July 25, 2013
Dear Sir,
RE: OPTIONS FOR REFORM OF THE REGULATORY FRAMEWORK FOR
PHARMACY COMPOUNDING : Consultation regulation impact statement.
I am responding to the above mentioned consultation focusing only on
Radiopharmaceuticals not including cyclotron Positron Emission Tomography
(PET) radiopharmaceuticals.
In line with the legislative process in the State of Victoria, Radiopharmacists have
to be pharmacists who are registered by the Pharmacy Board of Australia (PBA)
and licensed to handle radioactive materials by the Radiation Safety Section of
the Department of Health of Victoria (DOH). They compound and dispense
radiopharmaceuticals in a pharmacy specifically approved by the Victorian
Pharmacy Authority (VPA) for handling such radioactive pharmaceuticals. DOH
licenses the pharmacy to possess, handle, sell and transport radioactive
materials.
As the majority of radiopharmaceutical have to be compounded to order on a
daily basis (due to the short shelf lives of the radiopharmaceutical), I am
concerned that regulations for pharmacy compounding may not be appropriate
for radiopharmaceuticals, potentially reducing the positive effects of such a
community service. Possibilities that could occur if radiopharmacists are unable
to provide this service include nuclear medicine departments attempting to
compound radiopharmaceuticals themselves (with no true radiopharmacy
expertise) or the removal of procedures by nuclear medicine service providers
altogether, hence disadvantaging the Australian community in many ways.
Radiopharmaceuticals are a unique group of drugs that contain a radioactive
nuclide and are used predominantly for diagnostic purposes. Due to the extreme
sensitivity of the detection modality, they are applied in tracer amounts and
therefore have shown an excellent safety profile. Adverse reactions are
extremely rare; moreover radiopharmaceuticals are administered solely in a
clinical environment and usually only a few times in a patient’s lifetime. Recent
years have seen great development in molecular imaging technologies to
dramatically improve patient care, especially in oncology by the use of molecular
imaging based protocols using radiopharmaceuticals. Commercial products are
available but those with a very short half-life need to be prepared
extemporaneously and are used shortly after preparation. A major difference to
other pharmaceuticals prepared lies in the specific environment where the
radioactive drugs have to be handled.
A radiopharmacist is responsible for compounding and working with the various
radiopharmaceuticals used in therapies for cancer and other malignant
conditions. Since a radiopharmacist works with radioactive medicines they are
required to follow very strict policies and procedures when working with the
compounds. A radiopharmacist must be effective at determining which
radioactive markers are most appropriate for diagnosis or treatment of different
conditions. A strong chemistry and microbiology background is considered an
asset for radiopharmacists. Accurate and effective monitoring and tracking of all
radiopharmaceuticals used in the laboratory or pharmacy is also critically
important for a radiopharmacist.
Extemporaneous compounding and dispensing of radiopharmaceuticals by
qualified radiopharmacists is an important community service for the following
reasons
a) a number of radiopharmaceuticals have been withdrawn from the Australian
market, mainly because of financial reasons, not safety or efficacy reasons,
b) there are internationally available radiopharmaceuticals that will not be
registered in Australia because of the high costs of registrations and the limited
return on investments and,
c) there are instances when a radiopharmaceutical has to be prepared different
from TGA approved methods to suit a different need. An example is DMSA (dimercaptosuccinic acid) approved for renal imaging, but when the pH is raised
above 8 with pH intervention, it is more useful in the diagnosis of osteosarcoma.
Although the need for TGA approval for supply of these medicines is addressed
in the exemption stated in Schedule 5 of the Therapeutic Regulations, it is the
appropriate people responsible for compounding these products who need to be
allowed to do so. Very few nuclear medicine departments have radiopharmacists
working there.
In the State of Victoria, a radiopharmacist has to be a registered pharmacist who
is also eligible to hold a radiation license to handle unsealed radioactive sources.
This means that each radiopharmacist has the necessary requirements to be a
licensed pharmacist in addition to extra study and training to satisfy both the
PBA and DOH to handle radioactive pharmaceuticals. Most radiopharmacists
work with an experienced radiopharmacist initially when they begin working for
a pharmacy or laboratory.
As nuclear medicine procedures became more widely used, the need for
someone to prepare the labeled products for administration to the patients
became more evident. While many large hospitals are able to use pharmacists
with training in the handling of radioactive material, smaller sites are unable to
utilize nuclear medicine procedures because they do not have the qualified or
experienced staff to prepare the necessary radiopharmaceutical. A centralized
radiopharmacy serves as the compounding pharmacy for nuclear medicine
departments. When a particular radioactive material is needed, a trained
radiopharmacist will be available to prepare the product and dispense it to the
end user, the licensed nuclear medicine physician.
In most radiopharmacies, the radiopharmacist is responsible for obtaining the
desired radioactive material, either from a manufacturer, or from an in house
generator system. The most commonly used isotope in nuclear medicine is
Technetium-99m that is readily and continuously available from a generator
system. After performing quality assurance tests on the eluate, it can be used in
the preparation of the final radiopharmaceutical products. With over 100
different nuclear medicine procedures performed today, there are many
different products that can be used. Most radiopharmaceuticals are available as
"kit" formulations. All materials necessary for preparation are available in the
nonradioactive kit with the exception of the radioactive isotope. When the
radioactive isotope is added to the kit, the chemical reactions required for
binding the isotope occur within the vial. In most cases, when the tagging
reaction is complete, the final product will be ready for quality control
verification and unit dose dispensing. Since radiopharmacy practice involves the
on-site compounding of most of the products being dispensed, each product that
is compounded in the radiopharmacy must be tested prior to dispensing any
individual doses. When the radiochemical purity of the compounded product is
verified, it can be dispensed for use in patients.
An approved radiopharmacy especially in the State of Victoria has to be
approved as a Pharmacy by VPA as well as DOH. As a pharmacy for compounding
and dispensing sterile products, the facility must be appropriate to provide
adequate protection for the compounding and dispensing of such and for a
facility handling radioactive materials, the facility must provide proper
protection for both the environment and personnel in radiation safety matters.
Unlike a traditional pharmacist who will generally dispense the prescription to
the patient, the radiopharmacist is only allowed to dispense to a licensed nuclear
medicine physician in an accredited nuclear medicine facility where the dose will
be administered to the patient. The inherent differences in unique practice of
radiopharmacy compared to traditional pharmacy along with the separate class
of pharmaceuticals used warrants its designation as a specialty pharmacy
practice. The most striking would be the fact that radioactive material is being
used to create the final products. The radiopharmacist is extensively trained in
radiopharmaceuticals and their associated products for use in nuclear medicine
as well as the radiation safety and other aspects specific to the compounding and
preparation of radioactive materials
The issues raised in this consultation paper do not apply to
radiopharmaceuticals, with the exception of cyclotron produced PET
radiopharmaceuticals as:
1. Radiopharmaceuticals are not compounded in bulk due to the nature of
the radioactive content (ie: limited shelf life once compounded). They are
compounded on order for immediate use and dispensed only to
accredited and licensed nuclear medicine sites for licensed nuclear
medicine specialists to administer to their patients.
2. Radiopharmacists are specialist pharmacists trained and approved by
both PBA and their respective State or Territory Radiation Safety
regulatory body to handle radioactive materials. Radiopharmacists have
to satisfy both bodies that they are capable of performing their duties in
compounding and dispensing radiopharmaceuticals. Furthermore, any
misadministration of radiopharmaceuticals are reportable to the relevant
State or Territories Department of Health because of the nature of the
radioactive element in the radiopharmaceutical. In the absence of
radiopharmacists, non pharmacist personnel may step in to provide this
service which may not be in the best interests of the community as they
may lack the specific training of radiopharmacists or the procedure/s not
provided at all to the detriment of diagnostic imaging services to the
community.
3. Radiopharmacies have to be a) approved by the relevant Pharmacy
authorities to provide the appropriate pharmacy services and b) licensed
by the relevant Radiation Safety authorities to handle radioactive
materials in a safe manner.
The risks raised here are virtually non existent for radiopharmaceuticals when
properly compounded and dispensed by qualified radiopharmacists. All
radiopharmaceuticals compounded are required to meet the specifications of the
British Pharmacopoeia. The radiopharmaceuticals (both carrier pharmaceutical
and radioactivity) are compounded, quality assured and dispensed to a nuclear
medicine physician’s order. These are dispensed directly to the licensed nuclear
medicine facility for an accredited nuclear medicine physician to administer to
his patient. As these are tracer products for diagnostic imaging, the biological
distribution of the carrier pharmaceutical is very quickly determined.
Furthermore, all radioactivity at the site is checked before patient
administration. The expiry of radiopharmaceuticals is very easily noted
especially when the radioactivity present is constantly decaying and up to a
point, usually within the same day of its preparation is no longer usable.
The community exposure risk is greater if performed by other than
radiopharmacists in approved radiopharmacies. Radiopharmaceuticals are not
covered by the PBS but are included as part of the Medicare Rebate for a
diagnostic nuclear medicine procedure. In most instances, the
radiopharmaceutical is specified for the scan for the Medicare Rebate to be
applied. Furthermore, these products have to be dispensed to an accredited
nuclear medicine facility for a licensed nuclear medicine specialist to administer.
In reviewing the three options suggested, the interests of the community both as
patients and the nuclear medicine profession can be better served by allowing
qualified radiopharmacists to provide radiopharmaceuticals in approved
radiopharmacies on specific orders from a licensed nuclear medicine physician
and dispensed to an accredited nuclear medicine facility for administration to
their patient.