Yale study: Many opioid prescriptions allowed without restrictions

Oct. 09--NEW HAVEN -- While insurance plans have increased restrictions on the prescribing of opioids, the highly addictive drugs are still easily obtainable without limits such as requiring prior authorization, according to a Yale University study.

The researchers compared formularies for Medicare plans from 2006, 2011 and 2015 and found that two-thirds of these drugs were subject to restrictions. One-third, however, did not have such limits.

"I think we all know that we're in a national opioid crisis right now and we need to know what may be contributing and we need to have all possible strategies at our disposal to help curb this crisis," said Dr. Sanket Dhruva, a cardiologist at the Yale School of Medicine and member of the research team, on Monday.

The study was published Monday in the Annals of Internal Medicine.

The researchers compared Medicare Advantage and Part D formularies for 2006, 2011 and 2015 because Medicare is often a standard other insurers use for their formularies. "Essentially, formularies determine the availability of these medications," Dhruva said. If a drug is not on the formulary, the patient and doctor must go through an appeals process.

"If the drugs are available, the insurance companies can use one of three strategies," he said. They may require prior authorization from the insurance company before the prescription will be approved. They can implement so-called step therapy, in which "a patient must try drug X before he can receive drug Y," Dhruva said. Or they can limit the quantity of drugs that may be dispensed at one time.

Connecticut passed a law in 2016 limiting most opioid prescriptions to seven days, with some exceptions.

The Centers for Disease Control and Prevention issued guidelines in 2016 for opioid prescriptions, but the Yale researchers found that these were not always followed. "Still, a large number of opioids don't have restrictions imposed on them," Dhruva said. "We want to make sure that opioids are going to patients that are going to benefit and are not going out in high doses."

Comparing formularies from 2006 with 2015, "It's an improvement, but I still think we have a ways to go," he said.

The CDC guidelines use a measure called morphine milligram equivalents to compare different opioid medications and call for a limit of 90 per day on that scale.

"They say nothing more than 90 and what we found was, even if there was a quantity limit, 31 percent of the time a patient could receive more than 90 morphine milligram equivalents per day," and 33 percent of the time there were no restrictions placed on the drugs, Dhruva said.

"I think that insurance plans ... should use these tools that are at their disposal to bring their formularies more in line with the CDC's recommendations and we believe this would likely lead to safer opioid prescribing," Dhruva said.

"I think there's an important opportunity here and we hope that the formularies can be part of the solution to addressing this crisis."

More than 900 people died in Connecticut in 2016 of drug overdoses, according to the state's chief medical examiner's office.

Dr. Dan Knecht, head of clinical strategy and policy for Aetna Inc., said the company has instituted restrictions on all opioid prescriptions. As of Jan. 1, "For an initial prescription written, there will be a seven-day limit," he said.

"A research study showed that after a patient receives a prescription of more than seven days of opioids, the likelihood of abuse doubles," he said.

He said the insurer sent letters to the top 1 percent of opioid prescribers warning them that they are "outliers." "We do intervene on these physicians who are excessive prescribers," he said.

Knecht also said Aetna encourages other medications for pain-relief, such as Tylenol and ibuprofen before opioids are prescribed. The company also covers treatments such as physical and occupational therapy, acupuncture and chiropractic, "which are proven treatment modalities that do manage pain," he said.

"Our formulary has safety guardrails to keep our members safe," Knecht said. "But there is a therapeutic relationship between the patient and the physician that we also respect."

According to the CDC, opioid prescriptions peaked in 2010 and declined through 2015, but the dosages increased dramatically. Patients were prescribed an average 180 morphine milligram equivalents per day in 1999 and 640 in 2015.

It is important to prevent patients from becoming addicted to opioids, because many users then move on to illegal street drugs such as heroin or fentanyl. "Once you start, it just opens up the door," Dhruva said. "Of course, [in] the vast majority it doesn't, but we've got young people dying, we've got people addicted. We've got a real problem on our hands."

Contact Ed Stannard at [email protected] or 203-680-9382.

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