Legalizing Opioids Would Dramatically Reduce Overdoses

www.libertylawsite.org/liberty-forum/legalizing-opioids-would-dramatically-reduce-overdoses/#comments

In his Liberty Forum essay, Robert VerBruggen argues that the dramatic increase in opioid deaths in the United States over the past two decades has resulted mainly from over-selling by pharmaceutical companies and over-prescribing by physicians and other healthcare providers. As such, he concludes that policy should further restrict access to prescription opioids, while expanding access to Medication Assisted Therapies (MATs) such as methadone and buprenorphine.

I argue here that opioid overdoses occur mainly when policies are in place that restrict or outlaw opioids. The right policy is therefore legalization or at least substantially greater legal access; expanding MATs is only a small step in that direction. Legalization might increase opioid use, and legalization will not eliminate all adverse consequences from opioids. But legalization would dramatically reduce overdoses, facilitate safe use of opioids by pain patients and others, and reduce or eliminate other prohibition-induced ills such as violence, corruption, racial profiling, and civil liberties infringements.

This conclusion follows from historical and recent evidence on past restrictions and prohibitions on opioids, alcohol, and other drugs. These substances have been dangerous when illegal or highly restricted and far less dangerous—indeed, often beneficial—when legal or mildly restricted.

Prohibition makes opioids more dangerous because it forces the market underground, which inhibits normal quality control. In legal markets consumers know the potency of the drugs they purchase; they do not buy beer and receive grain alcohol or aspirin and get morphine. Similarly, if opioids were legal, consumers would not buy heroin and receive fentanyl or heroin laced with fentanyl. Legal markets provide good quality control, via several mechanisms, and therefore rarely produce accidental overdoses.

Under prohibition, however, buyers cannot sue or complain to consumer-protection agencies when a dealer sells them adulterated or mislabeled goods. Likewise, sellers cannot advertise their products against others whose drugs may be more dangerous. Canadian physician Evan Wood indicates that “simply cutting [patients] off of opioids can lead to all sorts of problems with people turning to the street and transitioning to intravenous use and, of course, with fentanyl out there in the drug supply it can be very, very, very dangerous.” Wood highlights that many users substitute harder street drugs when access to less potent opioids is cut off, yielding an increase in overdose deaths. As one recovering New Jersey addict told a reporter for nj.com, “They’re selling bags of fentanyl and calling it heroin. People are dropping like flies. People are used to using a bag or two of heroin and they’re getting straight fentanyl and it’s killing them.”

Note that even before the major crackdown on access to prescription opioids that occurred around 2010 in the United States, the increased prescribing occurred under a regime in which  access to prescription opioids was strictly limited. Thus many who began use for medical conditions were not allowed to continue use indefinitely, thereby creating a group of patients forced into the gray or black market, and into the uncertainties just described.

Prohibition also makes opioids more dangerous by encouraging drug mixing. In 2013, 77 percent of deaths involving prescription opioids involved mixing with either alcohol or another drug. If opioids are easily accessible, people tend to use the substance they desire; when access is limited, however, some consumers obtain an insufficient quantity and therefore improvise with alcohol, benzodiazepines, and other drugs. Taking these drugs together increases the risk of overdose, especially when dealing with depressants like opioids, which, according to a government document from the state of South Australia, “can cause a person’s breathing and heart rate to decrease dangerously.”

Prohibition further increases overdoses by disrupting tolerance, which makes use less dangerous as the body develops resistance to opioids’ respiratory-depressing effects. Medically, opioids neither cause organ damage nor have a dosage ceiling, in which “additional dose increases produce no change in efficacy and only cause more side effects or toxicities.”[1] If higher dosages can treat pain without damaging organs, limitations make little sense.

Worse, under prohibition users who have developed tolerance get cut off, whether by legal or  medical restrictions or by being forced into non-MAT treatment. Tolerance then declines, according to medical experts in drug rehabilitation, so users who resume use are more prone to suffer an overdose.

One study proposes that environmental factors also influence tolerance, and that “a failure of tolerance should occur if the drug is administered in an environment that has not, in the past, been associated with that drug.”[2] Therefore, prohibition may increase the chance of overdose by driving users out of their routine into unfamiliar settings in which their tolerance against the respiratory effect of opioids is diminished.

Prior to 1914 in the United States, opioids (and all other drugs) were legal, easily accessible, and commonly prescribed. Yet no opioid “crisis” or “epidemic” gripped the nation.[3] Similarly, alcohol consumption declined modestly during Prohibition in the 1920s and early 1930s[4], but deaths due to alcohol increased as adulterated, low-quality, and even poisonous versions of alcohol proliferated.[5] Thus in both cases, restrictions made use more dangerous, even if it reduced use.

More recently, Portugal decriminalized all drugs—including opioids—in 2001 and then witnessed a dramatic decline in drug-related deaths. In fact, “In 2012, they had just 16 drug-related deaths in a country of 10.5 million,” according to Justin McElroy of CBC News. Decriminalization also allowed individuals to purchase and use in safer settings and gain better access to harm-reduction resources such as needle exchanges, thus decreasing HIV and other transferable diseases.

Experience in other countries tells the same story. Between 2000 and 2005, the number of patients receiving buprenorphine, a partial opioid agonist, in France increased from 65,000 to 90,000. In this period, “the rapid spread of buprenorphine treatment in France has been associated with individual, social, and economic benefits” including “a dramatic reduction in deaths resulting from drug overdose [and] a reduction in HIV infection prevalence among [injection drug users].”[6] While the subdued euphoric effects of buprenorphine distinguish it from other opioids, this case still demonstrates how the de-stigmatization can facilitate access to medically efficacious treatments.

Compare this to the United States. Most opioids are listed by the DEA as prohibited Schedule I or Schedule II drugs. Buprenorphine and other medically efficacious alternatives are highly regulated and restricted. Yet overdoses continue to increase year after year even in the face of  heavy-handed interdiction. With fewer restrictions on methadone, buprenorphine, and other medically efficacious opioid addiction treatments, the detox process would be more accessible. VerBruggen acknowledges this point, suggesting that, “addiction medications have proven to be highly effective, if far from 100 percent so.” It is perplexing that he recognizes the benefits of allowing legal access to methadone and other MATs, but ignores this logic for other opioids. Methadone, a “very potent opiate medication,” is accepted as “safer” because it can be legally administered in a controlled setting with the contents known to the user. The same could be true for any opioid under legalization.

Prohibition proponents nevertheless argue that limiting opioid prescribing will decrease overdose deaths. VerBruggen commands that doctors “must prescribe” opioids “less often without denying relief to people who really do suffer from extreme pain.” This idealist policy prescription is a pipe dream. Take, for instance, the 2010 federal crackdown on pill mills (networks of doctors and pain clinics that prescribe high quantities of opioids and other painkillers). To limit prescribing, state legislatures passed laws limiting a doctor’s ability to dispense opioids. Concurrently, the federal Drug Enforcement Administration enhanced its efforts to raid pill mills.

Though perhaps well-meaning, these actions harm those who desire opioids for pain management. As one patient recently told a Boston radio station, providers “just do not have the medications because they have run out [of] their allocation within the first week . . . It’s just that bad where I know I am gonna end up in the ER because I don’t have my medications.” Limits on prescribing withhold medical treatment from those who need it because of the inability of sweeping regulation to discern need.

Evidence suggests that these policies have been counterproductive if the end goal is to decrease overdose deaths. A study of Proscription Drug Monitoring Programs in New York state finds that “prescription opioid morbidity leveled off following the implementation of a mandated PDMP although morbidity attributable to heroin overdose continued to rise.”[7] These results are consistent with the view that restrictions on prescribing induce substitution to more easily accessible—yet more dangerous—street drugs.

The fact that overdoses increased along with prescribing during the period before 2010 does not mean the prescribing caused the overdoses. Set aside the possibility that misreporting generated at least some of the measured trend in overdoses.[8] According to the Centers for Disease Control and Prevention, even if the increase in overdoses is entirely real, it occurred under strict restrictions on access to prescription opioids, and outright prohibition of other opioids such as heroin and fentanyl.

Since 2010, moreover, opioid prescribing has leveled off yet the opioid death rate has continued to increase, if anything at a faster rate than previously. A growing fraction of the recent deaths reflect heroin and fentanyl rather than prescription opioids. This illustrates perfectly the claim that more restrictions generate more dangerous use.[9]

Thus prescription opioids may have played a role in the deaths over this period, by increasing the number of people who would be tempted by the black market. Had the increase in prescribing occurred in a legal market, however, the vast majority of the deaths would not have occurred.

Opioid overdoses have increased substantially in the United States—this fact is undeniable. But the increased prescribing did not by itself cause the increase in overdoses; instead, restrictions on access cause overdoses by diverting consumers to the black market. If consumers could easily obtain opioids, no black market would arise, thus decreasing the violence, uncertainty of dosage, and ultimately opioid overdose deaths.

In addition to increasing overdoses, prohibition harms users and society by increasing violence and corruption, exacerbating racial discrimination, infringing civil liberties, limiting medical research and uses, and eroding respect for the law.[10] Prohibition and other restrictions also raise the costs of using opioids for those who benefit from such use, whether for medical or any other purposes.[11] VerBruggen puts forth an impassioned yet ultimately unpersuasive essay echoing the standard narrative of the opioid crisis—that prescriptions should be limited because an increase in prescriptions has caused the spike in deaths. This account fails to recognize that prohibition and associated restrictions—not prescribing per se—bear the primary responsibility for this human tragedy.

What is the “GATEWAY DRUG”… if prescribers don’t prescribe it and pharmacies don’t stock it ?

DEA: Methamphetamine bigger threat in San Antonio than opioids

https://www.ksat.com/news/dea-methamphetamine-bigger-threat-in-san-antonio-than-opioids

SAN ANTONIO – The U.S. Drug Enforcement Administration reports methamphetamine, which is manufactured by the ton in Mexico, is pouring across the border.

“In Texas, the biggest drug threat we have right now is methamphetamine,” said Will Glaspy, DEA special agent in charge of the Houston division.

Glaspy said were it not for the opioids that plague other parts of the country, “We’d be reading about the methamphetamine crisis.” He said the product is “high purity and relatively cheap to purchase.”

Princess Frago, a 32-year-old recovering meth addict, said the drug is so cheap, some dealers even offer free samples to get people hooked or “chase the dragon,” as it’s called.

But because it’s man-made, Frago said not all meth is the same.

“It’s crazy what I’m saying, but it does bring in different demonic spirits,” Frago said.

She said she was 28 the first time her now ex-boyfriend shot her up with meth.

“I found myself doing crazy stuff,” she said.

Frago said she after walking into a major retail store, “I started putting on stuff. I felt no one was watching me. I started taking stuff.”

Rosa Medrano, a 25-year-old recovering meth addict, said she was part of the DARE Just Say No to Drugs campaign at her school. She said students were warned about meth.

She told herself, “’I would never, ever.’ Like, that’s the scariest thing.”

That changed when Medrano was 21 after seeing people still being able to function after using meth to stay awake. Medrano said the people had houses, cars and jobs, so she inhaled it for the first time.

“It wasn’t that bad at first, until I started losing control of my life and myself,” Medrano said.

Both Frago and Medrano said they used meth to cope with personal trauma in their lives, but it came at high cost.

“I lost my friends. I lost my family. I lost my kids,” Medrano said.

“I lost everybody I loved, everyone I cared about,” Frago said.

They both lived to tell their stories, unlike many who did not.

In its 2015-2016 annual report, the Bexar County Medical Examiner’s Office recorded a 92 percent increase in meth-related deaths, yet a 24 percent decrease in deaths involving heroin. That came as a surprise to Medrano.

“Actually got told you can’t die from meth, so this is news to me,” she said.

Frago said she has almost died 17 times.

“Yes, 17 times God saved me from dying, from waking up in hospitals, in bathtubs, overdoses. God was there for me,” Frago said.

They both credit Bexar County Drug Court and Judge Ernie Glenn for helping turn their lives around.

Glenn said he’s also seeing more meth cases in his courtroom.

Medrano and Frago said the court’s resources and counseling have taught them the first step toward recovery is admitting your addiction.

Frago said for many like her, it takes hitting rock bottom. Medrano said she wanted to avoid falling to that level.

Medrano hopes to open a boutique someday, and Frago wants to use her experience to become a drug counselor. 

Medical Examiner’s Office 2015 Annual Report (See page 15 for information on overdose deaths)

Medical Examiner’s Office 2016 Annual Report  (See page 17 for information on overdose deaths)

There is a legal pharmaceutical product of Methamphetamine, the original brand name was Desoxyn and it was used back in the pre 80’s period as a “diet pill”, but it still has a indication for ADD/ADHD and very few – if any – prescribers use it to treat those disease issues.

So the question has to be asked… what is the “gateway drug” that leads to abuse/addiction to this drug ? Bureaucrats and law enforcement likes to blame the legal prescribing of opiates is the direct link to our “opiate crisis”.. which there is a growing evidence that this is a fallacy.

Basic Econ 101 states that a good business results when you find a need/demand and find a way to meet it… apparently the Mexican cartels have found a UNMET NEED/WANT/DEMAND and they are producing a product that meets that.

Who is the bureaucrats going to sue to recoup their expenditures for treating these abusers/addicts ?  The CARTELS…  the STREET DEALERS ?

Trey Gowdy Destroys DEA: “What the Hell Do You Get to Do?”

A attorney from DOJ.. can determine if a doc is over prescribing… his education in law school ?

Let’s let Mr. Barron DOJ- The Attorney on Dr.Tennant’s case come back from Holiday Vacation with this filling his inbox……please share in all social media..everyone please take a few minutes and send this or something better:

 

Ben.Barron@usdoj.gov

 

Dear Mr. Barron,

What exactly is your point in going after Dr.Tennant’s legitimate medical practice? He has had zero deaths, zero over-doses and zero diversion at his clinic. He has a very small practice and only takes those patients who have failed standard treatments. The patients he treats have gone through many, many different treatments and he is their doctor of last resort. Most have received treatments at the Mayo Clinic, Cleveland Clinic, Stanford, etc., and the treatments for their rare diseases and injuries failed. Some were left in worse condition after surgeries, invasive interventions including implants, spinal stimualtors, spinal epidural injections,and spinal blocks. They have tried so many treatments before coming to Dr.Tennant. Many have been severely injured trying procedures to treat their pain that failed and have been left in worse pain!

What exactly is it you are looking for?

 

 

Tennant Patients Live in Fear of DEA

 

 

 

Tennant Patients Live in Fear of DEA

By Pat Anson, Editor Deborah Vallier is living proof that high doses of opioid medication can safely relieve pai…

 

The feds can’t tell pill-pushers from honest doctors

 

 

 

The feds can’t tell pill-pushers from honest doctors

Forest Tennant, who has been treating and researching pain at his clinic in West Covina, Calif., since 1975, is …

 

 

DEA Tactics Questioned in Tennant Raid

 

 

 

DEA Tactics Questioned in Tennant Raid

By Roger Chriss, Columnist Agents with the Drug Enforcement Administration recently raided the offices and home …

 

 

Indiana: Help addicts recover while denying chronic pain pts adequate therapy ?

Indiana adopts plan to combat addiction

http://www.agrinews-pubs.com/news/overdosed-indiana-adopts-plan-to-combat-addiction/article_39f2fa40-80e1-5583-9685-67a5759dfe4c.html

INDIANAPOLIS — Opioid abuse is something that could happen to anyone.

It could be as simple as a patient becoming addicted to a painkiller that was legally prescribed to them. It could be complicated — someone seeking an escape from life’s pains, even if it means breaking the law.

Indiana’s leaders have recognized that opioid abuse prevention begins with awareness and action.

“Indiana’s opioid epidemic impacts all Hoosiers across our state in every age and socioeconomic group,” said Lt. Gov. Suzanne Crouch. “As a part of the governor’s Next Level Agenda,

we are committed to coming alongside those suffering from addiction and helping them on the path to recovery.

“We are taking this fight directly to this evil substance and those who push it, and along with our partners in the General Assembly, we are attacking the drug epidemic that is devastating our rural communities.”

Taking Action

Gov. Eric Holcomb made attacking the drug epidemic one of the five pillars of his agenda upon taking office in January.

“When it comes to taking down Indiana’s opioid crisis, we must apply every asset,” he said. “I am committed to using a comprehensive, data-driven strategy so that we can address gaps in the system and stop the current trajectory in Indiana.”

His main goals were:

  • Create the position of executive director for substance abuse prevention, treatment and enforcement.
  • Limit the amount of controlled substances prescriptions and refills.

  • Expand local authority to establish syringe exchange programs.
  • Enhance penalties for those who commit pharmacy robberies.

Holcomb appointed Jim McClelland as Indiana’s first executive director of drug prevention, treatment and enforcement.

“Hoosier communities are in jeopardy,” McClelland said. “The addiction epidemic is a very real threat to the well-being of our families, businesses, and our state’s social services and health care systems.

If Congress Cuts Entitlements In 2018, Medicare Advantage Enrollment Will Soar

https://www.forbes.com/sites/brucejapsen/2017/12/28/if-gop-cuts-entitlements-in-2018-medicare-advantage-enrollment-soars/#4a917b7b719f

Talk in Washington of entitlement reform that would include reductions in Medicare spending is almost certain to give private health insurance companies a greater role in administering the nation’s health insurance program for the elderly.

Medicare Advantage plans contract with the federal government to provide extra benefits and services to seniors, such as disease management and nurse help hotlines, with some even providing vision and dental care and wellness programs.

It’s long a tradition for Republicans when they are in control of Congress to want to hand off more business to the private sector. That happened with the Balanced Budget Act of 1997 when private insurers saw big increases in enrollment thereafter. But Medicare Advantage also had bipartisan support under the Obama administration and the Affordable Care Act of 2010 when major Medicare spending reforms were implemented. That, too, triggered more enrollment in Medicare Advantage plans.

 More recently, GOP House Speaker Paul Ryan talked of “entitlement reform” as a way to reduce spending and healthcare being critical to his goal. Ryan’s staff includes former executives at the health insurance lobby, America’s Health Insurance Plans who will bring the industry closer to any legislative discussions about the future role of Medicare Advantage in entitlement talks.

Seniors are already moving in large numbers to Medicare Advantage plans because out-of-pocket costs tend to be larger in traditional fee-for-service Medicare. Seniors in traditional Medicare “find their 20% coinsurance responsibility more burdensome as healthcare expenses continue to increase,” L.E.K consulting said in a November report.

 When seniors find their out-of-pocket costs rise, they are more open to switching to a Medicare Advantage plan, analysts say.

“Medicare cuts almost certainly mean more cost-sharing and higher deductibles for beneficiaries,” John Gorman , executive chairman of the Gorman Health Group says. “Medicare Advantage offers more benefits for lower cost, and offers an annual limit on out of pocket costs that will be even more attractive after cuts.”

Already, health insurance companies are making moves to prepare for increased enrollment in Medicare Advantage. Anthem last week closed on its acquisition of Florida’s HealthSun, which is a Medicare Advantage plan with 40,000 members. That deal came after Humana agreed to take a stake in Kindred Healthcare’s home division, which provides home health services to seniors and has significant overlap with the insurer’s Medicare Advantage membership.

And once CVS Health completes its acquisition of Aetna, the pharmacy chain and health insurer plan to roll out more programs to coordinate care for seniors in Medicare Advantage plans as a way to step up their marketing to potential customers.

Increasingly, seniors are choosing Medicare Advantage. Currently, just under 35% of Medicare beneficiaries, or about 20 million Americans, are enrolled in MA plans . But Medicare Advantage enrollment is projected to rise to 38 million, or 50% market penetration, by the end of 2025 , L.E.K. Consulting projects.

Insurers are banking on that figure. Four months before the L.E.K report, UnitedHealth Group executives predicted 50% Medicare Advantage penetration but didn’t say how soon that would happen.

“We do think there’s an opportunity to further advance the penetration of Medicare Advantage,” UnitedHealthcare CEO Steven Nelson said on the company’s second-quarter earnings call in July. “Where it can go, hard to tell, but I don’t think it’s unreasonable to think about something north of…40% approaching 50%. It doesn’t seem like an unreasonable idea to us.”

MEDICARE ADVANTAGE is the third attempt of the Feds to reduce costs for Medicare.  Their first attempt several decades ago was called Medicare HMO… it failed after about 10 yrs +/-… “extra” services started to be dropped, copays, deductibles, and premiums started to increase…  healthcare providers started dropping out of the program.. and Medicare HMO was abandoned

A decade or so later … the Feds brought out Medicare-C… with the same promises of extra services, lower copays and premiums and over a decade or so.. it followed the same path as Medicare HMO.

The latest reincarnation is Medicare Advantage… regular Medicare only uses insurance companies to process the claims for services provided Medicare beneficiaries.. the insurance companies only charge a administrative fee and are not a financial risk.

IMO, if you look at the current enrollment of Medicare Advantage I believe that you will find a very large percent of those that are on Medicare disability and those seniors who are “not too well off”..  Generally few – if any – Medicare supplements will write a policy for those on disability and some seniors cannot afford the cost of a Medicare supplement and Part D premiums.. upwards of $200 +/month for each patient..

So our bureaucrats are going to talking about turning over more – or all – of the Medicare population to FOR PROFIT insurance companies… that are going to promise more products/services for less out of pocket money for those on Medicare.

Isn’t it about time that someone DO THE MATH… you turn over healthcare to a number of FOR PROFIT health insurance companies and they are going to promise more product/services for less out of pocket costs for the Medicare beneficiaries they cover and the Feds gets to pay a flat $/person/month.

WHAT COULD GO WRONG ?

Oops, they did it again. Indiana agency wrongly issues fines to stores selling CBD oil

https://www.indystar.com/story/news/politics/2017/12/29/oops-they-did-again-indiana-agency-wrongly-issues-fines-stores-selling-cbd-oil/987596001/

The Alcohol and Tobacco Commission wrongly issued fines to at least two stores for selling cannabidiol, or CBD oil and cbd sour gummies, accidentally clouding Gov. Eric Holcomb’s promise not take such action until the end of January. 

In November, Holcomb said state excise police would resume checks for the cannabis extract after Attorney General Curtis Hill issued an opinion declaring CBD oil illegal in Indiana. However, for the first 60 days, he said excise police would only issue warnings, giving time for stores to pull the product from store shelves and lawmakers time to pass clarifying legislation. 

But at least two stores received a letter from ATC prosecutor David Coleman, stating they owed fines for citations excise police issued in May or June, before the ATC put a moratorium on CBD oil seizures. It’s another in string of incidents that have led to widespread confusion over the state’s CBD law. These days people can look for cbd flower near me and avail medicinal CBD.

The agency said the letters were sent in error. An ATC spokeswoman said she was uncertain how many more stores may have erroneously received a letter issuing fines, but the agency is working to determine that.

 

Jeff Shelton and his co-owner at Happy Daze Smoke Shop on the city’s west side received a letter just before Christmas asking them to pay $750 worth of fines. The shop was administratively charged with possession of marijuana, unlawful manufacture distribution or possession of counterfeit substance, tobacco sales at site of nuisance, prohibited smoking and hindering enforcement. 

Karma Smoke shop on the southwest side of Indianapolis also was a sent a letter issuing $200 worth of fines. 

David Cook, chairman of the ATC, called the shops this week to tell them that letter was a mistake. The agency is not taking any action against stores previously cited selling CBD.

“That letter was sent out erroneously,” Cook said in a statement to IndyStar. “The specific violations were mistakenly contained in our system, and should be disregarded. This was an administrative error and we are working to identify those who received a letter.”

Shelton said he was told “somebody pressed the wrong button.” 

Shelton saw the mistake as just the latest example of inconsistent policies on CBD oil within state government. 

“There’s not a consensus within the government,” Shelton said. “We’re still getting different statements from the attorney general and the governor. If they’re not even sure of what’s legal and what’s not legal or what their position is, then how can we be clear?”

Even during the phone call with Cook, Shelton said he wasn’t given a clear answer on whether his CBD products were legal, despite containing no tetrahydrocannabinol, or THC, the compound in marijuana that produces a high. 

Holcomb had previously said that after the initial 60-day grace period, violation citations would only be given to stores selling CBD products containing THC. 

The agency’s handling of CBD oil regulations has been heavily criticized by advocates of the product.  For more CBD Information make sure that you visit a reliable site. Prior to any guidance from Holcomb or a legal opinion from Hill, the ATC began issuing citations to stores selling CBD oil following the passage of a law that created a CBD oil registry for epileptic patients in April. 

In several cases, officers incorrectly told store owners that a prescription was required to possess CBD, according to incident reports. While the law does require a diagnosis for treatment-resistant epilepsy, it does not require a prescription. 

“It sounds like we’ve got an agency that is out of control,” Rep. Jim Lucas, R- Seymour said after learning about the confiscations.

Even after agency heads announced a moratorium on the confiscations in August, officers gave a warning to one store and issued a violation to another for selling CBD products.

The agency admitted those were errors too. 

Stephanie Wilson, a spokeswoman for Holcomb, said the latest “administrative error” isn’t indicative of a larger problem.

“I don’t think we should read too much into it,” Wilson said. “I think it was an administrative error that they’re already in the process of fixing.”

Call IndyStar reporter Kaitlin Lange at (317) 432-9270. Follow her on Twitter: @kaitlin_lange.

 

Congress To DEA: Update Schedule II Partial Fill Regulations Swiftly

www.fdalawblog.net/2017/12/congress-to-dea-update-schedule-ii-partial-fill-regulations-swiftly/

Obscured last week amidst the tumultuous passage of tax reform, Congress urged the Drug Enforcement Administration (“DEA”) in a bipartisan letter to quickly update its regulations and guidance on the partial filling of schedule II controlled substance prescriptions. The letter notes that “[l]arge amounts of unused medications are a key contributor” to the nationwide opioid crisis and that between 67% and 92% of surgery patients “reported they had unused opioids remaining after the procedures.”  Letter from Congress of the United States, to Robert Patterson, Acting Administrator, DEA (Dec. 21, 2017).

The letter states that Congress passed the Comprehensive Addiction and Recovery Act (“CARA”) in July 2016 in part to prevent further stockpiling of unused prescribed opioids by amending the Controlled Substances Act (“CSA”) to enable patients or physicians to request that pharmacists partially fill schedule II substances that include prescription opioids and to allow remaining quantities to be filled up to 30 days after issuance of a prescription if necessary.

Prior law and current DEA regulations allow pharmacists to partially fill schedule II controlled substance prescriptions only if the pharmacy is unable to dispense the full prescribed quantity. 21 C.F.R. § 1306.13(a).  Pharmacists may dispense the remaining quantity within 72 hours of the first partial dispensing and cannot dispense any further prescribed quantity beyond 72 hours thereby requiring the prescriber to issue a new prescription.  21 C.F.R. § 1306.13(a).  Current regulations also allow partial dispensing of schedule II prescriptions to patients in a Long Term Care Facility or those diagnosed with a documented terminal illness.  21 C.F.R. § 1306.13(b).  Pharmacists can partially fill schedule III-V controlled substance prescriptions as long as no dispensing occurs after six months from the date of issue.  21 C.F.R. § 1306.23.

CARA amended the CSA to allow for the partial dispensing of a schedule II prescription if not prohibited by state law, requested by the patient or prescriber and the total quantity dispensed in partial fillings does not exceed the total quantity prescribed. 21 U.S.C. § 829(f)(1).  The amended CSA prohibits further partial dispensings later than 30 days after the prescription is written and no later than 72 hours in emergency situations.  21 U.S.C. § 829(f)(2).  The letter urges DEA to “swiftly” update its regulation and guidance as pharmacists and prescribers, “critical partners in the fight against the opioid epidemic,” are reluctant to comply with the amended CSA’s partial dispensing provisions until the agency does so.

 

10 Myths About the Opioid Crisis

www.painnewsnetwork.org/stories/2017/12/24/10-myths-about-the-opioid-crisis

There is no shortage of false statements being made about opioids. As the overdose crisis worsens, old and debunked claims reappear, while new claims rise up alongside them. Pundits, politicians and even physicians are perpetuating them, despite all evidence to the contrary.

So let’s set the record straight in order to promote an informed dialog about opioid medication, chronic pain, and the opioid crisis.

Myth 1: America has 5% of the world’s population but uses 80% of the world’s opioids.

Numerous politicians, such as Missouri Sen. Claire McCaskill and former New Jersey Gov. Chris Christie, as well as many journalists, have made this statement. It is demonstrably false.

In fact, the U.S. only uses about 30% of the world’s opioid supply. That estimate includes the addiction treatment drugs methadone and buprenorphine, both of which are opioids.

Myth 2: 80% of heroin addicts began by abusing prescription opioids.

mime-2056078_640.jpg

This myth is pernicious because it is based on a kernel of truth. The number is correct but the implication is wrong. Only 4 to 6% of people who misuse prescription opioids go on to use heroin. And the number of people who start heroin without taking prescription opioids first has been rising in the past year.

Myth 3: Addiction starts with a prescription.

This claim persists despite decades of data to the contrary. A 2010 study found that only one-third of 1% of chronic pain patients without a history of substance abuse became addicted to opioids during treatment. Most abuse begins when people take medication that was not prescribed to them, using pills that were stolen, purchased illegally, or obtained from friends and family members.  

Myth 4: Opioid use leads to pain sensitization or ‘opioid induced hyperalgesia.’

Addiction treatment specialists like to repeat the claim that long-term opioid use makes patients hypersensitive to pain. But hyperalgesia is poorly understood and often confused with opioid tolerance. One study found that chronic pain patients on opioids had no difference in pain sensitivity when compared to patients on non-opioid treatments.    

Myth 5: Opioid overdoses are killing 64,000 people per year.

Nearly 64,000 Americans died from drug overdoses last year, according to the CDC, so that part is true. But opioids were involved in only about two-thirds of those deaths – and most of those overdoses involved heroin and illicit fentanyl.

Myth 6: Reduced opioid prescribing will end the overdose crisis.

Reduced prescribing is clearly not working.The number of opioid prescriptions has been in steady decline since 2010, yet fatal overdoses have risen sharply ever since.

Myth 7: Medical cannabis will cure the opioid crisis.

This is a recurring myth, made popular again in 2017. Unfortunately, not only does the recent data show that medical cannabis is not helping in states where it is legal, the underlying assumption of this myth is that chronic pain care is driving the opioid crisis. This is not the case.

Myth 8: Banning opioid medication will fix the opioid crisis.

This was put forth again early in 2017 by New Hampshire attorney Cecie Hartigan. Setting aside the problem of banning illegal drugs like heroin and fentanyl analogues (they are already banned), opioids are simply too medically useful to give up. Moreover, prior experience with drug bans, from Prohibition to the current overdose crisis, shows that bans do not stop misuse or addiction.

Myth 9: There are lots of ways to treat chronic pain

This myth has become increasingly popular as states, medical facilities, and health insurers pursue policies to reduce opioid prescribing. Although some of these methods, from physical therapy to spinal cord stimulators, may prove helpful, that misses the fundamental point. Chronic pain disorders are so horrible that all effective options, including opioid therapy, need to be on the table.

Myth 10: Opioids are ineffective for chronic pain.

This is the biggest myth of all. There is an abundance of high-quality research showing that opioids can be effective for some forms of chronic pain. Here’s a partial list of recent studies:

Adding to these studies is a recent review in Medscape, in which Charles Argoff, MD, a professor of neurology at Albany Medical College, said that “in multiple guidelines and in multiple communications, we have a sense that chronic opioid therapy can be effective.”

New myths appear regularly, but these persist despite all efforts to counter them. Like an ear-worm or viral meme, they cannot be eliminated. The only defense is knowledge.

Palliative Care Is About the Life That’s Left, Not the End of Life

https://www.medscape.com/viewarticle/887016

Distinguishing Between Palliative Care and Hospice

Diane E. Meier, MD: It’s a common confusion and misconception. The short answer is that all hospice is palliative care, but not all palliative care is hospice. That is the elevator speech version. The more nuanced version is that the Medicare Hospice Benefit, which was written into law about 25 years ago, was designed to reduce the number of people who would use it. They put strict eligibility criteria around access to hospice. One of the criteria is that two doctors have to agree that a patient is likely to be dead in 6 months in order to be eligible, which is already ridiculous because we have no idea who is going to be dead in 6 months. Second, the patient, or their decision-maker if they cannot decide for themself, literally has to sign a piece of paper agreeing to give up regular insurance coverage in return for hospice. It’s like you cannot have medical treatment, but you can have hospice.

That is called “the terrible choice.” That created the misconception that you could only get palliative care if you were dying and ready to give up. And that is a myth. The problem with that is that most people who need palliative care are not dying. They are living, and often for a very long time—10 years, 15 years—with serious illnesses like chronic obstructive pulmonary disease, heart failure, dementia, or end-stage renal disease. They have a tremendous burden of suffering and caregiver distress, but they are not dying. Palliative care was an answer to that gap. It was recognizing that living with a serious illness nowadays is almost always a chronic disease. No matter how long people have to live, they deserve the same attention to quality of life, treatment of symptoms, management of depression, support for their families, and support for social issues like financing and housing. It should be based on need, not prognosis.

 

The modern palliative care movement is a needs-based field. We take care of people who are going for lymphoma or leukemia cures, or who are getting a transplant or waiting for a transplant. They are not getting ready to die and they are not likely to die soon, but they have enormous palliative care needs.

Differing Views of Palliative Care

Dr Cassoobhoy: What is your experience in the hospital with other coworkers, other physicians, and healthcare providers as well as patients and their families?

Suzanne E. Zampetti, RN, MSN, FNP-BC: As a consulting service, what we hear often from other services is sort of, “We are not there yet. We are not ready for you yet.” To Diane’s point, it’s that perspective that we are just end-of-life care. It’s really important that we continue to educate other services and other physicians and nurses across the board about what palliative care does, so that we can be useful to them and we can reach out to the patients who need us.

Dr Meier: Let me give an example. For a very long time, oncologists at my medical center would say, “She’s not ready for that.” Although the patient was not dying, she was in excruciating pain and could not breathe, and all the rest. Then, in a pilot project, palliative care became something that every cancer patient was screened for; it did not depend on the attending physician thinking that “it’s time.” As a result, a much higher proportion of cancer patients received palliative care. And 6 months later, the oncologists now say, “We don’t know how we ever practiced without you.”

Oncologists are really busy and stretched, and they have more patients in the waiting room. And having a non-rushed conversation about what having a disease means, what to expect in the future, and what to do for a pain crisis in the middle of the night… they need help. We work side-by-side as an added layer of support to what the specialist does. Once they figured out what a huge benefit we were to them, they were like, “We need more.”

How Sick Does a Patient Need to Be to Receive Palliative Care?

Dr Cassoobhoy: How sick does a patient need to be for a palliative care consult? What are the spectrums of illnesses that a patient may have that would qualify them for a palliative care consult?

 

Ms Zampetti: I don’t think it’s ever too soon to call in a palliative care consult, particularly if you have a potentially life-threatening illness. If you have a diagnosis of cancer, no matter what that may be, there is never an inappropriate time to talk about goals of care—what is important to that patient, what they are hoping to get out of the treatment, and what they would want and hope for if things did not go the way that they wanted.

 

We do this with our patients who get left ventricular assist devices. They come in looking for this life-saving cardiac device and their hopes are great, and they should be great. We are not there to take away their hope. We are there to discuss what they want if things do not go the way they hope. What would they then hope for at that time? What is important to them, and how would they want to live their life if things were not going the way that they wanted?

 

Dr Cassoobhoy: It’s interesting, because different patients are going to give different answers. Your role is to respect and encourage the real answer to come out so that it can be respected and honored.

 

Ms Zampetti: Exactly. Those conversations are very important to have with the family members present because it’s important for everyone to hear what the patient is saying and to really be able to register and resonate with that. At the other side of things, the patient may not be able to speak for themself anymore, and it takes a tremendous burden off of family members to know what their loved one wanted beforehand.

In palliative care, we are not about end of life; we are about the life that you have left.
 

Dr Meier: I would just add another story. A medical resident who had worked with our palliative care team was pregnant and delivered a baby a few months after she finished residency. Two weeks later she became extremely short of breath and thought that she may have developed a pulmonary embolus from a deep vein thrombosis as a complication of the delivery. She went to see her primary care doctor and he did a chest x-ray in the office.

 

She said she knew the minute he opened the door that she had cancer, just from looking at his face. She is a doctor, so she could read the body language. She had a massive mediastinal lymphoma that required a bone marrow transplant at the major cancer hospital in New York City. The hematologist asked her if she had any questions before he began treatment and she said, “I assume you have palliative care on your team.” He said, “You don’t need that; you’re not dying.” She said back to him, “I’m not going through this devastating treatment without support from a palliative care team.” She could not get it at the cancer hospital, so she got her cancer care at the cancer hospital and her palliative care from us. She now says to whoever will listen that she could not have made it through the treatment without that support. She had terrible insomnia. She had terrible anxiety and depression. She was not allowed to touch her baby for quite a while because of the toxic treatment and radiation she was getting. She said it was hell, and that it was our team who managed her mood, physical symptoms, and addressed her existential and spiritual questions: How could this have happened to me? I just finished my residency. I just had my first baby. What did I do wrong? How did this happen?

 

She got great cancer care and she now appears to be cured, but it was a very difficult period in her life. This is an example of someone for whom the goal was always cure. She was to receive very aggressive treatment. She was an informed consumer, she was a doctor.

 

Dr Cassoobhoy: She could ask for palliative care.

 

Dr Meier: Yes.

 

Dr Cassoobhoy: It’s hard to imagine going through something like that without palliative care. It seems like that should not happen anymore.

 

Dr Meier: Right. The doctors and the public should take notice of someone who is facing a life-threatening illness with a realistic hope for cure. She understood what the treatment was like because she had witnessed it as a trainee. She knew that there was no need to go through this without very meticulous and sophisticated professional attention to suffering. It’s not just people who are going to die who need this kind of care. In fact, it’s way more people who are not going to die, but are either chronically ill or are pursuing a cure, who need this kind of care.

 

Ms Zampetti: In palliative care, we are not about end of life; we are about the life that you have left. It is really exploring with the patient what they would like to do with that time and helping them realize that.

 

We have a patient right now who is in the intensive care unit who had a heart transplant and was doing very well for a while, and things have taken a turn for the worse. He said to our social worker that he thought he was dying. She astutely asked him, “If that were true, what would you want to do? What’s important for you in that moment?” He asked to have his brother called and he asked to have certain people come to visit him, and we made that happen for him. It’s about exploring what they want to do with the rest of their life.

 

How Can You Set Realistic Expectations for Patients?

Dr Cassoobhoy: What expectations should patients have for palliative care?

 

Ms Zampetti: The expectation would be that they are going to get expert pain management. They are going to get expert symptom management. Palliative care looks at the person as a whole. They are going to address their social issues, their existential distress. One of the things that I love about the palliative care team is that it is made up of many different disciplines—social work, chaplaincy, nurses and nurse practitioners, and physicians—that are all working together to address all of the needs of the patient at one time. The patient should expect to be treated as a whole person and not as an illness.

 

Dr Cassoobhoy: I like that the social worker and the chaplain add so much to complete the addressing of the whole person.

 

How to Direct Patients to Palliative Care

Dr Cassoobhoy: How can patients find palliative care, and what if there is no provider close by?

 

Ms Zampetti: That is a real dilemma.

 

Dr Meier: First of all, there is a website called getpalliativecare.org. You can put in your city, state, or ZIP code and all of the programs in that area will drop down with the phone numbers. The second thing is that it is sometimes possible for palliative care teams to provide teleconsulting, which is the willingness to talk a colleague—who may be 1000 miles away—through a situation such as complex pain management or a complex family dynamic. This is increasingly common because there are so few palliative care professionals or specialists and so much need in areas of the country that do not have good access. If I were working in an area where there was not good regional palliative care specialty expertise, I would reach out to my nearest big city and ask to establish a telephone consulting relationship.