LOG SERVICE CALL

THE VALUE OF CENTRALISED RADIOPHARMACY

UNIT DOSE
PRODUCT SUPPLY
BENEFITS
LOCATIONS

UNIT DOSE

GMS Australia extemporaneously compounds SPECT & PET Radiopharmaceuticals made to order by customers for particular persons.

Unit Dose is GMS's complete solution to all of a Nuclear Medicine Department's radiopharmaceutical needs. The Unit Dose Service provides the right dose at the right place at the right time. Unit dose means that individual doses are prepared, quality assured and packaged for each individual scan. Doses are delivered on time to Nuclear Medicine departments for administration to patients.

The unit dose service includes the retrieval, decay and disposal of all radioactive waste from delivered doses. Unit Dose also includes free use of GMS's Secure Insert system, a safe reliable method for handling and disposal of radioactive sharps.

GMS's unit dose services save you time and money. Scientists can schedule patients more efficiently and respond to patients' needs on very short notice. There is no need to purchase bulk materials and mix individual doses on-site, and no need to worry about wasting time-sensitive radioactive materials, since you order only what you need, when you need it.

Unit Dose is the answer to all of your departments radiopharmaceutical needs. Contact one of our Customer Service Staff to find out how UNIT DOSE is the complete solution for your department.

PRODUCT SUPPLY

GMS Australia extemporaneously compounds SPECT & PET Radiopharmaceuticals made to order by customers for particular persons.

Supply mechanisms for FDG follow a standard product supply agreement, whereas other products are supplied under a Clinical Trial / Contract Manufacturing Agreement(s) or utilising the TGA Special Access Scheme or Authorised Prescriber rules.

None of the products being available for supply to the general public, and are only available to hospitals, doctors and certain other authorised persons.

- All SPECT/PET tracers other than FDG are currently considered by TGA to be unapproved medicines.

- All compounded products by GMS Australia are manufactured to GMP standards in a TGA-licenced manufacturing facility. Where a Pharmacopeia Monograph exists, GMS Australia manufactures to that specification.

- All Clinical Trials must have ethics approval in keeping with NH&MRC guidelines, with an appropriate Clinical Trials Notification (CTN) lodged with TGA.

- SAS A, B & C schemes may be used, depending on the tracer and application. See the TGA website for more information. https://www.tga.gov.au/form/special-access-scheme

- GMS Australia must be supplied with copies of the CTNs or appropriate SAS forms

- GMS Australia provides a regular consolidated report to TGA on the use of unapproved products using the special access scheme, which identifies the sites using such products

In addition to the above, GMS Australia and imaging sites need to have a Supply Agreement in place. We can also provide you with more detailed information on the regulatory requirements mentioned above

UNIT DOSE ENQUIRIES

BENEFITS

STAFF

DEPARTMENT

PATIENT

CONVENIENCE

Improved work flow with read to inject doses delivered daily

Reduced need for in-house compounding of doses that require multiple steps such as heating

No need to complete additional QC on compounded ready-to-inject radiopharmaceuticals

Single point of contacht for all of your department's radiopharmacy needs

Improved utiliisation of staff/resources due to decreased time required for complex compounding

GMS resources available to assist with troubleshooting and quality control enquiries

Reliable supply of compounded radiopharmaceuticals, cold reagent kits & raw materials allows more departments to offer a full suite of NM & related studies

Improved access to a greater range of studies via novel & exclusively licensed tracers - supported by a national radiopharmacy network

QUALITY

National network of TGA/GMP licensed & regulated radiopharmacies supported by a comprehensive regulatory & quality assurance team.

Stringent, validated quality control procedures in alignment with registered PI recommendations reduces need for in-house QC

Mitigate quality related risks via TGA/GMP licensed and pharmacy regulated centralised radiopharmacies

Batch tracked, traceability on all released products

All activity measured using equiopment regularly calibrated to manufacturer's recommendations

Patient's can be assured of the quality of the radiopharmaceuticals being injected

ARTG registered products used in the production of compounded radiopharmaceuticals

Patient safety protected by strict, validated SOP's and industry leading quality assurance measures

EFFICIENCY

Reduced laboratory workload and associated reduction in staff radiation exposure

Supply of ready to inject radiopharmaceuticals means staff can focus on other departmental tasks

Reduction in time spent by staff navigating regulatory issues

Unit dose decreases the need to use an entire cold kit vial for in-house compounding for a single patient

Radioactive waste can be handled more effectively and efficiently

Streamlined access to Section 19, SA, orphan, unregulated & other low-demand products

Department efficiency & patient throughput can be improved by utilising centralised radiopharmacies

The cost of therapeutic & international isotope orders are significantly reduced when ordering through CRP's due to efficiencies of scale and consolidated ordering processes

LOCATIONS