Consultation: Prescription strong (Schedule 8) opioid use and misuse in Australia – options for a regulatory response

19 January 2018

This consultation closes on 2 March 2018.

Invitation to comment

The TGA is seeking comments from interested parties on options for a regulatory response to the potential misuse of prescribed Schedule 8 (S8) opioids in Australia.

Consultation documents

How to access a pdf or Word document

Timetable

Document released for consultation on Friday 19 January 2017.

Interested parties should respond by close of business Friday 2 March 2018.

Feedback will be released following consideration of submissions. (See 'What will happen').

About the consultation

The paper examines the issues around prescription opioid use and misuse in Australia and explores options for a regulatory response to issues identified.

Acknowledging that strong opioids play a critical role in managing severe acute pain following trauma and major surgery, as well as pain experienced in many forms of cancer and some other conditions, any regulatory response must not unduly restrict informed, rational prescribing of these products.

It is noted that use, and misuse, of opioids is affected by a wider range of factors beyond regulation, but regulation as it relates to demand from patients and supply from prescribers can play an important role in underpinning appropriate use and minimising misuse.

The focus of this consultation is on the higher-risk S8 opioids, although some Schedule 4 (S4) opioids may also be considered.

Possible options (which are not mutually exclusive) include:

  • Option 1: Consider the pack sizes for strong (S8) opioids
  • Option 2: Consider a review of the indications for strong (S8) opioids
  • Option 3: Consider whether the highest dose products should remain on the market, or be restricted to specialist/ authority prescribing
  • Option 4: Strengthening of the Risk Management Plans for opioid products
  • Option 5: Review of label warnings and revision to Consumer Medicines Information
  • Option 6: Consider incentives for expedited TGA review of improved products for pain relief and opioid antidotes
  • Option 7: Potential changes to use of appendices in the Poisons Standard to provide additional regulatory controls for strong S8 opioids (this could potentially include controls of prescribing for particular populations or classes of medical practitioners, additional safety directions or label warning statements, specific dispensing labels).
  • Option 8: Increase health professional awareness of alternatives to opioids (both S4 and S8 opioids) in the management of chronic pain.

Background

In 2014, almost 3 million people in Australia were prescribed at least one opioid under the Pharmaceutical Benefits Scheme (PBS) or Repatriation PBS (RPBS). Since the end of 2009, there has been a general increase in prescriptions, from about 10 million annually to 14 million annually.

Levels of prescription opioid overdose, including accidental overdose are at record levels in Australia and internationally. One of the contributing factors has been significant 'indication creep' – their use in a range of types of chronic non-cancer pain, despite limited evidence of efficacy or safety for opioids in many of those patients.[1] Use in chronic pain is also driven by the inconsistent efficacy of alternative medicines in chronic pain such as non-steroidal anti-inflammatory drugs (NSAIDs), gabapentoids, antidepressants and muscle relaxants; opioid analgesics are often used when pain is refractory to these other treatments.[2] Judicious prescribing for some patients with chronic non-cancer pain has been described as an appropriate option.[3] [4]

Australia currently ranks eighth internationally on the numbers of defined daily doses of prescription opioids per million population (at about 40% the level of the USA).[5] In the USA, opioid analgesics are now the most commonly prescribed class of medications.[6]

Pharmaceutical opioid deaths in Australia now exceed heroin deaths by a significant margin – by 2-2.5 times – the reverse of what was seen in the 1990s. Between 2011 and 2015 there were 2145 deaths associated with oxycodone, morphine, codeine, fentanyl, tramadol and/or pethidine compared with 985 due to heroin. Pharmaceutical opioid deaths particularly dominate in the over 30 age group.[7]

Content of submissions

Submissions may address any, or all, of the options for a regulatory response to opioid use and misuse in Australia, or other identified issues.

In addition, submissions might include:

  • suggested improvements
  • an assessment of how the proposed regulatory responses will affect you
  • what you see as the likely benefits or costs to you, either financial or non-financial (if possible, please attempt to quantify these costs and benefits, as this will help the TGA quantify the regulatory impact of any proposed actions).

How to submit

Complete the online Consultation submission form, upload your submission in either pdf or word format and click submit.

Consultation submission form

Alternatively, hardcopy submissions with a printed coversheet may be mailed to:

Technical and Safety Improvement Section
Pharmacovigilance and Special Access Branch
Therapeutic Goods Administration
PO Box 100
WODEN ACT 2606

How to access a Word document

Enquiries

Any questions relating to submissions should be emailed to PSAB.Communications@tga.gov.au.

What will happen

All submissions will be placed on this website unless marked confidential or indicated otherwise in the submission form (see Privacy information).

Submissions will be reviewed by the TGA and feedback on submissions will be provided through this website.

Recommendations made by the TGA following consideration of submissions from interested parties will be published on the TGA website as outcomes.

Privacy information

  • The TGA collects your personal information in this submission in order to:
    • contact you if the TGA wants to seek clarification of issues raised in your submission or to check whether you consent to certain information that you have provided being made publicly available.
    • help provide context about your submission (e.g. to determine whether you are an individual or a director of a company or representing an interest group).
    • Seek feedback about how the consultation was undertaken.
  • Please do not include personal information about other individuals in the body of your submission. Personal information in this context means information or an opinion about an individual whose identity is apparent, or can reasonably be ascertained, from the information or opinion.
  • More information on consultations and privacy is included in the submission form and on our website.

Footnotes

  1. Becker WC and Fiellin DA, BMJ (2017); 357: J3115
  2. Kroenke and Cheville A, JAMA (2017); doi: 10.1001/jama2017.4884
  3. Reuben DB et al, Ann Intern Med (2015); 162, 295-300
  4. Dowell D et al, JAMA (2016); 315: 1624-1645
  5. Humphreys, K, Lancet (2017); 390: 437
  6. Centers for Disease Control and Prevention: www.cdc.gov/nchs/fastats/drug-use-therapeutic.htm
  7. www.penington.org.au/australias-annual-overdose-report-2017/