Public Consultation on the Proposed Amendments to the Poisons Standard Notice under subsections 42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations) A delegate of the Secretary to the Department of Health publishes herein all valid public submissions made in response to the invitation for public submissions on the proposed amendments to the Poisons Standard. These submissions were considered by the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS). In accordance with the requirements of subsection 42ZCZL of the Regulations these submissions have had confidential information removed. Material claimed to be commercial-in-confidence was considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015), issued by the Australian Health Ministers Advisory Council (AHMAC). The SPF is accessible at: https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and- chemicals.
Transcript
Public Consultation on the Proposed Amendments to the Poisons Standard Notice under subsections 42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations)
A delegate of the Secretary to the Department of Health publishes herein all valid public submissions made in response to the invitation for public submissions on the proposed amendments to the Poisons Standard. These submissions were considered by the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS).
In accordance with the requirements of subsection 42ZCZL of the Regulations these submissions have had confidential information removed.
Material claimed to be commercial-in-confidence was considered against the guidelines for the use and release of confidential information set out in Chapter 6 of the Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015), issued by the Australian Health Ministers Advisory Council (AHMAC). The SPF is accessible at: https://www.tga.gov.au/publication/ahmac-scheduling-policy-framework-medicines-and-chemicals.
The makes this submission in relation to proposed amendments to the Poisons Standard for consideration by the Advisory Committee on Medicines
Scheduling (ACMS) .
••• comments relate to the proposed amendments to bismuth oxychloride, naproxen, pantoprazole, paracetamol in combination with ibuprofen, and piracetam .
•
• •
I
Recommendations
Bismuth oxychloride: - does not support the proposal to exempt bismuth oxychloride for human therapeutic topical use from the Schedule 4 entry for 'Bismuth compounds '.
Naproxen: - supports the proposal to include naproxen in Appendix H.
Pantoprazole: - supports the proposal to include pantoprazole in Appendix H.
Paracetamol in combination with ibuprofen: - does not support the proposal to amend the Schedule 2 paracetamol entry to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less.
Piracetam:- does not support the proposal to unschedule piracetam by removing the substance from Schedule 4.
Comments on proposed amendments
Bismuth oxychloride
Proposal to exempt from the Schedule 4 BISMUTH COMPOUNDS entry bismuth oxychloride for human therapeutic topical use.
Schedule 4 of the Poisons Standard currently includes two entries for 'bismuth compounds', for 'cosmetic use' and 'human therapeutic use'. Bismuth oxychloride is exempt from scheduling when used for cosmetic purposes but is Schedule 4 when included in preparations for human therapeutic use.
The current proposal seeks exemption from scheduling for bismuth oxychloride for human therapeutic topical use.
Bismuth compounds and salts have been used2:
• for their mild astringent properties and antacid action in gastrointestinal disorders including diarrhoea
• in the treatment of peptic ulcer disease
• topically in skin disorders and anorectal disorders (e.g. haemorrhoids).
Sweetman SC, ed. Martindale: the complete drug reference, volume A. 37th edn. London: Pharmaceutical Press; 2011. p. 1860-2.
It can be considered that ‘cosmetic use’ and ‘topical use’ both result in the substance coming into contact with the surface of the body. Bismuth oxychloride is widely used in cosmetic products, for example as a colour additive, and can be used safely including in areas around the eyes.
This proposal, however, relates to ‘therapeutic use’ which clearly goes beyond what would be intended by ‘cosmetic use’ (which generally refers to actions such as altering appearance or odour, or for cleansing purposes). Reference to ‘topical use’ indicates that a localised effect is intended for absorption through the skin and into the tissues.
has not been able to ascertain the scope or rationale for the proposed amendments to the Poisons Standard. In order to enable due consideration of the safety and appropriateness of exempting bismuth oxychloride from Schedule 4, clear information is required, for example, about:
proposed indications
proposed presentation and pack size
restrictions on age that may need to be applied.
These considerations are important as they may impact on variations to any scheduling amendments.
In the absence of further details, is unable to support the proposed amendment to exempt bismuth oxychloride from Schedule 4.
Naproxen
Proposal to include naproxen in Appendix H.
Currently, naproxen is included in Schedule 3 when “in a modified release dosage form of 600 mg or less of naproxen per dosage unit in packs of 16 or less dosage units when labelled not for the treatment of children under 12 years of age”. However there do not appear to be any products fitting this category on the Australian Register of Therapeutic Goods.
Key points expressed through past submissions to the ACMS include the following:
Naproxen is widely available as an over-the-counter medicine and is used for its anti-inflammatory, analgesic and antipyretic properties.
Balancing risks and benefits is important given the wide range of availability of naproxen-containing medicines and the potential for adverse outcomes. The lowest effective dose for the shortest possible duration is recommended for optimal outcomes, and to ensure that potential harm is minimised. The elderly population group can be particularly vulnerable to gastrointestinal and renal side effects or exacerbation of co-existing diseases. Potential duplication of therapy also requires consideration.
The Schedule 3 pack size limit provides for continuous therapy for over two weeks. This supports the need for intervention by pharmacists to ensure modified-release naproxen can be used safely and optimally.
A study3 has shown that a sustained-release dosage form of naproxen administered as a single (1000 mg) daily dose provided similar clinical efficacy to conventional-release naproxen (500 mg) twice daily but delivered better tolerability. Potential benefits of extended-release products have been identified as: sustained blood levels, attenuation of adverse effects and improved patient compliance.4 Potential limitations include greater intra- and inter-subject variability5 and, as noted by previously, extended-release products are generally more difficult to manage in overdose cases, noting in particular that there is no specific antidote for naproxen.
On balance continues to support Schedule 3 as the most appropriate classification for modified-release naproxen. Further, given naproxen in Schedule 2 can already be advertised to consumers, it could be regarded that Appendix H listing would help reinforce the opportunity for pharmacist intervention.
is aware that Appendix H listing of naproxen was considered previously but not approved. We note the delegate had expressed concern that Schedule 3 advertising may encourage consumers to request a modified-release product over a conventional lower-dose product which might be more appropriate. The conclusion appeared to be that there was an inadequate body of evidence to support Appendix H listing of naproxen, and Schedule 3 advertising was not likely to provide any additional public health benefit. Thus, suggests it would be very helpful if we were able to consider or review any new information or evidence which addresses these concerns.
In summary, supports the proposal to include naproxen in Appendix H. Since naproxen (in Schedule 2) can already be advertised, we believe pharmacists can consider any consumer requests generated as a result of Schedule 3 naproxen advertising holistically and maximise the opportunity to focus on a quality use of medicines discussion.
Pantoprazole
Proposal to include pantoprazole in Appendix H.
has noted previously that proton pump inhibitors (PPIs) are well established in Australia as Pharmacist Only Medicines. Availability to consumers through this schedule best supports safe and optimal PPI therapy. Pharmacists can provide advice on appropriate dosages and duration of therapy, assess the consumer’s response to treatment, and provide appropriate and timely referral if further investigation is required.
The inclusion of a number of PPIs in Appendix H has been considered recently. The relevant PPIs were esomeprazole, lansoprazole, omeprazole and rabeprazole. These substances have similar safety profiles and are widely available as over-the-counter medicines for the relief of heartburn and other symptoms of gastro-oesophageal reflux disease (GORD).
3 Kelly JG, Kinney CD, Devane JG, Mulligan S, Colgan BV. Pharmacokinetic properties and clinical efficacy of once-daily sustained-release naproxen. Eur J Clin Pharmacol 1989; 36:383–8.
4 Sansom LN. Oral extended-release products. Aust Prescr 1999; 22:88–90.
5 ibid.
In relation to the recent Appendix H recommendation for esomeprazole, concurred with the delegate’s comments that increasing public awareness of the availability of a Schedule 3 PPI in pharmacy may have public health benefits. Other less effective treatments for GORD symptoms have been advertised to consumers for many years. Therefore, it is sensible to be able to make consumers aware that PPIs are safe and effective first-line treatments and available with pharmacist advice.
As stated above, considers the range of available PPIs to possess similar safety and efficacy profiles. The same rationale and recommendation regarding Appendix H listing should apply to pantoprazole.
Therefore, consistent with recent decisions on other PPIs, supports the proposal to include pantoprazole in Appendix H.
Paracetamol in combination with ibuprofen
Proposal to amend the Schedule 2 paracetamol entry to include paracetamol when combined
with ibuprofen in pack sizes of 12 dosage units or less.
stated previously that the use of paracetamol in combination with ibuprofen is not considered to be first-line therapy for the treatment of mild to moderate pain. We also noted the delegate’s comments6 that there are concerns about the safety of paracetamol and ibuprofen combination products with respect to gastrointestinal bleeding (compared to ibuprofen alone) and possible renal adverse effects.
We note that consumers are already exposed to advertising of paracetamol and ibuprofen single-ingredient products. In view of current best practice pain management options, believes a responsible quality use of medicines approach is to retain paracetamol–ibuprofen combinations in Schedule 3. This will facilitate a consistent environment where pharmacists can consider the most appropriate over-the-counter analgesic medicine (including consideration of paracetamol–ibuprofen combination products) and provide tailored advice for consumers.
commitment to promoting and supporting a best practice approach means that, in the current environment, we are not in favour of the proposal to amend the Schedule 2 paracetamol entry to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less.
Piracetam
Proposal to unschedule piracetam by removing the substance from Schedule 4.
Piracetam, currently included in Schedule 4, is classified as a nootropic substance which acts on the central nervous system and may enhance memory and other intellectual functions.
6 Final decisions and reasons for decisions by delegates of the Secretary to the Department of Health. Mar 2015. p. 20. At: https://www.tga.gov.au/file/7202/download
Piracetam has been used in dementia or cognitive impairment, but its mechanism of action is not well defined, and evidence for efficacy has not been demonstrated consistently.7 Other reported uses have included treatment of cortical myoclonus, stroke and vertigo.8 Researchers have indicated that, while evidence of benefit arising from the use of piracetam is limited, it is sufficient to justify further research.9
Possible adverse effects of piracetam include insomnia, weight gain, hyperkinesia and depression. Other reported effects include gastrointestinal symptoms (e.g. abdominal pain, diarrhoea), ataxia, confusion, hallucinations, angioedema, confusion, bleeding problems, vertigo and worsening of epilepsy.10,11
is not aware of any published evidence or rationale which suggests that the current scheduling of piracetam is not appropriate and requires amendment. Although the purpose of the current proposal is not clear, the documented characteristics and side effect profile of piracetam would suggest that less restricted availability could pose unacceptable risks to consumers. is aware that dietary supplements containing piracetam were the subject of compliance actions by the United States Food and Drug Administration.
In summary, does not support the proposed removal of piracetam from Schedule 4.
Contacts:
3 September 2015
7 Flicker L, Grimley Evans JG. Piracetam for dementia or cognitive impairment. Cochrane Database of Systematic Reviews 2004, Issue 1. Art. No.: CD001011. DOI: 10.1002/14651858.CD001011.
8 Sweetman, p. 398–9.
9 Pettersen K (on behalf of Cochrane Clinical Answers Editors). Cochrane Clinical Answers 2012. DOI: 10.1002/cca.161.
Applicat ion to amend the Schedule 2 paracetamol entry to include paracetamol when combined with
ibuprofen in pack sizes of 12 dosage units or less
In response to the proposed amendment referred for consideration by the Advisory Committee on
Medicines Scheduling (ACMS) we wish to register our opposition to the proposal.
Our opposition is based around the fact that the current 53 scheduling for Paracetamol and Ibuprofen
combination products allows a maximum pack size of 30 tablets. If t he proposed amendment is adopted
it will become very easy for consumers to purchase multiple smal ler packs in excess of the current
maximum allowable pack size, without any required consultation with a pharmacist. In addition,
Paracetamol/lbuprofen products are not listed on Appendix H of the Poisons Standard and therefore
cannot be advertised or promoted directly to consumers. Under the proposed rescheduling, smaller pack ... sizes (as Pharmacy Medicines) could be freely advertised and promoted to consumers, and purchased
without the current requirement for advice from a Pharmacist.
In early 2011, the ACMS recommended that paracetamol/ibuprofen combinations be rescheduled from
Schedu le 2 to Schedule 3 because there were concerns regarding the number of contraindications and
precautions and whether consumers would be able to interpret these appropriately without a
requirement for pharmacist advice.
There were also concerns raised regarding gastro-intestinal, renal and other adverse effects related to
the potential interactions of ibuprofen and paracetamol. Concerns were also raised at the time regarding
the potential for paracetamol overdose by users.
A lack of toxicity and clinical safety data for the combination was also cited at the time, with the ruling
stating that there was insufficient meaningful post-marketing data to ensure safe use without the need
to consult with a pharmacist or GP.
In October 2012 the ACMS recommended to refuse proposals to down-schedule Paracetamol/lbuprofen
for pack sizes of 12 units or less and to include Paracetamol when combined with Ibuprofen in Appendix
H. Some of the reasons cited at the t ime included:
• Safety concerns with this combination since 2009 and that there had not been enough data
provided to disprove these concerns.
• Lack of evidence to support rescheduling to Schedule 2. The Scheduling Policy Framework
scheduling factors for Schedule 2 had not been satisfied, especially in relation to the risk profile
of the product.
• Additive gastro-intestina l side effects.
• Concern about lack of professiona l intervention for this combination product to ensure safe and
effective use.
• Concern with the lack of long-term evidence.
• Potential for inadvertent misuse.
• No public benefit.
In 2014, ubmitted a further proposal to the ACMS to include
Paracetamol/lbuprofen on Appendix H of the Poisons Standard, and this was rejected earlier this year.
Reasons outlined for the rejection of this proposal included the following:
• Concerns regarding safety of paracetamol-ibuprofen combinations, particularly with respect to
gastrointestinal bleeding (in comparison with ibuprofen alone) and perhaps renal adverse
effects.
• Pharmacists can recommend a paracetamol-ibuprofen combination product to consumers who
request a Schedule 3 codeine-combination analgesic for pain relief. It is considered that more
effective promotion of paracetamol-ibuprofen combination analgesic products to pharmacists
would be more beneficia l than advertising to consumers.
The new scheduling proposal would effectively circumvent these concerns by allowing smaller packs of
Paracetamol/lbuprofen to be purchased as Pharmacy Medicines by consumers. Our Appendix H
submission last year focussed on enabling awareness of Paracetamol/lbuprofen products with
consumers, but recognised the central role of the Pharmacist in advising customers about their suitabi lity
and safety on an individual basis. This new proposa l would effectively enable Paracetamol/lbuprofen
products (as smaller Pharmacy Medicine pack sizes) to be advertised directly to consumers, and if buying
multiple small packs consumers the question is raised as to whether a pharmacist will have the same
interaction with the customer that is required under the current scheduling. If a customer presents three
12 tablet packs of Paracetamol/lbuprofen (36 tablets tota l) to a pharmacy assistant for purchase, what
flags would there be to highlight that the purchase was for more than the currently allowable maximum
pack size of 30 tablets? Even for the purchase of two 12 tablet packs, would this require the advice and
intervention of a pharmacist, as it would currently and in the new proposal for the purchase of just one
16 or 20 tablet pack?
We submit that the proposed scheduling change wou ld too easily result in inconsistencies and potentia l
abuse that is more than adequately catered for by the current scheduling. In addition, if the safety
concerns that were raised in previous scheduling submissions are sti ll relevant then the current
scheduling as a Pharmacist Only medicine should provide adequate safeguards for consumers.
As per our Appendix H submission from 2014, we believe that Paracetamol/lbuprofen combinations
should continue to be scheduled as Pharmacist Only (S3) medicines and if they are to be directly
advertised and promoted to consumers this should be under Appendix H with the advice and
intervention of the Pharmacist at the point-of-purchase. This new proposal would effectively circumvent
the current requirement to be listed on Appendix H in order to advertise directly to consumers, and
would avoid the Pharmacist interaction that previous judgements have highlighted as necessary to
mitigate potential safety concerns.
3 September 2015
Advisory Committee on Medicines Scheduling Therapeutic Goods Administration PO Box 100 WODEN ACT 2606
Re: Consultation: Proposed Amendments to the Poisons Standard (Medicines)
refers to the notice inviting public comment under subsection 42ZCZK/42ZCZL of the Therapeutic Goods Regulations 1990 (the Regulations). provides the following submissions in relation to two of the proposed amendments that will be referred to the November 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS).
1. Naproxen: Proposed inclusion in Appendix H
The agenda item for this consideration does not provide information as to what strength and format of naproxen is being considered for inclusion in Appendix H. Based on the current scheduling status of naproxen it is presumed that this application relates to the modified release dosage form of 600 mg or less per dosage unit in packs of 16 or less dosage units.
The Schedule 3 listing of modified release dosage form of naproxen 600 mg was resolved relatively recently, in March 2014. Furthermore a prior request for Appendix H listing of this product was rejected at the November 2014 ACMS Meeting.
In considering the prior application to list naproxen in Appendix H, the delegate’s interim decision was that the current scheduling of naproxen remained appropriate. This decision was made on the basis that there was no additional benefit in advertising the Schedule 3 naproxen product as advertising is already allowed for the Schedule 2 naproxen product and there was an inadequate body of evidence to support such a listing. Public submissions provided no evidence to alter this interim decision and the delegate rejected the application, confirming that the reasons for the final decision are in keeping with those for the interim decision.
In considering this earlier proposal the delegate noted the limited time in market for the Schedule 3 product, such that there was no experience with marketing the modified release naproxen in Australia. Irrespective of whether new data is included in the current submission, such little time has passed since the last application that limited in market experience remains a relevant consideration for the current application.
It also follows that the only likely rational basis upon which the current submission is being made so soon after the current decision is that new data are being presented to assuage prior concerns about the advertising modified release naproxen. New evidence that is not already in the public domain
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needs to be made clear in the delegate’s interim decisions in order to allow the opportunity for relevant commentary to be provided, as it cannot be provided on the basis of the agenda item alone.
2. Paracetmaol/Ibuprofen combination: Application has been made to amend the Schedule 2 paracetamol entry to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less.
In October 2012, the ACMS reviewed a similar application, the outcome of which was to refuse the proposal to down-schedule paracetamol/ibuprofen for pack sizes of 12 units or less. At that time, amongst the reasons behind this decision were lack of data to disprove safety concerns that had been raised with this combination since 2009 and lack of evidence in relation to the risk profile of the combination. Other concerns included the potential for additive gastro-intestinal side effects, lack of long-term evidence, therapeutically sub-optimal combination, potential for inadvertent misuse, no public benefit and no experience with the use of the product in Australia.
A request for Appendix H listing of this combination product was made to the November 2014 ACMS Meeting. This proposal was rejected on the grounds that there were concerns regarding safety of paracetamol-ibuprofen combinations and that there was a potential public health risk from advertising because paracetamol-ibuprofen combinations might be seen by consumers as first line therapy for pain relief.
The published literature is consistent with the findings of the delegate’s decision. For example a Cochrane Review (Derry, 2013) has been published but the applicability of its findings are limited because it included only a small number of studies all of which utilized the dental pain model.1
The lack of a demonstrated strong synergistic analgesic effect between paracetamol and ibuprofen, suggests that the two medicines may have similar modes of actions and their effects may not be additive. This lack of clear evidence of improved analgesia has led some experts to question the value of combination products containing paracetamol and ibuprofen.2
A study evaluating the long-term use of this combination in patients with knee-pain has reported that the proportion of drug-related adverse effects is higher in the treatment groups exposed to paracetamol/ibuprofen combinations.3 Such a study is highly relevant to this application since the request is for Pharmacy Medicine (Schedule 2) status; a situation where no Pharmacist intervention is necessarily applicable and thus a patient may unknowingly but reasonably use the product for a period that results in adverse events that would not unfold under the Schedule 3 (Pharmacist Only Medicine) regime presently applicable to this ingredient combination.
A literature search has revealed no new published data on this combination in the short time since the request to list paracetamol-ibuprofen combinations in Appendix H was rejected. There is nothing new to inform the safety profile of this combination and the prior reasons for retaining this combination in Schedule 3 remain appropriate.
Given the recent rejection to list this combination in Appendix H and the lack of any new, relevant published literature the prior reasons for retaining the paracetamol-ibuprofen combination in Schedule 3 remain relevant. Promotion of this product to Pharmacists, who in turn can inform consumers who request something more than a Schedule 2 analgesic for acute, short-term pain management, will provide an appropriate and adequate balance of access with public safety.
In summary, notes that both of the above proposals are similar to recently rejected proposals seeking similar scheduling outcomes. No new data are available in the published literature to revert these prior decisions. The reasons for the prior rejections in relation to naproxen and
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paracetamol/ibuprofen combination analgesics remain relevant and should be given due consideration in any decisions relating to the current applications.
Should you require any additional information please do not hesitate to contact me.
Yours sincerely,
References
1. Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013;6:CD010210.
2. Brune K, Hinz B. Paracetamol, ibuprofen, or a combination of both drugs against knee pain: an excellent new randomised clinical trial answers old questions and suggests new therapeutic recommendations. Ann Rheum Dis. 2011;70:1521-2.
3. Doherty M, Hawkey C, Goulder M, et al. A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain. Ann Rheum Dis. 2011;70:1534-41.
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Advisory Committee for Medicines Scheduling
Meeting November 2015
Comments by to the proposed amendments referred by the delegate for scheduling advice:
• Paracetamol in combination with ibuprofen – new Schedule 2 listing
• Naproxen – Appendix H listing
• Pantoprazole –Appendix H listing
• Bismuth Oxychloride – Schedule 4 exemption
• Piracetam – Schedule 4 removal
3 September 2015
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Introduction
Comments on Proposed Amendments
has considered the proposed amendments to the SUSMP of relevance to community pharmacy, with particular reference where applicable to Section 52E(1) of the Therapeutic Goods Act 1989. We provide comments for the following proposed amendments in line with the rationale for our position provided below:
1.1 - Paracetamol in combination with ibuprofen – New Schedule 2 listing 1.2 - Pantoprazole – Listing on Appendix H 1.3 - Naproxen – Listing on Appendix H 1.4 - Bismuth Oxychloride – Schedule 4 exemption 1.5 - Piracetam – Schedule 4 removal
Proposal 1.1 Paracetamol in combination with ibuprofen – New Schedule 2 listing
(Amend the Schedule 2 paracetamol entry to include paracetamol when combined with ibuprofen in pack sizes of 12 dosage units or less)
Overview
has no objections to this proposal. The risk profile of both paracetamol and ibuprofen are both well established and they pose no greater risk in combination. The proposed pack size limit of 12 dosage units is appropriate and is far stricter than the pack limits for single ingredient ibuprofen and paracetamol products.
Risks and benefits of th e use of a substance1
Given the smaller pack size of combination products compared to single ingredient paracetamol and ibuprofen products, a potential benefit is that consumers will use less of these products over a shorter period of time
Pharmacy assistants are able to provide advice to consumers regarding the suitability and appropriateness of using a combination product and can refer to the pharmacist where required.
Concurrent use of paracetamol and ibuprofen in children
The UK 's National Health Service (NH S) website advises there are very few situations in which a child would need to take both ibuprofen and paracetamol concurrently.2 T he N HS also advises that if a child has a fever (temperature above 37.5°C) paracetamol and ibuprofen should not be given at the same time. Consequently,--believes combination products should only be indicated for children aged 12 years and up.
R econunendation
has no objections to including paracetamol in combination with ibuprofen in Schedule 2 in pack sizes of 12 dosage units or less.--believes combination products should only be indicated for children aged 12 years and up.
Proposal1.2 Pantoprazole - Appendix H Listing (Include pantopra:zyle in Appendix H)
O verview
has no objection to this proposal and notes a proposal to include all Proton Pump Inhibitors (PPis) on Appendix H was considered at tl1e August 2015 ACMS meeting.--reiterates its supp01t for Appendix H listing on tl1e condition that all advertisements for these products highlight the mandat01y role of the pharmacist in determining tl1e suitability of the product for consumers.--believes it would be of benefit to consumers to be made aware of products that can treat frequent hea1tburn or GORD, subject to consultation witl1 a pharmacist.
I ncrease consumer awareness
Increased awareness of alternate treatments for heartburn and reflux may prompt consumers who regularly purchase antacids or ranitidine from supermarkets, where no healtl1 advice is available, to consult their pharmacist for more information. This would provide a pharmacist witl1 the opportunity to assess and provide otl1er therapeutic options and/ or lifestyle support as required, or to refer them to a doctor if required.
1 Section 52E(1A)- Therapeutic Goods A ct 1989 2 NH S choices website (Accessed 18 August 2015) lltti?: //www.nhs.uk/chq/Pages/?S69.aspx?CategorviD=73&SubCate~rviD=103
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Safety Issues
There is no potential significant abuse to justify restricting ‘direct to consumer advertising’ of Schedule 3 PPIs. The potential for overuse is limited by the fact PPIs are only available as OTC medicines in pack sizes of up to 14 days’ supply.
does not believe that allowing advertising of PPIs would be detrimental to public safety.
Recommendation
has no objection to this proposal, provided all advertisements for these products highlight the mandatory role of the pharmacist in determining the suitability of the product for consumers. The listing of pantoprazole and other PPI’s on Appendix H will increase awareness of effective treatments for heartburn and reflux which may in turn prompt consumers to consult a pharmacist for more information.
Proposal 1.3 Naproxen- Listing on Appendix H
(Proposal to include Naproxen on Appendix H)
has no objection to this proposal on the condition that any consumer awareness messages related to naproxen emphasises the essential role of pharmacists in the supply of Schedule 3 medicines and recommend consumers consult with their pharmacist to determine if naproxen is appropriate for them.
Risks and benefits of the use of a substance3
believes listing naproxen on Appendix H would increase consumer awareness of a specific therapeutic product that may be more suitable, simpler to take, available without a prescription and encourages consumers to seek advice from a pharmacist. We believe this proposal if adopted will lead to consumers being better informed about products that are available without a prescription and the role of the pharmacist in determining whether those products are appropriate.
We note that diclofenac, another non-steroidal anti-inflammatory medicine which has similar pharmacological properties and risk profile, has been listed on Appendix H since August 2001. As outlined in the committee report at the time, the decision to list diclofenac on Appendix H was based on the following the reasons:
• long history of safe use;
• well characterised adverse effects; and
• increasing consumer awareness of the range of over-the-counter NSAIDS that are available4
Dueto the broad similarities between naproxen and diclofenac, we believe these factors are equally pertinent to this proposal.
3 Section 52E(1A)- Therapeutic Goods Act 1989 4 National Drugs and Poisons Schedule Committee Record of Reasons 32nd Meeting 21-23 August 2001, 26
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Recommendation
has no objection to the proposal to include naproxen on Appendix H. We believe this proposal will better inform consumers of products that available without a prescription and encourage consumers to seek counseling and advice from a pharmacist. Naproxen also has broadly similar pharmacological properties to diclofenac which has been listed on Appendix H for over 10 years.
(Exempt from the Schedule 4 BISMUTH COMPOUNDS entry bismuth oxychloride for human therapeutic topical use)
Recommendation
notes that bismuth oxychloride is currently exempt from Schedule 4 listing for cosmetic use. believes the proposed exemption for human therapeutic use should be equivalent to the exemption that is currently in place for other bismuth compounds, namely in dusting powders containing 3 per cent or less of bismuth.
Proposal 1.5 - Piracetam - Schedule 4 removal
(Unschedule piracetam by removing the substance from Schedule 4)
does not support this proposal and believes the current scheduling remains appropriate. Removing piracetam completely from the poisons schedule could potentially lead to products containing this substance to be sold in a general retail setting (or online) which is not in the interests of public health. Given piracetam and analogues such as levetiracetam are used to treat potentially serious symptoms/conditions such as myoclonus, dementia, cognitive problems and epilepsy5, believes it should remain a scheduled medicine.
Risks and benefits of the use of a substance6
Piracetam is a derivative of gamma-aminobutyric acid (GABA) and is traditionally classified as a nootrope, a drug that acts to improve cognition. 7 Adverse effects of piracetam include gastric upset.8 Piracetam does not have a TGA pregnancy rating but consumers are advised to avoid it during pregnancy due to insufficient data.9
Consumer medicine information for piracetam products sold in other countries notes that piracetam is contraindicated for patients with serious kidney problems, Huntington’s disease and previous history of brain haemorrhage.10 Patients are also cautioned against using piracetam in combination with thyroid extract, anticoagulants such as warfarin and low dose aspirin.11
Side effects may include hallucinations, confusion, depression, weakness and vertigo.12
The potential for abuse of a substance13
notes products containing piracetam available for sale online are marketed to reduce depression and improve memory function.14 There have also been studies and reports in the media that suggest nootropics such as piracetam are used by Australian university students to help enhance their academic performance.15 believes unscheduling piracetam could to lead to increase in patients self-medicating for conditions (e.g. depression, general anxiety) that should be discussed with a doctor. As such, such medicines should only be available as a Schedule 4 medicine.
Recommendation
believes the current Schedule 4 listing for piracetam remains appropriate. Given piracetam and analogues such as levetiracetam have been used to treat potentially serious symptoms and conditions such as myoclonus, dementia, cognitive problems and epilepsy16, it should remain a scheduled medicine. Removing piracetam completely from the poisons schedule could potentially lead to products containing this substance to be sold in a general retail setting (or online) which is not in the interests of public health. The onus of proof rests with the applicants to show why removing piracetam from the Poisons Standard (thus allowing products containing this substance to be sold in a general retail outlets) does not pose a risk to public health.
12 IBID 13 Section 52E(1E)- Therapeutic Goods Act 1989 14 http://nootrico.com/buy/noopept 15 Cakic, Vince. "Smart drugs for cognitive enhancement: ethical and pragmatic considerations in the era of cosmetic neurology." Journal of medical ethics 35.10 (2009): 611-615. 16 Therapeutic Guidelines Online – Levetiracetam (Accessed 28/08/2015)
Re: Consultation: Invitation for public comment- ACMS meeting, November 2015
- believes that any changes to the scheduling of medicines should be driven and underpinned by the principles of patient safety.
Consistent with our submission regarding esomeprazole, - does not support any Schedule 2 entries for the PPis lansoprazole, ompeprazole and rabeprazole. Although the change would only apply to packs containing no more than 7 days' supply of the medicine, we believe that these medicines should be Schedule 3 to ensure appropriate consultation and review by a pharmacist to minimise the number of people who move to long term use of these medicines.
As part of Choosing Wisely Australia the Royal Australian College of General Practitioners (RACGP) have flagged the long term use of proton pump inhibitors (PPis) as one of the top five tests, treatments or procedures which should be questioned by GPs and their patients. That statement is based on the evidence that a high proportion of patients are kept on maximal doses long term when this should not be the case. (http://www.choosingwisely.org.au/recommendations/racgp)
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Proposed Amendments to Poisons Standard - ACCS and ACMS meeting, November 2015
Comments by
proposed amendments referred by the delegate for scheduling advice for consideration by the Advisory Committee on Medicines Scheduling
Lansoprazole, Omeprazole, Rabeprazole - New Schedule 2 entries
October 2015
PROPOSED AMENDMENTS- PROTON PUMP INHIBITORS (PPI) Lansoprazole (Proposal to amend the scheduling of lansoprazole to include oral preparations containing 15 mg or less of lansoprazole per dosage unit for the relief of heartburn and other symptoms of gastro
oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.)
Omeprazole (Proposal to amend the scheduling of omeprazole to include oral preparations containing 20 mg or less of omeprazole per dosage unit for the relief of heartburn and other symptoms of gastro
oesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2)
Rabeprazole (Proposal to amend the scheduling of rabeprazole to include oral preparations containing 10
mg or less of rabeprazole per dosage unit for the relief of heartburn and other symptoms of gastrooesophageal reflux disease, in packs containing not more than 7 days' supply in Schedule 2.)
Consideration could include whether the scheduling of all the over-the-counter proton pump inhibitors (i.e. esomeprazole, lansoprazole, omeprazole, pantoprazole and rabeprazole) should be consistent.
Overview •••• maintains its opposition to the Schedule 2 listing of PPis as we believe these products should only be used under the direct supervision of a pharmacist. also questions the benefit to patients of having PPis in packs containing not more than 7 days' supply, given the therapeutic guidelines recommend the initial course of treatment should be at least 4 weeks.1
However, given Schedule 2 entries have recently been created for esomeprazole and pantoprazole it is likely Schedule 2 entries will be created for the other PPis as well
Under these circumstances, ••• makes the following recommendations regarding the scheduling of the remaining PPis:
• The Schedule 2 entries for PPis should be consistent. The maximum strength allowable as a Schedule 2 entry should reflect the lowest effective dose.
• Given that consumers will be able to purchase these products without mandatory health professional oversight, a new advisory statement should be mandated that instructs a consumer to seek the advice of a health professional if they are pregnant or breastfeeding.
The risk and benefits of the use of the substance2
Use in pregnancy
Proton Pump Inhibitors have been given a 83 category rating for use in pregnancy.3 Given that consumers will be able to purchase these products without mandatory health professional oversight,. - believes it is appropriate a new advisory statement should be mandated that instructs a consumer to seek the advice of a health professional if they are pregnant or breastfeeding. Pack inserts and labelling outlining directions for use should complement the verbal instructions provided by pharmacy
•••• believes the maximum dosage strength for PPis in Schedule 2 should be consistent to reduce the likelihood of patient confusion. The maximum strength allowable as a Schedule 2 entry should reflect the lowest effective dose .
•••• notes manufacturers can produce products that contain an amount of active ingredient lower than the maximum stipulated under the Schedule if they choose. For example medicines containing lansoprazole are generally available in 15mg or 30 mg dosage strengths while pantoprazole products are generally available in 20mg or 40mg dosage strengths. 6
Summary
•••• reiterates its opposition to the Schedule 2 listing of PPis, as we believe these products should only be used under the direct supervision of a pharmacist.
However, given Schedule 2 entries have recently been created for esomeprazole and pantoprazole, it is likely Schedule 2 entries will also be created for the other PPI. Under these circumstances, ••• makes the following recommendations:
• The Schedule 2 entries for PPis should be consistent. The maximum strength allowable as a Schedule 2 entry should reflect the lowest effective dose.
• Given that consumers will be able to purchase these products without mandatory health professional oversight, a new advisory statement should be mandated that instructs a consumer to seek the advice of a health professional if they are pregnant or breastfeeding.
• Pack inserts and labelling outlining directions for use should complement the verbal instructions provided by pharmacy staff.
• Section 52E(1d)- Therapeutic Goods Act 1989 5 Therapeutic Guidelines online - Standard dose regimes of proton pump inhibitors 6 Australian Register of Therapeutic Goods
Proposed amendments to Poisons Standard ACMS and ACCS November 2015 meeting p 3 of 3
