Posts Tagged ‘opioid overdose deaths’

Black Box Warning

black coffin

 

 

Last month the FDA (Food and Drug Administration) announced their decision to require black box warnings on opioid and benzodiazepine prescribing information. This warning will state that co-prescribing these two classes of medications increases the risks to patients of death, coma, sleepiness, and respiratory depression. The FDA also said they would require medication guides for patients, describing these risks.

Black box warnings are the strongest warnings issued by the FDA. These warnings are literally placed in a bold black box at the top of the prescribing, where the information is most noticeable.

I applaud the FDA’s action. I think FDA’s statement will make physicians and other providers think twice before blithely writing a benzodiazepine prescription for a patient already prescribed opioids. A black box means, “Take this seriously!”

Ten years ago, co-prescribing of opioids and benzodiazepines was commonplace for primary care physicians in my area. Earlier this year, our state medical board announced they would investigate the top prescribers of opioids and benzodiazepines together. Since then, I have noticed some prescribers appear to be backing away from the routine prescribing of benzodiazepines..

Most opioid treatment centers have policies in place to address benzodiazepine use, both licit and illicit. There are still a few OTPs who approve benzodiazepines to be prescribed for methadone or buprenorphine patients, but I think they are in the minority. Most opioid treatment program physicians feel that besides the dangers of sedation and overdose, there are few medical indications for long-term (more than three months) benzodiazepine prescriptions, and much better long-term treatments for anxiety disorders.

An article In the April 16th, 2016 issue of the American Journal of Public Health underlined how important it is to evaluate benzodiazepine prescribing in the U.S., particularly when prescribed along with opioids. [1]

The authors begin the article by stating that benzodiazepines were found to be involved in nearly a third of opioid overdose deaths in 2013. The authors wished to investigate nation trends in benzodiazepine prescribing and in fatal overdoses involving benzodiazepines.

The authors found the percentage of U.S. adults filling benzodiazepine prescriptions increased significantly over past years. They also found that among people who filled benzodiazepine prescriptions, the amount, defined as lorazepam equivalent doses, also increased significantly. Simultaneously, overdose deaths rates involving benzodiazepines rose nearly four-fold, though deaths appear to have plateaued since 2010.

Another study, this time in Canada, evaluated the risk of death in polysubstance users. In a prospective cohort study of IV drug users, done from 1996 through 2013, benzodiazepine use was more strongly associated with death than any other substance of abuse. [2

Many patients ask why they can’t take benzodiazepines while on methadone or buprenorphine. I tell them I’m mainly worried about the increased risk for overdose death, but I also tell them benzodiazepines are over-prescribed. Prescribing information suggests benzodiazepines are most beneficial when prescribed for no more than three or four weeks. Long-term prescribing of benzodiazepines is generally discouraged, due to serious side effects seen even in patients with no substance use disorders.

Benzodiazepines are associated with increased risk of auto accidents, increased risk of completed suicide, worsening of mood disorders like depression, increased risk of drug-induced dementia, and increased risk of daytime fatigue. Benzodiazepines are also associated with increased risk of cancer, falls, and pneumonia.

Although an association of benzodiazepines with these conditions doesn’t necessarily mean benzodiazepines cause these conditions, it’s a good reason to be conservative when prescribing benzodiazepines and other sedatives, pending further studies.

Sedative medications including benzos can make undiagnosed sleep apnea worse, even to the point of causing death. Obesity increases the risk of sleep apnea, and with more adults becoming obese, the risks of benzodiazepines in such patients may be overlooked.

As for my patients, many of whom are prescribed methadone or buprenorphine, the risk of drug interaction and overdose with the hypnotics usually outweighs all of the benefits, and I recommend that patients do not mix these two types of medications.

  1. Bachhuber et. al., “Increasing Benzodiazepine Prescription and Overdose Mortality in the Unites States, 1996-2013,” American Journal of Public Health, April 16, 2016.
  2. Walton et. al., “The Impact of Benzodiazepine Use on Mortality Among Polysubstance Users in Vancouver, Canada,” Public Health Rep., 2016 May-June;13(3)491-9.
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Information from the ASAM Conference: the CDC

At the recent ASAM conference, Dr. Ileana Arias, Deputy Director for the Centers for Disease Control and Prevention, spoke at a plenary session, explaining the public health impact of our epidemic of prescription drug abuse and addiction. She did a great job explaining how bad the problem of opioid addiction has become in the U.S. She also had some great slides. The above slide shows how by 2008, poisonings overtook motor vehicle accidents as the number one cause of death in the U.S. Overwhelmingly, the poisonings were drugs, and the vast majority of these drug overdose deaths involved opioids. Dr. Arias explained the ice berg phenomenon, where for each person who dies from opioid overdose death, an estimated 118 are estimated to meet the diagnosis for opioid abuse and dependency. She presented information showing that the amount of prescription opioids sold quadrupled between 1999 and 2010.

Dr. Arias spoke at our conference to encourage us and to let us know the CDC was committed to help solve our nation’s prescription opioid addiction problem.

She outlined some of the measures the CDC is taking to help prevent opioid addiction and overdose deaths.  She explained the new lock-in programs now being used by some insurance companies, where the patient can have only one doctor and one pharmacy to prescribe and fill medications. The CDC is advocating for all states to have prescription monitoring programs, and for those state programs to be linked, so that a doctor can access medications filled in other states.

Dr. Arias mentioned the progress being made in Florida, where pill mills are being shut down. Unfortunately, some pill mills have moved to other states like Georgia, Texas, Louisiana, Ohio, and – my favorote state to criticize – Tennessee.

She also spoke of the success of medication take-back days, where people drop off old medication for appropriate disposal so that it doesn’t fall into the wrong hands, and she described many other actions the CDC has started.

This was all great information, familiar to those of us treating opioid addiction over the past five to ten years. I’m grateful the CDC has joined the effort to quelch this problem. Their resources and experience can help a great deal. I just wish all doctors in the country could hear her message.

The addiction medicine doctors had a chance to make comments and further suggestions to the CDC through Dr. Arias, and I was pleased to see how carefully she listened.

One of the suggestions I liked the best addressed the expense of maintaining state prescriptoin monitoring programs. Apparently these can cost around a million dollars a year to administer. One doctor said why not have the pharmaceutical companies that make and sell controlled substances pay or help pay for the monitoring programs? These companies are the main entities that have benefitted from the sales and diversion of their products; why not ask them to bear at least some of the cost for detecting the problems they cause? Genius, though it would be hard to mandate the pharmaceutical companies to do this.

One doctor suggested that law enforcement personnel be educated about the types of treatment available to opioid addicts, so they can stop being barriers toward effective treatments, namely medication-assisted treatments using buprenorphine and methadone.

Another doctor suggested the CDC promote the naloxone programs that provide kits to reverse fatal opioid overdoses. Why not help fund these projects and/or help create more? The Harm Reduction Coalition estimates there are around 155 naloxone programs in the U.S. Some are government-funded and some are privately funded, but around 10,000 fatal opioid overdoses have been reversed. Like Project Lazarus in North Carolina, many of these programs started at a grass roots level because citizens got involved.

Another doctor made the extremely common sense suggestion that the best way to allow more patients into suboxone treatment would be to allow doctors to treat more than one hundred patients at a time. At present, suboxone doctors are allowed to have no more than thirty patients on buprenorphine in their first year prescribing, and no more than one hundred after the first year. This would cost next to nothing for the government to implement, and expand treament dramatically.

One of our past ASAM presidents endorsed mandatory physician education as a requirement for maintaining medical license.

One person compared the prescription opioid addiction to HIV infection in past years, and commended the CDC on its past efforts to reduce the stigma associated with having HIV. This person asked the CDC to make public service announcements to help reduce the stigma of addiction, and encourge people to get treatment.

Another doctor asked the CDC to produce public service announcements telling people to lock up their medications, to prevent medication diversion to a teen or other person for whom it was not prescribed. This doctor also said that patients need to know that not all pain conditions require prescription opioids. He recommended telling the general public the true risks of opioid addiction, which have been downplayed. In the past, pain medicine experts underestimated the incidence of addiction in patients prescribe opioids for chronic pain for more than three months.

The CDC representative, Dr. Arias, confirmed that the CDC already has plans to make PSAs about pain pills and pain pill addiction, much like their present (and very successful) anti-smoking television PSAs.

All great information, and now let’s get the word out to all physicians, and the public too.