In the face of growing harm from accidental and deliberate overuse of prescription painkillers the Therapeutic Goods Administration is looking at ways regulation of the strong, high-risk opioid drugs could help reduce the abuse of these essential but potent drugs. There are many reasons why use of prescription painkillers can lead to abuse and accidental overdose. Regulation is not the only available path to combat abuse, but regulatory changes can help along with other measures. While several media reports have used headline banners along the lines of “TGA to consider banning GPs from prescribing strong opioids”, the TGA is considering a number of options. These are:

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.

The options have to consider the balance between effective relief for severe pain (which is often under treated) and limiting the potential for harm these compounds have. 

Changing pack sizes, by limiting the number of pills available will make it harder for dependence to be initiated. A similar move limiting paracetamol pack sizes has been successful in reducing accidental and deliberate paracetamol overdose. Incentives to bring new painkillers to market will help by being able to have alternatives to strong opioids (and currently we have few good alternatives). Increased education of the public and medical practioners is also highlighted.

While the focus of headlines, limiting the ability of GP’s to prescribe the highest strength opioids, or placing controls of their prescribing (eg limiting long term prescribing of strong opioids for low back pain where there is limited evidence of effectiveness) are but one option in the consultation.

The consultation is open to all submissions and does not close until March 2, so there is plenty of time for people to comment.

The fact that that the TGA is taking Australia’s burgeoning opioid appetite seriously is to be commended, but removing the ability of GPs to prescribe strong opioids is both political and medical ‘tiger-country’.

When the medical profession ignored the signs of a prescription opiate epidemic in the US for too long, and acted precipitously by drastically reducing access, white-collar dependent patients turned to other sources, including illicit fentanyls. This group of drugs is now killing more patients in Chicago than gun violence, which is a spectacular statistic in its own right. 

There may be some GPs who might welcome the removal of that particular chalice of prescription. There will be many others who will recognise the potential for increased aggression and in some cases, violence, towards practitioners when patients feel that they cannot get what they need. It remains to be seen what those in general practice would make of the removal of the right to prescribe, and whether it might be construed as a further slight to a profession that is clearly a speciality in its own right. Pain services around the country are already hard-pressed and would require significant additional resources, were this approach to be taken. 

Of course, there is one avenue that might be taken to mitigate against the fall-out of a ban on GP opiate prescribing, but as far as the TGA is concerned, it is an option whose Name Must Not Be Spoken. In jurisdictions in the US where medicinal cannabis has been introduced, deaths and injuries from opiates have reduced by as much as 30%.

In Canada & Israel, the vast majority of medicinal cannabis patients are managed by their GPs. In Australia, GPs are involved only as adjuncts to medical specialists, many of whom have absolutely no experience with medicinal cannabis themselves. Allowing those GPs who wish to prescribe medicinal cannabis autonomously to do so would address many problems in one fell swoop - the reasons for not doing so have yet to be coherently articulated.

There are significant, life-and-death lessons to be learned from overseas in addressing this issue - and disempowering or diminishing GPs, often the very first point of contact for patients, is never an intelligent starting point.

If the evidence and science prevails, many deaths will be avoided. The expectation is that it won’t.

We must ask how we have found ourselves in this position. Persistent pain is at epidemic proportions globally. One in five people suffer from persistent pain. And yet we are still reliant on a class of drugs that were first reported by Homer (The Iliad and The Odyssey) and Virgil (The Aeneid) as early as 850 BCE. for the management of pain.
 
It is clear from a range of global evidence that the management of persistent pain conditions solely with opioids is not world class level of care. Persistent pain needs to be treated in a multidisciplinary environment with the clinical wisdom of Doctors, Psychologists, Physiotherapists, Nurses, Pharmacists and Occupational Therapists.
 
This pain epidemic needs to be elevated to the level of critical attention and resourcing it deserves. General Practitioners need the ongoing training and support available through organisations like the Faculty of Pain Medicine and specialist pain clinics to guide patients through the agony and loss that is associated with experiencing persistent pain. One part of this process is the management of pain with drugs. But the global treatment of the individual is required.
 
Is there any hope? Sure there is. But we need Federal and State Governments to acknowledge that the science underpinning our understanding of persistent pain has been neglected and it must resourced at a level promotional to its prevalence. This will enable translational medical research in Australia which lead to new interventions in the battle to alleviate the chronic misery of patients suffering persistent pain.