Individualized Pain Care After Surgery Raises Patient Satisfaction

By Pat Anson, PNN Editor

An opioid prescribing guideline tailored to a patient’s specific needs – that doesn’t take a one-size-fits-all approach – resulted in high patient satisfaction rates and reduced the use of opioids after surgery.

The post-operative pain management guideline was developed by surgeons at Dartmouth-Hitchcock Medical Center in New Hampshire, who based the number of opioid pills sent home with patients on how many they needed the day before they were discharged from the hospital. Other guidelines typically base the number of pills on the type of operation that was performed and do not take into account a patient’s individual needs.

“In this new prospective study we found that 93 percent of patients had their post-surgery opioid needs satisfied,” said lead author Richard Barth Jr., MD, section chief of general surgery. “This finding means that this guideline can be used for a wide variety of operations to guide surgeons on how many opioids to prescribe when sending patients home after surgery.”

Barth and his colleagues enrolled 229 patients in the study who had elective general surgery, including colorectal, gynecological, thoracic and urological operations. Upon discharge, patients received prescriptions for acetaminophen and ibuprofen, as well as opioids, based on the guideline.

If they needed no opioids the day before discharge, they were sent home with the morphine milligram equivalent (MME) of five oxycodone 5mg pills. If they took one or three pills, they were given a prescription for 15 more. And if they needed four or more pills, they were given a prescription for 30 pills.  

Patient satisfaction was highest among those who needed the fewest number of pills. Despite being given an opioid prescription, 73 percent of the patients who were prescribed five pills used no opioids at home, and 85 percent used two pills or less.

In all, 60 percent of patients in the study had leftover opioid pills, according to findings published in the Journal of the American College of Surgeons. They were given instruction on how to dispose of them safely.

Barth says surgeons played a pivotal role in minimizing opioid use by talking to patients before surgery and setting their expectations for pain management. They told patients they were likely to be discharged with either no opioids or a small amount based on their opioid use in the hospital.

“The other part of that discussion involves letting patients know that they should expect some pain, that our goal isn’t to get rid of every last bit of their pain,” Barth said. “That was something that surgeons tried to accomplish years ago, but that’s not what we’re aiming for now. A low level of discomfort is acceptable, and patients need to have that expectation.”

That process also including prescribing, not just recommending, over-the-counter pain relievers.  

“By prescribing non-opioid analgesics, the surgeon sets the expectation that they should be used,” he said. “It’s a big difference if a surgeon prescribes non-opioid analgesics compared with just recommending that a patient take acetaminophen or ibuprofen that they might have at home.” 

In recent years, many U.S. hospitals have adopted policies that reduce or completely eliminate the use of opioids after surgery. Those policies unfairly leave some patients in pain, according to a recent study presented at the annual meeting of the American College of Surgeons. Researchers found that about half of patients need opioid medication after major surgeries.

“Our goal is to give them the exact right amount so that we limit the number of un-used opioids in our community while also making sure we don’t reduce it down too far and then leave them in pain,” said lead author Cornelius Thiels, DO, a surgical oncology fellow at Memorial Sloan Kettering Cancer Center.

“The right answer may be more non-opioid based pain medications, better patient education and setting of expectations, or in some cases patients may actually require slightly more opioid medications, and that is OK.”

Abuse of Rx Opioid Painkillers Unchanged During Pandemic

By Pat Anson, PNN Editor

An alarming spike in U.S. overdose deaths during the COVID-19 pandemic does not appear to be fueled by increased abuse of opioid painkillers, according to a new nationwide analysis of urine drug tests.

The Drug Enforcement Administration approved an exemption last year allowing patients to connect with doctors via telehealth – without a physical examination -- to get prescriptions for opioids and other controlled substances. While the relaxed rules made it easier for patients to get pain medication during the pandemic, they have not resulted in more diversion or abuse of oxycodone and hydrocodone, according to the Millennium Health Signals Report. Urine positivity rates for the two opioids remained flat during 2020.

“Despite the hardships faced during the pandemic, it is encouraging to see that positivity rates for non-prescribed use of hydrocodone and oxycodone have not changed,” said Michael Parr, MD, an addiction treatment specialist and consultant to Millennium.

“Patients requiring opioids for the treatment of pain have faced difficulty obtaining medications, as well as stigma, before the pandemic. Perhaps this data will reassure clinicians who have taken additional steps to safely prescribe these medications during the pandemic.”

There was an uptick in positivity rates for non-prescribed tramadol, a weaker opioid, particularly in Ohio, Tennessee and Kentucky. Millennium said there were more cases of people with substance use disorders using tramadol as their “drug of preference.”

Millennium researchers also found that positivity rates for non-prescribed gabapentin (Neurontin) showed little change in 2020 – but they remain at levels nearly three times higher than positivity rates for oxycodone, hydrocodone and tramadol. The abuse of non-prescribed gabapentin did rise significantly in Ohio and Virginia.

POSITIVITY RATES FOR NON-PRESCRIBED PAIN MEDICATIONS

SOURCE: MILLENNIUM HEALTH

The abuse of gabapentin has been going on for years, but with little public attention. Gabapentin is a non-opioid nerve medication increasingly prescribed for pain, despite the fact many patients say it doesn’t help and has too many side effects. Drug abusers, however, have found that gabapentin can heighten the effect of heroin and other street drugs.

While positivity rates for non-prescribed pain medication were mostly unchanged during the pandemic, they soared for illicit fentanyl and methamphetamine, increasing 78% and 29%, respectively.

After initially increasing in the early stages of the COVID-19 crisis, Millennium found that positivity rates for cocaine and heroin soon returned to pre-pandemic levels.

Another encouraging sign is that positivity rates for carfentanil, a deadly fentanyl analogue, have flatlined to nearly zero. It is unclear why carfentanil abuse has fallen so sharply, but Millennium said it may be because the pandemic has disrupted manufacturing and supply routes from China.     

Opioid Promotion Cited in FDA Warning Was Stopped in 2019

By Pat Anson, PNN Editor

A California pharmaceutical company that received a warning letter from the Food and Drug Administration over its promotion of a controversial opioid painkiller stopped using the marketing material over a year ago.

The FDA sent the warning letter to AcelRx Pharmaceuticals last week. The agency told the company to stop making “false and misleading claims” about Dsuvia, a potent opioid tablet used to relieve acute pain in hospital settings.

The “Tongue and Done” banner ads and tabletop displays emphasized how easy Dsuvia is to administer by using a plastic applicator that releases a single tablet directly into a patient’s mouth. The FDA said the promotions were misleading and dangerous.

“AcelRx has disseminated promotional communications that undermine key prescribing conditions required for the safe use of this opioid product. Dsuvia was approved with special restrictions requiring that it only be prescribed in a certified medically supervised setting by health care practitioners trained to properly administer it,” the FDA said in a statement.

“This promotion dangerously undercuts FDA-required conditions on the proper administration of the drug, which requires particular diligence to minimize the risk of serious or even fatal adverse events.”

The letter warns AcelRx to either stop using the marketing material or cease distributing Dsuvia. It gave the company 15 days to respond or face “further regulatory action.”    

ACELRX PROMOTION

But in a filing with the Securities and Exchange Commission, AcelRx said it could “easily address” the FDA’s concerns because it stopped using the “Tongue and Done” promotions in late 2019.

“The Company intends to respond to the FDA within the timeframe requested in the Letter and seek guidance and clarification from the FDA on the concerns raised in the Letter,” the SEC filing states. “The Company cannot give any assurances, however, that the FDA will be satisfied with its response to the Letter or that such response will resolve the issues identified in the Letter.”

Few Adverse Events Involve Dsuvia

The FDA approved the use of Dsuvia in 2018 over the objections of anti-opioid activists who said it was a “dangerously unnecessary opioid medication" that would be diverted, abused and lead to more overdoses. There is little evidence any of that has occurred.

Dsuvia contains sufentanil, an opioid 10 times stronger than fentanyl. It was developed to fulfill an unmet need in military and civilian hospitals, where patients need quick relief from acute trauma pain and can’t wait for opioids to be administered intravenously. Each Dsuvia tablet comes in a single dose applicator. The tablets quickly dissolve under the tongue and are not available for home use.

Those safety measures appear to be working. The FDA’s Adverse Events Reporting System lists only six cases involving Dsuvia in 2019 and 2020. There were no deaths and none of the cases were considered serious.

AcelRx recently published the results of a clinical study that showed surgery patients treated with Dsuvia used significantly fewer opioids than those treated with traditional IV opioids. They were also discharged sooner.

The FDA’s belated warning letter to AcelRx about its Dsuvia marketing comes as the agency faces renewed scrutiny for its regulation of opioids.

Acting FDA Commissioner Dr. Janet Woodcock is reportedly under consideration by President Biden for a formal nomination to the job, which has drawn the ire of some anti-opioid activists. A letter sent to the Acting Secretary of Health and Human Services accuses Woodcock of “dereliction of duty” for failing to address the opioid crisis by halting the approval of new opioids. Woodcock has been Director of the FDA’s Center for Drug Evaluation and Research for over 25 years.

Would Drug Legalization Reduce Overdoses?

By Roger Chriss, PNN Columnist

As the overdose crisis worsens, public health data and biostatistics become more important. Debates about opioid prescribing and drug legalization often center on two key concepts: incidence and prevalence as applied to drug use, substance use disorder (SUD) and overdoses.

Brandeis University researcher Andrew Kolodny, MD, recently argued against drug legalization on Twitter.

“Some critics of reducing Rx opioids don't believe that repeated use of highly addictive drugs cause addiction and/or they believe all drugs, including heroin & cocaine should be available over the counter. They don't believe that easy access can increase prevalence of SUD,” said Kolodny, who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Conversely, Columbia University professor Carl Hart, the author of “Drug Use for Grown-Ups,” believes legalizing recreational drugs would help reduce overdoses by making the drug supply safer.

“A large proportion of these deaths are caused by adulterated substances purchased on the illicit market. A regulated market, with uniform quality standards, would virtually put an end to contaminated drug consumption and greatly reduce fatal accidental drug overdoses,” Hart told Columbia Magazine.

Both claims hinge on a proper understanding of incidence and prevalence. In epidemiology, incidence is the rate of new-onset diagnosis of a medical condition. It is measured over a given period of time -- typically a year -- though sometimes the time period is shortened to a week for an urgent problem, such as a viral pathogen like the coronavirus.

By contrast, prevalence measures the total number of people in a population who have a specific medical condition. For prevalence, the duration of the condition is important. For an infectious disease, it may be brief. But for cancer, SUD and many other chronic conditions, it may last a lifetime.

For instance, the incidence of opioid use disorder (OUD) among people who are on long-term opioid therapy is 8-12%, according to the National Institutes of Health. But unlike claims frequently made by PROP, only a small fraction of patients who abuse prescription opioids start using heroin, less than 4% over a five-year period. So, making a clear distinction between OUD involving prescription opioids versus heroin becomes important.

The prevalence of OUD is a cumulative total of all people with OUD over time. This is because OUD and other substance use disorder diagnoses are lifetime diagnoses that remain on a person’s medical records forever. When we count people with OUD, we are counting everyone ever diagnosed with the condition, though in practice sometimes the OUD diagnosis is dropped due to administrative error, poor record-keeping or deliberate obfuscation.

This means that OUD prevalence can go up over time even when the incidence of OUD is going down. In fact, that is what is happening at present.

A recent report from the Substance Abuse and Mental Health Services Association showed modest declines for both prescription opioid misuse and heroin use. This came at a time when U.S. drug deaths were rising, fueled primarily by overdoses involving illicit fentanyl.

These counterintuitive trends make for intense debate about the success or failure of the 2016 CDC opioid guideline and state laws restricting prescription opioid use. A recent study from Indiana University concluded that limits on legal opioid prescribing may have actually driven more people to illicit drugs.

"Our work reveals the unintended and negative consequences of policies designed to reduce the supply of opioids in the population for overdose. We believe that policy goals should be shifted from easy solutions such as dose reduction to more difficult fundamental ones, focusing on improving social conditions that create demand for opioids and other illicit drugs," said co-author Brea Perry, PhD, a professor of sociology at Indiana University.

Even if drug legalization were to reduce drug risks, an increase in the number of drug users could lead to more harms. For instance, if an illicit drug harms 10% of users and there are 1 million users, that results in 100,000 people harmed. If that drug is then legalized and made safer, harming only 1% of users, that seems like an improvement. But if the number of users rises to 15 million, then 150,000 people would be harmed.

Since we don’t know how these numbers would change under a legalized drug regime, any claims about changes in incidence or prevalence are speculative at best.

What is counted and how it is expressed are very important in debates about the role of prescription opioids or drugs in general in SUD and overdose deaths. A failure to be specific about methodology or using data that is not well-founded can result in specious or even deceptive claims. And counterintuitive results are possible, as we are seeing at present in the ever-evolving overdose crisis.

Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

AMA Scolded for Seeking Changes in CDC Opioid Guideline

By Pat Anson, PNN Editor

Eight months after the American Medical Association told the CDC that its controversial opioid guideline has “harmed many patients” and needs to be revised, an anti-opioid activist group has accused the AMA of employing false moral arguments to justify using opioid medication to relieve human suffering.

The letter from Physicians for Responsible Opioid Prescribing (PROP) to AMA President Susan Bailey, MD, takes issue with the AMA’s position that the U.S. “no longer has a prescription opioid epidemic” and instead faces an overdose crisis fueled by illicit fentanyl and other street drugs.

“These statements send a strong message that opioid prescribing for pain is no longer problematic, and that the CDC’s recommended guardrails are no longer needed. Nothing could be further from the truth,” says the PROP letter, which was signed by the organization’s board of directors.

“There is compelling evidence that many of those currently struggling with opioid dependence and addiction were introduced to opioids through use of medically prescribed opioids used to treat chronic pain. Medically prescribed opioids remain a common gateway to illicit opioid use and are themselves frequent causes of opioid addiction and overdose, even if illicit opioids currently cause the greater number of deaths.”

The CDC’s 2016 guideline was only intended for primary care physicians treating chronic pain, but its voluntary recommendations on opioid prescribing have been widely adopted as policy by federal agencies, states, insurers, pharmacies and doctors of all specialties. The guideline has not only failed to reduce drug deaths – which now stand at record highs – but federal health experts admit that widespread misuse of the guideline has caused “serious harm” to patients, including forced tapering, withdrawal, uncontrolled pain and suicide.    

PROP’s letter to the AMA goes even further than the CDC recommendations, suggesting that opioid medications should only be used for short-term acute pain and end-of-life care.  

“All moral, ethical, regulatory, legal and political arguments that opioids are needed so that people do not suffer needlessly should apply specifically to short-term pain management where there is proven benefit, and not to long term pain management where evidence of benefit is largely anecdotal, and there is compelling evidence of harm,” PROP said.

“Why then is the AMA applying the moral argument to the false premise that people will suffer needlessly if they do not have unrestricted access to opioids? By all means apply moral arguments and principles to make sure opioids are available for the right indications, but it makes no sense at all to suggest that removing guidance on opioid dose and duration is needed so that people with chronic pain do not suffer.”

AMA: ‘Misguided Focus’ on Opioids Harms Patients

To be clear, opioid addiction is rare in patients and the AMA never said that people should have “unrestricted access to opioids.” The AMA called for balanced and individualized care based on patient need, not one-size-fits-all guidelines that dictate dosages or the type of treatment everyone should get.    

In a February 19th letter to PROP, AMA President Dr. Susan Bailey said the group mischaracterized the AMA’s position on opioid treatment.

“When policies or organizations focus only on the restriction of a legitimate pharmacologic option to help patients with pain, they miss the chance to address the complexity of policies needed to truly help patients with pain. That misguided focus also has led to harmful stigmatization and other stressors,” Bailey said.

“That is why the AMA provided comprehensive recommendations on the 2016 CDC Guideline and why we continue to advocate for policies that support comprehensive, multidisciplinary, multimodal pain care, including opioid therapy when appropriate.”

“Patients with chronic pain and patients with substance use disorder both need access to multimodal treatments for their medical care,” said Dr. Chad Kollas, a palliative care specialist who is an AMA delegate and Secretary of American Academy of Hospice and Palliative Medicine (AAHPM).

“AMA and AAHPM have recognized the importance of pursuing balanced opioid policy, policy that protects access to opioid analgesics for patients with medically legitimate needs for those medications, while also protecting the public safety and reducing potential harms of prescribed medications.”

Kollas said PROP’s belated response to the AMA’s position may be an attempt to deflect attention away from a recent report that found deaths due to illicit fentanyl soaring, while overdoses involving prescription opioids remained flat.  The research adds to a growing body of evidence suggesting the CDC opioid guideline was ineffective and misdirected.

Although opioid prescribing is at 20-year lows, PROP founder Dr. Andrew Kolodny has said prescriptions “still have a very long way to go” and should be reduced even further. Kolodny recently advised the World Health Organization in the development of a new guideline for treating chronic pain in children, which recommends that opioids only be given to children who are dying or in palliative care.

Slow Progress on Guideline Update

Faced with growing criticism of its own guideline, the CDC announced in 2019 that it was working on an update or possible expansion of its recommendations. Progress has been slow since then.  An advisory group appointed by the agency last summer has had only two preliminary meetings and will not review suggested changes to the guideline until next month, according to an update given Tuesday to the CDC’s Board of Scientific Counselors (BSC).

Draft guidelines are not expected to be available for public comment until the end of this year, meaning any revisions will likely not be finalized until 2022. Patient advocates told the BSC they were disappointed by the lack of progress.

“I would like to urge the members of this panel to please take seriously the issue of timely revision of the CDC guidelines for chronic pain. We have a catastrophe welling out across the country in a wholly marginalized and invisible group. On top of that, we are losing working physicians at a steady rate,” said Terri Lewis, PhD, a patient advocate and rehabilitation specialist. “Everybody is in the gun sights of policy that is not working for anybody. I beg you to please make this an urgent priority.”

Mexicans ‘Dying in Pain’ Because Rx Opioids Limited in U.S.

By Pat Anson, PNN Editor

Efforts to limit opioid prescribing in the United States are driving some Americans across the border to Mexico to purchase opioid medication, according to a new study that found shortages of painkillers in some of Mexico’s poorest regions.  

Mexico, along with many other third-world countries, have relatively low rates of opioid prescribing. Faced with international criticism that pain was going untreated, the Mexican government launched an initiative in 2015 to improve access to opioids for terminally ill patients in palliative care.

Doctors were allowed to write more prescriptions and there was expanded insurance coverage of opioids, which led to a steady increase in opioid dispensing in Mexico over the next few years – a period when opioid prescribing in the U.S. was falling sharply.

A team of researchers at UCLA, with funding from the U.S. National Institutes of Health, looked at prescription drug data in Mexico from 2015 to 2019. They found a steady increase in opioid dispensing nationwide, but the growth was concentrated in wealthier Mexican states and major metropolitan areas, particular those along the U.S. border. The research findings, published in The Lancet Public Health, suggest that some of the opioids intended for Mexican citizens wound up in American medicine cabinets.

"People in the poorest areas of Mexico are dying in pain," said lead author David Goodman-Meza, MD, an assistant professor of medicine at the David Geffen School of Medicine at UCLA. "A lot of work needs to be done to increase access to opioids for those who have a medical need for them in Mexico.”

Goodman-Meza and his colleagues found the highest opioid prescribing rates in Baja California, Mexico City, Nuevo Leon, Sonora and Jalisco. Fentanyl was the most frequently dispensed opioid medication, followed by methadone, morphine, tapentadol, oxycodone and hydromorphone.

Baja California, Nuevo Leon and Sonora all border the United States, and have a “heavy concentration of pharmacies” just a few miles away from San Diego, El Paso and other U.S. cities. The researchers noted that many of these pharmacies had an increase in opioid dispensing during the study period.

Although they did not examine cross-border purchase data, researchers believe “medical tourism” by Americans probably contributed to more opioid prescriptions being filled in Mexico.

"As the U.S. has tried to curb the epidemic related to prescription opioids by instituting structural mechanisms such as closing 'pill mills' and instituting prescription drug monitoring programs (PDMPs), individuals may be getting around them by going to Mexico to get opioids," Goodman-Meza said. "Continued surveillance at border crossings is necessary to avoid unmonitored entry of opioids into the U.S."

Unintended Consequences of PDMPs

Another unintended consequence of U.S. policy to limit opioid prescribing is that it may be forcing some patients to turn to illicit drugs.

A new study published in JAMA looked at state efforts to combat the opioid epidemic by using PDMPs to track opioid prescriptions. A team of Indiana University researchers found that while opioid misuse and “doctor shopping” by patients declined, drug deaths continued to increase, fueled largely by overdoses linked to illicit fentanyl, heroin and cocaine.    

“Heightened demand for diverted and illicit drugs might arise from limiting the supply of prescription opioids under certain conditions. These unintended consequences may occur if the fundamental causes of demand for opioids are not addressed and if the ability to reverse overdose is expanded without increasing treatment of opioid overdose,” researchers found.

“We believe that policy goals should be shifted from easy solutions (eg, dose reduction) to more difficult fundamental ones, focusing on improving social conditions that create demand for opioids and other illicit drugs.”

A 2019 study of PDMPs was more explicit, finding there was a “consistent, positive, and significant association” between them and heroin overdoses. A study conducted the previous year also found an increase in heroin deaths associated with PDMPs, along with a decline in overdoses linked to prescription opioids.  

CDC Focused on Rx Opioids While Fentanyl Deaths Soared 1,040%

By Pat Anson, PNN Editor

A new report from the Centers for Disease Control and Prevention documents an alarming increase in overdose deaths and how the agency’s 2016 prescription opioid guideline failed to stop the drug crisis from growing worse.

The study looked at fatal overdoses from 2013 to 2019, a period when U.S. drug deaths rose by over 56 percent, culminating with 70,630 Americans dying from overdoses in 2019.  

Deaths involving prescription opioids remained relatively flat during that period, while overdoses involving other substances rose, led by an astounding 1,040% increase in deaths linked to illicit fentanyl and other synthetic, mostly black market opioids. Overdoses involving heroin, cocaine and stimulants such as methamphetamine also rose.

DRUGS INVOLVED IN U.S. OVERDOSE DEATHS (2013-2019)

“Sharp increases in synthetic opioid- and psychostimulant-involved overdose deaths in 2019 are consistent with recent trends indicating a worsening and expanding drug overdose epidemic. Synthetic opioids, particularly illicitly manufactured fentanyl and fentanyl analogs, are highly potent, increasingly available across the United States, and found in the supplies of other drugs,” researchers reported in the CDC’s Morbidity and Mortality Weekly Report.

“Similarly, psychostimulant-involved deaths are likely rising because of increases in potency, availability, and reduced cost of methamphetamine in recent years. The increase in synthetic-opioid involved deaths in the West and in psychostimulant-involved deaths in the Northeast signal broadened geographic use of these substances.”

The new CDC study adds to a growing body of evidence suggesting that the agency’s controversial opioid guideline has been ineffective and misdirected. While the guideline helped reduce the already shrinking supply of opioid medication – prescription opioid use is now at 20-year lows – drug deaths linked to illicit fentanyl and other substances kept rising. Overdoses hit a record high last spring.

"This represents a worsening of the drug overdose epidemic in the United States and is the largest number of drug overdoses for a 12-month period ever recorded," the CDC said in a recent health advisory.

‘I Don’t Really Want to Die’

Many pain patients – including those who have used opioids safely and responsibly for years – now have difficulty obtaining opioid analgesics and live with untreated or poorly treated pain. A recent study found that nearly half of primary care clinics in the U.S. are unwilling to accept new patients on opioids, because they had either stopped prescribing them or feared scrutiny by law enforcement and regulators if they did.

“Why am I treated like a criminal for needing opioids? For 26 years opioids are the only treatment that allows me to have a life,” a pain patient recently told PNN. 

“My doctor stopped prescribing my pain medication without my consent, leading to rapid tapering and abrupt discontinuation. No medication and haven't heard from her since. She won't return my calls,” another patient said.  

“I'm at a very desperate point in my life,” said a patient with Complex Regional Pain Syndrome (CRPS). “The meds don't address my needs and I'm at my end. If something doesn't give right away, I will be gone! I don't really want to die but I feel that it is the only option left.” 

Some anti-opioid activists have turned a blind eye to pleas from patients and want opioid prescriptions reduced even further.

“Opioid scrips have been trending in a more cautious direction, (though we still have a very long way to go) while opioid OD deaths have soared. Some see this as a policy failure. They may not realize the main goal of more cautious Rx opioid use is to reduce incidence of OUD,” Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing (PROP), wrote in a recent Tweet.

But when asked by another poster if there have been declines in OUD — opioid use disorder — because fewer opioids are being prescribed, Kolodny said he didn’t know.

“OUD incidence isn't tracked. We're 25 years into an epidemic of OUD but still have lousy surveillance. So no hard data but if fewer people are exposed to a highly addictive drug, it's a safe bet that fewer people will become addicted,” Kolodny replied.

The CDC is currently working on an update and possible expansion of its opioid guideline – with the goal of releasing a revised guideline late this year. The agency’s Board of Scientific Counselors is holding a public hearing this Tuesday, February 16th to get an update from an “Opioid Workgroup” that is considering changes to the guideline. People interested in listening to the meeting online can register clicking here.

Acetaminophen Better Than NSAIDs for Acute Trauma Pain

By Pat Anson, PNN Editor

Acetaminophen (Tylenol) is superior to non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute pain in patients recovering from arm and leg trauma, according to new research published in the journal Academic Emergency Medicine. It’s the latest in a string of studies that recommend the use of non-opioid pain relievers for acute pain after discharge from a hospital.

The research is based on a study of 1,500 adults in the North African nation of Tunisia, nearly half of whom had bone fractures. Upon discharge from a hospital emergency department, the patients received either acetaminophen, a high-dose NSAID, or a combination of the two. Acetaminophen is commonly called paracetamol outside the United States.

After seven days, researchers found that nearly two-thirds (61.8%) of patients receiving paracetamol alone were “satisfied” or “very satisfied” with their pain relief. Only 11.4% required another oral pain reliever. The other two groups had similar satisfaction scores, but had lower rates of medication adherence. Side-effects such as vomiting and gastrointestinal pain were also more common in patients who received NSAIDs.  

“This study found that the combination of a high‐dose NSAID with paracetamol does not increase the analgesic effect compared to paracetamol alone. We also found that paracetamol alone is superior to high‐dose NSAID alone for post-traumatic extremity pain,” wrote lead author Mohamed Amine Msolli, MD, an emergency room physician at Fattouma Bourguiba University Hospital in Tunisia.

“Taking into account its superior efficacy and tolerability, paracetamol appears to be the most suitable first‐line therapy for managing mild to moderate posttraumatic extremity pain after discharge from the ED.”

Opioid analgesics are not widely available in Tunisia and most other Middle East countries, and were not included in the study. Nevertheless, the study findings are being cited as evidence that paracetamol is superior to both NSAIDs and opioids in treating acute trauma pain.

“The surprising efficacy of paracetamol over an NSAID, as shown by a 6.4% lower need for additional oral analgesics, may impact prescribing practices,” Andrew Chang, MD, a professor of emergency medicine at Albany Medical Center, said in a statement.

“Many ED patients who have a contraindication to NSAIDs but require analgesics upon ED discharge might be prescribed an opioid. Given the ongoing opioid epidemic, this study lends evidence to support the use of acetaminophen alone in such patients."

But the risk of long-term opioid use after an emergency room visit is actually quite low. A large 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

Acetaminophen also has risks that are not acknowledged in the Tunisia study. Excessive use of acetaminophen can lead to liver, kidney, heart and blood pressure problems. Acetaminophen overdoses are involved in about 500 deaths and over 50,000 emergency room visits in the U.S. annually.

WHO Guideline Only Recommends Opioids for Children Who Are Dying

By Pat Anson, PNN Editor

The World Health Organization (WHO) has released new guidelines on the treatment of chronic pain in children, recommending that prescription opioids only be used for children who are dying or seriously ill and not expected to recover.

The 56-page guideline calls access to pain management a “fundamental human right,” while at the same time warning that “evidence of the effectiveness and safety of opioids is completely lacking in children.”

The guideline emphasizes the use of physical and psychological pain therapies, while taking a cautious approach to opioids. Morphine is only recommended for children in palliative care and those with “life-limiting” conditions for which there is no cure and “an early death is expected.”

“Children who are appropriately prescribed morphine for chronic pain in the context of end-of-life care or in children with life-limiting conditions, may require morphine for the management of intercurrent, acute or breakthrough severe pain,” the guideline states.

“Time-limited use of morphine in these contexts should be at the lowest appropriate dose and duration possible and must be regularly reviewed in order to ensure the fewest possible adverse events. Healthcare providers and caregivers need to perform frequent and repeated reassessments of pain and other symptoms, and the principles and relevant guidelines for acute pain management should be followed, including having an opioid stopping plan.”

The new recommendations for children between 0 and 19 years of age are a marked departure from previous WHO guidelines for chronic pain, which said that opioids “are known to be safe and there is no need to fear accidental death or dependence.”

Those guidelines were withdrawn in 2019, after two U.S. congressmen accused the United Nation’s health agency of being “corruptly influenced” by opioid manufactures.  A coalition of palliative care organizations objected, saying WHO caved-in to political pressure.

“We are extremely concerned that the withdrawal of these guidance documents will lead to confusion and possible extreme measures that will hinder access to patients with legitimate medical needs,” the coalition said in a joint statement. “Lack of availability and limited access to these medications for legitimate medical treatment is a human rights violation.”

‘Very Low Certainty’ of Evidence

Most of the recommendations made by a WHO advisory panel – the Guideline Development Group (GDG) — are vague, conditional and based on “very low certainty” of evidence. One of GDG’s members was Andrew Kolodny, MD, a psychiatrist and addiction specialist who founded Physicians for Responsible Opioid Prescribing (PROP), an anti-opioid activist group.

Despite an admitted “paucity of high-quality research” on how to treat pain in children, the GDG recommended that children be treated from a “biopsychosocial perspective” that incorporates physical therapy and psychological interventions such as cognitive behavioral therapy.  

“Children with chronic pain and their families and caregivers must be cared for from a biopsychosocial perspective; pain should not be treated simply as a biomedical problem,” the GDG said.

There is surprisingly little discussion in the guideline about the risks and benefits of non-opioid drugs such as acetaminophen. Some of the recommendations border on platitudes, such as treatment being “child and family-centered” and “tailored to the family’s values, cultures, preferences and resources.”

One area where the GDG is adamant is the importance of treating childhood pain to prevent it from becoming a lifetime problem.

“Exposure to chronic pain in early life may have implications for the incidence, severity and duration of chronic pain, and may be associated with long-term, maladaptive neurological changes,” the guideline warns.

“Chronic pain in childhood is associated with progression of pain into adulthood and potentially predisposes these children to other chronic health problems in later life. The negative impacts of chronic pain also extend to family members who report a higher burden of care and a detrimental effect on family function. As such, chronic pain during childhood has a very significant negative impact on the child over their life course as well as their wider family unit, making appropriate diagnosis and management essential.”  

The GDG said large, multi-center trials are needed to examine the safety and efficacy of virtually all pain management therapies. Additional research is also needed for children suffering from cancer pain and those with developmental and intellectual disabilities.

Former President Trump withdrew the United States from WHO last year in a dispute over its handling of the COVID-19 pandemic. President Biden reversed that decision on his first day in office.  

Nearly Half of Primary Care Clinics Won’t Take New Patients on Rx Opioids

By Pat Anson, PNN Editor

A new study has confirmed what many pain sufferers have known for years: many primary care physicians in the U.S. are reluctant to accept new patients taking prescription opioids for chronic pain.

Researchers at the University of Michigan used a “secret shopper” technique by posing as female patients who have been taking opioids for years to relieve pain. They called 452 primary care clinics in nine states, asking if the clinic was taking new patients.

If the answer was yes, the “patient” said she was covered by insurance and was looking for a new provider because her primary care physician had either retired or stopped prescribing opioids. Each clinic was called twice with one of the two scenarios.

Nearly half (43%) of the clinics said their providers would not prescribe opioids in either scenario, while less than a third (32%) said their primary care providers (PCPs) might prescribe in both cases.

The remaining 25% of clinics gave mixed signals about what they would do. Simulated patients who said their doctor had retired were twice as likely to be told the clinic might prescribe opioids, compared with those who said their provider had stopped prescribing for an unknown reason – a scenario that suggested the patient may have been abusing opioids.

“These findings suggest that primary care access is limited for patients taking opioids for chronic pain, and differentially further reduced for patients whose histories are suggestive of aberrant use. This denial of care could lead to unintended harms such as worsened pain or conversion to illicit substances,” researchers reported in the journal Pain.

Many of the clinics that refused to prescribe said it was due to new policies, fear of legal ramifications, or administrative burdens involved in writing opioid prescriptions.

The findings are similar to another “secret shopper” study by the same research team in 2019,  which found that 40% of primary care clinics would not accept new patients on opioids, no matter what kind of health insurance they had.

Lead researcher Pooja Lagisetty, MD, an internal medicine physician at Michigan Medicine, says the new findings suggest that primary care clinics should consider whether they are discriminating against patients on opioid therapy.

"We need to make sure we're training prescribers and their teams in addressing the systemic biases that this research highlights," says Lagisetty. "We shouldn't even be thinking about the reason that patients are giving when they seek to access care.

"Even if you think that someone is using opioids for a reason other than pain, or that long-term opioids are not an effective pain care strategy, those are exactly the patients we in primary are should be seeing."

A 2019 PNN survey of nearly 6,000 pain patients found that nearly three out of four had difficulty finding a doctor willing to treat their chronic pain. Over a third of patients in our survey said they’d been abandoned by doctors and 15 percent said they were unable to find a new doctor.

Contact Congress to Make Changes in Federal Pain Study

By Richard Lawhern, PNN Contributor

On January 20, I sent a letter by email to the Acting Director and senior staff of the Agency for Healthcare Research and Quality (AHRQ).  The letter requests the federal agency to immediately withdraw its recent review of prescription opioids and other treatments for short-term acute pain. 

Grounds for the request are clear evidence of unjustified anti-opioid bias by the authors and gross fatal errors of methodology – all of which invalidate the review as resource material for efforts to revise and expand the 2016 CDC opioid guideline.

The anti-opioid bias of Roger Chou and his co-authors is revealed by their selective cherry-picking of references that fail to explore the major effects of genetics in patient response to opioid therapy, as well as improperly generalized findings based on trials of weak opioids like tramadol, which were applied to all opioids.

The AHRQ authors also omit any exploration of serious side effects and mortality caused by non-opioid treatments such at acetaminophen.

But the most fundamental error in the methods of the AHRQ Review is improper use of “meta-analysis” to lump together data and outcomes from multiple small-scale studies of opioid therapy for acute pain. A major underlying assumption of meta-analysis is that patient response in each trial is distributed on a Normal (bell-shaped) curve. However, this assumption doesn’t work for patients treated with prescription opioids.

The distribution of patient outcomes is actually “bi-modal.” One group of patients may experience side effects from opioids, but very little short-term pain relief; while a second group may have substantial pain relief from just one dose of opioid medication. This reality invalidates the major findings of the AHRQ review.

A detailed critique of the AHRQ study is available on my website. Feel free to review and share this information with your personal physician.

AHRQ is fully aware of the errors noted above but has no intention of responding to demands for a correction of its malfeasance and fraud.  Thus, it may be necessary for the U.S. House Government Oversight and Reform Committee to direct AHRQ to withdraw or rewrite its review. 

Such an action has precedents.  In 2015, the Oversight Committee reviewed complaints from the Washington Legal Foundation and others concerning inadequate public hearings on the CDC’s proposed opioid guideline. The committee sent a letter to then-CDC Director Thomas Frieden asking him to explain why so much secrecy was involved in the drafting of guideline and why it wasn’t made publicly available.

Faced with a congressional inquiry, CDC reversed course by delaying the guideline’s release and publishing the draft in the Federal Register for a 30-day public comment period. A new advisory committee was also formed to review the guideline, which resulted in some changes to its final recommendations.

Urgent Action Request

A similar effort is urgently needed by pain sufferers and their advocates to bring the AHRQ review to the attention of Congress, specifically to the House Government Oversight and Reform Committee. Those who wish to involve the committee in corrective action should telephone any or all of the Congressional offices of committee members. 

It is very doubtful that the representatives will actually see anything you leave in their contact portals online. But short, focused telephone calls are harder to ignore. The telephone numbers for members of the House Committee can be found here. If you reach a staff member in their office, you might offer the following information:

1) Identify yourself and provide a call-back number. If you are a medical professional, state your qualifications (i.e. “I am a board certified physician” or “I am a former nursing professional now disabled by agonizing pain.”)

2) If you are a resident of the Representative’s district, say so. You don’t have to be a constituent to make your input.

3) Tell the staffer that you want to report fraud and abuse to the Representative and to the House Congressional Oversight and Reform Committee. 

“I want the Committee to demand corrective action from the Agency for Healthcare Research and Quality, in the same way it did in 2015 when it told the CDC to re-open its proposed opioid guideline to extended public review.”

“AHRQ published a review of treatments for acute pain in December 2020. The review is deliberately biased against the only therapies that work, deeply flawed by errors of scientific method, and outright fraudulent in its conclusions. This review must be withdrawn for independent review.”

4)  Thank the staffer for their time.  Ask “May I expect a callback from a member of the Representative’s staff?”

This is an opportunity to be heard, despite the lies being shouted by anti-opioid fringe groups like Physicians for Responsible Opioid Prescribing (PROP) and Shatterproof.

It is time for you to speak up!

Richard “Red” Lawhern, PhD, has for over 20 years volunteered as a patient advocate in online pain communities and a subject matter expert on public policy for medical opioids.  Red is co-founder of The Alliance for the Treatment of Intractable Pain.

Over-the-Counter Pain Meds and Gabapentin Recommended for Trauma Patients

By Pat Anson, PNN Editor

Over-the-counter pain medications and gabapentin are the best line of treatment for trauma patients suffering from acute short-term pain, according to new study at a Texas hospital that minimizes the use of opioids.

Researchers at the Red Duke Trauma Institute at Memorial Hermann-Texas Medical Center in Houston assessed two different combinations of non-opioid pain relievers in over 1,500 patients being treated for acute trauma, such as bone fractures and head injuries.

The treatment protocol that was deemed superior included a combination of inexpensive over-the-counter drugs such as acetaminophen and naproxen, with the nerve medication gabapentin (Neurontin). Opioids such as tramadol and oxycodone were only prescribed for breakthrough pain.

"Narcotics are not the mainstay of therapy for acute pain," said lead author John Harvin, MD, a trauma surgeon at the hospital and an associate professor at The University of Texas Health Science Center at Houston. "The research shows us that seriously injured people with acute pain can effectively be treated with an opioid-minimizing strategy."

The study findings, published in the Journal of American College of Surgeons, showed that a first-line pain regimen that used acetaminophen, ketorolac, naproxen, gabapentin or lidocaine patches reduced the use of opioids without a significant difference in pain scores. Only 62 percent of the patients were discharged with an opioid prescription.

"We used a generic pain regimen that is affordable at discharge. The discharge medications acetaminophen and naproxen can be bought over the counter. The only drug that requires a prescription is gabapentin and an as-needed opioid, if prescribed," Harvin explained.

The use of gabapentin as a treatment for acute pain is controversial, because recent studies show it has no significant analgesic effect and is increasingly being abused. In 2019, the Food and Drug Administration warned that serious breathing problems can occur in patients who take gabapentin with opioids or other drugs that depress the central nervous system.

But the use of gabapentin and over-the-counter pain relievers is now the standard treatment protocol for trauma patients at Memorial Hermann-Texas Medical Center, and physicians there are working to adapt it for the treatment of acute burn pain.

"The best way to decrease someone's risk for long-term (opioid) use is to minimize their exposure during hospitalization and at discharge, and we now know there are excellent non-opioid medications available that effectively treat pain,” said Harvin. “We know that culture change will take time and effort, but we're excited to be learning how to best leverage opioid-minimizing drugs to improve care, and to offer a new model that can be adopted by any trauma center."

The risk of long-term opioid use after an emergency room visit is actually quite low. A 2017 study by the Mayo Clinic found that only about one percent of emergency room patients given an opioid prescription progressed to long term use.

"Our paper lays to rest the notion that emergency physicians are handing out opioids like candy," said lead author Molly Moore Jeffery, PhD, a Mayo Clinic researcher. “Most opioid prescriptions written in the emergency department are for shorter duration, written for lower daily doses and less likely to be for long-acting formulations."

California Doctor Reluctantly Agrees to Probation for Opioid Prescribing

By Pat Anson, PNN Editor

After a two-year battle with the state medical board, a northern California doctor accused of overprescribing opioid pain medication has agreed to a settlement that allows her to continue practicing while under probation for the next 35 months.

“I settled because I could not afford the legal fees to fight it further and because I was offered a deal that allowed me to continue to prescribe as I see fit, so that no one would get cut off their meds suddenly,” says Corinne (Connie) Basch, MD, a primary care physician in Arcata, a small city in rural Humboldt county.

“I was afraid if I went to a hearing and tried to appear pro se (without an attorney) and somehow pissed off the judge I might wind up with a settlement that prohibited prescribing for a year, which was their initial proposal, and that there might be preventable deaths in my patient population as a result.”

If Basch’s medical license was suspended or revoked, all 1,500 of her patients would have to find new doctors, not a simple task in a remote community where healthcare choices are already limited, especially for pain patients.

The 2019 complaint against Basch by the Medical Board of California centered on her treatment of five patients on relatively high doses of opioids and benzodiazepines, an anti-anxiety medication.

Although Basch tried to taper the patients to lower doses, the complaint alleges their dosages were still excessive and placed them at risk of overdose. No allegations were made that any of Basch’s patients were harmed while under her care.

DR. CORINNE BASCH

“I have a number of people who have been absolutely unsuccessful with every attempt to taper, for whom I was afraid,” Basch wrote in an email to PNN. “I also read some old decisions, basically convictions of doctors in my region. I read how the judges made their decisions: basically going completely on the credibility of this or that expert witness, imputing expertise on state expert witnesses who had not seen any patients for multiple years. 

“It was becoming increasingly clear to me that nobody was going to actually read any of the medical literature that objects to forced tapers and so on — that this whole thing was not going to be argued on its merits, that I was going to be perceived as a defensive miscreant, not as someone bound by conscience to make a different choice.”

Under the strict terms of her settlement, which takes effect today, Basch is required to keep detailed records of all controlled substances she prescribes, which must be “available for immediate inspection and copying” by board investigators. She must also take a series of educational classes on safe prescribing and medical record keeping, and have her practice monitored by another physician throughout her probation – all at her own expense.

Basch is worried about how she will pay for it all -- her entire income last year was $50,000 – but feels obligated to her patients to keep practicing.

“I have some guilt about caving, and also some fear about whether I can actually survive the financial costs of the probation, particularly in the middle of this pandemic which has been so incredibly expensive and challenging for my practice already, but ultimately I felt that I was going to be best able to protect my patients with this choice,” she said.

“As you can tell, I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.” 

Doctors Shamed for Prescribing Opioids

The California medical board has come under fire in recent years for its controversial “Death Certificate Project,” which resulted in threats of disciplinary action against hundreds of doctors who wrote opioid prescriptions for patients who fatally overdosed, sometimes years later.

The goal was to shame doctors to reduce opioid prescribing, but a recent study found that overdose deaths actually increased in the state after the project was launched. Many of the deaths involved street drugs, not prescription opioids.

Critics say the Death Certificate Project and other enforcement actions have had a chilling effect on doctors statewide.

“I am still incredibly angry about the whole thing, and I feel that the medical board is actually contributing to increased deaths in California, as well as tragically harming our profession.”

— Dr. Corinne Basch

“Through your project, you have attacked many prominent, respected physicians, publicly shaming them as careless prescribers and threatening any doctors who had ever prescribed opioid pain medications for someone who ultimately died. This ‘witch hunt’ has caused many deaths and much suffering,” Kristen Ogden and other patient advocates with Families for Intractable Pain Relief wrote in a recent letter to the medical board.

“When you consider how many California physicians have left the practice of pain care, only a small percentage of the patients harmed have managed to continue to receive pain care at all. Most have not found any pain care, and are suffering agonizing lives for no reason. A few patients we knew have committed suicide because they did not find adequate care and were unable to live with the agony of untreated severe, constant intractable pain.”

The Death Certificate Project is now under review by the medical board and has been given the less inflammatory name of “Prescription Review Program.”

Basch was not targeted under program, but believes the board’s disciplinary actions against her and other doctors have only made the opioid crisis worse.  

“I feel there is a significant parallel to the medical board claiming to ‘do something about the opioid crisis’ and in fact doing the exact wrong thing, taking stable patients off of predictable prescribed medications and throwing them out to street supply which is increasingly adulterated and hazardous. This triumph of appearance over substance is at the root of so many wrongs in our current system,” Basch said.

“I do feel that the medical board should in some way be held accountable for their own negligence, for making policies and not monitoring the outcome, for doubling down on these policies even when the error has been pointed out to them. I am not sure how to get politicians interested in the situation, because it implies understanding the situation with enough depth to see that ‘opioids – bad’ is not a well- conceived policy.”

It’s High Time to Stop the Hurt

By Leslie Bythewood, Guest Columnist

Imagine waking up one morning with the worst pain you could ever dream up.

That’s what happened to me in 2000, only it would take another seven years before my now retired doctor broke the news that I had Arnold-Chiari malformation, a rare and incurable disease that causes unrelenting head pain.

A brain MRI revealed that my skull was squeezing my brain like a sponge, putting extreme pressure on the arteries in my brain. “It herniates out,” my doctor explained.

Fortunately, he was willing to prescribe opiates and my pain was well-managed for the next decade.

But in 2017, the year I became eligible for Medicare, I learned my doctor had opted out of that federal program, forcing me to find a new primary care physician. That’s when my life suddenly took a nosedive.

For the next year, four different physicians would attempt to taper me off opiates without my consent, causing my chronic pain to escalate exponentially and inflicting all sorts of adverse side effects from the anticonvulsants and antidepressants they prescribed.

I eventually found a caring doctor who understood my pain and immediately put me back on the tried-and-true opiate treatment plan that enabled me to function.

LESLIE BYTHEWOOD

One year later that doctor was forced to abruptly surrender his DEA license without justification, preventing him from prescribing opiates to any of his patients, including me. Nevertheless, undeterred and refusing to leave his patients in the lurch, he provided a soft landing by referring all of us to new doctors, enabling me to carry out my daily activities with no pain or intolerable side effects.

Opiates are the only class of medication that work for me and millions of other Americans with intractable pain, but it’s hard for many of us to find doctors willing to prescribe them. What caused the vast majority of doctors to go running the other way with their tails tucked between their legs was the 2016 CDC opioid guideline, which encourages cautious prescribing and arbitrary 90 MME dose limits.

Almost immediately after the guideline was released, patients could no longer count on their doctor to make informed clinical decisions about whether to prescribe opiates. The CDC had driven a big fat wedge between the doctor and the patient.

Many doctors never considered the CDC guideline as voluntary and viewed it as an unbending rule that tolerates no wiggle room. They gave their patients two choices: either taper off opiates or be dismissed for good.

The truth of the matter is that only a small percentage of patients become addicted to opiates. The vast majority take their medications as prescribed and are never at risk for addiction or overdosing. And that’s exactly why, despite the fact that opioid prescribing is at a 20-year low, the number of U.S. overdose deaths continues to soar, driven by street drugs such as heroin, cocaine, illicit fentanyl and methamphetamines, not pain medication.

The blame for this lies squarely with the CDC, DEA, Department of Justice and the news media, who continue to point the finger at doctors for “overprescribing” when the real culprit is street drugs. We don’t have an “opioid epidemic” at all. What we have is a street drug overdose epidemic, plain and simple.

The harm that’s been inflicted on millions of chronic pain patients needs to be rectified by throwing out the misguided CDC guideline and leaving it to the Food and Drug Administration to publish a new set of guidelines that do not encourage arbitrary dosage limits and restore the doctor-patient relationship.

But scrapping the CDC guideline doesn’t go far enough.

We desperately need federal and state laws that protect doctors and patients from the unwarranted, overreaching scrutiny of the DEA and ensure that patients with serious and debilitating diseases get adequate care without delay. Forced tapering and leaving people to suffer in pain are not the answer.

Once and for all, the war on drugs must come to a screeching halt. Restricting legitimate patients from access to opiates is not going to end the street drug overdose epidemic.

Leslie Bythewood is a freelance writer who lives in North Carolina.

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

Opioid Prescribing Limits Failed to Reduce Overdoses in British Columbia

By Pat Anson, PNN Editor

British Columbia’s opioid guideline failed to have any significant impact on overdoses, hospital admissions or deaths in the year after it was adopted, according to new research published in CMAJ Open. The study is the latest to show that opioid prescribing limits have been misdirected and ineffective in slowing North America’s opioid crisis.

The College of Physicians and Surgeons of British Columbia released strict professional guidelines for the “safe prescribing” of opioids and sedatives in 2016, after the Canadian province was hit by a wave of overdoses and deaths. The BC guidelines, which are similar to the CDC’s opioid guideline in the United States, warn doctors to be cautious about opioid prescribing and to avoid increasing doses over 90 morphine milligram equivalents (MME) per day.

Researchers at the University of British Columbia wanted to see how effective the BC guideline was in reducing overdoses, so they analyzed health data on over 68,000 patients on long term opioid therapy. A previous study by the same research team found a “modest” reduction in opioid use in the 10 months after the guideline was introduced, as well as more tapering.

Did the reduced prescribing result in fewer overdoses?  No.

Researchers found no significant change in opioid overdose hospital admissions, opioid overdose mortality, all-cause emergency department visits, all-cause mortality, or all-cause hospital admissions after the BC guideline was adopted. They also found no evidence that pain patients turned to street drugs after their opioid prescriptions were reduced or stopped.

“Concern has been expressed that policies focused on reducing prescribing of opioid analgesics could increase opioid-related deaths if patients unable to access prescription opioids for adequate pain relief turned to street drugs and were exposed to dangerously high levels of synthetic opioids. Our study did not find evidence that the standards and guidelines had the unintended consequence of increasing opioid overdose hospital admissions or opioid overdose mortality,” wrote lead author Richard Morrow, a senior research analyst at UBC.

Critics say the lack of evidence is proof that opioid prescribing has little to do with British Columbia’s overdose crisis.   

“The results are not unexpected and demonstrate the folly of limiting opioids to pain patients in a futile attempt to deal with overdoses from illicit street drugs. The policy has created considerable pain and anxiety along with a worsening quality of life for nothing,” said Marvin Ross, a patient advocate with the Chronic Pain Association of Canada. 

British Columbia’s Coroners Office expects 2020 to be a record breaking year for overdoses in the province, with about five drug deaths every day. A recent study found that the vast majority of BC’s overdoses involved illicit fentanyl and other street drugs. Only 2.4% of the nearly 1,800 fatal overdoses in BC from 2015 to 2017 involved opioid medication alone.

Stricter opioid prescribing policies have also been ineffective in slowing the overdose crisis in the United States. Prescription opioid use in the U.S. is at its lowest level in 20 years, while more Americans are dying from overdoses than ever before.