Scheduling delegate's interim decisions and invitation for further comment: ACMS, October 2015

Scheduling medicines and poisons

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1 October 2015

Interim decisions on matters referred to an expert advisory committee (1.1)

1. Scheduling proposals referred to the August 2015 meeting of the Advisory Committee on Medicines Scheduling (ACMS #15)

1.1 Codeine

Scheduling proposal

The medicines scheduling delegate (the delegate) has referred the following scheduling proposal for consideration by the Advisory Committee on Medicines Scheduling (ACMS):

  • Proposal to delete the Schedule 3 entry for codeine, and reschedule all current Schedule 3 codeine to Schedule 4 due to issues including morbidity, toxicity and dependence.
  • Consideration could include whether all current Schedule 3 preparations should be rescheduled to Schedule 4, or whether any rescheduling to Schedule 4 should only apply to combination analgesic products containing codeine.
  • Consideration could include whether the Schedule 2 entry for codeine should also be amended.
Substance summary

Codeine or its salts, especially the phosphate, are given orally in the form of linctuses for the relief of cough, and as tablets for the relief of mild to moderate pain, often with a non-opioid analgesic such as aspirin, ibuprofen, or paracetamol. The phosphate is also given by intra muscular injection, in doses similar to those used orally, for the relief of pain; the intravenous, subcutaneous, and rectal routes have also been used.

For the relief of pain codeine phosphate may be given in doses of 30 to 60 mg every 4 hours to a usual maximum of 240 mg daily.

To allay non-productive cough codeine phosphate may be given in doses of 15 to 30 mg three or four times daily.

Codeine phosphate is also used as tablets or in mixtures for the symptomatic relief of acute diarrhea in doses of 15 to 60 mg given three to four times daily.

Other codeine salts used include the hydrochloride, saulfate, camsilate, and hydrobromide. Codeine polistirex (a codeine and sulfonate diethenylbenzene-ethenylbenzene copolymer complex) is used in modified-release preparation.

Scheduling status

CODEINE is currently listed in Schedules 8, 4, 3 and 2.

Schedule 8

CODEINE except when included in Schedule 2, 3 or 4.

Schedule 4

CODEINE when compounded with one or more other therapeutically active substances:

  1. in divided preparations containing 30 mg or less of codeine per dosage unit; or
  2. in undivided preparations containing 1 per cent or less of codeine,

except when included in Schedule 2 or 3.

Schedule 3

CODEINE when:

  1. not combined with any other opiate substance;
  2. compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance:
    1. in divided preparations containing 12 mg or less of codeine per dosage unit; or
    2. in undivided preparations containing 0.25 per cent or less of codeine;
  3. labelled with a recommended daily dose not exceeding 100 mg of codeine; and
  4. in packs containing not more than 5 days' of supply at the maximum dose recommended on the label, except when included in Schedule 2.
Schedule 2

CODEINE in preparations for the treatment of coughs and colds when:

  1. not combined with any other opiate substance;
  2. compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance:
    1. in divided preparations containing 10 mg or less of codeine per dosage unit; or
    2. in undivided preparations containing 0.25 per cent or less of codeine;
  3. labelled with a recommended daily dose not exceeding 60 mg of codeine; and
  4. in packs containing not more than 6 days' supply at the maximum dose recommended on the label.
Scheduling history
National Drugs and Poisons Schedule Committee: June 2008

The NDPSC agreed to form a Codeine Working Party to review the availability of all OTC combination analgesics containing codeine. This followed concerns raised at previous NDPSC meetings (June 2005, October 2005 and June 2007) of abuse of codeine from a codeine-ibuprofen combination analgesic product (by cutting a bi-layer tablet in half to access the codeine, or separating codeine from the product by simple dissolution in water).

National Drugs and Poisons Schedule Committee: February 2009

The NDPSC considered a report from the Codeine Working Party, together with findings from an evaluation of OTC codeine-containing analgesics, and agreed to foreshadow a proposal to reschedule all OTC codeine to Schedule 3 (with suggestions to limit the maximum daily dose to 100 mg codeine, limit the maximum pack size to 5 days' supply, restrict divided preparations to 12 mg of codeine per dosage unit and restrict undivided preparations to 0.25% codeine). In addition, a member proposed to maintain a Schedule 2 entry for codeine + phenylephrine, if all other OTC codeine was included in Schedule 3. The NDPSC foreshadowed a proposal to include all OTC codeine (and not just analgesics) to encourage public comment.

National Drugs and Poisons Schedule Committee: June 2009

The NDPSC agreed that the current scheduling of OTC codeine combinations for coughs and colds remained appropriate (but with a pack size limit of 5 days' supply), and that all OTC combination analgesics containing codeine should be rescheduled from Schedule 2 to Schedule 3 (with the maximum daily dose limited to 100 mg, the duration of treatment limited to 5 days, divided preparations restricted to 12 mg of codeine per dosage unit and undivided preparations restricted to 0.25% codeine) and that Schedule 3 codeine should not be included in Appendix H. The implementation date was to be 1 May 2010.

National Drugs and Poisons Schedule Committee: October 2009

Following consideration of June 2009 post-meeting submissions and further discussion, the NDPSC agreed to amend the pack size limit for Schedule 2 cough and cold preparations to a maximum of 6 days' supply. The NDPSC also confirmed the June 2009 resolution regarding the Schedule 3 entry for all OTC combination analgesics containing codeine. The implementation date remained as 1 May 2010. An editorial amendment was made to the Schedule 3 entry at the February 2010 NDPSC meeting.

Delegates Final Decision: September 2011 - Advisory Committee on Medicines Scheduling: July 2011

The scheduling of codeine was considered as a part of the cold and cough preparation review, which looked at the use of these preparations for the treatment of children aged 2 to 12 years. Taking into consideration the committee's recommendation, the delegate decided that there should be no change to the scheduling of codeine in cold and cough preparations.

Pre-meeting public submissions

60 submissions were received.

29 submissions supported. Main Points:

  • Reduce the potential for harm - particularly in paracetamol/ibuprofen products (complications due to overdose);
  • Reduce the potential for abuse;
  • Prevent ease of access to an opioid, meaning patients seek other low risk medications/further medical advice;
  • Numerous studies/clinical evidence shows misuse/abuse and significant risk to public health;
  • Not currently possible for pharmacists to monitor and control safe use of low dose codeine.
  • Low dose codeine not efficacious.

25 submissions opposed. Main Points:

  • Increase in bookings to see GP - cost prohibitive.
  • Unable to see GP on demand - potential increase at hospital emergency departments.
  • Issue for those in rural areas being able to access medication if it becomes S4.
  • Increase price of medication containing codeine.
  • Prefer a national, real time monitoring system.
  • Lower quality of life for those with chronic pain.
  • Research suggests codeine is affective for acute pain which meets the claim of short term relief.
  • In 2010, the NDPSC found the S2 entry for codeine appropriate.

6 submissions did not state whether they supported the proposal or not.

ACMS advice to the delegate

The ACMS recommended the deletion of the current Schedule 2 and 3 entries for codeine and amendment of the current Schedule 4 and 8 entries to reflect this change.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; e) the potential for abuse of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the recommendation comprised the following:

  • Risks of medication misadventure through polymorphic metabolism, deliberate misuse/abuse combined with the relative lack of efficacy compared to safer products.
  • OTC intended for management of acute self-limiting pain, however, there is inappropriate use for chronic pain.
  • Purpose is questioned since benefit is low.
  • OTC sales data are incomplete.
  • Codeine shares the properties of other opioid analgesics and is potentially capable of producing dependence and, in overdose, respiratory depression and reduced level of consciousness.
  • Changing the labelling and decreasing the pack size will not adequately address the problem of misuse and dependence.
  • Increasing amount of evidence for harm from abuse.
  • Misuse of OTC codeine products including deaths resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression.
  • Genetic influence on codeine's action complicates risk and benefit decisions, and leads to questions regarding the role of codeine in clinical practice.
  • To adequately determine the clinical needs an appropriately qualified practitioner to assess risk.

The ACMS recommended an implementation date of 1 June 2016.

Delegate's considerations

The delegate considered the following in regards to this proposal:

  • Scheduling proposal;
  • Public submissions received;
  • The evaluation report (not publically available);
  • ACMS advice;
  • Section 52E of the Therapeutic Goods Act 1989;
  • Scheduling factors1;
  • Other relevant information.
Delegate's interim decision

The delegate's interim decision is to delete the current Schedule 2 and 3 entries for codeine and amend the current Schedule 4 and 8 entries to reflect this change.

The proposed implementation date is 1 June 2016. This date will allow time for education of consumers, pharmacists and medical practitioners regarding pain management and alternative analgesia available. It is noted that comments made during the Interim decision consultation period will be taken into consideration in any final decision on implementation date.

The matters under subsection 52E (1) of the Therapeutic Goods Act 1989 considered relevant by the delegate included: a) the risks and benefits of the use of the substance; b) the purposes for which a substance is to be used and the extent of use of a substance; c) the toxicity of the substance; d) the dosage, formulation, labelling, packaging and presentation of a substance; e) the potential for abuse of a substance; and f) any other matters that the Secretary considers necessary to protect public health.

The reasons for the decision comprised the following:

  • Risks of medication misadventure through polymorphic metabolism, deliberate misuse/abuse combined with the relative lack of efficacy compared to safer products.
  • The risk/benefit profile for codeine in doses of 8mg - 15mg per dosing unit in combination with other analgesics is unfavourable. There is also a lack of evidence of any benefit of codeine over placebo in the relief of cough, making the risk/benefit profile for this indication unfavourable also. Codeine demonstrates marked variability in its transformation to morphine in different individuals, with the potential for very severe toxicity in ultra-rapid metabolisers.
  • OTC intended for management of acute self-limiting pain, however, there is inappropriate use for chronic pain.
  • Purpose is questioned since benefit is low.
  • The purposes for which codeine is intended to be used are for Schedule 2 products for the "treatment of coughs and colds" and for Schedule 3 products for the "temporary relief of strong pain and discomfort associated with a number of different medical conditions."
  • Codeine shares the properties of other opioid analgesics and is potentially capable of producing dependence and, in overdose, respiratory depression and reduced level of consciousness.
  • Codeine, as a prodrug, causes its direct toxicity primarily through its biotransformation into morphine. The metabolic polymorphism discussed above leads to major variability within the population in terms of the extent and rapidity of this conversion to morphine. Ultra-rapid metabolisers, who have an accelerated rate and higher extent of conversion, are exposed to morphine concentrations that are many-fold higher than those reached in poor metabolisers. This variant is found in up to 10% of Caucasians, and higher proportions of populations of North African, Oceanic and Middle Eastern origin. Very few individuals are aware of their own metaboliser status, and it would thus be very difficult to protect ultra-rapid metabolisers by way of warnings. High concentrations of morphine in the plasma can lead to serious sedation and respiratory depression, and potentially to death.
  • The potential for severe adverse effects at "usual" doses in ultra-rapid metabolisers is such that codeine appears to be an unsuitable candidate for OTC availability, with either S2 or S3 scheduling. This conclusion applies equally well to the products intended for treating coughs and colds, and those intended for the treatment of pain.
  • Changing the labelling and decreasing the pack size will not adequately address the problem of misuse and dependence.
  • Current labelling and packaging include insufficient warnings, and that there should be clear warning labels stating the risks of addiction and dependence, the risks of harm from the paracetamol or ibuprofen, and the risk of death. Access to codeine in Australia is inconsistent, in that the total amount of codeine available in a pack of Panadeine Extra® (40 tablets containing 15mg each) is the same quantity as that available in a pack of codeine phosphate (20 tablets containing 30mg each), which is included in Schedule 8 and recognised to have potential for abuse or addiction.
  • Some sources, including the Panadeine® product information, suggest or imply that before taking codeine a person should know their CYP4502D6 status, and this in turn means that no person should be able to self-administer codeine that has been obtained OTC. It is argued that the benefit of medical supervision that would be obtained with a rescheduling to S4 includes the ability of the prescriber to discuss with the patient the risks of excessive opiate effect, and provide advice about actions to take if this occurs. This argument applies equally well to products currently available in both S2 and S3.
  • Increasing amount of evidence for harm from abuse.
  • Codeine is emerging as an increasingly commonly used drug of abuse internationally and in Australia. Data from the national opioid pharmacotherapy statistics in 2013 showed that codeine was the opioid drug of dependence for 1,038 clients receiving opioid substitution pharmacotherapy. The actual number was likely to be higher than this because of missing data. Another recently published study of 902 people who inject illicit drugs found that about one third had misused OTC codeine during the preceding six months.
  • Misuse of OTC codeine products including deaths resulting from hepatic injury, gastrointestinal perforations, hypokalaemia and respiratory depression.
  • Genetic influence on codeine's action complicates risk and benefit decisions, and leads to questions regarding the role of codeine in clinical practice.
  • An appropriately qualified practitioner needs to assess the risk before making the decision that codeine will be used.
  • A recently released combination of two non-opioid analgesics (ibuprofen plus paracetamol) appears to be more effective than the CCAs, with a number needed to treat (NNT) of 1.5. This combination would fill any gap left by the unavailability of CCAs over the counter, giving consumers access to a more effective analgesic without requiring a prescription and without the risks of the marked variability in pharmacokinetics or abuse potential that are associated with codeine.
  • Potential unintended consequences and disadvantages of a decision to reschedule CCAs to S4 need to be considered. One would be a reduction in the availability of analgesics for moderate to severe pain, although the evidence suggests that the addition of codeine adds only a minor additional analgesic effect over and above that of the ibuprofen or paracetamol in the combination product. The recent introduction of a paracetamol/ibuprofen combination may fill this niche more effectively than the CCAs have done, without the disadvantages of codeine. A reduction in the availability of a drug known as an anti-tussive agent, despite the lack of evidence available to support this, would also occur, but significant actual disadvantages are unlikely to occur. No other potential disadvantages to the community are readily identified.
  • The major impact on public health of the proposed amendment would be a reduction in the risk to those individuals who, unbeknownst to themselves, have a rapid metaboliser phenotype of CYP4502D6 and are therefore at significant risk of excessive morphine concentrations following ingestion of usually recommended doses of codeine for any indication.
  • Codeine is an opioid which must be metabolised by CYP2D6 to its active metabolite, morphine, for its analgesic effect. Different genetic groups show significant variations in metabolism of codeine. Of particular concern are "ultra-rapid" metabolisers, where the accelerated metabolism of codeine to morphine results in an increased risk of morphine toxicity and adverse events.
  • The function of the enzyme carrying out that transformation is genetically controlled and highly variable between individuals because of the existence of multiple forms of the relevant gene; the difference in exposure to morphine following a standard dose of codeine can be up to 45-fold higher in ultra-rapid metabolisers compared with poor metabolisers.
  • Ultra-rapid metabolisers are therefore at risk of morphine overdose, with potentially fatal consequences, following "usual" doses of codeine.
  • Individuals rarely know their metaboliser status, and testing is not readily available.
  • All other opioids are at least Schedule 4.
  • The approved indication for the S3 codeine products is for the "temporary relief of strong pain and discomfort associated with a number of different medical conditions". It is noted that there is significant use of S3 codeine products for longer term relief of chronic pain and a number of public submissions by consumers have noted that this is how they use it.
  • The management of chronic pain would be better achieved by having medical practitioner input with appropriate advice on non-medicine treatments and appropriate medicinal treatment for the chronic pain, rather than self-treating with long term codeine containing analgesics (CCAs).
  • The presence of codeine in OTC combination analgesics contributes to severe adverse outcomes associated with overdosage of the paracetamol or ibuprofen component, because the development of dependence on codeine leads to overuse of the combination. Anecdotally some abusers of OTC codeine products are consuming 30 to 70 tablets/capsules per day of the CCAs.
  • In Europe codeine is not an OTC medicine (i.e. is a prescription only medicine at least) in 13 countries being Austria, Belgium, Croatia, the Czech Republic, Finland, Germany, Greece, Italy, Luxembourg, Portugal, Slovakia, Spain and Sweden.
  • Codeine is also a Prescription Medicine in the USA, Hong Kong, Iceland, India, Japan, the Maldives, Romania, Russia, and the United Arab Emirates.
  • There is no evidence that low dose codeine combination analgesics provide any additional analgesia over optimal dosing of paracetamol, aspirin or ibuprofen.
  • In February 2009 NDPSC decided that:
    • Based on the currently available information from Australia, the evaluator concluded that there was potential for significant harm from OTC combination analgesics containing codeine (CACC) and even death, and it was not possible to accurately estimate the associated risk, although the following were reasonably assumed:
      • the proportion of all users that abuse OTC CACC is low.
      • the risk of harm among all users of OTC CACC is low.
      • the risk of harm among abusers of OTC CACC is high.
    • Central consideration in allowing OTC supply of codeine combinations was that the benefits outweighed the risks and therefore asserted that the insufficient data on efficacy may mean that the benefits no longer outweighed the risks. While agreeing that efficacy remains important to any case justifying OTC supply of codeine, the Committee noted the Codeine Working Party advice that there was not sufficient information available to the Members at this time to resolve the question of codeine efficacy at ≤ 30mg.
  • The NDPSC rescheduled OTC codeine-containing combination analgesics to Schedule 3 in 2010, with the aim of increasing surveillance of codeine medication usage by pharmacists to ensure quality use of medicines, as it was recognised that there is a potential for harm if used inappropriately. The Schedule 3 entry included limits on the maximum daily dose and pack size, and restrictions on the quantities of codeine in divided (and undivided) preparations.
  • Rescheduling to Schedule 3 has not achieved the required reduction in harm to affected individuals. Since the rescheduling of codeine from 2010 there hasn't been the reduction in risk that might have occurred.
  • Codeine is increasingly a drug of abuse in Australia, and some individuals have developed severe adverse effects from the high doses of paracetamol and ibuprofen that accompany the use of large numbers of tablets in a codeine-dependent person. A pack of CCA available under S3 contains the same total dose of codeine as a pack of codeine available only under S8.
  • Since OTC CCAs were rescheduled to Schedule 3 in 2010, industry and pharmacy organisations have not been able to fully address concerns regarding codeine dependence.
  • Codeine in the unit doses present in OTC products provides very little additional analgesic effect over and above that provided by the accompanying drug in the combination. It is also noted that there are new combination products with paracetamol and ibuprofen which are more efficacious than low dose CCAs.
  • CCAs do not meet the criteria required for Schedule 3, particularly that they are not "substantially safe in use but require professional advice or counselling by a pharmacist", and cannot be said to "not require close medical management." Rather, it would be more appropriate for CCAs to be prescribed so that consumers can be warned about the potential risks and adverse effects can be more closely monitored.
  • Concurrently the Advisory Committee on the Safety of Medicines (ACSOM) has recently considered the risks of codeine use in children, and codeine use in persons who are ultra-rapid metabolisers of codeine. Excerpts from the meeting statement from ACSOM 28 state:
    • ACSOM agreed that the risks of respiratory depression and possible death in the context of ultra-rapid metabolism associated with codeine outweigh the benefits of codeine for all indications in children under the age of 12 years.
    • As it is not possible to identify in advance the subgroup of children who are at increased risk of toxicity (e.g. through being an ultra- rapid metaboliser), the committee's advice relates to the risks for all children under the age of 12.
    • ACSOM also agreed that the risks associated with codeine outweigh the benefits of codeine for analgesia in children under the age of 18 years who have undergone tonsillectomy or adenoidectomy for sleep apnoea, for the same reasons as for children under the age of 12 years, as above. This is consistent with the United States Food and Drug Administration (US FDA) position that codeine use after adenotonsillectomy is contraindicated. The committee also noted that there have been a number of adverse event cases observed that are not clearly explained but may relate to sleep apnoea.
    • ACSOM also agreed that the risks to breastfed infants associated with ultra-rapid metabolism of codeine by their mothers outweigh the benefits of codeine for any indication by breastfeeding mothers.
    • As a mother's knowledge of her own experience with codeine (and indirectly, metaboliser status) does not predict the infant's response, breastfeeding should be a contraindication for codeine.
    • ACSOM noted the following contraindications which were recommended in the TGA's safety review to be included in the codeine Product Information - use in children under the age of 12 for any reason; use in people of any age known to be ultra-rapid metabolisers; use in children younger than 18 years of age who have undergone adenotonsillectomy for obstructive sleep apnoea; and use by breastfeeding mothers.
    • The committee noted that the OTC availability of codeine-containing medicines supported a general perception in the community that codeine is safe. Therefore, communication of the contraindications by label changes alone was not likely to achieve the desired outcome of risk reduction. Additional measures including education and the possible rescheduling of codeine-containing medicines also needed to be considered. The committee supported consistency and harmonisation in labelling across all codeine-containing medicines, especially regarding advice to breastfeeding mothers.
    • Activities to reduce the use of codeine cannot occur in isolation from consideration of alternative pain management strategies. Pain management strategies that do not include codeine needed to be carefully defined and their implementation carefully considered. For example, direct administration of morphine could be considered as an alternative and the issues of analgesic polypharmacy and escalation up the 'pain ladder' also require consideration in the development of any pain management strategies that omit codeine.
  • It should be noted that the following factors for a Schedule 3 medicine in the Scheduling Policy Framework (SPF) are not met:
    • Codeine does not meet the SPF scheduling factors for inclusion in Schedule 3. In particular, criterion 2 is not satisfied - i.e. "The use of the medicine at established therapeutic dosages is not expected to produce dependency. Where there is a risk of misuse, abuse or illicit use identified, the risk can be minimised through monitoring by a pharmacist."
  • Codeine containing analgesics should now be included in Schedule 4 because codeine meets the factors in the Scheduling Policy Framework required for Schedule 4, and particularly the following factors:
    • In particular, use at established therapeutic dosage levels may produce dependency (criterion 3).
    • Codeine also meets SPF Schedule 4 criterion 1 (diagnosis, management or monitoring of chronic pain conditions requires medical or dental intervention before use and, although OTC codeine products are intended for short-term use, many consumers use them for chronic pain without medical intervention) and criterion 7 (its use has contributed to, or is likely to contribute to, communal harm).
  • Other issues:
    • Codeine alone is ineffective as an analgesic in doses <60mg (number needed to treat (NNT) to achieve one patient obtaining a 50% pain relief response is 12).
    • Compound analgesics containing codeine plus paracetamol or codeine plus ibuprofen, show minimal analgesic benefit compared to the simple analgesics (paracetamol or ibuprofen) alone.
    • In up to 10% of the population (poor metabolisers), it is ineffective but can still cause harmful effects.
    • In up to 4-10% of the population (ultra-rapid metabolisers), it can cause life threatening toxicity.
    • If codeine is to remain in use as an analgesic, then the patient's metaboliser status needs to be ascertained prior to prescription or dispensing, however this is not practical.
  • It was suggested that there were options to try and minimise the abuse related to CCAs by either expanding Project Stop or real-time monitoring of CCA use.
  • Project Stop relates to the monitoring of sales of pseudoephedrine and is a police related activity to prevent diversion of pseudoephedrine as a precursor for illegal methamphetamine manufacture.
  • The Project Stop website states its role as:
    • Project STOP is an initiative of the Pharmacy Guild of Australia to address the problem of precursor diversion through Australian Community Pharmacies. The most common precursor sourced through the community pharmacy channel is Pseudoephedrine which can be used in the illegal manufacture of methamphetamines.
    • Project STOP is an online tool which provides decision support to pharmacists who need to establish whether requests for products containing Pseudoephedrine are legitimate. It also assists pharmacists in meeting their state regulatory recording requirements where they exist.
  • Despite the risks of abuse identified when CCAs were up-scheduled in 2010 there has been no initiative to include CCAs into Project Stop prior to the application to up-schedule codeine to S4.
  • Real-time monitoring of medicines is not currently in place in any jurisdiction other than Tasmania where it is restricted to S8 medicines. There is no formal implementation of real-time monitoring across Australia and whether its implementation would it is unsure whether it would ever come down to S3 medicines.
  • In both Project Stop and real-time monitoring the onus on prevention of supplying CCAs would fall on pharmacists when dealing directly with consumers.
  • Another option considered was decreasing the pack size of CCAs from the current limit of five days with a recommended daily dose not exceeding 100 mg of codeine to a pack size limit of three days' supply as has occurred in the United Kingdom. However decreasing the available pack sizes of OTC codeine products might help reduce the incidence of new users becoming dependent on codeine, but is unlikely to be effective for those who are already dependent.
  • A number of the pre-meeting submissions considered it unduly burdensome to require consumers to obtain a prescription for supply of codeine combination analgesics. However, pharmacists can recommend alternate pain relief products, such as a paracetamol-ibuprofen combination, or consumers could obtain a prescription (to have on hand when needed for acute pain) if they visit a general practitioner for any reason.
  • To be consistent with the interim decision to remove the S3 entry for codeine and for the issues around codeine in the 12 and under population as recommended by ACSOM the S2 entry should also be deleted.
  • There are alternative OTC analgesic products for short-term pain relief.
  • The ACMS recommendation and reasons.
Schedule entry
Schedule 8 - Amendment

CODEINE except when included in Schedule 2, 3 or 4.

Schedule 4 - Amendment

CODEINE when compounded with one or more other therapeutically active substances:

  1. in divided preparations containing 30 mg or less of codeine per dosage unit; or a
  2. in undivided preparations containing 1 per cent or less of codeine.

except when included in Schedule 2 or 3.

Schedule 3 - Delete entry

CODEINE when:

  1. not combined with any other opiate substance;
  2. compounded with one or more other therapeutically active substances, of which not more than one is an analgesic substance:
    1. in divided preparations containing 12 mg or less of codeine per dosage unit; or
    2. in undivided preparations containing 0.25 per cent or less of codeine;
  3. labelled with a recommended daily dose not exceeding 100 mg of codeine; and
  4. in packs containing not more than 5 days' of supply at the maximum dose recommended on the label,

except when included in Schedule 2.

Schedule 2 - Delete entry

CODEINE in preparations for the treatment of coughs and colds when:

  1. not combined with any other opiate substance;
  2. compounded with one or more other therapeutically active substances, of which at least one is phenylephrine and not more than one is an analgesic substance:
    1. in divided preparations containing 10 mg or less of codeine per dosage unit; or
    2. in undivided preparations containing 0.25 per cent or less of codeine;
  3. labelled with a recommended daily dose not exceeding 60 mg of codeine; and
  4. in packs containing not more than 6 days' supply at the maximum dose recommended on the label.

Footnotes
  1. Scheduling Policy Framework for Medicines and Chemicals (SPF, 2015)

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