Scheduling delegate's interim decisions and invitation for further comment: ACCS/ACMS, May 2013

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23 May 2013

Interim decisions on proposal referred to an advisory committee: ACMS March 2013

3. March 2013 meeting of the Advisory Committee on Medicines Scheduling - ACMS #8

3.1 Benzodiazepines

Scheduling proposal

The medicines scheduling delegate considered a proposal to reschedule benzodiazepines from Schedule 4 to Schedule 8 in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

In May 1982, the general class of benzodiazepines was included into Schedule 4. In May 1986, individual benzodiazepine substances were listed in Schedule 4 (bromazepam, diazepam).

A review of scheduling for the benzodiazepine class of drugs in August 1998 found that the benzodiazepines entries in Schedule 4 remained appropriate, with the expectation of the substance flunitrazepam, which was included in Schedule 8 in November 1997 based on public health concerns associated with abuse of this substance.

The rescheduling of Alprazolam as a Schedule 8 substance was considered by the National Drugs and Poisons Scheduling Committee in June 2010, after the up-scheduling of Flunitrazepam. The committee stated that there was insufficient evidence to support a Schedule 8 restriction for alprazolam and agreed that until such information is provided to support a rescheduling application, the Schedule 4 entry remained appropriate.

Scheduling status

Group listing of benzodiazepine derivatives is included in Schedule 4. Other specific benzodiazepines are also included in Schedule 4 (other than flunitrazepam) and in Appendix K.

Public pre-meeting submissions

Seventy public pre-meeting submissions were received.

Fifty-two of those submissions were against the rescheduling of benzodiazepines on the grounds of negative impact to business. The main impacts related to increased administrative burden and the need to increase security for those who administer or dispense benzodiazepines, such as aged care facilities and pharmacies.

Sixteen submissions were in support of rescheduling benzodiazepines in Schedule 8 citing public health concerns associated with the abuse and trafficking of these substances.

Two submissions did not provide comment either for or against. One noted the misuse of alprazolam; the other outlined business impacts should the proposal go ahead.

At least 12 submissions—both for and against—suggested that alprazolam be included under Schedule 8 due to concerns regarding abuse of this substance.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that alprazolam be rescheduled from Schedule 4 to Schedule 8 and that the scheduling of the remaining benzodiazepines remains appropriate. The ACMS also recommends that benzodiazepines be included in Appendix D, paragraph 5.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included; (a) the risks and benefits of the use of a substance, (b) the purposes for which a substance is to be used and the extent of use of a substance, (c) the toxicity of a substance, (d) the dosage, formulation, labelling, packaging and presentation of a substance and (e) the potential for abuse of a substance.

The reasons for the recommendation comprised the following:

  • alprazolam: a public health problem of widespread use with possible increased toxicity. It does not appear to have any additional therapeutic benefits compared with any other substance in the class.
  • alprazolam: listing in Schedule 8 does not restrict short-term use for the approved indication. There has also been a rapid increase in use compared with other benzodiazepines.
  • alprazolam: increased morbidity and mortality in overdose. Misuse, particularly in association with opioids.
  • alprazolam: pack size and potency of dosage forms. Pack size inappropriate for approved indication.
  • alprazolam: evidence of widespread misuse.
Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors9;
  • other relevant information.
Delegates Interim Decision

The delegate has made the following interim decisions:

  • That alprazolam be rescheduled from Schedule 4 to Schedule 8;
  • That the scheduling of the remaining benzodiazepines remains appropriate; and
  • That benzodiazepines be included in Appendix D, paragraph 5.

The proposed implementation date for this decision is 1 January 2014.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of the use of a substance, (b) the purposes for which a substance is to be used and the extent of use of a substance, (c) the toxicity of a substance, (d) the dosage, formulation, labelling, packaging and presentation of a substance and (e) the potential for abuse of a substance.

The reasons for the interim decision comprised the following:

  • Alprazolam has increased morbidity and mortality in overdose with possible increased toxicity. It does not appear to have any additional therapeutic benefits compared with any other substance in the class.
  • There has also been a rapid increase in use of Alprazolam compared with other benzodiazepines and evidence of widespread misuse.
  • Alprazolam - Concerns of possible increased toxicity.
  • Alprazolam - concern that current pack size is inappropriate for indications.
  • There is evidence of abuse of the substance and misuse with opiods.
  • Listing in Schedule 8 of Alprazolam does not restrict its short-term use for the approved indication.
Scheduling entry
Schedule 4 - amendment

ALPRAZOLAM - Delete entry.

Schedule 8 - new entry

ALPRAZOLAM.

Appendix D, paragraph 5 - new entry

BENZODIAZEPINE DERIVATIVES, including those separately specified in Schedule 4 and Schedule 8.

Benzodiazepine entries will be amended to include the "#" symbol beside their name to indicate their inclusion under Appendix D, paragraph 5.

3.2 Diclofenac

Scheduling proposal

The medicines scheduling delegate considered a proposal to exempt from scheduling diclofenac, when presented as a 140 mg or less diclofenac transdermal drug delivery system from the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

In March 1981, diclofenac was included in Schedule 4.

In February 1997, the National Drugs and Poisons Schedule Committee (NDPSC) rescheduled from Schedule 4 to Schedule 2, dermal preparations (creams) containing 1 per cent or less of diclofenac. This decision was based on the safety profile of a 1 per cent formulation and the then approved indications for use in readily recognised conditions (minor pain relief), which did not include treatment of solar keratosis.

In August 1999, the NDPSC decided that the scheduling of diclofenac in dermal preparations remained appropriate after considering recommendations from the Trans-Tasman Harmonisation Working Party to exempt diclofenac for dermal use.

In November 1999, the NDPSC deferred consideration of the scheduling of diclofenac in dermal preparations.

In February 2000, the NDPSC exempted dermal preparations of diclofenac from scheduling based on additional safety data.

In March 2011, following advice from the December 2010 ACMS meeting, the delegate included dermal preparations containing more than 1 per cent of diclofenac or preparations for the treatment of solar keratosis in Schedule 4.

In February 2012, following advice from the October 2011 ACMS meeting, the delegate rescheduled dermal preparations containing more than 1 per cent up to 4 per cent or less of diclofenac, except when for the treatment of solar keratosis, to Schedule 2. The delegate also confirmed that Schedule 4 remained appropriate for preparations containing more than 4 per cent of diclofenac, that preparations containing 1 per cent or less of diclofenac would remain unscheduled and that preparations for use in solar keratosis would remain in Schedule 4.

In February 2013, following advice from the October 2012 ACMS meeting, the delegate included transdermal preparations for topical use containing 140 mg or less of diclofenac in Schedule 2, with an implementation date of 1 May 2013.

Scheduling status

Diclofenac is currently included in Schedules 2, 3 and 4 and Appendices F and H.

Public pre-meeting submissions

Four public pre-meeting submissions were received.

Three did not support the proposal.

One indicated that it would have liked to comment on the proposed scheduling changes but felt that there was not information available regarding the proposal in order to comment.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that the current scheduling of diclofenac remains appropriate.

The matter under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS included (d) dosage, formulation, labelling, packaging & presentation.

The recommendation comprised of the following:

  • there has been no clinical/marketing experience with this novel formulation in Australia; and
  • Schedule 2 allows capacity to obtain professional advice from a pharmacist at the time of purchase.
Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors10;
  • other relevant information.
Delegates interim decision

The delegate has made an interim decision that the current scheduling of diclofenac remains appropriate.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (d) the dosage, formulation, labelling, packaging and presentation of a substance.

The decision that the entry for diclofenac remains appropriate included the following reasons:

  • there has been no clinical/marketing experience with this novel formulation in Australia; and
  • Schedule 2 allows capacity to obtain professional advice from a pharmacist at the time of purchase.

3.3 Hydrocortisone and hydrocortisone acetate

Scheduling proposal

The medicines scheduling delegate considered a proposal to reschedule preparations containing 1 per cent or less of hydrocortisone and hydrocortisone acetate when combined with antifungal substances for dermal use from Schedule 3 to Schedule 2 in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

In May 1981, the Poisons Schedule Committee (PSC) confirmed that the scheduling of hydrocortisone remained appropriate, i.e. in Schedule 4. The PSC confirmed this position again in February 1982.

In August 1985, the PSC decided to reschedule to Schedule 3, 0.5% or less of hydrocortisone when present as the only therapeutically active substance.

In November 1988, the Drugs and Poisons Schedule Committee (DPSC) decided not to reschedule 1% or less of hydrocortisone to Schedule 3 on the basis of advice from the then Australian Drug Evaluation Committee (ADEC) that the product in question was pharmacologically more active than other brands of 1% hydrocortisone cream in causing vasoconstriction.

In May 1995, the National Drugs and Poisons Schedule Committee (NDPSC) considered an application to reschedule rectal preparations containing hydrocortisone and cinchocaine from Schedule 4 to Schedule 3. The NDPSC gave in-principle support to the scheduling proposal, pending further advice. A decision was subsequently made out–of-session to reschedule hydrocortisone and cinchocaine topical preparations for rectal use, from Schedule 4 to Schedule 3.

In February 1996, the NDPSC confirmed that the intent of the May 1995 decision was to allow preparations containing 0.5% or less of hydrocortisone (alone or in combination with cinchocaine) to be available for rectal use (internal and externally) in both the ointment and suppository form, as Schedule 3.

In August 1998, the NDPSC decided not to list hydrocortisone and cinchocaine rectal preparations in Appendix H. This decision was primarily on the grounds that the incidence of misdiagnosis of fungal infections may be increased.

In February 1999, the NDPSC decided to reschedule hydrocortisone and hydrocortisone acetate (for dermal use containing 0.5% or less of hydrocortisone in packs containing 30 g or less of such preparation, with no other therapeutically active substance or an antifungal as the only other therapeutically active substance ), to Schedule 2. The Schedule 3 entry was also amended to include a specific reference to suppositories.

In May 1999, the NDPSC decided to include hydrocortisone in preparations for rectal use in Appendix H. This decision was based on controls on advertising and that the Therapeutic Good Advertising Council allows advertising of haemorrhoid treatments, provided there are statements limiting the nature of the relief; that advertising of both Schedule 2 and Schedule 3 products will enable pharmacists to offer comparative professional advice; and the issue of possible systemic absorption would be addressed through pharmacist counselling.

In November 2001, the NDPSC considered the scheduling of products containing hydrocortisone and hydrocortisone acetate, with astringents as active ingredients, for rectal use. The NDPSC decided to amend the scheduling of hydrocortisone and hydrocortisone acetate to exempt unscheduled astringents and restore the product to Schedule 3. The NDPSC considered that the presence of aluminium acetate and zinc oxide the product, whilst therapeutically active, were there primarily for their astringent effects rather than for systemic effects.

In June 2002 the NDPSC decided not to include hydrocortisone for dermal use in Appendix H. However, in response to post-meeting comment, the October 2002 NDPSC reconsidered this scheduling proposal and decided to include hydrocortisone for dermal use in Appendix H.

In October 2005, the NDPSC considered an application for the rescheduling of hydrocortisone acetate (in combination with an anaesthetic) for rectal use from Schedule 3 to Schedule 2. The NDPSC decided that the scheduling of hydrocortisone remained appropriate. This decision was based on concerns that consumers may sometimes have difficulty in differentiating between haemorrhoids and other conditions for which the use of a corticosteroid would be inappropriate; that if used on infected skin, there was potential for any infection to be masked or exacerbated; and concern that the safety data presented as part of the rescheduling application did not truly reflect the safety of the product for anorectal use as it included all adverse events relating to hydrocortisone, regardless of route, dose or duration of treatment.

In June 2006, the NDPSC reconsidered an application to reschedule hydrocortisone acetate (in combination with an anaesthetic) for rectal use. After due consideration of the new safety data presented, the NDPSC decided that the current scheduling of hydrocortisone and hydrocortisone acetate remained appropriate. The applicant had again not adequately justified exactly what advantage there would be to the consumer, should this product be down scheduled and therefore accessed without mandatory intervention of the pharmacist.

In February 2007, the NDPSC decided to reschedule hydrocortisone 0.5% in combination with an anaesthetic for rectal use from Schedule 3 to Schedule 2 to harmonise with New Zealand.

In June 2007, the NDPSC decided to amend the Schedule 2 and 3 entries to only capture human use. This was a result of a decision to vary the February 2007 decision to capture all veterinary use in Schedule 4.

In October 2007, the NDPSC decided to correct the wording of the Schedule 2 entry for hydrocortisone to specify human rectal use, in line with the decision of the June 2007 NDPSC meeting.

In June 2008, the NDPSC decided to include hydrocortisone in Appendix F, Part 3, with warning statements 38, 72, 73, 74 and 75 (for dermal use when included in Schedule 2 or 3), and warning statements 38 & 75 (for topical rectal use when included in Schedule 2 or 3).

Scheduling status

Hydrocortisone is currently included in Schedules 2, 3 and 4 and Appendices F and H. Hydrocortisone acetate is included in Schedules 2 and 3.

Public pre-meeting submissions

Four public pre-meeting submissions were received. One supported the scheduling proposal. Three did not support the scheduling proposal.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that the current scheduling of hydrocortisone and hydrocortisone acetate remains appropriate.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS include (a) the risks and benefits of the use of a substance.

The reason for the recommendation comprised of the following:

  • This product contains an increased concentration of hydrocortisone. Therefore, there are increased risks of:
    • masking symptoms, particularly in children, which can be mitigated by mandatory pharmacist intervention;
    • exacerbation of bacterial infections through inappropriate application;
    • inappropriate use with a higher concentration, with no demonstrated increase in benefit were it to be down-scheduled.
Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors11;
  • other relevant information.
Delegates interim decision

The delegate has made an interim decision that the current scheduling of hydrocortisone and hydrocortisone acetate remains appropriate.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of a substance.

The decision that the entry for hydrocortisone and hydrocortisone acetate remains appropriate included the following reasons:

  • This product contains an increased concentration of hydrocortisone. Therefore, there are increased risks of:
    • masking symptoms, particularly in children, which can be mitigated by mandatory pharmacist intervention;
    • exacerbation of bacterial infections through inappropriate application;
    • inappropriate use with a higher concentration, with no demonstrated increase in benefit were it to be down-scheduled.

3.4 Lisdexamfetamine

Scheduling proposal

The medicines scheduling delegate considered a proposal to include lisdexamfetamine in Schedule 8 in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

There is no scheduling history for lisdexamfetamine as is it not currently scheduled.

Scheduling status

Lisdexamfetamine is not scheduled.

Public pre-meeting submissions

One public pre-meeting submission was received, who supported the proposal.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that lisdexamfetamine be listed under Schedule 8.

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS include: (a) the risks and benefits of the use of a substance, and (e) the potential for abuse.

The reasons for the recommendation comprised of the following:

  • On account of its long acting characteristics, it is useful and convenient for the treatment of ADHD, but it does carry all the risks of the amphetamines.
  • Amphetamines are well established as substances of abuse which warrant inclusion in Schedule 8.
Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors12;
  • other relevant information.
Delegates interim decision

The delegate has made an interim decision that lisdexamfetamine be listed under Schedule 8.

The proposed implementation date for this decision is 1 September 2013.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of a substance and (e) the potential for abuse of a substance.

The decision that the entry for including lisdexamfetamine in Schedule 8 included the following reasons:

  • On account of its long acting characteristics, it is useful and convenient for the treatment of ADHD, but it does carry all the risks of the amphetamines.
  • Amphetamines are well established as substances of abuse which warrant inclusion in Schedule 8.
Scheduling entry
Schedule 8 - new entry

LISDEXAMFETAMINE.

3.5 Nabiximols

Scheduling proposal

The medicines scheduling delegate considered a proposal to reschedule Nabiximols from Paragraph 3 of Appendix D to Paragraph 1 of Appendix D in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

In October 2009, the committee considered an entry specific for Cannabis sativa extract, Nabiximols, after the issue that certain jurisdictions were unable to allow SAS access to the substance as it was captured under Schedule 9 was raised in the June 2009 meeting. As discussed in June, the Committee members agreed on the Schedule 8 listing. The Committee also agreed that the Schedule 8 entry should limit the allowed presentation to buccal sprays as this would further reinforce the very restricted scope of this entry and would require any new presentation to be brought to the attention of the Committee.

In May 2010, Nabiximols were included in Schedule 8 and Appendices D and K.

The committee advised that Nabiximols needed to be added to Appendix D, paragraph 3 to limit access through SAS Category A. This addition would allow restricted access to Nabiximols only, not to cannabis extracts but would not prohibit use for clinical trials provided by an authorised prescriber only. The Committee agreed to not restrict the Schedule 8 Nabiximols entry by indication (for Multiple Sclerosis).

Members additionally agreed that it would be appropriate to include Nabiximols in Appendix K due to sedating effects.

Scheduling status

Nabiximols are included in Schedule 8, Appendix D and Appendix K.

Nabiximols is defined with the Standard for the Uniform Scheduling of Medicines and Poisons as "botanical extract of Cannabis sativa, which includes the following cannabinoids: tetrahydrocannabinol, cannabidiol, cannabinol, cannabigerol, cannabichromene, cannabidiolic acid, tetrahydrocannabinolic acid, tetrahydrocannabivarol, and cannabidivarol, where tetrahydrocannabinol and cannabidiol (in approximately equal proportions) comprise not less than 90 per cent of the total cannabinoid content) in a buccal spray for human therapeutic use".

Public pre-meeting submissions

Eight public pre-meeting submissions were received addressing the proposal to reschedule Nabiximols from Paragraph 3 of Appendix D to Paragraph 1 of the same appendix. All 8 submissions supported the proposal.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that paragraph 1 of Appendix D be amended to include the entry of Nabiximols.

The proposed implementation date for this decision is 1 September 2013.

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the Committee included (a) the risks and benefits of the use of a substance.

The reasons for the recommendation comprised of the following:

Specialist oversight is required for safe prescribing of the drug and an entry in Appendix D paragraph 1 is consistent with TGA's decision with respect to specialist prescribers for the current registered products.

Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors13;
  • other relevant information.
Delegates interim decision

The delegate has made an interim decision to reschedule Nabiximols from Paragraph 3 of Appendix D to Paragraph 1 of Appendix D.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of a substance.

The decision that the Appendix D entry for nabiximols be amended included the following reasons:

  • Appendix D, paragraph 1, is for medicines approved on the ARTG for use in Australia whereas Appendix D, paragraph 3, is for medicines that are not included in the ARTG and thus not approved for use in Australia.
  • One product containing nabiximols has been approved for use in Australia and is included on the ARTG.
  • Specialist oversight is require for safe prescribing of the drug and an entry in Appendix D paragraph 1 is consistent with TGA's decision with respect to specialist prescribers for the current registered products.
Scheduling entry
Appendix D, paragraph 3 – amendment

NABIXIMOLS – Delete entry

Appendix D, paragraph 1 – new entry

NABIXIMOLS.

3.6 Oseltamivir

Scheduling proposal

The medicines scheduling delegate considered a proposal to reschedule oseltamivir for the treatment and prevention of influenza type A and type B from Schedule 4 to Schedule 3 in the Standard for the Uniform Scheduling of Medicines and Poisons.

The delegate referred the proposal to the Advisory Committee on Medicines Scheduling (ACMS) for advice.

Scheduling history

In November 2000, the National Drugs and Poisons Schedule Committee (NDPSC) decided to include oseltamivir in Schedule 4 following a recommendation made by the then Australian Drug Evaluation Committee (ADEC) to register a new drug application for Tamiflu® capsules, containing 75 mg of oseltamivir phosphate, for the treatment of infections due to influenza A and B viruses in adults and children aged twelve years and older.

In October 2004, the NDPSC considered an application to reschedule oseltamivir from Schedule 4 to Schedule 3, and for inclusion in Appendix H. The NDPSC deferred making a decision to allow input by the National Influenza Pandemic Action Committee (NIPAC). The NDPSC considered the available data to be inadequate in providing a reassurance that widening the availability of oseltamivir for the treatment of influenza through inclusion in Schedule 3 would not facilitate the spread of resistance to neuraminidase inhibitor (NI) class of drugs. The NDPSC also considered it important to its consideration if advice was received from authorities that deal with communicable diseases to gain an understanding of the implications a Schedule 3 availability of oseltamivir for the treatment of influenza would have on the national strategies for managing influenza epidemics or pandemics.

In October 2005, following receipt of advice from the National Influenza Pandemic Action Committee (NIPAC), the NDPSC reconsidered a proposal to reschedule oseltamivir from Schedule 4 to Schedule 3, and for inclusion in Appendix H. The NDPSC decided that the scheduling of oseltamivir remained appropriate. This decision was based on concerns regarding the likelihood of correct diagnosis by pharmacists without accurate point-of-care tests or physical examination during non-pandemic periods and concerns raised in regard to the then available inconclusive data relating to the likelihood of the development of resistance. In line with these concerns, the NDPSC acknowledged the need for the continued gathering of epidemiological data in relation to prevalence/resistance of influenza, which would be logistically difficult if oseltamivir was down-scheduled to Schedule 3. The NDPSC wanted to see possible arrangements explored for appropriate access to oseltamivir should either a localised outbreak or an influenza pandemic occur.

In February 2006, following suggestion for rapid access to oseltamivir in extenuating circumstances, the NDPSC noted the legislative powers that exist at State and Territory level as well as activity at the Commonwealth level which would facilitate the supply of a Schedule 4 substance (such as oseltamivir) without a prescription during either a localised outbreak or an influenza pandemic.

In October 2006, the NDPSC considered a request from the New Zealand Medicines Classification Committee (NZ MCC) to harmonise the scheduling of oseltamivir with NZ. The NDPSC agreed that Australia was harmonised with NZ on the scheduling of oseltamivir given that the only change to the NZ classification was an exemption to do with supply of the medication and that such mechanisms of supply set down by jurisdictions had been duly explored at the February 2006 NDPSC meeting. Thus the NDPSC concluded that the scheduling of oseltamivir remained appropriate.

In October 2008, the NDPSC considered an application to reschedule oseltamivir from Schedule 4 to Schedule 3. The NDPSC decided that the scheduling of oseltamivir remained appropriate. The NDPSC remained concerned about the risk of the development of resistance, and that down-scheduling could potentially lower influenza vaccination rates, including among vulnerable patient groups. The NDPSC also noted that without appropriate physical examination the risk of misdiagnosis could lead to delays in treatment and potential exposure to adverse effects without the prospect of a significant benefit. The NDPSC expressed confidence that all States and Territories had established, or were planning to establish, mechanisms to facilitate rapid access to oseltamivir should circumstances warrant.

Scheduling status

Oseltamivir is included in Schedule 4.

Public pre-meeting submissions

Four public pre-meeting submissions were received.

Two submissions supported the proposal; one submission did not support the proposal; one submission indicated that while rescheduling has the potential to improve timely access to oseltamivir, there are concerns which may outweigh the benefit.

The redacted public submissions are available at: Public submissions on scheduling matters.

ACMS advice to the delegate

The ACMS recommended that the current scheduling of oseltamivir remains appropriate.

The matters under subsection 52E(1) of the Therapeutic Goods Act 1989 considered relevant by the ACMS include: (a) the risks and benefits of the use of a substance, and (f) other matters considered necessary to protect public health.

The reasons for the recommendation comprise of the following:

  • Concern about the potential for increased resistance with widespread use.
  • Concern about misdiagnosis in the context that a doctor would be able to follow-up laboratory tests and improve surveillance.
  • Risk of reduced level of laboratory surveillance of influenza in the absence of medical prescribing.
  • Arrangements exist within the jurisdictions for access to oseltamivir during influenza pandemic situations.
Delegates consideration

The delegate considered the following in regards to this proposal:

  • scheduling proposal;
  • public submissions received;
  • the evaluation report (not publicly available);
  • ACMS advice;
  • section 52E of the Therapeutic Goods Act 1989;
  • scheduling factors12;
  • other relevant information.
Delegates interim decision

The delegate has made an interim decision that the current scheduling of oseltamivir remains appropriate.

The delegate decided that the relevant matters under section 52E (1) of the Therapeutic Goods Act 1989 include (a) the risks and benefits of a substance and (f) any other matters that the Secretary considers necessary to protect public health.

The decision that the entry for oseltamivir remains appropriate as a Schedule 4 listing included the following reasons:

  • the potential for increased resistance;
  • the potential for misdiagnosis; and
  • the potential for decreased laboratory surveillance in the absence of medical prescribing.

Footnotes

9-15 Scheduling Policy Framework for Medicines and Chemicals

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