Regulatory options

Substances can either be up-scheduled or down-scheduled on application to the Secretary (or scheduling delegate). Re-scheduling applications may be submitted by the general public, industry or state and territory authorities.

An application to up-schedule codeine was made to the Secretary (or the Secretary's medicines scheduling delegate (the Delegate)) who sought advice on the proposed amendment from the Advisory Committee on Medicines Scheduling (ACMS) and an independent external evaluator. Additionally, the Delegate will also consider all public submissions received regarding how codeine should be made available to the Australian public.

Due to the significant health risks associated with OTC codeine-containing medicines (as outlined in the preceding sections as well as in the original scheduling application) and to ensure that public health and safety is protected using best practice regulation, the Department of Health, through the TGA, is currently reviewing OTC access to codeine-containing medicines in Australia.

On this page: What are the regulatory options and scenarios being considered? | Why are regulatory options being considered? | Real-time monitoring programs

What are the regulatory options and scenarios being considered?

The interim decision in October 2015 was to up-schedule all Schedule 2 and Schedule 3 codeine preparations to Schedule 4. In December 2015, the delegate considered other regulatory options such as restricting pack size and labelling. The final proposed options are summarised in Table 1.

Table 1: Summary of regulatory options

Option 1	The current scheduling of codeine remains appropriate.
Option 2	The current Schedule 2 entries for codeine in cough and cold medicine preparations be amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction.
Option 3	The current Schedule 2 entries for codeine in cough and cold medicine preparations are up-scheduled to Schedule 3, and that the pack size is reduced to not more than 3 days' supply and include a label warning that codeine can cause addiction.
Option 4*	Up-schedule the current Schedule 2 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries: this forms part of the interim decision.
Option 5	The current Schedule 3 entries for codeine (including, but not limited to codeine-containing analgesics) is amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction.
Option 6*	Up-schedule the current Schedule 3 entries for codeine to Schedule 4 and amend the current Schedule 4 and 8 entries: this forms part of the interim decision.

* The current interim decision consists of Option 4 plus Option 6.

Unless Option 1 is chosen, the scheduling decision is likely to be a pair of options (a scenario) selected from Options 2 to 6. In effect, the options could result in the four different scenarios summarised in Table 2.

Table 2: Summary of scenarios

Scenario 1 (Option 1)	No change to the status quo.
Scenario 2 (Options 2 and 5)	Schedule 2 and Schedule 3 entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine-containing analgesics) is amended to reduce the pack size to not more than 3 days' supply and include a label warning that codeine can cause addiction. Summary: - Reduce pack size and include warning label for Schedule 2 and Schedule 3
Scenario 3 (Options 3 and 5)	The current Schedule 2 entries for codeine in cough and cold preparations is up-scheduled to Schedule 3. All Schedule 3 entries (i.e. those currently Schedule 3 and those previously Schedule 2) for codeine (including, but not limited to, cough and cold medicine preparations and codeine-containing analgesics), be amended to reduce the pack size to not more than 3 days' supply, and include a label warning that codeine can cause addiction. Summary: - Schedule 2 up-scheduled to Schedule 3 - Reduce pack size and include warning label for Schedule 3.
Scenario 4* (Options 4 and 6) (interim decision)	Schedule 2 and Schedule 3 entries for codeine (including, but not limited to, cough and cold medicine preparations and codeine-containing analgesics) be up-scheduled to Schedule 4. Summary: - Schedule 2 and Schedule 3 up-scheduled to Schedule 4

* The current interim decision

To understand the impacts of any re-scheduling of codeine, the economic, social and regulatory impacts of the codeine scheduling options has been modelled. An important distinction between this RIS and those RIS' that are often associated with policy decisions, is that the scheduling delegate must consider the factors prescribed by subsection 52E of the Therapeutic Goods Act (the TG Act), and the scheduling policy framework (SPF) when making a scheduling decisions, and not necessarily the economic or social impacts of that decision.

Why are regulatory options being considered?

The above regulatory scenarios are being considered to protect public health and safety and discourage the abuse of medicines. The regulatory options are required because the current level of access to low-dose codeine products (as Schedule 2 and Schedule 3 products) do not provide the incentives for consumers to seek alternative treatment pathways that may provide better health outcomes.

To achieve better health outcomes for consumers, the following changes are required:

• Increased education to consumers and the community about the risks of misuse of low-dose codeine-containing medicines. During targeted stakeholder consultations, most stakeholders indicated that additional face-to-face education^[69] for prescribers and pharmacists was unlikely to be necessary. With an estimated one million people using at least one Schedule 3 low-dose codeine medicine product a year, the need to invest in an education and awareness campaign, particularly for consumers is apparent.
• Increased awareness to consumers of the limited clinical information relating to incremental effectiveness of low-dose codeine in combination analgesics when compared to ibuprofen or paracetamol. That is, there is insufficient evidence to suggest that adding codeine to a medicine will increase its effectiveness as a pain reliever compared to paracetamol or ibuprofen alone.
• To encourage an appropriate level of medical intervention and oversight when codeine-containing medicines are required for particular health conditions (e.g. cancer pain).
• Discourage the use of low-dose codeine analgesics for chronic pain relief.
• To encourage exploration of alternative treatment or referral pathways (non-pharmacological pain management etc.) for chronic conditions.
• To encourage the use of safer analgesics (paracetamol and/or ibuprofen) in the first instance, even for strong pain relief.
• To promote a change in consumer purchasing behaviour in relation to low-dose codeine-containing medicines such that consumers do not inadvertently self-treat serious conditions with medicines that are ineffective for such a purpose (e.g. cough suppressant for chronic pain).
• To promote the quality use of medicines with the appropriate level of medical oversight, either through greater number of more frequent use of pharmacists consultations and GP oversight

Real-time monitoring programs

There is no provision in the Therapeutic Goods Act, Regulations (Part 6, Division 3A) or the SPF that allows for a real-time monitoring (RTM) system to be mandated as part of the delegate's scheduling decision. However, for the purpose of attempting to minimise the abuse and misuse of codeine-containing medicines, it is possible that a mandated RTM could be considered by the commonwealth, state and territory governments.

The Self Medication Association of South Africa (SMASA), the Community Pharmacy Sector and the Pharmacy Society of South Africa (PSSA), launched the real-time monitoring system known as the Codeine Care Initiative in 2013. In November 2016, an update on this initiative was provided to the TGA by SMASA. One key point that came out of this update was that the program was limited by a lack of universal adoption throughout the country. This was largely driven by operational limitations, as not all public hospitals have access to computerised record keeping.^[70] This appears to be the only RTM program associated with codeine identified overseas.

If Australia was to mandate a RTM program for codeine, this would be inconsistent with Australia's national scheduling framework, as no such RTM programs currently exist for Schedule 4 (prescription medicines) or Schedule 8 (controlled drugs) medicines despite the higher risks associated with these medicines.

In 2005, a RTM program known as Project STOP commenced as an initiative of The Pharmacy Guild of Australia (PGA) and sought to prevent diversion of products containing pseudoephedrine for preparation of illicit drugs (predominately methamphetamine). This RTM program's aim was to monitor diversion rather than to prevent morbidity associated with high risk medicines.

MedsASSIST program

The Pharmacy Guild of Australia (PGA) has rolled out a new voluntary real-time monitoring program called MedsASSIST. This system, which captures OTC codeine product sales information, involves a pharmacist-consumer consultation whereby the therapeutic need of a codeine medicine for the individual patient is assessed by the pharmacist. Furthermore, pharmacists ask for ID and seek consent to record the ID number in the system. If the patient does not consent to providing an ID, the pharmacist may choose not to supply the medicine. The pharmacist also records the name and the quantity of the requested codeine medicine and reviews any previous purchases of codeine medicine. If the pharmacist decides it is not therapeutically appropriate to supply a codeine medicine, they will explain the reason for this decision and may provide further clinical information or recommendations to support the patient's health. This will also be recorded in the system. The system does not prevent sales of OTC codeine-containing products, but incidents of where sales have been made under duress are recorded.

Since the introduction of MedsASSIST in February 2016, and as of 23 November 2016, approximately 68% (3810)^[71] of pharmacies across Australia have adopted the monitoring system, with over 2.7 million OTC codeine transactions recorded. The results of the MedsASSIST program have been periodically presented by the PGA to the TGA and ACMS during 2016 (Table 3).

Table 3: Results of PGA's MedsASSIST program

Parameter/Report Date	July 2016	September 2016
Data collection period	8 Feb – 14 July 2016	8 Feb – 13 Sept 2016
No. of pharmacies/No. of transactions	3413 (62%)/1,573,471	3652 (65%)/2,728,904
Average transactions/pharmacy	461	747 (+38%)
Number of unique ID numbers	796,850	1,313,709
ID appears once/more than once	72%/28%	66%/34%
ID appears 2-3 times (numbers)	20% (160,641)	22% (288,970)
ID appears more than 3 times (numbers)	8% (62,896)	12% (153,037)
Data analysis period	8 Feb - 30 June 2016	8 Feb - 6 Sept 2016
Number of transactions analysed	1,328,545	2,601,353
Number of denials	30,416 (2.29%)	51,247 (1.97%)
Number of safety sales*	12,603 (0.95%)	24,115 (0.93%)
Number of sales due to staff safety concern (this is a subset of safety sales)	756 (0.06%)	1447 (0.06%)

* Reasons for safety sales include 'patient risk inconclusive', 'patient distressed', and 'staff safety'

An overview of the MedsASSIST data:

• 62% (June 2016), 65% (September 2016) and 68% (November 2016)^[71] of all pharmacies are using MedsASSIST across various geographical locations (both city and rural pharmacies).^[72]
• Between July and September there was a 38% increase in the number of transactions recorded per pharmacy with only a 3% increase in the number of pharmacies participating in the program. Despite the increase in the number of transactions between July-September (38%), no increase in the level of denial was recorded.
• Between 8 February and 6 September 2016 (7 months), over 2.6 million transactions were recorded.^[73] During this period:
  • Over 97% of transactions were for a Schedule 3 combination analgesic product; the remaining were for Schedule 2 cold and flu products.
  • Approximately 2% of transactions were denied. ^[71,72]
  • Approximately 0.06% of transactions were made under duress in pharmacies (following a real or perceived threat to the safety of pharmacy staff).
  • 66% of patients requested a codeine product once, while 12% requested a codeine product more than three times
• The most recent November 2016 figures suggest the number of recorded transactions has risen to 4 million transactions since March 2016.^[74] During this period:
  • 86% of consumers who had made five or more purchases were recommended to seek medical advice with regards to managing pain, abuse and misuse. ^[74]

Where a unique ID appears more than 3 times (within 7 months), it is likely that the person is dependent on codeine and therefore at risk of serious morbidity. As of September 2016, this number is 153,037 individuals.^[72] It is also noted that this number does not include the 35% of pharmacies who were not participating in the MedsASSIST program, and that codeine-dependent consumers are likely to seek out these pharmacies to obtain a supply of codeine products.

For the July 2016 period, there were a significant number of occasions when a consumer was denied a codeine product by a particular pharmacy,^[71,72] but the data also highlighted that shopping at a second pharmacy subsequently allowed the individual to access codeine. ^[71] One example provided to TGA during the consultation process showed that an individual received 660 tablets over the period despite their purchasing behaviour being tracked in MedsASSIST. This brings into doubt whether MedsASSIST is actually deterring consumers with codeine-dependence problems from accessing codeine, with the data suggesting that consumers with addiction problems will change their behaviour in order to source codeine. Some GPs and specialists have expressed concerns around the effectiveness of RTM.^[75]

Furthermore, the following issues have been raised by independent experts of the ACMS (Advisory Committee and Medicine Scheduling) or Australian Medical Association (these experts are qualified pharmacists, medical practitioners or other health professionals):

Given the instances of 'pharmacy shopping' to source codeine,^[76] questions have been raised whether the patient use of codeine is best monitored by general practitioners noting their ability to better diagnose, treat and manage patient care in relation to chronic pain. Often general practitioners are familiar with the available treatment options available for their patient, that may include any, or a combination of the following:

• Non-pharmacological treatment - pain management clinic, recommend exercise regime, stress or weight management; and/or
• Other non-opioid pharmacological interventions such as ibuprofen, paracetamol as well as sumatriptan or rizatriptan for migraine.

GPs also have the ability to refer patients to pain management specialists or clinics for greater oversight and intervention, a formal referral system that is not available for pharmacists.

• While MedsASSIST aims to provide pharmacists with a purchasing history for codeine-containing medicines, reservations were expressed relating to the limited ability of pharmacists to actively engage with 'challenging' patients to manage the use of codeine in OTC medicines, noting that the pharmacy environment does not usually allow for private conversations in the way that doctors' rooms do.
• States and territories will need to agree to support MedsASSIST with mandatory reporting; such changes require uniform adoption at the jurisdiction level and changes to relevant jurisdiction legislation, which would take time.
• Also questioned is whether a recording and monitoring system is consistent, in principle, with an OTC medicine (Schedules 2 and Schedule 3). Previous review of Schedule 8 (drugs of dependence) restrictions has recommended the use of Electronic Recording and Reporting of Controlled Drugs (ERRCD), a nationally consistent recording system for capturing all transactions involving Schedule 8 medicines in line with mandated state and territory requirements. ERRCD has not been implemented to date.