Doctors Caught Between Patient Pain, Prescriptions

For some physician leaders, pain management may become a significant boon to their business, especially as the U.S. population ages. In a Health Leaders Media Industry survey this year, 37% predicted pain management will grow 1 to 5% over the next five years.

But doctors are on a precipice as they prescribe pain medication, especially long-acting and extended-release opioid analgesics such as oxycodone. Most are aware of the persistent potential for abuse, misuse, or mistaken use of the highly potent prescription drugs among patients. And the stress is mounting – for the docs. 

States are tightening treatment requirements, while the federal government weighs the possibility of mandatory educational plans for doctors in their handling of opioids, putting federal officials at loggerheads with much of the medical establishment.

Some physicians are so upset over what they term the "bureaucratic" infringements, that they are considering no longer seeing patients who seek pain treatment. Instead, they would prefer to refer those patients to colleagues who are willing to prescribe potent analgesics.

In an effort to reduce the painkiller overdoses and deaths, state and federal governments are stepping up their efforts to regulate, or at least better inform, physicians who prescribe the opioids. They aren't targeting just the "pill mills," those corrupt docs who loosely prescribe painkillers for big profits.
No, they are trying to reduce drug abuse or the mishandling of drugs by setting their sights on the ordinary physicians who stand on the front line between pain and prescriptions.

It is a constant, aching problem in the U.S. An estimated 60 million here have some type of chronic, nonmalignant pain. To treat that pain, extended-release, long-acting opioid analgesics are widely prescribed, with an estimated 22.9 million prescriptions dispensed in 2011, according to IMS Health, which provides information services to pharmaceutical firms. At least 320,00 physician prescribers who are registered with the Drug Enforcement Administration wrote at least one prescription for the drugs in 2011.

While most recipients of these prescriptions use opioid analgesics for pain control, some use these powerful drugs for non-medical purposes. In 2009, there were 425,000 emergency department visits involving non-medical use of the drugs, according to the Food and Drug Administration.
In addition, there were 15,597 deaths from opioid pain relievers in 2009, the Centers for Disease Control and Prevention reported – four times more deaths than in 1999.

The drug-pain scenario amounts to a "perfect storm" of two huge issues, says Glen Stream, MD MBI president of the 105,000-member American Academy of Family Physicians, which has been a major opponent of proposals in Congress to mandate continuing medical education (CME) related to the opioids as a prerequisite for licensing. The AAFP contends such actions would, among other things, place unfair "limitations on patient access to legitimate pain management needs that may occur."

Stream acknowledges that physicians may feel caught in the middle. "We want to make sure legitimate pain gets appropriate treatment and there is relief of suffering," he told HealthLeaders Media. "But we don't want to add to the opioid abuse problem by prescribing medication people don't have a legitimate need for."

Stream's own state of Washington has been among the strictest regulators involving opioid prescriptions, according to the American Medical Association. It includes rules with detailed instructions about how to evaluate and care for patients with chronic non-cancer pain, and requires "patient contracts" that call for mandatory, periodic urine screenings. 

At least seven states, including Florida, require medical licensure contingent on whether physicians complete CME courses related to pain management or prescribing controlled substances, according to the AMA.  Many other states have initiated prescription-monitoring programs.

"It seems well-intentioned, but if there is going to be legislation telling doctors every time they need to take additional training, there won't be enough hours in the day to take it all," Stream says, referring to the Washington law. Some states are considering fellowship-training requirements that could impact primary care physicians, he says. "We've been concerned about some states whose efforts to control opioid misuse is actually getting in the way of physician treatment."

In Washington State, some primary care physicians have opted out of the pain treatment business instead of complying with state regulations, Stream explains. "They are saying ‘I'm not going to treat (patients for chronic pain)."  "(Patients) can find someone else. The trouble is, in rural areas, there isn't someone else. This is a huge concern." Oddly enough, Stream estimates that 40% of chronic pain among patients is not treated.

Federal agencies are also trying to enhance education programs about opioid analgesics. They are becoming mandatory for drug manufacturers, but voluntary for physicians – as of now.

Last month, the Food and Drug Administration released  a Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-active opioid medications. The REMS is part of a multi-agency federal effort to address the growing problem of prescription drug abuse and misuse, with educational programs as a key component.

"Misprescribing, misuse and abuse of extended-release and long-acting opioids are a critical and growing public health challenge," FDA Commissioner Margaret A. Hamburg, MD, said in a statement when the REMS was released. "The FDA's goal with this REMS approval is to ensure that health care professionals are educated on how to safely prescribe opioids, and that patients know how to safely use these drugs."

While there is no current mandatory requirement that physicians take training as a precondition to prescribing long-acting and extended release opioids, an FDA statement notes that the Obama administration endorsed a mandatory training program on responsible opioid prescribing practices in April 2011 "as part of its comprehensive plan to address the epidemic of prescription drug abuse."

Such a program would be linked to a DEA registration by providers and "would require legislative changes that are being pursued by the administration," according to the FDA.

The FDA program will impact at least 20 drug manufacturers, which would be required to  make educational programs available to providers based on an FDA Blueprint. Companies can meet their obligations by providing educational grants to continuing education providers, who will develop and deliver the training, according to the FDA.

The REMS also requires companies to make available FDA-approved patient education materials about the safe use of the drugs. It is expected that the first continuing education activities will begin March 1, 2013. The FDA expects the training to take about three hours, but the continuous education providers can determine the number of credit hours that will be offered at no cost.

The AAFP's Stream sees the FDA program as onerous. "This isn't a simple legislative and regulatory solution," he says.

Not all physician groups have been as upset as the AAFP about the government's educational efforts to deter opioid abuse. "Through proper education and training, opioids can be administered safely to patients and continue to be an important option in the treatment of chronic and debilitating pain that is suffered by millions of Americans," the 2,600-member American Academy of Pain Medicine said in a statement about the federal plan. The AAFP's Stream says his organization wants to battle the opioid issue on other fronts, such as advocating increased national funding to support research into "evidence-based strategies" for pain management to be included in patient-medical home programs.

Each day, Stream acknowledges there's a "fine line" that physicians must walk in the drug treatment-for-pain issue.

"We've got to treat people's pain so they aren't suffering so much they want to kill themselves, but we can't let them kill themselves with drugs, either," he says.