Poor Management of Pain

The Poor Management of Pain

by Richard Lee

Government restrictions to discourage the growing concern of drug abuse, trafficking, and physical dependence are resulting in physicians undertreating patients with chronic pain.
It is seemingly a no-win situation. On the one hand, the more you treat pain with opioids, the more likely you will be investigated by state or federal authorities. But, on the other hand, the less you treat pain with opioids, the greater your chances of being sued for civil damages on the grounds of undertreatment.1
“Lawyers are lining up right now...looking for cases of poor pain management,” according to remarks given by Bill McCarberg, MD, director of the Chronic Pain Management Program at Kaiser Permanente in San Diego and an assistant clinical professor at the University of California, San Diego, who also serves on the board of the American Pain Society. “Whenever you encounter litigation against doctors for pain management, it is never because...we do not allow the patient to get a muscle relaxant...It is always about opioid management. We get sued because we’re not using opioids.”

William Marcus, JD, a consultant on pharmacy-controlled substances, pain management, and administrative law (he is also a part-time administrative law judge with the Office of Administrative Hearings in Los Angeles), told a lecture audience that physicians are just as nervous about criminal prosecution as they are about being the target of a personal injury case when it comes to ordering potent relief for pain.2 Indeed, fear of regulatory scrutiny for prescribing controlled substances has been shown to discourage physicians from prescribing opioids of sufficient strength for the patient’s pain, especially for chronic nonmalignant pain.3 Such fears can result in the selection of less effective analgesics and, ultimately, undertreatment of the patient’s pain. Of course, fears of getting into trouble with authorities or of being hauled into civil court are not the only factors making physicians reluctant to prescribe. Many physicians worry that their patients will become addicted to opioid and codeine medications,3 or that insurance companies will make it hard for patients to access the medications in the first place.

Meanwhile, studies have found that the reluctance to prescribe opioids for noncancer pain treatment has resulted in ineffective relief for large groups of patients.3 For example, in a recent study of 805 chronic pain sufferers, it was reported that more than 50% found it necessary to change physicians in their quest for pain relief.

That is unfortunate, because “pain is highly prevalent in our society, and it is being grossly undermanaged,” in the words of McCarberg, who noted that pain (as a symptom in itself) is the third most common reason sick patients give for missing work. And, with 75% of the US adult population regularly using over-the-counter pain medicine, 35% of that total also take prescription drugs for pain.1
Further, stated McCarberg, “pain is frequently disproportionate to the injury involved when it becomes chronic. This is why it’s hard: It persists well beyond expected healing, you frequently have numerous, fruitless diagnostic interventions, and our biomedical model fails. The biomedical model states that if a patient’s in pain, there is a pain generator that’s causing that pain. All you have to do is find the generator, fix that—that disc, or that facet joint, or that muscle that’s tight—and [theoretically] the pain goes away.”

Overcoming Reluctance

Taking a closer look at the laws and regulations concerning the prescribing of medicines covered by the federal Controlled Substances Act (CSA), it is easy to see why orthopedists and other practitioners are skittish, but the fact is that these rules are not intended to interfere with the legitimate processes of the doctor-patient relationship. The goal of the CSA is simply to prevent abuse, trafficking, and diversion of medications with a potential for producing psychological or physical dependence. However, the CSA recognizes that such medications “are necessary for public health and that their availability for medical and scientific purposes must be assured.”

CSA requires that prescriptions for Schedule II drugs (the most potent of controlled substances) must be in written form and may not be refilled, while five refills are permitted for drugs in Schedules III and IV. CSA imposes no limits on the sizes of the prescription or on the duration of prescribing.

The imposition of limits is left to the states, which in most cases have stepped up to that responsibility with considerable zeal. All of the states’ own versions of CSA permit prescribing of controlled substances, although it is hit-or-miss as to whether they specifically reflect the recognition by federal law of the medical uses of controlled substances.

Typically, the criminal provisions of the state acts are enforced by state and local police agencies, while the drug regulatory aspects of state-controlled substances laws are administered by a variety of state agencies, including departments of regulation and licensing and medical or pharmacy boards. These agencies often have their own regulations governing the prescribing and dispensing of controlled substances, and they are usually more stringent than the provisions of the federal CSA. For example, some states limit the amount that can be prescribed at one time, and limit the validity of a controlled substance prescription to a few days or weeks. Some have overly broad definitions of the term “addict” that can be interpreted to include physically dependent pain patients (in several jurisdictions, prescribing to such persons is outright prohibited; in others, physicians are required to supply names of patients receiving controlled-substances prescriptions to one or more state agencies).4
Some states have also adopted laws that require physicians and pharmacists to use special government forms when prescribing and dispensing certain controlled substances. These programs allow state health departments or law enforcement agencies (and even licensing boards) to monitor prescriptions of potent pain drugs and uncover fraud and abuse. State special-prescription programs differ considerably: they require use of either a triplicate, duplicate, or single-copy form, usually state-issued.

In recent years, many states have adopted “intractable pain treatment acts” (IPTAs). These are often modeled after an 1989 measure adopted by Texas. The idea is to address physician reluctance to prescribe opioids for the treatment of chronic pain by providing—at minimum—immunity from discipline at the hands of state medical boards.

Most states that have IPTAs have also taken the step of adopting practice statements or guidelines to further clarify physician responsibilities and, hopefully, further reassure them on prescribing opioids.2 As one example, California law now requires 12 hours of continuing medical education on effective pain-management techniques and medication.

“The more practitioners, regulators, and the public understand pain and pain management, the better care we will all get because there’s no regulator who is so converted as the regulator who’s been in pain, or whose family has been,” Marcus contended in his lecture.

That notwithstanding, many experts believe the best way to avoid problems with authorities—and with patients’ lawyers—is to get in the habit of producing accurate and thorough documentation on your cases requiring pain management. Records on each such patient should include: medical history and physical examination findings; diagnostic, therapeutic, and laboratory results; evaluations and consultations; treatment objectives; discussion of risks and benefits; treatments; medications (including date, type, dosage, and quantity prescribed); instructions and agreements; and periodic reviews.

Rapid Advances

McCarberg made the point that advances in the field of pain management are these days arriving faster than in any other branch of medicine: “Everything I learned in medical school about pain management is outdated today.”1
Among the relatively recent innovations worth noting are medications that include diclofenac sodium with misoprostol, extended-release morphine sulfate capsules, and levetiracetam.

Diclofenac sodium with misoprostol is indicated for treatment of pain associated with symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications (diclofenac sodium is a nonsteroidal anti-inflammatory drug with analgesic properties, while misoprostol is a gastrointestinal mucosal protective prostaglandin E1 analog).

In pharmacological studies, diclofenac sodium has been shown to be effective as an anti-inflammatory and analgesic agent (it is also used for reducing fever). The mechanism of action of diclofenac sodium (like other NSAIDs) is not completely understood, but may be related to prostaglandin synthetase inhibition. It achieves peak plasma levels in about 2 hours (the range is 1 to 4 hours).7 Each tablet consists of an enteric-coated core containing 50 mg or 75 mg of diclofenac sodium surrounded by an outer mantle containing 200 mg of misoprostol. For osteoarthritis, the recommended dosage for maximal gastrointestinal mucosal protection is 50 mg three times a day (patients who experience intolerance can be given 75 mg twice daily or 50 mg twice daily, but these are less effective in preventing ulcers). For rheumatoid arthritis sufferers, the recommended dosage is 50 mg three or four times daily (intolerance can be addressed the same as with the alternate dosing for osteoporosis patients).

The cost of 60 tablets, 50 mg/200 mg, runs about $100.
Then there is the morphine sulfate extended-release capsule for once-daily treatment of chronic, moderate-to-severe pain in patients who require continuous, long-duration, around-the-clock therapy (each capsule provides relief for a full 24 hours). A morphine sulfate extended-release capsule product approved 2 years ago by the FDA features a novel dual release formulation containing immediate and sustained-release morphine beads. Once steady-state plasma levels of morphine are achieved, the immediate-release beads enable morphine sulfate extended-release capsules to provide rapid exposure to morphine. The sustained-release beads enable morphine to be absorbed by the body gradually, thus maintaining plasma morphine levels over a 24-hour dosing period.

In a double-blind, placebo-controlled trial, this particular morphine sulfate extended-release capsule product improved physical function in patients with chronic moderate-to-severe osteoarthritis pain. The lead author of the study was quoted as saying, “Opioids are never the first tier treatment choice for osteoarthritis. But I think it is useful to point out that morphine is not end-organ toxic, which cannot be said for [nonsteroidal anti-inflammatory drugs].”

Capsules come in strengths of 30, 60, 90, and 120 mg.
Levetiracetam provides an intriguing twist in that it is primarily intended as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy. However, some new studies suggest that levetiracetam also exhibits pain-blocking properties, and so may be useful in treating chronic pain.

Levetiracetam is available in strengths of 250, 500, and 750 mg tablets for oral administration. The main drawback of levetiracetam is that it is substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. Thus, dosing must be individualized according to the patient’s renal function status.9 The cost is about $50 for 30 tablets at 250 mg strength.

Patients Phobic, Too

The National Institute on Drug Abuse (NIDA) reports, “Many health care providers under-prescribe painkillers because they overestimate the potential for patients to become addicted to medications such as morphine and codeine. Although these drugs carry a heightened risk of addiction, research has shown that providers’ concerns that patients will become addicted to pain medication are largely unfounded.” NIDA refers to this fear of prescribing opioid pain medications as “opiophobia.”10 NIDA insists that “most patients who are prescribed opioids for pain, even those undergoing long-term therapy, do not become addicted to the drugs. The few patients who do develop rapid and marked tolerance for and addiction to opioids usually have a history of psychological problems or prior substance abuse. In fact, studies have shown that abuse potential of opioid medications is generally low in healthy, non-drug-abusing volunteers. One study found that only four out of about 12,000 patients who were given opioids for acute pain became addicted. In a study of 38 chronic pain patients, most of whom received opioids for 4 to 7 years, only two patients became addicted, and both had a history of drug abuse.

But try convincing patients otherwise. In one survey, fear of addiction (as well as fear of developing tolerance and experiencing side effects) was described by patients as their most important concern—the very kind of concern that can readily result in reluctance to report pain or comply with a regimen that involves opioid medication.

In other words, blame for the underutilization of pain medications can be placed on patients’ fears, not just those of physicians.11 No matter who is to blame, many will likely agree that there is just too much fear at play in the system. The sooner it is tamed, the better off everyone will be.

http://www.orthopedictechreview.com/issues/julaug03/pharma.htm

Lifted verbatim in case the webpage disappears