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Nuclear Pharmacy: Yesterday Reviewed Today
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NU'C LEAR PHARMACY
Nuclear Pharmacy: Yesterday Reviewed Today The specialty of nuclear pharmacy owes its success today to the hard work, innovation, and dedication of early pioneers.
This session focused on the critical events that led to the formation of the Section on Nuclear Pharmacy as a section of the American Pharmaceutical Association (APhA) Academy of Pharmacy Practice and Management. It also examined the development of the practice concepts that underlie today's specialty nuclear pharmacy services.
Formation of the Section on Nuclear Pharmacy Rodney D. Ice, PhD, began his presentation by noting that in the 1960s, nuclear medicine and the use of radiopharmaceuticals were increasing in popularity. The few pharmacists who were involved varied in their backgrounds, training, and practice sites. They met informally at professional nuclear medicine meetings to share information and concerns about the forces affecting their practice. The need soon became apparent for a national professional organization devoted to nuclear pharmacy - an organization that would emphasize communication and professional development as well as review the regulations and pending legislation that could adversely affect nuclear pharmacy. To ascertain interest in such an organization, a questionnaire was developed and distributed through a national newsletter. Based on those results, the APhA was asked to sponsor a I-day session on nuclear pharmacy, which was held August 8, 1974 in Chicago at the APhA Annual Meeting. That session stimulated the generation of a formal petition for the formation of the Section on Nuclear Pharmacy in the Academy of General Practice (currently, the Academy of Pharmacy Practice and Management). The petition was approved in San Francisco on April 23, 1975. The formation of the Section on Nuclear Pharmacy was an important step toward recognition of nuclear pharmacists by regulatory agencies and as members of the health care team associated with radiopharmaceuticals.
Task Analysis-Standards of Practice Ron Calahan, PhD, BCNP, described another early task facing nuclear pharmacy: the development of documentation S68
Supplement to the Journal of the American Phannaceutical Association
describing the responsibilities of a practitioner. A committee was formed to list the numerous daily functions of a nuclear pharmacy practitioner, and these efforts resulted in a list of 343 separate tasks in several general areas of practice. Nuclear pharmacy practitioners around the country assessed and validated the list. The finalized document was adopted in 1978 and published as "Nuclear Pharmacy Practice Standards." This document served as the basis for developing a petition for recognition of nuclear pharmacy as a specialty practice by the Board of Pharmaceutical Specialties (BPS). The document has undergone several revisions and exists currently as "Nuclear Pharmacy Practice Guidelines."
Nuclear Pharmacy Specialization Process James F. Cooper, PharmD, reviewed the various factors that stimulated the process for recognition of nuclear pharmacy as a specialty practice in pharmacy. Recognition was necessary because of regulatory issues that threatened the rights of a nuclear pharmacist to compound radiopharmaceuticals as part of pharmacy practice. Specialty recognition also would enhance the identity needed by nuclear pharmacy educators and practitioners alike. Furthermore, nuclear pharmacy most clearly satisfied the criteria for recognition that were established by the BPS. A 16-member committee was formed to address the criteria for specialization. Kenneth R. Hetzel, who was then affiliated with the University of Michigan, assembled input from committee members into a petition, which included letters of support from physicians that added considerable strength. The BPS approved the petition in 1978. The BPS created the Council on Nuclear Pharmacy. The Council was responsible for establishing knowledge areas, determining requirements for eligibility to sit for board certification, preparing an examination, and setting scores for passing. Many members of the Section on Nuclear Pharmacy participated in preparing questions (item writing) for the Council to consider. This important task encouraged members to be September/October 2000
Vol. 40, No.5, Suppl.l
Nuclear Pharmacy: Yesterday Reviewed Today
actively involved in professional affairs within the Section. The examination process has been described in depth. 1 The first examination for board certification in nuclear pharmacy was given simultaneously in Atlanta and Las Vegas on April 24,
1982.
Early Years at the NIH Radiopharmacy Captain Ray Farkas, U.S. PHS (Ret), provided a brief history of the establishment of the National Institutes of Health (NIH) radiopharmacy. Shortly after joining the staff at the NIH in Bethesda, Md., Captain (then Lieutenant Commander) William (Bill) H. Briner was approached by physicians to aid in the provision of radioactive compounds for use in patients. Briner agreed but insisted that these products be under the control of the pharmacist, who would certify them as quality drug products. Briner developed protocols for the preparation and assurance of safety for radioactive drugs, and was a leader in developing quality control procedures to assure products could be administered safely to patients. He developed the NIH Radiopharmacy that exists today, realizing, in 1961, the establishment of a centralized radiopharmacy with a designated space and budget. Manyoutstanding nuclear pharmacists received their training while working under Briner in the NIH Radiopharmacy, and many commonly accepted services performed by nuclear pharmacists originated there.
The Concept of Centralized Nuclear Pharmacy Richard Keesee, PharmD, discussed the evolution of the centralized nuclear pharmacy. The basic premise of a commercial, centralized nuclear pharmacy is that it exists as part of a retail pharmacy, recognized by a state board of pharmacy, with licensed pharmacists who are authorized users of radioactive materials. A centralized nuclear pharmacy also is unique in offering service on a 24-hour basis every day of the year. Regulatory concerns were common in the early years of centralized nuclear pharmacy. A particular problem was the U.S. Food and Drug Administration (FDA) view that centralized nuclear pharmacies were manufacturing operations. Briner was key in aiding nuclear pharmacy in establishing pharmacy practice guidelines that were acceptable to FDA. Other individuals also Were important to the success of centralized nuclear pharmacies including: Cannen Bliss, dean of the College of Pharmacy at the University of New Mexico, who offered support to develop the concept of a commercial, centralized nuclear pharmacy; Thomas Gnau created a record-keeping system that is the basis for those now used in centralized nuclear pharmacies; William J. Baker, after finishing a residency under Gnau, brought this system to the University of New Mexico. The Board of Pharmacy of New Mexico was the first to issue a permit to a pharmacy intending to dispense radioactive drugs. The issue of a license to operate Vol. 40, No.5, Suppl. 1
September/October 2000
NUCLEAR PHARMACY
Panelists
Rodney D. Ice, PhD Principal Research Scientist Georgia Institute of Technology Atlanta, Ga. Ron Calahan, PhD, BCNP Director of Nuclear Pharmacy Massachusetts General Hospital Boston, Mass. James F. Cooper, PharmD Scientific Director and Founder Endosafe, Inc. Charleston, S.C. Capt. Ray Farkas, U.S. PHS (Ret) Nuclear Pharmacist U.S. Food and Drug Administration Division of Medical Imaging and Radiopharmaceutical Drug Products Rockville, Md. Richard Keesee, PharmD Consultant Syncor International Carlsbad, Calif. Mark Hebner President Index Funds Advisors, Inc. Newport Beach, Calif. Walter Wolf, PhD Distinguished Professor of Pharmaceutical Sciences Director, Pharmacokinetic Imaging Program University of Southern California School of Pharmacy Los Angeles, Calif. Gerald A. Bruno, PhD President SL Ventures Wyckoff, N.J. Dennis Hoogland, PhD Consultant Durango, Colo. This session was coordinated by Clyde Cole, RPh, nuclear pharmacy manager, Nycomed Amersham, Chicago, ill.; Stanley Shaw, PhD, professor of nuclear pharmacy, Purdue University School of Pharmacy, West Lafayette, Ind.; and James F. Cooper, PharmD, scientific director and founder, Endosafe, Inc., Charleston, S.C.
Supplement to the Journal of the American Pharmaceutical Association
S69
NUCLEAR PHARMACY Nuclear Pharmacy: Yesterday Reviewed Today
from the Atomic Energy Commission was another key event in the development of centralized nuclear pharmacies.
Marketing Centralized Nuclear Pharmacy Mark Hebner, founder of Pharmatopes, Inc., recounted that in the early days of marketing centralized nuclear pharmacy services, pharmacists first had to determine the available market. Initially, this was accomplished through searching a directory of health care instituti~ns to identify hospitals with large nuclear medicine departments. To aid in the preparation and dispensing of radiopharmaceutical doses, the first computer program for a cen~alized nuclear pharmacy was developed in 1977. As the company increased in size, national advertising was prepared and social events were offered at national meetings. The company was successful because of teamwork, complementary skills, capital investment, and hard-working, dedicated employees. Timing was important to success, because nuclear medi,cine was growing rapidly when the centralized nuclear pharmacies were created.
Master of Science (MS) in Radiopharmacy Walter Wolf, PhD, reviewed the development of the MS in radiopharmacy. The University of Southern California radiopharmacy training program was' funded in 1968 and initiated its first formal MS degree in radiopharmacy in 1969. The first class of students was selected based on their experience in pharmacy, maturity, and desire to innovate. Although those involved in nuclear medicine supported the concept of specialization, some pharmacists were concerned that the field would be divided by specialization. From its inception, the focus of the MS program was to develop drug (radiopharmaceutical) specialists who would become members of the nuclear medicine team, serving as experts in selecting products and providing other clinical pharmacy services. In the future, radiopharmacy is expected to expand beyond diagnostic radiopharmaceuticals to encompass other imaging modalities, such as positron emission tomography, as well as pharmacodynamics, therapeutic radiopharmaceuticals, and patient-specific antibodies.
Radiopharmaceutical Industry Gerald A. Bruno, PhD, reviewed important developments during the 10-year period from 1965 to 1975, before the more formal recognition of the practice of nuclear pharmacy. During this period, the field of nuclear medicine experienced dramatic changes that laid the foundation for current practice. One force . contributing to this change was the development of new radiopharmaceuticals with superior physical characteristics ideally suited for use with gamma camera instrument technology. 870
Supplement to the Journal of the American Phannaceutical Association
Bruno described his first assignment as head of the Squibb Radiopharmaceutical Research and Development Department, which was to develop a sterile Mo-99/Tc-99m generator that would deliver pharmaceutical grade Tc-99m that the end-user could use without further processing. The result of this rapid development program was a relatively crude and cumbersome generator design that satisfied Squibb's stringent pharmaceutical manufacturing controls and yielded a sterile, pyrogen-free solution of sodium pertechnetate, suitable for human use. The sterile Mo-99/Tc-99m generator was a major contributing factor to the dramatic change and growth in the routine practice of nuclear medicine that occurred in the 1970s and 1980s. The sterile Mo-99/Tc-99m generator was developed and brought to market in less than a year-and without the benefit of computers and sophisticated nuclear detection and analysis instruments. These limitations were, however, more than offset by the lack of regulatory controls that allowed market introduction without an extensive approval process. Generator design was improved substantially as use of Mo-99ITc-99m became more widespread. In later years, innovative generator designs, coupled with the use of fission product Mo-99, resulted in more compact packaging that allowed better shielding and reduced radiation exposure to personnel using the generator. Squibb pioneered the development of sterile kits for the onsite preparation of Tc-99m radiopharmaceuticals. The availability of kits played a major role in the growth of nuclear medicine and stimulated the development of the commercial nuclear pharmacy industry.
Unique Products and Services Dennis Hoogland, PhD, reviewed the involvement of nuclear pharmacists in the preparatiqn of radiopharmaceuticals for use in clinical trials. QualIty control procedures were used to assure that the product was acceptable for administration to patients. Supplying investigational radioactive drugs to hospitals within the metropolitan area was a significant endeavor and contribution within nuclear pharmacy. As these presenters made clear in their varied historical accounts, the modem specialty of nuclear pharmacy owes its success to the creativity, commitment, and perseverance of its early pioneers. These pathfinders serve as an inspiration to the many current practitioners who are forging new directions in this growing specialty practice. This program was made possible by an unrestricted educational grant from Nycomed Amersham.
Reference 1. Grussing PG, Allen DR, Callahan RJ, et al. Development of pharmacy's first specialty certification examination: nuclear pharmacy. Am J Pharm Ed. 1983;47:11-8.
September/October 2000
Vol. 40, No.5, Suppl. 1
NU'C LEAR PHARMACY
Nuclear Pharmacy: Yesterday Reviewed Today The specialty of nuclear pharmacy owes its success today to the hard work, innovation, and dedication of early pioneers.
This session focused on the critical events that led to the formation of the Section on Nuclear Pharmacy as a section of the American Pharmaceutical Association (APhA) Academy of Pharmacy Practice and Management. It also examined the development of the practice concepts that underlie today's specialty nuclear pharmacy services.
Formation of the Section on Nuclear Pharmacy Rodney D. Ice, PhD, began his presentation by noting that in the 1960s, nuclear medicine and the use of radiopharmaceuticals were increasing in popularity. The few pharmacists who were involved varied in their backgrounds, training, and practice sites. They met informally at professional nuclear medicine meetings to share information and concerns about the forces affecting their practice. The need soon became apparent for a national professional organization devoted to nuclear pharmacy - an organization that would emphasize communication and professional development as well as review the regulations and pending legislation that could adversely affect nuclear pharmacy. To ascertain interest in such an organization, a questionnaire was developed and distributed through a national newsletter. Based on those results, the APhA was asked to sponsor a I-day session on nuclear pharmacy, which was held August 8, 1974 in Chicago at the APhA Annual Meeting. That session stimulated the generation of a formal petition for the formation of the Section on Nuclear Pharmacy in the Academy of General Practice (currently, the Academy of Pharmacy Practice and Management). The petition was approved in San Francisco on April 23, 1975. The formation of the Section on Nuclear Pharmacy was an important step toward recognition of nuclear pharmacists by regulatory agencies and as members of the health care team associated with radiopharmaceuticals.
Task Analysis-Standards of Practice Ron Calahan, PhD, BCNP, described another early task facing nuclear pharmacy: the development of documentation S68
Supplement to the Journal of the American Phannaceutical Association
describing the responsibilities of a practitioner. A committee was formed to list the numerous daily functions of a nuclear pharmacy practitioner, and these efforts resulted in a list of 343 separate tasks in several general areas of practice. Nuclear pharmacy practitioners around the country assessed and validated the list. The finalized document was adopted in 1978 and published as "Nuclear Pharmacy Practice Standards." This document served as the basis for developing a petition for recognition of nuclear pharmacy as a specialty practice by the Board of Pharmaceutical Specialties (BPS). The document has undergone several revisions and exists currently as "Nuclear Pharmacy Practice Guidelines."
Nuclear Pharmacy Specialization Process James F. Cooper, PharmD, reviewed the various factors that stimulated the process for recognition of nuclear pharmacy as a specialty practice in pharmacy. Recognition was necessary because of regulatory issues that threatened the rights of a nuclear pharmacist to compound radiopharmaceuticals as part of pharmacy practice. Specialty recognition also would enhance the identity needed by nuclear pharmacy educators and practitioners alike. Furthermore, nuclear pharmacy most clearly satisfied the criteria for recognition that were established by the BPS. A 16-member committee was formed to address the criteria for specialization. Kenneth R. Hetzel, who was then affiliated with the University of Michigan, assembled input from committee members into a petition, which included letters of support from physicians that added considerable strength. The BPS approved the petition in 1978. The BPS created the Council on Nuclear Pharmacy. The Council was responsible for establishing knowledge areas, determining requirements for eligibility to sit for board certification, preparing an examination, and setting scores for passing. Many members of the Section on Nuclear Pharmacy participated in preparing questions (item writing) for the Council to consider. This important task encouraged members to be September/October 2000
Vol. 40, No.5, Suppl.l
Nuclear Pharmacy: Yesterday Reviewed Today
actively involved in professional affairs within the Section. The examination process has been described in depth. 1 The first examination for board certification in nuclear pharmacy was given simultaneously in Atlanta and Las Vegas on April 24,
1982.
Early Years at the NIH Radiopharmacy Captain Ray Farkas, U.S. PHS (Ret), provided a brief history of the establishment of the National Institutes of Health (NIH) radiopharmacy. Shortly after joining the staff at the NIH in Bethesda, Md., Captain (then Lieutenant Commander) William (Bill) H. Briner was approached by physicians to aid in the provision of radioactive compounds for use in patients. Briner agreed but insisted that these products be under the control of the pharmacist, who would certify them as quality drug products. Briner developed protocols for the preparation and assurance of safety for radioactive drugs, and was a leader in developing quality control procedures to assure products could be administered safely to patients. He developed the NIH Radiopharmacy that exists today, realizing, in 1961, the establishment of a centralized radiopharmacy with a designated space and budget. Manyoutstanding nuclear pharmacists received their training while working under Briner in the NIH Radiopharmacy, and many commonly accepted services performed by nuclear pharmacists originated there.
The Concept of Centralized Nuclear Pharmacy Richard Keesee, PharmD, discussed the evolution of the centralized nuclear pharmacy. The basic premise of a commercial, centralized nuclear pharmacy is that it exists as part of a retail pharmacy, recognized by a state board of pharmacy, with licensed pharmacists who are authorized users of radioactive materials. A centralized nuclear pharmacy also is unique in offering service on a 24-hour basis every day of the year. Regulatory concerns were common in the early years of centralized nuclear pharmacy. A particular problem was the U.S. Food and Drug Administration (FDA) view that centralized nuclear pharmacies were manufacturing operations. Briner was key in aiding nuclear pharmacy in establishing pharmacy practice guidelines that were acceptable to FDA. Other individuals also Were important to the success of centralized nuclear pharmacies including: Cannen Bliss, dean of the College of Pharmacy at the University of New Mexico, who offered support to develop the concept of a commercial, centralized nuclear pharmacy; Thomas Gnau created a record-keeping system that is the basis for those now used in centralized nuclear pharmacies; William J. Baker, after finishing a residency under Gnau, brought this system to the University of New Mexico. The Board of Pharmacy of New Mexico was the first to issue a permit to a pharmacy intending to dispense radioactive drugs. The issue of a license to operate Vol. 40, No.5, Suppl. 1
September/October 2000
NUCLEAR PHARMACY
Panelists
Rodney D. Ice, PhD Principal Research Scientist Georgia Institute of Technology Atlanta, Ga. Ron Calahan, PhD, BCNP Director of Nuclear Pharmacy Massachusetts General Hospital Boston, Mass. James F. Cooper, PharmD Scientific Director and Founder Endosafe, Inc. Charleston, S.C. Capt. Ray Farkas, U.S. PHS (Ret) Nuclear Pharmacist U.S. Food and Drug Administration Division of Medical Imaging and Radiopharmaceutical Drug Products Rockville, Md. Richard Keesee, PharmD Consultant Syncor International Carlsbad, Calif. Mark Hebner President Index Funds Advisors, Inc. Newport Beach, Calif. Walter Wolf, PhD Distinguished Professor of Pharmaceutical Sciences Director, Pharmacokinetic Imaging Program University of Southern California School of Pharmacy Los Angeles, Calif. Gerald A. Bruno, PhD President SL Ventures Wyckoff, N.J. Dennis Hoogland, PhD Consultant Durango, Colo. This session was coordinated by Clyde Cole, RPh, nuclear pharmacy manager, Nycomed Amersham, Chicago, ill.; Stanley Shaw, PhD, professor of nuclear pharmacy, Purdue University School of Pharmacy, West Lafayette, Ind.; and James F. Cooper, PharmD, scientific director and founder, Endosafe, Inc., Charleston, S.C.
Supplement to the Journal of the American Pharmaceutical Association
S69
NUCLEAR PHARMACY Nuclear Pharmacy: Yesterday Reviewed Today
from the Atomic Energy Commission was another key event in the development of centralized nuclear pharmacies.
Marketing Centralized Nuclear Pharmacy Mark Hebner, founder of Pharmatopes, Inc., recounted that in the early days of marketing centralized nuclear pharmacy services, pharmacists first had to determine the available market. Initially, this was accomplished through searching a directory of health care instituti~ns to identify hospitals with large nuclear medicine departments. To aid in the preparation and dispensing of radiopharmaceutical doses, the first computer program for a cen~alized nuclear pharmacy was developed in 1977. As the company increased in size, national advertising was prepared and social events were offered at national meetings. The company was successful because of teamwork, complementary skills, capital investment, and hard-working, dedicated employees. Timing was important to success, because nuclear medi,cine was growing rapidly when the centralized nuclear pharmacies were created.
Master of Science (MS) in Radiopharmacy Walter Wolf, PhD, reviewed the development of the MS in radiopharmacy. The University of Southern California radiopharmacy training program was' funded in 1968 and initiated its first formal MS degree in radiopharmacy in 1969. The first class of students was selected based on their experience in pharmacy, maturity, and desire to innovate. Although those involved in nuclear medicine supported the concept of specialization, some pharmacists were concerned that the field would be divided by specialization. From its inception, the focus of the MS program was to develop drug (radiopharmaceutical) specialists who would become members of the nuclear medicine team, serving as experts in selecting products and providing other clinical pharmacy services. In the future, radiopharmacy is expected to expand beyond diagnostic radiopharmaceuticals to encompass other imaging modalities, such as positron emission tomography, as well as pharmacodynamics, therapeutic radiopharmaceuticals, and patient-specific antibodies.
Radiopharmaceutical Industry Gerald A. Bruno, PhD, reviewed important developments during the 10-year period from 1965 to 1975, before the more formal recognition of the practice of nuclear pharmacy. During this period, the field of nuclear medicine experienced dramatic changes that laid the foundation for current practice. One force . contributing to this change was the development of new radiopharmaceuticals with superior physical characteristics ideally suited for use with gamma camera instrument technology. 870
Supplement to the Journal of the American Phannaceutical Association
Bruno described his first assignment as head of the Squibb Radiopharmaceutical Research and Development Department, which was to develop a sterile Mo-99/Tc-99m generator that would deliver pharmaceutical grade Tc-99m that the end-user could use without further processing. The result of this rapid development program was a relatively crude and cumbersome generator design that satisfied Squibb's stringent pharmaceutical manufacturing controls and yielded a sterile, pyrogen-free solution of sodium pertechnetate, suitable for human use. The sterile Mo-99/Tc-99m generator was a major contributing factor to the dramatic change and growth in the routine practice of nuclear medicine that occurred in the 1970s and 1980s. The sterile Mo-99/Tc-99m generator was developed and brought to market in less than a year-and without the benefit of computers and sophisticated nuclear detection and analysis instruments. These limitations were, however, more than offset by the lack of regulatory controls that allowed market introduction without an extensive approval process. Generator design was improved substantially as use of Mo-99ITc-99m became more widespread. In later years, innovative generator designs, coupled with the use of fission product Mo-99, resulted in more compact packaging that allowed better shielding and reduced radiation exposure to personnel using the generator. Squibb pioneered the development of sterile kits for the onsite preparation of Tc-99m radiopharmaceuticals. The availability of kits played a major role in the growth of nuclear medicine and stimulated the development of the commercial nuclear pharmacy industry.
Unique Products and Services Dennis Hoogland, PhD, reviewed the involvement of nuclear pharmacists in the preparatiqn of radiopharmaceuticals for use in clinical trials. QualIty control procedures were used to assure that the product was acceptable for administration to patients. Supplying investigational radioactive drugs to hospitals within the metropolitan area was a significant endeavor and contribution within nuclear pharmacy. As these presenters made clear in their varied historical accounts, the modem specialty of nuclear pharmacy owes its success to the creativity, commitment, and perseverance of its early pioneers. These pathfinders serve as an inspiration to the many current practitioners who are forging new directions in this growing specialty practice. This program was made possible by an unrestricted educational grant from Nycomed Amersham.
Reference 1. Grussing PG, Allen DR, Callahan RJ, et al. Development of pharmacy's first specialty certification examination: nuclear pharmacy. Am J Pharm Ed. 1983;47:11-8.
September/October 2000
Vol. 40, No.5, Suppl. 1