Hydrocodone Rescheduling Fueled Online Drug Sales

By Pat Anson, Editor

Hydrocodone was once the most widely prescribed and one of the most abused drugs in the United States. Over 135 million prescriptions were filled in 2012 for hydrocodone combination products such as Vicodin, Lortab and Norco.

Then in 2014 the Drug Enforcement Administration rescheduled the opioid painkiller from a Schedule III controlled substance to the more restrictive category of Schedule II. The move was intended to reduce the prescribing of hydrocodone – and it quickly had the desired effect.  By 2017, only 81 million prescriptions for hydrocodone were filled.  

But while legal prescriptions for hydrocodone have gone down, the DEA’s 2014 rescheduling may have fueled a surge in illegal online sales of hydrocodone and other opioids, according to a new study in the British Medical Journal.    

“The scheduling change in hydrocodone combination products coincided with a statistically significant, sustained increase in illicit trading of opioids through online US cryptomarkets. These changes were not observed for other drug groups or in other countries,” wrote lead author Jack Cunliffe, PhD, a lecturer in data analysis and criminology at the University of Kent.

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Cunliffe and his colleagues studied these online cryptomarkets – also known as the “dark web” – by using web crawling software that scans the internet looking for websites dedicated to online sales of illicit drugs. From October 2013 to July 2016, they found that sales of prescription opioids on the dark web nearly doubled, from 6.7% to 13.7% of all online drug sales.  

“Our results are consistent with the possibility that the schedule change might have directly contributed to the changes we observed in the supply of illicit opioids,” said Cunliffe. “One explanation is that cryptomarket vendors perceived an increase in demand and responded by placing more listings for prescription opioids and thereby increasing supply.”

‘Iron Law of Prohibition’

The increase in supply and demand wasn’t just for hydrocodone. The researchers also noted a growing number of online listings for more potent opioids, such as oxycodone and fentanyl. They attribute that to the “iron law of prohibition” – banning or reducing the supply of one drug encourages users to seek more potent drugs from new sources.

“We found that users were first buying oxycodone followed by fentanyl. Drug users adapt to their changing environment and are able to source drugs from new distribution channels if needed, even if that means by illegal means. In a context of high demand, supply side interventions are therefore likely to push opioid users towards illicit supplies, which may increase the harms associated with their drug use and make monitoring more difficult,” Cunliffe wrote.

As PNN has reported, business is booming for illegal online pharmacies. As many as 35,000 are in operation worldwide and about 20 new ones are launched every day. About half are selling counterfeit painkillers and other medications. Overdoses involving fentanyl and other synthetic opioids – most of them purchased on the black market – have also increased and now outnumber those linked to prescription opioids.

"The study’s findings are troubling but not surprising. As you’ve well reported, there are often unexpected and negative externalities resulting from well-intended anti-addiction interventions," Libby Baney, Principal, Faegre Baker Daniels Consulting and senior advisor to Alliance for Safe Online Pharmacies said in an email to PNN. 

"What’s worse still, when buying medicine online - whether from dark or surface web sellers - it is virtually impossible for the consumer to know if the product is what it claims (in this case, an opioid like oxycodone) or is a dangerous counterfeit laced with a deadly dose of elephant tranquilizer or poison. As too many victims have shown, even one pill can kill."

A recent study at the University of Texas Medical Branch also found an association between hydrocodone's rescheduling and increased opioid abuse.  Researchers found that hydrocodone prescriptions for Medicare patients declined after rescheduling, but opioid-related hospitalizations increased significantly for elderly patients who did not have a prescription for opioids.

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. 

Getting off Painkillers With Lidocaine Infusions

By Crystal Lindell, Columnist

I keep telling myself I’ll write about my weekly lidocaine infusions when I finally have everything figured out. 

I just need to figure out how to pay the $80-a-week co-pay, figure out who can drive me two hours each way to the hospital, and figure out how to manage the extreme fatigue I endure for at least 24 hours after each infusion. And I need to figure out how I can possibly do this every single Friday for the rest of my life.  

And then, once I figure everything out, I can tell you guys how I solved all of it and you will think I’m awesome. 

But I can’t freaking figure anything out.

I started the infusions this summer at the suggestion of my pain management doctor. I did a trial run, which was completely insane, but actually worked to cure my chronic pain for six days. And then I decided to continue the treatments weekly, because that’s how long it lasts for me. 

The first infusion was intense. Symptoms included: randomly crying and laughing because I lost control of my emotions, my lips going numb, extreme fatigue, losing coordination in my legs, nausea, and not being able to make basic life choices afterward — to the extent that I couldn’t even pick out which rice I wanted at Qdoba.  

Thankfully, the symptoms seem to be less intense as you get more of the infusions. I’m still extremely tired after each one though, and unable to drive, and my heart always feels weak. Also, I still can never decide on which rice to get. But I don’t feel like I’ve lost my mind each time. 

Each one takes about two hours at the hospital from start to finish, but that also include a saline flush at the end. I also need a full 24 hours to recover from every single one. And it’s not like an “Oh, I’m so high and this is fun!” 24 hours. It’s more of a hangover/flu/fatigue 24 hours. 

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Also, like I said above, I have an $80 co-pay every week that I cannot afford at all. But actually that’s a great deal because the total bill for each one is about $500. I’m blessed to work full-time from home and have great insurance that mostly covers it. As far as chronic pain patients go, I’m probably in the top 1 percent. But it’s still too much for me. 

Honestly though, the hardest part has been finding rides. It’s a two-hour drive each way I’m and way too out of it afterward to drive myself. I have not been able to find anyone locally who does the infusions because the treatment is relatively new for chronic pain. And my town is so rural that we don’t even have Uber. If I ever have to stop the infusions, it will probably be because of that.

At this point you might be asking, “Crystal, this sounds like A LOT! Why are you even doing this? Why not just stick with hydrocodone?”

Because it freaking works. Really freaking well. And I kind of hate that it works because it is a traumatic experience every time, and I literally lose a day of my life every week and have no money. 

But dang if I haven’t had the best summer of my (post-pain) life this year. I’ve lost 33 pounds. I’ve been walking about six miles a day, six days a week. And while I still have some flares, I have entire pain-free days with NO hydrocodone or any other types of pain meds. And that means I get to live my life AND have complete mental clarity. In short, my quality of life has improved dramatically. 

It’s been miraculous. And thus, I am highly motivated to continue this treatment. 

Since starting the infusions, I have discovered a few helpful things. For example, drinking a full-sugar Gatorade and eating a Snicker’s bar right before the infusion seems to help with the fatigue. And doing a longer saline flush also helps with the after-effects. 

Also, the less I do physically the day of the infusion, the easier it is for me to recover afterward. And it’s important to wear extremely comfortable clothes and a large sweater regardless of the weather because the medication messes with your body temperature. 

I have not figured out the transportation yet, obviously. I actually called my insurance company today to ask if they had any suggestions, and they literally said, “Have you tried Googling it?” 

Yes. I have tried Googling it. 

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I also called the hospital and they told me the only transportation they do is with an ambulance. Cool. Thanks. 

I’ve called a million local pain doctors and infusion centers and had appointments with a handful of them trying to find a local provider. One pain doctor said he could do them for me once a month, but that’s not enough and I’d just end up going on and off hydrocodone all the time. 

Every time I talk to a new pain doctor I beg them to start or expand this treatment so that others with chronic pain can get the same relief I do. 

With all the anti-opioid hysteria you would think doctors would be begging patients to try treatments like this. But alas, they are still sticking to the classic list of things that don’t really work — mindfulness, Cymbalta, nerve blocks, epidurals, and my personal favorite: “You should be taking fewer meds but I have no alternatives to offer.”

In contrast, research is showing that lidocaine infusions can be very effective. In a study recently published in Pain Medicine, they were shown to provide long-lasting and adequate analgesia in 41 percent of patients with chronic pain, most of whom had neuropathic pain. 

I am holding out hope that treatments like this will become more common and less expensive. But there’s another part of me that does worry that pumping my body full of an intense drug every week could have long-term effects that haven’t been discovered yet. 

In the end of course, treatment decisions like this have to be made on an individual level. Only you and your doctor can decide if getting drugged every week is worth it for six pain-free days.

For me though, it definitely is. 

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Crystal Lindell is a journalist who lives in Illinois. She loves Taco Bell, watching "Burn Notice" episodes on Netflix and Snicker's Bites. She has had intercostal neuralgia since February 2013.

Crystal writes about it on her blog, “The Only Certainty is Bad Grammar.”

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.

Significant Decline in U.S. Opioid Prescribing

By Pat Anson, Editor

Nearly 17 million fewer prescriptions were filled for opioid pain medications in the U.S. in 2015, driven largely by a significant decline in prescriptions for hydrocodone, according to a new report by IMS Health.

The report adds further evidence that the so-called “epidemic” of opioid abuse and addiction is increasingly being fueled by illegal opioids such as heroin and illicit fentanyl, not by prescription pain medication intended for patients.

Hydrocodone was reclassified by the Drug Enforcement Administration as a Schedule II controlled substance in October, 2014 – making 2015 the first full year that more restrictive prescribing rules for the pain medication were in effect. But hydrocodone prescriptions were falling even before the rescheduling. They peaked in 2011 at 137 million and fell to 97 million in 2015, a 30% decline.

Hydrocodone is typically combined with acetaminophen to make Vicodin, Lortab, Lorcet, Norco, and other brand name hydrocodone products. The rescheduling of hydrocodone limits pain patients to an initial 90-day supply and then requires them to see a doctor for a new 30-day prescription each time they need a refill.

“It is not surprising that we have seen a dramatic drop in hydrocodone prescribing,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and vice president of scientific affairs at PRA Health Sciences.Patients are being told they are not going to be prescribed opioids in general by many physicians. Since hydrocodone has been the most prescribed, it is the most affected. Schedule II opioids are more of a hassle so prescribers shun away from them.

“What is most striking is that the number of unintentional overdoses are still climbing despite fewer pills being prescribed.  Obviously this is a reflection that the goal to reduce harm from reduced prescribing is not working.  We have to wait to see if that trend continues.”

The Centers for Disease Control and Prevention recently adopted new guidelines that discourage primary care physicians from prescribing opioids for chronic pain. The agency also reported that 28,647 Americans died from opioid overdoses in 2014 and attributed about 19,000 of those deaths to prescription opioids. However, the CDC admits the data is flawed. Some overdoses may have been counted twice and some deaths blamed on prescription medications may have been caused by illegal opioids.

Hydrocodone Falls to #3

For several years hydrocodone was the #1 most widely filled prescription in the U.S. It now ranks third behind levothyroxine (Synthroid), which is used to treat thyroid deficiency, and lisinopril (Zestril), which is used to treat high blood pressure.

“Over 16.6 million fewer prescriptions were filled for narcotic analgesics, driven mainly by a sharp decrease in prescriptions for acetaminophen-hydrocodone, whereas prescriptions for oxymorphone, another controlled substance, increased 5.3%,” the IMS report said.

Oxymorphone is the generic name for Opana, a semisynthetic opioid that is also abused by drug addicts.  

The IMS report also found an increasing number of prescriptions being written for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 57 million prescriptions were written for gabapentin in 2015, a 42% increase since 2011.

After steadily increasing for several years, the number of prescriptions for tramadol appears to have leveled off, according to IMS. Last year about 43 million prescriptions were written for tramadol, a weaker acting opioid also used to treat chronic pain.

Overall spending in prescription drugs reached $310 billion in 2015, according to IMS, a 8.5% increase largely fueled by expensive new brand name and specialty drugs.