Is the DEA Branching Out Into Regulating Medicine?

Posted on September 23, 2019 by Pharmaciststeve

Is the DEA Branching Out Into Regulating Medicine?

https://www.cato.org/blog/dea-branching-out-regulating-medicine

The Drug Enforcement Administration, having virtually eliminated the diversion of prescription pain relievers into the underground market for nonmedical users, appears to be setting its sights on regulating the medical management of pain, a mission not suited for law enforcement. Acting under the authority of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), the DEA announced a proposal to reduce, once again, the national production quotas for fentanyl, morphine, hydromorphone (Dilaudid), oxycodone, and oxymorphone, bringing the production levels down 53 percent from 2016 levels.

The September 12, 2019 new quota proposal from the DEA states (Federal Register page 48172):

As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to controlled substances in 2018 represents less than one percent of the total quantity of controlled substances distributed to retail purchasers.(emphasis added)

The ostensible purpose of the production quotas is to reduce the amount of prescription opioids that get diverted into the underground market. As has been clearly demonstrated, the overdose rate from the nonmedical use of licit and illicit drugs has been on a steady, exponential increase since at least the late 1970s, with the only variation being the particular drug in prominence at any given period. As opiophobia receded in the 1990s, opioid prescribing increased, with prescription volume tripling from 1999 to 2015. The drug of choice for nonmedical users during the early part of this century became diverted pain relievers, which then became a dominant component of the opioid-related overdose statistics. Concerted efforts by policymakers to reduce opioid production and prescribing led to a 58 percent reduction in per capita high-dose opioid prescription volume from 2008 to 2017 while total opioid prescription volume dropped 29 percent from 2010 to 2017. Despite these reductions, the overdose rate continued to surge. It increased 13 percent between 2016 and 2017, although preliminary data suggests the overdose rate might be starting to level off.

Overdose deaths soared while prescription volume dropped as nonmedical users migrated to cheaper and more readily available heroin and now fentanyl. Between 2011 and 2017 the proportion of opioid-related overdose deaths due to prescription pain relievers dropped precipitously while those due to heroin and fentanyl surged. Preliminary data for 2018 point to this trend continuing. The share of opioid-related deaths involving fentanyl rose from 14 percent in 2010 to 60 percent in 2017. Based on data from the Centers for Disease Control and Prevention, fentanyl or heroin was involved in 75 percent of opioid-related deaths in 2017. Just 30 percent involved prescription opioids, down from 52 percent in 2010, but 68 percent of those cases also involved heroin, fentanyl, cocaine, barbiturates, benzodiazepines, or alcohol—meaning fewer than 10 percent of opioid-related deaths involved prescription opioids without those other dangerous substances.

Set aside the evidence that reducing the amount of prescription opioids available for diversion helped drive up the overdose rate by driving nonmedical users to more dangerous substances. With the DEA telling us that less than 1 percent of prescription opioids are currently diverted into the black market, why is it necessary for the DEA to tighten quotas even further?

Aside from the apparent desire of law enforcement to regulate the practice of medicine, there can be no justification for the continued reduction in opioid manufacturing –unless it is based upon the belief that the prescription opioids are producing all of the heroin and fentanyl addicts by “hooking” patients on opioids.

Such a belief ignores the evidence. According to data from the CDC and the National Survey on Drug Use and Health there is no correlation between prescription volume per capita and “past month nonmedical use of prescription pain reliever” or “pain reliever use disorder in the past year” among persons aged 12 or above. The NSDUH repeatedly reports that less than 25 percent of nonmedical users of prescription opioids get them through a doctor—most get them from a friend, relative or dealer. And a classic study in 2007 that examined OxyContin addicts admitted to rehab between 2001 and 2004 found 78 percent claimed the drug had never been prescribed for them, and 92 percent used OxyContin in conjunction with multiple other drugs—cocaine being the drug 66 percent of the time. Also notable is that 78 percent reported previous treatment for substance use disorder.

The continued clampdown by the DEA also shows a complete lack of understanding about the nature of addiction. Addiction is a disorder characterized by compulsive use despite negative consequences. The etiology and pathogenesis of addiction involves psychological trauma during early development, and a significant association with psychoneurological comorbidities, often with genetic and epigenetic connections. Addiction is not the same as physical dependence. And addicts are not “possessed,” i.e., their brains are not “hijacked” by the drug to which they are addicted. As Drs. Nora Volkow and Thomas McLellan of the National Institute on Drug Abuse have pointed out, addiction to opioids is very uncommon, “even among those with preexisting vulnerabilities.”

Highly rigorous and respected Cochrane systematic studies in 2010 and 2012 of chronic pain patients found addiction rates in the 1 percent range, and a report on over 568,000 patients in the Aetna database who were prescribed opioids for acute postoperative pain between 2008 and 2016 found a total “misuse” rate of 0.6 percent.

The DEA is tasked with the impossible assignment of determining just how many opioids, of all types, are needed to treat pain or provide anesthesia to roughly 325 million Americans in any given year, and to apportion specific production quotas to individual manufacturers. As the central planners of the former Soviet Union—and the countless Russians who stood in long queues to buy necessities—would attest, it is impossible to plan how much of any product consumers need in a given year, let alone predict needs in the future.

An acute national hospital shortage of injectable opioids in 2018 was largely the result of DEA production quotas set for that year along with an unanticipated shutdown, for quality control purposes, of a major manufacturing plant. This caused many postoperative patients to suffer from under-medication of their pain and caused the cancellation of numerous elective surgeries. There is also evidence that many chronic pain patients, suddenly cut off or abruptly tapered from long-term opioid therapy, have turned to the dangerous black market in search of relief. Worse, many have turned to suicide.

A strong case can be made that the clampdown on prescription opioids has only served to drive up the overdose rate among nonmedical users while inflicting unintended harm on patients. The management of acute and chronic pain—as well as substance use disorder—is not in law enforcement’s wheelhouse. If relaxing the quotas is not in the cards politically, then the least the DEA can do is to stop making matters worse.

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Dr Arnold Feldman: Medical Board Corruption is violating Your Constitutional Rights!”

Posted on September 22, 2019 by Pharmaciststeve

Dr Arnold Feldman: Medical Board Corruption is violating Your Constitutional Rights!”

http://chng.it/JysWFBJ8Fp

 Feldman v Federation
                                               Patient Petition

              For Patients and their families, friends and loved ones
 
 
We, the undersigned, submit this petition in support of the above lawsuit, filed by Drs. Feldman and Kaul. We are the patients, the people without whom the American healthcare system would not exist, and the people for whom the system was intended to serve. We all suffer from chronic debilitating pain, that has had devastating and tragic consequences on our lives, and those of our fathers, mothers, brothers, sisters and children. We, the voting public, the people of this country, have been forgotten by the politicians, the insurances companies and healthcare corporations, who have raped our healthcare system for profit, mercilessly and behind their faceless corporations, have, through their predatory pricing deprived us of life saving care. We are dying and no one cares, except our doctors, healers like Drs. Feldman and Kaul.
 
Within at least the last five years, our access to life saving treatment has been either severely reduced or completely eliminated. This is a direct consequence of rampant corruption within state medical boards like any corruption in the workplace and reckless, evidentially unsupported policies propagated by politically motivated state and federal bureaucrats. These agencies and the people who work within them do not care for our welfare, our lives and the unrelenting pain in which we now live, because of their own selfish economic and political agendas. We wake in pain, we live in pain, and when we can actually go to sleep, we know that our relief will be short lived. Many of us think about suicide every day. At least in death we will have relief from the excruciating agony that now plagues our existence, because corrupt medical boards have taken away the licenses of our doctors, and deprived us of care. For some of us, our doctors have been sent to jail for life, for simply doing their job, that of healing our pain. We are shocked, saddened and find it hard to believe we live in America, the supposed land  of the free and the brave. Well those brave enough to treat our complicated and debilitating pain have been mercilessly thrown into concrete cages, had their careers destroyed and left to rot, while we, and there are now many of us, have been abandoned by the profiteers and opportunists who now run our healthcare system. At the center of this cesspool of corruption are the state medical boards, who claim to “protect the public”. This is a massive lie.
 
These agencies abuse their power, unregulated, unsupervised and existing not to help the public, but to exploit and profit from the public, us. They use us as their excuse, their cover, to perpetrate their crimes against humanity. Their crimes contribute to the epidemic of physician suicides in the United States, reported as four hundred a year, although the number is likely much higher, and they kill patients, by taking away our doctors, jailing our doctors and causing them to commit suicide. Corrupt medical boards have permitted corrupt insurance companies, pharmaceutical companies and healthcare corporations to financially rape the American public, dictate local healthcare policy, and revoke the licenses of our doctors in the most cruel and arbitrary manner, with no regard for due process or the law. All of these events have caused us and our families immense suffering, and for too long we have suffered in silence, hoping that eventually sense would prevail, that our doctors would start to take care of us once again, without fear of jail or license revocation. We now see that hope in the lawsuit that Drs. Feldman and Kaul are about to file. We see two dedicated, courageous and committed men, whose fight is a righteous one, one for the people, for us, the American people, the people who pay taxes, who vote and who power, we are convinced, will cause Drs. Feldman and Kaul to prevail in their landmark case to end medical board corruption.
 
We will be victorious in our fight for justice.

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NY: the tax on opioids, especially generics, can cost more than the drug itself

Posted on September 22, 2019 by Pharmaciststeve

New York State Drew Up a Tax to Punish Opioid Makers—But Found Some Unanticipated Side Effects

https://fortune.com/2019/09/16/new-york-opioid-tax-drugmakers-side-effects/

Earlier this summer, New York became the first state to place an excise tax on opioids sold to or within the state. Backers expect the tax to generate $100 million in revenue for the state, which Gov. Andrew Cuomo and his administration have said will be plowed into helping victims of the opioid crisis.

The idea was to punish pharmaceutical companies for their role in the opioid epidemic: Pay a tax on opioids you sell to the state, and we’ll use that money to fund treatment and recovery programs. Sounds simple. But the reality has been much more complicated. The tax, which went into effect July 1, has already set off a ripple effect across the entire supply chain, as manufacturers and distributors have either stopped shipping to the state altogether or passed the tax onto each other. The law allows the cost to be passed on further, to pharmacies and even consumers.

And then there are the feared social costs. Health officials worry the tax could drive patients to seek out opioids on the black market.

New York’s experiment is both a cautionary tale for other states—and a look at how difficult it is to make drugmakers pay for fueling the opioid crisis.

The tax is based on the amount of opioid in each unit sold, as well as wholesale acquisition cost, and applies to whatever entity makes the first sale—the manufacturer or the wholesaler. But since the tax was announced in July, at least three manufacturers have discontinued opioid shipments to the state: Epic Pharma, AvKARE and Lupin Pharmaceuticals. Two others, Mallinckrodt Pharmaceuticals and Upsher-Smith Laboratories, are in deliberations over also exiting the state, they told Fortune.

Mallinckrodt said in a statement its effort to provide affordable access to its products “has been greatly challenged” by the tax, which it calculates to be “in excess of our net revenues on these products, making it cost prohibitive for either generic manufacturers or our wholesale/distribution partners to ship product into the state without a practical pass-through mechanism to recoup the tax.” 

Manufacturers pulling out is no small matter. Without them, pharmacies are left scrambling to find replacements. 

Xpress Lane Pharmacy in Manhattan confirmed it is having difficulties accessing opioids for its patients, said owner Lev Zavulunov. Its supplier Cardinal Health, which offers pharmacies a database to order products from its partner manufacturers, now shows certain drugs as no longer available to ship to the state. Cardinal Health confirmed some manufacturers working with Cardinal are refusing to ship directly into New York themselves, or refuse to ship to Cardinal’s National Logistics Center in Ohio at an additional charge to the drug makers. For those that refuse, Cardinal has stopped supplying their products, the wholesaler told Fortune. Cardinal also confirmed it has stopped shipping opioids to state ambulatory care centers altogether. For Xpress Lane Pharmacy, according to Zavulunov, out of 10 possible manufacturers, only one or two now ship to the state. Zavulunov explained as a result, certain doses may no longer be available, and doctors are having to change the dose or the prescription altogether.

As manufacturers exit the state, more market share falls on the remaining drug makers, who must comply with annual Drug Enforcement Administration production quotas. With an increase in demand, supply could fluctuate dangerously low, according to Tara Ryan, vice president of state government affairs at the Association of Accessible Medicines (AAM). 

If manufacturers choose to stay in the game despite the tax, they will, inevitably, raise their prices to offset the cost, perhaps even beyond just their opioid products, Ryan explained. Onisis Stefas, vice president and chief pharmacy officer of Northwell Health, agreed that over time, there will be price hikes. And if manufacturers sell to wholesalers (and more than 90% of all pharmaceuticals flow through these distributors, according to the Healthcare Distribution Alliance), the cost gets passed on to them. 

“I get the politics of having to single out a bad guy,” said Assemblyman John McDonald III, who owns a pharmacy himself and has publicly opposed the tax. “You can tax these manufacturers as much as you want; the reality is, all they need to do is turn around and raise the prices, and they can overcome that.” 

Opioid shortages

Wholesalers with facilities in the state are already seeing shortages, said Steve Moore, president of the Pharmacists Society of the State of New York. Some lack the infrastructure and technology to handle the nuances of processing the tax, so are disincentivized from shipping to the state at all, Moore said. Other wholesalers may choose to supply the state, but to pass on the cost.  

Pharmacies are in a much tougher spot, as raising out-of-pocket expenses for consumers is often not viable, and some contracts explicitly prevent pharmacies from passing on the cost to patients, McDonald explained. Since insurance companies are not required by law to match the rising costs, pharmacies are in a bind. 

Diamond Drugs II, a pharmacy on Long Island, says it is not able to order oxycodone or hydrocodone from suppliers out of state. It now relies on one manufacturer in New York, and thus, has limited opioid supply. Diamond Drugs is receiving calls from patients belonging to other pharmacies whose access has also waned, asking if Diamond Drugs will fill their prescriptions, owner Harvey Staub said. But since the independent pharmacy’s supply is limited, its priority is to fill prescriptions for long-time patients who have done business with the pharmacy before—new patients are being turned away. As a result, the pharmacy is losing business, Staub said, and turning away patients with legitimate needs for the medicine. 

“For most pharmacies, dispensing narcotics—controlled substances in general, and opioids specifically—we do it. It’s not a profitable venture,” McDonald said. “[Pharmacy benefit managers] cut reimbursement drastically on these items.”

At the time of Cuomo’s proposal, the HDA calculated for the administration the estimated tax of some products based on publicly reported wholesale acquisition costs and their morphine milligram equivalents. What it found was the tax can result in anywhere from a 60% to 100% markup on a regular drug price.

Gov. Cuomo’s office did not respond to Fortune’s requests for comment.

According to McDonald and Moore, the tax on opioids, especially generics, can cost more than the drug itself. Considering generic medications make up nearly 90% of the controlled substance market, generics will be hit hardest by the tax, meaning huge ramifications for patients who rely on generics to afford their prescriptions.

“With inventories of opioids dwindling in New York, and state policymakers ignoring the limitations of the national contracts and supply chain that dictate the distribution and reimbursement for medication across the country, patients with legitimate pain management needs are at risk of losing access to the affordable generic opioids that are most affected by this tax,” Mallinckodt told Fortune.

The black market

Indeed, one unintentional consequence of the new tax could be boosting the black market for opioids. “We made it clear, every which way, for two years in New York that there could be negative outcomes,” said Matthew DiLoreto, vice president of state government affairs at the Healthcare Distribution Alliance (HDA). DiLoreto said the HDA was told by policymakers they “did not believe the concerns we raised were significant enough or that they would ever actually occur.” 

Kathryn Carroll, manager of government affairs at the Center for Disability Rights, who was also part of budget negotiations, said, “It seemed like of all the things the legislature had to fight for, this just fell to the bottom of the list.”

A 2018 study published by two professors of economics at Union College predicted that not only will the tax cause restricted consumer access to opioids, but also will strengthen the black market, which offers cheaper illegal alternatives like heroin and fentanyl.

National data shows that of the patients prescribed opioids for chronic pain, between 8% and 12% develop an addiction. “Many have raised concerns that while the prescribing for FDA approved opioids has gone down and the death rate from the misuse and abuse of FDA approved opioids has fallen, the death rates from illegal opioid overdoses (fentanyl and other opioids) continues to rise,” said Ryan. 

The HDA echoed her concerns, stating the law does not focus on the “very real, and growing” threat of illicit drugs.

Where is the tax going?

Though Cuomo promoted the tax on the idea that the revenue would be used to fund treatment and recovery programs, the money was ultimately not earmarked for any specific programs in the final budget.

“The whole thing is ill-conceived,” Assemblymember Linda Rosenthal said. “I think it’s a talking point, rather than New York actually dealing with the overdose crisis.”

As it now stands, the tax revenue can merely supplant the funding already set aside for agencies like the Office of Alcoholism and Substance Abuse Services (OASAS). Rosenthal urges the state to dedicate more funding to the issue. 

“There’s no guarantee that that money would be in addition to what agencies are already funded,” she said. 

McDonald agreed, saying, “If you’re going to make a political statement about taxing the bad guys, it would have been even more appropriate to take the next step, and actually demonstrate where the money is going.”

However, with manufacturers already pulling out, it’s unclear to Rosenthal and others whether the state will reach its anticipated goal of $100 million.. 

Various trade groups representing manufacturers, pharmacies and patients with disabilities predict moving forward, other states will enact similar policies, and prices will go up for that class of drugs across the board. At least 14 other states have proposed or introduced similar legislation. Some shortages may work themselves out, Moore said, though the first few months will be logistically challenging, while other products just won’t be available.

Like many drug warnings state: There may be side effects.

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Lawsuit blames medication mix-up at CVS Wichita pharmacy for man’s stroke

Posted on September 22, 2019 by Pharmaciststeve

Lawsuit blames medication mix-up at CVS Wichita pharmacy for man’s stroke

https://www.kansas.com/news/local/crime/article235213437.html

A Sedgwick County man is suing Kansas CVS Pharmacy after he says the branch at 13th and Maize in Wichita filled his prescription for a blood thinner with the wrong drug.

Kansas CVS Pharmacy says in a court response that it did not provide the wrong medication or cause the stroke.

Ben Huie is blaming the pharmacy for a stroke he suffered in July 2017 after he took that drug — metoprolol, a beta-blocker used to treat chest pain, high blood pressure and heart failure — not knowing that it wasn’t what he had been prescribed.

Huie was supposed to get warfarin sodium, an anticoagulant used to treat and prevent blood clots and reduce stroke and heart attack risk.

But the pharmacy made a mistake and gave him metoprolol instead, a lawsuit filed last week in federal court claims.

Huie had a stroke within 10 days of taking it. He is seeking more than $75,000 in damages.

“Kansas CVS was negligent in dispensing the wrong drug for the prescription, and as a result of its negligence, Plaintiff (Huie) suffered his injuries,” the lawsuit says.

Kansas CVS Pharmacy, in its Sept. 13 response to the suit, said it had filled warfarin prescriptions for Huie but denied giving him the wrong medication in December 2016 and denied causing the stroke.

“The negligence of others for whom this Defendant is not responsible for, caused or contributed to cause any alleged injury or damage,” CVS said in the response, adding that the stroke was the “direct and unavoidable consequence” of Huie’s preexisting medical condition.

Huie is not entitled to damages because “he was informed of and consented to the medical risks of the treatment provided,” the CVS response continues.

Attorneys for Kansas CVS Pharmacy did not respond to messages seeking comment on the case. Huie’s attorney, Kurt Harper, would not comment, citing pending litigation.

According to the lawsuit, Huie has unspecified medical conditions that require him to take varying dosages of warfarin sodium depending the results of regular tests he takes that measure how well his blood clots.

He has prescriptions for several different strengths of warfarin sodium and keeps a stockpile of tablets “so that his dosage can be readily adjusted.”

Huie had filled those prescriptions “at Kansas CVS for years,” his lawsuit says.

In December 2016, Huie asked Kansas CVS to refill an existing prescription for warfarin sodium at its 10405 W. 13th St. W. location because his insurance benefits made it advantageous to do so at that time.

But instead of warfarin sodium, the pharmacy gave him metoprolol, the lawsuit says.

In July 2017, Huie started using the prescription — taking the first tablet on or sometime after July 5 — and within days certain aspects of his health monitored by the regular tests “unbeknownst to him, fell well below the therapeutic level.” He suffered a stroke on July 15, 2017, as a result, the lawsuit says.

“Several days after July 15, 2017, when a new prescription for warfarin was obtained, his INR (international normalized ratio) numbers returned to the therapeutic level and it was determined that the previous prescription had been filled with the wrong drug,” the lawsuit says.

“The lack of warfarin during the first half of July 2017, was the cause of Plaintiff’s stroke.”

Court records show Huie originally filed the lawsuit in Sedgwick County District Court in June. But the case was moved to federal court late last week at the request of Kansas CVS Pharmacy.

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Proposed bill would make doctors liable for opioid-addicted patients

Posted on September 21, 2019 by Pharmaciststeve

Proposed bill would make doctors liable for opioid-addicted patients

A proposed bill that would make doctors held responsible for patients who become addicted to prescription opioids has been met with criticism from advocates and the medical community.

“Many prescribers underestimate the risk of opioids, particularly when it comes to addiction, and overestimate their effectiveness,” Rep. Peter Capano (D-Lynn) said Tuesday before the Joint Committee on the Judiciary.

“An act requiring practitioners to be held responsible for patient opioid addiction,” Bill H.3656, would require a practitioner who prescribes an opioid to be liable to the patient if they become addicted and therefore pay for the patient’s first 90 days in treatment.

Capano said the opioid crisis is “fueled by the overprescription of opioids,” saying that doctors should exercise caution in their prescribing practices and take more responsibility for patients who become addicted.

Steve Tolman, president of the Massachusetts AFL-CIO labor union and a former state senator, presented the bill alongside Capano and said when patients return to their doctor with an addiction problem they get “shut off.”

“If a prescribing physician gives dangerously addictive drugs to a patient, and then they’re hooked, then they should pay for the first 90 days of treatment. It’s common sense,” Tolman said. “The physician should not be allowed to turn his back.” Tolman and Capano suggested doctors could take out an insurance policy to shoulder the potential financial burden.

The bill is not intended to take painkillers away from patients with cancer, major surgery, or their end-of-life care, Capano said.

According to the Centers for Disease Control and Prevention, 58 opioid prescriptions were written for every 100 Americans in 2017. From 1999 to 2017, nearly 218,000 people died in the United States from overdoses related to prescription opioids.

But the proposed bill isn’t sitting well with doctors and members of the recovery community.

Tiffany Anderson, a mom in recovery and maternal recovery specialist with Jewish Family and Children’s Service, said the bill is “unfair.”

“I don’t think it’s right because addiction truly is a disease,” said Anderson. “I don’t think it’s fair for doctors who have done their homework to be put at fault.”

Anderson said doctors should consider other pain management options before jumping to opioids, but responsibility should also lie in properly weaning patients off prescription painkillers.

Dr. Saul Weingart, chief medical officer at Tufts Medical Center, said the bill presents a lot of challenges such as finances and vast patient variability.

“I just worry that it is overly simplistic. We need to hold physicians accountable for practicing safely … but we need to do it under some of the traditional rules of physicians’ behavior,” Weingart said.

Weingart said physicians should always be transparent about the risk of taking opioids and consider alternative treatments with their patients.

“Our responsibility is to educate ourselves about what our practice is and try to understand the epidemic and understand the tools and resources that are out there,” Weingart said.

Frank Melaragni, a professor at Massachusetts College of Pharmacy and Health Science, said having the “Right to Know” law in the Bay State, which requires doctors to discuss the addictive potential of opioids to patients before prescribing them, would help residents the most.

“Having unused prescription opiates is like having a loaded gun in your house,” said Melaragni. “We still overprescribe, there’s no question, we’re still getting far too many opiates, still consuming far too many opiates in this country.”

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Hospital strike: 2,200 University of Chicago Medical Center nurses walk off the job

Posted on September 20, 2019 by Pharmaciststeve

Hospital strike: 2,200 University of Chicago Medical Center nurses walk off the job

https://www.chicagotribune.com/business/ct-biz-university-of-chicago-hospital-nurse-strike-20190920-7ddk2jacgbgsxea47kqwp6delu-story.html

Nurses at University of Chicago Medical Center — 2,200 of them — went on strike at 7 a.m. Friday, the first strike in the history of the 618-bed hospital, one of Chicago’s largest and most prestigious.

Hundreds of nurses wearing red shirts marched at the intersection of 58th Street and Maryland Avenue, holding signs that said, “On strike for my patients” and chanting, “What do we want? Safe staffing. When do we want it? Now.”

Though the nurses union called only a one-day strike, it will turn into a lockout. The nurses won’t be allowed to return to work until Wednesday morning because the hospital contracted with temporary nurses to take their places until that time.

The hospital spent the days leading up to the strike curtailing services in some areas. Dozens of babies and children who were in intensive care units were moved to other hospitals.

Nurses walk the picket line outside the Duchossois Center for Advanced Medicine at University of Chicago Medical Center on Sept. 20, 2019.
Nurses walk the picket line outside the Duchossois Center for Advanced Medicine at University of Chicago Medical Center on Sept. 20, 2019. (Jose M. Osorio/Chicago Tribune)

The hospital went on full bypass late Wednesday, meaning it is asking ambulances to take new patients to other hospitals, including trauma patients — sparking concern from some in the community who spent years fighting for trauma services on the South Side.

It is also limiting transfers from other hospitals, temporarily closing some units, transferring some patients to other hospitals, and rescheduling some elective procedures.

Hospital spokeswoman Ashley Heher couldn’t say Friday whether the ambulance diversions and curtailed services would continue in the coming days. She said the hospital is continually assessing the situation. The union said that picketing would be limited to Friday.

The service cutbacks were necessary to ensure quality care for patients still in the hospital during the strike, said Dr. Stephen Weber, U. of C. Medicine’s chief medical officer.

“Fundamentally, no matter how many patients we’re caring for, we want to ensure the security and safety of each one of them,” Weber said.

He said he didn’t know Friday how many of the hospital’s beds were still occupied.

Some patients wove through the crowds of striking nurses early Friday to get to appointments at the hospital. A number stopped to take video on their phones of the chanting protesters.

Loeita Williams said she’s always been happy with the care she’s received at the hospital but she believes the nurses when they say they’re understaffed. The South Shore resident said she wasn’t concerned about the care she’d receive Friday because she was visiting for a straightforward appointment.

Renee Jackson, of Hyde Park, voiced her support for the strikers as she walked to her doctor’s office at the hospital Friday morning. She’s been particularly pleased with the nurses.

“I’ve seen them at work,” she said. “They deserve everything they’re asking for.”

Jean Greenberg watched the strike unfold from down the street Friday morning.

Her husband, who had lymphoma, was a patient at the hospital for years until he died in June. She said his nurses were excellent and she supports them in their strike, though she worried about the effects of the noise from the strike on arriving patients.

“If I had to bring my husband, as sick as he was, to this setting, it would have been very distressing,” Greenberg said.

Vivian Nunn, of the South Loop, visited the hospital Friday for a test. She said the strike didn’t have an impact on her care, but she could see how it might affect some patients. Nunn worked as an administrative assistant and clerk at the hospital more than 20 years ago.

“If I had to go to a regular floor and all the nurses were out here and we had temporary nurses in there, I’d be a little concerned,” Nunn said.

Still, she said she’s sure the temporary nurses are qualified, and she agrees with the striking nurses that they need more staff in certain departments.

The hospital said negotiations broke down late Wednesday over the issue of incentive pay for future job applicants. But Marti Smith, Midwest director of the National Nurses Organizing Committee/National Nurses United, attributed the breakdown to disagreement on overtime and staffing issues that the nurses feel affect patient safety.

Marjorie Feria, who’s worked as an operating room nurse at the hospital for nearly five years, said nurses who usually work in the adult operating rooms are often expected to work in the pediatric operating rooms on weekends and holidays when pediatric operating nurses are short.

“It’s not optimal,” said Feria, standing outside the facility Friday morning. “As a nurse, patients trust you with their lives, and that’s something we all take seriously.”

Also outside the hospital was nurse Grazyna Cohen, who works with many cancer patients. She said she understands it would be expensive to hire more nurses but it’s time for the hospital to step up.

 

The hospital, it’s a financially, clinically, academically successful organization, and is in a position where they can very well afford to provide adequate staff,” Cohen said.

Racheal Feliz, a pediatric intensive care unit nurse, said it’s vital that nurses be able to provide the kind of care sick patients need.

″It’s important for us to be out here so we can fight for safe staffing ratios,” Feliz said.

A lineup of city aldermen, state lawmakers and other union leaders from across the city echoed the nurses’ comments at a rally outside the hospital midday Friday.

Weber disputed the nurses’ claim that more staffing is needed on a regular basis to keep patients safe.

“I think there’s very clear information that that’s just not the case,” Weber said. “The benchmarks show that nurse staffing is not our challenge. Like any place, we have other challenges but we’re going to keep directing our resources and investments based on the needs of our patients.”

Weber said Friday morning that things had gone smoothly at the hospital so far and that the hundreds of replacement nurses brought in to work during the strike had adjusted quickly.

Nurses will not return to the medical center until Wednesday because the hospital has said it needed to guarantee five days of work for replacement nurses in order to recruit as many as possible.

Hospital leaders said in a staff memo earlier this week that they had hoped to maintain normal hospital operations during the work stoppage.

But fewer replacement nurses were available than expected because nurses at about a dozen other hospitals across the country also planned to strike Friday, the memo stated. Also, the time between the notice of the strike and the day of the strike was shorter than it was during the last planned strike in 2015, the memo stated. That strike was averted shortly before it was scheduled to occur.

There was a similar nurses’ strike a number of years ago… as I remember in California… and their was AT LEAST ONE HORRIBLE ACCIDENT WHEN A PT DIED. There was this one female pts – very high acuity – and had both a central IV line and a implanted enteral feeding tube ( Jejunostomy feeding tube).  Somehow the “temporary nurse” got the two lines mixed  up and hooked up the enteral feeding to the IV tube and the IV bag to the enteral feeding tube…  While putting a IV solution into a enteral feeding tube will probably not do any harm – nor any good…. putting a enteral feeding solution in a IV line – WILL KILL YOU … which is what happened to this particular pt.  🙁

I am sure that there was numerous other “near misses”, that we did not hear about and hopefully this strike will not produce any “bad pt outcomes”

 

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24 dose purchase limit of Imodium/Loperamide implemented.

Posted on September 20, 2019 by Pharmaciststeve

FDA OKs New Packaging for OTC Loperamide to Help Stem Misuse, Abuse

https://www.medscape.com/viewarticle/918786

In its ongoing effort to stem misuse and abuse of loperamide (Imodium, Johnson & Johnson), the US Food and Drug Administration (FDA) has approved changes to the packaging for brand-name, over-the-counter (OTC) tablet and capsule formulations of the opioid-based antidiarrheal medication.

The changes to Imodium A-D, Imodium Multi-Symptom Relief, and Be Health Loperamide HCl Capsules limit each carton to no more than 48 mg of loperamide and require the tablets and capsules to be packaged in individual (unit-dose) blister packs, according to an FDA safety communication. 

The maximum approved daily dose for adults is 8 mg/day for OTC use and 16 mg/day for prescription use. Abuse and misuse of loperamide is an ongoing problem in the US, the FDA said, with some individuals taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

“The FDA has worked with manufacturers to approve package size limitations and unit-dose packaging for certain over-the-counter loperamide products. These changes are intended to increase the safe use of loperamide products without limiting over-the-counter access for consumers who use these products for their approved uses at the approved dose, according to labeling,” Acting FDA Commissioner Ned Sharpless, MD, said in a statement.

He said the agency is also asking online distributors to take “voluntary steps to help reduce the risks of loperamide abuse and misuse by not selling more than one package of these drugs to each customer.” 

The FDA is also taking steps to ensure that consumers can easily access and read the product labeling and warnings for drugs sold on shelves or on websites before purchase.

In 2016, the FDA warned about life-threatening cardiac events, including QT interval prolongation, torsades de pointes or other ventricular arrhythmias, syncope, and cardiac arrest, with loperamide misuse and abuse, as reported by Medscape Medical News.   

In 2017, the FDA added a warning to the product label about the risk of taking high doses of loperamide. They noted that some individuals are taking higher-than-recommended doses of loperamide to treat symptoms of opioid withdrawal or to achieve euphoric effects of opioid use.

Also in 2017, the FDA added a Heart Alert warning to loperamide “drug facts” labels that warned consumers about the risks of taking higher-than-recommended doses.

The FDA said evidence suggests that package size limits and unit-dose packaging may reduce medication overdose and death.

In 2018, the agency asked manufacturers and packagers of OTC loperamide products to make these changes, as Medscape Medical News reported. Today, the FDA formally notified the public of these approved changes. 

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Baltimore’s drug problem is all about crime and open borders, NOT opioid prescriptions

Posted on September 19, 2019 by Pharmaciststeve

Baltimore’s drug problem is all about crime and open borders, NOT opioid prescriptions

https://www.conservativereview.com/news/baltimores-drug-problem-crime-open-borders-not-opioid-prescriptions/

As you can see, the entire surge since 2014 was all driven by fentanyl and cocaine. It was also initially driven by heroin overdoses, but much of that was because the cartels began lacing the heroin with fentanyl, just as they are doing today with cocaine. Every DEA and CBP agent I’ve spoken to tells me those are the biggest problems, and they are all coming from the Mexican cartels. Meth, another non-opioid, is also a big problem in the more rural states. The drugs are then processed and distributed primarily through criminal alien networks trafficking them without any fear of either being deported or serving hard time.

But the entire political class is focusing on prescription drugs and lawsuits against pharmaceutical companies. The reality is that opioid prescriptions have plummeted in Maryland, even as the fatalities surge. The prescribing rate in Maryland has dropped by 29 percent since 2011 and is now below the national average.

As you can see from the chart, just 379 of the overall 2,406 decedents in 2018 had prescription drugs in their toxicology reports. That is just 16 percent. But it’s really less than that. According to the annual report, almost all of those people also had other illicit drugs or alcohol in their blood. So, these were drug addicts, not chronic, stable pain patients who were wrongly prescribed by doctors or who were made addicted by the evil pharmaceutical companies.

This is why the trajectory of prescription overdoses has actually stayed fairly stable, unlike the fatalities for cocaine and fentanyl. Here are some more charts from the Maryland Department of Health report:

This is also why 73 percent of all decedents were male. If anything, there are more female chronic pain patients. The fact that most of the deaths are males demonstrates once again that this is not a painkiller addiction problem but more of a cultural problem of drugs and alcohol of all sorts, which overwhelmingly affects males more than females.

The 800-pound gorilla in the room when discussing Maryland’s illicit poly-drug crisis, not prescription opioid crisis, is of course Baltimore City. It accounted for 37 percent of all drug deaths in Maryland last year, even though it is just 10 percent of the state’s population of six million. Nearly half of those fatalities were from cocaine, which is not even an opioid. Drug traffickers are lacing the psychostimulant (cocaine) with a killer depressant (fentanyl).

Baltimore City is where one can find the worst convergence of “criminal justice reform,” aka not locking up drug traffickers, and sanctuary cities, aka not turning over criminal aliens to ICE. The most common “low-level” crime that illegal aliens are picked up on is drugs. To begin with, American drug traffickers barely serve any time in prison any more, particularly in Baltimore. Maryland’s prison population has plummeted by 29 percent over the past decade and is now lower than at any time since the 1980s. No wonder crime is now spiking to pre-1990s levels and Baltimore is now on pace for another year of record homicides. It’s the same reason why the drug crisis is worse than ever. Finding аn affordable bail bondsman does nоt hаvе tо bе difficult but іt does require a little research. Thіѕ саn easily bе dоnе bу checking wіth thе local authorities оr thе convenience оf thе internet. If a bail bond company саn provide a lоng list оf satisfied clients, оnе саn rеѕt assured thаt thе fate оf thеіr loved оnе іѕ іn thе hands оf a trustworthy company. A dependable bail bonds agent wіll gіvе thе help thаt іѕ needed durіng thіѕ stressful, difficult tіmе.

Drug charges, drunk driving оr оthеr legal issues аrе nоt tоо big fоr аn experienced bail bondsman. Nо matter whаt thе situation mау bе, a bail bond іѕ аlwауѕ available. Nо оnе ѕhоuld еvеr hаvе tо feel stuck оr hopeless whеn thеу аrе incarcerated оr whеn thеу аrе trying tо bail a friend оr family member оut оf jail.

If уоu hаvе a relative оr a near оnе іn jail thеn уоu need bail bond services getting hіm оut оf thе jail. Bail bonds аrе bonds thаt аrе dоnе bу thе bail bondsman tо gеt уоur loved оnе оut оf thе jail.

Bail bondsman іѕ thе person whо guarantees thаt thе person fоr whоm hе іѕ putting uр thе insurance wіll appear іn court. Thе bail bondsman bу himself саnnоt dо аnуthіng аѕ hе wіll need tо hаvе adequate money іn case thе said person does nоt appear. Thаt іѕ whу іn general thе bondsman wіll hаvе a tie uр wіth аn insurance agency аnd thаt insurance agency wіll provide thе insurance cover. Connecticut Bail Bonds Group available 24 hours easy and fast bail bond service.

Thеrе аrе a lot оf companies thаt operate оn a nationwide basis аnd hаvе offices іn аll major counties. Thеѕе bail companies employ thе bail bondsman tо help уоu оut. Onсе уоur relative оr friend hаѕ bееn detained thеn make sure tо саll thе bail bond agent аnd hе wіll start thе things аt hіѕ end.

In mоѕt cases thіѕ bail bond service companies аrе available 24 hours a day аnd уоu саn just gіvе thеm a саll. Make sure tо bе rеаdу wіth thе documentation thаt іѕ needed аѕ wеll аѕ thе fees thаt need tо bе given tо thе bail bond agent. Thе bets thіng tо dо іѕ tо gо fоr a local person whо іѕ reputed аnd hаѕ еnоugh contacts wіth thе jail authorities аѕ thаt саn help secure thе release vеrу quick аnd fast.

But removing the criminal alien gangs and cartel networks from the country would increase the prices of these drugs because the networks would be disrupted. As Robert Murphy, the DEA special agent in charge of Atlanta, told me earlier this year: “The people who are here operating the networks are all illegal immigrants. … Without the people, the cartels have no success.”

Why did the prices decrease so much right around the surge of Central American migrants in 2013-2014? The amalgamation of Obama’s border policies together with sanctuary policies has protected all of these trafficking networks. No wonder Baltimore City has a higher drug mortality rate (56.6 per 100,000) than any county even in hard-hit New Hampshire.

So, the next time Baltimore politicians want to discuss “low-level” drug offenses and the need to protect criminal aliens from ICE, just remember this is the true source of thousands of dead residents of Baltimore. Any focus on health care is a distraction of epic proportions from open borders, sanctuary cities, and weak-on-crime policies the politicians don’t want you to know about.

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Coast Guard Commander Charged with Importing Narcotics

Posted on September 19, 2019 by Pharmaciststeve

Coast Guard Commander Charged with Importing Narcotics

https://www.military.com/daily-news/2019/09/19/coast-guard-commander-charged-importing-narcotics.html

OAKLAND — A United States Coast Guard commander was charged with illegal importation of controlled substances Wednesday, a U.S. Justice Department spokesman said.

According to a complaint, James Silcox III, 41, received three shipments of Tramadol, a controlled substance and narcotic, to post-office boxes over the summer.

In July, an 865-gram package from Singapore headed for a post-office box was flagged by Customs and Border Protections officers at the U.S. Postal Service’s international mail facility at New York’s John F. Kennedy Airport.

Officers at the postal service’s San Francisco air-mail facility intercepted another 650-tablet Tramadol package from Singapore in August, before receiving another package September 13 that held 458 grams of Tramadol.

After law-enforcement officers swapped out the August package’s Tramadol for substitute material, they delivered it to Silcox’s post-office box Monday. He picked up the package the same day, and officers arrested him Tuesday at his Coast Guard Island residence.

Silcox was released on a personal-recognizance bond after appearing in San Francisco federal court Wednesday morning, and he will return Sept. 26 to identity counsel and attend a preliminary hearing before U.S. Magistrate Judge Kandis Westmore.

He faces up to five years in prison and a $250,000 fine for each violation, but federal sentencing guidelines will ultimately affect any imposed sentence.

In addition, indictments are only allegations of committed crimes and Silcox is considered innocent until proven guilty beyond a reasonable doubt.

Assistant U.S. Attorney Sarah Griswold is prosecuting the case, which came from an investigation by the Homeland Security Investigations; the High Intensity Drug Trafficking Area-Transnational Narcotics Team; the U.S. Postal Inspection Service; the Department of Homeland Security Office of Inspector General; and the Coast Guard Investigation Service,

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Here is a report from the DOJ about the DEA

Posted on September 19, 2019 by Pharmaciststeve

https://lookaside.fbsbx.com/file/DEA%20Quota.pdf?token=AWzUGmSNaWNztF1-OwxoYDqgeKVT5RLNGdMtrYWDhQsG8V5RUnPTkGMPbDJE-vnXJ1syacnixAPNGqYl7v1z7qC2Yp7UD4UmhNP-8655nNvhbNY6EYr14GUNGL-I8iTM-v9-nOxYqnyo13fnSfJnnkibl74DACLra0vaA5lS8rHZ-awLTKdz7epJIXfehvWi95R2NZSQYBxi_7nTQ2bfRiS-

 

a couple of interesting quotes:

The NSS and NFLIS data reports included total seized Weight without reference to whether it is finished dosage forms. container weight. tablets or pill weight provides no reference to specific API concentrations; and the databases do not distinguish between pharmaceutically and illicitly manufactured controlled substances …..

As a result of considering the extent of diversion, DEA notes that the quantity of FDA-approved drug products that correlate to diverted controlled substances in 2018 represents less than one percent of the total quantity of controlled substances distributed to retail purchasers.

This is a 22 page document dates Sept 2019… the above is just a couple of quotes that I pulled out of the report…  Appears to show how convoluted the mythology in how they come to final conclusions on the legit use and abuse of various legal and illegal opiates.

 

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