Should Opioids Be Sold Over-The-Counter?

By Crystal Lindell, PNN Columnist

There are currently two opioid crises going on. Too many people are dying of overdoses and too many chronic pain patients are being denied the medications they need to function. 

I have a solution for both — make hydrocodone and other opioid medications available over-the-counter without a prescription.

Yes, I know the idea of adding more opioids to the overdose crisis sounds counter-intuitive. But hear me out, because this is the solution that both pain patients and illegal drug users should be fighting for.

In short, it would make it much easier for pain patients to treat their symptoms, while also providing a safe supply for those dealing with addiction.

But isn’t hydrocodone dangerous and addictive? Well yes, it is. But so is alcohol and so is tobacco. So let’s compare.

According to the CDC, cigarette smoking is responsible for more than 480,000 deaths annually in the United States, including more than 41,000 deaths resulting from secondhand smoke. As for alcohol, the CDC says it causes about 88,000 deaths per year.

How does that compare to hydrocodone? According to the DEA, of the 1,826 hydrocodone exposures reported to poison control centers in 2016, only two resulted in deaths. That’s right, two.

Another report by the CDC estimates there were 3,199 overdose deaths involving hydrocodone in 2016. But many of those deaths involved other drugs and we don’t know whether the pills were prescribed or not.  

Both estimates pale in comparison to the number of people dying from alcohol and tobacco.  

Yes, the number of deaths might go up if hydrocodone is sold over-the-counter. However, if you factor in how many lives we could save, we would come out far ahead.  

And you know what? The acetaminophen found in hydrocodone products like Vicodin could cause an overdose before the hydrocodone does.  

“The scientifically and medically accepted amount to produce a fatal overdose of hydrocodone is 90 mg. Thus, 18 (5mg) Vicodin pills can lead to an overdose,” explains an addiction recovery website.

“This already puts an individual far above the liver’s tolerance of acetaminophen at 5,400 mg, meaning an individual would experience two separate overdoses if they managed to consume this many pills.”  

Although opioid tolerance can greatly impact how much would be needed to cause an overdose, the fact remains that the acetaminophen might actually be the most dangerous part of the medication. The solution for that? Sell hydrocodone over-the-counter without the acetaminophen.   

Patients Turning to Street Drugs

How do we save lives by giving people more access to drugs? To answer that you have to understand how people are actually dying as a result of the opioid crisis.  

Here’s a hint: it’s not usually caused by hydrocodone. 

First, the misguided fight against the opioid epidemic has led to many doctors refusing to prescribe any opioid medications. Unfortunately, taking medications away from people who need them to function doesn’t somehow result in them magically fighting through the pain. Instead, it just pushes them to take more acetaminophen or some dangerous illegal drug that we’re trying to curb.  

When that happens, people are left to find illegal alternatives — and what they discover is that heroin and illicit fentanyl are actually cheaper than hydrocodone sold on the black market.  

Our system of prohibition is forcing pain patients and illegal drug users to turn to street drugs. We are doing something wrong when it’s easier and cheaper to take heroin or fentanyl than it is to take hydrocodone.  

Making hydrocodone over-the-counter would create a safe supply and would undoubtedly save a lot of lives. It would also have the added benefit of saving patients a lot of money on doctor visits.   

We are at a point when the war on drugs is doing more harm than good for everyone. It’s time for us to consider more radical solutions to these issues. And making hydrocodone available over-the-counter should be at the top of that list.  

Decriminalize Opioids

Thankfully, the country seems to be moving in this direction somewhat. Cannabis is being legalized recreationally, as everyone realizes how pointless marijuana prohibition is. And just this month, Democratic Presidential Candidate Andrew Yang announced his proposal to decriminalize opioids.  

“We need to decriminalize the possession and use of small amounts of opioids,” Yang says on his website. “Other countries, such as Portugal, have done so, and have seen treatment go up and drug deaths and addiction go down. When caught with a small quantity of any opioid, our justice system should err on the side of providing treatment.” 

No, Yang is not likely to win. And no, his proposal doesn’t go far enough. But it’s a start — and will hopefully start to shift the conversation.  

Is there anything we can do as patients to help this cause? Honestly, I believe there is. I constantly see pain patients and advocacy groups post disparaging comments about people who use drugs illegally. I understand why it’s easy to blame them for the crackdown on opioids. But they aren’t the ones who put the new regulations in place — for that you can blame the CDC, DEA and FDA.  

Instead of fighting illegal users, we should be trying to work with them as part of a common cause — decriminalization and legalization. It’s a fight we can all get behind.  We can post about that stance online and we can tell our loved ones why it’s important to us. We can also tell our elected officials. You can reach your federal representatives in the House here, and in the Senate here.

If we all take up this cause together, there is real hope we can make progress.  

Crystal Lindell is a journalist who lives in Illinois. She eats too much Taco Bell, drinks too much espresso, and spends too much time looking for the perfect pink lipstick. She has hypermobile Ehlers Danlos syndrome. 

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.

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.

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.

Opioid Painkillers Top Selling Drug in 10 States

By Pat Anson, Editor

If you live in Oklahoma, the drug you’re most likely to be prescribed is the opioid painkiller Vicodin -- or some other combination of hydrocodone and acetaminophen.

In Texas, the #1 drug is Synthroid (levothyroxine) – which is used to treat thyroid deficiencies.

In California, its Lipitor (atorvastatin) – a statin used to treat high cholesterol.

And Tennessee has the unique distinction of being the only state in the country where the addiction treatment drug Suboxone (buprenorphine/naloxone) is the most prescribed drug.

These findings are part of an interesting study by GoodRx, an online discount drug company, on prescribing trends in all 50 states. GoodRx looked at pharmacy and insurance data from around the country – not just its own customers -- from March 2017 to February 2018.

It then developed a map to show how prescription trends can vary by region and by state.

Levothyroxine (Synthroid) is easily the top selling drug in the country. It’s #1 in 26 states (AR, AZ, CO, CT, FL, IA, KS, KY, LA, ME, MI, MN, MT, ND, NJ, NV, OR, PA, SD, TX, UT, VT, WA, WI, WV, WY).

Hydrocodone (Vicodin, Norco, Lortab) is #1 in 10 states (AK, AL, GA, ID, IL, IN, MS, NC, NE, OK), mainly in the South and Midwest. As recently as 2012, hydrocodone was the most widely prescribed medication in the country. Since then, hydrocodone prescriptions have fallen by over a third and it now ranks 4th nationwide.

Atorvastatin (Lipitor) is #1 in 5 states (CA, HI, MD, MO, VA) and so is lisinopril (MA, NH, NM, OH, RI), a medication used to treat high blood pressure.

There are a few outliers. New York, for example, is the only state that’s #1 in amlodipine (Norvasc), a blood pressure medication, and Delaware and South Carolina are the only states where the leading prescription drug is Adderall, a medication used to treat Attention Deficit Hyperactivity Disorder (ADHD).   

That brings us to Tennessee, one of the states hardest hit by the opioid crisis. In 2012, doctors wrote 1.4 opioid prescriptions for every citizen in Tennessee, the second highest rate in the country. The state then moved aggressively to shutdown pill mills and expand access to addiction treatment -- which explains why Tennessee is #1 for Suboxone.

Prescriptions for opioid pain medication have dropped by 12% in Tennessee since their peak, but overdose deaths and opioid-related hospitalizations continue to climb, due largely to heroin and illicit fentanyl.  No other state even comes close to Tennessee in per capita prescriptions for Suboxone.  Addiction treatment has become such a growth industry that Tennessee has adopted measures to rein in the overprescribing of Suboxone.

Hydrocodone Prescriptions Continue Falling

By Pat Anson, Editor

For the fifth year in a row, fewer prescriptions for the opioid painkiller hydrocodone were dispensed in the U.S. in 2016, according to a new report by the QuintilesIMS Institute, which tracks prescription drug use and spending.

The report adds further evidence that the nation’s overdose epidemic is being fueled by illegal opioids such as heroin and illicit fentanyl, not prescription painkillers.

About 7 million fewer prescriptions were filled last year for hydrocodone, which is usually combined with acetaminophen in Vicodin, Lortab, Lorcet, Norco, and other hydrocodone combination products.

As recently as 2012, hydrocodone was the #1 most widely dispensed medication in the nation, with 136 million prescriptions filled. Since then, hydrocodone prescriptions have fallen by over a third, to 90 million prescriptions.

Hydrocodone now ranks fourth, behind the thyroid drug levothyroxine (Synthroid), the blood pressure medication lisinopril (Zestril), and the statin atorvastatin (Lipitor).

Hydrocodone was reclassified by the DEA as a Schedule II controlled substance in 2014, making it harder to obtain. Opioid guidelines released last year by the CDC also probably had an impact, although hydrocodone prescriptions were falling long before the CDC and DEA acted.

HYDROCODONE PRESCRIPTIONS IN U.S. (MILLIONS)

Source: QuintilesIMS Institute

Prescriptions for hydrocodone and other opioids are likely to fall even further in 2017, because the DEA plans to reduce the supply of almost every Schedule II opioid pain medication by 25 percent or more "to prevent diversion." The 2017 quota for hydrocodone is being reduced by a third, to 58.4 million prescriptions, which the DEA considers an adequate supply.

Overall, QuintilesIMS reported 13 million fewer prescriptions for pain medicines in 2016, “as restrictions on prescribing and dispensing become increasingly common and impactful.” The company includes both narcotic and non-narcotic treatments in its pain medicine category.

Over 7 million more prescriptions were written last year for gabapentin (Neurontin), a medication originally developed to treat seizures that is now widely prescribed for neuropathy and other chronic pain conditions.  About 64 million prescriptions were written for gabapentin in 2016, a 49% increase since 2011.

More prescriptions are also being written for ibuprofen, a widely used pain reliever available both by prescription and in over-the-counter drugs. About 44 million prescriptions were filled for ibuprofen in 2016, a 19% increase since 2012.

The shift in prescribing away from opioids is hardly a surprise to pain sufferers. According to a recent survey of over 3,100 patients by PNN and the International Pain Foundation, over 70% said they were no longer prescribed opioids or were getting a lower dose since the CDC guidelines were released. About half of the doctors and pharmacists we surveyed also said they were writing or filling fewer opioid prescriptions, or had stopped them altogether.  

“My doctor cut me off hydrocodone cold turkey last fall leading to an overnight in the hospital emergency room,” a patient with chronic back pain and anxiety told PNN. “For years I have been stable on a mix of hydrocodone and Valium. Last October my doctor said he would only fill one prescription and asked me to make a choice so I stayed with the Valium.”

“With the VA allowing me only 2 hydrocodone per day now, I get very little exercise and stay in bed a lot,” a 70-year old veteran wrote. “My quality of life has gone down considerably. Before the changes, I stayed quite active taking 4 hydrocodone a day.”

“I had an interventional pain management doctor scream at me that the guidelines were mandatory and he refused to write for any type of opioids even though I've been on the same level of hydrocodone for several years,” another patient said.

“I took hydrocodone pain medicine for 25 years as the doctor proscribed. Never called in for more, now I'm having to go a pain doctor and get steroid shots every 3 months,” wrote a patient with lives with chronic back pain.

Overall spending on prescription drugs in the U.S. reached $323 billion in 2016, a 4.8% increase that is less than half the rate of the previous two years. The QuintilesIMS report blames the slowdown in growth on increased competition among drug makers and efforts to limit price increases.

“New medicines introduced in the past two years continue to drive at least half of the total growth as clusters of innovative treatments for cancer, autoimmune diseases, HIV, multiple sclerosis, and diabetes become accessible to patients,” said Murray Aitken, Senior Vice President and Executive Director, QuintilesIMS Institute.

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.

Major Decline in Hydrocodone Prescribing

By Pat Anson, Editor

Prescriptions for Vicodin and other hydrocodone products declined dramatically in the United States after the opioid pain medication was rescheduled by the Drug Enforcement Administration to make it harder to obtain. But there may have been unintended consequences for cancer patients, according to a new study published in JAMA Internal Medicine.

In October 2014 the DEA rescheduled hydrocodone from a Schedule III controlled substance to a more restrictive Schedule II medication because of its “high abuse potential.”

The rescheduling limits patients taking Vicodin, Lortab, Lorcet and other hydrocodone combination products to an initial 90-day supply and requires them to see a doctor for a new prescription each time they need a refill.

In the first year after rescheduling, the number of hydrocodone prescriptions in the U.S. plunged by 22 percent, from nearly 120 million to 93.5 million.

“Dispensed hydrocodone combination product prescriptions decreased substantially after rescheduling by the US Drug Enforcement Administration, with 26.3 million fewer hydrocodone combination product prescriptions and 1.1 billion fewer hydrocodone combination product tablets dispensed in the year after rescheduling,” wrote lead author Christopher Jones, PharmD, U.S. Department of Health and Human Services. “Most of this decline was due to the elimination of hydrocodone combination product prescription refills, consistent with the prohibition on prescription refills for schedule II medications.”

The decline in prescribing was seen in almost all healthcare specialties, including primary care, surgery, dentistry, emergency medicine and oncology. Nearly 187,000 fewer prescriptions for hydrocodone were written for cancer patients in the first year after rescheduling, a decline of nearly 21 percent.

“It appears that up-scheduling of hydrocodone accomplished the goal of the DEA,” said Lynn Webster, MD, past president of the American Academy of Pain Medicine and author of The Painful Truth. “The more important question is what impact this has had on the rate of abuse and patient access to the medication. It may be too early to know whether rescheduling has affected the rate of people abusing opioids or if it just forced some abusers to seek alternatives like heroin.

“The JAMA report suggests that even cancer patients found it more difficult to obtain hydrocodone. That should be alarming to the medical community and illustrate to policy makers and law enforcement there are consequences to every action and in this case some people have been subjected to more cost, inconveniences and abandonment without any data to suggest an improvement in abuse or overdoses.”

Interestingly, the number of hydrocodone prescriptions written by pain management specialists after rescheduling increased by 7 percent. And there was a modest 4.9% increase in the number of prescriptions for opioids other than hydrocodone, as some patients apparently switched to opioids that were easier to obtain.

"The uptick from pain specialists most likely reflects a transfer of narcotic provision from non-specialists to specialists. That is, a decrease in prescribing from those who have less training in prescribing opioid pain relievers offset to some extent by an increase from those who have more such training," said Stuart Gitlow, MD, Executive Director of the Annenberg Physician Training Program in Addictive Disease and past president of the American Society of Addiction Medicine.

Gitlow believes the large overall decline in hydrocodone prescribing was a sign that many of the refills being ordered before rescheduling "were ultimately determined to be unnecessary."

"This was not meant to address the overall opioid prescribing problem, but was rather filling one hole in the dike," Gitlow wrote in an email to Pain News Network. "There remains much left to do, such as removal of the cap for treatment of opioid use disorders in office settings, and availability of tapering to avoid having patients move to heroin when their supply of prescription narcotics is suddenly cut off."

Hydrocodone was once the most widely prescribed medication in the United States, with over 137 million prescriptions annually. Prescribing of hydrocodone was already in decline before rescheduling, because of growing concern the drug was being abused and diverted.