FDA Warns Drug Distributor

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration has sent a warning letter to a wholesale drug distributor rebuking the company for its handling of several tampering cases involving oxycodone and other medications.

The letter to the CEO of the McKesson Corporation involves incidents in 2016 when pharmacies notified the company about the tampering and theft of medications it had supplied them with.    

In one such case, a Rite Aid pharmacy in Michigan found that the seal to a bottle labeled as containing 100 tablets of oxycodone had been broken. Inside the bottle a pharmacist found 15 tablets of Aleve, a non-steroidal anti-inflammatory pain reliever.  Two other Rite Aid pharmacies also reported to the company that oxycodone bottles had been tampered with. McKesson investigated the reports and determined the tampering and thefts likely occurred while the bottles were in its possession.  

Similar tampering incidents involved drugs used to treat bipolar disorder, high blood pressure and HIV.

According to the FDA, McKesson did little to identify and quarantine other products in its distribution system that also may have been tampered with and failed to warn other pharmacies that illegitimate products were in the supply chain.

"This is simply unacceptable. A distributor’s failure to have systems in place to investigate and quarantine suspect and illegitimate products within their control is a violation of the law," said FDA commissioner Scott Gottlieb, MD, in a statement.

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"But this is even more concerning given that we’re in the midst of a widespread opioid crisis. Opioids that leave the legitimate supply chain could end up being sold illegally, or a patient who was appropriately prescribed these drugs to treat pain may not get the treatment they need or may unknowingly take a medication that’s not meant for them."

The FDA did not say why it waited so long to send the warning letter or notify the public about the 2016 tampering incidents. McKesson is the first company to receive a warning letter under the Drug Supply Chain Security Act (DSCSA), which was enacted by Congress in 2013.

McKesson is one of the largest wholesale drug distributors in the country. It is being sued by dozens of states, cities and counties for its role in the opioid crisis. In 2017, McKesson was fined $150 million for failing to report suspicious orders for oxycodone, hydrocodone and other controlled substances. In 2008, the company agreed to pay $13.25 million in penalties for similar violations.

Memories, Medications and Hospital Horrors

By Tom Parker, Guest Columnist

Some things you never forget. Your mother’s love, your favorite teacher, your first home run (oh, that’s right, I’m 61 and that still hasn’t happened yet), your first date, your first kiss and your wedding.

Christmas to the Parker family is also memorable for many reasons. My delightful wife and I have always sought to make Christmas a precious time for our family. We listen to Christmas music off and on throughout the year, but nonstop in the fall and winter. Bing Crosby and Karen Carpenter mellifluously bless our home with the glorious sounds of Christmastime.

So why do I not remember a season of joy that just ended a month ago?

For several weeks, I had been experiencing pain and an inability to fully empty my bladder. I have quite a few health problems, so I just chalked this up as just another one and pretty much ignored it as it continued to get progressively worse.

My wife and son were on a long trip to take my youngest daughter back to college. I was home alone and finally felt the need to call my doctor about the urinary retention. My doctor’s sagacious nurse urged me to immediately go to the ER, so I called for an ambulance.

I was in St. Peter’s Hospital in Albany for almost a week while an interminable number of tests were conducted to determine what was wrong. I was not allowed any of my normal medications, pain or otherwise, or food or liquids while the initial tests were conducted. Nothing whatsoever passed my lips.

TOM PARKER

TOM PARKER

When my normal medication regimen finally resumed, I found out very quickly that I had to specifically request an oxycodone tablet when meds were dispensed or I wouldn’t get one.

Which leads me to very distinct memories of my roommate for the rest of my stay. A very brawny young man of 30 or so, a massively-muscled professional bodybuilder, was wheeled into the room and into the next bed. He was just out of elective bilateral double knee replacement surgery. Forgive me for listening as his mother and wife conversed waiting for him to come out of anesthesia.

PNN readers are all too acutely aware of how pain medications are no longer properly given for serious conditions -- which would seemingly include bilateral double knee replacement. As my compatriot emerged from anesthesia, it was very audibly obvious that he was quite understandably in unimaginable agony. Multiple nurses and techs rushed in and out, and at one point a resident was summoned as the young man was having difficulty breathing.

There was serious conversation about rushing him back into surgery when I heard a loud thump. My roommate had hit his head against the headboard, knocking himself out. His relatives argued with the nurses and resident about what pain medicines should be administered during his recovery.

We live in an ungodly, strange and insidiously cruel perverse world!  When medical professionals seriously consider Tramadol as the most viable and appropriate medicine at such a time, we have reached a new low standard of medical barbarity in these United States of America.

Paging Dr. Sessions, paging Dr. Sessions….

Yes, Tramadol is a somewhat effective pain reliever for some people. But for an operation as critically complex as bilateral double knee replacement surgery?   It never was effective for me and it engendered extreme vomiting for several days.

The agonized screams of that young man over three days still haunt my sleep today -- hopefully, not again tonight.

All of us are familiar with the 1 to 10 pain scale and how it often seems wholly inadequate for describing the pain that many of us feel every day. When the young fellow awoke from his self-induced head to the headboard knockout, he was asked what his pain level was at that moment. Three numbers unmistakably rang out, loud, clear and true: “555! What the blank do you think?”

His anguish was finally lessened by multiple doses of Dilaudid, both orally and intravenously. He was also administered Celebrex for inflammation, and oxycodone. I was a very personally-interested witness to this for several days.

He and I left the hospital at almost the same time, me to go home with my beloved, and he to a rehabilitation facility nearby. His last pain attestation before leaving was “10 or 12.” I was utterly appalled to hear him say that “I will do it all over again” if he were unable to resume his bodybuilding career after rehabilitation.

Well, I have had my follow-up visit with my GP now. He renewed my oxycodone prescription without even asking me about it. For that, I am eternally grateful to God and to my kindhearted physician. He explained to me that he was very glad that I had listened to his nurse’s urging to go to the ER.

I asked him, “Why are my memories of Christmas just a month ago so very foggy?”

It was then my physician made it very clear to me, for the first time, that I had almost died from blood poisoning and kidney failure.

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Tom Parker was born in beautiful Charleston, South Carolina. He currently lives in the Albany region of frozen upstate New York with his wonderful Vermont wife of 30 years, Kelly Sue. They have four adult children. Tom has multiple spine problems, including severe cervical spinal stenosis, osteoarthritis, and was born with just one kidney.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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

Don’t Take Away Our Medicine

By Lynn Joyce, Guest Columnist

I am a 62-year-old woman who -- aside from my intensely painful back --- enjoyed a full life of work, swimming, going to the gym, outings to various places with my husband and friends, and running my household.

A few years ago, my back pain became so severe I had to move from my primary care doctor to pain management after all the solutions we tried, including physical therapy, various pain treatments, x-rays and MRIs could not diagnose or in the end treat me. I went to a doctor in Sarasota who gave me pain medicine. which helped a little. I also had several procedures under anesthetic, which again did not totally relieve the pain.

I was desperate, as I spent much of the day and night with ice packs on my back to ease the pain. My ordinary life went down the drain, my husband got fed up with me not being able to accompany him and looking after my home went downhill.

I cried as I went to bed early with a sleeping pill to take away the pain -- though this did not always work as the pain woke me up. I tried various types of pain medicine and the one that worked best was oxycodone.

Nearly a year ago my doctors finally found a combination of drugs that made me pain free and able to resume my normal life. I was ecstatic to be able to do all the things I enjoyed again and to be able to run my home and look after my family.

I then had a shock a month ago when my doctor told me that my medicine would have to be reduced. I had two tearful visits to his office, where he told me that starting July 1st I would receive only one oxycodone a day.  

LYNN JOYCE

LYNN JOYCE

My doctor knows that this is not even a therapeutic dose and yet is being forced to break his sacred oath to "First do no harm." After getting my life back, I was so upset that I would have to go back to my previous existence, where every day is full of pain and there is very little joy.

I am not a drug addict. I am a person that needs medication for a condition that curtails my enjoyment of life, just as much as another person who needs a drug to alleviate their condition or keep them alive. My doctor should be allowed and supported in the care of his patients, not vilified by government and media alike.

There are legitimate people who are truly suffering and need the medication that is being taken from them. I am one of these people -- the other side of this so-called crisis – and we are being ignored and used as scapegoats by the government.

I do not understand how such arbitrary, draconian laws can be passed in a modern society. This government’s heavy-handed solution to the "opioid crisis" is targeting the wrong people. We are not the ones selling drugs like fentanyl and heroin, we are just people with an illness. We are not lawbreakers, although some of us may be driven to escape the pain with illegal drugs or, in some tragic cases, suicide.

There are studies that totally refute the reasoning behind these opioid laws and guidelines, doctors who have tried to stop this from happening to their patients, and those who know the science and social reasons that show we are not the cause. We are not out there selling our drugs or "doctor shopping."

I see and read daily about politicians and stores that are jumping onto the false bandwagon to further their own careers and profits. Pharmacies that are too afraid or are taking a false moral stance about the prescriptions they will or won't fill.

There has been mishandling of prescriptions in the past, but systems have been put in place to remedy that. Yet the media screams about this person or that who has overdosed and stores like Walmart that will limit a person’s medication to seven days. I hope there are the few that get opioids for short term use if they need it, but they are not long-term pain sufferers who need their therapeutic doses daily to ameliorate their pain.

I have read that companies are being forced by the DEA to reduce their drug production so much that there are worries about hospitals not having enough to treat patients or with surgeries being delayed.

Those of us that need long term drug treatment are your family member, a friend, or a familiar stranger like the postal worker who you see every day. We are not the archetypal addict that people think of when the words “drug user” comes up. Think of a time in your life when you or someone you care about was in pain and were helped by medication to make it go away.

We have that pain every day and it doesn't go away without our medicine. The government or anyone else in a position of power who keeps on pushing this inhumane agenda should walk in our shoes for a day.

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Lynn Joyce lives in Florida.

Pain News Network invites other readers to share their stories with us. Send them to editor@painnewsnetwork.org.

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

Painkiller Study Conducted at Poorly Rated Hospital

By Pat Anson, Editor

Over-the-counter pain relievers are just as effective as opioid medication in treating short-term acute pain in a hospital emergency room, according to a widely touted study published in the Journal of the American Medical Association (JAMA).

The study was relatively small – only 416 patients participated – and it was conducted at a New York City hospital with a poor history of pain care. Still, it's getting a lot of media coverage. “Milder pill may be best for pain” is the front page headline in the Los Angeles Times. “Drugstore pain pills as effective as opioids” said STAT News. “Opioids Not the Only Answer for Pain Relief” reported HealthDay.  

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Researchers said patients with moderate to severe acute pain in their arms or legs got just as much pain relief after being given a combination of acetaminophen and ibuprofen than those who took hydrocodone, oxycodone or codeine. The study only measured pain relief for two hours.

Patients with sickle cell disease, fibromyalgia, neuropathy or any type of pain that lasted more than seven days were excluded from the study because researchers only wanted to focus on short term pain.

"Although this study focused on treatment while in the emergency department, if we can successfully treat acute extremity pain with a non-opioid combination painkiller in there, then we might be able to send these patients home without an opioid prescription," said lead author Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center.

"We know that some patients who are given an opioid prescription will become addicted, so if we can decrease the number of people being sent home with an opioid prescription, then we can prevent people from becoming addicted in the first place."

What Chang, JAMA and the news reports all fail to mention is that the study was conducted at one of the worst hospitals in the nation. In an annual survey of Medicare patients, Montefiore Medical Center in New York City was given only one star (out of five possible), placing it in the bottom 2.44% of hospitals nationwide.

Montefiore was rated poorly on a variety of quality measures, including pain care. Only 64 percent of the patients treated there said their pain was “always” well controlled, compared to the national average of 71 percent.

‘Worst Hospital in the Entire City’

Many of the online reviews of Montefiore’s emergency room are scathing.

“Please do not come to the ER unless you want to die or are used to unsympathetic health professionals,” warned Amanda G. on Yelp.  “I have severe abdominal pain and I'm walking home in tears right now. I came in told the nurse there my symptoms and she couldn't have made it clearer that she couldn't care less.”

“This has to be the worst hospital in the entire city. The nurses in the ER are rude and don't care about your well being. The ER is filthy. People stacked on top of each other,” wrote Robert in a Google review.

MONTEFIORE MEDICAL CENTER PHOTO

MONTEFIORE MEDICAL CENTER PHOTO

“The emergency room sucks. The doctors sit around on the computers gossiping. I even overheard a few doctors saying ‘why aren’t we picking up patients?’ Meanwhile there’s a room full of patients not being taken care of. There’s a patient screaming for help and no one hears him. All the staff members just walk by him,” wrote Zoe D. on Yelp.

“Somebody told me this place was the equivalent of going to a hospital in Manhattan. They lied! I went to the emergency room today for chest pains, I ended up sitting there for four hours never to be seen by a doctor. I ended up walking out and leaving still with my chest pains,” said Phonz R. on Yelp.

“Their ER department is horrible. I went to the ER with my mom via ambulance, we got there (a little) before 1pm. Fast forward 1:58 in the morning she still wasn't put in a room,” wrote J.L. Eaddy on Google. “This was the absolute worst ER I've ever encountered. And I NEVER want to come back again. I wish I had the option to give it negative stars.”

Unfortunately, complaints such as these are not unusual in busy, urban teaching hospitals like Montefiore.  And not all the reviews are poor. U.S. News and World Report gave high rankings to Montefiore in a number of areas, although it didn’t specifically rank its emergency department. Montefiore was recently given a lukewarm “C” rating by the Leapfrog group, a non-profit that grades hospitals on quality and safety.  

Many pain patients have poor experiences in hospitals. In a survey of nearly 1,300 patients by PNN and the International Pain Foundation, over half rated the quality of their pain care in hospitals as either poor or very poor. About two-thirds of the patients said non-opioid pain medications were ineffective.

New Opioid Painkiller Has Less Abuse Potential

By Pat Anson, Editor

A new opioid medication being developed by Nektar Therapeutics for the treatment of moderate to severe chronic pain has significantly less abuse potential than oxycodone -- even at high doses – according to the results of a new clinical study.

The investigational oral drug – known as NKTR-181 -- is the first analgesic opioid designed to reduce side effects such as euphoria, which can lead to abuse and addiction.

In a small study involving 54 recreational drug users, NKTR-181 had significantly less “drug liking” than oxycodone in the first hours of use. The dosage given to the study participants ranged from a maximum therapeutic dose of 400mg of NKTR-181 to a “supratherapeutic” dose that was 3 to 12 times higher than common doses of oxycodone.

"It is clear from our new study results that NKTR-181 is highly differentiated in this respect from oxycodone, which is a choice drug of abuse.  Further, and critically important in the context of this public health emergency, NKTR-181's less rewarding properties and strong analgesia are inherent to its novel molecular structure and independent of any abuse-deterrent formulation,” said Ivan Gergel, MD, Senior Vice President and Chief Medical Officer of Nektar. 

“Many patients do not receive adequate pain relief because they fear taking conventional opioids, including abuse-deterrent formulations, because of their potential for abuse and addiction.  We believe NKTR-181 is a transformational pain medicine that should significantly advance the treatment of chronic pain and could be a fundamental building block in the fight against prescription opioid abuse.”

nektar therapeutics

nektar therapeutics

In March, NKTR-181 received “fast track” designation from the Food and Drug Administration -- a status that allows for an expedited review of the drug – after Nektar reported positive results from a Phase 3 study of over 600 patients with chronic back pain.  Pain scores dropped by an average of 65% in patients taking NKTR-181 twice daily.

The molecular structure of NKTR-181 is designed to have low permeability across the blood-brain barrier, which slows its rate of entry into the brain – thus reducing the “high” or euphoric effect. Many pain sufferers say they do not get high or experience euphoria from opioid medication, but drug makers and regulators are working to develop painkillers with less risk of abuse and addiction.  

"Getting very high, very fast, is a mark of conventional high-risk, abused opioids," said Jack Henningfield, PhD, vice president at Pinney Associates and adjunct professor at The Johns Hopkins University School of Medicine. "NKTR-181 represents a meaningful advance in the treatment of pain as the first opioid analgesic with inherent brain-entry kinetics that avoids this addictive quality of traditional opioids. This prevents the rapid 'rush' that abusers seek during the critical period immediately after dosing. Importantly, these properties of NKTR-181 are inherent to its molecular structure and are not changed through tampering or route of administration." 

Because NKTR-181 produces less euphoria, Nektar believes it should be scheduled as a Class III or Class IV controlled substance, a less restrictive schedule than Class II medications, a category that includes oxycodone, hydrocodone and many other opioids.

Nektar is a research-based biopharmaceutical company that discovers and develops new drugs for which there is a high unmet medical need. It has a pipeline of new investigational drugs to treat cancer, auto-immune disease and chronic pain.

Utah Raid Uncovered Large Fentanyl Pill Ring

By Pat Anson, Editor

A drug bust in a Utah home last November has uncovered one of the largest counterfeit pill operations in U.S. history.

This week a federal grand jury in Salt Lake City indicted six individuals for manufacturing nearly 500,000 pills laced with illicit fentanyl that were disguised to look like the painkiller oxycodone and the anti-anxiety drug alprazolam (Xanax). The counterfeit pills were distributed throughout Utah and the United States to customers who ordered them online.

Fentanyl is a powerful synthetic opioid that it is 100 times more potent than morphine and 50 times more potent than heroin. In recent years, illicit fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada.

“What we feared and hoped somehow would stay away has arrived in spades,” said Brian Besser, the DEA’s agent in charge in Utah. “Fentanyl is as dangerous as it gets.”

According to documents filed in federal court, the pill ring was created by Aaron Shamo and Drew Crandall, both Utah residents who worked together at eBay, but quickly grew to include the other conspirators. Prosecutors say the defendants purchased pill presses, dies and stamps so the counterfeit pill markings would match those of legitimate pharmaceutical drugs. Some items were purchased legally and others, such as fentanyl and alprazolam, were illegally imported from China

The fake pills were sold on a “dark net online store” at a significant profit. Once sold, Shamo and Crandall used their co-conspirators to package the pills and ship them to customers. In less than a year, the operation mailed 5,606 drug orders totaling $2.8 million, according to court documents.

“Shamo’s customer base was extremely comprehensive and widespread, touching every corner of the United States,” Besser said. “It touched large cities and rural communities.”

The round blue tablets manufactured by the pill ring were offered for sale online as oxycodone 30mg tablets. The tablets were debossed with “A 215” on the bisected side, with an “M” on one side and a “30” above the bisect on the other side. The indictment alleges the defendants did not use oxycodone at all in the manufacturing process, but instead used illicit fentanyl.

Federal agents arrested Shamo last November. During a raid on Shamo’s suburban Salt Lake City home, agents discovered a pill press capable of manufacturing several thousand pills an hour. Agents also seized 70,000 pills and $1.2 million in cash stuffed in garbage bags.

Crandall fled to Australia with his girlfriend and was in Laos when agents raided Shamo’s house. He was arrested last month in Hawaii. A summons will be issued for the other four conspirators for their initial appearances in federal court.

A Deadly Mix: Opioids and Alcohol

By Pat Anson, Editor

Taking one oxycodone tablet together with alcohol significantly raises the risk of respiratory depression and possible death, according to a new study by Dutch researchers. Elderly people were more likely to experience this complication, researchers found.

The study, published in the journal Anesthesiology, is one of the first to address the effect of alcohol and opioids on respiratory depression, which causes breathing to become extremely shallow or stop altogether.

"Unfortunately, we're seeing more fatalities and people in emergency rooms after having misused or abused legally prescribed opioids, like oxycodone, while having consumed alcohol," said lead author Albert Dahan, MD, a professor of anesthesiology at Leiden University Medical Center in the Netherlands.

"Respiratory depression is a potentially fatal complication of opioid use. We found alcohol exacerbated the already harmful respiratory effects of opioids."

Dahan and his colleagues studied the effects of oxycodone and alcohol on breathing in 12 healthy young volunteers (ages 21 to 28) and 12 elderly volunteers (ages 66 to 77). On three separate occasions, the volunteers were given one 20 mg oxycodone tablet combined with an intravenous infusion of ethanol (alcohol).

The amount of alcohol was increased until blood-alcohol levels reached 0.5 g/L on the second visit and 1.0 g/L on the third visit, as measured through the volunteers' breath. A man would need to consume about 5 alcoholic drinks to reach the latter level.

Taken alone, one oxycodone tablet reduced respiratory ventilation – the amount of air the volunteers breathed per minute -- by 28 percent. Adding 1.0 g/L of alcohol caused ventilation to further decrease by another 19 percent - a total decrease of 47 percent.

The combination of alcohol and oxycodone also caused a significant increase in the number of times volunteers temporarily stopped breathing. This was especially true in the elderly volunteers, who were more likely to experience repeated episodes where they temporarily stopped breathing.

"We hope to increase awareness regarding the dangers of prescription opioids, the increased danger of the simultaneous use of opioids and alcohol, and that elderly people are at an even greater increased risk of this potentially life-threatening side effect," said Dahan. "Ultimately, people should know that it is never a good idea to drink alcohol with opioids."

Although warning labels for oxycodone and other opioids caution against using them with alcohol, it’s common for the two to be mixed. A recent study by the Centers for Disease Control and Prevention found that alcohol was involved in about 15 percent of drug overdoses, including deaths associated with oxycodone, hydrocodone, morphine and fentanyl. 

FDA Approves New Version of Oxycodone

By Pat Anson, Editor

The U.S. Food and Drug Administration has approved a new extended released version of the opioid painkiller oxycodone that has abuse deterrent properties unlike anything else on the market.

The drug – called Xtampza – can be ingested in capsule form, but users can also sprinkle the capsule contents on soft foods or into a cup, and then directly into the mouth.

The medication, which can also be ingested through a feeding tube, is the sixth opioid pain medication with an abuse deterrent formula to be approved by the FDA.  

Xtampza is made by Massachusetts-based Collegium Pharmaceutical (NASDAQ: COLL) with proprietary technology that combines oxycodone with fatty acid and waxes to form small spherical beads that are placed inside the capsule.

The beads are designed to resist breaking, crushing, chewing, dissolving and melting, methods long used by drugs abusers to snort or inject opioids.  

collegium pharmaceutical image

collegium pharmaceutical image

That novel approach is different from other abuse deterrent formulas, which generally make it harder for tablets to be crushed or liquefied; or come with a chemical irritant to discourage tampering.

“The FDA approval of Xtampza ER is a major milestone for Collegium. Our DETERx technology platform was developed internally and our lead product completed an extensive battery of abuse-deterrent testing consistent with the FDA Guidance on Abuse-Deterrent Opioids,” said Michael Heffernan, CEO of Collegium.

Another advantage of Xtampza is that it gives an alternative to patients who have trouble swallowing tablets or capsules, a condition know as dysphagia.  

"People like me live with dysphagia that prevents us from swallowing normally all the time. Up until this new drug coming out, people not able to swallow have had to rely on liquids and patches for relief - not being able to take their oxycodone," said PNN columnist Ellen Lenox Smith, who suffers from Ehlers Danlos syndrome and sarcoidosis. She testified in favor of Xtampza's approval for the U.S. Pain Foundation.

"Although this is a medication not compatible to my body, I testified on it's behalf for those people around the country not able to take their medications and thus not getting the relief they deserve. I am thrilled that this got approved so soon and that people will have this as an option and hope that this safer  formula will help to calm the nerves of all the people out there concerned about addiction to opiates," Smith said.

“Xtampza ER also allows for flexible dosing administration for patients with difficulty swallowing. Patients or their caregivers often inadvertently crush their medication to facilitate swallowing, which can be very dangerous with currently marketed ER products,” said Dr. Jeffrey Gudin, Director of Pain Management and Palliative Care at Englewood Hospital and Medical Center.

Xtampza, which is designed to be taken twice a day by patients who need around-the-clock pain relief, comes with an FDA warning to take the medication with food. Taking it on an empty stomach could lead to inadequate pain control.

Collegium plans to launch Xtampza ER in the U.S. in mid-2016 with five dosage strengths equivalent to 10 mg, 15 mg, 20 mg, 30 mg and 40 mg oxycodone.

Fake Oxycodone Seized at US-Mexican Border

By Pat Anson, Editor

Federal prosecutors this week filed charges against an alleged smuggler caught at the California-Mexico border with nearly 1,200 fake oxycodone pills, the latest sign that Mexican drug cartels are targeting pain patients in the U.S.

The pills were made with illicit fentanyl, a synthetic opioid that is 50 to 100 times more potent than morphine and can be lethal in very small doses. Counterfeit fentanyl pills are blamed for 11 deaths and dozens of overdoses in recent weeks in the Sacramento area, where they were disguised to look like Norco pain medication. Some of the victims were patients who sought painkillers on the street because they couldn’t obtain them legally.

Fake oxycodone, Percocet and Xanax pills have also been appearing in Florida, where they are blamed for at least one death.

19-year old Sergio Linyuntang Mendoza Bohon of Tijuana, Mexico was arrested at the Otay Mesa port of entry on February 10. Border patrol agents became suspicious when they saw “an unnatural looking bulge” in his underwear.

A search turned up 1,183 tablets labeled as oxycodone and 5.4 grams of powdered fentanyl. Laboratory tests later determined the pills were made with fentanyl, not oxycodone.

“This investigation involves the first interdiction of counterfeit oxycodone pills containing fentanyl that were smuggled from Mexico into the U.S. at the local ports of entry,” said Dave Shaw, special agent in charge for Homeland Security in San Diego.

FILE PHOTO of otay mesa border crossing

FILE PHOTO of otay mesa border crossing

“While this time we’ve successfully prevented a potentially deadly drug from reaching the streets, we face an uphill battle stemming from the rapidly growing demand for pharmaceutical painkillers on the black market.”

Last year, the DEA issued a nationwide public health alert for acetyl fentanyl, a synthetic opioid produced by illegal drug labs in China and Mexico. Acetyl fentanyl is virtually identical to fentanyl, a Schedule II controlled substance that is often used in patches to treat more severe forms of chronic pain.

Acetyl fentanyl has been blamed for thousands of overdose deaths in the U.S. and Canada. It typically is mixed with heroin and cocaine to make the drugs more potent, but is now showing up in pill form – sometimes disguised as pain medication.

“These criminals are putting fentanyl into fake pills and passing them off as legitimate prescription medications.  Fentanyl is extremely powerful and can very easily lead to overdose deaths,” said William Sherman, DEA Special Agent in Charge.

“Unsuspecting individuals who illegally purchase oxycodone could potentially die from the ingestion of what turns out to be fentanyl tablets,” said U.S. Attorney Laura Duffy. “We are very concerned that these counterfeit pills could cause serious harm to users. Even miniscule amounts of fentanyl can have devastating consequences for those who abuse it or literally even touch it.”

Bohon faces up to 20 years in prison if convicted of unlawfully importing a controlled substance. His next court appearance is scheduled for May 2.

Public Health Emergency in Canada

British Columbia this week became the first province in Canada to declare a public health emergency due to a spike in fentanyl overdoses. Health officials say 201 overdose deaths were recorded in the first three months of 2016. 

Counterfeit fentanyl pills disguised as oxycodone started appearing in Canada about two years ago, where they are often called “greenies” when sold on the street.

ROYAL CANADIAN MOUNTED POLICE photo

ROYAL CANADIAN MOUNTED POLICE photo

“When it's mixed into these tablets it's highly variable from one to the next. So an individual who uses a pill they bought off the street that contains fentanyl may crush up a tablet, inject it and be fine but with the next one they do they may overdose.” Dr. Matthew Young, a substance abuse epidemiologist in Ottowa, told Vancouver Metro.

Like the United States, Canada has a serious problem with opioid abuse and addiction. Young says efforts to reduce opioid prescribing may have contributed to the current wave of fentanyl overdoses.

“That also created a market where organized crime stepped in and started selling these counterfeit tablets containing fentanyl,” he said.

Opioid Dispensing and Overdoses Down Sharply

By Pat Anson, Editor

Dispensing of opioid pain relievers and painkiller overdoses both declined substantially after an abuse-deterrent formula of OxyContin was introduced and the painkiller propoxyphene was withdrawn from the U.S. market in 2010, according to a new study published online in JAMA Internal Medicine.

The study is another indication there has been a reversal in the growth of opioid prescribing – which has long been blamed for the so-called “epidemic” of prescription drug abuse. Last week another study was released showing that the painkiller hydrocodone was no longer the most-widely prescribed drug in the U.S. 

Researchers analyzed claims from over 31 million members of a large national health insurer, and estimated that by 2012 total opioid dispensing declined by 19% and the overdose rate dropped by 20 percent. The drop in prescription opioid overdoses was partially offset by a 23% increase in overdoses due to heroin.

“Our results have significant implications for policymakers and health care professions grappling with the epidemic of opioid abuse and overdose,” said lead author Marc Larochelle, MD, of the Harvard Medical School and Boston University School of Medicine.

"Changes imposed through regulatory mandates or voluntary company actions may be a viable approach to stemming prescription abuse. However, identifying interventions that reduce opioid supply without affecting access to individuals who benefit from opioid therapy remains a challenge.”

Propoxyphene (also known as Darvon) was voluntarily withdrawn from the U.S. market after data emerged about its cardiac toxic effects.

The abuse-deterrent formula of OxyContin introduced by Purdue Pharma in 2010 is harder for drug abusers to crush or dissolve for snorting or injecting. Researchers said the prescribing of OxyContin and other extended released oxycodone products dropped by 39% in the two years after the formulation change.

They noted there was “minimal” evidence that people switched to other pain medications because of the formulation change – an indication they weren’t taking OxyContin for pain relief.

"These results suggest that many people who were prescribed OxyContin before it was reformulated may have been diverting or misusing the drug," said Larochelle. "Given the decreased supply of prescription opioids, those seeking out an opioid could be turning to heroin, which may partially explain the tremendous increase in heroin overdose deaths over the past few years both locally and nationally."

“This study parallels other independent and internal research that shows reformulated OxyContin is associated with a reduction in abuse,” Purdue Pharma said in a statement.

“We agree with the FDA, the U.S. Drug Enforcement Administration, The White House Office of National Drug Control Policy and many federal and state policymakers that abuse-deterrent formulations are a valuable public health tool that must be part of any comprehensive approach to combatting prescription drug abuse.”

The study also suggests that legitimate pain patients were not the ones abusing opioids.

“Most overdoses do not occur among patients who are receiving daily prescribed opioids or among those receiving the highest doses,” said Hillary Kunins, MD, of the New York City Department of Health and Mental Hygiene in an editorial also published in JAMA Internal Medicine.

"Recasting the often-maligned 'doctor-shopper' instead as a patient with a substance use disorder reminds us that using public health strategies to promote judicious opioid prescribing, including via pharmaceutical market change to reduce overdose risk, needs to be accompanied by similar policy approaches to provide accessible and effective services for people who use drugs.”