Real-time monitoring of Schedule 8 medicines in Australia: evaluation is essential

Over the past decade, increased prescribing of pharmaceutical opioids in a number of countries has raised professional and public concern about iatrogenic opioid dependence and fatal opioid overdoses. Most fatal drug overdoses in the United States are now from opioids.1 Although not as high as in the US in absolute terms, the number of opioid prescriptions in Australia increased by around 300% between 1992 and 2007.2,3 This was accompanied by increased rates of injection of pharmaceutical opioids by people who regularly inject drugs,4 and professional concern about the appropriateness of prescribing these drugs for people with chronic non-cancer pain.

The regulation and monitoring of Schedule 8 medicine prescribing in Australia differs among the eight states and territories (see Appendix). Researchers have argued for more timely and nationally consistent monitoring of these prescriptions in combination with strategies to reduce inappropriate opioid prescribing.5 The Prescription opioid policy released in 2009 by the Royal Australasian College of Physicians recommended the adoption of a web-based, real-time system for monitoring prescriptions of drugs of dependence used to treat chronic pain.6 The aim of the proposed system was to ensure that Schedule 8 drugs were available for clinically appropriate use, while minimising harms to individuals and the community. In February 2012, the Australian government announced that a real-time reporting system for controlled drugs (like that in effect in Tasmania) would be introduced nationally.

Research on the impact of retrospective prescription monitoring programs (PMPs) in the US has found mixed benefits at the population level. Although overall prescribing was reduced, it was not clear whether harms were also reduced, or if clinically appropriate use had been restricted.7 There is also evidence that PMPs in the US have shifted prescribing patterns towards less closely monitored medicines without substantially reducing harms or prescribing of the monitored medicines.8

There is even less research on the impact of real-time reporting (RTR) systems, which have only recently been introduced. One study of RTR in an emergency department in Ohio found that clinicians changed their opioid prescription in 41% of cases after reviewing the patient’s prescription history in real time. Of those patients whose prescription was changed, 61% received no opioids or less than originally intended, but 39% received higher doses of opioids than initially planned.9 Thus, in more than a third of cases, real-time access to prescription history may have increased the prescriber’s confidence in prescribing opioid analgesics. The Tasmanian RTR system has not yet been evaluated, but many of the prescribers recently interviewed in a review of opioid prescribing in that jurisdiction supported RTR and remote access to patients’ Schedule 8 prescribing history.10

For health professionals, the system promises to provide better information for decision making. It will also, however, require alternative physician responses, such as the use of safe medication reduction strategies, and increased access to physiotherapists, psychologists, occupational therapists and addiction medicine specialists. These will require resourcing, particularly in regional and remote areas. For some patients, the RTR will mean changes to their prescribed medications and chronic pain management that they may not initially welcome but that may prove to be safer and more effective in the long run.

Any benefits from the new Australian system will depend on a variety of critical design features, including:

• who has access to patient prescription histories;

• whether patients can opt into or out of the system;

• the quality of consumer education and information provided;

• the level of support given to prescribers and pharmacists;

• the availability of health staff to treat newly identified patients with opioid dependence and to provide alternative forms of pain management;

• the potential for individual doctors and pharmacists to ignore or override the system;

• the way in which the health system differences between jurisdictions are managed; and

• how national electronic medical records are integrated across primary, outpatient specialist and hospital networks.

Given the sizeable investment required to create an RTR system, it is critical that its impact is evaluated (Box). It is unclear how much the mooted Electronic Recording and Reporting of Controlled Drugs system will cost at the jurisdictional and national levels, but the Australian government has committed $5 million initially to begin setting up the national system, compared with the $1.1 billion allocated to the new national e-health system. Although these are quite different systems, the $1.1 billion for the national e-health system suggests that a far more substantial investment than $5 million will be required to establish a national RTR system.

The costs and benefits of this system may take some time to become apparent, so a series of linked studies will be required over time. These will include assessments of the effects of RTR on fatal and non-fatal pharmaceutical opioid overdoses; presentations for treatment of pharmaceutical opioid dependence; and rates of pharmaceutical opioid use among injecting drug users. Much of this research could be carried out if linkage of existing datasets was allowed. It will be critical to evaluate the impact of the RTR on the quality use of opioid analgesics in managing chronic non-cancer pain by assessing whether patients are regularly reviewed by their prescribing doctors to ensure that opioids are still effective in controlling pain (eg, assessing patients against an acceptable set of criteria as part of a multimodal pain management plan). Such indicators could be built into the RTR system to improve the quality use of Schedule 8 medicines in Australia.

Australia is introducing one of the world’s first national RTR systems; an evaluation of this experience will provide important lessons for other countries struggling to effectively regulate appropriate medical use of opioids for pain. A well designed RTR system has the potential to make a significant contribution to the quality use of medicines in Australia.