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International Nuclear Pharmacy
NUCLEAR PHARMACY
International Nuclear Pharmacy Around the world, nuclear pharmacy practice is evolving in new directions.
Approaches to the practice of nuclear medicine vary greatly around the world. The preparation and delivery of radiopharmaceuticals and the support services provided by nuclear pharmacists also differ significantly. This symposium examined the diverse states of nuclear pharmacy in three geographic areas: Israel, Europe, and Southeast Asia.
Israel Yaakov Cass began the session with a discussion of the state of nuclear pharmacy in Israel, and the story behind the development of two new commercial sites in that country. Approximately 20 hospitals in Israel have nuclear medicine departments, and 17 diagnostic clinics have nuclear medicine units. Until recently, drugs were prepared for patients in nucleat medicine departments by technicians with no pharmaceutical background. Preparations took place in far from ideal conditions. An important move forward was made when, separately, two international companies, Syncor (in partnership with Nahal Soreq, the atomic research center) and Nycomed Amersham (in partnership with Israel Pharmacy Services, or IPS), applied for licenses to operate a "nuclear pharmacy." Each planned to supply unit-dose radioactive medications to hospitals and diagnostic centers. To accomplish this, the companies had to derive ways to build pharmacies complying to both the "opening of new pharmacies act," and the laws relating to handling of radioactive agents.
Based on presentations by Yaakov Cass, regional pharmaceutical officer, Israel Ministry of Health, Jerusalem, Israel; Peter Cox, BSc, PhD, MRPharmS, director, Department of Nuclear Medicine, Daniel den Hoed Cancer Center, Rotterdam, The Netherlands; and Monty Fu, chairman, Board of Directors, Syncor International Corporation, Woodland Hills, Calif.
S64
Supplement to the Journal of the American Phannaceutical Association
Syncor developed a site at Yavne, 25 km south of Tel Aviv, and IPS built one at Rosh Haayin, 20 km north of Tel Aviv. Both designed facilities with special systems for radiological safety and pharmaceutical efficacy. However, the IPS phar. macy was challenged on both legal and technical issues. In response to this, an ad hoc committee was formed to set up guidelines for running safe nuclear pharmacies. A select committee was appointed to write the law pertaining to the opening and running of nuclear pharmacies, including credentials for nuclear pharmacists and superintendents, format and transfer,of prescriptions, quality assurance, and quality control requirements, and protection of product and environment. This . group continues to meet to address these issues. By the time of APhA2000 in March, the two new nuclear pharmacies had been open for 6 months. About 12% of the market in Israel had moved to unit dose, and four diagnostic groups and four hospitals were using the service. At least 30% of the market was expected to move to unit dose by the end of 2000, providing an important role for nuclear pharmacists in Israel.
Europe Next, Peter Cox, PhD, MRPharmS, examined the state of radiopharmacy in Europe. Since the continent encompasses 15 countries and supports a large population, the issues facing nuclear pharmacy are complex. The most difficult problem in Europe has been attempting to standardize an enormous number of programs, each with different origins and organization. With the formation of the European Union (EU), the need to standardize has become both more pressing and more complex. Other areas that the EU must address include good manufacturing practice (GMP), management of nuclear pharmacies, and handling of radiopharmaceuticals. An attempt at establishing central registration for radiopharmacy was frustrated by the September/October 2000 Vol. 40, No.5, Suppl. 1
International Nuclear Pharmacy
expense of the process and, in the end, had a negative effect on the development of nuclear pharmacy on the continent. Further complicating issues is that pharmacists can move from one country to another, but the training required to call oneself a pharmacist may vary between countries. The members of the EU now have agreed on criteria for equivalence and a requisite demonstration of language skills and knowledge of pharmacy laws in the second country. However, the training and recognition of nuclear pharmacists still varies from country to country, and consistent guidelines remain to be developed in this area. Much work remains to be done to bring together and harmonize the often disparate radiopharmacy programs in Europe.
Southeast Asia and Australia Monty Fu turned the focus to Asia and the state of nuclear pharmacy there. He chose to concentrate on five countries because of their size and influence: Japan, South Korea, China, Taiwan, and Australia. He pointed out, first of all, that the size of the market does not necessarily correlate with the way nuclear pharmacy is practiced in a country. For example, Japan, the second largest market for nuclear medicine in the world, has no radiopharmacy practice. On the other hand, Taiwan, with a much smaller market, employs unit-dose services in a system quite similar to that of the United States.
Vol. 40, No.5, Suppl.l
September/October 2000
NUCLEAR PHARMACY
The question of pharmacy praotice versus manufacturing is often an issue in countries where nuclear pharmacy has not previously existed. In some countries, the law requires ownership of a facility by pharmacists to classify it as a pharmacy. Other countries treat nuclear pharmacies as manufacturers and require them to follow current GMPs. Regulatory policies and practices differ in each country, with some demanding registration of every product, including size and dosage form. Some require the radiopharmaceutical kit, not the isotope, to be registered. Training and education requirements for personnel also vary by country. Nuclear pharmacy services differ greatly from country to country in Asia. As each country develops its own approach to this unique medical specialty, influences include: • Supply and demand • Prevalence of certain diseases • Historical practices .. Economics • Politics • Logistical realities As the market grows, a significant evolution in practice patterns can be expected in the countries of Asia and in Australia.
This program was made possible by an unrestricted educational grant from Syncor International Corporation.
Supplement to the Journal of the American Pharmaceutical Association
S65
International Nuclear Pharmacy Around the world, nuclear pharmacy practice is evolving in new directions.
Approaches to the practice of nuclear medicine vary greatly around the world. The preparation and delivery of radiopharmaceuticals and the support services provided by nuclear pharmacists also differ significantly. This symposium examined the diverse states of nuclear pharmacy in three geographic areas: Israel, Europe, and Southeast Asia.
Israel Yaakov Cass began the session with a discussion of the state of nuclear pharmacy in Israel, and the story behind the development of two new commercial sites in that country. Approximately 20 hospitals in Israel have nuclear medicine departments, and 17 diagnostic clinics have nuclear medicine units. Until recently, drugs were prepared for patients in nucleat medicine departments by technicians with no pharmaceutical background. Preparations took place in far from ideal conditions. An important move forward was made when, separately, two international companies, Syncor (in partnership with Nahal Soreq, the atomic research center) and Nycomed Amersham (in partnership with Israel Pharmacy Services, or IPS), applied for licenses to operate a "nuclear pharmacy." Each planned to supply unit-dose radioactive medications to hospitals and diagnostic centers. To accomplish this, the companies had to derive ways to build pharmacies complying to both the "opening of new pharmacies act," and the laws relating to handling of radioactive agents.
Based on presentations by Yaakov Cass, regional pharmaceutical officer, Israel Ministry of Health, Jerusalem, Israel; Peter Cox, BSc, PhD, MRPharmS, director, Department of Nuclear Medicine, Daniel den Hoed Cancer Center, Rotterdam, The Netherlands; and Monty Fu, chairman, Board of Directors, Syncor International Corporation, Woodland Hills, Calif.
S64
Supplement to the Journal of the American Phannaceutical Association
Syncor developed a site at Yavne, 25 km south of Tel Aviv, and IPS built one at Rosh Haayin, 20 km north of Tel Aviv. Both designed facilities with special systems for radiological safety and pharmaceutical efficacy. However, the IPS phar. macy was challenged on both legal and technical issues. In response to this, an ad hoc committee was formed to set up guidelines for running safe nuclear pharmacies. A select committee was appointed to write the law pertaining to the opening and running of nuclear pharmacies, including credentials for nuclear pharmacists and superintendents, format and transfer,of prescriptions, quality assurance, and quality control requirements, and protection of product and environment. This . group continues to meet to address these issues. By the time of APhA2000 in March, the two new nuclear pharmacies had been open for 6 months. About 12% of the market in Israel had moved to unit dose, and four diagnostic groups and four hospitals were using the service. At least 30% of the market was expected to move to unit dose by the end of 2000, providing an important role for nuclear pharmacists in Israel.
Europe Next, Peter Cox, PhD, MRPharmS, examined the state of radiopharmacy in Europe. Since the continent encompasses 15 countries and supports a large population, the issues facing nuclear pharmacy are complex. The most difficult problem in Europe has been attempting to standardize an enormous number of programs, each with different origins and organization. With the formation of the European Union (EU), the need to standardize has become both more pressing and more complex. Other areas that the EU must address include good manufacturing practice (GMP), management of nuclear pharmacies, and handling of radiopharmaceuticals. An attempt at establishing central registration for radiopharmacy was frustrated by the September/October 2000 Vol. 40, No.5, Suppl. 1
International Nuclear Pharmacy
expense of the process and, in the end, had a negative effect on the development of nuclear pharmacy on the continent. Further complicating issues is that pharmacists can move from one country to another, but the training required to call oneself a pharmacist may vary between countries. The members of the EU now have agreed on criteria for equivalence and a requisite demonstration of language skills and knowledge of pharmacy laws in the second country. However, the training and recognition of nuclear pharmacists still varies from country to country, and consistent guidelines remain to be developed in this area. Much work remains to be done to bring together and harmonize the often disparate radiopharmacy programs in Europe.
Southeast Asia and Australia Monty Fu turned the focus to Asia and the state of nuclear pharmacy there. He chose to concentrate on five countries because of their size and influence: Japan, South Korea, China, Taiwan, and Australia. He pointed out, first of all, that the size of the market does not necessarily correlate with the way nuclear pharmacy is practiced in a country. For example, Japan, the second largest market for nuclear medicine in the world, has no radiopharmacy practice. On the other hand, Taiwan, with a much smaller market, employs unit-dose services in a system quite similar to that of the United States.
Vol. 40, No.5, Suppl.l
September/October 2000
NUCLEAR PHARMACY
The question of pharmacy praotice versus manufacturing is often an issue in countries where nuclear pharmacy has not previously existed. In some countries, the law requires ownership of a facility by pharmacists to classify it as a pharmacy. Other countries treat nuclear pharmacies as manufacturers and require them to follow current GMPs. Regulatory policies and practices differ in each country, with some demanding registration of every product, including size and dosage form. Some require the radiopharmaceutical kit, not the isotope, to be registered. Training and education requirements for personnel also vary by country. Nuclear pharmacy services differ greatly from country to country in Asia. As each country develops its own approach to this unique medical specialty, influences include: • Supply and demand • Prevalence of certain diseases • Historical practices .. Economics • Politics • Logistical realities As the market grows, a significant evolution in practice patterns can be expected in the countries of Asia and in Australia.
This program was made possible by an unrestricted educational grant from Syncor International Corporation.
Supplement to the Journal of the American Pharmaceutical Association
S65