ontario, and another in Petten, the Netherlands. The rest came from other nuclear reactors outside the United States.

TH‐SAMS‐AUD B‐01: The Good, The Bad and the Ugly — A Regulatory Update

There have been a number of new NRC orders that impact unescorted access to Category 1 and 2 materials such as gamma knife and blood irradiators. Fingerprinting and FBI background checks must now be done. In addition, 10 C.F.R. Part 35 requires that a preceptor statement be signed by an individual that is an Authorized medical Physicist, Radiation Safety Officer, Authorized User or Authorized Nuclear Pharmacist. Recently the Nuclear Regulatory Commission (NRC) has issued findings against signors of preceptor statement for falsifying information. This session will address the liabilities of medical physicists in signing preceptor states, in serving as the “trustworthy and reliable” official for a license in determining unescorted access. It will address differences in non‐agreement states and agreement states.Finally, the AAPM has a policy statement that states: in essence to practice medical physics you must have a masters or Ph.D. and be board certified in one of the disciplines of medical physics. There are four states that required licensure of medical physicists for a number of years. The final talk in this session will look at whether or not having licensure has made a difference in the quality of medical physics practiced and the ramifications of the new Part 35 requirements for training and experience.

Deficiencies of Product Labeling Directions for the Preparation of Radiopharmaceuticals

To identify potential deficiencies in product labeling (package insert) instructions for the preparation of radiopharmaceuticals. 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. 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. 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"). 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.

Organization of a health-system pharmacy team to respond to episodes of terrorism

The role of a pharmacy emergency response team (PERT) trained to respond to episodes of terrorism involving chemical, biological, radiological, and nuclear (CBRN) agents is described. Pharmacists must be prepared to support their health systems in responding to episodes of terrorism by detecting exposure to CBRN agents and mitigating, treating, and preventing casualties resulting from exposure to those agents. Maimonides Medical Center, whose pharmacists responded to the medical and pharmaceutical needs of victims of the World Trade Center attacks and anthrax exposures, has developed the PERT, modeled after the Health Emergency Incident Command System, to standardize the response of their pharmacists in the event of such an attack. Each team member has a specific role and can assume any other team member's role, if needed. Key players in the PERT include the pharmacy administrator, drug information pharmacist, intensive care unit pharmacist, infectious diseases pharmacist, nuclear pharmacist, management-information-system pharmacist, hazardous materials pharmacist, and auxiliary-site pharmacist. The most important features of this disaster response model include activating the PERT to establish command and control in the pharmacy department, conducting a disaster-needs analysis, deploying PERT members in support of the medical center during a public health emergency involving CBRN agents while maintaining normal operations in the pharmacy, and maintaining, mobilizing, distributing, and receiving a pharmaceutical stockpile while ensuring that timely antidotes are available and used appropriately when distributed. The PERT allows for a comprehensive pharmacy response within a health system to episodes of terrorism involving CBRN agents.

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

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. 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. 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. 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.

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). 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. Expanding the role of the nuclear pharmacist in treating patients with NHL using radiolabeled monoclonal antibodies (MABs). 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. Number of patients treated with radiolabeled MABs. 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. 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.

Strategies for Recruiting, Incentivizing, and Retaining Nuclear Pharmacists: Confronted with an acute shortage of nuclear pharmacists, companies need to take creative steps to win the war for talent.

Strategies for Recruiting, Incentivizing, and Retaining Nuclear Pharmacists: Confronted with an acute shortage of nuclear pharmacists, companies need to take creative steps to win the war for talent.

Strategies for Recruiting, Incentivizing, and Retaining Nuclear Pharmacists: Confronted with an acute shortage of nuclear pharmacists, companies need to take creative steps to win the war for talent.

Strategies for Recruiting, Incentivizing, and Retaining Nuclear Pharmacists: Confronted with an acute shortage of nuclear pharmacists, companies need to take creative steps to win the war for talent.

The Role of the Practice of Nuclear Pharmacy in Positron Emission Tomography

As nuclear medicine evolved from an obscure research tool to a mainstream clinical diagnostic and therapeutic modality, so has the role of the practice of pharmacy in nuclear medicine also evolved. A similar evolution is unfolding today in the practice of positron emission tomography (PET). The skills of many diverse professionals, including pharmacists, are essential for the safe and efficient operation of a modern PET facility. The importance of the role of pharmacists in PET has been increasing as the use of PET radiopharmaceuticals has matured from research to clinical to commercial arenas. While it is clear that pharmacists can contribute clinical and technical skills to the operation of a PET center, perhaps one of the most important factors influencing the increased role of pharmacists in PET is their expertise and experience in the drug regulatory process. The commercial distribution of PET radiopharmaceuticals, primarily [ 18F]2-fluorodeoxyglucose (FDG), is currently being performed by a variety of corporate and institutional facility partnerships, with the likelihood of several new players entering the marketplace in the near future. This factor has served to dramatically increase the role for nuclear pharmacy in PET. The practice of nuclear pharmacy is a well-established component of PET. The role of nuclear pharmacists in PET is complementary to the many other professionals currently practicing in this specialty. With the rapidly increasing clinical demand for FDG imaging, it is likely that the number of facilities and institutions entering into the commercial distribution of PET radiopharmaceuticals will also increase. Such growth will also serve to solidify and expand the role for the practice of nuclear pharmacy in PET.