Making opiates safe, efficient in the office

A pendulum is swinging back and forth on the topic of prescribing opiates, from undertreatment to overtreatment. Each new drug over the years, from oxycodone to methadone, has brought with it the promise of slowing that pendulum down.

Each time, some unintended consequence has kept the swinging in motion.

Barak Gaster, MD, FACP, who practices at the University of Washington in Seattle, said the goal of his talk at Internal Medicine 2012 was to slow the pendulum down, to help it stop at a happy medium. He focused on keeping opiate prescribing efficient and workable in a primary care practice.

Randomized, controlled trials show opiates have only mild to moderate efficacy for chronic pain, and very low doses are as likely to work as very high doses, Dr. Gaster said. And high dosing and long-term prescribing may have adverse effects on the neuroendocrine system, including hypogonadism, low cortisol levels, sleep apnea, permanent hyperalgesia (presenting as a change in how people perceive routine or mild pain), and even death due to unintentional overdose.

Yet prescriptions for opiates have tripled in the past 10 years, with an accompanying increase in risk for abuse. One in 20 Americans has taken prescription opiates to get high, Dr. Gaster said, and prescription opiates kill more people due to accidental overdoses than cocaine and heroin combined.

Safety and efficiency

Dr. Gaster's #1 pearl for safe and efficient management is to set clear upper limits on dosing. The conventional wisdom is 120 milliequivalents of morphine per day, but Dr. Gaster believes even that's too much. “We should all have in our heads what we feel is a safe upper dose of opiate” to prescribe, he noted, whether that dose is 60, 80, 100, or 120 milliequivalents per day.

Clinicians should be wary when patients request more and more medications. “The failure to respond in any meaningful way to low doses is a red flag for possible abuse,” Dr. Gaster said. Especially beware of self-dose escalations, such as when patients run out of pills early.

For more efficient clinic visits with opioid-taking patients, Dr. Gaster recommends that physicians practice the patient encounter and have a prepared sentence in mind for patients who seek more than they are comfortable prescribing. Dr. Gaster suggested the following: “Honestly, I don't believe that the higher doses would be safe for you. This is the maximum dose that I feel comfortable prescribing in a safe way.”

Another valuable tool is a written care agreement, which helps identify high-risk patients who can't abide by the limitations that are set. Keep the care agreement simple because “kitchen sink” agreements that include every possible contingency become a contract, Dr. Gaster warned. With too much fine print, it can become “something the people don't read,” he noted.

View the agreement as a communication tool, one that should be discussed three or four times throughout the continuum of care. It's not effective to just have the contract signed and filed in the medical record without discussion.

“It's a powerful tool, but it's not the be-all and end-all of whether to continue opiates,” Dr. Gaster said.

Having a signed agreement in the chart is far less important than documenting the repeated reviews of expectations. For example, aberrant behavior doesn't have to be listed in the care agreement for a physician to decide to discontinue opiates. When red flags arise, it's always the physician's prerogative to stop or continue opiates, Dr. Gaster stressed.

Dr. Gaster recommended that physicians focus on some key features of the agreement, first and foremost, that medications cannot be refilled early. Pseudoaddiction is a common occurrence; patients run out of medication early because they are desperate and in a lot of pain.

“You can easily imagine how they'd take more pills in the course of the month than they were prescribed, and they are going to ask for an early refill that from afar will look like aberrant behavior [or] drug-seeking behavior. It will look like drug abuse,” Dr. Gaster said.

Communicate clearly that pills need to last the allotted prescription duration, Dr. Gaster advised.

“If you really communicate that point and people are still not able to keep to that schedule, then your suspicion for drug abuse goes up and your suspicion for pseudoaddiction, for desperate pain behavior, goes down,” he said.

Another important point is to emphasize that lost or stolen medications or prescriptions cannot be refilled. Warn the patients that “This bottle of pills is like cash and I cannot replace it,” he said.

The other key points to communicate are the following:

• Refills are done by appointment only.
• There can be no urgent requests. Appointments for refills must be requested at least two business days in advance.
• Failure to follow the agreement will result in discontinuation of pain medications.

Other red flags

A history of previous substance abuse raises the risk for prescription opiate abuse, Dr. Gaster said. Often a physician won't ask about this, he said, feeling sure that the patient wouldn't admit to it.

“It's true that the person who is really trying to scam you, really has a history of substance abuse, is not going to disclose it. It's still important to ask and document the answer,” he said. “And if later you find 10 years ago they did have a positive cocaine use toxicology screen, the fact that they did not disclose that to you is even more of a high-risk behavior.”

Another important red flag is a medical history of chronic hepatitis C, the vast majority of which is acquired through drug abuse.

“The presence of history of drug abuse should be treated with extreme caution,” Dr. Gaster said. “This is a completely different class of prescribing that needs to be approached differently.”

It becomes complicated and even heart-wrenching for clinicians who have an emotional connection or long treatment history with patients, but it is simply not safe for physicians in a primary care setting to prescribe chronic opiates to patients who have ongoing substance abuse, even if they have a clear source of somatic pain, Dr. Gaster stressed.

“It may feel compassionate to prescribe opiates in that way, but the risk is too high,” he said.

Urine screens

Urine toxicology screening is the one piece of hard data that can be used to determine who is abusing prescription drugs. The tests should be performed frequently, but not at every visit, Dr. Gaster recommended, so true prescription drug abusers aren't prepared to attempt evasion every time.

The most useful information in a urine toxicology screen is a positive result for cocaine, because of its very high correlation with prescription drug abuse and the low incidence of false positives.

Also, a non-test is a positive test, Dr. Gaster emphasized. Patients who make excuses about being late or not being able to produce enough urine should be considered to have an aberrant test result.

“The moment you allow someone to leave your office without a sample, you have lost all the power of that test to detect drug abuse, because someone who knows that their sample is going to get them in trouble is going to find a reason to leave without giving a sample,” he said.

For the sake of office workflow and efficiency, and to avoid confrontations, Dr. Gaster advised having patients leave samples for next-day testing.

“For me, the danger that somebody who has a positive urine toxicology screen walks away with one last prescription, that danger for me is, in the big picture, much less of a danger than the potentially violent, very time-consuming face-to-face confrontation,” he said.

When next-day testing does yield a positive result, Dr. Gaster sends a letter that details this and spells out his intention to not prescribe future opiates to the patient.

Clinicians should remember that urine toxicology screening does not detect semisynthetic opiates such as oxycodone, which has to be at a very high concentration to turn an opiate assay positive. A separate oxycodone assay should be included as part of a toxicology screen, Dr. Gaster advised.

False-positive results for amphetamines are another issue to watch for, he said. The ELISA for amphetamines is nearly 100% cross-reactive with 20 to 30 other drugs, including bupropion, promethazine, and ADHD drugs such as methylphenidate (Concerta) or dextroamphetamine and amphetamine (Adderall). Patients on those drugs will always have a positive screen that the lab needs to confirm with gas chromatography, Dr. Gaster said.

Finally, urine toxicology screening can be used to detect diversion, the practice of illegally reselling prescription opiates to third parties.

“That can be really, really hard to detect,” Dr. Gaster said. “It is harder to detect diversion from a urine toxicology screen than detecting unexpected use. While an unexpected positive is nearly always a sign of drug abuse, an unexpected negative for a drug which is being prescribed at lower doses is really only a minor red flag.”

The screening assays were developed for use in emergency departments to detect very high doses in a patient. Patients on low doses may have low levels anyway, especially if there's been a lag in the time since they've taken the most recent pill, Dr. Gaster noted.

“If they told you they had taken it that morning or they were supposed to be on a huge dose and hadn't taken it for a few days,” Dr. Gaster said, “be aware that a negative urine toxicology screen in that situation is still quite damning.”

Handling methadone

Methadone is a unique opiate with a high number of active metabolites and therefore a highly variable dose response, Dr. Gaster said. When prescribing it, physicians need to communicate to patients that it will take as long as two weeks to reach a steady state in terms of its analgesic effect.

During those first two weeks, as metabolites accumulate, the respiratory depressive effect of the starting dose gradually rises. That creates a dangerous situation if patients don't understand that the pain relief takes time to reach full potential.

The other big pitfall is that methadone is extremely potent. The pills have traditionally been used to treat heroin addiction, in which patients enter treatment with already a very high level of tolerance. It is a dangerous coincidence that methadone pill sizes are the same as oxycodone, so people assume that they have similar potency. But the smallest 5-mg tablet of methadone is three to four times as potent as the smallest 5-mg tablet of oxycodone.

Actually, Dr. Gaster said, 60 mg of methadone is like 200 mg of oxycodone. An opiate-naïve person should be started at a tiny half-tablet twice a day for two weeks. Titrate slowly and continue to warn patients not to exceed the dose.

Stopping opiates

To help identify patients in whom continued prescribing of chronic opiates is too much of a risk, use a patient's problem list to track red flags, sometimes over years. Once the evidence clearly shows that opiates are becoming a problem, the doctor must tell the patient that he or she is discontinuing opiates, but the doctor is not “firing” the patient or refusing further care.

“Ethically and legally it's not right to abandon a patient in that situation. You're still willing to provide ongoing care,” Dr. Gaster said. “You're not willing to prescribe opiates for their chronic pain. It may well be likely that they will not come back to see you. But your message to them is ‘I'm still willing to be your doctor.’”

Tapering opiates is an option, but not for obvious cases of prescription drug abuse because the patient is not going to follow any tapering schedule. If the signs of abuse are less prevalent, and the doctor's clinical suspicion warrants it, then tapering is OK, Dr. Gaster said.

Stopping opiates against a patient's wishes is one of the most difficult interactions that doctors have, Dr. Gaster said, right up there with having to deliver a cancer diagnosis.

For physicians discontinuing opiates, Dr. Gaster recommends beginning the interaction by telling patients, “This type of pain medicine is simply not safe for you and I cannot prescribe it for you anymore.”

The typical response? “What are you going to do about my pain?”

Physicians should suggest non-steroidal anti-inflammatories, gabapentin, tricyclic antidepressants, physical therapy and acupuncture, Dr. Gaster recommended.

Patients typically respond, “But none of those things work.”

That's when physicians need to try to be sincerely empathic and firmly repeat, “I'm really sorry. This must be terrible for you, but medical opiates are not a safe option for you,” Dr. Gaster said.