5.4 Authorisation Patient-specific authorisation is required for initial and continuing access to the supply of government-funded immunoglobulin products. An overview of the process for authorisation is in Figure 1 – Authorisation process diagram. AUTHORISATION PROCESS CCLLIINNIICCAALL DDIIAAGGNNOOSSIISS OBTAIN PATIENT PRIVACY CONSENT CREATE AUTHORISATION REQUEST SUBMIT REQUEST RECEIVE DECLINED NOTIFICATION APPROVED NO CRITERIA ASSESS REQUEST ELIGIBLE FOR FUNDED IG? YES RECORD AUTHORISATION IN BLOODSTAR Figure 1 – Authorisation process diagram Request for authorisation A request for authorisation for a patient is initiated by the treating clinician through BloodSTAR. The treating clinician must be registered in the system as an approved prescriber and initiates a request by entering relevant patient and diagnosis details and supporting substantiation, as prompted by the system, to enable an assessment of eligibility to be made against the Criteria. This includes information to allow a substantiated assessment to be made against requirements such as: indication for use – the purpose for which therapy would be considered, to prevent or manage a particular manifestation of the disease qualifying criteria – patient selection, particular disease characteristics, disease severity, requirements for other treatments to have been demonstrably unsuccessful before Ig is considered exclusion criteria – specific indications and circumstances where Ig should not be used dose and frequency – specific to the indications and circumstances to aim for the minimum dose to achieve optimum clinical outcome for the patient. Additional access rules apply for SCIg and NHIg as detailed at appendices A and B, respectively. Authorisation assessment The Australian Red Cross Blood Service (Blood Service) is contracted by the NBA to process all requests for authorisation and has the role of authoriser. When a prescriber completes a request for authorisation in BloodSTAR, the request is electronically referred to the Blood Service for consideration. Authorisation is established in BloodSTAR through an assessment of eligibility against the Criteria, as described above. Patients may be authorised for a single one-off dose or course of treatment over a number of months. The prescriber is notified electronically of the decision by the authoriser. If the request is authorised, the requested dispensing facility or dispenser, is also notified of the details of an authorisation through BloodSTAR.
declining authorisation for access to product where the qualifying criteria are not met determining and allocating product type (Australian or imported product), in accordance with agreed local and national arrangements, if required. 6.6 Distributor The distributor’s responsibilities include holding and managing appropriate inventory, receiving product orders, distributing product to dispensers and ensuring product integrity during transportation. These responsibilities are discussed in more detail below. Holding and managing appropriate inventory The distributor is responsible for planning and managing an appropriate inventory for distribution in accordance with government-agreed standards for timely distribution. Receiving product orders The distributor’s responsibilities include: accepting product orders from dispensers via BloodNet (or alternative arrangements if necessary) supporting dispensers in the timely supply of replacement product in emergency situations. Distributing product to dispensers The distributor is responsible for distributing the ordered product in accordance with the agreed service requirements and standards. Ensuring product integrity during transportation The distributor ensures product integrity by: ensuring all blood products are transported in dedicated and designated insulated containers advising blood couriers and dispensers on the appropriate transportation, storage and handling of product to maintain cold chain integrity in accordance with the required product- specific temperature conditions providing advice regarding management of the product that breaches cold chain integrity. 6.7 Dispenser The dispenser’s responsibilities include ordering product from the distributor appropriate to clinical demand, ensuring product cold integrity, dispensing product for authorised patients only, applying appropriate inventory management practices, and reporting. These are discussed in more detail Ordering product from the distributor appropriate to clinical demand Responsibilities include: coordinating product ordering from the distributor on clinical demand for authorised patients, as specified in the prescription by the prescriber and subsequent blood product order, with consideration of inventory holdings placing product orders and receipt orders in BloodNet (or making alternative arrangements if necessary)
8. DEFINITIONS AND ACRONYMS This table of definitions and acronyms is specifically intended for interpretation of terms in relation to this policy and associated processes. Term Acronym Related terms Definition Adverse event A harmful or serious reaction to immunoglobulin product administration requiring further treatment that should be reported within the hospital and to the Therapeutic Administration (TGA), the Authoriser and Suppliers, as appropriate. Allocation Allocation of product to patients based on available domestic and imported immunoglobulin product, taking into account supply security reserve levels endorsed by governments to ensure sufficiency of supply Alternative therapy Substitute therapy Other clinical treatments that can be substituted for immunoglobulin therapy to a condition (i.e. plasma exchange). Australian Health Ministers’ Advisory Council AHMAC The council provides support to the COAG Health Council (CHC), by advising health ministers on strategic matters relating to the coordination of health services. AHMAC considers blood sector matters referred to it by the Jurisdictional Blood Committee (JBC) through the Hospitals Principle Committee, and reports as necessary to the CHC. Australian Red Blood Service Blood Service The organisation that collects, processes and distributes and blood components sourced from voluntary Australian blood donors. Authorisation The process for assessing eligibility for access to immunoglobulin products funded the national blood arrangements based on the Criteria. Authorisation date The point at which the patient is approved for initial qualifying or continuing immunoglobulin treatment. Patients will be authorised for a single dose or period of continuing treatment according to the Criteria.
Term Acronym Related terms Definition Authorisation request A form containing details of a patient and their medical condition for which a prescriber wishes to prescribe immunoglobulin treatment, used to obtain initial access to the supply of government-funded immunoglobulin product. Authoriser A person or responsible for overseeing authorisation requests for immunoglobulin products and delegating the approval or rejection of an authorisation request. BloodNet A web-based system that allows staff in health providers (hospitals) across Australia to order and receipt blood and blood products. BloodSTAR A web-based system that facilitates authorisation for access and management of immunoglobulin products for the treatment of medical conditions identified in the Criteria. Condition Diagnosis Clinical conditions are categorised according to the quality of the available evidence and whether immunoglobulin treatment is considered beneficial. Contraindicated A situation where therapy should not be used because it may be harmful to the patient. Council of Australian Governments Health Council CHC The CHC is responsible for overseeing and managing the blood sector. It sets the governance, policy and financial frameworks under which the NBA operates. Criteria for the clinical use of intravenous immunoglobulin in Australia, Second Edition 2012. Criteria Identifies the indications for which IVIg is funded under national blood arrangements by all Australian governments; the book is not a medical or clinical guideline on treatment of the indications listed. Regular review of the Criteria is needed to align funded access to IVIg with the latest evidence, or in the case of limited evidence, a consensus of expert opinion. Diagnostic conditions Condition determined from medical examination of signs and symptoms and other investigations.