Saturday, March 6, 2010

Opiophobia and Incompetent Pain Management in America

By J.S. Hochman MD



Chronic Pain-causing Conditions
» Failed back syndrome
» Degenerative disc disease of the spine
» Late complications of surgery, particularly orthopedic
procedures involving the insertion of hardware
» Osteoarthritis
» Rheumatoid arthritis
» Post-traumatic arthropathies
» Chronic daily migraine
» Classic migraine
» Peripheral neuropathies, including diabetic neuropathy
» Post-herpetic neuropathy
» Complex Regional Pain Syndrome
» Chronic hepatitis
» Coronary artery disease
» Interstitial cystitis
» Fibromyalgia
» Chronic pancreatitis
» Ulcerative colitis
» GERD
» Ehlers-Danlos syndrome
» Temporomandibular joint disease
» Late complications of TMJ surgery
» Chronic renal lithiasis
» Chronic endometriosis

It is estimated that 17 to 30 million Americans suffer significant chronic pain. The American Medical Association has editorialized that inadequately treated pain, both acute and chronic, is one of the most important issues in contemporary American medicine. Eleven years ago, the AMA specifically described this situation in a press release as a “crisis in American medicine.” The situation has not improved.

In the United States, almost 1,000,000 practitioners hold licenses from the federal Drug Enforcement Administration (DEA) to prescribe controlled substances. There is ample evidence in the medical literature that both acute and chronic pain can be contained by the appropriate use of opioid medications (if physicians were willing to prescribe them). The problem is so significant that the Veterans Administration has required pain assessment and management for every patient, and the Joint Commission on Accreditation of Health Care Organizations has made improving assessment and treatment of pain in hospitals and nursing homes a performance standard for the facilities they accredit. Major medical societies have issued standards and guidelines that make it clear that opioids can be safely and effectively used to treat acute and chronic pain.

Despite the medical and organizational consensus, American doctors remain unwilling to prescribe opioids. The following case story paints the perfect picture of the situation.

A case story
A 57-year-old woman fell while trekking after lowland gorillas in Gabon, western Africa. A physician in the travel group preliminarily diagnosed a fracture of the upper left humerus, with possible rotator cuff injury to that arm. The woman was located 7.5 kilometers into the jungle, at a gorilla research station that was unavailable except by a strenuous hike through daunting terrain. Her pain was severe and agonizing.

The research station had only Ibuprofen 400mg available in its emergency medical kit. The leader of the expedition had 20 hydrocodone in his emergency kit and complained that 10 years previously he always traveled with several doses of injectable morphine for emergencies. Now, however, “because of the war on drugs, he could no longer find a physician willing to prescribe morphine for his emergency kit.” The hydrocodone, taken two or three at a time, every four to six hours, provided sufficient pain relief to reduce the patient’s agony to a severe level of pain.

No helicopter was available in Gabon to provide evacuation. Oil company helicopters were “not available for personal medical situations.” The national independence holiday in that country made both military and the Presidential helicopter unavailable for 48 hours. The patient had no option except to hike out of the jungle, which took three hours.

After an additional 90-minute drive over a primitive logging road, she was air evacuated from a jungle airstrip to the capital at Liberville. There, she was competently examined at a hospital and received an X-ray that revealed a complex fracture of the proximal head of the left humerus, with 5mm of displacement in two axes. This took an additional five hours, as the only working X-ray in the capital was at a private clinic on the other side of the capital city.

The patient was then transported by commercial airliner to Paris (the only direct flight to Europe from Gabon). She boarded the plane, with only five minutes to spare, for the six-hour flight. In Paris, she transferred to another direct flight back to the United States, taking nine additional hours.

Back in the United States, she was taken to an orthopedist who specializes in injuries to the upper arm and shoulder. After additional X-rays, he confirmed the fracture. He gave the patient the choice of a surgical intervention for the placement of a plate, or conservative management with immobilization. He noted that the choice was “50-50” and provided a brace.

When queried about pain management, he offered hydrocodone, or Tylenol with codeine. The patient reported that three 10mg hydrocodone and acetaminophen taken every four hours gave her only minimal relief and that on the one previous occasion that she had taken codeine, it made her violently ill. The doctor replied that he could offer her nothing stronger, as he did not have a narcotics license for schedule II medications. “Not having a schedule II license saved him a lot of complications and potential problems,” he explained. “I leave pain management up to pain doctors,” he said.

The patient subsequently obtained 5mg oxycodone, without acetaminophen, from a pain management specialist, a day later. It finally gave her effective control of the pain. She was then able to sleep—after three days of uncontrolled pain.

The orthopedist’s explanation is not uncommon. Very few surgeons are currently willing to prescribe schedule II pain medications outside of an in-patient environment. And even within the hospital, they now most often defer pain management to anesthesiologists. It is fair to assert that few surgeons currently have any competence in pain management. Similarly, few physicians seeing patients in outpatient status are competent (and/or willing) to manage either acute or chronic pain.

Fear
There are many complex reasons for this failure, but more than half of the doctors who have responded to surveys about under-treatment of pain list fear of the DEA and medical board sanctions as a major factor that makes them unwilling to prescribe opioids. They emphasize that if an investigation is begun, whether or not it turns out to be baseless, they have lost time, money, and reputation in defending their practices. Although most state medical boards, some state statutes, and the DEA officially approve opioid use in appropriate cases, the burden is on the doctor to prove that his or her prescriptions have a “legitimate medical purpose.” Doctors are often blamed when their prescriptions are diverted and abused, even when the original prescription was reasonable and medically necessary. Legal defense is not covered by malpractice insurance, and the cost coming out of their pockets can run from $25,000 in the simplest matter, to $1,000,000+ in criminal charges. Further, few attorneys understand the medical issues involved in pain management, and doctors rarely get fully effective, informed defense teams. Given this situation, the unwillingness of most doctors to treat pain is no mystery.

In the United States, the “war on drugs” has put at risk physicians who prescribe controlled substances to treat pain and its related symptoms. This risk is far from insignificant.

Opiophobia
The medical management of intractable pain remains controversial. As recently as 2008, Washington state established guidelines limiting the total daily amount of opioid to 120mg of morphine sulfate for chronic, noncancer pain (or its equivalent). These guidelines are scientifically indefensible, and a lawsuit has been brought to set them aside.

A substantial percentage of cases handled by state medical boards continue to involve the prescription of opioids. The exact number of the cases they annually pursue remains elusive. However, the DEA annually investigates more than 500 physicians, causes the surrender of more than 400 narcotic licenses, and prosecutes approximately 60 physicians. There are now almost 100 instances a year of SWAT team assaults on physician offices—pursuing evidence of “opioid prescription abuses.”

The chilling effect of these activities has reduced the number of physicians who are willing to sub-specialize in the treatment of intractable pain from more than 35,000 in 1985 to approximately 5,000 today. Among the general medical community, opioids are still viewed with fear, discomfort, and anxiety. Addiction, tolerance, abuse, and diversion remain significant causes of anxiety and disapproval among physicians.

The medical literature on these causes of concern remains sparse. The single, recent, “peer reviewed” publication on the subject concluded that the maximum daily dose of morphine sulfate should be 120mg. No scientifically defensible basis for this absolute conclusion was provided. Yet this “peer-reviewed” article appeared in a prestigious medical journal.

These fears doggedly remain part of the opiophobic mythology that persists in American medicine. Major medical organizations and professional associations concur that addiction, tolerance, abuse, and diversion are statistically insignificant complications of the treatment of legitimate pain, both acute and chronic. In the example of methadone, 558 million doses were legitimately prescribed in the United States in 2006. Yet, 3,800 overdose deaths from methadone occurred in the same period, all from illicit use and none from the prescribed use of the drug. Similarly, in the last four years, there has not been a single instance of a death caused by the use of oxycodone as prescribed.

With complete disregard of the statistical insignificance of overdose or addiction in the legitimate use of opioids, media exploitation, self-perpetuating drug enforcement propaganda, and political opportunism have all combined to promote and sustain opiophobia. Even highly intelligent and intensively trained physicians are susceptible to this cynical hysteria. The consequence is the crisis in pain care. The solution to this crisis will not be simple. A number of elements are essential, including:
1. Establishing clear and understandable guidelines for patient evaluation and treatment and for maintaining excellent records by treating physicians. Experience demonstrates that many physicians get into trouble because they fail to document their evaluations and treatments involving opioids and do little to document patient compliance and functional improvement. Documenting medical necessity and treatment outcomes are essential.
2. Providing physicians with clear standards of care for intractable pain that meet all requirements of regulatory and licensing bodies.
3. Training every physician involved in clinical care in competent pain management and ceasing tolerance for any form of opiophobia within the medical profession.
4. Utilizing inexpensive, efficient, electronic medical record keeping and prescribing to improve the quality of pain-patient care and maintain a comprehensive electronic record of care.
5. Providing expert proactive consultation and guidance in the medical management of pain by physicians with impeccable reputation and credentials in intractable pain management.
6. Providing unimpeachable expertise to assist in the defense of those physicians who do follow the treatment and documentation standards and are nonetheless subjected to investigation and allegations of improper prescribing.
7. Making available affordable insurance to pay for the legal defense of legitimate physicians by highly qualified and experienced attorneys with established excellence in the legal area of administrative and criminal defense related to opioid prescription (www. pplaonline.com).
8. Legislating federal law compelling adequate pain management in the United States, requiring pain management competence by all physicians, and eliminating any tolerance of opiophobia.
The compelling truth is that there is no person in the world who is more than a single accident or illness away from acute and/or chronic pain. Further, with age and illness, every person ultimately must face suffering. As the situation now exists, virtually no one can currently expect effective, legitimate, unbiased, and unfearful pain treatment, a national folly and tragedy of historical proportions. Such a situation did not exist prior to the Harrison Narcotics Act, which has accomplished nothing useful in decreasing the abuse of drugs. Substance abuse is a medical issue involving addictive disorders. Law enforcement has failed spectacularly as a societal response to the abuse of or addiction to drugs. Physicians must lead in the fight to restore the role of the medical profession in the control and use of pain medications. For, when it comes to pain: “Ask not for whom the bell tolls; it tolls for thee.”

Dr. Hochman is the executive director of the National Foundation for the Treatment of Pain.