“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
A colleague who I highly respect just informed me of a woman with intractable angina who had multiple, inserted coronary splints and required a high daily dose of morphine. Without warning, her insurance company arbitrarily decided she did not need opioids. As one might expect, the forced cessation of opioids led to her death.
The forced reduction and/or cessation of daily opioids in stabilized patients have, in some corners of our country, reached the point of unscientific and inhumane hysteria. The craze to fight opioid abuse and force opioid dosages below 100 to 120 mg of morphine equivalents a day (MEQ) is now harming some patients who have been doing quite well on stable, daily opioid dosages. Some of the rhetoric and tactics being used to force opioid reduction are farcical if they weren’t so tragic in their consequences.
First, who is doing the forcing? There are multiple culprits: insurance companies, state legislators, regulators, and suppliers. Some of the tactics to force opioid reduction are indirect, such as limiting the amount of opioids a pharmacy can stock. Others are blatant, such as states that require physicians to seek a pain consultation if they continue to prescribe over a threshold MEQ level, even to patients who have been well maintained for a considerable time period. For example, in Washington State, a 120 mg/d MEQ threshold will trigger the prescribing physician to conduct, or refer the patient for, a pain consultation (exceptions and exemptions do exist). As noted by Stephen J. Ziegler, PhD, JD, “in some states, these thresholds appear in regulations, making the actions required actions, while in other states the thresholds appear in guidelines, making the actions merely recommended.”
Insurance companies are currently the most dangerous “forcers.” Neither patient, pharmacist, nor physician is prepared when a stable, opioid-maintained patient goes to fill a long-standing opioid prescription only to be told their insurance company has suddenly decided the patient should immediately cut their opioid daily dose by 30% to 70%, or even stop it altogether. The saddest aspect of this dangerous practice is that the motive is clearly greed, although the reduction may be accompanied by an “out-of-the-blue” statement that the forced reduction is for the patient’s safety. For example, insurance companies have recently informed long-standing, opioid-maintained patients that they have suddenly and capriciously decided they will no longer cover brand name opioids, injections, patches, compounded formulations, or a daily dosage above a specific level.
Insurance companies and some state guidelines are spitting out two illogical excuses for the forced reduction of opioids. One is that opioids dosages above 120 mg or so of MEQ are unsafe. Show me a study that indicates tissue toxicity of opioids at dosages over 120 mg in patients who have been maintained at a stable dosage for over 1 year. Patients who have been titrated up to dosages above 120 mg of morphine and periodically monitored by competent physicians almost always experience improved health and function, not the reverse. I have several patients who have been safely maintained on high opioid dosages and led quality lives for over 20 years!! Why force these folks into sickness, suffering, and possibly death by suddenly and capriciously claiming their life-saving medication is dangerous?
The other straw-dog is “hyperalgesia.” Would someone please tell me how I’m to define and diagnose hyperalgesia in a patient who has been well maintained on a stable opioid dosage—high or low—for over a year? Hyperalgesia has become a label and excuse to force down opioid dosages. Reputable and credible pain practitioners are not even sure it exists in a human who is well maintained on opioids. Whenever I see a patient who is on opioids and claims their opioids aren’t working as well as they used to, I take a hormone profile. Once I replace any deficient hormones, the patients’ opioids resume working.
My demand is for someone to send me the consensus document that tells me how to objectively diagnose hyperalgesia in patients who have been well maintained on opioids over 90 days. What’s more, if hyperalgesia exists, what harm does it do? If we really believe that hyperalgesia is a problem with high-dose opioids, we must remove all intrathecal opioid pumps because these devices deliver a MEQ directly to the CNS receptors that is far in excess of any dosage we can achieve by peripheral administration!!
Readers of Practical Pain Management well know that severe, constant pain has far more risks than any stable, daily opioid dosage. Severe pain adversely affects the cardiovascular, endocrine, immune, and neurologic systems. It sends patients to bed in agony to lead a short, suffering life. There is no need to take these risks in a caring, concerned society, as a minute extract from the opium plant can prevent these complications and the pathetic, miserable death that a forced opioid reduction can bring.
So what do we do at this point? First, physician’s need to correct any false comments about the imagined dangers of stable, on-going opioid dosages. Whenever possible, pain practitioners should attempt to prescribe non-opioid pharmaceuticals that have come forward in recent years. In the latter category, I place ketamine, anti-epileptic agents (gabapentin, pregabalin, etc), and neurohormones (oxytocin, human chorionic gonadotropin, and progesterone). I’ve cut my patients’ opioid use by about 50% over the past 5 years by use of these new agents. I also recommend obtaining an opioid serum level in patients who take over 100 mg of MEQ. The presence of a reasonable opioid serum level indicates that the patient is ingesting opioids and is functioning well with a high opioid dosage.
Lastly, and most important, families of patients who must take a high daily opioid dosage need to become publicly active as advocates for their loved one. Unfortunately, but realistically, patients who must take a high opioid dosage always have a debilitating condition such as arachnoiditis, CRPS, traumatic brain injury, post-encephalitis headache, or facial neuropathy, and are too ill to fend for themselves. But their family can. Its time families demand the right of their suffering loved ones to obtain opioids, and their direct and blunt communication should go to State Medical Boards, insurance companies, wholesale suppliers, and their elected representatives.
Also, pain patients and family members should start joining the emerging nationwide organizations that are now forming to fight back. While we physicians have little public voice left, families of pain patients can, should, and will be heard.
Dr. Forest Tennant is pain management specialist in West Covina, California who has treated chronic pain patients for over 40 years. He has authored over 300 scientific articles and books, and is Editor Emeritus of Practical Pain Management.
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.
One of my readers took exception to me using this graphic on a recent post… believing that it referenced the 19th and early 20th century lynching that occurred in our country.
I used this graphic in regards to situation in Buffalo NY where
when a pain physician was shut down and untold thousands of pts were tossed into the street .. in a community that knowingly did not have the health care resources to absorb these pts..
Here is another similar incident in Fort Wayne , IN
where abt 5000 chronic pain pts were thrown to the street and the local health care community knew that they didn’t have the resources to even begin to absorb and treat these pts.
These are the ones that have showed up on my “radar screen”… I am sure that there are numerous others with smaller numbers of pts involved. Who believes that all of these pts will regain a practitioner that will treat their pain… how many die from the consequences of being thrown into cold turkey withdrawal?… how many have committed suicide ?
How much difference is there between the mindset of those lynching blacks and whites in the 19th and 20th century and what is happening today? Back then we had a certain group of individuals.. that believed that they had the right to “sanitize” our population from what they had decided was “undesirables”. Unlike today, the victims of this genocide was much more visible … because many were found hanging from trees.
Today, those who are trying to “sanitize” our population of – in their opinion – “undesirables”.. but today.. those people/groups are much more subtle in how they operate.. Instead of finding bodies hanging from trees. They are – for the most part – silently removed in body bags, and they become a statistic on some “bean-counter’s” spreadsheet.
Then they slice/dice the numbers and various parts of the Federal alphabet.. regurgitate the GROSS NUMBERS to condemn all of these deaths that the same or other parts of the Federal alphabet has caused or contributed to.
If the first graphic is OFFENSIVE… is the second graphic ACCEPTABLE ? Is “invisible genocide” on certain segments of our population acceptable ? Perhaps, offending some.. to get them to see the larger picture is just as necessary as trying to being politically correct and allowing those who are conducting this “invisible genocide” to continue.
The question has to be asked… if a pt is harmed because a practitioner does not follow all CDC guidelines to the same extent as the opiate guidelines… could the practitioner be guilty of MALPRACTICE ? For example.. a practitioner doesn’t INSIST/DEMAND that all pts have flu shots, Zostavax (Shingles), Prevnar-13, Pneumovax 23 and/or any other recommended vaccine or booster vaccines. Should a practitioner have the latitude to strictly adhere to some CDC guidelines and ignore others without liability if pts suffer consequences ?
Roughly 3 in 4 physicians said in a Medscape Medical News poll that they lean toward adopting the stricter guidelines on prescribing opioids for chronic pain that the Centers for Disease Control and Prevention (CDC) issued in March to combat an epidemic of addiction and overdose deaths.
The guidelines, aimed at primary care prescribers, state that opioids should not be considered as first-line therapy for chronic pain and that clinicians should first consider nonopioid pain relievers or nondrug alternatives, such as exercise, meditation, and cognitive-behavioral therapy.
Although 76% of physicians said in the online poll that they were very (49%) or somewhat (27%) likely to incorporate the CDC’s recommendations into their practice, they also pointed to roadblocks in their way. These include pressure from patients to prescribe opioids and the lack of third-party reimbursement for nondrug treatment of chronic pain. ‘Nurses, including advanced practice nurses (APNs), were slightly less willing (62%) to embrace the government’s recommendations.
For many clinicians, treating chronic pain is a significant part of their work. Thirty-five percent of all physicians said they see 31 or more patients with chronic pain per month, or slightly more than one a day on average.
Of the 483 Medscape readers who completed the poll as of noon on April 6, 241 were physicians, and of that number, roughly 20% were from outside the United States. Ninety-four nurses, including APNs, also weighed in.
“Good to Know I Was Right All Along”
In comments posted on the poll, some readers affirmed the CDC guidelines for prescribing opioids. One family physician wrote that it was the government’s responsibility to respond to the “huge problem” of opioid abuse that is killing 40 people a day. “I am going to strive to work with the guidelines and refer when the tools of my disposal have been exhausted,” he wrote.
A number of physicians indicated that the new government guidance is old hat to them. “CDC’s guidelines align with decades of evidence based medicine,” wrote one pain management physician. An internist exclaimed, “Good to know that I was right all along — denying patients opiates when other docs handed them out like candy — ridiculous!”
Contrary to what the poll results might suggest, however, most readers commenting on the guidelines expressed dismay. Many of them warned that the CDC recommendations, if followed, would make it so hard for patients in pain to get relief that they would turn to illegal street drugs, such as heroin. “I wonder how long it will be [before] any ‘unintended consequences’…begin to appear?” asked one neurologist. “Will the number of ‘accidental deaths’ actually increase?”
Other readers predicted that stricter prescribing of opioids will drive some desperate pain patients to commit suicide. “Get ready for a big increase,” said one pain management physician.
Another thread in antiguideline comments was resentment of a perceived government intrusion into the practice of medicine. A psychiatrist put it like this: “Kindly allow us to make the independent decisions about prescribing, for which we obtained a medical doctorate.”
Acceptance of the guidelines may be grudging. “I worry that most docs will want to follow them to feel protected against potential lawsuits,” wrote a healthcare administrator.
What About the Patients Already Taking Opioids?
Some of the criticism that Medscape readers leveled against the CDC opioid guidelines center on their real-world feasibility. The Medscape poll attempted to better understand that complaint by asking readers to identify the biggest barrier to implementation from a list of four that readers frequently mentioned in article comments.
Table 2. What Do Clinicians See as the Biggest Obstacle to Following These Guidelines?
Responses
All Physicians (%)
Nurses, Including Advanced Practice Nurses (%)
All Respondents (%)
Not enough safe pharmalogic alternatives to treat pain effectively
21
23
28
Lack of insurance coverage for nonpharmalogic modalities
19
20
17
Concerns about patient complaints, low satisfaction scores when pain isn’t resolved with nonopioids
20
14
19
Patients already receiving opioids for chronic pain
33
31
30
Other
6
9
6
The obstacle identified by the most physicians (33%) as number one is that many patients already take opioids for chronic pain. Physicians question whether they can switch these patients to nonopioid analgesics or nondrug therapy. “The CDC doesn’t seem to have any recommendations about what to do for them,” said one family physician. A clinical nurse specialist asked, “If a patient has been stable for years on a regimen [of opioids] and is not demanding more, where is the problem?”
To 21% of physicians, the biggest hindrance to implementation is not enough safe pharmaceutical alternatives to opioids for effective pain relief. In the words of one family physician, “acetaminophen doesn’t work [and] NSAIDs [nonsteroidal anti-inflammatory drugs] cause renal failure and GI [gastrointestinal] bleeding. Insurance won’t pay for topicals; steroid injections, at least into the spine, are rarely ever effective.”
A nearly identical proportion of physicians put lack of insurance coverage for nonpharmaceutical treatment of pain at the top of the obstacle list. “It would be nice if Medicare put their money where their mouth is in regard to paying for functional recovery programs to get long-term users off the opioids,” wrote one physician. “They agree it works, but won’t pay for it, at least in Michigan.”
Another one in five physicians pointed to the problem of patient complaints and low patient satisfaction scores when nonopioid pain relief doesn’t work. In their article comments, many physicians trace this phenomenon back to the movement in healthcare to make pain the fifth vital sign and never undertreat it. “As long as hospitals pay attention to patient satisfaction surveys, [patients] will be getting their happy pills,” said an emergency medicine physician.
A colleague added, “Let ER [emergency room] and primary doctors feel empowered to say no to drug-seeking patients without fear of reprisal from administrators who are ignorant of what drives true quality.”
Along those lines, many physicians contended that the opioid epidemic is not “doctor driven,” as CDC Director Thomas Frieden, MD, MPH, claimed recently but partly is the result of outside pressures to prescribe these drugs.
“It bothers me that Dr Frieden calls this a ‘doctor driven epidemic’,” said a pain management specialist. “Big Pharma’s push for profits by aggressively marketing opioids such as OxyContin is also a driving factor. The push that pain is the fifth vital sign and that we can achieve pain free life drives this as well. The policies of the government that drive a vision of healthcare where patients are customers to be satisfied and tying payments to satisfaction surveys drives this.
“Doctors bear our share of responsibility, but this national crisis has many authors,” the specialist said.
Remember that time you told your rowdy niece Elsa (her parents are “Frozen” nuts) to stop banging that pot, only to have her switch to banging a pan instead? That’s kind of like what a STAT report says some Chinese chemical companies are doing, except instead of switching from pots to pans, they’re switching from old deadly drugs to designer deadly drugs. This week’s three W’s: What? Which? And What Else?
What?
The feds haven’t outlawed unicorn trafficking. Why? Because (spoiler alert!) unicorns don’t exist. Similarly, they don’t ban drugs that don’t exist. Thus, Chinese chemical companies have been slightly altering drugs to make new compounds that can’t be regulated until the DEA learns they exist, STAT says. The DEA then confabs with the FDA and it makes the drugs controlled substances. The company, of course, then just alters the drugs again. Said a spokesman from the DEA’s Department of Understatement: “It is a challenging process for us.”
Which?
According to the STAT report, the most recent culprit is the pleasantly alliterative furanyl fentanyl, a tweaked version of fentanyl, the narcotic painkiller involved in thousands of overdose deaths. This newest version already reportedly chalked up a kill, a 30-year-old man in Illinois.
What else?
Tweaking the chemical structure of drugs isn’t the only trick. The Washington Post reported that a Chinese chemist recently resurrected a powerful, synthetic opioid painkiller that was patented in North America in the 1980s, but abandoned before it ever came to market. The drug is known only as W-18, and an expert told the Post that it is, oh, about 10,000 times stronger than morphine and around 100 times more potent than fentanyl. But who’s counting, amirite?!?
They Said It
A Chinese chemical company told STAT that furanyl fentanyl was new to its catalogue, and for “laboratory research.” Uh huh.
After 45 years, more than $1 trillion wasted, and the creation of the world’s largest prison system, America still lacks the political will to change its failed drug policy
Forty-five years later, America is still grappling with the dark origin of the Drug War, launched in 1971 by President Nixon.
In March, the commander in chief of the War on Drugs stood in front of a crowd of policymakers, advocates and recovering addicts to declare that America has been doing it wrong.
Speaking at the National Prescription Drug Abuse and Heroin Summit in Atlanta – focused on an overdose epidemic now killing some 30,000 Americans a year – President Barack Obama declared, “For too long we have viewed the problem of drug abuse … through the lens of the criminal justice system,” creating grave costs: “We end up with jails full of folks who can’t function when they get out. We end up with people’s lives being shattered.”
Touting a plan to increase drug-treatment spending by more than $1 billion – the capstone to the administration’s effort to double the federal drug-treatment budget – Obama insisted, “This is a straightforward proposition: How do we save lives once people are addicted, so that they have a chance to recover? It doesn’t do us much good to talk about recovery after folks are dead.”
Obama’s speech underscored tactical and rhetorical shifts in the prosecution of the War on Drugs – the first durable course corrections in this failed 45-year war. The administration has enshrined three crucial policy reforms. First, health insurers must now cover drug treatment as a requirement of Obamacare. Second, draconian drug sentences have been scaled back, helping to reduce the number of federal drug prisoners by more than 15 percent. Third, over the screams of prohibitionists in its ranks, the White House is allowing marijuana’s march out of the black market, with legalization expected to reach California and beyond in November.
The administration’s change in rhetoric has been even more sweeping: Responding to opioid deaths, Obama appointed a new drug czar, Michael Botticelli, who previously ran point on drug treatment in Massachusetts. Botticelli has condemned the “failed policies and failed practices” of past drug czars, and refers not to heroin “junkies” or “addicts” but to Americans with “opioid-abuse disorders.”
“One of the biggest reasons why people don’t seek care is shame and stigma,” Botticelli told reporters last year. “What we’ve been trying to do is change the language.”
Despite strides toward a more sane national drug policy, the deeper infrastructure of the War on Drugs remains fundamentally unaltered under Obama. Work focused on public health has not replaced paramilitary anti-trafficking efforts, known as interdiction, at home or abroad. Rather – much like an “all of the above” energy strategy that embraces solar while continuing to remove mountaintops in pursuit of coal – the new policies supplement the old.
As a result, the Drug War is costing taxpayers more than ever. Obama’s 2017 drug budget seeks $31 billion, an increase of 25 percent from when he took office. This year, the federal government is spending more than $1,100 per person to combat the habit of America’s 27 million illicit-drug users, and 22 million of them use marijuana.
Watch “The War on Drugs: By the Numbers.”
The blinkered drug-warrior culture in the ranks of the departments of Justice, State and Defense remains similarly entrenched. The acting chief of the Drug Enforcement Administration calls medical marijuana “a joke.” The State Department’s top drug official insists, “Our objective remains … eliminating the use of marijuana in the United States.” With pot, such knee-jerk commitment to prohibition might be amusing. With harder drugs, it has deadly ramifications. At home, the administration’s early crackdown on prescription opioids helped drive the current spike in heroin deaths. South of the border, cartel violence rages unabated, despite the recapture of Mexico’s most notorious drug lord; the country’s homicide rate in February spiked to 55 murders a day.
The futility of the greater Drug War was laid bare in recent Senate testimony by top admirals charged with combating global narcotraffic. They confessed they had no solution to halt the flow of heroin from Mexico; admitted global drug suppliers would invariably service U.S. demand; and pressed the government to steel itself for a 30-year nation-building effort in drug-ravaged Mexico and Central America.
Sen. Bill Nelson (D-Florida), the senior member of the Armed Services Committee, sought to put a rosy spin on proceedings. “At least we got El Chapo,” he said. “So that was a step in the right direction.”
Forty-five years on, America is still grappling with the dark origins of the Drug War, launched in 1971 by President Richard Nixon – for political purposes.
Nixon’s domestic-policy adviser, John Ehrlichman, in an interview published posthumously in Harper’s this year, revealed the true aim of the Drug War was to criminalize the administration’s “two enemies: the anti-war left and black people.” As Ehrlichman explained, “We could arrest their leaders, raid their homes, break up their meetings and vilify them night after night on the evening news.”
Nixon himself wove anti-Semitism into the mix. “Every one of the bastards that are out for legalizing marijuana is Jewish,” Nixon groused to his chief of staff, Bob Haldeman, in a conversation recorded in the Oval Office in May 1971. “What the Christ is the matter with the Jews, Bob?” Nixon asked. “By God, we are going to hit the marijuana thing, and I want to hit it right square in the puss.”
More than $1 trillion later, Nixon’s war has hollowed out urban black communities, visited death upon downtrodden whites in rural America and unleashed horrific violence from Bogotá to Ciudad Juarez. In Mexico, since 2007, as many as 80,000 civilians have been murdered in drug violence. Despite the carnage, prohibitionist policies enforced through military interdiction and domestic incarceration have done little to curb the American drug habit – which fuels $64 billion a year in cartel profits, according to an estimate by the Treasury Department.
America remains the world’s top consumer of illicit drugs. The government’s National Survey on Drug Use and Health from 2015 found nearly one in 10 Americans over the age of 12 had used an illicit drug in the previous month. The surge in Drug War spending notwithstanding, American drug use is up modestly – the highest since 2002.
By the government’s own metrics, the Drug War is failing. In December, the Government Accountability Office published a report titled “Office of National Drug Control Policy: Lack of Progress on Achieving National Strategy Goals.” GAO found that “none of the goals” of the Obama drug strategy have been met, and significant progress can be seen only in a slight reduction in drug use among teens.
Obama’s Drug War leadership has been uneven, an evaluation shared by drug warriors and reformers alike. Beyond big-picture objectives – softening mandatory-minimums, ensuring drug treatment and avoiding a firestorm over marijuana – the first six-plus years of the administration were marked by the president’s lack of interest in the nuts and bolts of the Drug War. “I don’t think it’s controversial by any stretch of the imagination to say that drug policy was not a priority,” says Kevin Sabet, a senior adviser in Obama’s ONDCP from 2009 to 2011.
The administration’s previous drug czar, gruff former Seattle police chief Gil Kerlikowske, reported to Vice President Joe Biden, who had made his bones as one of the Senate’s top drug warriors. Obama did not even introduce the National Drug Strategy in 2010. “This was the ‘president’s drug strategy,'” laments one of its drafters, “and there just wasn’t interest.”
As a result, much of the Drug War continued on a glide path. Obama even carried over George W. Bush’s DEA chief, Michele Leonhart, who would refuse to admit, under House grilling in 2012, that marijuana is a less dangerous drug than crack cocaine.
Obama’s inattention also sparked infighting among reformers and hard-liners in the policy ranks – explaining the whipsaw treatment of medical marijuana during Obama’s first term. A 2009 Justice Department memo, interpreted in the states as a green light for commercial-scale medical marijuana, was unceremoniously revoked in 2011 – after rearguard action by career drug warriors, including Sabet: “I pushed very hard behind the scenes to get a clarifying memo in 2011, saying, ‘Oh, wait a minute, you guys took it the wrong way.'” The new directive sparked a resurgence of marijuana prosecutions, above all in California.
Illustration by Victor Juhasz
Even the historic decision to condone pot legalization in Colorado and Washington in 2013, insiders say, reflected a White House desire to sidestep a political fight, rather than to provide bold leadership. Sabet calls the legalization decision “Obama’s ‘don’t ask, don’t tell'” – a reference to the clumsy compromise under President Clinton to allow gays to serve in the military, provided they stayed in the closet.
Only recently, confronted by a deadly spike in heroin overdoses nationwide, has Obama taken a hands-on approach to drug policy. Kerlikowske took a new position as the head of customs enforcement, and was replaced at ONDCP by his deputy Botticelli.
A study in contrasts from his cop predecessor, Botticelli is the first drug czar with experience in recovery: He’s an alcoholic 27 years sober. And as the former head of treatment services in Massachusetts, he pioneered the deployment of overdose-reversal drugs to police on the front lines of the opioid crisis.
“There’s a reason why my drug czar is somebody who came not from the criminal justice side but came really from the treatment side,” Obama told the crowd at the Atlanta heroin summit. “The only way that we reduce demand is if we’re … thinking about this as a public-health problem.
“It is so much more expensive,” Obama said, “for us not to … do the right thing on the front end.”
That is a lesson the White House learned at high cost. The administration’s first effort to crack down on opioids – focusing on Rx pills – contributed to the deadliness of today’s epidemic.
During the George W. Bush presidency, the death toll from prescription-opioid abuse, driven by easy access to drugs like OxyContin, tripled – approaching 15,000 in 2008. As Kerlikowske took the reins at ONDCP in 2009, he was determined to reduce the supply of painkillers available for abuse. “People were dying from OxyContin. We had to do something,” Sabet recalls, to stop “the carnage.”
The crackdown included a DEA campaign to shutter pill mills in states like Florida, where unscrupulous doctors liberally supplied opioids to addicted patients. The feds ratcheted up prescription monitoring to stop patients from stockpiling pills from multiple providers. The administration also forced drug companies to introduce abuse-resistant reformulations of drugs like OxyContin and Opana so they couldn’t be crushed and snorted.
These reforms showed early promise – slowing the rise in prescription-overdose deaths. But the administration failed to plan for the unintended consequences of restricting the prescription-drug supply: Americans desperate for a fix would turn to heroin instead. “No one considered the fact that these people aren’t going to go away,” says Theodore J. Cicero, a top academic opioid researcher at Washington University in St. Louis. “You make their drug harder to get, they don’t just stop taking drugs. That’s a very naive assumption. They switch to something else. Heroin has turned out to be a very inexpensive, readily accessible alternative.”
The consequences of that switch turned out to be deadly. And the overdose epidemic is now deadlier still because dealers often cut heroin with fentanyl, a fast-acting synthetic drug up to 40 times as powerful as heroin itself. “From a public-health perspective, we’ve gone in a reverse direction,” says Cicero. “We’ve generated a big problem from opiate-overdose deaths because we’re shifting people into heroin.” Today, about 75 percent of heroin users are former prescription-drug users.
The data tells the story: Heroin-overdose deaths surged, more than tripling from 2009, rising to 10,500 in 2014, driving an “epidemic,” according to the Centers for Disease Control and Prevention. “More persons died from drug overdoses in the United States in 2014,” the agency reports, “than during any previous year on record.” After a short plateau, prescription ODs have also spiked again, to nearly 19,000. The 30,000 combined opioid deaths now rival the carnage from car crashes (33,804) and gunshots (33,636).
Drug stats in America skew by race. But unlike arrests and incarceration, overdose deaths hit whites at nearly twice the rate of black Americans and three times the rate of Hispanics. Obama is now using this fact to push for a culture shift. “I’m going to be blunt,” he said in Atlanta. “Part of what has made it previously difficult to emphasize treatment over the criminal justice system has to do with the fact that the populations affected in the past were … stereotypically identified as poor, minority, and as a consequence, the thinking was it is often a character flaw in those individuals … and it’s not our problem they’re just being locked up. And I think that one of the things that’s changed in this opioid debate is a recognition that this reaches everybody.”
The severity of the epidemic has worn down historic Republican resistance to public-health-driven drug policy. In the 2016 federal budget, Republicans lifted a decades-long prohibition on most of the federal funding for needle exchanges.
On a conference call with reporters in March, Botticelli praised such programs as being “a great intervention point for out-of-treatment injection-drug users.” Answering a question from Rolling Stone, Botticelli even expressed openness to safe-injection sites – now being considered in cities from San Francisco to Ithaca, New York – where opioid users can shoot up under medical supervision, often with prescription-grade heroin.
“We haven’t taken a formal position on safe-injection sites,” Botticelli says. This is a startling about-face from past ONDCP pronouncements. Bush drug czar John Walters blasted safe injection as “state-sponsored suicide”; Kerlikowske has called these programs “a failure.”
Botticelli continued: “Taking a close look at these programs becomes very important for us – not only in terms of reducing overdose and infectious disease, but also how these programs might or might not [be] an entryway into treatment. It will be very interesting to see how these programs develop over the years.”
Police raid an opioid pill mill in Tampa in 2010. Edward Lin/Alamy
The administration’s increasingly enlightened approach to opioid addiction stands at odds with its confounding approach to a drug at the other end of the harm spectrum, marijuana.
Pot is far and away America’s illicit drug of choice, with 22.2 million users. (Texas, by comparison, has 27 million residents.) Marijuana use is increasing modestly – driven by a surge of adult use during the Obama years.
The administration’s hands-off approach to state legalization has broken the Berlin Wall of prohibition. Recreational pot is now legal in Alaska, Washington, Oregon, Colorado and the District of Columbia. And, not surprisingly, marijuana is a boom business: Colorado pot sales topped $1 billion last year, producing $135 million in tax revenue, including $35 million for school construction. The research firms Arcview and New Frontier project that the national legal market (recreational and medicinal) will be $7.1 billion in 2016.
The American public has never been more pro-cannabis: According to an AP poll, a supermajority 61 percent favor legalization – including 47 percent of Republicans. And legalization is expected to advance on the 2016 ballot. In California, the campaign for the Adult Use of Marijuana Act is funded by Facebook billionaire Sean Parker and backed by Lt. Gov. Gavin Newsom, who says the Drug War is an “abject – and expensive – failure.” Legalization proponents also point to promising November ballot initiatives in Nevada and Arizona.
Vermont may move sooner to become the first state to legalize through the legislative process. “The War on Drugs has failed when it comes to marijuana prohibition,” Gov. Peter Shumlin told lawmakers in January, promoting a bill to tax and regulate recreational pot. “Vermont can take a smarter approach.”
Prohibition took another blow this year when Prime Minister Justin Trudeau took power in Canada after campaigning in part on a legalization platform. According to a lawmaker close to the effort, Canada is likely to implement a regime for legal marijuana by 2017.
In the face of this progress, however, federal policymakers are redoubling prohibition efforts. In March, assistant secretary of state for drugs and law enforcement William Brownfield declared, “Our objective remains that of limiting and eventually eliminating the use of marijuana in the United States of America because of its harm and its dangers.”
Although he touts “evidence-based” drug policy, Botticelli cites risks to young users to advocate for pot prohibition. This is a phantom menace. State legalization is not creating a generation of underage potheads: Marijuana use is flat among 12- to 17-year-olds, nationally, and there has been no spike in teen usage in legal states.
Michele Leonhart, the holdover DEA administrator, was finally pushed out in 2015 in the wake of a sex scandal in her ranks. (An inspector general discovered that DEA agents attended cartel-affiliated sex parties with prostitutes in Colombia, but had received no more than 10 days suspension.) The acting director, Chuck Rosenberg, is no reformer. A former senior FBI official tapped by Attorney General Loretta Lynch, Rosenberg insists pot is “bad” and “dangerous” and told reporters in November, “Don’t call it medicine – that is a joke.”
Now legal in 24 states and Washington, D.C., medical marijuana is scientifically effective as a treatment for nausea and nerve pain, and for symptoms of multiple sclerosis, epilepsy, Crohn’s disease and PTSD. It has also shown potential against diseases as serious as diabetes and cancer. On the House floor, Rep. Earl Blumenauer (D-Oregon) blasted Rosenberg as “an example of the inept, misinformed zealot who has mismanaged America’s failed policy of marijuana prohibition.” A paper by the Brookings Institution called out the administration for having “paralyzed science and threatened the integrity of research freedom” on medical marijuana.
There are hints, however, that the DEA is not fully impervious to the shifting reality on pot. In a first, the agency’s acting chief acknowledged that “heroin is clearly more dangerous than marijuana.” The DEA has also said it hopes to produce, by July, the results of a five-year review to determine whether pot should remain with heroin on the most restrictive drug schedule.
Federal enforcement for marijuana is also shifting: In 2010, the DEA seized nearly 726,000 kilograms of pot in domestic raids. By 2014, the latest data available, that fell to just 74,000. Domestic DEA pot arrests are also down sharply – from nearly 7,000 in 2010 to around 4,000 in 2014 – “due in part,” the agency explains, “to state-approved marijuana measures.”
The drop in federal busts is sharper, in fact, than the decline in marijuana arrests by local cops. According to the latest FBI figures, the feds arrested almost 620,000 Americans for pot possession in 2014 – down from a 2007 high of 775,000, but still comprising 40 percent of all drug arrests, and five percent of total arrests. Yet treating marijuana possession as a crime continues to disrupt lives and drain city budgets. As recently as 2010, states spent $3.6 billion enforcing marijuana laws.
The unequal enforcement of pot laws also lays bare the racism latent in the American justice system. Despite roughly equal use rates, blacks are 3.7 times more likely to be arrested than whites. This pattern persists even in legalization states: Marijuana arrests have fallen 90 percent in pot-legal Washington, but blacks are still busted at twice the rate of whites.
On any given day in America, nearly 470,000 people are behind bars for drug offenses. That represents a fifth of the total incarcerated population of 2.2 million and the equivalent of every man, woman and child in Kansas City, Missouri. The United States remains the world’s largest jailer by a wide margin.
Inmates at a state prison in Lancaster, California, that was operating at more than twice its capacity. Gary Friedman/Getty
But the mass incarceration of drug users may have finally peaked. At the federal level, historic – though far from sweeping – drug-sentencing reforms have significantly reduced the population of drug prisoners. The Fair Sentencing Act, passed by Democrats in 2010, eliminated the federal mandatory minimum for crack possession and reduced the unjustifiable sentencing disparity for possessing powder versus crack cocaine – shaving an average of 2.5 years off sentences for more than 7,500 crack offenders.
Obama’s first attorney general, Eric Holder, championed a pair of similar measures to reduce drug sentences. In 2013, Holder instructed U.S. attorneys to not specify drug quantity in the prosecution of nonviolent offenders if doing so would trigger a mandatory minimum. Holder also embraced a reform called “drugs minus two,” which lowered the sentencing guidelines judges use for drug crimes by two degrees of severity across the board. Made retroactive in 2014, this reform spurred the early release of nearly 6,000 drug inmates at the end of 2015.
From a peak of 101,000 in 2012, the number of federal drug prisoners has dropped to 85,000 in March, according to data obtained from the Federal Bureau of Prisons. Despite this progress, the federal government imprisons as many drug offenders as it did in 2003, during Bush’s first term. And drug cases continue to clog the courts: 32 percent of the district-court caseload, with marijuana accounting for more than one in four drug cases.
States – red and blue alike – are also reducing their drug incarceration numbers, emboldened by low crime and the strapped budgets of the Great Recession. Forty states eased drug-sentencing laws between 2009 and 2013, according to Pew Research. Cumulatively, such reforms have driven a 20 percent reduction in drug imprisonment. From 2004 to 2014, the number of drug inmates held by states decreased by 60,000, according to the Bureau of Justice Statistics, to 208,000. Of these, more than 160,000 are locked up for trafficking and other drug offenses, while more than 47,000 serve time for possession.
The third, and likely largest, population of American drug offenders is in jail – city and county lockups where people serve short sentences or await trial. Nearly a quarter of the roughly 744,000 Americans now in jail – 184,000, according to the Sentencing Project – are locked up for drugs.
Of all states, California is taking the most aggressive lead on jail reform. Prop 47, passed by voters in 2014, downgraded most personal-use offenses to misdemeanors. Rather than being jailed to await trial, drug users are now typically cited and released. According to research by the Public Policy Institute of California, jail bookings for possession charges have fallen by 68 percent.
For taxpayers, the Drug War imposes huge costs: nearly $55 billion a year. Harvard economist Jeffrey Miron, in a study published by CATO in 2010, found state enforcement of drug prohibition – accounting for cops, judges, jails and prisons – costs more than $25 billion a year, with more than $5 billion spent fighting pot.
Federal Drug War spending has now topped $30 billion. ONDCP divides its spending in two buckets: one for “supply reduction” (global interdiction and law enforcement) and the other for “demand reduction” (prevention and treatment). When Obama took office, 60 percent of Drug War spending targeted supply. In 2016, the administration touts that “for the first time” the drug czar’s office is seeking “more funding for demand-reduction efforts than those focused on supply reduction.”
Director of National Drug Control Policy Michael Botticelli is a recovering alcoholic working to change what he calls the “failed policies” of the Drug War. Mandel Ngan/Getty
But this increase in demand-reduction spending has not come at the expense of the draconian supply side, which has held steady. Instead, the Obama administration ballooned the Drug War budget by more than a quarter.
On the supply-reduction side, there has been reorganization. International funding has been slashed from $2.5 billion in Obama’s first budget to $1.6 billion in the current request. These cuts have downsized the role of the State Department and the Department of Defense in combating the international drug trade – reducing funding for drug eradication and military equipment in countries like Afghanistan, Colombia and Mexico. The DEA’s international footprint, in contrast, has grown slightly and now accounts for about one-sixth of the agency’s $2.8 billion budget.
The Drug War budget has grown by billions on the demand-reduction side, from $9.1 billion to $15.8 billion. Prevention funding is actually down; the administration killed a feckless $300 million education grant to the states in 2010. But the drug-treatment budget has nearly doubled – from $7.2 billion to $14.2 billion in the latest request. The biggest driver of this spending is Obamacare, which mandates drug-treatment coverage under both private insurance and government programs.
The transformation of Medicaid from its traditional focus on poor mothers and children to a broad-based health program covering low-income Americans is making drug treatment available to millions for the first time. In several states, expanding Medicaid has doubled the population of people with substance-abuse disorders now able to seek treatment. Studies going back decades demonstrate that treatment spending saves money in the long run, with every $1 spent on treatment saving as much as $7 in social costs. “Dollar for dollar, best thing they could do,” says Ethan Nadelmann, executive director of the Drug Policy Alliance.
Still, Obama insists that treatment remains “grossly under-resourced” because Republican leaders in 19 states have blocked Medicaid expansion – denying health coverage to millions. As a workaround, the president’s latest ONDCP budget has added nearly $1 billion in targeted treatment funding, including for states that haven’t expanded Medicaid, but are being hit hard by the opioid epidemic. “We’ve got to make sure,” Obama said, that people “can get the treatment when they need it.”
The changes to the War on Drugs under Obama are historic, and many appear irreversible, but the hard-line ideology of the Drug War is not everywhere in retreat. In many states, the conflict is being waged as though Nixon were still in power. Maine’s Republican governor, Paul LePage, said in January that his strategy to curb the opioid crisis is to toughen penalties for out-of-state traffickers. Recalling the worst rhetoric of the Drug War’s past, LePage vilified dealers as “guys with the name D-Money, Smoothie, Shifty.” LePage has endorsed Donald Trump, who paints Mexicans as drug dealers and rapists. Trump promises to curb the heroin epidemic by walling off the border with Mexico. “You have a tremendous problem with heroin and drugs,” he told voters in New Hampshire. “We’re gonna have borders again and … help you solve that very big problem.”
The trouble with Trump’s proposal is the problem at the root of the War on Drugs itself: A wall is no more a barrier to addiction than a war is an effective treatment.
In fact, Trump’s wall would be of no value against heroin traffickers, who cross the most fortified parts of the Mexican border every day. Take it from Adm. Bill Gortney, head of U.S. Northern Command. In Senate testimony in March, Gortney told the Senate Armed Services Committee that “a wall will not solve the immense problems” of narcotraffic.
The most dangerous drugs, the admiral told senators, are not entering the United States through the open desert, as in years past. “Heroin and fentanyl are coming through … the legal entry-control points across our border,” he said. The drugs are smuggled in “very, very small shipments, which is very, very difficult for our partners to be able to detect.” The best U.S. counternarcotics strategies and technology, Gortney testified, have been “circumvented by a very adaptable enemy.”
In its full scope, the admiral’s testimony underscored the futility of the war effort – a lesson that should not have taken the world’s leading capitalist society 45 years and more than $1 trillion to learn: Military might is no match for market economics.
“If there’s a demand” for drugs, Sen. John McCain posed to the admiral, “there’s going to be a supply.”
cartel members took a man and used a knife to slice every part of his body but they didn’t kill him,” he said. “They they staked him to the ground and let the buzzards eat him.”
The Jefferson County Drug Court celebrated National Drug Court Month on Friday, and the supervisory special agent for the Drug Enforcement Administration in Arkansas said that while enforcement of drug laws helps, education and rehabilitation are also needed.
Anthony Lemons, who is based in Little Rock, was the featured speaker for the event, which was held on the steps of the Jefferson County Courthouse.
He said that when he was first assigned to Arkansas in 2000, the biggest threat facing Arkansas was methamphetamine, produced from what he called mom-and-pop labs at homes, hotel rooms, rental properties and the like, which produced a few ounces of methamphetamine at a time.
“It was extremely dangerous,” Lemons said. “During that time, you would see a lot of explosions, a lot of fires, and they destroyed a lot of lives and a lot of families.”
A few years later, Lemons said crack cocaine investigations picked up, and with the crack came a lot of violence.
“In Little Rock, there were drug dealers killing drug dealers over territory,” he said. “We had mobile enforcement teams and we came to Pine Bluff twice because of crack problems. We started to work those cases involving gangs and in one case, solved three homicides. We had a wire tap and a guy confessed to the three.”
Methamphetamine is back now, but Lemons said that unlike the old days when it was produced in mom-and-pop labs, it’s now produced in “super labs” controlled by the cartels.
“Mom-and-pop labs were producing a few ounces,” Lemons said. “These super labs are producing hundreds of pounds. The cartels are here now.”
He said agents are working to combat the drugs by trying to find the sources, using things like video and wire taps.
“I remember seeing one video where cartel members took a man and used a knife to slice every part of his body but they didn’t kill him,” he said. “They they staked him to the ground and let the buzzards eat him.”
Along with methamphetamine, Lemons said Arkansas, like most other states, has a major problem with prescription drugs, explaining that the recent drug take back event collected 25,000 pounds of prescription drugs in the state “before they got in the hands of our kids.”
As the supervisory agent for the DEA, Lemons said, “I want to arrest every person who sells drugs, but I can’t do it by myself.”
“I can’t arrest them all, so we’ve got to educate people about drugs and what they can do,” he said.
Before proclaiming the month of May Drug Court Month, Jefferson County Judge Dutch King said, “This problem didn’t happen overnight and it’s not going to be solved overnight.”
“It’s going to take all of us working together to fix it,” King said.
Circuit Judge Berlin C. Jones, who has administered the drug court since it began with five people in 2004, said one of the goals is to build stronger individuals, which builds stronger families, which builds a stronger community, and a stronger community builds a better city, better county and better place to live.
One of the requirements of drug court is that every participant has to either be working or getting an education, and Jones said currently, only three to five of the 61 participants are not working.
Seeing State Sen. Stephanie Flowers in the crowd, Jones thanked her for her help in getting the project that uses people on probation and parole to tear down derelict houses in Pine Bluff.
“We’ve got five slots, and as our people move out of that and into the workforce, we fill them again, so instead of just five slots, we’ve got more,” he said. “People are working instead of walking the streets looking for something they can steal.”
Senator Chas Schumer and 27 from the House of Representatives from New York https://en.wikipedia.org/wiki/List_of_United_States_Representatives_from_New_York are up for reelection this Nov. These are the people who fund and oversee the DEA… The BUCK STOPS WITH THEM… Don’t send them a letter, fax, email… send YOUR VOTE to their OPPONENT this fall.. that is the ONLY MESSAGE they understand ! It WASN’T YOU THIS TIME… BUT.. it could be the next time..
The temporary closing of Dr. Eugene J. Gosy’s Amherst medical office after his criminal indictment last week – cutting off hundreds, if not thousands, of his panic-stricken patients from their opioid medications – has created a public health crisis in Erie County.
Patients depending on the pain specialist for relief from their chronic painful conditions are demanding help.
“These people are desperate. They’re really suffering. They’re desperate, and they’re scared,” said Dr. Gale R. Burstein, health commissioner for the county. “At this point, we’re at a public health crisis.”
Her department has fielded hundreds of calls in recent days.
But county government’s limited capacity to help the patients has helped drive their desperation to new heights.
“What are we supposed to do?” patients of Dr. Gosy yelled during a county-sponsored town hall-style meeting Wednesday night at Kenmore West High School in the Town of Tonawanda.
“Basically, we don’t have the providers in our community to manage this,” Burstein said Thursday. “There’s really only so much we can do.”
The county Health Department has reached out to local insurance providers to try and connect patients with pain specialists in the region who can prescribe the medication they need. But few local providers are taking new patients.
The county is also working with the New York State Department of Health, which is aware of the nature of the problem and has worked to identify pain-management clinics across the state that can assist patients. The state Health Department is also expected to provide educational and technical assistance next week to primary care physicians in Erie County to help them manage patients with chronic pain until the patients can find new pain specialists.
But patients are also turning to the county to try to get immediate help.
Wednesday night’s public meeting was meant to educate community members on the overdose epidemic. But addiction specialists and overdose victim advocates soon found themselves answering patients on the flip side – those taking their medication as prescribed but now facing the return of serious pain symptoms.
County Executive Mark C. Poloncarz found himself surrounded by patients and office workers from Gosy’s office at Wednesday’s meeting. One patient asked him why he can’t order doctors in Erie County to take Gosy’s patients.
“I don’t have that power,” Poloncarz said. “I don’t know that anyone has that power.”
They also asked why he can’t have county Health Department physicians care for these patients.
The Health Department, he replied, employs only two doctors: Burstein and the medical examiner.
Avi Israel, a community advocate on the opioid overdose crisis, said he abruptly ended the official part of the forum after getting screamed and yelled at by people in the audience.
One even accused him of being of being responsible for the dire situation in which Gosy’s patients now find themselves.
Israel’s son, Michael, 20, became addicted when doctors started prescribing opioid painkillers in treating him for Crohn’s disease. He took his own life in 2011.
“If you had control of your son, we wouldn’t be in this place right now,” a patient at Wednesday’s meeting told him, Israel said.
Meanwhile, Burstein’s office has been inundated with angry mail. Messages filled with outrage have been posted on the Health Department’s Facebook page. Some of them accused county leaders of shutting down Gosy’s practice, but it was the doctor who chose, after he was indicted April 26, to temporarily close his office until May 16. The federal investigation and indictment had nothing to do with any Erie County department, officials said.
“Everybody needs a scapegoat,” Burstein said.
Gosy is charged with authorizing more than 300,000 illegal prescriptions for controlled substances over four years – more than some hospitals. Federal prosecutors allege that Gosy, 55, a Clarence resident, set up a prescription-renewal process that was “batch-signing” 300 illegal renewals each day. The doctor pleaded not guilty and was released on bail.
Gosy, one of the state’s busiest pain-management doctors, surrendered his license to prescribe controlled substances while keeping his license to practice medicine.
Joel L. Daniels, one of Gosy’s lawyers, has said his client has between 8,000 and 10,000 active patients. Burstein, Poloncarz and Israel said that they have sympathy for those now suffering and wish that more options were available to them.
Israel stood with the county executive and others for nearly half an hour after the public meeting Wednesday night to talk with patients and staff members from Gosy’s office. Gosy’s staff told him that they don’t have the ability to release patients’ records to other doctors who are willing to treat them.
Although Gosy’s practice includes another physician and physicians assistants who could help provide continuing care to Gosy’s patients, they have not done so, Israel said.
“There’s a game being played here, and the question is, why did Dr. Gosy close his office?” Israel asked. “And what will happen when it reopens?”
By now, you’ve probably heard about the Johns Hopkins study, published in BMJ, that called medical errors the third leading cause of death in the U.S. That works out to slightly more than 250,000 unnecessary deaths annually, or about 9.5 percent of all fatalities in the country.
It’s a staggering figure, far above the range of 44,000 to 98,000 preventable deaths in hospitals alone that the Institute of Medicine estimated in the seminal 1999 work, “To Err Is Human.” However, it’s not the first time someone has called medical error the No. 3 cause of death in the U.S. John T. James, founder of a group called Patient Safety America, did that in a 2013 report in the Journal of Patient Safety.
What’s different this time? Has anything changed for the better since 1999?
Frank Federico, a vice president at the Institute for Healthcare Improvement — the Cambridge, Massachusetts-based organization founded by Dr. Donald M. Berwick — has plenty of thoughts on this study and those questions. He shares them in this podcast.
Rx Drug Abuse Not Just a Campaign Slogan | NCPA Executive Update | May 6, 2016
Rx Drug Abuse Not Just a Campaign Slogan
Dear Colleague,
Next week has been nicknamed “Opioid Week” in Congress as more than a dozen opioid abuse-related bills will be considered by House committees.
The epidemic of prescription drug abuse is not new. As the epidemic has gone on, it’s hard to find someone who hasn’t been directly or indirectly affected. You probably know someone whose family has been devastated by prescription drug abuse whether that impact was addiction, loss of career, family, or worse. Since 1999 the number of opioid-related deaths has quadrupled.
Pharmacy more than any other occupation respects the power of prescription drugs, and pharmacists more than any other professional, can’t stand to see the core tool of our profession misused. Being on the watch for forged prescriptions and verifying with the prescriber that the quantity, dose, sig, or refills have not been manipulated are just some of the ways that pharmacists do their part to stop abuse. Some community pharmacists also speak to school or civic groups about abuse to discourage inappropriate use.
NCPA’s Dispose My Meds™ was on the leading edge when it launched five years ago. Since then, hundreds of thousands of pounds of medications have been taken out of medicine cabinets and disposed of properly. Even though controlled substances could not be returned to pharmacies until 2014 when DEA issued a final rule allowing for take-back of controls. Dispose My Meds also raised awareness of proper storage and disposal of controlled substances.
While community pharmacy is committed to stopping prescription drug abuse, the tactics must be well thought out and not a knee jerk reaction to this understandably emotionally charged issue. The majority of patients who are prescribed prescription pain medications have legitimate needs and should not be disadvantaged. Community pharmacies should not have to administer another unfunded mandate. DEA and other policymakers should focus on tracking overprescribing, prescribing unnecessarily high quantities, and the small number but highly damaging pill mills.
Congress has dabbled in this arena before. Hydrocodone was rescheduled to a C-II over a year ago. NCPA opposed rescheduling because we doubted that it would have the desired effect of curbing abuse and instead would limit access for the many patients with legitimate pain med needs. Unfortunately, rescheduling has done little to slow down drug abuse, but has added one more hurdle for patients in need of pain medications.
On the other hand, in March the Senate passed the Ensuring Patient Access and Effective Drug Enforcement Act, which would give pharmacies and wholesalers a mechanism to appeal some of the heavy-handed actions the DEA had taken.
Earlier this year, the Senate also passed an opioid bill, the Comprehensive Addiction and Recovery Act, so the two chambers will have to conference the legislation when it passes the House. Among the “Opioid Week” bills that are of particular importance to community pharmacy is one authorizing partial fills of Schedule II controlled substances as well as setting requirements related to the OTC sale of products containing dextromethorphan. Another bill of high interest would require that pharmacies serve as drug take-back sites with funding coming from manufacturers. NCPA continues to meet with committee staff on changes to bills to ensure there are no overly broad or burdensome requirements on community pharmacists.
States are also taking legislative action. New York’s ISTOP (Internet System for Tracking Overprescribing) went into effect March 27. It requires prescribers to e-prescribe controlled substances and to check an improved, real time prescription monitoring program registry. Maine also recently passed a similar law that goes into effect July 1, 2017.
The epidemic of prescription drug abuse is not new, but expect a lot of media attention next week. After all, it’s an election year so politicians will be looking for sound bites to get re-elected. That’s all well and good I suppose, but it’s important that the recent desire to do something results in meaningful changes and not just another campaign slogan.
WASHINGTON (Sinclair Broadcast Group) — As deaths and medical costs associated with opioid painkiller addiction and abuse continue to rise in the U.S., the Obama administration is considering a recommendation to mandate new training for doctors who prescribe the drugs.
Following two days of hearings on improving the safety of opioid use, the Food and Drug Administration Drug Safety and Risk Management Advisory Committee agreed Wednesday to recommend that doctors be required to complete specialized training in order to be able to prescribe them.
The FDA does not have to follow the recommendations of its advisory panels, but it often does. Imposing this mandate would require congressional action.
Despite a similar expert panel recommendation in favor of mandatory training in 2012, the FDA had opted to make educational courses on safe pain prescription voluntary. As of March 2015, less than half of the 80,000 doctors the agency wanted to complete that training had done so.
Prescription opioid overdose deaths have quadrupled since 1999 as sales of the drugs have rapidly increased, according to the Centers for Disease Control and Prevention (CDC). About half of opioid overdose deaths now involve prescription drugs, including 14,000 deaths in 2014.
The prescription drugs most commonly involved in these deaths are methadone, oxycodone, and hydrocodone. The drugs have also been linked to risks of nonfatal abuse, misuse, and addiction.
The issue of opioid painkiller abuse has been thrust into the national spotlight by reports that singer Prince was suffering from addiction to pain medication prior to his death last month. The Associated Press reported that law enforcement is investigating whether he died from an overdose.
While many medical professionals and experts agree that opioid addiction and abuse must be addressed, some organizations that represent physicians balked at the proposal to require doctors to undergo additional training on the subject.
The American Medical Association (AMA) has opposed mandatory physician education on pain management and opioid abuse in the past, although the organization recognizes the need to improve training on the subject and is engaging with the FDA on the latest proposal. Dr. Patrice Harris, chair-elect of the AMA and chair of its Task Force to Reduce Opioid Abuse, said, “We support a voluntary approach to physician education and training, with the profession being responsible for articulating the standards and what is best for specific specialties and patient populations – rather than a one-size-fits-all response.”
“Linking mandatory training on opioids to the DEA registration process raises legitimate questions of how to best ensure the competency of physicians and other prescribers, what are possible unintended consequences for patients and their physicians, and what is the appropriate role of the federal government in this process,” Harris said in a statement.
The American Academy of Family Physicians (AAFP) has also rejected calls for additional mandatory training on painkiller prescription. The organization argues that family physicians already undergo extensive training on drug prescribing and are required to complete 150 credits of continuing medical education every three years.
The AAFP contends that further education of doctors will not address the illegal transfer of opioids from patients to others or the misuse of pain medications that are driving the epidemic. There is also concern that more training requirements will put a burden on overextended physicians or leave doctors who do not have time to take the classes unable to prescribe pain medication to patients who legitimately need them.
However, AAFP board chairman Dr. Robert Wergin emphasized that the organization does believe opioid abuse requires a response. The AAFP provides education on the subject and encourages members to participate, but he does not think it should be required.
“We certainly acknowledge and recognize the problems with opioid use… but there may be some unintended consequences with mandatory CME (Continuing Medical Education) requirements,” he said.
Wergin, a practicing physician in a rural area, said imposing training requirements that doctors may not be able to meet will create “an access problem” because there are not enough pain management centers to treat the patients whose family doctors would no longer prescribe the medication under those circumstances.
Wergin identified several steps that could be taken to address the dangers of opioid abuse, some of which he said have already proven successful in several states. One is placing restrictions on the number of pills a patient can get, and another is prescription monitoring programs that prevent patients from doctor-shopping and pharmacy-shopping.
He also recommended doctors create contracts with their pain patients to ensure that they use the medication responsibly, and he suggested drug testing to prove patients are taking the medicine, which would discourage drug diversion.
According to Wergin, it is a “mischaracterization” to suggest that family physicians currently lack the training and education to responsibly prescribe pain medication. Between medical school, residency, and existing CME courses, he feels they have access to the information they need.
Cynthia Kear, senior vice president of the California Academy of Family Physicians (CAFP), said “education is key” to addressing the opioid epidemic, but her organization also fears the unintended effects that mandatory training could have.
Kear, who participated in this week’s FDA advisory committee meetings, said there is consensus among many physicians that more needs to be done to educate doctors about pain management. The CAFP and its partner organizations attempt to make voluntary training as accessible as possible for those who want to participate.
“There has never been any documented evidence that mandatory education is any more effective in facilitating behavior change than voluntary,” said Dr. Carol Havens, a California family physician and former CAFP president who has been active in teaching other doctors about these issues.
Havens, director of Physician Education and Development for Northern California Kaiser Permanente, said the CAFP has found that doctors do want more education about the risks and benefits of prescribing pain medication. This education needs to be practical and implementable, though, and that means they need alternatives to opioids that their patients have access to and can get covered by their insurance companies.
“It’s not enough to simply say, ‘Don’t prescribe opioids,'” she said.
Kear pointed to the comprehensive, “full court press” approach that the government and the medical community took to stopping smoking, and said that coordinated effort is missing on this issue. Public service announcements and public education efforts could help fight abuse and misuse.
According to Havens, there are several other factors that present challenges for family physicians. One is that their time with each patient is often limited to a few minutes due to the demands of their busy schedules. This is why she feels it is important for insurance companies to provide sufficient reimbursement for those who undertake the necessary and time-consuming evaluation of pain patients.
“It takes time to be able to do this and to do it appropriately,” Havens said.
Doctors must contend with the threat of litigation from patients who feel they have received inadequate treatment for their pain. They also face insurance companies that sometimes tie their reimbursement to patient satisfaction.
In those cases, refusing to prescribe opioids or offering safe alternatives could lead to negative evaluations that damage their practice. Similarly, hospitals may be evaluated on ensuring that their patients do not report pain. This can all result in misplaced pressure on physicians who are making treatment decisions.
According to Kear, mandatory guidelines imposed by some states about frequency, amounts, and dosage of opioids have left physicians “feeling the rope tightening a bit.” That can drive some to not provide pain treatment at all, and patients who genuinely need that medication may not always have access to specialists, clinics, and other alternatives.
Critics of the training programs supported by the FDA have also questioned their effectiveness because it is unclear what percentage of opioid deaths are the result of inappropriately prescribed drugs rather than those that were obtained by the user illegally.
According to the Associated Press, FDA advisory panel members were unable to determine whether actions taken by the agency so far have actually reduced the threat of opioid misuse and abuse. The number of opioid prescriptions began dropping before the current rules were imposed, but overdose deaths have continued.
An expert from Public Citizen who testified before the FDA panel this week complained of the influence of “opioid industry-funded ‘education’ and promotion.” Instead, the organization called for mandatory training with minimal industry involvement
The dispute over potential training requirements for physicians underlines the complexity of the opioid abuse issue and the difficulty the FDA and the medical community must now overcome to prevent further overdose deaths.
“Everybody wants a quick fix and it does not exist,” Havens said.