Real-time monitoring of over-the-counter codeine purchases through a national pharmacy database called MedsASSIST is proposed as an alternative to rescheduling codeine to prescription-only. Real-time monitoring would allow legitimate pain patients to continue accessing codeine over the counter while curbing abuse and dependence by refusing sales to problematic users based on purchase history data. Rescheduling risks shifting codeine abusers to doctor shopping instead of pharmacy hopping and may reduce access for legitimate users by overburdening general practitioners. Real-time monitoring provides a means of continuously evaluating codeine use patterns at a population level to guide future policy changes.

1. Rescheduling vs Real-Time Monitoring
of
OTC Codeine

2. Rescheduling vs Real-Time Monitoring
Some Background
 Oct 1 2015 - TGA passed an interim decision to reschedule all OTC codeine
products as schedule 4 (prescription only)
 WHY???? – because of several concerns including risk of dependence and
adverse effects compared to other available OTC products.
 Stakeholders were given until 15/10/15 to make submissions to TGA
 During this consultation process 127 submissions received by TGA of which 113
opposed rescheduling
 19/11/15 TGA announced that final decision on the matter to be referred to
Advisory Council on Medicines Scheduling (ACMS) and changes to be effective
from 2017

3. Rescheduling vs Real-Time Monitoring
TGA Proposal
 Schedule 2 (cough and cold medicine preparations):
1. Proposal to amend the Schedule 2 entry to reduce the pack size to not more than
3 days' supply and include a label warning that codeine can cause addiction; OR
2. Proposal to up-schedule the Schedule 2 entry to Schedule 3 and reduce the pack
size to not more than 3 days' supply and include a label warning that codeine can
cause addiction; OR
3. Retain the interim decision to up-schedule to Schedule 4
 Schedule 3 (including, but not limited to codeine containing analgesics):
1. Proposal to amend the Schedule 3 entry to reduce the pack size to not more than
3 days' supply and include a label warning that codeine can cause addiction; OR
2. Retain the interim decision to up-schedule to Schedule 4.

4. Rescheduling vs Real-Time Monitoring
Journey back in time
 In 2009 NDPSC concluded that there was potential for significant harm from
OTC codeine analgesics although it was not possible to accurately estimate
the associated risk.
 the following were assumed:
 the proportion of all users that abuse OTC codeine is low.
 the risk of harm among all users of OTC codeine is low.
 the risk of harm among abusers of OTC codeine is high.
 In 2010 the NDPSC rescheduled OTC codeine to S3 to ensure surveillance by
pharmacists
 2010 rescheduling also included limits on maximum daily dose and pack sizes.

5. Rescheduling vs Real-Time Monitoring
Journey back in time
 Has it worked??
 Rescheduling to Schedule 3 has not achieved the required reduction in harm
to affected individuals.
 Codeine is increasingly a drug of abuse in Australia, and some codeine-
dependent individuals have developed severe adverse effects from the high
doses of paracetamol and ibuprofen that accompany the use of large numbers
of tablets.
 Since OTC codeine analgesics were rescheduled to Schedule 3 in 2010,
industry and pharmacy organisations have not been able to fully address
concerns regarding codeine dependence

6. Rescheduling vs Real-Time Monitoring
How much codeine do we use?
 Purchases of OTC codeine-based medicines, 2014
 Analgesics that include codeine -16.4 million units
 Cold and flu medication that includes codeine -5.2 million units
 OTC products containing codeine comprise 22% of the analgesics sold in
pharmacies
 This equates to $145 million in annual OTC codeine sales for the
pharmaceutical industry – BIG BUSINESS
 So what now for OTC codeine?

7. Rescheduling vs Real-Time Monitoring
So what now for OTC Codeine?
Real-Time Monitoring of OTC
Codeine

8. Rescheduling vs Real-Time Monitoring
Real-Time Monitoring of OTC Codeine
 MedsASSIST - $300k in development cost and $300k in annual maintenance.
 User testing of the prototype took place in December involving approximately
30 pharmacies in the Newcastle, NSW area.
 Modifications have been incorporated and the system is undergoing a pilot
involving up to 150 pharmacies in the Newcastle and North Queensland
regions.
 Pharmacy Guild aiming to commence national rollout at APP Conference in
mid March.
 In addition to RTM, “The system will also have the capacity for pharmacists
to record clinical information and provide guidance regarding suitable
referral pathways to support patients to better manage their pain and
enhance health outcomes”

9. Rescheduling vs Real-Time Monitoring
How does it work?
Patient requests OTC codeine product/presents with pain
Pharmacist conducts consultation and deems OTC codeine appropriate
Data entry into MedsASSIST
OTC product supplied with counselling Supply refused and discussion with
patient of their pain management
options

10. Rescheduling vs Real-Time Monitoring
MedsASSIST – Can it work?
 Project STOP has been an effective tool in reducing the diversion of locally
sourced pseudoephedrine while maintaining OTC access for patients using the
product appropriately for legitimate use.
 Will require universal uptake by pharmacies to maximize effectiveness.
 Pharmacists will require training on appropriately responding in situations
where supply needs to be refused.
 Increased consumer education to raise public awareness of risks of OTC
codeine
 The data from MedsASSIST can help guide future regulatory changes to OTC
codeine.

11. Rescheduling vs Real-Time Monitoring
Rescheduling or RTM?
REAL-TIME MONITORING

12. Rescheduling vs Real-Time Monitoring
Reduce Dependence and Adverse Effects
 Both will reduce access to codeine-dependent individuals at the pharmacy
 Only RTM will allow usage to be monitored
 Risk with rescheduling that abusers will transition from pharmacy hopping to
doctor shopping
 Both might result in codeine-dependent individuals moving on to other drugs
 In the case of rescheduling both legitimate and abusers of OTC codeine will
be accessing GPs for prescriptions making it a little bit harder to distinguish
between them
 Doctors might opt to prescribe stronger codeine preps (PBS listed) and/or in
larger quantities

13. Rescheduling vs Real-Time Monitoring
Impact on access for “legitimate” users
 RTM would allow “legitimate” users to retain access to OTC codeine
 With rescheduling “legitimate” users might be unable see GP in time due to
increased waiting times to treat acute pain and end up enduring the pain or
in ED
 Patients with other more serious conditions might have their access to GPs
impacted due to “new” pain patients taking up all appointments.
 Rescheduling might make “legitimate” users resort to “borrowing”
inappropriate pain meds from family or friends
 NSAIDs contraindicated & previously used OTC codeine-might resort to NSAIDs
either by not mentioning contraindication to pharmacists or purchasing from
supermarkets

14. Rescheduling vs Real-Time Monitoring
Cost implications for consumers?
 Both would possibly see increase in prices of OTC codeine due to reduction in
demand
 Cost of RTM will probably be passed on to pharmacies who might pass it on to
consumers
 Cost of GP visits
 Be forced to utilize sick days to get prescriptions
 Opportunity cost

15. Rescheduling vs Real-Time Monitoring
Economic costs?
 Cost to MBS-Guild funded report- $316 million, ASMI $170 million
 Both potentially overestimate the costs, but……
 However increase in GP visits might help identify other medical conditions?
 Rescheduling - Cost to private health insurance?
 Rescheduling - Productivity loss?
 Reduction in ED admissions for adverse effects from codeine combinations?
 Increase in ED admissions for NSAID adverse effects?
 Increased ED admissions due to new drug of abuse?

16. Rescheduling vs Real-Time Monitoring
Verdict?