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National Health Amendment (Fifth Community Pharmacy Agreement Initiatives) Bill 2012

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2010-2012

 

 

 

THE PARLIAMENT OF THE COMMONWEALTH OF AUSTRALIA

 

 

 

 

SENATE

 

 

 

 

 

 

 

 

 

 

 

NATIONAL HEALTH AMENDMENT

(FIFTH COMMUNITY PHARMACY AGREEMENT INITIATIVES)

BILL 2011

 

 

 

 

 

REVISED EXPLANATORY MEMORANDUM

 

 

 

 

 

 

 

(Circulated by authority of the Minister for Health,

the Hon Tanya Plibersek MP)

 

 

 

THIS MEMORANDUM TAKES ACCOUNT OF AMENDMENTS MADE BY THE HOUSE OF REPRESENTATIVES TO THE BILL AS INTRODUCED





NATIONAL HEALTH AMENDMENT (FIFTH COMMUNITY PHARMACY AGREEMENT INITIATIVES) BILL 2011

 

OUTLINE

The Fifth Community Pharmacy Agreement (Fifth Agreement) between the Australian Government and the Pharmacy Guild of Australia commenced on 1 July 2010.  The Fifth Agreement provides funding for a number of professional pharmacy programs to be implemented in community pharmacy sector. 

This Bill will support the implementation of two new initiatives funded through the Fifth Community Pharmacy Agreement, ‘Continued Dispensing of Pharmaceutical Benefits Scheme (PBS) Medicines in Defined Circumstances’ and ‘Supply and PBS Claiming from a Medication Chart in Residential Aged Care Facilities’.  The Bill will enable pharmacists to claim pharmaceutical benefits where the following types of supply have occurred:

a)         a pharmaceutical benefit has been provided by an approved pharmacist to a patient, in accordance with specific conditions, where a patient is unable to present a valid prescription.

b)         eligible medicines have been provided from a standardised medication chart for persons receiving care in a residential care services.  The PBS prescriber will not be required to prepare a separate PBS/RPBS prescription form for these supplies.

The Bill also makes some technical changes which will support efficient prescribing practices for certain authority required medicines, and determination of rules for decisions about increased quantities and repeats.

Financial Impact Statement

Funding of up to $1 million for the Continued Dispensing of PBS Medicines in Defined Circumstances initiative and up to $3 million for the Supply and PBS claiming from a Medication Chart in Residential Aged Care Facilities initiative is included under the Fifth Agreement.

The funding included in the Fifth Agreement was approved by the Department of Finance and Deregulation as part of the Agreement negotiations and announced as part of the 2010-2011 Budget.

The funding allocation to each initiative is for implementation purposes only and covers the development, education materials and training as well as a review of the initiative.  There is no ongoing funding for either of these initiatives. There is no expected further financial impact as a result of the implementation of these initiatives.

The Continued Dispensing initiative introduces an additional mechanism to trigger supply of pharmaceutical benefits where a prescription is not available.  In these circumstances, prior to this initiative being implemented, pharmacists would have the option to undertake the supply via a communicated prescription and therefore this initiative should have no impact on PBS growth as volumes for these medicines will not be affected.

The technical amendments in Schedule 3 concerning prescriptions for the supply of pharmaceutical benefits have no financial implications.



NATIONAL HEALTH AMENDMENT (FIFTH COMMUNITY PHARMACY AGREEMENT INITIATIVES) BILL 2011

 

 

NOTES ON CLAUSES

 

Clause 1 - Short Title

This clause provides that the Bill, once enacted, may be cited as the National Health Amendment (Fifth Community Pharmacy Agreement Initiatives) Act 2011 .

Clause 2 - Commencement

This clause provides that the Bill commences on Royal Assent and the Schedules to the Bill commence on the dates specified (1 July 2012).

Clause 3 - Schedule(s)

This clause provides that each Act that is specified in a Schedule to this Bill is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item has effect according to its terms.  Schedules 1, 2 and 3 amend the National Health Act 1953 .

 

SCHEDULE 1 —    CONTINUED DISPENSING OF PHARMACEUTICAL BENEFITS

Item 1

Paragraph 89(b)

This item entitles a person to receive a pharmaceutical benefit without a prescription where the requirements of the new section 89A have been met.

Item 2

89A   When pharmaceutical benefits may be supplied by approved pharmacists without prescription

Under this item the pharmacist must be satisfied that certain conditions have been met prior to undertaking a supply in accordance with this section.  The specific conditions which must be met as well as the limited pharmaceutical benefits eligible to be supplied will be set out in a legislative instrument.

The Act contemplates that a pharmaceutical benefit can only be supplied upon presentation of a prescription or in limited circumstances when a prescription is communicated orally.  Subsection 89A(1) creates a new section that provides for an exception enabling an approved pharmacist to supply a pharmaceutical benefit in the absence of a prescription.  Subsection 89A(2) operates to deem a record created at the point of supply of the pharmaceutical benefit as a prescription for the purposes of the Act.

This item omits from the operation of the deeming provision certain sections of the Act under subsection 89A(2)(c).  This is to address the issue of the express requirement for the presentation of a prescription to enable the lawful supply of a pharmaceutical benefit.  

Subsection 89A(2)(d) amends the definition of concessional benefit prescription, concession card prescription and entitlement card prescription to remove reference to section 84AA.  Section 84AA provides that access to concessional pharmaceutical benefits can only occur when a prescription has been written by a PBS prescriber. 

Subsection 89A(3) creates a power for the Minister to make a legislative instrument setting out the class of pharmaceutical benefits that may be supplied by an approved pharmacist under this arrangement. The legislative instrument must also set out the conditions that the approved pharmacist must be satisfied have been met prior to undertaking a supply in accordance with this section.

Subsection 89A(4) requires that PBS statistics on continued dispensing supplies be published annually.  These statistics will be made available through the Department of Health and Ageing’s existing publication Expenditure and prescriptions: twelve months to 30 June .

Subsection 89A(5) requires that a review of the Continued Dispensing initiative be completed within two years of the commencement of the Bill (ie 1 July 2012) and that findings of the review be reported and presented to each House of the Parliament within six months of the review’s commencement.  The review is anticipated to measure the extent to which the initiative has met the objectives identified within the Fifth Agreement.

Item 3

Application of Amendment

This item indicates that supplies enabled under this Schedule can occur from the commencement of the Schedule, that is, 1 July 2012.

 

SCHEDULE 2 —    SUPPLY OF CERTAIN PHARMACEUTICAL BENEFITS TO PERSONS RECEIVING CARE IN RESIDENTIAL CARE SERVICES

Item 1

At the end of subsection 93A(2)

This item inserts a note of clarification that is intended to allow determinations under this subsection to be made that can differentiate between conditions for persons receiving treatment in private hospitals as opposed to conditions that are determined for persons receiving care in residential care services

 

SCHEDULE 3 - PRESCRIPTIONS FOR THE SUPPLY OF PHARMACEUTICAL BENEFITS

Item 1

Subsection 85A(2A)

Proposed new subsection 85A(2A) provides for the Minister to make a determination setting conditions that must be satisfied when writing a prescription to which a particular maximum quantity or repeats determination made under paragraph 85A(2)(a) or (b) applies.

The Minister may determine a maximum quantity and a number of repeats for all purposes or for particular purposes under s85A(2).  Where a particular medicine has a number of different uses, and the appropriate dosage or length of treatment differs, the Minister is able to specify different maximums for different uses (or ‘purposes’).  For example a medicine may be prescribed for any purpose with a maximum quantity of 25 and 0 repeats, but a maximum quantity of 50 and 3 repeats if prescribed for initial palliative care purposes or a maximum quantity of 50 and 5 repeats if prescribed for malignant neoplasia (late stage).

If a determination has been made for a particular maximum quantity or number of repeats for a specific purpose, then conditions may be set for the writing of a prescription to which that specific maximum quantity or repeats determination applies.  Using the example above, it is envisaged that the Minister could determine a condition requiring that prescribers get authority from Medicare (including using existing streamlined authority processes) before prescribing the quantities or repeats permitted for initial palliative care.  The determination might only require the authority to be obtained if prescribing more than the ‘general’ maximum quantity (ie: more than 25 and 0 repeats in the example above).

When making the proposed determinations the Minister may take into account advice already routinely given by the Pharmaceutical Benefits Advisory Committee as part of its functions for PBS listing recommendations.  This is similar to what currently happens for some other determinations, like maximum quantities and repeats for PBS medicines.

Item 2

Subsection 85A(3A)

Proposed new subsection 85A(3A) provides that the Minister may make a determination setting out rules that must be applied when deciding on an application under Regulation 13 of the National Health (Pharmaceutical Benefits) Regulations 1960 (the Regulations) to vary the maximum quantity or number of repeats that may be prescribed in one prescription. 

The provision allows parameters to be placed on administrative decisions concerning a variation to quantities and repeats that may be prescribed in one prescription.  For example, for certain medicines, it may not be appropriate for any increases in maximum quantity or repeats to be permitted, or those increases may need to be capped.  It is envisaged that the approach to determining rules would be consistent with current guidelines on quantity increases set out in the Schedule of Pharmaceutical Benefits.

When making the proposed determinations the Minister may take into account advice already routinely given by the Pharmaceutical Benefits Advisory Committee as part of its functions for PBS listing recommendations.  This is similar to what currently happens for some other determinations, like maximum quantities and repeats for PBS medicines.

Item 3

Subsection 85A(4)

Proposed new subsection 85A(4) provides that the determinations made under section 85A are legislative instruments.

Item 4

Application of amendments

This proposed provision provides that the amendments made by this Schedule apply to prescriptions written on and after the commencement of the Schedule. In practice, the changes set out in subsections 85A(2A) and 85A(3A) would become effective on commencement of any conditions or rules determined under those new subsections.