Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing - [2013] AATA 649

[2013] AATA 649

Division GENERAL ADMINISTRATIVE DIVISION

File Number(s)

2012/0348

2012/0350

Re

Aspen Pharmacare Australia Pty Ltd

APPLICANT

And

Minister for Health and Ageing

RESPONDENT

Decision

Tribunal
President Kerr
Senior Member Nicoletti

Date 12 September 2013

Place Sydney
The Tribunal sets aside the decisions under review, decides that Di-Gesic and Doloxene should remain on the Australian Register of Therapeutic Goods, and imposes the conditions set out in Schedule 1 to these Reasons.
The Tribunal notes the undertaking proffered by the applicant on 9 September 2013 as set out in paragraph 31 of these Reasons.
....................[sgd]....................................................
President Kerr
Catchwords
Health – Therapeutic goods – Cancellation of registration of products containing dextropropoxyphene (DPP) – Whether quality, safety or efficacy is unacceptable within meaning of the Therapeutic Goods Act – Previous decision of Tribunal that imposition of conditions would provide acceptable safety – Conditions determined by Tribunal after parties unable to reach agreement
Practice and Procedure – Judgments, decisions and orders – Relevance of prospect of appeal to proposed orders
Legislation
Administrative Appeals Tribunal Act 1975 ss 42D, 43(5C)
Therapeutic Goods Act 1989 ss 19, 28, 30(2)(a), 31
Cases
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 93
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 376
Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2013] AATA 197
REASONS FOR DECISION
President Kerr
Senior Member Nicoletti
12 September 2013

On 15 June 2012, the Tribunal made findings in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 in respect of its review of a decision of the Minister for Health and Ageing to cancel the registration of Di-Gesic and Doloxene (the Products), both of which contain dextropropoxyphene (DPP) on the basis that the safety and efficacy of the Products for the approved indications was unacceptable.
Having considered expert evidence and submissions from the parties, the Tribunal made findings that the Products were analgesic for mild to moderate pain [38], that the safety of the Products in therapeutic doses was similar to other weak opioids and not unacceptable [49]-[60] and that there was a subset of patients (those who require pain relief with a weak opioid but are unable to tolerate other weak opioids such as codeine and tramadol) for whom there was no currently available and suitable alternative to DPP for mild to moderate pain [83]-[91]. However, the Tribunal also made findings, on largely undisputed evidence, that DPP (in common with a number of other pharmaceuticals) has been used for the purpose of deliberate suicide [44]-[45] and that there were greater than usual risks of accidental overdose with the Products compared to other analgesics because of the relatively small variation between amounts prescribed for therapeutic use and the amount sufficient to create a risk of serious adverse harm and even fatality [46]-[48].
The Tribunal rejected the Minister’s submission that the Products could be removed from the Australian Register of Therapeutic Goods (ARTG) with little or no concern because their removal would only negatively impact a small handful of people. The Tribunal expressed its opinion that the requirement to come to the correct and preferable decision meant that the needs of those individuals were not to be subjected to the larger community interest unless their needs and those interests were incapable of reconciliation [96]. The Tribunal referred to evidence before the Tribunal that suggested there was no true inconsistency requiring the Products to be removed from the ARTG. The Tribunal therefore tentatively concluded that the quality, efficacy and safety of the Products would not be unacceptable provided that conditions under s 28 of the Therapeutic Goods Act 1989 (TG Act) could sufficiently minimise the risk associated with their use, particularly the risk of overdose and the risk of self-harm [99]-[102].
The Tribunal then indicated that it was contemplating exercising its authority under s 42D of the Administrative Appeals Tribunal Act 1975 (the Act) to remit the matter to the respondent for reconsideration to allow the parties time to explore whether, in light of the Tribunal’s reasons they could find an agreed solution rather than having one imposed on them [103]. However, mindful that both the applicant and the respondent had requested that they be given an opportunity to be heard should the Tribunal be minded to make a decision other than simply affirming or setting aside the decision on review, the Tribunal agreed to receive submissions as to the merits of that proposed course [104].
The hearing resumed on 17 June 2012. Both Mr Lloyd SC for the applicant and Dr Renwick SC for the respondent asked the Tribunal to refrain from the task of drafting detailed final orders. Counsel agreed that the parties should be given the opportunity to negotiate mutually acceptable conditions consistent with the Tribunal’s findings before returning to the Tribunal. They differed only as to the process that should be followed.
Mr Lloyd’s preferred position was that the Tribunal should simply allow a period of time for informal discussion between the parties to reach common ground, rather than remit the matter under s 42D of the Act. Dr Renwick submitted that remitting the matter to the respondent for reconsideration as had been foreshadowed by the Tribunal was the appropriate course to follow.
On 20 June 2012, the Tribunal gave oral reasons (published 21 June 2012) for its decision to remit the matter to the respondent. The Tribunal extended the period within which the respondent was required to reconsider the decision to 56 days at the joint request of the parties: Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 376.
The respondent later sought additional time to complete the reconsideration. Counsel advised the Tribunal that discussions between the parties had continued in good faith. By consent, the Tribunal made orders extending the period within which the reconsideration had to be finalised.
Ultimately on 12 September 2012, the respondent made a decision in respect of the remitted matter based on factual findings in respect of safety and efficacy that differed from the findings of the Tribunal in its 15 June 2012 decision. Having reached those different conclusions, the respondent’s delegate, Dr McEwen, determined that there were no conditions capable of being imposed under s 28 of the TG Act which would make the continued registration of the Products acceptable. The original decision of the Minister for Health and Ageing to cancel the registration of the Products on the basis that their safety and efficacy was unacceptable was therefore affirmed.
As a result, pursuant to s 42D(8) of the AAT Act, these review proceedings automatically resumed before the Tribunal. The respondent’s delegate’s decision on remittal and a large volume of supplemental “T” documents were duly filed with the Tribunal.
However, to the surprise of the Tribunal, when the review resumed on 27 February 2013 the respondent did not defend the decision that had been made on remittal. Dr Renwick SC advised the Tribunal that the respondent would not be putting into evidence the reasons of the respondent’s delegate. The respondent explicitly eschewed all reliance on those reasons.
Dr Renwick further informed the Tribunal that, notwithstanding the remittal decision, the respondent no longer disputed any of the findings of the Tribunal in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362.
Instead the respondent urged the Tribunal to consider an alternative means of allowing access to the Products. Dr Renwick drew the Tribunal’s attention to an undertaking by the Secretary of the Department of Health and Ageing to establish a bespoke Special Access Scheme pursuant to s 19 of the TG Act. He submitted that the Special Access Scheme had been purpose designed to permit continued but controlled access to the Products by those for whom the Products were clinically appropriate. Doctors would have only to fill in a simple ‘tick a box’ form and send it as a request to the Department where, unless there was a trigger for concern, the request would be quickly and almost automatically approved. Dr Renwick submitted that in the light of that undertaking the Special Access Scheme could provide a safe and suitable alternative means for controlled but continued access to the Products. Accordingly the correct and preferable decision, given the availability of that alternative and given the acknowledged risks of overdose and the Products being used for self-harm, was that the Products should be removed from the ARTG.
The Tribunal considered, and rejected, that proposition: for its reasons see Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2013] AATA 197 at [16]-[28].
With that large issue excepted, the balance of the hearing of 27-28 February was taken up with submissions about whether the Tribunal could be satisfied that appropriate conditions could be imposed under s 28 of the TG Act to enable the Tribunal to reach the conclusion that the quality, safety and efficacy of the Products was not unacceptable and, if so, what those conditions should be.
Mr Lloyd submitted that, having regard to the findings recorded in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362 the only conclusion properly open to the Tribunal was that the quality safety and efficacy of the Products was not unacceptable within the meaning of s 30(2)(a) of the TG Act. The Tribunal was provided with a cascading set of proposed conditions of registration which the applicant contended were consistent with the Tribunal’s conclusions. The document containing those conditions was titled “Applicant’s Proposed Amended Final Decision” but, as indicated above, it set out a series of incremental options rather than a single proposal.
Mr Lloyd argued that the first of the conditions Aspen proposed in its draft (essentially a continuation of the requirement to include “black box” Product Information warnings in similar terms to those imposed by the Tribunal as a condition of staying the implementation of the respondent’s deregistration decision (Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 93) ought give the Tribunal sufficient confidence that the Products would, with few and unavoidable exceptions, be supplied only to those for whom they were clinically appropriate and that those patients would be adequately warned of the risks associated with the Products’ misuse. However, recognising that the Tribunal might take the view that additional conditions were required Mr Lloyd indicated that the applicant would accept any or all of the draft conditions included for the Tribunal’s consideration in that document.
The applicant’s additional options included draft conditions the intent of which was to ensure that wholesalers engaged by the applicant would be contractually bound not to supply the Products unless the pharmacist ordering them had undertaken not to dispense those Products to a patient unless the patient had presented a form signed by a prescriber certifying, inter alia that: (a) the precriber was aware that the Product was only approved for use in patients not able to be adequately treated with other analgesics, (b) the prescriber had considered the contraindications, (c) the prescriber had considered any recent changes to their patient’s clinical presentation, (d) the prescriber had warned the patient about the approprate use of the Product, and (e) the prescriber was satisfied that the patient’s history did not indicate a risk of accidental or deliberate self-harm.
Dr Renwick for the respondent contested Mr Lloyd’s primary proposition that the only conclusion properly open to the Tribunal was that the quality safety and efficacy of the Products was not unacceptable within the meaning of s 30(2)(a) of the TG Act. He submitted that a finding that the Products should remain on the ARTG was far from inevitable given the Tribunal’s earlier findings particularly those at [2012] AATA 362 [46]-[48] regarding the risks of accidental overdose.
Dr Renwick further submitted that if conditions were to be imposed a system of monitoring would be needed to ensure that there had been compliance with those conditions.
Assuming the Tribunal was to find, subject to the imposition of appropriate conditions under s 28 of the TG Act, that the quality, safety and efficacy of the Products was not unacceptable, both Dr Renwick and Mr Lloyd then urged the Tribunal to indicate only the nature of the conditions which the Tribunal regarded as necessary. They submitted that the drafting of conditions was a matter that the Tribunal should permit the parties to discuss and settle the fine details of between themselves. Counsel submitted that their clients would approach that task in good faith and would be able to reach agreement if the Tribunal were to accommodate that request.
The Tribunal published its reasons responding to those submissions on 5 April 2013: Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2013] AATA 197.
The Tribunal rejected Mr Lloyd’s contention that its earlier reasoning compelled the conclusion that the quality, safety and efficacy of the Products was not unacceptable within the meaning of s 30(2)(a) of the TG Act [31]-[33]. The Tribunal held that it had remained open to the respondent to seek to persuade the Tribunal that no conditions could be devised to address adequately the safety issues associated with supply of the Products [33].
However, the Tribunal stated that it had concluded that the imposition of appropriate conditions under s 28 of the TG Act could ensure that the quality, safety and efficacy of the Products was not unacceptable [29]. The Tribunal accordingly decided that the Products ought to remain on the ARTG [50].
The Tribunal’s reasons for those conclusions can be found at [38]-[46].
The Tribunal stated at [48]:
The Tribunal acknowledges that the contractually-based mechanisms Aspen has proposed [all of which, including the most stringent, were cumulatively required by the Tribunal’s decision] cannot guarantee 100% compliance. Within the range of practicable measures available, no mechanism, including the s 19 mechanism which the Secretary undertook to implement if the Tribunal reached the conclusion that the quality, safety and efficacy of the products was unacceptable, can guarantee 100% compliance. However, the interlocking system of safeguards for patient protection that were put forward by Aspen as conditions it was prepared to accept is sufficient to give the Tribunal confidence that the products will, with few and unavoidable exceptions, be supplied only to those for whom they are clinically appropriate and that those patients will be warned of the danger of the products’ misuse. The level of confidence is of an order of magnitude greater than that which applies in the ordinary supply of other pharmaceutical products, many of which, if prescribed when contra-indicated or taken in larger than prescribed doses, are also extremely dangerous, if not lethal.
The Tribunal also observed [49] that it wanted to be satisfied that a practical but not unduly burdensome system would be put in place to monitor the effectiveness of the safety arrangements that were included in the conditions.
The parties were directed to bring in short minutes of orders, incorporating any necessary timetable for their implementation, consistent with the tenor of the Tribunal’s reasons [51].
Unfortunately, as Robbie Burns notes “the best laid schemes o’ mice an’ men/Gang aft agley”. Despite counsel’s confidence that it would be sufficient for the Tribunal to indicate in general terms the nature of the conditions which the Tribunal had determined to be appropriate to be imposed on the Products’ registration, the parties were unable to settle agreed orders. As a result the Tribunal relisted the matter to hear and decide the issues relating to conditions which the parties had repeatedly previously urged the Tribunal to leave to them to resolve.
Mr Lloyd and Dr Renwick each supplied the Tribunal with their versions of the orders sought and marked up copies indicating where they differed. The hearing resumed on 17 June 2013.
As a condition of staying the implementation of the Respondent’s decisions the former President of the Tribunal, Justice Downes ordered that the product information for Di‑Gesic and Doloxene continue to include black box warnings (see [17] above). Each of the parties submitted draft orders which assumed that Aspen would, shortly after the Tribunal’s decision came into effect submit updated PI documents to the TGA incorporating such amendments as appropriate, for example, deleting the current references to these proceedings. On 9 September 2013 Aspen gave a written undertaking to the Tribunal in the following terms:
The Applicant proffers an undertaking to, within fourteen days of the date on which the Tribunal’s final decision comes into operation:
i.make such applications and requests of the Secretary to the Department of Health and Ageing (“the Secretary”) as are necessary or convenient to vary information included in the ARTG with respect to Di-Gesic (“Di-Gesic PI”) substantially to the effect of the amendments appearing in the document at Attachment 1 to this document; and
ii.make such applications and requests of the Secretary as are necessary or convenient to vary information included in the ARTG with respect to Doloxene (“Doloxene PI”) substantially to the effect of the amendments appearing in the document at Attachment 2 to this document.
The Tribunal formally notes that undertaking. The documents comprising Attachment 1 and Attachment 2 to the applicant’s undertaking have been initialled by the President and placed on the Tribunal’s file to permit their identification should the necessity for that arise. They are too lengthy to include in these published reasons. However, in summary, their terms are consistent with the parties’ common understanding that the PI for both Di‑Gesic and Doloxene should continue to include similar black box warnings.
Although the parties had reached agreement as to a number of the conditions that should be imposed there was no common ground with respect to four issues: :
(a)Strict liability: whether the applicant would be strictly liable to ensure that Australian Pharmacies complied with the proposed Special Arrangements.
(b)Effective date: the date upon which the Tribunal’s decision was to come into operation.
(c)Scope and Mechanics for Prescriber Confirmations: how the Special Arrangements should apply to repeat dispensing and hospital pharmacies.
(d)Monitoring: the system that should be put in place to monitor the effectiveness of the system and compliance with the conditions of registration.
There is no reason for the Tribunal to differ from the approach of the parties in respect of the conditions which the Tribunal should impose where they had reached a common position. These reasons therefore focus upon the key issues where differences were unresolved as identified in [32] above. Minor changes to some of the dates referred to in the proposed conditions have been made to reflect the time that has passed since their drafting.
In reaching our decision on the conditions to be imposed we have taken into account the submissions of the parties having regard to the Tribunal’s obligation to ensure, as far as possible, that the safety of the Products for the purposes for which they are to be used is satisfactory. We have given no weight to Mr Lloyd’s submission that the Tribunal should not impose requirements so onerous and burdensome that it would be impractical and uneconomic for the Products to remain on the market to any extent that that consideration conflicted with that obligation. However, where that obligation could be satisfied either with or without the imposition of onerous and burdensome conditions the Tribunal has taken the view that the correct and preferable decision requires the least burdensome path to be chosen.

The conditions which we have decided should be imposed on the registration of the Products are set out in Schedule 1.
Our consideration of each of the key differences above is discussed in detail below.
Strict liability
The applicant has agreed that it will contractually bind wholesalers of its pharmaceutical products to not supply the Products to a pharmacist unless the pharmacist has undertaken to only dispense the goods where a patient has presented a form signed by a prescriber certifying that:
(a)the prescriber was aware that the product was only approved for use in patients not able to be adequately treated with other analgesics;
(b)the prescriber had considered the contraindications;
(c)the prescriber had considered any recent changes to their patient’s clinical presentation or biochemical status;
(d)the prescriber had warned the patient about the appropriate use of the product; and
(e)the prescriber was satisfied that the patient’s history did not indicate that the patient was at risk of accidental or intentional self-harm.
As referred to above the Tribunal acknowledged in its 5 April 2013 reasons that the contractually-based mechanisms Aspen has proposed cannot guarantee 100% compliance. However, it said that the interlocking system of safeguards for patient protection put forward by the applicant as conditions it was prepared to accept was sufficient to give the Tribunal confidence that the Products would, with few and unavoidable exceptions, be supplied only to those for whom they are clinically appropriate and that those patients would be warned of the danger of the Products’ misuse. This level of confidence is of an order of magnitude greater than that which applies in the ordinary supply of other pharmaceutical products, many of which, if prescribed when contra-indicated or taken in larger than prescribed doses, are also extremely dangerous, if not lethal.
The Tribunal is therefore satisfied that once those arrangements are put in place it is highly improbable that a medical practitioner would prescribe the Products without completing the Prescriber Form, given that those safeguards include arrangements such that pharmacies will decline to fill such a prescription without it. The process requires that both the medical practitioner and the patient are made acutely aware of the considerations relevant to those Products’ use.
Conditions imposed under s 28 of the TG Act are conditions imposed on the Sponsor, not in relation to third parties. The Sponsor, the applicant, does not directly supply the Products to pharmacies. The applicant’s products are supplied by wholesalers to pharmacies. The conditions the Tribunal has imposed will require the Sponsor to enter into contractual relationships with its wholesalers not to supply the Products to any pharmacy save in the terms of these arrangements. The conditions bind the applicant to put in place and monitor the contractual system it has proposed as a condition of the continuing registration of the Products on the ARTG.
The system of controls the conditions impose will provide that supply of the products to pharmacies or wholesalers who do not comply with their obligations will be suspended. The conditions distinguish between a ‘Minor Breach’ and a ‘Serious Breach’ of the arrangements to be established between the Sponsor on the one hand and pharmacies and wholesalers on the other, with repetition of a Serious Breach by a pharmacy or wholesaler leading to suspension or, in the worst cases, termination. It would seem to us that as long as the applicant has taken the necessary steps to ensure that pharmacies understand their obligations to only dispense the products following the production of a Prescriber Confirmation form, then it has discharged its obligations. In the Tribunal’s view there is no proper or necessary reason for the Tribunal to impose conditions which would apply strict liability to the applicant in respect of what would almost certainly be the unprofessional conduct of a pharmacist who dispensed the Products negligently or in contempt of these arrangements.
The Tribunal is satisfied that it is neither legally sound nor practically essential for the Tribunal to endorse the respondent’s proposition that the applicant should be held to have breached a condition of registration for the Products if, notwithstanding that the applicant might have absolutely no notice of the problem, a pharmacy is discovered to have been non-compliant.
Effective Date: When should the final decision come into operation?
The respondent proposed, at paragraph 3 of its proposed orders that the Tribunal specify that its final decision will come into operation immediately, or at least on a date shortly after, the Tribunal makes its decision.
Section 43(5C) of the AAT Act provides:
Despite subsections (5A) and (5B), if:
(a) the Tribunal has made an order under subsection 41(2) staying the operation or implementation of the decision under review; and
(b) the order was in force immediately before the decision given by the Tribunal on the review;
then, unless the Tribunal, the Federal Court of Australia or the Federal Circuit Court of Australia otherwise orders, the operation or implementation of the Tribunal's decision is stayed until:
(c) subject to paragraph (d), the end of the period within which a party to the proceeding before the Tribunal may appeal from the decision to the Federal Court of Australia under subsection 44(1) (including any further time for bringing the appeal that is allowed by the Federal Court before the end of that period); or
(d) if such an appeal is brought--the appeal is determined.[1]
[1] For completeness, subsection 43(5A) provides that subject to subsection (5B), a decision of the Tribunal comes into operation forthwith upon the giving of the decision. Subsection 43(5B) provides that the Tribunal may specify in a decision that the decision is not to come into operation until a later date specified in the decision and, where a later date is so specified, the decision comes into operation on that date.
On 16 February 2012 the Tribunal as originally constituted by its then President, Justice Downes, made orders staying the implementation of the decision under review. Accordingly, pursuant to s 43(5C) above, unless the Tribunal otherwise orders, the operation or implementation of the Tribunal will not take effect until 28 days after the date of its decision.
That period of 28 days corresponds with the limitation period within which one or both of the parties may file an appeal from the Tribunal’s decision.
The respondent submitted that because the Tribunal had found that the safety of the Products would be unacceptable without imposing further conditions on their registration beyond those required by the stay, it should not permit the Products to remain on the market for a further period of a considerable extent should either of the parties exercise a right to appeal to the Federal Court of Australia. Dr Renwick submitted that even with the “restrictive conditions” imposed by the Tribunal pursuant to the stay orders, the safety of the goods would be, by the Tribunal’s own reasoning, unacceptable.
Mr Lloyd, for the applicant, submitted that it was inherent in the nature of the conditions that the Tribunal had indicated would be imposed that time would be required before they could be brought into effect. Those conditions were complex and could not be put into effect overnight. It was therefore appropriate that conditions relating to the stay should remain in force until the Tribunal’s orders came into effect in the ordinary course as provided for by the AAT Act. Mr Lloyd disputed that the hypothetical prospect of an appeal should dictate otherwise. It would be unreasonably onerous and burdensome for the Tribunal to bring forward the time for the coming into operation of its reasons to require Aspen to immediately implement the Tribunal’s decision (which necessarily would be expensive and administratively complex) against the contingency that the respondent was contemplating an appeal in the Federal Court based on the proposition that the Tribunal had erred.
The Tribunal accepts Mr Lloyd’s contention that it is inherent in the nature of the conditions that are to be imposed by the Tribunal that they cannot be given effect to overnight. If the Tribunal were to specify that its decision comes into effect immediately it would then have to provide for the transition period. There is a degree of artificiality in what the respondent seeks.
The stay and its associated conditions have been in place since February 2012. Dr Renwick, on behalf of the respondent frankly acknowledged on 17 June 2013 that no safety concerns have been identified by the TGA since the stay orders were introduced. The Tribunal has received evidence that there has been a marked change in prescribing practices since Justice Downes made orders requiring the inclusion of ‘black box’ warnings as a condition of the stay. Most doctors appear to have taken those warnings into account and modified their prescribing practices accordingly. There has been a significant decline in the Products’ sales. The Tribunal’s discussion of the relevant evidence can be found in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 197 at [41]-[43].
In those reasons the Tribunal did reject Aspen’s submission that simply continuing those conditions should be sufficient for the continuing registration of the Products but the Tribunal is not be taken, for that reason, as subscribing to the view that the stay was improperly granted or that patient health has been compromised in consequence of it. The conditions imposed by Justice Downes as the price for the stay were similar to the most robust conditions hitherto imposed on any therapeutic good on the ARTG. The Tribunal is now insisting on additional conditions that will provide a further level of confidence but the status quo that emerged following the stay has endured for nearly a year and a half without any identified safety concerns. There is no reason for the Tribunal to conclude that the correct and preferable decision requires such urgency as to ignore the practical realities that some form of transition will be required. Unless otherwise ordered by the Tribunal the law provides for a short continuation of the existing status quo before the decision of the Tribunal comes into operation. Setting aside the suggested relevance of a possible appeal, the Tribunal has not been persuaded to make orders otherwise.
Nor is the Tribunal persuaded that the hypothetical prospect of an appeal should compel a different conclusion. Dr Renwick submitted that the prospect of an appeal was a relevant consideration notwithstanding having informed the Tribunal on 27 February 2013 that the respondent did not dispute any of the findings of the Tribunal in Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2012] AATA 362. Those uncontested findings remain the foundation for the orders that the Tribunal now makes. Even if (which the Tribunal need not decide) in some circumstances it could be appropriate to take into account a foreshadowed appeal as a reason for adjusting the time for the coming into effect of a Tribunal decision, where the party raising that prospect has formally acknowledged the correctness of the key findings upon which the Tribunal’s decision is based no circumstances requiring such an adjustment, in our opinion, arise.
That being the case, the Tribunal is not inclined to make additional orders in respect of the date of implementation of its decision and, in particular, the conditions of registration imposed on the Products. Accordingly, pursuant to s 43(5C) of the AAT Act, in light of the stay orders made by the Tribunal on 16 February 2012, the operation or implementation of the Tribunal’s decision will take effect 28 days after the date of the decision.
Scope and Mechanics for Prescriber Confirmations
First Dispensing and Repeat Dispensing
The applicant has proposed, for practical reasons, that the Prescriber Confirmation need only be sighted by a pharmacist on the “first dispensing”, and that a single Prescriber Confirmation be sufficient to allow the patient to receive the first prescription and any repeats.
The respondent submitted that while a new Prescriber Confirmation was not necessary when a repeat was being dispensed, a pharmacy dispensing a repeat prescription should either verify that it already holds the original Prescriber Confirmation or, if it did not dispense the first prescription, it should obtain a copy of the original Prescriber Confirmation. This would seem to be an impractical and unnecessary requirement, given that a patient cannot obtain a repeat prescription without the first prescription being dispensed, and a first prescription cannot be dispensed without the patient providing a Prescriber Confirmation to the Pharmacist. The Tribunal also notes that if the patient returns to their doctor for another prescription (after all the repeats have been dispensed), then the doctor will need to issue another Prescriber Confirmation.
The Tribunal is satisfied that it is reasonable for a pharmacist who is presented with a repeat prescription for the Products to assume that a Prescriber Confirmation was issued to the pharmacist who first dispensed the Products. Based on this assumption, the Tribunal considers that it is not necessary for a pharmacist dispensing a repeat prescription to either verify that it holds the original Prescriber Confirmation (if it dispensed the first prescription), or obtain a copy of the original Prescriber Confirmation. The Tribunal notes, additionally, that the periodic audits which the applicant will be required to conduct will identify any non-compliance with respect to the dispensing of the first prescription.
Hospital Pharmacies
The respondent submitted that Prescriber Confirmations should also apply to Hospital Pharmacies. The applicant submitted, however, that in-patients do not receive a prescription which they then present to a pharmacist. Rather, prescribers within a hospital environment specify the medication that the patient should be administered in a National Inpatient Medication Chart or an individual medicine order, which is not provided to the patient. These provide sufficient authority for the medication to be dispensed by the hospital pharmacy, for controlled administration by healthcare professionals. In addition, the applicant submitted, and the Tribunal agrees, that the danger of an accidental overdose would be very low in the supervised hospital environment. The respondent also conceded, when it was put by the Tribunal, that the apprehensions that gave rise to the Prescriber Confirmations, particularly the fear of overdose, inappropriate clinical use and inappropriate patient use, were less in a hospital setting.
Based on the controlled prescribing and administration which applies in a hospital setting, the Tribunal has decided that Prescriber Confirmations are not required in order for a prescription for the Products to be dispensed in that setting.
Monitoring
Time in which to prepare an audit report
The respondent submitted that the applicant’s proposed conditions did not identify specifically when an audit report should be prepared. The applicant responded with a proposed condition that the report be prepared within four months of the end of each audit period. The respondent’s proposed condition imposed a two month time period, from the end of each audit period, in which to prepare a report.
Apart from the obvious requirement to collect and analyse data, the applicant did not make submissions as to why it required four months after the end of each six month audit period to prepare and submit its audit report. The Tribunal considers that this time frame might have been reasonable if the applicant was collecting six months’ data in each six month period, and therefore was not in a position to prepare a report until each six month period ended. However, based on a condition requiring only three months’ data to be collected and analysed, and whereby collection and analysis can potentially occur well before the end of the six month period, then a three month time period, after the end of each six month period, in which to prepare and submit an audit report would seem to be an adequate balancing of the interests in obtaining a timely audit report with the interests of providing sufficient time in which to properly prepare a report. The Tribunal has settled the conditions consistently with that conclusion.
Data to be sampled in each audit period
The applicant proposed that the sample of data to be used in each audit include at least one sample month in each six month audit period. The respondent proposed instead that the data to be used in each should cover all six months in each audit period. One of the applicant’s arguments for only collecting data from one sample month in a six month period was that data could potentially be collected during the audit period rather than after the end of the audit period, leading to the benefit that an audit report could be prepared sooner. Whilst that may be the case, the applicant did not suggest that providing data from more than one sample month would be particularly more onerous, apart from the increased amount of forms that would have to be collected and analysed. In this regard, the applicant noted that the Tribunal could be minded to require “two or three” months’ data.
Particularly in the earlier stages of the implementation of the conditions, the Tribunal considers that a representative sample during a six month period is important in order to assess compliance. Whilst we do not consider that the entire six months of data are necessary to analyse from each audit period, we have decided to require at least three months’ data in a six month period. This gives the Tribunal confidence that sufficient data will have been collected to assess compliance, but would still permit the applicant to collect data before the end of each six month period to facilitate the preparation of a report. The requirement to collect a representative sample of three months’ data will continue in the later stages of the implementation of the conditions, however from the date which is three years after the implementation date the sample period during which the data is to be collected will be extended from six to twelve months.
Pharmacists to be audited
The respondent submitted that each audit should target the highest volume dispensers. The Tribunal accepts the submissions of the applicant that this would mean that the top 5% of pharmacies would have a 100% chance of being audited every 6 to 12 months, and that the bottom 95% of pharmacies would only have a 5% chance of being audited.
The applicant submitted, and the Tribunal agrees, that all pharmacies should have a broadly equivalent chance of being audited. To address the respondent’s concern to ensure that high volume dispensers are included in each audit, the applicant’s proposed conditions split the sample to be audited between higher-volume dispensers and lower-volume dispensers. The Tribunal has adopted that approach.
As to the volume of pharmacies to be audited, the respondent sought that 20% of pharmacies be audited in calendar years 2014 and 2015 and then 10% of pharmacies in each year thereafter. However, the applicant submitted that this volume would be unduly burdensome. The applicant instead proposed to audit 10% of pharmacies each year which, it anticipated, would amount to around 442 pharmacies per year.
The Tribunal considers that this should be a sufficient sample to identify any systemic issues of non-compliance arising with the Prescriber Confirmations and to keep all pharmacies aware of the prospect that they might be selected for audit. Our conclusion reflects the Tribunal’s view that the monitoring system should be ‘practical but not unduly burdensome’: Aspen Pharmacare Australia Pty Ltd and Minister for Health and Ageing [2013] AATA 197 at [49]. It would also seem that the respondent recognises that a 10% sample would be sufficient, given that it has agreed to an audit sample of 10% from 2016 onwards. The Tribunal also notes, as stated in [64] above, that the applicant has undertaken to include both high volume dispensers and low volume dispensers in the audit sample, which will assure that data are collected and analysed from a cross-section of dispensers.
Review of effectiveness of conditions of registration

The respondent submitted that the applicant ought to be obliged to participate in reviews by the TGA every 18 months of the effectiveness of the conditions of registration, whilst the applicant submitted that it indicated (and believes) that a review of the effectiveness of the imposed conditions of registration would be appropriate after they had been in force for “a reasonable period of time”.
The applicant submitted, in this regard, that the form and timing of any review by the TGA would be in response to the Secretary’s reasonable requests for information in relation to the implementation or operation of the conditions of registration.
In our view, it is open to the Secretary to request information about the implementation or operation of the conditions of registration at any time by issuing a request to the applicant for information pursuant to s 31 of the TG Act. Under this provision, the Secretary is entitled to request information from the applicant at a time and in a manner and form that she considers necessary or appropriate. If such a request is issued, the applicant would be required to respond to the Secretary with the information reasonably requested pursuant to timelines imposed by the Secretary.
Based on [69] above, the imposition of a condition requiring the applicant to participate in reviews by the TGA of the effectiveness of the conditions of registration is, in the Tribunal’s opinion unnecessary, and the facility under s 31 of the TG Act for the Secretary to request information is sufficient to achieve this purpose.
Taking into account the Tribunal’s resolution of the key differences identified in [32], as discussed in paragraphs [33] to [69] above, the conditions imposed on the registration of the Products are as set out in Schedule 1.

72. I certify that the preceding seventy-one (71) paragraphs are a true copy of the reasons for the decision herein of Justice D Kerr, President & Senior Member T Nicoletti.

..........[sgd]..............................................................
Associate
Dated 12 September 2013

Dates of hearing

17 June 2013

Counsel for the Applicant

Mr S Lloyd SC

Mr S Robertson

Solicitors for the Applicant

King & Wood Mallesons

Counsel for the Respondent

Dr J Renwick SC

Dr H Bennett

Solicitors for the Respondent

Corrs Chambers Westgarth

SCHEDULE 1
Conditions Applying to Dextropropoxyphene-containing products under section 28 of the Therapeutic Goods Act 1989
Consumer medicine information
1The sponsor must:
a.include a consumer medicines information document (“CMI”) within each pack of the good that it supplies or is supplied on its behalf. For goods that are manufactured after the date which is three months from the Implementation Date (or such earlier date as may be reasonably practicable) that document must be in a form consistent with the Product Information for the good as at the date of the manufacture of that good and must include:
i.the “black box warnings” forming part of the Product Information for the good, the wording of which is to be reproduced exactly and enclosed in a black “box” and to be on the front page of the CMI; and
ii.a clear statement of the conditions imposed on the supply of the good in Australia that are described in this document, including in relation to the requirements concerning Prescriber Confirmations.

b.on any reasonable request by an Australian Pharmacy, provide that Australian Pharmacy (at no cost to the Australian Pharmacy) with a hardcopy or electronic copy, as requested by the Australian Pharmacy, of a CMI. For requests after the date which is three months from the Implementation Date (or such earlier date as may be reasonably practicable), that CMI must be in the form described in paragraph 1(a) of this document.

Letters to prescribers
2The sponsor must:
a.within 30 days of the Implementation Date, send a letter substantially in the form of:
i.the letter at Annexure A1 to these conditions to every prescriber who is recorded in a comprehensive and commercially available directory or list of medical practitioners as at the Implementation Date; and
ii.the letter at Annexure A2 to these conditions to every prescriber who is recorded in a comprehensive and commercially available directory or list of dental practitioners as at the Implementation Date;

b.during the month that is seven months from the Implementation Date, send a letter substantially in the form of the letter at Annexure B to these conditions to each Australian Prescriber who is recorded in a comprehensive and available directory or list, whether available for purchase or otherwise, of medical practitioners, dental practitioners and nurse practitioners as at the commencement of that month;
c.during July of calendar year 2014 and in February of each calendar year thereafter, send a letter to each Australian Prescriber who is recorded in a comprehensive and commercially available directory or list of medical practitioners as at the commencement of that month, addressing only the following:
i.the class of patients for whom the good is indicated;
ii.the contraindications and warnings outlined in the Product Information for the product; and
iii.matters relating to supply of the good in Australia, including information regarding the requirements concerning Prescriber Confirmations.

Patient information sheet
3The sponsor must:
a.within 30 days of the Implementation Date, supply a reasonable number of Patient Information Sheets to every pharmacy which is an Australian Pharmacy at the Implementation Date. Such Patient Information Sheets are different to the CMI and must be substantially in the form of the document appearing at Annexure C to these conditions (or otherwise in the form approved by the Secretary); and
b.on any reasonable request of an Australian Pharmacy, supply a reasonable number of Patient Information Sheets (at no cost to the Australian Pharmacy) to that Australian Pharmacy within a reasonable time after that request. Such Patient Information Sheet must be substantially in the form of the document appearing at Annexure C to these conditions (or otherwise in the form approved by the Secretary), amended to the extent necessary to reflect the Product Information for the good as at the time that the Patient Information Sheets are provided to the Australian Pharmacy.

Letters to pharmacies
4The sponsor must:
a.within 30 days of the Implementation Date, send a letter substantially in the form of the letter at Annexure D to these conditions to every pharmacy that is recorded in a comprehensive directory or list of Australian Pharmacies at the Implementation Date;
b.during the month that is six months after the Implementation Date, send a letter substantially in the form of the letter at Annexure E to these conditions to every Australian Retail Pharmacy that is recorded in a comprehensive and commercially available directory or list of Australian Retail Pharmacies at the commencement of that month;
c.during July in calendar year 2014 and in February of each calendar year thereafter, send a letter to every Australian Retail Pharmacy that is recorded in a comprehensive and commercially available directory or list of Australian Retail Pharmacies at the commencement of that month addressing only the following:
i.information as to how further Patient Information Sheets and CMIs can be requested from the Sponsor;
ii.matters relating to supply of the good, including information regarding the requirements concerning Prescriber Confirmations.

Dispensing guidelines
5The sponsor must, within a reasonable period after the Implementation Date, do all things reasonably necessary to:
a.work with the Pharmaceutical Society of Australia with a view to that society, within four months after the Implementation Date (or as soon as possible thereafter), promulgating guidelines; and
b.work with the Pharmacy Guild of Australia with a view to that guild, within four months after the Implementation Date (or as soon as possible thereafter), promulgating recommendations,

promoting compliance with the obligation not to dispense the good (on a first dispensing) unless the pharmacists have obtained a Prescriber Confirmation from an Australian Prescriber as described in these conditions.

Pharmacy and wholesaler obligations
6Within 30 days after the Implementation Date, the sponsor must make available to every prescriber who is recorded in a comprehensive and commercially available directory or list of medical practitioners and dental practitioners as at the date on which these conditions are imposed (at no cost to the prescriber), copies of the Prescriber Confirmation.
7From the date which is 2 months after the Implementation Date the sponsor must not supply the goods to a person that is not an Approved Wholesaler at the time of the supply.
8The sponsor must, within ten business days of becoming aware of any Serious Breach of any Enforceable Undertaking or Enforceable Agreement by an Approved Wholesaler or an Approved Pharmacy, send a notice to the Approved Wholesaler or Approved Pharmacy:
a.identifying the breach; and
b.warning the Approved Wholesaler or Approved Pharmacy that that person’s status as an Approved Wholesaler or Approved Pharmacy will be suspended or terminated if any further Serious Breaches of the Enforceable Undertaking or Enforceable Agreement given by that Approved Wholesaler or Approved Pharmacy occur in the twelve months following the relevant audit period.

This condition does not apply with respect to a Serious Breach of any Enforceable Undertaking or Enforceable Agreement by an Approved Wholesaler or Approved Pharmacy in respect of which a notice for the purposes of this condition has been given in the preceding twelve months.
9The sponsor must, within ten business days of becoming aware of any Minor Breach of any Enforceable Undertaking or Enforceable Agreement by an Approved Wholesaler or an Approved Pharmacy, send a notice to the Approved Wholesaler or Approved Pharmacy:
a.identifying the breach; and
b.reminding the Approved Wholesaler or Approved Pharmacy of its obligations under its Enforceable Undertaking or Enforceable Agreement.

10If the sponsor becomes aware of any Serious Breach of any Enforceable Undertaking or Enforceable Agreement by an Approved Wholesaler or an Approved Pharmacy which has been given a notice under condition 7 of these conditions in the preceding twelve months, the sponsor must, within ten working days of becoming aware of that further breach:
a.suspend the Approved Wholesaler or Approved Pharmacy’s Enforceable Undertaking or Enforceable Agreement for a period of not less than three months; or
b.terminate the Approved Wholesaler or Approved Pharmacy’s Enforceable Undertaking or Enforceable Agreement.

Monitoring and auditing – years 1 to 3
6 monthly monitoring of a sample of pharmacies and wholesalers, and pharmacies and wholesalers who have been found to be in Serious Breach
11The sponsor must, within 6 months of the Implementation Date and within each 6 month period thereafter, until the date which is three years after the Implementation Date, make all necessary requests for Audit Information and Wholesaler Information relating to at least three sample calendar months within that 6 month period, and provide that information to an independent party for the purposes of that party reviewing and reporting on (within three months of the end of the relevant audit period):
a.the compliance of an Initial Audit Sample of Approved Pharmacies with their Enforceable Agreements;
b.the compliance of Approved Wholesalers with their Enforceable Undertakings; and
c.compliance by the sponsor with its obligations under conditions 7 to 10.

Monitoring and auditing – year 4 onwards
Monitoring of pharmacies and wholesalers who have found to be in Serious Breach
12Where the sponsor has issued a notice under condition 8 after the date which is three years after the Implementation Date, the sponsor must, within 6 months of giving that notice, make all necessary requests for Audit Information and Wholesaler Information relating to at least three sample calendar months within that 6 month period for the purposes of the sponsor determining:
a.the compliance of those Approved Pharmacies with their Enforceable Agreements; and
b.the compliance of those Approved Wholesalers with their Enforceable Undertakings.

Twelve monthly monitoring of pharmacies and wholesalers
13From the date which is three years after the Implementation Date, the sponsor must, within 12 months of that date and within each 12 month period thereafter, make all necessary requests for Audit Information and Wholesaler Information relating to at least three sample calendar months within that 12 month period, and provide that information to an independent party for the purposes of that party reviewing and reporting on (within three months of the end of the relevant audit period):
a.the compliance of an Ongoing Audit Sample of Approved Pharmacies with their Enforceable Agreements;
b.the compliance of Approved Wholesalers with their Enforceable Undertakings; and
c.compliance by the sponsor with its obligations under conditions 7 to 10 and 12.

14The sponsor must provide a copy of each report it receives pursuant to condition 11 and 13 above to the TGA within 14 days of receiving it.
15After the date on which condition 7 comes into effect, the sponsor must, on a reasonable request by the Secretary, provide to the Secretary any information reasonably requested by the Secretary relevant to the implementation or operation of conditions 7 to 14 including information as to the monthly volume of sales by the sponsor of the good at any time since the date that these conditions became effective.
In these conditions:
a.“the Act” means the Therapeutic Goods Act 1989 (Commonwealth).
b.“Approved Pharmacy” means a pharmacy that is an Australian Retail Pharmacy that is subject to an Enforceable Agreement (that has not been suspended or terminated).
c.“Approved Wholesaler” means a wholesaler that is subject to an Enforceable Undertaking (that has not been suspended or terminated).
d.“Audit Information” means a record of:
i.the number of first dispensings by the Approved Pharmacy in a specified one month period;
ii.the number of Prescriber Confirmations received by the Approved Pharmacy in that specified period.

e.“Australian Pharmacy” means a pharmacy business which is authorised to operate under Australian state or territory legislation regulating the operation of pharmacies.
f.“Australian Prescriber” means a general practitioner, cardiologist, gastroenterologist, neurologist, physician, rehabilitation specialist, nephrologist, rheumatologist, obstetrician, orthopaedic surgeon, ophthalmologist or gynaecologist in Australia, and any other prescriber in Australia who indicates to the sponsor that they wish to receive communications in relation to the Good.

However, a prescriber that has indicated to the sponsor that they do not wish to receive communications in relation to the Good is not an Australian Prescriber.
g.“Australian Retail Pharmacy” means an Australian Pharmacy in so far as that pharmacy is not a Hospital Pharmacy.
h.an “Enforceable Agreement” is an enforceable agreement between the sponsor and an Australian Retail Pharmacy which requires the Australian Retail Pharmacy to take reasonable steps to:
i.only dispense the good (on a first dispensing of a prescription) to a patient whose prescriber in respect of the good has provided a Prescriber Confirmation (for the avoidance of doubt, this obligation does not apply in relation to a repeat prescription);
ii.provide Audit Information to the sponsor, at the sponsor’s reasonable request; and
iii.cooperate in relation to any review carried out as contemplated by clauses 11 to 13.

In the absence of exceptional circumstances, a pharmacy that has breached its Enforceable Agreement in a particular calendar month will be taken to have committed a “Serious Breach” if that pharmacy is not able to demonstrate the following with respect to that calendar month:
iv.if it has no more than 5 first dispensings, the pharmacy has no more than two first dispensings for which it does not have a record of receiving a Prescriber Confirmation; or
v.in any other case, the pharmacy has a record of receiving a Prescriber Confirmation in respect of at least 90% of first dispensings.

A breach of an Enforceable Agreement that is not a Serious Breach is a “Minor Breach”.
i. an “Enforceable Undertaking” is an enforceable written undertaking provided by a wholesaler to the sponsor that the wholesaler will take reasonable steps to:
i.only supply the good to Hospital Pharmacies and Approved Pharmacies;
ii.from the time which is 14 business days after receiving notification from the sponsor that a pharmacy is not an Approved Pharmacy, not supply that pharmacy;
iii.advise the sponsor in writing of the Australian Retail Pharmacies that have been supplied the good within one calendar month of the end of that month (“Wholesaler Information”); and
iv.cooperate in relation to any review carried out as contemplated by clauses 11 to 13.

A wholesaler who has breached their Enforceable Undertaking in a particular calendar month will be taken to have committed a “Serious Breach” if that wholesaler is not able to demonstrate that at least 95% of supplies made by the wholesaler in that month period have been to an Approved Pharmacy.
A breach of an Enforceable Undertaking that is not a Serious Breach is a “Minor Breach”.
j.“the Good” means a dextropropoxyphene-containing product and, in relation to these conditions, means Di-Gesic or Doloxene.
k.a “Hospital Pharmacy” is an Australian Pharmacy in so far as it dispenses goods for patients who are admitted to hospital.
l.“Implementation Date” means the first day, following the date on which these conditions are imposed, on which the sponsor is informed that the Product Information for the good is varied by the Secretary.
m.“Initial Audit Sample” means a sample of Approved Pharmacies that comprises:
i.a random sample of not less than 5% of Approved Pharmacies that are not Hospital Pharmacies which have been supplied with the good during the preceding six months, 2.5% of those Approved Pharmacies being in the top 50% of Approved Pharmacies by volume, and 2.5% of those Approved Pharmacies being in the bottom 50% of Approved Pharmacies by volume; and
ii.pharmacies that have received a notice under condition 7 above in the previous 12 months.

n.“Ongoing Audit Sample” means a sample of Approved Pharmacies that comprises a random sample of not less than 10% of Approved Pharmacies that are not Hospital Pharmacies which have been supplied with the good during the preceding twelve months, 5% of those Approved Pharmacies being in the top 50% of Approved Pharmacies by volume, and 5% of those Approved Pharmacies being in the bottom 50% of Approved Pharmacies by volume.
o.“Prescriber Confirmation” with respect to a particular patient is a written confirmation from an Australian Prescriber that, in respect of that patient, he or she:
i.is aware that the good is only approved for use in patients not able to be adequately treated with other mild analgesics;

ii.has considered the contraindications for the good outlined in the PI in relation to the patient and explained them to the patient at the time of prescribing;
iii.has considered any recent changes to the patient’s clinical presentation or biochemical status;
iv.has warned the patient at the time of prescribing about appropriate use of the product; and
v.was, at the time that he or she gave a prescription to the patient, satisfied that the patient’s history did not indicate that the patient was at risk of accidental or intentional self-harm.

p.“Product Information” means the product information for the good as approved by the Secretary of the Department of Health and Ageing under the Act from time to time.
q.“the Secretary” means the Secretary of the Department of Health and Ageing.
r.“TGA” means the Therapeutic Goods Administration.

X 2013

Annexure A1
Dear Doctor,
Important information regarding prescribing of Di-Gesic (dextropropoxyphene HCl 32.5mg/paracetamol 325mg) and Doloxene (dextropropoxyphene napsylate).
On 5 April, 2013 the Administrative Appeals Tribunal (AAT) decided that both Di-Gesic and Doloxene should remain on the Australian Register of Therapeutic Goods (ARTG), subject to the implementation of conditions to promote the safe use of these medicines. Details in relation to these conditions, which were imposed pursuant to the AAT’s decision on 12 September 2013, are set out below.
The AAT’s decision was made after considering the evidence of scientific and medical experts put forward by both the Therapeutic Goods Administration (TGA) and Aspen over the course of a week during 2012, and further hearings in February and June 2013.
Product Information
Please note that Di-Gesic and Doloxene are only indicated for the relief of mild to moderate pain in patients who are not able to be adequately treated with other mild analgesics.
Please also note that amendments have been made to the Product Information for each of these products to highlight important warnings and contraindications.
Special arrangements for prescribing and dispensing Di-Gesic and Doloxene
In accordance with directions made by the AAT, from [insert date – 2 months from Implementation Date] it will be necessary for you to complete and sign a Prescriber Confirmation Form (see forms attached) for patients who are prescribed Di-Gesic or Doloxene. This form will indicate that:
1you are aware that the product is only approved for use in patients who are not able to be adequately treated with other mild analgesics;
2you have considered the contraindications outlined in the PI;
3you have considered any recent changes to the patient's clinical presentation or biochemical status;
4you have warned the patient about appropriate use of the product; and
5the patient's history does not indicate that the patient is at risk of accidental or intentional self-harm.

Except where dispensing for patients who are admitted to hospital, Pharmacists will not be permitted to dispense Di-Gesic or Doloxene on a first dispensing of a prescription unless they first obtain confirmation of the matters in 1 to 5 above from prescribers. Pharmacies must obtain this confirmation by collecting a copy of the Prescriber Confirmation Form at the point of first dispensing. The copy of the Prescriber Confirmation Form that will be used to monitor compliance with these conditions will not contain identifying information concerning patients or prescribers.
To avoid your patients experiencing any difficulties in relation to the dispensing of the products, Aspen suggests that you provide each patient who is prescribed Di-Gesic or Doloxene with a Prescriber Confirmation Form with each prescription.
The conditions of registration of Di-Gesic and Doloxene require Aspen to enter into arrangements with pharmacies and to conduct various audits of pharmacies to ensure the products are not dispensed in the absence of appropriate confirmation from prescribers. Information collected as part of the audit process will be de-identified to protect both prescriber and patient privacy.
Enclosed are two Prescriber Confirmation Forms. As you will see, each Prescriber Confirmation Form comprises four copies. You may keep the copy which is marked “Prescriber Copy” for your records, however you should provide the copies marked “Patient Copy” (for the patient to keep), “Pharmacy Copy” and the deidentified “Audit Copy” (to be provided to the dispensing pharmacy) to the patient.
Additional copies of the Prescriber Confirmation Form may be ordered from our website; Sign in with the username Physician and password Healthy and follow the prompts to “Di-Gesic / Doloxene Prescriber Confirmation Form”. Alternatively, you may call Aspen on 02 8436 8300 or speak to your Aspen representative.
Except where dispensing for patients who are admitted to hospital, Pharmacists will also be required to provide patients with a Patient Information Leaflet (in the form attached) at the point of dispensing for a period until updated Consumer Medicine Information that is consistent with the updated Product Information is added to individual packs. Additional copies of the Patient Information Leaflets may be requested by pharmacists after this time.
Dispensing Guidelines
Aspen is in the process of working with the Pharmaceutical Society of Australia to prepare guidelines and the Pharmacy Guild to prepare recommendations advising pharmacists (other than hospital pharmacists, to the extent the products are dispensed to patients who are admitted to hospital) not to dispense a new prescription for Di-Gesic or Doloxene unless a Prescriber Confirmation Form is provided to them, and reminding pharmacists to provide a Patient Information Leaflet to patients at the point of dispensing (when applicable).
Aspen intends to periodically send further information and reminders in relation to the special arrangements which apply to the supply of Di-Gesic and Doloxene to general practitioners, cardiologists, gastroenterologists, neurologists, physicians, rehabilitation specialists, nephrologists, rheumatologists, obstetricians, orthopaedic surgeons, ophthalmologists and gynaecologists. Please complete the enclosed Business Reply Paid card if you are NOT in this group of prescribers and you WOULD like to receive further communications in relation to these products (that is, you would like to opt in to receive these communications).
If you have any questions about the conditions which apply to the prescribing and dispensing of Di-Gesic and Doloxene please feel free to contact me on the numbers below. Aspen would like to take this opportunity to thank you for your assistance in implementing these special arrangements.
Yours sincerely,
[to be signed for and on behalf of Aspen by an authorised person]
Before prescribing please review Product Information available via or call 1300 659 646
INSERT PBS BOX
INSERT UPDATED BLACK BOX WARNING AND MIN PI
INSERT ASPEN COMPANY MANDATORIES
X 2013

Annexure A2
Dear Dentist,
Important information regarding prescribing of Di-Gesic (dextropropoxyphene HCl 32.5mg/paracetamol 325mg) and Doloxene (dextropropoxyphene napsylate).
On 5 April, 2013 the Administrative Appeals Tribunal (AAT) decided that both Di-Gesic and Doloxene should remain on the Australian Register of Therapeutic Goods (ARTG), subject to the implementation of conditions to promote the safe use of these medicines. Details in relation to these conditions, which were imposed pursuant to the AAT’s decision on 12 September 2013, are set out below.
The AAT’s decision was made after considering the evidence of scientific and medical experts put forward by both the Therapeutic Goods Administration (TGA) and Aspen over the course of a week during 2012, and further hearings in February and June 2013.
Product Information
Please note that Di-Gesic and Doloxene are only indicated for the relief of mild to moderate pain in patients who are not able to be adequately treated with other mild analgesics.
Please also note that amendments have been made to the Product Information for each of these products to highlight important warnings and contraindications.
Special arrangements for prescribing and dispensing Di-Gesic and Doloxene
In accordance with directions made by the AAT, from [insert date – 2 months from Implementation Date] it will be necessary for prescribers to complete and sign a Prescriber Confirmation Form for patients who are prescribed Di-Gesic or Doloxene. This form will indicate that:
1the prescriber is aware that the product is only approved for use in patients who are not able to be adequately treated with other mild analgesics;
2the prescriber has considered the contraindications outlined in the PI;
3the prescriber has considered any recent changes to the patient's clinical presentation or biochemical status;
4the prescriber has warned the patient about appropriate use of the product; and
5the patient's history does not indicate that the patient is at risk of accidental or intentional self-harm.

Except where dispensing for patients who are admitted to hospital, Pharmacists will not be permitted to dispense Di-Gesic or Doloxene on a first dispensing of a prescription unless they first obtain confirmation of the matters in 1 to 5 above from prescribers. Pharmacies must obtain this confirmation by collecting a copy of the Prescriber Confirmation Form at the point of first dispensing.
Because the matters that prescribers are required to confirm may require detailed knowledge of a patient’s history and clinical presentation (particularly 3 and 5 above), Aspen anticipates that dentists may have difficulty completing a Prescriber Confirmation Form for their patients. Aspen suggests that if you anticipate that one of your patients may require Di-Gesic or Doloxene, you make arrangements for their regular doctor to prescribe the product for them. Patients will not be able to be dispensed Di-Gesic or Doloxene without a completed Prescriber Confirmation Form.
Aspen intends to periodically send further information and reminders in relation to the special arrangements which apply to the supply of Di-Gesic and Doloxene to general practitioners, cardiologists, gastroenterologists, neurologists, physicians, rehabilitation specialists, nephrologists, rheumatologists, obstetricians, orthopaedic surgeons, ophthalmologists and gynaecologists. However, please complete the enclosed Business Reply Paid card if you would like to receive further communications in relation to these products (that is, you would like to opt in to receiving these communications).
If you have any questions about the conditions which apply to the prescribing and dispensing of Di-Gesic and Doloxene please feel free to contact me on the numbers below.
Yours sincerely,
[to be signed for and on behalf of Aspen by an authorised person]
Before prescribing please review Product Information available via or call 1300 659 646
INSERT PBS BOX
INSERT UPDATED BLACK BOX WARNING AND MIN PI
INSERT ASPEN COMPANY MANDATORIES
X 2013

Annexure B
Dear Doctor,
REMINDER: SPECIAL ARRANGEMENTS FOR PRESCRIBING AND DISPENSING DI-GESIC (dextropropoxyphene HCl 32.5mg/paracetamol 325mg) and DOLOXENE (dextropropoxyphene napsylate).
As you know, following a decision made by the Administrative Appeals Tribunal (AAT) a few months ago, special conditions now apply to the registrations of Di-Gesic and Doloxene to ensure the safe use of these medicines.
Further information in relation to these conditions and the special arrangements which apply to the supply of these products is below.
Class of Patients
Di-Gesic and Doloxene are only indicated for the relief of mild to moderate pain in patients who are not able to be adequately treated with other mild analgesics.
Please note the important warnings and contraindications in the Product Information for each of the products.
Special arrangements for prescribing and dispensing Di-Gesic and Doloxene
In accordance with directions made by the AAT it is now necessary for you to complete and sign a Prescriber Confirmation Form for patients who are prescribed Di-Gesic or Doloxene. This form will indicate that:
1you are aware that the product is only approved for use in patients who are not able to be adequately treated with other mild analgesics;
2you have considered the contraindications outlined in the PI;
3you have considered any recent changes to the patient's clinical presentation or biochemical status;
4you have warned the patient about appropriate use of the product; and
5the patient's history does not indicate that the patient is at risk of accidental or intentional self-harm.

Except where dispensing for patients who are admitted to hospital, Pharmacists will not be permitted to dispense Di-Gesic or Doloxene on a first dispensing of a prescription unless they first obtain confirmation of the matters in 1 to 5 above from prescribers.
Pharmacists must obtain this confirmation by collecting a copy of the Prescriber Confirmation Form at the point of dispensing. The copy of the Prescriber Confirmation Form that will be used to monitor compliance with these conditions will not contain identifying information concerning patients or prescribers.
To avoid your patients experiencing any difficulties in relation to the dispensing of the products, Aspen suggests that you provide each patient who is prescribed Di-Gesic or Doloxene with a Prescriber Confirmation Form with each prescription.
Additional copies of the Prescriber Confirmation Form may be ordered from our website; Sign in with the username Physician and password healthy and follow the prompts to “Di-Gesic / Doloxene Prescriber Confirmation Form”. Alternatively, you may call Aspen on 02 8436 8300 or speak to your Aspen representative.
Aspen will periodically send further information and reminders in relation to the special arrangements which apply to the supply of Di-Gesic and Doloxene to general practitioners, cardiologists, gastroenterologists, neurologists, physicians, rehabilitation specialists, nephrologists, rheumatologists, obstetricians, orthopaedic surgeons, ophthalmologists and gynaecologists. Please complete the enclosed Business Reply Paid card if you are a prescriber in this group of prescribers and you would NOT like to receive further communications in relation to these products (that is, you would like to opt out of receiving these communications). If you have any questions about the conditions which now apply to the prescribing and dispensing of Di-Gesic and Doloxene please feel free to contact me on the numbers below.
Aspen would like to take this opportunity to once again thank you for support in complying with the special conditions for prescribing Di-Gesic and Doloxene.
Yours sincerely,
[to be signed for and on behalf of Aspen by an authorised person]
Before prescribing please review Product Information available via or call 1300 659 646
INSERT PBS BOX INSERT
INSERT UPDATED BLACK BOX WARNING AND MIN PI
INSERT ASPEN COMPANY MANDATORIES
Annexure C
X 2013

Annexure D
Dear Pharmacist,
Important information regarding dispensing of Di-Gesic (dextropropoxyphene HCl 32.5mg/paracetamol 325mg) and Doloxene (dextropropoxyphene napsylate).
On 5th April, 2013 the Administrative Appeals Tribunal (AAT) decided that both Di-Gesic and Doloxene should remain on the Australian Register of Therapeutic Goods (ARTG), subject to the implementation of conditions to promote the safe use of these medicines. Details in relation to these conditions, which were imposed pursuant to the AAT’s decision on 12 September 2013, are set out below.
The AAT’s decision was made after considering the evidence of scientific and medical experts put forward by both the Therapeutic Goods Administration (TGA) and Aspen over the course of a week during 2012, and further hearings in February and June 2013.
Product Information
Please note that Di-Gesic and Doloxene are only indicated for the relief of mild to moderate pain in patients who are not able to be adequately treated with other mild analgesics.
Please also note that amendments have been made to the Product Information and Consumer Medicine Information for each of these products to highlight important warnings and contraindications.
Special arrangements for retail pharmacies dispensing Di-Gesic and Doloxene
From [insert date – 2 months from Implementation Date], it will be necessary for doctors to complete and sign a Prescriber Confirmation Form (see sample form attached) for patients who are prescribed Di-Gesic or Doloxene. This form will indicate that:
a)they are aware that the product is only approved for use in patients who are not able to be adequately treated with other mild analgesics;
b)they have considered the contraindications outlined in the PI;
c)they have considered any recent changes to the patient's clinical presentation or biochemical status;
d)they have warned the patient about appropriate use of the product; and
e)the patient's history does not indicate that the patient is at risk of accidental or intentional self-harm.

FROM [INSERT DATE - 2 months from Implementation Date] Except where dispensing for patients who are admitted to hospital, PHARMACISTS MUST OBTAIN CONFIRMATION OF THE MATTERS OUTLINED ABOVE FROM PRESCRIBERS BEFORE DISPENSING DI-GESIC OR DOLOXENE ON A FIRST DISPENSING OF A PRESCRIPTION (THAT IS, OTHER THAN IN THE CASE OF REPEAT PRESCRIPTIONS) .
To obtain this confirmation, you should collect a copy of the Prescriber Confirmation Form at the point of dispensing. The Prescriber Confirmation Form you receive from patients will comprise three copies. You should provide the copy marked “Patient Copy” to the patient. Enclosed is a folder for you to keep the copies of the Prescriber Confirmation Forms marked “Pharmacy Copy” and “Audit Copy”. These forms must be kept for a period of two years.
It is not necessary for you to obtain a Prescriber Confirmation Form for repeat prescriptions.
Retail Pharmacy Undertakings
In accordance with directions made by the AAT, the continued registration of Di-Gesic and Doloxene requires Aspen to enter into arrangements with pharmacies (other than hospital pharmacies, to the extent the products are dispensed for patients who are admitted to hospital) and wholesalers to ensure that retail pharmacies will not be supplied Di-Gesic or Doloxene stock by wholesalers unless they agree to:
1only dispense Di-Gesic and Doloxene to patients on a first dispensing of a prescription where the prescriber has provided the confirmation discussed above; and
2on Aspen’s request (and on 24 hours notice), provide information and documents to enable Aspen to determine whether these requirements have been complied with. This information will include copies of your records in relation to the number of first dispensings in a given period and the prescriber confirmations you have received for that corresponding period.

If you wish to receive stock of Di-Gesic and Doloxene after [insert date – 2 months from Implementation Date], you must agree to the terms in the attached schedule. You may agree to these terms by either sending Aspen written confirmation that you agree to the terms, or by ordering stock after [insert date – 2 months from Implementation Date]. Please note that by giving Aspen written confirmation that you agree with the terms or by ordering Di-Gesic or Doloxene after this date, you will have entered into a binding contract with Aspen on the terms in the attached schedule.
If you do not agree to the terms in the attached schedule and do not wish to participate in the special scheme that applies to these products, you may send Aspen written notice that you do not want to participate, or simply cease ordering Di-Gesic and Dolexene after [insert date – 2 months from Implementation Date].

Auditing
Aspen is also required to carry out monitoring to determine compliance with these terms by auditing a sample of pharmacies in certain months.
In order to comply with this requirement, Aspen representatives may request that you provide a record of the number of first dispensings of Di-Gesic and Doloxene in a given month period, together with the copies of the Prescriber Confirmation Forms marked “Audit Copy” collected in the same period. You will receive at least 24 hours notice that this request will be made. Information collected as part of the audit process will be de-identified to protect both prescriber and patient privacy.
If this monitoring indicates that you have not complied with the terms in the attached schedule but that you have a record of receiving a Prescriber Confirmation in respect of at least 90% of first dispensings (or, for pharmacies that have no more than 5 first dispensings in a particular month, that you have no more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation) (a “Minor Breach”), in the absence of exceptional circumstances, Aspen is required to give you a notice identifying the breach, and reminding you of your obligations.
If monitoring indicates that you do not have a record of receiving a Prescriber Confirmation in respect of at least 90% of first dispensings (or, for pharmacies that have no more than 5 first dispensings in a particular month, that you have more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation) (a “Serious Breach”), Aspen is required to give you a written warning that further non-compliance will mean that you are no longer eligible to receive stock of Di-Gesic and Doloxene from your wholesaler. In the event that you are found to have not complied, Aspen will also work with you to help ensure that you are able to comply.
If monitoring indicates that there has been a Serious Breach of your obligations, Aspen is required to carry out further reviews of your compliance in the following months. If this subsequent review indicates that there has been a further Serious Breach, , in the absence of exceptional circumstances, Aspen is required to instruct your wholesaler that you are not to receive further stock of Di-Gesic or Doloxene for at least three months. Recommencement of supply to you will be at Aspen’s discretion.
Patient Information Leaflet
The special conditions also require Aspen to provide you with Patient Information Leaflets to give to patients at the point of dispensing Di-Gesic and Doloxene for a period until updated Consumer Medicine Information is included in individual packs. Additional copies of the Patient Information Leaflets may be requested after this time. The Patient Information Leaflets provide further information about the warnings and contraindications associated with the products.
For your convenience we have enclosed with this letter 50 Patient Information Leaflets. To order additional copies please visit our website, select 'Pharmacy DPP' from the Secure Access dropdown, and use the password: pharmacydpp. You may also order more by calling Aspen on 02 8436 8300 or by speaking to your Aspen Representative.
Dispensing Guidelines
To assist retail pharmacists in complying with the special conditions, Aspen is committed to working with the Pharmaceutical Society of Australia to prepare guidelines and the Pharmacy Guild to prepare recommendations advising (non-hospital) pharmacists not to dispense Di-Gesic or Doloxene on a first dispensing of a prescription unless the necessary confirmation has been received from the prescriber.
In summary, unless you are a hospital pharmacist dispensing for patients who are admitted to hospital, by ordering stock of these products you have opted into the supply arrangements outlined in the Schedule. If you opt out by informing Aspen you do not accept the terms, you will be removed from the approved supplier list. Retail pharmacies that opt in will be required to sight and keep a copy of the Prescriber Confirmation Form as part of the supply arrangements. Pharmacies who cannot confirm Prescriber Confirmation Forms (for first dispensings) have been sighted and kept for audit purposes may be removed from the approved supplier list.
For the avoidance of doubt, these special arrangements do not apply to hospital pharmacies, to the extent the products are dispensed for patients who are admitted to hospital.
If you have any questions about the conditions which will now apply to the dispensing of Di-Gesic and Doloxene please feel free to contact me on the numbers below. Aspen would like to take this opportunity to thank you for your assistance implementing these special conditions.
Yours sincerely,
[to be signed for and on behalf of Aspen by an authorised person]
Before dispensing please review Product Information available via or call 1300 659 646
INSERT PBS BOX
INSERT UPDATED BLACK BOX WARNING AND MIN PI
INSERT ASPEN COMPANY MANDATORIES
Schedule
1Except where dispensing for patients who are admitted to hospital, you must take reasonable steps to ensure that you do not supply Di-Gesic (ARTG 52509) or Doloxene (ARTG 161853) to a patient on a first dispensing of a prescription (ie not a repeat) unless you first obtain a signed Prescriber Confirmation Form in relation to that patient.
2If you breach these conditions but are able to demonstrate the following:
a)if you have no more than 5 first dispensings in any specified calendar month period, there are no more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation Form; or
b)if you have 6 or more first dispensings, there is a record of receiving a Prescriber Confirmation Form in respect of at least 90% of first dispensings,

in the absence of exceptional circumstances, you will be taken to have committed a “Minor Breach”.
3If you breach these conditions and are not able to demonstrate the following, in the absence of exceptional circumstances, you will be taken to have committed a “Serious Breach”:
a)if you have no more than 5 first dispensings in any specified calendar month period, there are no more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation Form; or
b)if you have 6 or more first dispensings, there is a record of receiving a Prescriber Confirmation Form in respect of at least 90% of first dispensings.

4The approved form of the Prescriber Confirmation Form is enclosed and may only be changed by notice from Aspen.
5You agree to, on 24 hours notice, provide Aspen with the following records (in a form that will not contain identifying information concerning patients or prescribers) that will be used to determine compliance with these conditions:
· a record of the number of first dispensings of Di-Gesic or Doloxene in a specified month (nominated by Aspen);
· “Audit” copies of the Prescriber Confirmation Forms collected in the specified month.
6If you:
a)commit a Minor Breach of these conditions, Aspen will send you a notice identifying the breach and reminding you of your obligations under these conditions;
b)commit a Serious Breach of these conditions, each of Aspen and your wholesaler(s) must stop supplying Di-Gesic and Doloxene to you for at least three months, in which case recommencement of supply will be at Aspen’s absolute discretion.

These are Aspen’s sole remedy for breach of these conditions and Aspen will not claim moneys from you solely for breach of these conditions.
7You must not make a claim against Aspen or your wholesaler(s) if Aspen refuses to supply or stops supplying Di-Gesic and Doloxene to you.
8Unless and until you provide 28 days notice to Aspen that you do not agree to these conditions, the conditions apply as an agreement between you and Aspen from the later of:
· [insert date - 2 months from the Implementation Date]; or
· the date you order Di-Gesic or Doloxene (where this occurs after [insert date - 2 months from the Implementation Date]).
9You must notify Aspen if you no longer operate the pharmacy you currently operate, for example, if you sell your business.

PRESCRIBER CONFIRMATION FORM IN RELATION TO TREATMENT WITH DIGESIC (dextropropoxyphene HCl 32.5 mg/paracetamol 325 mg) OR DOLOXENE (dextropropoxyphene napsylate)
Di-Gesic and Doloxene will not be dispensed by pharmacists unless this form is signed by prescribers and provided, with the prescription, to the pharmacy at the time of dispensing
I confirm that I have prescribed (Tick one):
.. Di-Gesic; or
.. Doloxene
(The Product)
To the following patient:
....................................................................................................................
Print Name
•I am aware that Di-Gesic and Doloxene are only approved for use in patients who are not able to be adequately treated with other mild analgesics;
•I have considered the contraindications outlined in the PI;
•I have considered any recent changes to the Patient’s clinical presentation or biochemical status;
•I have warned the Patient about appropriate use of the Product; and
•The patient’s history does not indicate that the patient is at risk of accidental or intentional self-harm

Prescriber: ...................................................................................................
Address: ......................................................................................................
Signature:......................................................... Date: ...................................
Prescriber Copy
PRESCRIBER CONFIRMATION FORM IN RELATION TO TREATMENT WITH DIGESIC (dextropropoxyphene HCl 32.5 mg/paracetamol 325 mg) OR DOLOXENE (dextropropoxyphene napsylate)
Di-Gesic and Doloxene will not be dispensed by pharmacists unless this form is signed by prescribers and provided, with the prescription, to the pharmacy at the time of dispensing
I confirm that I have prescribed (Tick one):
.. Di-Gesic; or
.. Doloxene
(The Product)
To the following patient:
....................................................................................................................
Print Name
•I am aware that Di-Gesic and Doloxene are only approved for use in patients who are not able to be adequately treated with other mild analgesics;
•I have considered the contraindications outlined in the PI;
•I have considered any recent changes to the Patient’s clinical presentation or biochemical status;
•I have warned the Patient about appropriate use of the Product; and
•The patient’s history does not indicate that the patient is at risk of accidental or intentional self-harm

Prescriber: ...................................................................................................
Address: ......................................................................................................
Signature:......................................................... Date: ...................................
Pharmacy Use Only
Name:..........................................................................................................
Address: ......................................................................................................
Phone:.............................................................. Date: ...................................
PATIENT COPY
PRESCRIBER CONFIRMATION FORM IN RELATION TO TREATMENT WITH DIGESIC (dextropropoxyphene HCl 32.5 mg/paracetamol 325 mg) OR DOLOXENE (dextropropoxyphene napsylate)
Di-Gesic and Doloxene will not be dispensed by pharmacists unless this form is signed by prescribers and provided, with the prescription, to the pharmacy at the time of dispensing
I confirm that I have prescribed (Tick one):
.. Di-Gesic; or
.. Doloxene
(The Product)
To the following patient:
....................................................................................................................
Print Name
•    I am aware that Di-Gesic and Doloxene are only approved for use in patients who are not able to be adequately treated with other mild analgesics;
•    I have considered the contraindications outlined in the PI;
•    I have considered any recent changes to the Patient’s clinical presentation or biochemical status;
•    I have warned the Patient about appropriate use of the Product; and
•    The patient’s history does not indicate that the patient is at risk of accidental or intentional self-harm
Prescriber: ...................................................................................................
Address: ......................................................................................................
Signature:......................................................... Date: ...................................
Pharmacy Use Only
Name:..........................................................................................................
Address: ......................................................................................................
Phone:.............................................................. Date: ...................................
PHARMACY COPY
PRESCRIBER CONFIRMATION FORM IN RELATION TO TREATMENT WITH DIGESIC (dextropropoxyphene HCl 32.5 mg/paracetamol 325 mg) OR DOLOXENE (dextropropoxyphene napsylate)
Di-Gesic and Doloxene will not be dispensed by pharmacists unless this form is signed by prescribers and provided, with the prescription, to the pharmacy at the time of dispensing
I confirm that I have prescribed (Tick one):
.. Di-Gesic; or
.. Doloxene
(The Product)
•    I am aware that Di-Gesic and Doloxene are only approved for use in patients who are not able to be adequately treated with other mild analgesics;
•    I have considered the contraindications outlined in the PI;
•    I have considered any recent changes to the Patient’s clinical presentation or biochemical status;
•    I have warned the Patient about appropriate use of the Product; and
•    The patient’s history does not indicate that the patient is at risk of accidental or intentional self-harm
Pharmacy Use Only
Name:..........................................................................................................
Address: ......................................................................................................
Phone:.............................................................. Date: ...................................
AUDIT COPY
X 2013

Annexure E
Dear Pharmacist,
REMINDER: SPECIAL ARRANGEMENTS FOR PRESCRIBING AND DISPENSING DI-GESIC (dextropropoxyphene HCl 32.5mg/paracetamol 325mg) and DOLOXENE (dextropropoxyphene napsylate).
As you know, following a decision made by the Administrative Appeals Tribunal (AAT) a few months ago, special conditions now apply to the registrations of Di-Gesic and Doloxene to ensure the safe use of these medicines.
As a reminder, I am providing a summary of the conditions and the special arrangements which apply to the supply of these products below.
Special arrangements for retail pharmacies dispensing Di-Gesic and Doloxene
Since [insert date – 2 months from Implementation Date], EXCEPT WHERE DISPENSING FOR PATIENTS WHO ARE ADMITTED TO HOSPITAL, PHARMACIES HAVE BEEN REQUIRED TO COLLECT PRESCRIBER CONFIRMATION FORMS BEFORE DISPENSING DI-GESIC OR DOLOXENE ON A FIRST DISPENSING OF A PRESCRIPTION (THIS DOES NOT APPLY TO REPEATS).
The copy marked “Patient Copy” should be given to the Patient. The remaining copies must be kept by the pharmacy which first dispenses the prescription, for a period of 2 years.
Pharmacy Undertaking
The continued registration of Di-Gesic and Doloxene also require Aspen to enter into arrangements with pharmacies (other than hospital pharmacies, to the extent the products are dispensed for patients who are admitted to hospital). Unless you are a hospital pharmacy, if you are currently receiving stock of Di-Gesic and Doloxene you have agreed to the terms of the schedule (attached again for your convenience) and therefore have entered into a binding contract with Aspen.
If you do not agree to the terms in the attached schedule and you no longer wish to participate in the special scheme that applies to these products, please send Aspen written notice that you do not want to participate.
Auditing
As a reminder, the special scheme requires Aspen to carry out monitoring to determine compliance with these terms by auditing a sample group of pharmacies in certain months.
The monitoring of the scheme may involve a review of the number of first dispensings of Di-Gesic or Doloxene you have dispensed (that is, other than as a repeat prescription) in a given month together with the copies of the Prescriber Confirmation Forms for that period. You will receive at least 24 hours notice that this request will be made. Information collected as part of the audit process will be de-identified to protect both prescriber and patient privacy.
If this review indicates that you have not complied with the terms in the attached schedule, but that you have a record of receiving a Prescriber Confirmation in respect of at least 90% of first dispensings (or, for pharmacies that have no more than 5 first dispensings in a particular month, that you have no more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation) (a “Minor Breach”), in the absence of exceptional circumstances, Aspen is required to give you a notice identifying the breach, and reminding you of your obligations.
If monitoring indicates that you do not have a record of receiving a Prescriber Confirmation in respect of at least 90% of first dispensings (or, for pharmacies that have no more than 5 first dispensings in a particular month, that you have more than two first dispensings for which you do not have a record of receiving a Prescriber Confirmation) (a “Serious Breach”), Aspen is required to give you a written warning that further non-compliance will mean that you are no longer eligible to receive stock of Di-Gesic and Doloxene from your wholesaler. In the event that you are found to have not complied, Aspen will also work with you to help ensure that you are able to comply.
If monitoring indicates that there has been a Serious Breach of your obligations, Aspen is required to carry out further reviews of your compliance in the following months. If this subsequent review indicates that there has been a further Serious Breach, in the absence of exceptional circumstances, Aspen is required to instruct wholesalers that you are not to receive further stock of Di-Gesic or Doloxene for at least three months. Recommencement of supply to you will be at Aspen’s discretion.
Patient Information Leaflet
The special conditions also require Aspen to provide you with Patient Information Leaflets to give to patients at the point of dispensing Di-Gesic and Doloxene for a period until updated Consumer Medicine Information is included in individual packs. You may request additional copies of the Patient Information Leaflets after this time. The Patient Information Leaflet provides further information about the warnings and contraindications associated with the products.
To order additional copies, please visit our website, select 'Pharmacy DPP' from the Secure Access dropdown, and use the password: pharmacydpp. You may also order more by calling Aspen on 02 8436 8300 or by speaking to your Aspen Representative.
In summary, if you are a retail pharmacy that has been receiving stock of Di-Gesic or Doloxene, you have opted into the supply arrangements and agree to participate in the audit process. Please ensure you keep a copy of the Prescriber Confirmation Form [and that you provide a copy of the Patient Information Leaflet each time you dispense Di-Gesic of Doloxene].[2]

[2] To be deleted from letters sent 12 months after the Implementation Date
If you have any questions about the conditions which will apply to the dispensing of Di-Gesic and Doloxene please feel free to contact me on the numbers below. Aspen would like to take this opportunity to thank you for your assistance in implementing these special conditions.
Yours sincerely,
[to be signed for and on behalf of Aspen by an authorised person]
Before prescribing please review Product Information available via or call 1300 659 646
INSERT PBS BOX INSERT
UPDATED BLACK BOX WARNING AND MIN PI
INSERT ASPEN COMPANY MANDATORIES
Schedule
[See Annexure D]

Division	GENERAL ADMINISTRATIVE DIVISION
File Number(s)	2012/0348 2012/0350
Re	Aspen Pharmacare Australia Pty Ltd
APPLICANT
And	Minister for Health and Ageing
RESPONDENT

Tribunal	President Kerr Senior Member Nicoletti
Date	12 September 2013
Place	Sydney

Dates of hearing	17 June 2013
Counsel for the Applicant	Mr S Lloyd SC Mr S Robertson
Solicitors for the Applicant	King & Wood Mallesons
Counsel for the Respondent	Dr J Renwick SC Dr H Bennett
Solicitors for the Respondent	Corrs Chambers Westgarth