Regulation of opioid prescribing

Long before the discovery of endogenous opioid systems, opium was used to produce insensibility and relieve pain. Societies began regulating opiates when the availability and use of opiate drugs reached a level that made opiate addiction a problem to society. In the United Kingdom and the United States this was at the beginning of the 20th century, with the Drug Enforcement Act in the UK (1920) and the Harrison Act in the US (1918). Before regulations, opiates were widely available in chemist shops, doctors' surgeries, and opium dens, and the choice of use was entirely up to the individual, with the risk of addiction being understood. None the less, a stigma was attached to the use of opiates, even therapeutically, but nothing like that seen after regulations made the use of opiates, other than by prescription, a criminal offence. Once these regulations were introduced, a hugely profitable illicit trade in opiates began. This, along with the increasing problems in society attributed to abuse of opiates and other drugs, inevitably compounded the stigma attached to these drugs and affected the use of opiates for relieving pain.

Pain advocacy—lobbying for (opiate) treatment of pain—is a powerful movement in the US, more so than in the UK. This is probably because early US regulations made it illegal for doctors to prescribe opiates to treat opiate addiction (addendum to the Harrison Law, 1919), whereas in the UK doctors could treat addicts with opiates in their surgeries until 1965 (Brain Committee formed in 1965, Misuse of Drugs Act 1971). Punishment for inappropriate opiate prescribing in the US could (and still does) include loss of medical licence, criminal prosecution, and imprisonment. Therefore, the prescription of opiates to relieve pain effectively ceased when these regulations were introduced.

Advocacy was needed in the US to restore the use of these invaluable drugs for the treatment of pain. Even though UK and European governing bodies have gradually adopted American style regulations (European and US laws allow only limited prescribing of opiates for addiction, with special certification),1 pain advocacy remains a more powerful force in the US, and one that is needed to counteract the “opiophobia” still prevalent here. Pain advocates have consistently lobbied the US regulatory authority, the Drug Enforcement Agency (DEA), in an effort to protect prescription of opiates for pain. The level of the DEA's cooperation with pain advocates has varied over time, partly with the political winds. In 2001, the DEA signed a consensus statement, published in 2004, that outlined legitimate prescribing practices—so that practitioners might feel protected.2 3 But then inexplicably, and without agreement from the healthcare agencies involved in producing the original consensus statement, the DEA withdrew its support, saying that the original document contained “misstatements.”4 In 2006, the DEA was persuaded it should at least retain the provision from the 2004 consensus statement that allows the issuing of multiple prescriptions to be filled sequentially over 90 days. This is especially important for patients in rural communities, who find it difficult to reach distant clinics to pick up prescriptions. Physician and pharmacy groups argued that providing multiple prescriptions with a “do not fill until” instruction, which had been a widespread though not officially sanctioned practice, increases safety as the alternative is to prescribe greater amounts. The DEA published notice of this proposed change in September 2006, and invited comment from the public.5 Whether or not the proposed change in DEA regulations will receive final approval remains to be seen.

We have seen a change in opiate prescribing over the past few decades. In the US, many patients with acute pain and pain during terminal illness who would have been denied opiate treatment a few decades ago are now likely to receive appropriate treatment. Others, though, still fall victim to prejudices against opiates. An emerging problem, however, is that the success of pain advocacy in restoring opiate treatment of acute and end of life pain has been used to advocate extension of opiate treatment to patients with chronic and non-terminal causes of pain. Here the benefits for patients are less clear.

Although opiates have reduced pain and improved quality of life for some patients with chronic non-terminal pain,6 the long term use of these drugs has many problems. For example, a recently published epidemiological study from Denmark, where opiates have been liberally prescribed for chronic pain, found that pain, quality of life, and function were worse in patients with chronic pain who were treated with opiates than in a matched group not receiving opiates.7 8 Treatment goals were not met—at least not in this population. Such large scale epidemiological studies are not feasible in the US, but trends here that affect the decisions of regulators include the documented increases in misuse of prescription drugs9; high profile stories about the misuse of prescription drugs, such as the proliferation on the streets of OxyContin (“hillbilly heroin”)10; and the addiction to pain medication of celebrities such as the radio commentator Rush Limbaugh.11 At the same time, many US doctors remain fearful of prescribing when they learn of colleagues imprisoned for prescribing apparently in good faith. In fact, the authorities tend to target only those doctors who flagrantly flout the law, but the fear persists none the less.12

Friction between regulators and medical providers is perhaps inevitable, as they both have noble yet conflicting goals—the one to control diversion, the other to preserve treatment for pain. As drug misuse becomes a greater problem, legislators react by tightening regulations.1 4 9 The American experience teaches that over aggressive regulations that ignore legitimate needs for opiates compromise doctors' ability to treat pain. As the pendulum has swung here between medical underuse and overuse, patients have been harmed. Now that it is becoming clear that the outcome of chronic opioid treatment is often poor, studies are urgently needed to investigate who benefits and under what conditions. The bigger question may be whether regulations have succeeded at all in controlling drug misuse, but the more immediate question for doctors in the US and elsewhere is how they should control their own prescribing so that interference by regulators does not discourage appropriate medical use of opiates.