A Pained Life: Who Benefits From the Opioid Crisis?

By Carol Levy, PNN Columnist

For the first time in almost 40 years, I have to fight to get my codeine prescription filled.

I understand intellectually what so many pain patients have said about the frustration, upset and upheaval they experience when a pharmacist refuses to fill their prescription or insurance refuses to pay for it. Or harder still, what they go through having their opioid medications cut down or stopped completely.

But I did not understand the emotional side of it until it happened to me.

The insurance company refused to pay for my codeine prescription. They had no problem filling it for the last many, many years but suddenly they need "authorization" from the doctor. How does that make sense? Writing the prescription was authorizing. Why do they need to add a second permission?

It is now over three weeks. The pharmacist tells me they have contacted the doctor's office three times: "You need to call them and find out why they haven't responded."

When I call the office, they tell me the pharmacy never sent over the forms they need.

So I call the pharmacy back. They recite a fax number for the doctor’s office. It is not the right number. I give them the number the doctor's office just gave me. “We'll try it again right now,” she says.

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I keep my fingers crossed and hope I don't run out of pills before it is resolved — if it is resolved.

The pharmacy clerk and I talked the day the prescription was refused by the insurance company. I was venting my frustration over not being able to get the prescription filled, especially because it is the same prescription I have had for years, one that was always covered by my insurance.

To my surprise she says: "It is not just narcotics. Many insurance companies are refusing to cover or making unwarranted demands, requiring many more hoops to jump through. They have refused to cover certain creams and hormones, other prescriptions, non-narcotics that are routinely given and, until now, paid for by the insurance companies."

This is appalling. And makes no sense.  

But then I start thinking about it and was struck by a thought: Yes, there is an opioid crisis. And we’ve all heard the reasons they blamed patients for the “crisis.”  But I think there may be another factor at play: the profit margin.

After all, if we pay insurance premiums but they refuse to pay for our medication -- forcing some folks to pay cash rather than wait for all the rigamarole to be completed -- then the insurance company comes out way ahead. They get our monthly fees and work to make sure we get as little as possible in return. 

I hope I am merely being paranoid. But somehow, I doubt it.

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Carol Jay Levy has lived with trigeminal neuralgia, a chronic facial pain disorder, for over 30 years. She is the author of “A Pained Life, A Chronic Pain Journey.” 

Carol is the moderator of the Facebook support group “Women in Pain Awareness.” Her blog “The Pained Life” can be found here.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represent the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

FDA: Opioid Cold Meds Too Risky for Kids

By Pat Anson, Editor

The Food and Drug Administration has ordered stronger warning labels for cough and cold medications containing opioids and said they should no longer be prescribed to patients younger than 18. The agency also signaled it that it could enact new limits on the dose and duration of other types of opioid prescriptions.

“Given the epidemic of opioid addiction, we’re concerned about unnecessary exposure to opioids, especially in young children. We know that any exposure to opioid drugs can lead to future addiction,” said FDA Commissioner Scott Gottlieb, MD. “It’s become clear that the use of prescription, opioid-containing medicines to treat cough and cold in children comes with serious risks that don’t justify their use in this vulnerable population.”

The FDA action involves nine different types of cough and cold medicines, four of which contain codeine and five that have hydrocodone. The brand names include Tuxarin ER, Tuzistra XR, Triacin C, FlowTuss and Zutripro. Several of the medications also come in generic form.

The FDA said it conducted an extensive review of the products and convened a panel of pediatric experts, who said the risk of misuse, abuse and addiction outweighed the benefits in patients younger than 18.

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“These products will no longer be indicated for use in children, and their use in this age group is not recommended.  Health care professionals should reassure parents that cough due to a cold or upper respiratory infection is self-limited and generally does not need to be treated.  For those children in whom cough treatment is necessary, alternative medicines are available,” the FDA said in a statement.

The agency also ordered stronger “Black Box” warning labels on opioid cough and cold medicines to make them more consistent with safety warnings that come with opioid pain medications.

‘Too Many People Prescribed Opioids’

The FDA this week also released its 2018 Strategic Policy Roadmap, which outlines four priority areas in the year ahead.

The agency's first goal is to reduce the abuse of opioid medication. The FDA said opioid addiction and overdoses were claiming lives at a “staggering rate” of 91 deaths every day – although it failed to point out that most of those deaths involve illegal opioids such as heroin and illicit fentanyl, not prescription pain medication. Also unmentioned in the “roadmap” is that opioid prescriptions have been declining since 2010.

“Too many people are being inappropriately prescribed opioid drugs. When these prescriptions are written, they are often for long durations of use that create too much opportunity for addiction to develop,” the FDA said.

“We need to take steps to reduce exposure to opioid drugs by helping to make sure that patients are prescribed these drugs only when properly indicated, and that when prescriptions are written, they are for dosages and durations of use that comport closely with the purpose of the prescription.” 

Several states have already enacted limits on opioid prescriptions for acute, short term pain. Minnesota, for example, recently adopted strict new guidelines that limit the initial supply of opioids for acute pain to just three days. 

FDA Bans Use of Codeine and Tramadol in Children

By Pat Anson, Editor

The U.S. Food and Drug Administration is tightening restrictions on the use of codeine and tramadol in young children.

The agency says the opioid medications carry "serious risks" for children under the age of 12, including slowed or difficult breathing and possibly even death. The FDA is also recommending against the use of codeine and tramadol by breastfeeding mothers due to possible harm to their infants.

Codeine is approved to treat mild pain and cough, while tramadol is used to treat moderate pain. Codeine is usually combined with other medicines, such as acetaminophen, in prescription pain medication, as well as in some over-the-counter (OTC) cough and cold remedies. The FDA action only applies to prescription codeine.

"We know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize these medicines much faster than usual, casing dangerously high levels of active drug in their bodies," said Doug Throckmorton, MD, deputy director for regulatory programs, at the FDA Center for Drug Evaluation and Research.

"This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk."

In a review of adverse event reports from 1969 to 2015, the FDA said it identified 64 cases of serious breathing problems, including 24 deaths, with codeine-containing medicines in children younger than 18. The agency also identified nine cases of serious breathing problems, including three deaths, with the use of tramadol by children.

The majority of serious side effects with both codeine and tramadol occurred in children younger than 12, and some cases occurred after a single dose.

The FDA is requiring drug makers to add a tougher warning to the labels of codeine and tramadol products, alerting healthcare providers and parents that codeine should not be used to treat pain or cough and tramadol should not be used to treat pain in children younger than 12.

The new labeling also cautions against their use in adolescents between 12 and 18 who are obese or have conditions such as obstructive sleep apnea or severe lung disease. Breastfeeding mothers will also be warned not to use the medications.

The FDA said it is considering additional regulatory action for the OTC codeine products that are available in some states. It is also considering an FDA Advisory Committee meeting to discuss the role of prescription opioid cough-and-cold medicines, including codeine, to treat cough in children.

The agency did not recommend or suggest any alternatives to codeine and tramadol to treat childrens' cough or pain. OTC medicines such as acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs) also have risks and side effects.

"We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe," said Throckmorton.

In 2015, the FDA approved the use of OxyContin in children ages 11 to 16  who are in severe pain, a move widely panned by addiction treatment activists who claimed kids would get easily hooked on the painkiller.