Report to Parliament on the operation of s 89A of the National Health Act 1953 (‘Continued Dispensing’)
Page last updated: 3 December 2014
This Report to Parliament is made in compliance with subsection 89A (5) of the National Health Act 1953.
Part 1 of this report describes how the Continued Dispensing arrangements were developed. Part 2 describes the operation of the arrangements from their commencement on 1 September 2013 until 30 June 2014.
Part 1: Implementation
Continued Dispensing is the supply of an eligible medicine to a consumer under the Pharmaceutical Benefits Scheme (PBS) when there is an immediate need for that medicine but it is not practicable to obtain a prescription, provided:
• the medicine has been previously prescribed, therapy is stable, and there has been prior clinical review by the prescriber that supports continuation of the medicine; and
• the medicine is safe and appropriate for the consumer.
The Continued Dispensing arrangements commenced formally on 1 September 2013, when
Commonwealth PBS claims systems for Continued Dispensing transactions
were activated.
Consultation
Indicative funding of $1m was allocated under the Fifth Community Pharmacy Agreement to establish arrangements for the supply of certain medicines without a formal prescription. Originally referred to as ‘Medication Continuance’, the title of the initiative was changed to Continued Dispensing to better reflect the intent of the proposed arrangements.
The Department of Health undertook a written public consultation on the proposed arrangements during 2011, with responses from a broad range of stakeholders, including prescriber, pharmacy and consumer groups, that assisted in establishing the final policy parameters. Consultation continued during the implementation phase, as appropriate.
In particular, the Department engaged the Pharmaceutical Society of Australia to draft professional practice guidelines, Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists. An expert reference group of key industry representatives provided assistance in refining the implementation model for the arrangements.
Legislation
The Australian Government introduced section 89A to the National Health Act 1953, as part of the National Health Amendment (Fifth Community Pharmacy Agreement Initiatives) Bill 2011. Paragraph 89(b) of the Act entitles a person to receive a pharmaceutical benefit without a prescription where the requirements of the new section 89A have been met. The Minister may determine the specific conditions which must be met, as well as the limited pharmaceutical benefits that may be supplied under this new power. The amendments commenced on 1 July 2012.
The National Health (Pharmaceutical Benefits) Regulations 1960 were amended at the same time to include a new regulation 32A. This required a pharmacist to hold appropriate records to support the claim for payment under the PBS, and the information supplied to the most recent prescriber about the supply of the medicine to their patient under Continued Dispensing.
The National Health (Continued Dispensing) Determination 2012 also commenced on 1 July 2012. The determination specifies the pharmaceutical benefits that may be supplied, and the conditions that must be satisfied when the pharmaceutical benefits are supplied by a pharmacist under the Continued Dispensing provisions. The determination requires pharmacists to consider the Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists when satisfying the conditions set out in the determination, and when deciding whether those conditions are satisfied.
While the provisions for Continued Dispensing were established in Commonwealth law in 2012, practical commencement of the arrangements was delayed until at least half the states and territories had introduced enabling legislation to permit pharmacists to use Continued Dispensing.
Health professional communications
A copy of the Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists was distributed to each registered pharmacist in Australia during August 2013, through special arrangements with the Pharmacy Board of Australia. Further information was made available on the websites of the Department of Human Services, and Fifth Community Pharmacy Agreement, managed by the Pharmacy Guild of Australia. Generic information sheets were also available to support articles in industry publications.
The Guidelines for the Continued Dispensing of eligible prescribed medicines by pharmacists includes background information on the new arrangements, practical guidance on how pharmacists might satisfy the conditions of supply, communication templates to advise prescribers of their patients being supplied medicines under the Continued Dispensing arrangements, and a Practice Tool for Continued Dispensing.
Information technology changes
The Department of Health supported changes to pharmacists’ dispensing software, and the PBS claims system of the Department of Human Services. As part of these changes, each Continued Dispensing transaction is identified as such within the PBS claims database. This permits statistical reporting to be developed to monitor these arrangements.
Part 2: Operation
The Continued Dispensing arrangements commenced formally on 1 September 2013, when Commonwealth PBS claims systems for Continued Dispensing transactions were activated by the Department of Human Services.
The following states had made amendments to relevant legislation to permit Continued Dispensing supply in their jurisdictions from 1 September 2013:
• South Australia
• Tasmania
• Victoria
• Western Australia
New South Wales enabling legislation was introduced on 20 September 2013. Enabling legislation followed in the Australian Capital Territory in late November 2013. On 1 May 2014, regulations became effective that permitted Continued Dispensing to occur in the Northern Territory.
At the time of this report, Queensland is the only jurisdiction in which Continued Dispensing has not been enabled.
Data tables
The data are for the period 1 September 2013 to 30 June 2014, by date of processing by the Department of Human Services.
|
2390 |
Number of valid Continued Dispensing transactions |
|---|---|
|
61 |
Number of invalid transactions |
|
11 |
Number of transactions that were ‘beyond power’ |
|
779 |
Number of pharmacists making at least one Continued Dispensing supply |
|
532 |
Number of pharmacies at which at least one Continued Dispensing supply was made |
In the above table, a ‘valid transaction’ is a Continued Dispensing supply by a pharmacist for an eligible pharmaceutical benefit, in a jurisdiction for which enabling legislation was in force at the time of supply.
An ‘invalid transaction’ is a supply which was flagged as a Continued Dispensing transaction by the pharmacist in the PBS claim, but was not for an eligible medicine. Subsequent investigation by the Department has identified that all these transactions had been incorrectly flagged as Continued Dispensing supplies by the pharmacists, and should be disregarded. Pharmacists’ dispensing software has been amended to prevent this error occurring in the future.
‘Beyond power’ transactions are those intended by the pharmacists to be valid Continued Dispensing supplies, but were made in a jurisdiction for which enabling legislation was not in force at the time of supply. All these transactions occurred in Queensland, and were referred by the Department of Health to the state regulator for appropriate action.
Transactions in the above three categories are mutually exclusive.
|
Jurisdiction |
ACT |
NSW |
SA |
TAS |
VIC |
WA |
Total |
|---|---|---|---|---|---|---|---|
|
Transactions |
154 |
586 |
183 |
192 |
908 |
367 |
2390 |
|
Per cent |
6.4% |
24.5% |
7.7% |
8.0% |
38.0% |
15.4% |
100% |
|
Pharmacies |
16 |
131 |
44 |
38 |
204 |
99 |
532 |
|
PBS generic name |
Count |
Per cent |
|---|---|---|
|
Oral hormonal contraceptive |
||
|
Oral Contraceptive Preparations |
992 |
41.50% |
|
Lipid modifying agents |
||
|
Atorvastatin |
627 |
26.20% |
|
Rosuvastatin |
528 |
22.10% |
|
Simvastatin |
199 |
8.30% |
|
Pravastatin |
42 |
1.80% |
|
Fluvastatin |
2 |
0.10% |
|
Total |
2390 |
|
|
PBS item code |
PBS item description |
Number of times dispensed |
|---|---|---|
|
01392G |
Ethinyloestradiol + Levonorgestrol |
112 |
|
01394J |
Ethinyloestradiol + Levonorgestrol |
725 |
|
01456P |
Ethinyloestradiol + Levonorgestrol |
33 |
|
01967M |
Norethisterone |
9 |
|
02011W |
Simvastatin 10mg + 5R |
21 |
|
02012X |
Simvastatin 20mg + 5R |
61 |
|
02013Y |
Simvastatin 5mg + 5R |
2 |
|
02416E |
Ethinyloestradiol + Oestradiol |
8 |
|
02574L |
Rosuvastatin 20mg + 5R |
28 |
|
02584B |
Rosuvastatin 10mg + 5R |
2 |
|
02590H |
Rosuvastatin 5mg + 11R |
6 |
|
02594M |
Rosuvastatin 40mg + 5R |
16 |
|
02606E |
Rosuvastatin 5mg +5R |
17 |
|
02609H |
Rosuvastatin 20mg + 11R |
6 |
|
02628H |
Rosuvastatin 10mg + 5R |
39 |
|
02636R |
Rosuvastatin 40mg + 11R |
2 |
|
02774B |
Ethinyloestradiol + Norethisterone |
44 |
|
02775C |
Ethinyloestradiol + Norethisterone |
29 |
|
02833D |
Pravastatin 10mg + 5R |
4 |
|
02834E |
Pravastatin 20mg + 5R |
10 |
|
02913H |
Levonorgestrol |
26 |
|
03179H |
Mestranol + Norethisterone |
6 |
|
03402C |
Rosuvastatin 5mg + 11R |
1 |
|
03403D |
Rosuvastatin 10mg + 11R |
2 |
|
03404E |
Rosuvastatin 20mg + 11R |
5 |
|
03405F |
Rosuvastatin 40mg + 11R |
1 |
|
08024H |
Fluvastatin 40mg + 5R |
2 |
|
08173E |
Simvastatin 40mg + 5R |
95 |
|
08197K |
Pravastatin 40mg + 5R |
16 |
|
08213G |
Atorvastatin 10mg + 5R |
91 |
|
08214H |
Atorvastatin 20mg + 5R |
187 |
|
08215J |
Atorvastatin 40mg + 5R |
247 |
|
08313M |
Simvastatin 80mg + 5R |
16 |
|
08521L |
Atorvastatin 80mg + 5R |
86 |
|
08829Q |
Pravastatin 80mg + 5R |
11 |
|
09042X |
Rosuvastatin 5mg + 5R |
68 |
|
09043Y |
Rosuvastatin 10mg + 5R |
175 |
|
09044B |
Rosuvastatin 20mg + 5R |
111 |
|
09045C |
Rosuvastatin40mg + 5R |
49 |
|
09230T |
Atorvastatin 10mg + 11R |
2 |
|
09231W |
Atorvastatin 20mg + 11R |
6 |
|
09232X |
Atorvastatin 40mg + 11R |
6 |
|
09233Y |
Atorvastatin 80mg + 11R |
2 |
|
09239G |
Pravastatin 40mg + 11R |
1 |
|
09243L |
Simvastatin 20mg + 11R |
1 |
|
09244M |
Simvastatin 40mg + 11R |
1 |
|
09245N |
Simvastatin 80mg + 11R |
2 |
All information in this publication is correct as at October 2014
10902 October 2014
Report to Parliament on the operation of s 89A of the National Health Act 1953 (‘Continued Dispensing’)
ISBN: 978-1-76007-014-4
Online ISBN: 978-1-76007-015-1
Publications Approval Number: 10902
© Copyright of Australia 2014
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© Copyright of Australia 2014
This work is copyright. You may download, display, print and reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given the specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the Communication Branch, Department of Health, GPO Box 9848, Canberra ACT 2601, or via e mail to copyright@health.gov.au
