Why is there a nationwide hospital shortage of injectable opioids? – follow the money. (part 3 of a continuing case study on the opioid crisis)

“The incident command system kicked in at Brigham and Women’s Hospital about a week ago. A large team of doctors, pharmacists, and nurses began assembling every morning to confront an emerging crisis with the potential to severely undermine care for patients.
The challenge was different than it was during the Boston Marathon bombing, another event that triggered the command response. This one wasn’t rushing toward caregivers as fast. But it was similarly daunting and logistically demanding: Amid a nationwide crisis caused by too-easy access to medical painkillers, hospitals are now struggling to find enough of that same class of drugs to keep their patients’ pain controlled.
That is the reality now facing Brigham and Women’s and other medical providers across the country. Production of injectable opioids has nearly ground to a halt due to manufacturing problems, creating a shortage of staple medications used to treat a wide array of patients. Alarms are now ringing at all kinds of medical providers, from sprawling academic hospitals to small hospice programs, and many are launching efforts to conserve injectable opioids and institute safeguards to prevent dosing errors that can result from rapid changes in medication regimens.” (A)

“The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs needed for patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.
As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.
In the institute’s survey of hospital pharmacists last year, one provider reported that a patient received five times the appropriate amount of morphine when a smaller-dose vial was out of stock. In another case, a patient was mistakenly given too much sufentanil, which is about 10 times more powerful than fentanyl, which was the ideal medication for that situation.
In response to the shortages, doctors in states as far-flung as California, Illinois and Alabama are improvising the best they can. Some patients are receiving less potent medications like acetaminophen or muscle relaxants as hospitals direct their scant supplies to higher-priority cases. Others patients are languishing in pain because preferred, more powerful medications aren’t available, or because they have to wait for substitute oral drugs to kick in.” (B)

The shortages involve prefilled syringes of these drugs, as well as small ampules and vials of liquid medication that can be added to bags of intravenous fluids.
Drug shortages are common, especially of certain injectable drugs, because few companies make them. But experts say opioid shortages carry a higher risk than other medications.
Giving the wrong dose of morphine, for example, “can lead to severe harm or fatalities,” explained Mike Ganio, a medication safety expert at the American Society of Health-System Pharmacists.
Calculating dosages can be difficult and seemingly small mistakes by pharmacists, doctors or nurses can make a big difference, experts said.
Marchelle Bernell, a nurse at St. Louis University Hospital in Missouri, said it would be easy for medical mistakes to occur during a shortage. For instance, in a fast-paced environment, a nurse could forget to program an electronic pump for the appropriate dose when given a mix of intravenous fluids and medication to which she was unaccustomed.
“The system has been set up safely for the drugs and the care processes that we ordinarily use,”…“You change those drugs, and you change those care processes, and the safety that we had built in is just not there anymore.”
Chicago-based Marti Smith, a nurse and spokeswoman for the National Nurses United union, offered an example.
“If your drug comes in a prefilled syringe and at 1 milligram, and you need to give 1 milligram, it’s easy,” she said. “But if you have to pull it out of a 25-milligram vial, you know, it’s not that we’re not smart enough to figure it out, it just adds another layer of possible error.” (C)

Experts say opioid pills are most often the culprits behind this abuse. It is not those drugs, but the liquid form that hospitals depend upon for general surgery, sedation, trauma treatment and pain management. And it is those drugs — namely ketamine, fentanyl and hydromorphone — that are in critically low supply.
Pfizer, a major injectable drug supplier, had to stop production of the medications after the Food and Drug Administration found problems at a manufacturing facility in Kansas. Work to upgrade the facility took longer than expected, Pfizer wrote in a letter to its customers in November.
In that letter, Pfizer said syringes would not be available until 2019.
Roper St. Francis’ medication safety officer, Kim Gaillard, said the system gets 60 percent of its IV opioid drugs from Pfizer…
Clinicians have had to find solutions. Gaillard was sure to stress there are other medications in many cases. Other types of painkillers have worked just as well in some surgeries, she said. The shortage has led the hospital system to speed up its review of different ways to deal with pain.
“I know that this is alarming,” Gaillard said, “but we have other strategies.”
Leaders at MUSC restricted ketamine, fentanyl and hydromophone to the system’s intensive care unit, emergency department and operating rooms. An email circulated to MUSC prescribers cited “critical shortages.”
Clinicians were told they need to convert all patients to morphine, if possible. The email warned further restrictions are possible.
Heather Easterling, administrator of pharmacy services at MUSC Medical Center, said in a statement the pharmacy team is working with wholesalers every day to order more of the medications. The DEA’s restrictions are at the heart of the issue, she said.
The DEA’s quotas are quarterly, so Easterling said the shortages hospitals are seeing may continue at least until mid-April.” (D)

“This fact sheet provides an outline of potential actions for organizations to consider in managing the acute shortages of injectable hydromorphone, morphine, and fentanyl. Healthcare professionals should use their professional judgment in deciding how to use the information in this document, taking into account the needs and resources of their individual organizations.
Critical importance
Shortages of injectable opioids can be particularly challenging due to the range of uses in various healthcare settings, including emergency response, ambulatory surgery centers, and hospitals. Injectable opioids are used for acute, acute-on-chronic, or chronic pain that cannot be controlled by other pain management options. Some injectable opioids are used for sedation or anesthesia. Intermittent shortages of specific injectable opioids may require institutions to convert temporarily to a more available product. Not all injectable opioids are interchangeable for all indications. Improper conversion between morphine and hydromorphone caused two deaths during a similar shortage in 2010.
ISMP Medication Error Reporting
ASHP encourages the reporting of any medication errors related to drug shortages to the Medication Error Reporting page on the Institute for Safe Medication Practices (ISMP) website.
What can clinicians do to mitigate the impact?
• Switch therapy to a clinically appropriate oral or enteral opioid whenever possible. o The Pharmacy and Therapeutics (P&T) committee should review current IV-to-oral policies; there may be an opportunity to expand policies to include drug classes affected by shortages.
• Provide multimodal pain management by using parenteral and enteral alternatives to opioids. Consider nonpharmacologic treatments, local nerve blocks, or other pharmacologic adjuncts, as appropriate.
• Engage the institution’s experts in anesthesia and pain and palliative medicine to further develop guidance and formulate strategies for dealing with intermittent shortages.
• Ensure relevant institutional pain medication guidelines are up to date. o To reduce the risk of conversion errors, use a uniform opioid conversion tool that is approved by the anesthesia team and the P&T committee and distributed throughout the entire health system. o Resources like the ASHP Demystifying Opioid Conversion Calculations reference may be helpful in establishing guidelines.
• Product availability can vary by wholesaler and may change from week to week. Guiding prescribers to choose between the available injectable opioids can help institutions reserve certain opioids for specific populations or indications (for example, reserve fentanyl for operating-room use). Use systemwide communications to alert all clinicians who prescribe, dispense, or administer injectable opioids.
• Ensure the electronic health record (EHR) displays opioid options that match the products currently in stock. Do not underestimate the informatics resources that will be needed during this shortage. Inventory control strategies
• Consider reserving supplies of specific injectable opioids for specific indications and limiting the placement.” (E)

“Regrettably, we believe the forecast for drug shortages is grim. There is little relief in sight to halt the rapid escalation of shortages in large part because the conditions that lead to shortages are varied and FDA lacks the necessary regulatory authority to proactively manage potential shortages. It is not always clear what causes drug shortages, as drug companies are not required to disclose the underlying reason or notify FDA regarding a decision to stop production unless they are the sole-provider of the product and it is a medically necessary product. Few manufacturers will supply letters to healthcare providers regarding the reason behind the shortage and the anticipated duration, which is very frustrating to healthcare personnel. The drug shortage lists maintained on the ASHP and FDA Web sites attempt to provide a reason for the shortage in very general terms.
Some of the more common reasons for drug shortages include the following:
– Unavailability of bulk and raw materials used to produce pharmaceuticals, of which 80% come from outside the US
– A delay or halt of production in response to an FDA enforcement action regarding noncompliance with good manufacturing practices identified during an inspection
– Voluntary recall of a drug after the manufacturer discovers a problem with the medication, such as inadvertent bacterial or fungal contamination
– Change in the manufacturer or product formulation (e.g., inhalers without chlorofluorocarbons) that delays production
– Manufacturer’s business decision to halt production of a drug due to availability of generic products, patent expiration, market size, drug approval status, regulatory compliance requirements, anticipated clinical demand, and/or reallocation of resources to other products (FDA does not have authority to require a company to continue manufacturing a medically necessary product)
– Manufacturer mergers that narrow the focus of product lines, causing discontinuation of certain products, or move production of a drug to a new facility, causing production delays
– Poor inventory ordering practices, stockpiling before price increases, and hoarding caused by rumors of an impending shortage
– Unexpected increases in demand for a drug when a new indication has been approved, usage changes due to new therapeutic guidelines, or a substantial disease outbreak occurs
– Natural disasters that involve manufacturing facilities or that lead to demands for certain classes of medications to treat disaster victims.” (F)

“Other companies can’t make up the difference because they don’t have the capacity. Even if they did, the Drug Enforcement Administration is unwilling to give them large amounts of raw materials. The DEA implements annual caps on the amount of raw material a manufacturer can use to make opioids—one mechanism it has to try to limit the diversion of the addictive drugs amid the addiction epidemic.
The DEA has not shifted those caps to allow other manufacturers to produce enough to offset the shortage of injectable narcotics, according to Premier, which has advocated for the agency to loosen its quota restrictions.
“We understand and support the DEA’s goal to be judicious about the production of narcotics, but we believe we are in the midst of a public health crisis,” Mike Alkire, chief operating officer of Premier, said in a statement. “A temporary reallocation of supply quotas would allow others to step into the void, potentially addressing a multi-year shortage in a matter of months.”
Injectable opioids aren’t the ones getting diverted, said Scott Knoer, chief pharmacy officer at Cleveland Clinic.
“We have to do something to try to limit controlled substances, but limiting injectable opioids is not helpful for patients who need them,” he said. “ (G)

“The Drug Enforcement Administration has raised production quotas for drug manufacturers Fresenius Kabi and West-Ward Pharmaceuticals to mitigate the shortage of opioid injectables, but relief is likely months away…
Providers, lawmakers, group purchasing organizations and industry groups like the American Hospital Association have been lobbying the DEA to raise production quotas amid the shortage. In a survey of 116 member health systems, GPO and consulting group Premier found that nearly all of them are experiencing moderate-to-severe shortages of injectable opioids. More than half reported that the shortage affected patient care, including delaying or canceling surgeries or lowering patient satisfaction scores.
“We are encouraged that the DEA did transfer raw material allocations to the three other companies, and we applaud Pfizer for recognizing the need to transfer some of their excess raw material allocation to other suppliers to help meet the inpatient needs for injectable narcotics,” Todd Ebert, CEO of the Healthcare Supply Chain Association, said in an email. “However, we hope that the DEA will develop processes and procedures to recognize and respond to these market issues much more quickly in the future, as three months seems to be too long.”…
The DEA has been under immense pressure to rein in production as the opioid epidemic has worsened.
The agency reduced its production quota of opioids by at least 25% in 2016, which was the first reduction of its kind in more than two decades. But DEA-approved opioid production volumes remain high—including a 55% increase in oxycodone levels in 2017 compared with 2007, according to a July 2017 letter to the DEA signed by 16 senators…
Between 1993 and 2015, the DEA allowed production of oxycodone to increase 39-fold, along with drastic increases for other opioids, the letter said. The number of opioid prescriptions increased from 76 million in 1991 to more than 245 million prescriptions in 2014, resulting in a dramatic rise in overdoses. More than 42,000 people died from opioid overdoses in 2016, according to the Centers for Disease Control and Prevention, a five-fold increase from 1999… (H)

“Hydrocodone and oxycodone are semi-synthetic opioids, manufactured in labs with natural and synthetic ingredients. Between 2007 and 2016, the most widely prescribed opioid was hydrocodone (Vicodin). In 2016, 6.2 billion hydrocodone pills were distributed nationwide. The second most prevalent opioid was oxycodone (Percocet). In 2016, 5 billion oxycodone tablets were distributed in the United States.
The International Narcotics Control Board reported that in 2015, Americans represented about 99.7% of the world’s hydrocodone consumption.” (I)

“Governments allege that opioid companies unreasonably interfered with the public’s health by oversaturating the market with drugs and failing to implement controls against misuse and diversion, thereby creating a public nuisance.” (J)

So why didn’t manufacturers switch to a higher percentage of injectable opioids?
“Part of the issue is that there are a limited number of manufacturers that produce syringes of opioids. The products are heavily regulated given the complexity of making a syringe and the return on investment is slim.” (H)

(A) Hospitals are confronting a new opioid crisis: an alarming shortage of pain meds, by Casey Ross, https://www.statnews.com/2018/03/15/hospitals-opioid-shortage/
(B) Opioid shortages leave US hospitals scrambling, by Pauline Bartolone, https://www.cnn.com/2018/03/19/health/hospital-opioid-shortage-partner/index.html
(C) The Other Opioid Crisis: Hospital Shortages Lead To Patient Pain, Medical Errors , by Pauline Bartolone, https://www.washingtonpost.com/national/health-science/the-other-opioid-crisis-hospital-shortages-lead-to-patient-pain-medical-errors/2018/03/16/91d2c6fe-28fa-11e8-a227-fd2b009466bc_story.html?noredirect=on&utm_term=.d44201ad0fd6
(D) South Carolina hospitals dealing with ‘critical shortage’ of opioids, by Mary Katherine Wildeman, https://www.postandcourier.com/health/south-carolina-hospitals-dealing-with-critical-shortage-of-opioids/article_33c49db6-2c7a-11e8-b468-eb78b128b456.html
(E) Injectable Opioid Shortages Suggestions for Management and Conservation (Compiled by ASHP and the University of Utah Drug Information Service, March 20, 2018), https://www.ashp.org/-/media/assets/drug-shortages/docs/drug-shortages-iv-opioids-faq-march2018.ashx
(F) Drug Shortages Threaten Patient Safety, https://www.medscape.com/viewarticle/727958,
(G) Injectable opioid shortage compromises care, by Alex Kacik, http://www.modernhealthcare.com/article/20180321/TRANSFORMATION03/180329986
(H) DEA lifts production quotas to ease injectable opioid shortage, by Alex Kacik, http://www.modernhealthcare.com/article/20180414/NEWS/180419944
(I) Opioid Crisis Fast Facts, https://www.cnn.com/2017/09/18/health/opioid-crisis-fast-facts/index.html
(J) Drug Companies’ Liability for the Opioid Epidemic, by Rebecca L. Haffajee and Michelle M. Mello, http://www.nejm.org/doi/full/10.1056/NEJMp1710756

Part 1
CASE STUDY ON THE OPIOID CRISIS. “We still have lacked the insight that this is a crisis, a cataclysmic crisis”

Part 2
“In 2016, more than 40 percent of opioid overdose deaths in the U.S. involved a prescription opioid.”

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“In 2016, more than 40 percent of opioid overdose deaths in the U.S. involved a prescription opioid.”

I have recently been posting CURATED CONTEMPORANEOUS CASE STUDIES with the objective of developing real-time health care policy information and analysis.
The OPIOID CRISIS has been a real challenge absent any federal government leadership for state governments, public health agencies, hospitals, and the public.
So this post is to catch-up on the various threads out there since the initial case study:
CASE STUDY ON THE OPIOID CRISIS. “We still have lacked the insight that this is a crisis, a cataclysmic crisis” http://doctordidyouwashyourhands.com/2018/03/case-study-on-the-opioid-crisis-we-still-have-lacked-the-insight-that-this-is-a-crisis-a-cataclysmic-crisis/
And I think it will continue with various well intentioned initiatives but no evidenced-based platform.

“Surgeon General Jerome Adams is issuing a rare public health advisory on Thursday, calling for friends and family of people at risk for opioid overdoses to carry the OD-reversal medication naloxone. He likened the treatment to other livesaving interventions, such as knowing how to perform CPR or use an EpiPen.
The recommendation comes in the form of a surgeon general’s advisory, a tool used to draw attention to major public health issues. The last one, focused on drinking during pregnancy, was issued in 2005.
“What makes this one of those rare moments is we’re facing an unprecedented drug epidemic,” Adams told STAT in a phone interview Wednesday.
Tens of thousands of Americans are dying from drug overdoses each year, largely driven by opioids. While paramedics — and increasingly, police officers — carry naloxone, they often arrive too late for it to save someone’s life. In countless cases, family members and friends — often other people using drugs — have reported using naloxone to save an overdose victim, and the idea is that if more people have naloxone on hand, more people could be saved.
“It’s easy to use, it’s lifesaving, and it’s available throughout the country fairly easily,” Adams said.” (A)

“Dr. Nora Volkow has heard a frightening scenario play out around the country. People are administering naloxone to synthetic opioid drug users who have overdosed. But the antidote doesn’t work well. So they give another dose. And it’s only after multiple doses — four, five, even six times — that drug users finally come to their senses.
Naloxone is the only widely available drug to reverse opioid overdoses. But anecdotal reports of its limitations against synthetic opioids are on the rise. Spurred by that public health threat — as well as a booming commercial market for the antidote — drug companies, researchers, and health officials are eagerly eyeing the development of new treatments to augment the use of naloxone or, in some cases, potentially replace it.
“The strategies we’ve done in the past for reversing overdoses may not be sufficient,” Volkow, director of the National Institute for Drug Abuse, said in a recent speech at the 2018 National Rx Drug Abuse and Heroin Summit. “We need to develop alternatives solutions to reversing overdoses.”..
“Naloxone seemed to be great for the older opioids,” Kuchera said. “But now that we’re encountering these nonmedical, ungodly [opioids] like carfentanil … we need to get with the times.” (B)

“Gov. Phil Murphy wants to spend $100 million to fight opioid addiction in New Jersey. But exactly how that money would be allocated is an open question.
The governor, speaking at a recovery house for people with drug addiction in Trenton on Tuesday, said the money would come from his proposed budget.
It would include $87 million on prevention, treatment and recovery, and another $13 million on new technology for treatment centers. The funds would go to, among other things, outpatient treatment.
But beyond that, further details were scant even though Murphy told reporters his administration had “taken a couple of months across all of our departments to do a deep dive” study about how to use state money to fight the opioid scourge.
“We must be strategic,” Murphy said. “We cannot just blindly throw money at the opioid problem.” (C)

“Gov. Phil Murphy has steered the ship of state away from many of former Gov. Chris Christie’s preferred destinations, reversing policies and ending programs in largely predictable fashion. That’s what happens when gubernatorial ideologies change so starkly. Murphy brings a very different governing philosophy to the big chair.
To his credit, however, Murphy hasn’t arrived in office hellbent on erasing every piece of his predecessor’s legacy — in contrast to a certain current occupant of the White House. For instance Murphy hasn’t derailed one of the last crusades of Christie’s tenure — combating the opioid addiction epidemic. In fact, Murphy wants to enhance it. On Tuesday he unveiled his own $100 million plan dedicated to the crisis.
The initiative in many respects serves as a continuation of Christie’s efforts, but don’t expect Murphy to characterize it that way. He won’t go that far in acknowledging previous work. Murphy’s approach will also include some key differences…
In general, however, under Murphy officials will look more toward developing community-based outpatient services and maximizing efforts to connect patients with those services…
While this plan unfolds, another piece of the opioid puzzle is expansion of the medicinal marijuana program and possible legalization of pot. Wider access to cannabis could serve to mute the opioid crisis by providing patients with less addictive pain-relief alternatives.
Let’s just hope the analytics offer up the right solutions.” (D)

“A particularly heartbreaking aspect of New Jersey’s opioid epidemic is the growing need for effective care for pregnant women, new mothers, and newborn babies struggling to break free of a dependence on painkillers, alcohol or illicit drugs like heroin.
Yesterday, the state Department of Health launched a public education campaign to increase awareness about these painful facts, connect healthcare providers with proven treatment protocols for babies born exposed to these drugs, and help pregnant women who are under the influence of opiates learn about and connect with healthier options before they give birth…
But as the opioid crisis swells, so does its impact on maternal health: Since 2008, New Jersey cases of Neonatal Abstinence Syndrome (NAS) — which occurs when infants are exposed to drugs or alcohol in the womb — more than doubled to 685 babies in 2016, according to state statistics. Nationwide, there were enough NAS babies in 2012 for one to be born every 25 minutes.
“Babies that are exposed to drugs in the womb are at risk of prematurity, birth defects and withdrawal symptoms such as seizures and vomiting,” said health commissioner Dr. Shereef Elnahal. “By encouraging pregnant women to seek help, their addiction can be treated to reduce the impact to their unborn child.” (E)

“California lawmakers advanced 10 opioid-related bills Tuesday in an effort to address the drug abuse crisis in the state, including a proposal that would let California share prescription records with other states.
Half of the bills passed by a legislative committee would increase monitoring or make it easier to track opioid prescriptions to help police and doctors spot problematic prescriptions. Others would place limits on doctors prescribing the addictive drugs to children or increase access to addiction treatments…
Low’s AB1751 would allow California’s justice department to share prescription records with other states. It’s aimed at making it easier to spot patients who cross state lines to get more prescriptions for opioid drugs.
Opponents are concerned the bill doesn’t do enough to safeguard patients’ privacy. The bill limits data sharing to states that meet certain security standards, but Samantha Corbin, a lobbyist representing the Electronic Frontier Foundation, said the requirements don’t provide enough protection for patients.
Megan Allred of the California Medical Association, a trade group that represents doctors, raised concerns about many of the bills and echoed the Electronic Frontier Foundation’s worries about privacy.
The proposal passed out of the committee unanimously.
Another bill, AB2741, passed Tuesday by the committee would limit doctors from prescribing more than five days’ worth of opioid drugs to minors unless it is medically necessary. The bill also requires doctors to discuss risks posed by the addictive drugs with children and their caretakers and requires a guardian to sign a consent form.
“Overprescribing of opioid medications has directly contributed to the addiction crisis,” said Autumn Burke, a Los Angeles Democrat who authored the bill.
The California Medical Association opposes the legislation because it doesn’t give doctors enough discretion, Allred said.” (F)

“Governor Scott Walker plans to sign two bills into law aimed at opioid abuse prevention.
The first bill, Assembly Bill 906, includes creating grant programs related to drug trafficking, evidence-based substance abuse prevention, juvenile and family treatment courts, and drug treatment for inmates of county jails. It also creates two attorney positions in the Department of justice to assist the division of criminal investigation in the Wausau and Appleton field offices, and to assist district attorneys in the prosecution of drug-related offenses.
The second bill, Assembly Bill 907, includes continuing education in prescribing controlled substances for health care practitioners, maintenance and detoxification treatment provided by physician assistants, and advanced practice nurse prescribers. It also requires school boards to provide instruction about drug abuse awareness and prevention, and includes providing $50,000 of funding to the Department of Children and Families to develop and maintain online training resources for social services workers who deal with substance abuse-related cases.” (G)

“New York made history this past week when it became the first state to work out a deal to hold the pharmaceutical industry responsible for at least some of the financial costs of the deadly and growing opioid drug epidemic.
Those costs have thus far been borne by taxpayers, as people addicted to powerful prescription painkillers, heroin, fentanyl and other opioids cycle in and out of ambulances, emergency rooms, jails, courts, rehabilitation centers and social service programs. In 2016, more than 3,000 New Yorkers overdosed on the drugs and died.
But the passage Saturday of the Opioid Stewardship Fund in the 2018-19 state budget will now require opioid manufacturers and distributors to pay into a $100 million annual fund designed to cover the costs of prevention, treatment and recovery programs. It was cheered by substance abuse providers and addiction recovery advocates, who say it’s only right that the industry which helped create the crisis should help pay for it.
“When BP polluted our ocean they had to pay for the cleanup,” said Stephanie Campbell, executive director of Friends of Recovery – New York. “I would suggest that the opioid industry has polluted our environment. They have contributed to the flooding of the market with opioids, which have proven addictive and deadly, and made incredible profits while doing it.”… (H)

“Jessica Hulsey Nickel had only just begun to speak at a House hearing last month when a man in the back corner of the committee room stood, unfurling a paper banner and shouting toward the witness stand.
“I would like to know how much money the Addiction Policy Forum has received from the pharmaceutical industry,” yelled Randy Anderson, a well-known addiction treatment and recovery advocate in Minneapolis. “We’ve asked the question and no one will tell us. I figured I’d fly here today and ask.”
A congressman tried to gavel Anderson quiet. Committee aides scurried to fetch police. Nickel — the target of Anderson’s protests and Addiction Policy Forum’s president and CEO — ignored the interruption and continued with her testimony about legislation that would reshape federal laws regulating addiction treatment. When the hearing finished two hours later, no one besides Anderson had raised questions about potential conflicts of interest.
Despite Anderson’s difficulty in getting her attention, Nickel’s three-year-old nonprofit is increasingly in the spotlight, both for its high-profile advocacy work and its close ties with drug makers. The vast majority of the group’s funding comes from pharmaceutical companies, some of whose executives sit on its advisory board. Overshadowed by APF’s funding sources, however, is a more striking connection: Until last fall, Nickel was concurrently working as a lobbyist for Alkermes, the maker of a drug used to treat opioid addiction, while heading the nonprofit.” (I)

“In 2016, more than 40 percent of opioid overdose deaths in the U.S. involved a prescription opioid.
So hospitals around the country are thinking hard about whether they should be prescribing as many opioids as they do. Geisinger, a health service organization serving patients in Pennsylvania and New Jersey, has managed to reduce its prescriptions by more than 50 percent over the past few years.
Back in 2012, Geisinger realized its patients were not really satisfied with the way their pain was being controlled. Health workers looked through the electronic database and realized that, in some cases, doctors were prescribing more opioids than their patients needed. Paradoxically, that can sometimes make the pain worse.
Michael Evans, the chief pharmacy officer at Geisinger, said the organization showed those doctors what they had found.
“And, most of the time, the reaction from the prescribers is, ‘Wow, I had no idea I was prescribing like that,’” he said.
The pharmacists worked with doctors to come up with better ways of treating pain, depending on the cause.
In cases of patients with lower back pain, physical therapy proved more effective than medication. And when doctors determined painkillers were a necessity, they went through a longer list of alternatives before prescribing opioids.
It turned out, a lot of patients didn’t need opioids after all. (J)

“Hospitals in New Hampshire have agreed to kick in $50 million toward the state’s opioid epidemic efforts, just the latest example of hospitals taking significant steps toward addressing the crisis.
The funding will be invested over the next five years into a number of the state’s opioid programs, Gov. Chris Sununu announced Friday.
“It is the single largest secured financial investment the state has ever seen in funding substance abuse disorder programs,” Sununu said.
Sununu told the Associated Press that the alliance is a “great example of planning in the long-term” and “simply not accepting the way we used to do it.”
It makes sense for hospitals and other providers to take the lead on combatting the opioid crisis since they’re on the front lines of patient care, Joseph Pepe, CEO of Catholic Medical Center in Manchester, told the outlet.
“We understand how essential it is to invest in programs to address substance abuse disorder,” Pepe said. “By working together, like we are today, we can make a life-saving difference.” (K)

“In response to the opioid overdose crisis, federal Medicare officials are considering new rules that would discontinue payment for long-term, high-dose opioid therapy beginning in 2019. The vote on the new rules takes place Monday.
This is an ill-advised approach. Currently, some 1.6 million people receive opioid medication through Medicare equivalent to 90 mg per day of morphine or more. Sharp cutbacks in doses will result in hundreds of thousands of men and women with chronic pain developing withdrawal, craving and poor pain control.
While I too have deep concern about the opioid epidemic gripping our country, this outrageously short-sighted plan by the federal Centers for Medicare and Medicaid Services has the potential to cause grave harm. It could drive hundreds of thousands of people to extreme measures to avoid unintended and profoundly miserable outcomes.
Moreover, the proposal doesn’t address the real cause of most opioid overdose deaths. Earlier on in the opioid epidemic, most overdose deaths and emergency department visits resulted among chronic pain patients who were taking prescription opioids. But since then, the opioid epidemic has rapidly transitioned into an illicit drug problem.
Yet the dose-reduction proposal is aimed at this old problem, and seems blind to the current reality. To be clear: Drastic dose reductions for patients who are physically dependent on opioid therapy too often causes individuals to turn in desperation to far more dangerous and addictive illicit drugs like fentanyl and heroin.
We must do all we can to prevent individuals from developing addiction to these street drugs. Heroin and fentanyl are readily available, inexpensive, highly purified, look identical to prescription painkillers, and are peddled the same way pizzas are delivered.”
In my state of North Carolina and others around the nation, the situation is rapidly deteriorating, with far more people overdosing and dying from street-purchased opioids than from prescription painkillers.
The Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain, the de facto standard for safe opioid practice in our country, recommends that prescribers “should avoid increasing dosage to 90 mg of morphine or equivalent (MME) or more per day or carefully justify a decision to titrate dosage to 90 MME or more per day.” The new proposal flies in the face of these expert recommendations by mandating lower dosages, rather than allowing doctors to make reasoned decisions.
The CDC Guideline also contains extensive safety measures, widely agreed upon though largely ignored by prescribers. (L)

“Instead, we need a rational drug policy both to rein in the excessive prescribing of opioids and to help the people who are already dependent on them.
First, we need a national prescription database. The state-level databases that we have now are not enough. They allow clinicians to identify patients who “doctor shop” and are high consumers of opioids, but patients can still fill their prescriptions in nearby states, and no one is the wiser.
We also have to deal with doctors who contribute to the epidemic. The Drug Enforcement Administration, using that national prescription database, should identify clinicians, particularly those who aren’t pain specialists, who are outliers in their opioid prescribing patterns, review their treatments and clamp down on inappropriate and excessive prescribing.
This is tricky; we do not want to discourage doctors from adequately treating pain out of fear of legal sanction. But those who adhere to current standards of care should have little to fear.
Finally, reasonable drug policy has to take account of the fact that opioid-dependent individuals have different levels of tolerance, which means there cannot be a one-size-fits-all guideline, like the Medicare proposal, to limit prescribing.
To be sure, there is solid evidence that nonopioid treatments are safer and just as effective as opioids for certain types of chronic pain — and it’s critical that we improve pain education for all health care professionals so this becomes common knowledge.
But for those who are dependent on opioids, doctors must have the ability to adjust treatment to the neurobiological and clinical reality. The fact is that an opioid-dependent brain requires considerable time to adapt to any change in treatment.
Any opioid policy that ignores this will not just throw an untold number of people into withdrawal and misery; it could well unleash a synthetic opioid epidemic of staggering lethality.” (M)

“The new Director of the CDC…” called the opioid-driven surge in drug overdose deaths “the public health crisis of our time,” and he stressed the importance of getting treatment for addicts and enhancing the CDC’s tracking of the epidemic. “We will help bring this epidemic to its knees,” he said.”” (N)

“It took several months and a team of half a dozen doctors, nurses and therapists to help Kim Brown taper off the opioid painkillers she’d been on for two years.
Brown, 57, had been taking the pills since a back injury in 2010. It wasn’t until she met Dr. Dennis McManus, a neurologist who specializes in managing pain without drugs, that she learned she had some control over her pain.
“That’s when life changed,” she said.
During a 12-week series of appointments at McManus’ clinic in Peoria, Ill., Brown learned new ways to prevent and cope with pain, as she gradually reduced her opioid doses.
Roughly a third of Americans live with chronic pain, and many of them become dependent on opioids prescribed to treat it. But there’s a growing consensus among pain specialists that a low-tech approach focused on lifestyle changes can be more effective.
This kind of treatment can be more expensive — and less convenient — than a bottle of pills. But pain experts say it can save money over the long term by helping patients get off addictive medications and improving their quality of life.
She has just learned how to manage life with it.” (O)

“I’m feeling human again, thanks.
After three weeks of living in opioid hell – of constantly being sick to my stomach, of throwing up, of having the shakes and feeling depressed and crying – my body and brain are back to normal.
I’m no longer high and messed up on painkillers.
I’m no longer trying to withdraw from them.
And I have a new, up-close-and-personal understanding of the country’s opioid epidemic and how easy it is for a 70-something guy like me to become addicted to potent pain pills.
My opioid nightmare started on March 13 when I had my left knee replaced. The surgery went fine, but with knee replacement all the pain comes during recovery.
When I was released from the hospital on March 15 my doctor wrote me a prescription for oxycodone.
Fifty pills. Two every four hours at first, then one every 12 hours.
Hello opioid addiction.”…
I now understand how powerful and dangerous opioids are. And how important it is to have a loving family at home to take care of you when you’re taking them or trying to get off them.
During the last few days I’ve run into several other guys who had their knees replaced.
What they said made me feel kind of stupid.
One guy said he never touched oxycodone. He took Tylenol 3, which has codeine but is less potent.
When I ran into George Thomas, the retired foreman of my father’s ranch, he told me he had had both of his knees replaced.
When I told him I was still recovering from opiates, he said, “I didn’t take anything.”
OK, well.
I’m not as tough as old George.
I know opioids are valuable weapons against pain, and that before they were over-prescribed to help create the current crisis they were often under-prescribed.
But if I have to have my other knee replaced, I’m going to take Tylenol 3 and keep the oxycodone in the box.” (P)

“Experts have proposed using medical marijuana to help Americans struggling with opioid addiction. Now, two studies suggest that there is merit to that strategy.
The studies, published Monday in the journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.
The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.
“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.” (Q)

“Human resource departments should be a first line of defense in dealing with the opioid crisis, and more employers need to do a better job in readying assistance for workers who may be addicted to opioids or other substances, a group of health care experts urged.” (R)

“With deaths from opioid overdose rising steeply in recent years, and a large segment of the population reporting knowing someone who has been addicted to prescription painkillers, the breadth of the opioid crisis should come as no surprise, affecting people across all incomes, ages, and regions. About four in ten people addicted to opioids are covered by private health insurance and Medicaid covers a similarly large share.
Private insurance covers nearly 4 in 10 non-elderly adults with opioid addiction
The cost of treating opioid addiction and overdose has risen, even as opioid prescription use has fallen among people with large employer coverage…
We find that opioid prescription use and spending among people with large employer coverage increased for several years before reaching a peak in 2009. Since then, use of and spending on prescription opioids in this population has tapered off and is at even lower levels than it had been more than a decade ago. The drop-off in opioid prescribing frequency since 2009 is seen across people with diagnoses in all major disease categories, including cancer, but the drop-off is pronounced among people with complications from pregnancy or birth, musculoskeletal conditions, and injuries.
Meanwhile, though, the cost of treating opioid addiction and overdose – stemming from both prescription and illicit drug use – among people with large employer coverage has increased sharply, rising to $2.6 billion in 2016 from $0.3 billion 12 years earlier, a more than nine-fold increase.” (S)

“Much as the role of the addictive multibillion-dollar painkiller OxyContin in the opioid crisis has stirred controversy and rancor nationwide, so it has divided members of the wealthy and philanthropic Sackler family, some of whom own the company that makes the drug.
In recent months, as protesters have begun pressuring the Metropolitan Museum of Art in New York City and other cultural institutions to spurn donations from the Sacklers, one branch of the family has moved aggressively to distance itself from OxyContin and its manufacturer, Purdue Pharma. The widow and one daughter of Arthur Sackler, who owned a related Purdue company with his two brothers, maintain that none of his heirs have profited from sales of the drug. The daughter, Elizabeth Sackler, told The New York Times in January that Purdue Pharma’s involvement in the opioid epidemic was “morally abhorrent to me.”
Arthur died eight years before OxyContin hit the marketplace. His widow, Jillian Sackler, and Elizabeth Sackler, who is Jillian’s step-daughter, are represented by separate public relations firms and have successfully won clarifications and corrections from media outlets for suggesting that sales of the potent opioid enriched Arthur Sackler or his family.
But an obscure court document sheds a different light on family history — and on the campaign by Arthur’s relatives to preserve their image and legacy. It shows that the Purdue family of companies made a nearly $20 million payment to the estate of Arthur Sackler in 1997 — two years after OxyContin was approved, and just as the pill was becoming a big seller. As a result, though they do not profit from present-day sales, Arthur’s heirs appear to have benefited at least indirectly from OxyContin.” (T)

“In 2015, when they unveiled the city’s plan to battle opioid-related deaths, Mayor Bill de Blasio and his wife, Chirlane McCray, said that from that day on, New Yorkers would be able to get the overdose-reversing drug naloxone at participating pharmacies without a prescription.
“Anyone who fears they will one day find their child, spouse or sibling collapsed on the floor and not breathing now has the power to walk into a neighborhood pharmacy and purchase the medication that can reverse that nightmare,” Ms. McCray said, with the mayor by her side.
But three years later, an examination by The New York Times has found that of the 720 pharmacies on the city’s list of locations that provide the drug, only about a third actually had it and would dispense it without a prescription. The list is used on the city’s website, the NYC Health Map, the Stop OD NYC app and when someone calls 311.
Phone calls placed to every pharmacy on the list last month found compliance with the program to be spotty, at best.
In the Bronx, which is battling a surge in heroin use and where more people died of opioid-related overdoses than in any other borough in 2016, only about a quarter of the more than 100 pharmacies on the list had the drug and followed the protocol. Requests for it were often met with bewilderment.” (U)

(A) In rare advisory, surgeon general urges public to carry overdose-reversal medication, by ANDREW JOSEPH, https://www.statnews.com/2018/04/05/surgeon-general-advisory-naloxone/
(B) The next naloxone? Companies, academics search for better overdose-reversal drugs, by MAX BLAU, https://www.statnews.com/2018/04/10/next-naloxone-overdose-reversal-drugs/
(C) Murphy wants to spend $100M to fight opioid addiction (but none on Christie-like ads), by Matt Arco, http://www.nj.com/politics/index.ssf/2018/04/phil_murphy_wants_to_spend_100m_to_fight_opioid_ad.html
(D) EDITORIAL: A different take on opioid crisis, https://www.mycentraljersey.com/story/opinion/editorials/2018/04/05/editorial-different-take-opioid-crisis/33552363/
(E) Rise in Opioid-Exposed Newborns in NJ Prompts State Awareness Campaign, http://www.njspotlight.com/stories/18/04/09/rise-in-opioid-exposed-newborns-in-nj-prompts-state-awareness-campaign/
(F) California lawmakers advance measures to curb opioid crisis, by Sophia Bollag, http://www.kcra.com/article/california-lawmakers-advance-measures-to-curb-opioid-crisis/19736309
(G) Gov. Walker to sign bills addressing opioid crisis, http://www.wsaw.com/content/news/Gov-Walker-to-sign-bills-addressing-opioid-crisis-479088493.html
(H) N.Y. gets pharma to pay up amid opioid epidemic, but concerns linger, by Bethany Bump, https://www.timesunion.com/news/article/NY-gets-pharma-to-pay-up-amid-opioid-epidemic-12802636.php
(I) With the drug industry as its partner, an addiction policy group invites tough questions, by LEV FACHER, https://www.statnews.com/2018/04/05/drug-industry-addiction-policy-forum/
(J) How a Pa. health system reduced opioid prescriptions by more than half, by Alan Yu, https://whyy.org/articles/how-a-pa-health-system-reduced-opioid-prescriptions-by-more-than-half/
(K) New Hampshire hospitals take aim at the opioid epidemic, invest $50M in state initiatives, https://www.fiercehealthcare.com/hospitals-health-systems/new-hampshire-hospitals-take-aim-at-opioid-epidemic-invest-50m-state?mkt_tok=eyJpIjoiWVRKa1ltUmxZV0kxTWpabCIsInQiOiJRbUJKN29ubnc4aWp5YytEYWRBREk3YUdjNUozQWJsMmRBNEJXSVk3c2V6WWVKeFc4ZGRsMEUrT2QyendwTGtvS1p1OEhDSmZUTndMaFVTbkZneEgyTHFkNVk3VXNOcmQxNFwvbjNnc09IcU1oQmxDMFYwSXVFMlh2Z01HdW9makEifQ%3D%3D&mrkid=654508
(L) New rules could worsen the opioid crisis, not help it, by LARRY GREENBLATT, http://thehill.com/opinion/healthcare/381058-new-rules-could-worsen-the-opioid-crisis-not-help-it
(M) Ordering Five Million Deaths Online, by Richard A. Friedman, https://www.nytimes.com/2018/04/04/opinion/carfentanil-fentanyl-opioid-crisis.html
(N) CDC director pledges to bring opioid epidemic “to its knees”, https://www.cbsnews.com/news/cdc-director-pledges-to-bring-opioid-epidemic-to-its-knees/
(O) For chronic pain, a change in habits can beat opioids for relief, by Christine Herman, https://whyy.org/npr_story_post/for-chronic-pain-a-change-in-habits-can-beat-opioids-for-relief/
(P) Conservative columnist: My personal trip through opioid hell and back, by Michael Reagan, http://www.nj.com/opinion/index.ssf/2018/04/the_story_of_my_personal_trip_through_opioid_hell.html
(Q) Medicare, Medicaid Opioid Scripts Decline in Medical Marijuana States, by Judy George, https://www.medpagetoday.com/neurology/opioids/72105
(R) The Opioid Discussion: HR departments must do more to assist opioid-addicted employees A panel presented by NJBIZ, by Vince Calio, http://www.njbiz.com/article/20180402/NJBIZ01/180409998/the-opioid-discussion-hr-departments-must-do-more-to-assist-opioidaddicted-employees
(S) A look at how the opioid crisis has affected people with employer coverage, by Cynthia Cox, Matthew Rae and Bradley Sawyer, https://www.healthsystemtracker.org/brief/a-look-at-how-the-opioid-crisis-has-affected-people-with-employer-coverage/#item-start
(T) Sacklers Who Disavow OxyContin May Have Benefited From It, by David Armstrong, https://www.propublica.org/article/sacklers-who-disavow-oxycontin-may-have-benefited-from-it?utm_source=STAT+Newsletters&utm_campaign=431b02b011-MR&utm_medium=email&utm_term=0_8cab1d7961-431b02b011-149527969
(U) Overdose Antidote Is Supposed to Be Easy to Get. It’s Not, by ANNIE CORREAL, https://www.nytimes.com/2018/04/12/nyregion/overdose-antidote-naloxone-investigation-hard-to-buy.html

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Can/should health care workers be fired for using appropriately prescribed medical or legally purchased recreational marijuana?

“Whether your employee is driving a truck cross-country or working in your ICU, there is almost always a protection that allows employers to enforce policies to protect those that they’re serving,” … “That applies no matter what the cannabis laws are in your state. You’re dealing with employees that are directly impacting the health and safety of individuals, so the obligation of protecting the people you are serving is paramount.” (A)

“Acceptance of medical marijuana, and the patients who medicate with marijuana, is sweeping state legislatures across the country. Of the 21 states that have passed laws addressing medical marijuana, nine have done so in the past three years. A growing number of Americans appear willing to allow those with chronic illness or pain to alleviate their symptoms with the plant, quite apart from the issue of recreational use, which Colorado and Washington State recently approved.
But even as recreational usage is gaining acceptance, people who medicate with marijuana across most states can still get fired for failing their employers’ drug test. Both Washington and Colorado have legalized recreational marijuana use, but it’s still unclear whether employees’ jobs are protected in those states if they smoke off duty — either for recreation or medical use. In Colorado, for instance, the marijuana law allows employers to impose any drug policies they see fit.
There are a lot of unanswered questions, and it’s time for U.S. lawmakers to clarify how companies should treat these cases. Regardless of a state’s law, using marijuana remains a violation of federal law. This conflict has important consequences in the workplace: Employees are left with no protection and employers with little guidance.” (B)

“Since the passage of Proposition 64 making recreational cannabis legal in California, there has been some confusion among employers as to whether they are required to accommodate an employee’s use or possession of the drug.
What should an employer do, for instance, if a new employee tests positive for cannabis? Since use of cannabis for medicinal purposes has been legal since 1996, what if a worker presents a doctor’s note for it? Are employees now allowed to smoke, vape or nibble cannabis edibles while at work? What if an accident occurs and an employee subsequently tests positive for cannabis?
The short answer is that employers do not have any obligation to accommodate cannabis use…
Although legal issues have arisen over the termination of workers for cannabis use, employers are protected by language in the law.
“Prop. 64 does nothing to change an employer’s right to drug testing or termination. There is a clause specifically written into the legislation that expressly protects an employer’s right to do so….”
“Under California law, an employer may require pre-employment drug tests and take illegal drug use into consideration in making employment decisions,” the ruling said.
“The law in this case immunizes employees from criminal law but doesn’t change an employer’s drug policy,” Largent said….
However, employers who do not have a well-documented cannabis policy could expose themselves to allegations of discrimination.
“I advise clients to modify their policy if necessary to make clear it’s illegal, giving employees clear expectations,” …
Employers should make it clear that marijuana use is included in a restrictive policy.
“It’s one thing to have a policy; it’s another thing to enforce it,” … “I tell people, you don’t want to have a policy if you’re not willing to enforce it. If an employer is going to test for drugs, they should let the employees know they are going to do it….” (C)

“Q: But what about people with a doctor’s recommendation to use marijuana for a medical condition? Employers can’t prohibit them from taking their medicine, right? Or fire them?
“In California, there are no workplace provisions protecting the rights of medical marijuana patients. There is no law requiring accommodation for medicating on the job or protection from termination.
In fact, the state Supreme Court has ruled that companies can fire workers who fail drug tests even if they present evidence of a doctor’s recommendation for legal medicinal use.
In a landmark case, Carmichael resident Gary Ross was fired after 10 days as a lead systems administrator for a Sacramento firm RagingWire Telecommunications. Ross, an Air Force veteran, made no secret when he was hired – and drug tested – that he had a medical marijuana recommendation for service-related back-pain and spasms. But he was let go anyway as soon as his pre-employment drug test came up positive.
In 2008, the Supreme Court rejected Ross’ claim of job discrimination under the California Fair Employment and Housing Act. It said California’s 1996 Proposition 215 medical marijuana law contained nothing “to address respective rights of employers and employees.”
Four states – Arizona, Delaware, New York, and Minnesota – offer limited anti-discrimination protections for people with doctors’ recommendations for medical marijuana use. The rules require that employers demonstrate impairment on the job rather than just a positive test for pot, which can stay in the system for days or weeks.” (D)

“On November 8, 2016, Florida voters approved the legalization of medical marijuana. Although not legal under Federal law, the effect of voters amending the Florida Constitution to allow for such use creates an immediate conflict of laws.
Many health care professionals ask what will be the impact on them of medical marijuana. On January 17, 2017, the Florida Department of Health issued its first draft of proposed rules for regulation…
Can DOH discipline the license of a physician, nurse, or other health care professional for use of medical marijuana?
Yes. This is where the issue gets complicated.
While hypothetically, a nurse could get a certification from a physician that he/she has a “debilitating medical condition”[ii] that requires medical marijuana, Florida law still prohibits licensed health care providers from being impaired at work.
The law regulating licensed health care professionals prohibits practicing with an impairment or while impaired…
In my review of the law and conversations with DOH officials, it is my impression that a licensed health care worker that uses medical marijuana would run the risk of termination from employment, discipline of their license by DOH, or both.
The very language of Amendment 2 states: “Nothing in this section shall require any accommodation of any on-site medical use of marijuana in any correctional institution or detention facility or place of education or employment, or of smoking medical marijuana in any public place.” [emphasis added]. This language now in the Florida Constitution appears to preclude use of medical marijuana in the work place.
Similarly, the Amendment also states: “Nothing in this section allows for a violation of any law other than for conduct in compliance with the provisions of this section.” Any other law would include Chapters 456, Florida Statutes and all other regulations governing health care licensees. Therefore, it is safe to assume that the medical marijuana amendment was not meant to override existing health care regulations.
However, our democracy provides for citizens the ability to ask the courts to interpret laws. To the extent someone may want to argue there is a conflict between the law governing medical marijuana and health care license regulations we may see a different interpretation. Stay tuned.
“The safe course of action would be to assume that your regulatory Board would not approve if you tested positive for marijuana, even if you had a valid certification to use medical marijuana.” (E)

Another question posed by a reader asked, “Can a nurse be fired for using recreational marijuana on his or her day off, when recreational use is legal in the nurse’s state?”…
The take-home message for nurses (and all healthcare professionals) is: If you want to protect your career, don’t use marijuana recreationally, even if it is legal in your state and even if you use on your own time and off premises. It is still illegal under federal law. If you decide to take a legal risk and partake in marijuana, don’t do so for at least a month before you will be working. Employers don’t all conduct random drug tests, but some do, and sometimes nurses are included in widespread drug testing, even if the individual nurse has not been accused of being impaired. It is so much easier to prevent this legal problem than to deal with it after being fired.
Furthermore, we don’t know how Boards of Nursing stand on the issue. Nurses have reported that they have lost their licenses and/or been referred to impaired nurse programs for testing positive for marijuana. We don’t know how every Board of Nursing would act on any given day, but at minimum, a firing would lead to a report to the Board of Nursing, and then the burden is on the nurse to prove he or she was not impaired at work. That, too, is more easily prevented than dealt with after the nurse is reported.” (F)

“Recreational marijuana laws are still relatively new, but more states are considering and passing these types of laws each year. However, these laws generally do not protect employees from being fired for legal, off-duty recreational use. Many state laws expressly state that they are not intended to interfere with an employer’s ability to enforce zero-tolerance drug policies. For example, California’s recreational marijuana law states that employers are allowed to continue to test employees and applicants for marijuana and maintain a drug-free workplace.” (G)

“The overwhelming majority of states believe patients should be able to medicate with marijuana. But legalizing marijuana use without protecting the rights of people who use it frustrates the spirit of the law and voters’ intent: it forces seriously ill people to choose between receiving the benefits of marijuana and their job. This conflict frustrates the growing market for marijuana. Only nine states seem to have found the balance between protecting a patient’s right to medicate with marijuana and an employer’s right to a productive workforce. The rest of the states should follow their example: following the law should not cost you your job.” (H)

“If you’re a federal contractor, you can’t allow any marijuana use, regardless of what state law says,” Urban notes.
For employers with a choice, the question becomes whether you really want to take this hard-line stance on marijuana, DiNome says.
“You may not attract the best work force in your state if the state allows the use of marijuana, medically or recreationally,” he says. “You would have to consider that some educated, qualified people come to your state because that substance is legal, and whether you want to eliminate all of those people as potential employees.”… (A)

(A) Legal Marijuana Requires Reassessing Hospital Drug Policies, by Greg Freeman, https://www.ahcmedia.com/articles/139987-legal-marijuana-requires-reassessing-hospital-drug-policies
(B) Can you get fired for smoking medical marijuana?, by Kabrina Krebel Chang, http://fortune.com/2014/05/07/can-you-get-fired-for-smoking-medical-marijuana/
(C) Workplace cannabis: What employers and employees need to know, by CYNTHIA SWEENEY, http://www.northbaybusinessjournal.com/industrynews/law/6579082-181/cannabis-marijuana-employment-law-rights
(D) Can I get fired for using legal recreational marijuana? An FAQ for California workers, by Peter Hecht, http://www.sacbee.com/news/state/california/california-weed/article152918329.html
(E) Medical Marijuana & Healthcare Professionals, by Jeff Howell, https://www.floridahealthcareattorney.com/2017/03/medical-marijuana-licensed-healthcare-professionals/
(F) Marijuana and Your Job: What You Need to Know, by Carolyn Buppert, https://www.medscape.com/viewarticle/846984_4
(G) Can I Be Fired from My Job for Using Legal Marijuana?, by Sachi Barreiro, https://www.lawyers.com/legal-info/labor-employment-law/can-i-be-fired-from-my-job-for-using-legal-marijuana.html
(H) You can be fired for using marijuana even when it’s legal, by Kabrina Krebel Chang, https://work.qz.com/1109564/you-can-be-fired-for-using-marijuana-even-when-its-legal/

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CASE STUDY ON THE OPIOID CRISIS. “We still have lacked the insight that this is a crisis, a cataclysmic crisis”

“The opioid crisis has cost the U.S. $1 trillion since 2001, according to Altarum, a nonprofit health research firm. Those costs have been increasing more rapidly over the past few years, and Altarum projects they’ll grow by another $500 billion just by 2020.
By the numbers:
Most of that $1 trillion comes from lost wages, productivity and tax revenue, Altarum said.
The health care system directly bore about a quarter of the total financial burden — $215 billion — largely from emergency treatment of overdoses.
The human cost: Roughly 64,000 people died of drug overdoses in 2016, driven by a recent surge in deaths from fentanyl, heroin and prescription opioids — making today’s addiction crisis worse than the HIV epidemic at its peak.
Between the lines: “Lost wages and productivity” can seem like a nebulous cost, but it’s a good way to think about the ripple effects of this crisis beyond the people who die from it. When 116 people per day are dying from opioid-related overdoses, at an average age of just 41, their “lost wages and productivity” are a partial measure of the hole that’s left in their families and their communities.” (A)

“The omnibus bill adds $3.3 billion to address the opioid and mental health crisis in fiscal year 2018, with a focus on public health efforts. Here are some of the big programs:
$1.4 billion will go to the Substance Abuse and Mental Health Services Administration, including $1 billion for a new State Opioid Response Grant program and a $160 million increase in the Mental Health Block Grant
$500 million for the National Institutes of Health for more opioid addiction research
$350 million to the Centers for Disease Control and Prevention (CDC) for opioid overdose prevention, surveillance, and improving state prescription drug monitoring programs
$415 million for the Health Resources and Services Administration to, among other efforts, improve access to addiction treatment in rural and other underserved areas
$100 million to the Administration for Children and Families to help children whose parents misuse drugs
An additional $299.5 million to the Department of Justice’s anti-opioid grant funding
An additional $500 million to the Department of Veterans Affairs for mental health programs
An additional $94 million to Food and Drug Administration efforts to inspect mail for illicit drugs
All of this is on top of the $500 million in fiscal year 2018 approved in the 21st Century Cures Act to combat the opioid epidemic.
The concern here, as usual, is that even this large commitment of money is not enough. When Congress first announced its spending deal — to add $6 billion over two years to combat the opioid crisis — earlier this year, Sarah Wakeman, the medical director at the Massachusetts General Hospital Substance Use Disorder Initiative, told me that “[i]t’s hard to imagine $6 billion being enough, especially when you think about the annual budget for other illnesses like HIV, which is $32 billion.”
Any increase is, of course, welcome. But when dealing with one of the worst public health crises in history, Congress will have to go really big — and it’s just not there yet.” (B)

“President Donald Trump, targeting the U.S. opioid epidemic, called again on Monday for the execution of drug dealers, a proposal that so far has gained little support in Congress, amid criticism from some drug abuse and criminal justice experts.
At an event in Manchester, New Hampshire, Trump unveiled an anti-opioid abuse plan, including his death penalty recommendation and one for tougher sentencing laws for drug dealers…,
The White House did not offer examples of when it would be appropriate to seek the death penalty for drug dealers and referred further questions to the Justice Department.” (C)

“On Monday, President Donald Trump unveiled his latest plan to address the opioid epidemic, once again suggesting the death penalty for drug dealers.
“We can have all the blue ribbon committees we want, but if we don’t get tough on the drug dealers, we’re wasting our time,” he said at a New Hampshire event to announce the White House’s Initiative to Stop Opioid Abuse. “Just remember that: We’re wasting our time. And that toughness includes the death penalty.”
Though the plan includes initiatives to increase access to treatment and reduce the flow of drugs, Trump’s speech focused on cracking down on drug dealers. As he said, “I love tough guys—we need tough guys.” But the president’s initiative overlooks the glaring reality that drug dealers and drug users are often the same people, selling drugs to feed their own addictions. “I think it reflects a lack of a broader understanding of the factors in this crisis,” said Sen. Maggie Hassan (D-N.H.) in a statement. “Law enforcement have been the first people to tell us we can’t enforce our way out of this.”….
Critics say that the plan is yet another example of the president talking a big game when it comes to opioids but not following up with action. Trump did not call for more funding for the epidemic even though paying for the plans’ provisions would likely far exceed the $6 billion the administration budgeted to address the epidemic over the next two years. “Policy without budget is just hot air,” Humphreys said. While Trump has repeatedly promised to address the epidemic, his actions suggest otherwise: His budget requests have included cuts to the Centers for Disease Control and Prevention, the National Institutes of Health, Medicaid, and the Office of National Drug Control Policy.
Still, Trump assured the audience he was prioritizing the issue. “I don’t want to leave at the end of seven years and have this problem,” Trump said. “We’re gonna solve it with brains, we’re gonna solve it with resolve, we’re gonna solve with toughness. Toughness is the thing that they most fear.” (D)

“President Trump walked through core elements of his administration’s three-pronged attack on the opioids epidemic during a visit to New Hampshire, while simultaneously pushing for voter support in the next election.
“This is about winning a very, very tough problem … I don’t want to leave at the end of 7 years and have this problem,” he said.
The president declared the opioid epidemic a public health emergency in October, but has been criticized for not offering tangible support for it….
Trump framed his border wall plan as part of the opioid fight, saying it was needed “to keep the damn drugs out.”
Similarly, eliminating “sanctuary cities,” another frequent Trump target, is critical to “stopping the drug addiction crisis.”
The president’s comments directly addressing the opioid crisis focused primarily on law enforcement.
“Whether you are a dealer or doctor or trafficker or a manufacturer, if you break the law and illegally pedal these deadly poisons, we will find you, we will arrest you and we will hold you accountable,” he said to booming applause.” (E)

“President Trump spoke Monday of using federal prosecutors to pursue “major litigation” against drug manufacturers alleged to have played a role in creating a nationwide epidemic of opioid abuse.
Speaking in New Hampshire at the White House’s rollout of a national opioids strategy, the president expanded upon a Department of Justice release last month in which Attorney General Jeff Sessions pledged to “hold accountable those whose illegality has cost us billions of taxpayer dollars.”
“Our Department of Justice is looking very seriously into bringing major litigation against some of these drug companies,” Trump said. “We will bring it at a federal level. Some states are already bringing it, but we are thinking about bringing it at a very high federal level, and we will do a job.”
DOJ filed a statement of interest on March 1 in a federal court in Ohio, asking the judge collectively overseeing hundreds of opioid-related lawsuits to allow federal lawyers 30 days to decide whether the United States would participate in the legal proceedings.
Manufacturers, including Purdue, Endo Pharmaceuticals, Insys, Janssen, and Teva, have faced scrutiny and often aggressive legal action from state and local governments seeking compensation for what many plaintiffs allege are the costs resulting from the companies’ disingenuous marketing tactics. In 2006, Purdue and several high-ranking executives paid a collective $635 million in fines pertaining to the marketing of its opioid painkiller, OxyContin, which understated the drug’s addictiveness…
The president also name-checked two drug companies that manufacture various forms of the overdose-reversal drug naloxone: Adapt Pharma, which makes the nasally administered Narcan, and Kaleo, which makes Evzio, an automatic injector that has drawn scrutiny for its price tag but drew congratulations from Trump for having distributed more than 300,000 units for free.” (F)

“The U.S. Department of Justice plans to hold providers accountable per a new large-scale effort to tackle the opioid crisis, Deputy Attorney General Rod Rosenstein reiterated here Wednesday.
Addressing the annual policy conference sponsored by America’s Health Insurance Plans, Rosenstein said the new opioids task force announced by Attorney General Jeff Sessions last week will hold everyone accountable; he then specifically cited physicians.
The proliferation of prescription painkillers, including opioids, has countered the ethos of “do no harm,” Rosenstein said, noting that the average American life expectancy has decreased along with the 21st century opioid spread — after nearly doubling over a century. “These drugs have caused a lot of collateral damage,” Rosenstein said, including costing American healthcare more than $1 trillion this century.
In addition to the Task Force, Rosenstein cited as another solution the Justice Department’s involvement with the new Joint Criminal Opioid Darknet Enforcement team; it has been established in large part to counter the flow of painkillers, especially synthetics such as fentanyl, from foreign countries into the U.S.
“We ought to all be about prevention,” he said, citing over-prescription as a major cause of the opioids crisis.
Rosenstein asked insurance companies to utilize their monitoring systems to identify patients receiving too many painkillers and those receiving them for conditions that don’t warrant them. “We recognize that you have a financial incentive” to limit prescriptions, he noted.
Rosenstein also encouraged providers, insurers and others to follow the CDC’s 2016 opioid guidelines…
“The pharmaceutical industry is almost completely responsible for this epidemic,” Fugh-Berman said, citing misleading advertising and their practice of hiring “thought leaders” to shame providers into prescribing more opioids. These individuals told physicians they were “torturing our patients” by not issuing painkillers whenever they complained of pain.
Pharmaceutical companies “misused” medical literature by consistently citing small-scale studies and research letters as evidence for supporting opioid prescriptions, she said. They also published ghostwritten articles in medical and consumer publications, and launched disease awareness campaigns. In addition, they funneled money to medical advocacy groups, including the U.S. Pain Foundation ($2.9 million during 2012-2017) and the American Academy of Pain Medicine ($1.2 million) to promulgate messages such as “restricting opioids in any way disadvantages pain patients” and “the needs of patients with [opioid use disorder] must be balanced with the needs of pain patients.” (G)

“Public health experts also warned that the amount of funding included in the spending plan for the opioid crisis may not meet need. Congress set aside more than $4 billion to be split among several opioid initiatives, including for law enforcement and additional research.
That is just a drop in the bucket, though, compared to what is needed to fully mobilize against the drug addiction epidemic, according to an article from the Associated Press. A recent report from the White House estimates that the opioid epidemic cost more than $500 billion in 2015…
In response, states are stepping up to fill the gaps, according to the article. Ohio Gov. John Kasich estimates that the state is spending $1 billion a year on opioid programs, while New Jersey has put $200 million toward combating the crisis.” (H)

“The president went on at length about his preposterous proposal to fight the scourge of drugs by executing drug dealers — an idea that many experts say would not stand up in court and would do little to end this epidemic. He also reprised his cockamamie idea to build a wall along the nation’s southern border, arguing that it would “keep the damn drugs out,” and accused so-called sanctuary cities of releasing “illegal immigrants and drug dealers, traffickers and gang members back into our communities.”
It was Mr. Trump playing his greatest “law and order” hits — as usual, full of sound and fury but signifying nothing.
Mr. Trump seems so enamored with autocrats and strongmen that he wants the United States to imitate governments like China and the Philippines by executing drug dealers, claiming such countries “don’t have a drug problem” because of their brutality. This is patently absurd. While it is hard to analyze the experience of many of these countries because they do not collect and publish reliable data about substance use, experts say it is clear that they have not eliminated drug abuse or the crime that often accompanies it. More broadly speaking, many scholars have concluded that there is no good evidence that capital punishment deters crime.” (I)

“Republican and Democratic governors don’t agree on much in the healthcare space but when it comes to opioids there is consensus: Real dollars are needed.
Governors pressed senators for more funding to help tackle the opioid epidemic, as well as flexibility for states in tailoring spending to suit their specific needs, during a hearing of the Senate Health, Education, Labor and Pensions (HELP) Committee on Thursday.
Gov. Larry Hogan (R-Md.) thanked Congress for the $6 billion secured in its budget agreement to fight the opioid and heroin crisis, but “it’s a drop in the bucket compared to what we actually need,” he said.
Maryland, a small state, has already spent $500 million to battle the opioid epidemic alone, he continued.
“Six billion stretched across the country is not going to go very far … It’s the long-term recovery support services that we’re going to need a way to pay for.” “ (J)

“Congress sent states hundreds of millions of dollars to fight an opioid crisis claiming more than 100 lives a day — money they’ve largely been unable to spend after a year.
Mixed signals from the Trump administration on how to use the money and state challenges ramping up their efforts have left untouched more than three-quarters of the $500 million Congress set aside under the 21st Century Cures Act in late 2016.
As President Donald Trump heads to hard-hit New Hampshire today to tout his plan to combat the crisis, the slow drip of dollars into communities hit hard by addiction has put state officials in a bind and frustrated addiction experts and some treatment organizations.
“This is a total failure,” said Andrew Kolodny, former chief medical officer at Phoenix House and now a Brandeis University researcher, likening the situation to food and water “stuck in an airport somewhere, while people are starving to death.”
The grants for opioid addiction and prevention efforts were part of a $1 billion commitment over two years authorized in the Cures Act, which then-President Barack Obama signed just before leaving office.
But state officials were quickly caught in a dilemma: They were happy to receive new money, but it was guaranteed for only two years, making it difficult to get long-term commitments from health care providers and others to build programs and hire a workforce.” (K)

“Former Novartis sales reps from around the U.S. are expected to testify they were “essentially buying” prescriptions in exchange for providing doctors with paid speaking engagements, fancy meals, and alcohol in a closely watched lawsuit that is being pressed by the federal government.
And both doctors and sales reps are expected to testify that payments were made for speaking engagements that never took place, and that many of these events had little to no educational content, but were really just schmoozefests, according to a court filing on Monday by federal prosecutors.” (L)

“As tens of thousands of Americans die from prescription opioid overdoses each year, an exclusive analysis by CNN and researchers at Harvard University found that opioid manufacturers are paying physicians huge sums of money — and the more opioids a doctor prescribes, the more money he or she makes.
In 2014 and 2015, opioid manufacturers paid hundreds of doctors across the country six-figure sums for speaking, consulting and other services. Thousands of other doctors were paid over $25,000 during that time.
Physicians who prescribed particularly large amounts of the drugs were the most likely to get paid.
“This is the first time we’ve seen this, and it’s really important,” said Dr. Andrew Kolodny, a senior scientist at the Institute for Behavioral Health at the Heller School for Social Policy and Management at Brandeis University, where he is co-director of the Opioid Policy Research Collaborative.
“It smells like doctors being bribed to sell narcotics, and that’s very disturbing,” said Kolodny, who is also the executive director of Physicians for Responsible Opioid Prescribing.
The Harvard researchers said it’s not clear whether the payments encourage doctors to prescribe a company’s drug or whether pharmaceutical companies seek out and reward doctors who are already high prescribers.
“I don’t know if the money is causing the prescribing or the prescribing led to the money, but in either case, it’s potentially a vicious cycle. It’s cementing the idea for these physicians that prescribing this many opioids is creating value,” said Dr. Michael Barnett, assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health.” (M)

“Gov. Rick Scott signed legislation Monday in Boca Raton that limits opioid prescribing and provides tens of millions in new funding to combat an overdose epidemic that is killing more than 1,000 people in South Florida every year.
Flanked by elected leaders and law enforcement, Scott said the Legislature set aside $65 million to expand treatment and provide the overdose antidote naloxone to law enforcement and paramedics.
The package also will impose a three-day limit on most opioid prescriptions, though doctors could provide a seven-day supply if “medically necessary.” Previously, state law didn’t limit opioid prescriptions.
The new limits would not apply to patients with pain related to “cancer, terminal illness, palliative care or serious traumatic injuries.” Physicians will now be required to check a prescription-monitoring database to prevent doctor shopping.
“The best thing we can do is stop drug addiction before it happens,” Scott said. “This bill should have an impact on that.” “ (N)

“Fresh on the heels of President Donald Trump’s plan to tackle the opioid crisis, House lawmakers this week plan to introduce more than two dozen bills aimed at ending the epidemic, ranging from better access to treatment programs to exploring opioid alternatives for pain…
One of the bills, called the Preventing Overdoses While in Emergency Rooms act, or POWER act, is a bipartisan measure that seeks to provide patients who have overdosed better access to treatment when they get discharged from emergency rooms.
The bill would set up protocols for emergency rooms around the nation on how best to discharge overdose patients, making sure they have the opioid overdose antidote naloxone and access to other medication-assisted treatment, as well as being linked up with peer-support specialists and other treatment programs that best fit the patient….
The bills range from efforts to explore non-addictive alternatives for pain to easier ways to dispose of extra opioid pills to better data sharing of a patient’s medical records with health care providers.
Several bills seek to give the US Food and Drug Administration more authority and new methods to streamline its efficiency and effectiveness. One measure seeks to accelerate bringing a breakthrough treatment for pain to the market. The proposals also want to study the long-term efficacy of opioids and allow for the FDA to consider the potential for drug abuse before bringing a new drug to the market.
CNN spoke with multiple health policy experts about the legislative initiative. While they lauded the efforts being put forward, every one of them said Congress and President Trump need to back any such plan with tens of billions of dollars in new funding.” (O)

“When President Trump spoke of the White House’s new plan to stop the opioid crisis in New Hampshire on Monday his core focus was on the bad guys and his answer was tougher penalties.
When top leaders from the Department of Health and Human Services and the National Institutes of Health pitched the same plan, the focus shifted to the victims of the epidemic and a kinder, gentler approach: science and public health.
HHS Secretary Alex Azar, JD, NIH Director Francis Collins, MD, PhD, and Nora Volkow, MD, director of the National Institute on Drug Abuse (NIDA) pitched the president’s opioid initiative to reporters during a press briefing on Wednesday afternoon.
Collins and Volkow spoke of the NIH’s work to develop non-addictive alternatives to opioids, new formulations of naloxone, and one day, a vaccine to prevent addiction.
To do these things, scientists need to better understand the neurobiology of pain and to locate new drug targets — information private industry is eager to leverage, Collins said.
He described research involving a 17-year-old man with congenital insensitivity to pain and temperature — research that could ultimately “point us to a new idea about how to provide pain relief to people who aren’t born like this young guy, but who might on a temporary basis benefit” from an inability to feel pain.” (P)

“For once, Casey is optimistic about his future. After 16 years of struggling with drug addiction, he no longer feels the need to use. He has a steady job doing hazard tree removal for a Fortune 500 energy company. He’s working on getting specialized training for a license to help him land better-paying jobs. He’s even going to the gym.
But Casey, who asked that I only use his first name for this story, knows this could have turned out very differently. In fact, it had the past few times he was released from prison. Before, he had relapsed as quickly as a matter of days — not only exposing himself to the risk of a deadly overdose but leading to a spiral of drug use that hindered just about every aspect of his life and, often, landed him in prison again.
The big difference: This time, he got treatment — real treatment — while he was in prison…
In other words, the majority of state prisons don’t offer full access to what experts say is the mainline form of treatment for opioid addiction — and the kind of treatment that has helped Casey get his life back in order…
When an inmate addicted to opioids is released from prison, his chances of a fatal overdose are massively elevated: According to a 2007 study published in The New England Journal of Medicine, former inmates’ risk of a fatal drug overdose is 129 times as high as it is for the general population during the two weeks after release. Other studies have backed this up, putting the increased risk of overdose death in the tens of times or above 100 times.” (Q)

“Even as opioids flood American communities and fuel widespread addiction, hospitals are facing a dangerous shortage of the powerful painkillers needed by patients in acute pain, according to doctors, pharmacists and a coalition of health groups.
The shortage, though more significant in some places than others, has left many hospitals and surgical centers scrambling to find enough injectable morphine, Dilaudid and fentanyl — drugs given to patients undergoing surgery, fighting cancer or suffering traumatic injuries. The shortfall, which has intensified since last summer, was triggered by manufacturing setbacks and a government effort to reduce addiction by restricting drug production.
As a result, hospital pharmacists are working long hours to find alternatives, forcing nurses to administer second-choice drugs or deliver standard drugs differently. That raises the risk of mistakes — and already has led to at least a few instances in which patients received potentially harmful doses, according to the nonprofit Institute for Safe Medication Practices, which works with health care providers to promote patient safety.” (R)

“An important study published this week in JAMA suggests what we in the Slow Medicine community had suspected: opioids may be no better than non-opioid analgesics for patients with chronic pain. Despite the widespread use of opioids for the management of chronic pain, as well as guidelines suggesting they are an appropriate therapy for chronic pain, there had been disconcertingly little evidence on the topic. The best studies were no longer than 12 weeks in duration and involved only a small number of subjects.
This new JAMA study is also small, involving 240 patients with severe chronic back pain or pain from osteoarthritis of the hip or knee. However, investigators tracked pain-related function for a full year. Compared to non-opioid analgesic therapy, opioids resulted in similar functionality at 1 year, and pain intensity was slightly improved in the non-opioid therapy group. As anticipated, rates of adverse effects were higher in the opioid therapy group. These results follow another JAMA study published in the fall suggesting that non-opioid therapy may be as effective as opioids in treating acute pain in the emergency room.
With this information, coupled with growing evidence about the epidemic of opioid abuse, the role of opioids in pain management outside of the palliative setting is growing increasingly narrow. Nevertheless, there remain millions of Americans who depend on opioids, and we must be compassionate in managing their care, even if we now know it is not an effective pain treatment strategy.” (S)

“Dr. Mark Rosenberg of St. Joseph’s Regional Medical Center in Paterson told the story of being approached by a man named Michael at an event who wanted to thank him for saving his life when he was in the emergency department for a heroin overdose.
“I said to him, ‘Michael, how did you get started on opioids?’ And he laughed and said, ‘Doc, you were the one who gave me my first prescription. I came in with a shoulder injury and you gave me some opioids.’ This is before we started ALTO,” he said, referring to the hospital’s Alternatives to Opiates program. “I was part of the problem, as most physicians across the country were part of the problem.”
Rosenberg remembers reading articles in the late 80s that said opioids were not addictive and should be given to patients in pain. Today, health care providers write over 250 million prescriptions for painkillers every year.
“We ended up with an entire society that is dependent on opioids, in part by a mistake of the drug companies, physicians, researchers alike,” he said…
In 2016, Rosenberg launched the Alternatives to Opiates program, otherwise known as ALTO. Emergency departments like the one at St. Joseph’s in Wayne now have protocols to manage pain without using opioids.
“We use them for certain conditions like kidney stones, back pain, headaches,” said Dr. Marjory Langer.
Rosenberg told the Passaic County Drug Policy Advisory Committee his method is not substituting a lesser pain medication for an opioid; it’s a layering treatment.
“I may be giving a nerve block so you don’t have any pain from the fracture, or I may be giving you a trigger point injection so your muscle spasm actually goes away,” said Rosenberg.
He says the results of the ALTO program have been positive.
“In the first year, we were able to get a 57 percent reduction in opioid use. In the second years, we have a total of an 82 percent reduction of opioid use in the emergency department,” he said.” (T)

“A program at St. Joseph’s Healthcare System that began a revolutionary change in the way emergency rooms handle opioid prescriptions is going national.
One of the creators of the Alternatives to Opiates program, Dr. Mark Rosenberg, is testifying on Capitol Hill on Thursday on a bill that would create a national demonstration of the success he has seen in New Jersey.
This is just the latest bout of attention the program has received on a national level.
Recent articles from Colorado, Massachusetts and Washington state have highlighted the ALTO program — without crediting St. Joseph’s or the team of doctors there. Two new bipartisan bills in Congress are highlighting it as well, aiming to set up a nationwide demo and study the results.” (U)

“The amount of opioids prescribed after gynecologic surgery declined by almost 90% with few complaints from patients after implementation of a restrictive prescription protocol, as reported here at the Society of Gynecologic Oncology (SGO) meeting.
Over a 6-month period, the total opioid pill count declined by 89% as compared with historical prescribing practices. The total included a 73% reduction the number of pills dispensed after open surgery and 97% after minimally invasive procedures.
Patients undergoing ambulatory/minimally invasive procedures and with no history of chronic pain received only prescription-strength ibuprofen or acetaminophen at discharge. Those with a history of opioid exposure or chronic pain, received a 3-day supply (12 pills) of hydrocodone-acetaminophen (Norco) or oxycodone-acetaminophen (Percocet).
Patients undergoing open surgery received either nonopioid pain medication or a 3-day opioid prescription at discharge. If a patient used an opioid for pain in the previous 24 hours, then a 3-day supply consisting of 24 pills (two every 6 hours) was prescribed.” (V)

“The (American Dental) Association on March 26 announced a new interim policy on opioids that supports prescription limits and mandatory continuing education for dentists.
The new policy, officially titled Interim Board Policy on Opioid Prescribing, is believed to be one of the first of its kind from a major health professional organization.
“I call upon dentists everywhere to double down on their efforts to prevent opioids from harming our patients and their families,” said ADA President Joseph P. Crowley. “This new policy demonstrates the ADA’s firm commitment to help fight the country’s opioid epidemic while continuing to help patients manage dental pain.”
In the interim policy, the Association says it supports the following:
Mandatory continuing education on prescribing opioids and other controlled substances.
Prescribing limits on opioid dosage and duration of no more than seven days for the treatment of acute pain, consistent with the Centers for Disease Control and Prevention’s evidence-based guidelines.
Dentists registering with and utilizing prescription drug monitoring programs to promote the appropriate use of opioids and deter misuse and abuse.” (W)

“The White House’s national strategy to combat the opioid crisis, unveiled last week, would expand a particular kind of addiction treatment in federal criminal justice settings: a single drug, manufactured by a single company, with mixed views on the evidence regarding its use.
Federal prisons should “facilitate naltrexone treatment and access to treatment” to inmates as they transition out of incarceration, according to a fact sheet circulated by the administration. A White House spokesman later confirmed to STAT that the document referred specifically to naltrexone in its injectable form…
When asked about the plan, administration health officials themselves expressed doubts about the approach.
“We don’t per se favor one drug over the other, because some patients respond better to one or the other,” said Nora Volkow, the director of the National Institute on Drug Abuse, at a press event on Tuesday. “It is clear that treatment in the prison system significantly improves outcomes, whether it’s [with naltrexone or buprenorphine].”
Health secretary Alex Azar was unfamiliar with the proposal to provide Vivitrol exclusively, saying in response to a STAT question: “I have a feeling that was an inadvertent reference. I think the key thing was the prison population, as opposed to any one product.”
Azar, who was sworn in as health secretary in late January, walked back his remark 15 minutes later, citing “staff-level discussions” and a directive from the Substance Abuse and Mental Health Services Administration that anyone “coming out of prison or a detox program should in fact be put on naltrexone, but that doesn’t mean it’s the best form [of MAT] for all populations.” (X)

“Former U.S. representative Patrick Kennedy, a Democrat who served on President Donald Trump’s opioid commission last year, said there are clear solutions but that Congress needs to devote more money to them.
“We still have lacked the insight that this is a crisis, a cataclysmic crisis,” he said.” (Y)

“Two bills which passed both Oregon’s House and Senate with unanimous bipartisan support are set to receive Governor Kate Brown’s signature on Tuesday, March 27.
House Bill 4143 will require the Department of Consumer and Business Services to study stumbling blocks in methods of effective treatment for recovery from substance abuse—particularly opiate addiction—and provide a report to lawmakers by June 30 of this year.
House Bill 4137 charges a new Director of the Alcohol and Drug Policy Commission with providing recommendations for a comprehensive plan to address addiction, prevention, treatment and recovery by December 31 of this year. The bill also declares a public health “emergency.”
While neither bill directly provides the means for combating the opioid crisis, both were drafted to give lawmakers the best and most recent information—a roadmap—so that subsequent legislation and programs can more effectively create change.” (Z)

“Medicare officials thought they had finally figured out how to do their part to fix the troubling problem of opioids being overprescribed to the old and disabled: In 2016, a staggering one in three of 43.6 million beneficiaries of the federal health insurance program had been prescribed the painkillers.
Medicare, they decided, would now refuse to pay for long-term, high-dose prescriptions; a rule to that effect is expected to be approved on April 2. Some medical experts have praised the regulation as a check on addiction.
But the proposal has also drawn a broad and clamorous blowback from many people who would be directly affected by it, including patients with chronic pain, primary care doctors and experts in pain management and addiction medicine.
Critics say the rule would inject the government into the doctor-patient relationship and could throw patients who lost access to the drugs into withdrawal or even provoke them to buy dangerous street drugs. Although the number of opioid prescriptions has been declining since 2011, they noted, the rate of overdoses attributed to the painkillers and, increasingly, illegal fentanyl and heroin, has escalated.” (AA)

“The Global Center for Health Innovation (Global Center) and Accenture have formed a working group to explore data-driven solutions that better integrate the continuum of addiction services (first responders, ER and inpatient, outpatient, behavioral health) to improve treatment and move toward prevention. The group’s formation was announced at the Global Center’s second Executive Briefing, The Role of Private Capital in Attacking the Opioid Crisis.” (BB)

“In 2017, the Centers for Disease Control and Prevention (CDC) warned that life expectancy in the United States dropped for the second year in a row — and drug overdoses are the single biggest reason why.
As states and communities on the front lines struggle to respond to the opioid crisis, Washington has only nibbled around the edges. Politicians and policymakers make vague promises, treating the crisis as if it is a novel, intractable problem. It is neither.
America has addressed this kind of public health emergency before, and we call on Congress to do so now.
Three decades ago, another epidemic that was highly stigmatized, greatly misunderstood and severely underestimated was spreading through our country and killing tens of thousands of otherwise healthy people each year. That epidemic was HIV/AIDS.
In the 1980s, stigma prevented many Americans from acknowledging their infections or seeking treatment. Evolving treatment protocols were new and complex, and few doctors were trained in how to use them to provide care for patients. Our existing medical infrastructure was not equipped to efficiently distribute information and resources to communities trying to understand, treat and prevent the spread of the epidemic.
The federal government alone possessed the resources capable of addressing the epidemic, but for years Washington refused to devote meaningful resources to combating HIV/AIDS, even as it continued to kill more Americans day after day. This inaction ended because people with HIV/AIDS and their loved ones fought back, side by side with doctors, scientists and lawmakers representing communities devastated by the disease.
In 1990, our colleagues in Congress — Rep. Henry Waxman, Sen. Ted Kennedy, and Sen. Orrin Hatch — worked together to pass the bipartisan Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, named after an Indiana teenager who was diagnosed with AIDS at the age of 13. Ryan White bravely fought AIDS-related discrimination and became a leading national voice on AIDS education before his untimely death — 28 years ago next month.
The Ryan White CARE Act recognized the gravity — and the urgency — of the HIV/AIDS crisis by setting forth a comprehensive approach to treatment and providing significant new funding for individualized support services..…
The program they created provides vital services to more than half a million people every year. Although the HIV/AIDS epidemic is by no means over, life-saving medications are available, new infections have plummeted and science — rather than stigma — guides medical care.
It is time for Congress to show the same political courage that our colleagues showed nearly 30 years ago. That’s why we intend to introduce legislation to establish a comprehensive system for funding and local decision-making to address opioid addiction and substance use that is modeled directly on the highly successful Ryan White CARE Act…
President Trump’s declaration that the opioid crisis is a public health emergency has amounted to little more than empty words. His latest response to this epidemic — an announcement that he will seek the death penalty for drug dealers — is the crudest indication yet of how little he understands about what the problem is or how to fix it.
We propose a different approach. The Ryan White CARE Act is an enduring example of what Congress can achieve when it works to help states and communities address a national public health crisis by providing significant federal support…
American families — not just in Maryland or in Massachusetts, but all across this country — desperately need us to take action against an epidemic terrorizing every single community. Urban, suburban and rural; poor, middle-class and wealthy; red, blue and purple. We urge our colleagues to join us in this effort, to show courage, to combat ignorance and ill-informed stigmas and to step up with significant new resources. This isn’t about politics. This is about saving lives.” (CC)

(A) Opioid crisis has cost the U.S. $1 trillion, by Sam Baker, https://www.axios.com/opioid-crisis-has-cost-the-us-1-trillion-1518490361-3f5c1717-7bc2-445a-961c-0200d76f3f78.html
(B) Congress’s omnibus bill adds $3.3 billion to fight the opioid crisis. It’s not enough, by German Lopez, https://www.vox.com/policy-and-politics/2018/3/22/17150294/congress-omnibus-bill-opioid-epidemic
(C) Trump Pushes Drug-Dealer Death Penalty As Opioid Crisis Response, by Roberta Rampton, https://www.huffingtonpost.com/entry/donald-trump-opioids-death-penalty_us_5ab006b6e4b0e862383a6489
(D) Trump Doesn’t Understand the Opioid Crisis. Just Check Out His Latest Proposal, by JULIA LURIE, https://www.motherjones.com/politics/2018/03/trump-doesnt-understand-the-opioid-crisis-just-check-out-his-latest-proposal/
(E) Trump Talks Up Major Offensive on Opioids. Death penalty for certain traffickers; ‘on demand’ treatment for veterans, by Shannon Firth, https://www.medpagetoday.com/publichealthpolicy/opioids/71855
(F) DOJ weighing ‘major litigation’ against opioid makers, Trump says, by LEV FACHER, https://www.statnews.com/2018/03/19/trump-opioid-department-of-justice/
(G) DOJ Repeats Threat to Hold Opioid Prescribers Accountable, by Ryan Basen, https://www.medpagetoday.com/publichealthpolicy/opioids/71661
(H) Public health experts skeptical that spending plan will lead to gun violence research, effectively address opioid crisis, by Paige Minemyer, https://www.fiercehealthcare.com/regulatory/2018-spending-plan-cdc-gun-violence-research-opioids-public-health?utm_medium=nl&utm_source=internal&mrkid=654508&mkt_tok=eyJpIjoiWXpRNE56aGpaVFl3TXpZeiIsInQiOiJad0h3VjJoQWd6YjY3R0twYUg5anYzVjRpZ3NHMHBZZktjRUJxWW5XdkVNVFNkWGRIRUNxeUpqckJLT1BFMFpGcWZwc0xUMHZzRCtmbDBGMkFkUFNYREdsYUFrVHg4aTNmVGhPYk1jR213WnpTbk5VdkRUZjRsXC9VMkxaRDhzbzkifQ%3D%3D
(I) Trump’s Bluster on the Opioid Epidemic, by THE EDITORIAL BOARD, https://www.nytimes.com/2018/03/20/opinion/trumps-bluster-on-the-opioid-epidemic.html
(J) D.C. Week: States Plead for Federal $$ in Opioid Fight, by Shannon Firth, https://www.medpagetoday.com/washington-watch/washington-watch/71685?xid=nl_mpt_DHE_2018-03-12&eun=g1223211d0r&pos=1&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-03-12&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days
(K) Hundreds of millions in state opioid cash left unspent, by RACHANA PRADHAN and BRIANNA EHLEY, https://www.politico.com/story/2018/03/19/opioid-crisis-funding-unspent-468658
(L) Former Novartis sales reps will testify they ‘essentially’ bought prescriptions by wooing doctors, by ED SILVERMAN, https://www.statnews.com/pharmalot/2018/03/20/former-novartis-sales-reps-bribes-doctors/
(M) CNN Exclusive: The more opioids doctors prescribe, the more money they make, by Aaron Kessler, Elizabeth Cohen and Katherine Grise, https://www.cnn.com/2018/03/11/health/prescription-opioid-payments-eprise/index.html
(N) Gov. Scott signs opioid package that includes millions to fight South Florida epidemic, by Skyler Swisher, http://www.sun-sentinel.com/news/florida/fl-reg-rick-scott-opioids-bill-20180319-story.html
(O) This is how lawmakers plan to end the opioid crisis, by Wayne Drash, https://www.cnn.com/2018/03/20/health/house-bills-opioid-legislation/index.html
(P) NIH, HHS to Fight Opioids Epidemic with Science, by Shannon Firth, https://www.medpagetoday.com/publichealthpolicy/opioids/71904
(Q) How America’s prisons are fueling the opioid epidemic, by German Lopez, https://www.vox.com/policy-and-politics/2018/3/13/17020002/prison-opioid-epidemic-medications-addiction
(R) The other opioid crisis: Hospital shortages lead to patient pain, medical errors, https://www.news-medical.net/news/20180316/The-other-opioid-crisis-Hospital-shortages-lead-to-patient-pain-medical-
(S) Slow Medicine: Role Narrows for Opioids in Chronic Pain, by Pieter Cohen, MD, and Michael Hochman, https://www.medpagetoday.com/blogs/slowmedicine/71664
(T) St. Joseph’s ER has reduced opioid use by 82 percent, BY Leah Mishkin, https://www.njtvonline.org/news/video/st-peters-alternatives-opioids/
(U) St. Joseph’s ALTO opioids program to go national, by Anjalee Khemlani, http://www.roi-nj.com/2018/03/20/healthcare/st-josephs-alto-program-to-go-national/
(V) Women Do Well Without Opioids after Gyn Surgery, by by Charles Bankhead, https://www.medpagetoday.com/meetingcoverage/sgo/72003
(W) ADA adopts interim opioids policy, by Jennifer Garvin, https://www.ada.org/en/publications/ada-news/2018-archive/march/ada-adopts-interim-opioids-policy?nav=news&utm_source=STAT+Newsletters&utm_campaign=8abdf7c408-MR&utm_medium=email&utm_term=0_8cab1d7961-8abdf7c408-149527969
(X) Trump opioid plan writes in favoritism to single company’s addiction medication, by LEV FACHER, https://www.statnews.com/2018/03/26/trump-opioid-plan-alkermes-vivitrol/
(Y) States: Federal money for opioid crisis a small step forward, by GEOFF MULVIHILL, http://www.concordmonitor.com/States-Federal-money-for-opioid-crisis-a-small-step-forward-16435985
(Z) GOVERNOR BROWN WILL SIGN NEW LAWS TO COMBAT OPIOID CRISIS, by Jamie Parfitt, http://www.kdrv.com/content/news/Governor-Brown-Will-Sign-Legislature-to-Combat-Opioid-Crisis-477954183.html
(AA) Medicare Is Cracking Down on Opioids. Doctors Fear Pain Patients Will Suffer., by JAN HOFFMAN, https://www.nytimes.com/2018/03/27/health/opioids-medicare-limits.html
(BB) Global Center for Health Innovation and Accenture Form a Working Group to Address Opioid Epidemic, http://www.wlns.com/ap-top-news/global-center-for-health-innovation-and-accenture-form-a-working-group-to-address-opioid-epidemic/1083225045
(CC) Treat the opioid crisis like the HIV/AIDS epidemic: Elizabeth Warren & Elijah Cummings, https://www.usatoday.com/story/opinion/2018/03/29/new-legislation-treat-opioid-crisis-hiv-aids-epidemic-congressman-cummings-senator-warren-column/459036002/


Other posts that are part of this Case Study:

“For most of my surgical career, I gave out opioids like candy….” “With approximately 142 Americans dying every day”….” We need to take away the matches, not put out the fires.”

August 9, 2017

“We would never tolerate a situation where only one in 10 people with cancer or diabetes gets treatment, and yet we do that with substance-abuse disorders,” (A)

August 11, 2017

As Washington dawdles, the States step in on the opioid crisis, with initiatives and lawyers

August 17, 2017

“To manage and (eventually) reverse the opioid epidemic, state Medicaid programs should now take a deeper look at the role prescribing plays…”,

August 22, 2017

Opioid Crisis. ““We got here in part because there was a paper done in the 1980s by a well-meaning physician that said opioids are not addictive….

September 1, 2017 | Edit

The rise of ‘grandfamilies’: Opioid crisis requires more Hoosier grandparents to raise children..

September 14, 2017

Congress blocked DEA action against drug companies suspected of flooding the country with prescription narcotics, http://doctordidyouwashyourhands.com/2017/10/congress-blocked-dea-action-against-drug-companies-suspected-of-flooding-the-country-with-prescription-narcotics/
October 17, 2017

“At a time when the United States is in the grip of an opioid epidemic, many insurers are limiting access to pain medications that carry a lower risk of addiction or dependence…..”

October 19, 2017

“…the president.. reversed course to instead declare opioids a public health emergency, a move that releases no new funding to contend with a drug crisis….”

October 29, 2017

Facebook users can easily find these drugs – Oxycodone, Hydrocodone, and Percocets,

November 29, 2017

“White House counselor Kellyanne Conway will be the point person for the Trump administration’s opioid crisis efforts…

December 9, 2017

The Trump administration “… hasn’t done squat” about the Opioid Crisis – but is prosecuting marijuana offenses & fired all HIV/AIDS Commission members

January 6, 2018

Opioid Crisis. President Trumps “thoughts and prayers have helped.. “But additional funding and resources would be more helpful.”

January 14, 2018 | Edit

Opioid commission member: Our work is a ‘sham’

January 24, 2018

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Should the terminally ill have the RIGHT-TO-TRY non-FDA approved therapies?

“Five years ago, the phrase “right to try” wasn’t yet an inkling in the minds of its staunchest advocates. Today, the pithy shorthand for the campaign to get dying patients access to experimental treatments has been slapped on bumper stickers, emblazoned on T-shirts, and uttered by some of the most powerful figures in Washington…
But the story of the five-year fight over “right to try” actually starts at a small lunch meeting of Republican health care experts in Phoenix. It then winds through more than three dozen state legislatures and into the stately meeting rooms of Capitol Hill, where pharmaceutical company lobbyists, Food and Drug Administration officials, and libertarian leaders are still pushing to shape or even upend the ultimate package.
In September 2012, a group of executives from the Cancer Treatment Centers of America reached out to the Goldwater Institute, a small, libertarian think tank named for the former senator and presidential candidate.
Goldwater — which has in past years accepted support from major conservative organizations like the Charles Koch Foundation and Donors Capital Fund — had taken on a wide-ranging libertarian agenda that included activism on campus free speech and school choice. The for-profit hospital chain CTCA also has its own ties to the Koch family.
CTCA and, ultimately, the Goldwater experts believed the FDA’s existing expanded access program — through which the agency approves some 99 percent of requests from dying patients who can’t get into clinical trials but want to try experimental treatments — was too cumbersome.
It was time to do something about it, and a consultant with CTCA, Chuck Warren, coined the term “right to try,” recalled Starlee Coleman, a Goldwater senior adviser.
A little over a year after their meeting with CTCA, Goldwater’s model legislation was signed into law in Colorado, a largely Democratic state with a Democratic governor. Thirty-nine other state legislatures eventually followed, many without a single dissenting vote. (A)

“House lawmakers have unveiled their version of a bill that lets terminally ill patients try experimental treatments.
The bill was released early Saturday morning and is the House companion of a Senate version that passed last year. The White House has also made pushing legislation for right-to-try a major priority, with President Trump even mentioning it during his State of the Union address in January….
The bill would let patients gain access to a drug that has gone through the first of three phases of clinical trials. The patient must be terminally ill and have no other options to qualify to get the drug.
Manufacturers wouldn’t be required to supply the drug to terminally ill patients, but the bill hopes to entice drugmakers to participate in the program.
Drugmakers are sometimes hesitant to provide a drug outside of a clinical trial to a terminally ill patient because if the patient dies, then it could affect the approval of the product by the Food and Drug Administration. Experts have said that patients who would use right-to-try would likely be sicker than patients in a clinical trial.
The bill seeks to provide certainty to manufacturers on how the FDA will use patient outcomes when evaluating whether to approve the product. (B)

“In a major blow to the effort to pass a federal “right-to-try” law, House Republicans failed to muster the votes to pass a key compromise measure Tuesday.
The legislation was rejected by a vote of 259-140. The bill needed two-thirds majority to pass under suspension of rules.
The vote was an embarrassing defeat not only for House Republicans but for President Trump, who had called on Congress to quickly pass right-to-try legislation, and Vice President Mike Pence, a longtime supporter of the effort. It was also a rare misstep from Speaker Paul Ryan, who like most congressional leaders almost never schedules votes on legislation without some certainty that the given measure has the support to pass.
The controversial “right-to-try” bill would offer a pathway for patients with a terminal disease to get around Food and Drug Administration rules to request an experimental treatment from a drug maker before the agency has approved it. Supporters of the legislation, including the libertarian Goldwater Institute that first conceived of the pathway, say it would offer a necessary respite from what they say are overly cumbersome FDA rules.
Critics, however, including Minority Leader Nancy Pelosi of California, pointed out that the FDA already has a program in place to offer access to terminal patients, and the agency grants some 99 percent of all the requests it receives, often within a short time frame. They also argued that without more FDA oversight of the use of experimental therapies, desperate patients could be vulnerable to bad actors or unsafe treatments.” (C)

“Supporters of this legislation talk as if effective treatments are being withheld from patients,” said Dr. Robert M. Califf, who was the commissioner of the Food and Drug Administration under President Barack Obama. “The vast majority of experimental therapies are toxic or ineffective. The only way we find out is through controlled studies where we measure the effects.”
In a letter to House leaders, more than 75 patient advocacy groups, including the lobbying arm of the American Cancer Society, opposed the bill.
The American Medical Association said it “does not believe that the bill will substantially improve patient access to investigational therapies.” And the American Society of Clinical Oncology, representing cancer doctors, said the bill “could do more harm than good for patients with life-threatening illnesses” because it would remove the Food and Drug Administration from the evaluation of the risks and potential benefits of some treatments.
Drug companies can already provide experimental medicines to patients outside clinical trials under a program known as expanded access or compassionate use. The F.D.A. says it approves about 99 percent of compassionate use requests. In emergencies or other urgent cases, the agency says, it approves requests for the use of experimental medicines within hours or days of being contacted by a doctor.
Representative Jan Schakowsky, Democrat of Illinois, said the bill would have created “a dangerous back door around the F.D.A. approval process.”..
The drug industry was uncharacteristically quiet. The main lobbies for the industry — the Pharmaceutical Research and Manufacturers of America and the Biotechnology Innovation Organization — said they had not taken a formal position on the legislation.
The drive for right-to-try legislation was spearheaded by the Goldwater Institute, a public policy organization that advocates free markets and limited government.
Starlee Coleman, a policy adviser at the institute, said 38 states had adopted right-to-try laws, often with broad bipartisan support.” (D)

“The House will have to try again, before the bill can go back to the Senate (where it previously passed in August by unanimous consent) for further consideration. Before the new draft is revealed, here are several things about the Right To Try movement that need to be cleared up.
The “Right To Try” Is Not A New “Right”
A qualifying individual may petition to access an experimental therapy, but that does not mean they will receive it. Drug companies still have the authority to refuse any request. Thus, the right to try is really just federal-level permission to ask for an experimental therapy. The bill does, however, attempt to incentivize manufacturers by acknowledging that Right To Try patients will be sicker, and thus any negative outcomes from allowing terminally ill patients to try therapies will not be included in the FDA’s decision-making for future approvals.
Treatments Must Still Have Some Rigor. According to the new legislation, even an eligible investigational treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the FDA; and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act. This is good news for those concerned about safety, but some argue the barriers are not enough.
Clinical Trial Efforts Have Failed Patients. The truth is that many individuals pursue the right to try because they have been unsuccessful in clinical trials. Further, traditional trials add not only years to the review process for therapies, but inevitably increase drug costs. Ongoing arguments suggest that if the clinical trial process in the U.S. were improved, the need for the Right To Try Act wouldn’t exist. However, others contend that the FDA trial process is necessarily rigorous and that any patient rights to skip clinical trials will undermine future trial enrollment. (E)

“Every day, every hour, counts for them. But the process by which the federal Food and Drug Administration approves medicines and treatments takes an average of 14 years, and during that time, patients are, with a tiny number of exceptions, legally barred from using medicines that could save their lives — medicines the FDA has deemed safe and that it is giving people in clinical trials…
“The Right to Try movement was born to change this cruel reality. Alongside patients, doctors and policymakers nationwide, the Goldwater Institute crafted a new approach, a state-law reform that allows ill Americans to seek investigational treatments when they’re out of other options.
Right to Try’s success has been spectacular. In just five years, Right to Try bills have been introduced in every state, and 38 have adopted it, including Arizona, where voters passed it overwhemingly in 2014. The Wisconsin Legislature just sent a bill to the governor for his signature…
The wealthy and privileged have always been able to get the medicines they need, even without FDA approval. They can travel to other countries where they can get the medicines the FDA keeps locked up here.
A fortunate few get FDA permission to enter clinical trials or receive the so-called “Expanded Access” exception. It allows some people, on a case-by-case basis and through a cumbersome process, to request permission from the FDA to access medications outside of a clinical trial.
But these options provide false hope for most people, because only a fraction of those who need these exemptions are even allowed to request them, and most people can’t afford to travel the world to get treatment.” (F)

“Four former commissioners of the Food and Drug Administration are expressing opposition to congressional “right to try” legislation, just as Republican House leaders prepare to bring a bill up for another vote a week after it failed to pass….
“There is no evidence that either bill would meaningfully improve access for patients, but both would remove the FDA from the process and create a dangerous precedent that would erode protections for vulnerable patients,” they say…
The statement by the former FDA heads was signed by Robert Califf and Margaret Hamburg, who were commissioners during the Obama administration, and Mark McClellan and Andrew von Eschenbach, who served under George W. Bush. Some have previously expressed reservations individually about the bills. The joint statement is a show of bipartisan unity to try to slow the legislation’s progress on Capitol Hill.” (G)

“Thirty eight States have enacted right-to-try (RTT) laws, the intent is to increase the availability of experimental medicines to individuals battling life-threatening conditions A federal version has support at the highest levels of the Trump administration including the president himself. Yet the Goldwater Institute, which created and has strongly championed these laws, cannot provide clear examples of patients who have gained access to potentially life-saving treatments through state RTT laws that they otherwise wouldn’t have received under the FDA’s current Expanded Access Program (EAP). Furthermore, federal RTT law will not increase access either…
All this being said, one cannot ignore the desire to increase the access of critically and terminally ill individuals to experimental medicines. The question then becomes how to accomplish this in a way that meets the needs and requirements of regulators, companies and the current and future individuals in need?
One way to meld the intent of RTT laws with the existing EA process would be to create a more explicit regulatory pathway. This allows EA safety and efficacy data to be incorporated into the label of a new medicine once it is formally approved for its primary indication via “traditional,” highly controlled clinical trials.
In this way, companies could more fully balance the risks and benefits of an EAP to the overall development process of the experimental medicine. Companies would be incented to undertake these broader EA programs because they could determine how the EA program would potentially lead to the ability to treat a larger future patient population.
This would require legislative and regulatory changes to existing guidelines for intermediate- or large-scale EAPs, but would still be within the framework and intent of the 21st Century Cures Act.
Rather than circumventing the FDA oversight process, companies would have to reach agreement with the FDA as to the parameters under which “real-world evidence” (evidence regarding the potential benefits and risks of a product) collected from patients enrolled in expanded access trials could be used to support additional label claims for a new medicine. These programs would be overseen as if they were formal clinical trials designed to provide full input into the drug development process.” (H)

“Right-to-try legislation would create a pathway to remove FDA oversight of experimental, unproven therapies. These are the treatments that most need rigorous regulatory oversight tempered by willingness to allow pre-approval access for patients who need them most: those who have run out of treatment options. Excluding the FDA from the development and delivery of these therapies will make it harder to gauge their safety and effectiveness.
Advocates like us have spent decades fighting to accelerate the pace of scientific discovery and the development of new treatments, with patient safety and effectiveness as the North Star. We have each seen firsthand the perils of disease and the anguish of loved ones who have run out of options to fight deadly diseases like cancer or AIDS. But we cannot allow this pain, and our unwavering commitment to end suffering, blind our judgment about legislation that would create a climate where the most vulnerable patients are taken advantage of, their safety endangered, and drug development driven off track.
During the peak of the AIDS crisis, with 50,000 Americans dying from the disease each year, brave and determined activists pushed the FDA to increase regulatory flexibility — creating a variety of mechanisms that brought patients faster access to lifesaving therapies, therapies that are now saving millions of lives around the world and preventing new HIV infections. Cancer advocates have also long worked side-by-side with the FDA and Congress and continue to successfully enact innovative policy changes and expedited approval mechanisms such as Accelerated Approval and the Breakthrough Therapy designation. These changes have made a significant and lasting difference for patients.
If the right-to-try legislation can’t speed expanded access by circumventing FDA review, then what would it do? One result is certain: It would create uncertainty. In the 38 states that have passed similar bills, there is no evidence so far showing if these policies have increased patient access to experimental therapies. The absence of data here is both alarming and telling.” (I)

“The right-to-try bill, which suffered a surprise 259-140 defeat in the House of Representatives last week, is scheduled for another vote this week. The House Committee on Rules was scheduled to meet late in the day Monday to change the procedure so that it could be passed with just a simple majority, rather than a two-thirds majority, and this time approval seems likely.” (J)

“The House, spurred on by President Trump, passed a bill on Wednesday that would give patients with terminal illnesses a right to try unproven experimental treatments.
The measure, which was approved by a vote of 267 to 149, appears to have a good chance of becoming law. The Senate approved a similar proposal last year…
Mr. Trump endorsed the right to try in his State of the Union address in January and again on Monday, on a trip to Manchester, N.H., where he described potential beneficiaries of the bill.
“A patient is terminal,” Mr. Trump said. “There’s good progress made with a certain drug. We’re going to make it possible for that patient to get that drug. And maybe it’s going to work. It’s hope.
Thirty-five House Democrats voted for the bill on Wednesday night, along with 232 Republicans…
The House and Senate bills would establish a new pathway providing access to unapproved medicines for certain patients who had exhausted other treatment options. To qualify under the House bill, a patient would have to have some kind of terminal illness: a condition that is likely to cause death “within a matter of months” or “irreversible morbidity that is likely to lead to severely premature death.”
Nothing in the bill would require pharmaceutical companies to provide experimental drugs to patients who requested them. Drug manufacturers sometimes turn down requests because they have only a limited supply or they are concerned about legal and medical risks.
To address such concerns, the legislation would shield drugmakers, doctors and hospitals from some of the legal risks of providing unapproved drugs to patients. Doctors and hospitals would generally be protected unless they engaged in gross negligence or willful, reckless or criminal misconduct.” (K)

“Republican supporters of the bill said the “right-to-try” law would allow patients to have more control over their care. “I’m a physician and scientist with over 40 years’ experience treating patients, some of whom had the dreaded diagnosis of cancer,” said Rep. Phil Roe, MD, R-Tenn. “Six months ago, I was operated on for cancer, and I — to this day — am a cancer survivor. If needed, I would like to have the right to try.”” (L)

(A) How the ‘right-to-try’ movement muscled its way into Washington, by ERIN MERSHON, https://www.statnews.com/2018/03/07/right-to-try-movement-washington/
(B) House panel unveils right-to-try bill, by Robert King, https://www.washingtonexaminer.com/house-panel-unveils-right-to-try-bill/article/2651259
(C) ‘Right-to-try’ bill rejected by House, in major blow to GOP efforts, by ERIN MERSHON, https://www.statnews.com/2018/03/13/right-to-try-house-vote/
(D) House Rejects Bill to Give Patients a ‘Right to Try’ Experimental Drugs by By ROBERT PEAR, https://www.nytimes.com/2018/03/13/us/politics/house-rejects-right-to-try-bill.html
(E) 7 Things To Know About Experimental Drugs And The ‘Right To Try’ Act, by Nicole Fisher, https://www.forbes.com/sites/nicolefisher/2018/03/13/7-things-to-know-about-experimental-drugs-the-right-to-try-act/#501fe15e2084
(F) Your Turn: How Right to Try laws could one day help save your life, Christina Sandefur, https://www.azcentral.com/story/opinion/op-ed/2018/03/17/right-try-law-helps-terminally-ill/418559002/
(G) Former FDA commissioners say right-to-try bills could endanger ‘vulnerable patients’, by Laurie McGinley, https://www.washingtonpost.com/news/to-your-health/wp/2018/03/18/former-fda-commissioners-say-right-to-try-bills-could-endanger-vulnerable-patients/?utm_term=.f7bf4c56b4c6
(H) Here’s how to structure successful right-to-try laws, by BY KENNETH I. MOCH, ANDREW MCFADYEN AND ARTHUR CAPLAN, http://thehill.com/opinion/healthcare/377794-heres-how-to-structure-successful-right-to-try-laws
(I) ‘Right-to-try’ law threatens patient safety and rational drug development, By MARK HARRINGTON and ELLEN V. SIGAL, https://www.statnews.com/2018/03/12/right-try-law-safety-drug-development/
(J) Republicans Get Ready to Vote on “Right-to-Try” Bill Again, by Allison Inserro, http://www.ajmc.com/newsroom/republicans-get-ready-to-vote-on-righttotry-bill-again
(K) House Passes Bill That Would Give Patients Access to Experimental Drugs, by ROBERT PEAR, https://www.nytimes.com/2018/03/21/us/politics/house-passes-right-to-try-bill.html
(L) House passes ‘right-to-try’ bill on 2nd vote: 10 things to know, by Megan Knowles, https://www.beckershospitalreview.com/quality/house-passes-right-to-try-bill-on-2nd-vote-10-things-to-know.html

Revised 3/22/18

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Case Study on Disruption/Disintermediation in health care (10 posts)

Please feel free to use this case study, with attribution, and pass it onto others as well
and…your feedback would be appreciated jonathanmetsch@gmail.com

1. August 23, 2017 | UBER HEALTH Inc., WALMART HOSPITALS NFP, AMAZONrx (Ireland), MicrosoftCare LLC.

2. November 3, 2017 | Is “Silicon Valley” – artificial intelligence – disrupting and taking over the health care system?

3. December 25, 2017 | In 2018 the CVS-Aetna “Unicorn” will buy a mega-hospital system and become a very disruptive patient “ownership” trajectory

4. January 3, 2018 | Health care disruption….”executives are paying close attention to who/what poses the greatest threat to their business models.”

5. January 24, 2018 | Health care “disruption” doesn’t have any rules!

6. February 12, 2018 | Amazon is openly DISRUPTING health care as well as quietly under-the-radar

7. February 20, 2018 |health care DISRUPTERS like Amazon “have a strong self-interest in keeping hospital leadership on edge…”

8. February 26, 2018 | AMAZON: Health Care DISRUPTION by DISINTERMEDIATION. (what the heck is that?)

9. March 7, 2018 | The power of artificial intelligence in disrupting health care

10. March 15, 2018 | The HEALTH SECTOR is ripe for DISRUPTION… organizations need to rethink how & where care is delivered to consumers

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The HEALTH SECTOR is ripe for DISRUPTION… organizations need to rethink how & where care is delivered to consumers (F)

“Some of the biggest and most famous brands in America are making big bets on health care. The blue chips of Silicon Valley — Amazon, Apple, Google, Uber — have announced in the past few weeks they’re interested in disrupting an industry that has bedeviled us with rising costs and inefficiencies for decades.
Amazon is setting up a mysterious new partnership with JPMorgan Chase and Warren Buffett. Apple is planning a line of (surely sleek and minimalist) medical clinics. Google’s sibling under the umbrella company Alphabet, Verily, is looking at the Medicaid market. Uber wants to disrupt ambulances.
It is way, way, way too early to start imagining a world where health care is truly owned by Big Tech — you order prescription drugs with your Amazon Prime account, see a nurse at the Apple Clinic, get your benefits statements from Google, and call an Uber instead of an ambulance when you need to go to the hospital.
But something is happening here. The most proven, forward-thinking, and, dare I say, disruptive companies in our country have decided health care should be their next big move. They see a system rife with administrative inefficiencies, opaque prices, and customer dissatisfaction. In other words, a huge opportunity.” (A)

“Out of the gate, the new health care venture from Amazon, Berkshire Hathaway and JPMorgan Chase seems to be headed in the right direction — using new technology to provide their employees better value and health outcomes. That’s where things will start, but this could be a laboratory for a more sweeping transformation.
The big picture: To bring lower costs and better care to their employees and others, these companies will need to do more than deploy a modern technology overlay. They will have to better align payments and outcomes in health care across the board. If they accelerate this process, we will all benefit.
The problems: Our health care system is afraid of new technology, partially because of outdated ideas about how to pay for care that are layered into government programs. Consider the example of Type 1 diabetes — a chronic condition that affects more than 1.2 million Americans.
New technology called continuous glucose monitoring, or CGM, uses a digital sensor to monitor patients’ blood-sugar levels throughout the day, without requiring them to draw blood.
CGM is even more effective when it pairs with analytic algorithms and a smartphone. Patients can share readings with a doctor in real time, or automatically alert loved ones in the case of an emergency. These are precisely the kind of technologies a company like Amazon should know how to leverage.
Because of old and often inflexible rules, Medicare won’t have anything to do with CGM if a smartphone is involved. The government doesn’t want to be in the business of paying for smartphones.” (B)

“All journeys begin with a single step. The journey to value-based care is no different. One foot in front of the other. The steady accumulation of those steps and one finds oneself a thousand miles from the starting point. The same will be the story of artificial intelligence in healthcare.
For AI in healthcare, there is more focus on the high-profile failures than the small successes — the incremental steps. Yet those small wins offer a vibrant story of transformation, re-invention, and improved patient experience.
It is these small wins, in concert with each other that will alter the trajectory of healthcare in the U.S. and beyond. Let’s take a look at the range of some of these wins and consider the collective implications if adopted broadly across a major U.S. system.” (C)

“Alphabet, Microsoft and Apple have filed more than 300 healthcare patents between 2013 and 2017 — revealing the tech giants’ increasing desire to disrupt the healthcare space, according to a new report by Ernst & Young.
Between 2013 and 2017, Google’s parent company Alphabet filed 186 patents, Microsoft filed 73 and Apple filed 54.” (D)

“EY’s analysis of the US health patents filed by major technology players, including Alphabet, Apple and Microsoft, shows the investment technology giants are making in health care (see Figure 1). Alphabet, for instance, has a range of initiatives that span DeepMind and Verily Life Sciences, including joint ventures in diabetes (Onduo), bioelectronics (Galvani Bioelectronics) and smart operating rooms (Verb Surgical). Apple, meanwhile, has filed patents to turn its phones into medical devices capturing biometric data such as blood pressure and body fat levels; it has also partnered with Stanford University to develop algorithms to predict abnormal heart rhythms. Based on its filed patents, Microsoft has focused on expanding its AI capabilities and developing monitoring devices for chronic conditions.” (E)

“Patients and physicians both are ready to engage with one another using digital tools, according to a new Ernst & Young national survey released at HIMSS18 this week.
The survey found 54 percent of consumers said they are comfortable contacting their physician digitally and further expressed interest in using technology such as at-home diagnostic testing (36 percent), using a smartphone or connected device for information sharing (33 percent) and video consultations (21 percent).
There is widespread agreement among physicians that digital technologies and data sharing will contribute effectively to the overall well-being of the population, the survey found. And 83 percent of physicians believe that increased patient-generated data from connected devices would benefit the overall quality of care and enable more personalized care plans.
Further, 66 percent of physicians said that increased use of digital technologies would reduce the burden on the healthcare system and its associated costs, and 64 percent think it would help reduce the burden on doctors and nurses and have a positive impact on the critical issue of burnout, the survey said.
“The health sector today is ripe for disruption, and these findings reinforce the need for organizations to rethink how and where care is delivered to consumers,” said Jacques Mulder, U.S. health leader at Ernst & Young. “Both consumers and physicians are empowered by emerging technology and are hungry for better, more connected experiences. This demand paves the way for nontraditional players to make an impact on the industry, and is another indicator that health in entering an era of convergence.” (F)

“For the better part of a decade, the drive to adopt health information technology was focused on just that, adopting technology. Now, the push seems to be twofold: actually finding value in the billions spent on health IT and, equally as significant, trying to keep pace with consumer demand.
That means an increased focus on telehealth and virtual care; deploying consumer-friendly apps; experimenting with artificial intelligence; and collecting, analyzing and pushing out actionable data. Hospital executives, vendors and others gathered here last week at the Healthcare Information and Management Systems Society’s annual meeting were adamant in their belief that healthcare organizations need to stop nibbling at the edges and pick up the pace of embracing consumerism.
That push, however, has to be balanced with the reality that provider revenue streams are tightening, as well as the fact that payers, employers, consumers and the government are clamoring for more preventive and population health-based care.” (G)

“Interoperability” isn’t a word most people hear every day. But when it comes to the future of patient-centered healthcare in the United States, few technological developments may prove to be more important.
Interoperability is essentially the ability of different computer systems to communicate with each other quickly and effectively. For healthcare specifically, that means being able to share patient data in an instant regardless of what hospital, pharmacy, laboratory, or clinic houses the information—and being able to do so with complete reliability and privacy protection.
The Trump Administration views interoperability as a top priority for the Federal government. This week, White House Senior Adviser Jared Kushner laid out President Donald J. Trump’s plan at HIMSS18, a leading conference focusing on health information and technology transformation.
“Interoperability is about our shared bottom line: saving lives,” Kushner said. “There is overwhelming consensus: America needs better access to patient data and interoperability now.” (H)

“Amazon.com Inc said on Wednesday it was expanding its discounted Prime membership offer to Medicaid members, the U.S. government’s health insurance program for the poor.
The move from the e-commerce giant comes nine months after it said it would offer a discount on its popular Prime subscription service for shoppers who receive U.S. government aid.
To qualify for the discounted $5.99 monthly Prime membership, customers must have a valid Electronic Benefits Transfer or Medicaid card and can renew it annually for up to four years, the company said.
The $12.99-per month or $99-per-year prime service offers users added perks like low prices and faster delivery for certain purchases and shipped over 5 billion items worldwide last year.
Any push by Amazon into poorer demographics comes at a time when traditional brick-and-mortar suppliers like Walmart Inc have been fighting the online shopping giant’s arrival by seeking to attract more high-spending shoppers.
The Medicaid connection may also stir more nerves among healthcare companies worried about tentative moves by Amazon to sell and distribute some medical supplies and drugs. (I)

“The program has earned Amazon praise for “doing well by doing good” but also draws attention to product offerings that will likely come in handy specifically for customers on Medicaid, such as over-the-counter medications and eyewear. Healthcare consultant Lyndean Brick of the Advis Group noted to the Indianapolis Star that the move is also aligned with the company’s larger strategy to expand into the healthcare marketplace. Amazon recently announced a plan to partner with Berkshire Hathaway and JPMorgan Chase to launch their own employee healthcare company.
“They have a strategy to enter into the healthcare market and it’s clearly well thought out, and they are going to enter the industry from all sides simultaneously,” Brick said.” (J)

“If you’re in the pharmacy business, Amazon’s roster of employees is starting to look ominous. In the past 18 months, the e-commerce giant has poached more than 20 employees from industry heavyweights such as CVS Health, Express Scripts, and UnitedHealth Group, according to a STAT review of available LinkedIn data. The new hires include software engineers, data analysts, business strategists, and others with years of experience in the prescription drug and health care” (K)

“Walmart Inc., the largest private employer in the U.S., has been buying health care for its workers directly from providers in six different regions — bypassing insurers who usually negotiate with doctors and hospitals. The retailer is trying to find out if its formidable purchasing power can squeeze out middlemen and drive down costs in the same way that its tough bargaining has brought down prices for shoppers.
“We wanted to see what was more effective — what works, and what doesn’t work,” said Lisa Woods, the company’s senior director of U.S. health care. “If we can’t impact and influence cost or how cost trends are increasing, then we need to change or do something different.”
Companies are the largest providers of health insurance in the U.S., giving more than 150 million people access to coverage. While premiums have soared 55 percent over the past decade, according to the Kaiser Family Foundation, most firms have done little tinkering with their health plans beyond asking employees to pay higher contributions and out-of-pocket costs.” (L)

“Uber launched Uber Health on March 1, a new form of non-emergency medical transportation. The new service allows patients to schedule rides to and from medical appointments hours before or up to 30 days in advance. Providers who order the rides do so through an online dashboard, and patients receive a text message or phone call for information about their trip, making rides accessible to those without smartphones.
Lyft Concierge, which launched in 2016, allows businesses to schedule rides on behalf of individuals, and Lyft has already partnered with health-care providers such as Blue Cross Blue Shield with this platform. On March 5, Lyft announced it is expanding its medical transportation service after partnering with Allscripts, one of the largest electronic health-care service companies.
Uber and Lyft have touted their services as solutions for the 3.6 million people who miss appointments due to a lack of accessible medical transportation. Although their services should be great ways to modernize medical transportation, Uber Health and Lyft Concierge come with concerns.
Unlike Medicaid’s non-emergency transportation program, for which a transportation provider’s staff must receive patient privacy and safety training, neither ridesharing company requires drivers to have any special training for escorting patients to and from their appointments. This poses a serious health risk for passengers who may be dealing with severe, chronic illnesses and, in the event of an emergency, will not have proper assistance.” (M)

“So, then why such a big buzz?…
In other words, whether or not these three companies will deliver true transformation in the future is still TBD, but they are absolutely providing motivation right now. And this is huge.
Why is this outside influence so critical in this industry? The simple truth is that healthcare delivery systems are incredibly complex multibillion dollar operations with tens of thousands of employees. All businesses of this size and scale, both inside and outside of healthcare, have an extremely hard time being nimble and are always at risk for innovation happening on the edge of their business model. So, while group purchasing, employer clinics and transportation are not burning platforms for any executive team in a hospital today, when they see the names Amazon, Apple and Uber playing in those spaces, these areas immediately become board level agenda items and initiatives…
There is a great line from a Tracy Chapman song All That You Have is Your Soul that goes “don’t get tempted by the shiny apple.” While it is easy to be attracted to simple ideas, healthcare is an incredibly complex industry with an overwhelming number of problems that need to be solved. And truly solving these problems is incredibly challenging work.
With that said, for too long it is has been too easy to accept healthcare’s shortcomings. And that is exactly why Amazon, Apple and Uber can be incredibly helpful — not just in producing ideas, but in providing the inspiration for us to truly take action to help heal healthcare, not in the future but right now.
And if they can do that it would truly be an, “OH MY!” (N)

“Health 2.0 looked at five drivers that could advance healthcare; the new interoperability and the increased use in FHIR and SMART system; novel modalities, such as voice assistants and virtual reality; new market entrances like Amazon and JP Morgan; business model disruptions, and new environments for health systems like schools.
But Subaiya said that no one system can solve healthcare a crisis alone. Partnering is key to solving some of the most pressing issues in healthcare, Subaiya said. However, some healthcare providers are still reluctant to embrace the change, citing little resources, difficulty in integration and a lack of domain experience.
Subaiya urged providers to go beyond their walls. She gave the example of the opioid epidemic. The condition isn’t limited to one type of doctor or care. Treating addiction includes mental health services, physician referrals, Pharma regulations, and emergency care.
“These problems are complex, the solution sets are starting to aggregate into small clusters that make sense for a large problem. Now they need the mechanism and the infrastructure with the care delivery system to have true impact,” she said.
For example, in solving the opioid epidemic innovation around the opioid epidemic is clustering into care coordination, digital therapeutics, identifying and monitoring, social determinant side.
“I think you’ll see incredibly powerful platforms that are consolidating units of innovations. We are going to be seeing people putting pieces of innovation together,” said Subaiya.” (O)

“Given that government intervention a la the “Affordable Care Act” failed to drive efficiencies or bend the cost curve in health care, now Amazon, Berkshire Hathaway and JPMorgan will have the opportunity to try their hand at modernizing the health care system.
While time will tell whether (and how) Amazon, et al. can make an impact on the market, their potential entrance thereto is already driving change in the industry as existing market players are having to re-think their strategies related to innovation, efficiency, and transparency in preparation for new competitive entrants.
And, as anyone with experience dealing with the health care system will quickly acknowledge, change to the status quo is sorely needed given that the current byzantine nature of the American health care system has over the course of several decades created barriers to entry for new competitors while also reinforcing perverse incentives among and between various players in the space.
In addition to stock price movements, 2017’s health care merger activity is an indication that change may be apace.
From horizontal mergers of hospitals and insurers to vertical mergers involving players in historically isolated segments of the industry, such as the proposed merger of pharmacy giant CVS Health and insurer Aetna, it appears that the market is positioning to improve integration and efficiency.” (P)

“Eric Schmidt delivered a hearty dose of optimism Monday evening in the HIMSS18 opening keynote.
“A revolution has been happening in my industry. Scale changes the rules, scale changes everything,” said Schmidt, who is the former Executive Chairman of Alphabet and today serves as a Technical Advisor to Google’s parent company. “The combination of cloud, deep neural networks, the explosion of data will give you a model.”..
Schmidt pointed as example to a theoretical technology product he called Dr. Liz — named in honor of the first woman to earn a medical degree, Elizabeth Blackwell — a scenario wherein a voice assistant in patient rooms interacts with consumers, makes evidence-based recommendations to doctors and handles all the administrative burden of working in an EHR.
“Everything I just described is buildable today or in the next few years,” Schmidt added. “All it takes is for all of us to figure out how.”
That’s not to say it will be here tomorrow, but Schmidt laid down a clear path toward just such an innovation akin to email, the Internet or smartphones that will be the proverbial killer app that causes all sorts of interactions and connections.
Here’s what Schmidt said that will take: A clinical data warehouse packed with diverse data sets that are curated and normalized such that sophisticated analytics can be run against the data and accessed with a rich API. Hospitals then need a second tier of data to supplement EHRs…
Reinforcement learning requires those powerful networks. Schmidt described the concept of consisting of a simulator, training data, real-time experience to that looks at forwarding outcomes.
“We believe we can build reinforcement solutions to significantly improve pathways of care,” Schmidt said.” (Q)

“Artificial intelligence is all the rage in Silicon Valley, but it has so far not made much of a dent in health care. That’s largely because the technology just isn’t good enough yet, according to a report in VentureBeat.
The most interesting applications so far have focused on diagnostics — using algorithms to process and distill published medical research at a volume humans simply couldn’t handle, or having them read patient data and look for abnormalities, the report says.
Key quote: “I have no doubt that sophisticated learning and AI algorithms will find a place in health care over the coming years,” data scientist Andy Schuetz tells VentureBeat. “I don’t know if it’s two years or 10 — but it’s coming.”” (R)

“Dan Patterson: Can you forecast the future for us? Some advice and insight on what technologies may be most disruptive, and what technologies may be most helpful in the next 18-36 months?
Ted Smith: I’ll leave you with something controversial that will be memorable. But my money is on the toilet, just to be clear, based on biometrics, considering all that can be done by sampling by what’s going on with someone, believe it or not, we can learn a lot about your health with a smart toilet.
It’s kind of a gross thought, but it’s something we all use multiple times a day. It’s probably the gateway to always knowing about your health.” (S)

““What if we told you we could back up your mind?”
So yeah. Nectome is a preserve-your-brain-and-upload-it company. Its chemical solution can keep a body intact for hundreds of years, maybe thousands, as a statue of frozen glass. The idea is that someday in the future scientists will scan your bricked brain and turn it into a computer simulation. That way, someone a lot like you, though not exactly you, will smell the flowers again in a data server somewhere.
This story has a grisly twist, though. For Nectome’s procedure to work, it’s essential that the brain be fresh. The company says its plan is to connect people with terminal illnesses to a heart-lung machine in order to pump its mix of scientific embalming chemicals into the big carotid arteries in their necks while they are still alive (though under general anesthesia).” (T)

(A) Why Apple, Amazon, and Google are making big health care moves, by Dylan Scott, https://www.vox.com/technology/2018/3/6/17071750/amazon-health-care-apple-google-uber
(B) How Amazon & Co. can revolutionize the health care system, by Dan Mendelson,https://www.axios.com/mendelson-on-amzbhjpmc-health-1517524125-2f8d2447-c121-4f02-a902-5b9d1eb128dc.html
(C) Small wins vs. big losses: AI in healthcare, by JONATHAN MUISE, https://medcitynews.com/2018/03/small-wins-vs-big-losses-ai-healthcare/
(D) Google’s parent Alphabet, Microsoft and Apple have filed 300+ healthcare patents: 5 things to know, by Alia Paavola, https://www.beckershospitalreview.com/healthcare-information-technology/google-s-parent-alphabet-microsoft-and-apple-have-filed-300-healthcare-patents-5-things-to-know.html
(E) When the human body is the biggest data platform, who will capture value, http://www.ey.com/Publication/vwLUAssets/ey-when-the-human-body-is-the-biggest-data-platform-who-will-capture-value/$FILE/ey-when-the-human-body-is-the-biggest-data-platform-who-will-capture-value.pdf
(F) Survey: Patients are comfortable engaging doctors digitally, but not with sharing data, by Bill Siwicki, http://www.healthcareitnews.com/news/survey-patients-are-comfortable-engaging-doctors-digitally-not-sharing-data
(G) Drive to embrace consumerism forcing change in health IT strategies, by Matthew Weinstock and Rachel Z. Arndt, http://www.modernhealthcare.com/article/20180310/NEWS/180319989
(H) The Trump Administration’s Plan to Put You in Charge of Your Health Information, https://www.whitehouse.gov/articles/trump-administrations-plan-put-charge-health-information/
(I) Amazon offers discount Prime membership to Medicaid recipients, by Tamara Mathias, by Sarah Young, https://www.reuters.com/article/us-britain-facebook-far-right/facebook-bans-far-right-group-britain-first-for-inciting-hatred-idUSKCN1GQ1JS
(J) MEMBERSHIP TAKEAWAYS FROM AMAZON’S MEDICAID DISCOUNT, by ERNIE SMITH, https://associationsnow.com/2018/03/membership-takeaways-amazons-medicaid-discount/
(K) Amazon’s pharmacy hires hint of ambitions to upend a $360 billion market, by By CASEY ROSS, https://www.statnews.com/2018/03/09/amazon-pharmacy-hires/
(L) Amazon Isn’t the Only Retail Giant Trying to Remake Health Care, by Zachary Tracer, https://www.bloomberg.com/news/articles/2018-03-08/amazon-isn-t-the-only-retail-giant-trying-to-remake-health-care
(M) Corporations struggle to do what health-care system won’t, http://www.columbiachronicle.com/opinion/article_877679c4-23f2-11e8-ab72-ffbfd0590f7e.html
(N) The No. 1 takeaway from HIMSS 2018: ‘Amazon and Apple and Uber, oh my!’ by Dan Michelson, https://www.beckershospitalreview.com/healthcare-information-technology/the-no-1-takeaway-from-himss-2018-amazon-and-apple-and-uber-oh-my.html
(O) Health 2.0 sees the future of healthcare innovation in collaboration, by Laura Lovett, http://www.mobihealthnews.com/content/health-20-sees-future-healthcare-innovation-collaboration
(P) Amazon’s early impact on health care, by David Bottoms, http://www.mdjonline.com/cobb_business_journal/amazon-s-early-impact-on-health-care/article_06e8141a-1d81-11e8-85c8-5b11d94855e4.html
(Q) Eric Schmidt lays out formula for healthcare innovation, by Tom Sullivan, http://www.healthcareitnews.com/news/eric-schmidt-lays-out-formula-healthcare-innovation
(R) When AI will start to disrupt health care, by Sam Baker, https://www.axios.com/artificial-intelligence-disrupt-health-care-b879abb2-af8c-45c8-a65c-ef5d82471850.html
(S) A smart toilet may be the future of IoT healthcare, by Dan Patterson, https://www.techrepublic.com/article/a-smart-toilet-may-be-the-future-of-iot-healthcare/
(T) A startup is pitching a mind-uploading service that is “100 percent fatal”, by Antonio Regalado, https://www.technologyreview.com/s/610456/a-startup-is-pitching-a-mind-uploading-service-that-is-100-percent-fatal/

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