“The moral test of a government is how it treats those who are at the dawn of life, the children; those who are in the twilight of life, the aged; and those who are in the shadow of life, the sick and the needy, and the handicapped.” – Hubert Humphrey
passionate pachyderms
Pharmacist Steve steve@steveariens.com 502.938.2414
#Costco to pay $11.75M over handling of opioids and other drugs
Medications sit locked behind the counter of a pharmacy inside a Costco store. The Justice Department said some of Costco’s pharmacies improperly filled prescriptions for controlled substances.
Costco will pay $11.75 million to settle allegations that some of its pharmacies improperly filled prescriptions for controlled substances and failed to properly track opiods and other dangerous drugs, the U.S. Justice Department said Thursday.
Costco will pay $11.75 million to settle allegations that some of its pharmacies improperly filled prescriptions for controlled substances, the U.S. Justice Department said Thursday.
The Justice Department alleged that Costco pharmacies filled prescriptions that were incomplete, lacked valid Drug Enforcement Administration (DEA) numbers or were for substances beyond some doctors’ scope of practice, and that Costco failed to keep and maintain accurate records for controlled substances, according to a news release from the department.
Costco did not immediately have a comment on the settlement.
“Pharmacies across this country are on the leading edge of the battle against our prescription drug abuse crisis,” U.S. Attorney Annette Hayes of the Western District of Washington said in a statement. “A company such as Costco that distributes a significant volume of controlled substances has a responsibility to ensure it complies with regulations that help prevent opioids and other dangerous drugs from being misused or otherwise added to the illegal marketplace.”
Eileen Decker, U.S. Attorney for the Central District of California, said: “These are not just administrative or paperwork violations – Costco’s failure to have proper controls in place in its pharmacies played a role in prescription drugs reaching the black market.”
Under the settlement, which was reached Wednesday, Costco acknowledged that between Jan. 1, 2012 and Dec. 31, 2015, some of its pharmacies had violated the Controlled Substances Act by “filling prescriptions from practitioners who did not have a valid DEA number; incorrectly recording the practitioner’s DEA number; filling prescriptions outside the scope of a practitioner’s DEA registration; filling prescriptions that did not contain all the required information; failing to maintain accurate dispensing records; and failing to maintain records for their central fill locations in Sacramento, California and Everett, Washington,” according to the news release.
Costco also agreed to allow the DEA to conduct unannounced inspections of all DEA-registered Costco pharmacies over the next three years.
In addition, Costco has made improvements to its pharmacies, including buying a new pharmacy management system and implementing an audit program of its pharmacies that will include internal and exertal auditors.
Costco will pay the $11.75 million to the U.S. government. The settlement was announced by U.S. attorneys for western and eastern Washington, central California, eastern Michigan and eastern California. The case was investigated by the DEA in Seattle, Los Angeles, Sacramento and Detroit.
Walgreens Boots Alliance Inc (WBA.O) will pay $50 million to resolve a U.S. lawsuit accusing it of violating federal law by providing beneficiaries of government healthcare programs discounts and other incentives to fill their prescriptions at its pharmacies.
The settlement, announced by Manhattan U.S Attorney Preet Bharara on Thursday, resolves a whistleblower lawsuit that the government joined related to the national pharmacy chain’s Prescription Savings Club program.
The request asks specifically for the clearing of misconceptions that cannabis is a gateway drug and causes irreversible cognitive decline in adults, psychosis, and lung cancer.
WASHINGTON, DC — Over 100,000 people have signed an Americans for Safe Access petition on Change.org demanding that the Drug Enforcement Administration (DEA) stop disseminating false information about medical cannabis immediately and ensure that all of their future information on medical cannabis treatment reflect medically-accurate, up-to-date facts.
Last year, Americans for Safe Access (ASA), a national nonprofit organization dedicated to ensuring safe and legal access to medical cannabis for therapeutic use and research, filed a legal request with the Department of Justice demanding that the DEA immediately update misinformation about cannabis.
The request asks specifically for the clearing of misconceptions that cannabis is a gateway drug and causes irreversible cognitive decline in adults, psychosis, and lung cancer.
The filing references the Information Quality Act (IQA, aka Data Quality Act), which requires administrative agencies to devise guidelines that ensure the “quality, objectivity, utility, and integrity of information” they distribute and to “[e]stablish administrative mechanisms allowing affected persons to seek and obtain correction of information maintained and disseminated by the agency that does not comply with the guidelines.”
If granted, the filing could bring major changes to the way medical cannabis laws and regulations are treated by public officials. For decades, politicians have stated that now-disproven harmful effects were reasons to either prohibit or impose burdens on patients seeking safe and legal access to medical cannabis.
While the DEA admitted in August that the gateway theory and other harmful claims are not supported by science, they have yet to remove all references of the disproven information, thereby continuing to spread inaccurate information.
“Over 100,000 people agree that the DEA must stop disseminating blatantly false information,” said Beth Collins, Senior Director of Government Relations and External Affairs for Americans for Safe Access. “The DEA has admitted that cannabis is not a gateway drug and does not cause long-term brain damage, psychosis, and other alleged harms, yet they continue to obfuscate the truth. This misinformation affects the decisions elected officials make about cannabis, meaning that our government has been legislating on behalf of millions of medical cannabis patients using false information for years. As a result, these patients are left to fend for themselves when it comes to a drug they are prescribed and need to manage severe symptoms like pain, nausea, and more. It’s time to put this issue to rest once and for all. We hope that President Obama will perform this final action to show his support for suffering Americans across the nation.”
As a country we put warning labels on tobacco products in the early 60’s and we still have 35 million Nicotine addicts and some 450,000 dying every year from the use/abuse of Nicotine… There are no WARNING LABELS on the drug Alcohol which we have 45 million alcoholics and in 2016 the death rate from the use/abuse of Alcohol exceeded 100,000 for the first time … abt a 20% increase over 2015. I guess that some parts of our bureaucracy just keeping doing the same thing over and over again and expecting a different outcome.. Most of us know Einstein’s option of that behavior.
Throughout 2016, we at the FDA have announced requirements for manufacturers to create new product labeling information for a variety of opioid medications.
These safety labeling changes are all effective as of Dec. 16, 2016.
A wide range of products, across virtually all opioids, will have some form of new labeling information. Here are the highlights of the new requirements.
• A new boxed warning for immediate-release (IR) opioids about the serious risks of misuse and abuse, which can lead to addiction, overdose and death (announced March 22, 2016). The updated labeling clarifies that because of these risks, IR opioids should be reserved for pain severe enough to require opioid treatment and for which alternative treatment options (e.g., nonopioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated. The dosing information also provides clearer instructions regarding patient monitoring and drug administration, including initial dosage, dosage changes during therapy and a warning not to abruptly stop treatment in a physically dependent patient. This action also included several additional changes across all prescription opioid products also addressing the risk of these medications.
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• Safety labeling changes for methadone and buprenorphine products when used by pregnant women for medication-assisted treatment (MAT) of opioid use disorder (announced May 26, 2016). This new labeling addresses a key concern over neonatal opioid withdrawal syndrome (NOWS), which can be effectively managed, but may be life-threatening if not recognized and treated. Our action requiring safety labeling changes for MAT-only methadone and buprenorphine products informs prescribers about the risks for NOWS without inadvertently discouraging treatment for pregnant women with opioid addiction.
• Classwide changes to drug labeling to include information about the serious risks associated with the combined use of certain opioid medications and benzodiazepines (announced Aug. 31, 2016). This includes boxed warnings and requirements for patients to receive Medication Guides when they get their prescriptions. Serious risks from combined use include extreme sleepiness, respiratory depression, coma and death. Among other important information, these labeling changes encourage prescribers to use the lowest effective dose over the shortest duration of time necessary if analgesic opioids and benzodiazepines must be used concurrently. Additionally, the labeling says that opioid cough syrups should never be used simultaneously with benzodiazepines. Of note, labeling for all of the affected benzodiazepine products will also be effective on Dec. 16, 2016.
When the FDA requires new product labeling, manufacturers are given time to meet the requirements and submit the new labeling information to the FDA for approval. For regulatory efficiency, and for a smoother transition of information for stakeholders, including prescribers, the FDA arranged to have all of these separately required changes to be effective on the same date.
The updated labels are an important part of the FDA’s continuing effort to educate patients and prescribers about the risks related to prescription opioids, including the importance of balancing the benefits and risks for each individual patient and emphasizing information important for appropriate patient selection.
After AG investigation, Walgreens says it will improve opioid policies
Attorney General Maura Healey holds a CVS prescription bottle as she announced last September a first-in-the-nation settlement with CVS Pharmacy to strengthen its policies and procedures for dispensing opiods.
An investigation by Attorney General Maura Healey found that some Walgreens pharmacies failed to monitor patients’ drug use patterns and didn’t use sound professional judgment when dispensing opioids and other controlled substances — a concern because of soaring overdose deaths in Massachusetts.
Walgreens agreed to pay $200,000 and follow certain procedures for dispensing opioids, in a settlement filed Wednesday in Suffolk Superior Court.
“Our records show,” Walgreens spokesman Phil Caruso said in an e-mail, “that the prescriptions in question were dispensed to patients for a legitimate medical purpose and issued by licensed practitioners,” suggesting the drugs were not diverted to the black market.
But the attorney general’s Medicaid Fraud Division found that, from 2010 through most of 2015, multiple Walgreens stores across the state failed to monitor the opioid use of some Medicaid patients who were considered high-risk. Such patients are supposed to obtain all prescriptions from only one pharmacy, and that pharmacy is required to track the patient’s pattern of prescription use.
Charles Krupa/AP/File 2014
A Walgreens in Boston.
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Some of the state’s 160 Walgreens accepted cash for controlled substances from patients in the state’s Medicaid program, known as MassHealth, rather than seeking approval from the agency. In some cases, MassHealth had rejected the prescription; other times, MassHealth was never billed.
Walgreens agreed to update its policies and procedures, and train its staff, to ensure that pharmacists properly monitor and do not accept cash payments from patients deemed high risk.
The agreement follows a similar enforcement action against the pharmacy giant CVS, which in September paid $795,000 and agreed to improve procedures after Healey alleged improper dispensing of opioids.
“We’re pleased to see Walgreens joining as a partner with the payment with this agreement,” Healey said in a phone interview Wednesday. “It’s great to see them stepping up to put in place best practices.”
The $200,000 from Walgreens will be added to a youth opioid education and prevention fund set up with $500,000 of the CVS money. Healey’s office received 120 applications requesting a total of $3.9 million from the fund, but will not be able to give money to them all.
“What we see is a huge demand and huge unmet need,” Healey said. “Schools and parents want this, but many just don’t have the resources to deliver it.”
Caruso said Walgreens’ contribution to the grant fund “supports Walgreens’ ongoing commitment to combat prescription drug abuse in Massachusetts and across the US.” And he said the company “will continue to review, monitor, and reinforce the policies and procedures we already have in place, and look forward to working with the attorney general’s office to further assist in their efforts to combat opioid abuse and misuse.”
Massachusetts is among the states hit hardest by a national epidemic of opioid abuse and overdose deaths. The state Department of Public Health estimates more than 1,700 people died of drug overdoses in 2015, more than triple the number in 2010.
Most of those who died had illicit fentanyl, heroin, or tranquilizers in their systems, rather than prescription opioids. But Healey said four of five Massachusetts residents who became addicted to heroin started by taking painkiller pills, usually before age 18.
“We have a real opportunity and a real need to focus on helping to educate and prevent opioid abuse among young people,” she said.
Healey’s agreement with Walgreens also addresses the state’s Prescription Monitoring Program, a database of every prescription for a controlled substance dispensed in the state, which can alert pharmacists when someone is visiting several doctors or pharmacies, a sign of drug misuse. The agreement requires Walgreens to ensure that its pharmacists check the prescription database before dispensing certain drugs to anyone, not just people covered by MassHealth.
State law does not require pharmacists to consult the prescription database, although doctors, nurses, and others who write opioid prescriptions must do so. And Healey’s office did not have any reason to believe that Walgreens pharmacists were not using the database. But now the agreement requires they do so.
The settlement with CVS, which has 350 stores in Massachusetts, has a similar requirement. In the case of CVS, the attorney general found the chain’s pharmacists had not been routinely checking the prescription database, and before March 2013, many stores didn’t have adequate Internet access to allow them to do so. Like Walgreens, CVS was also found to have violated the MassHealth rules by accepting cash payments for controlled substances, and agreed to stop doing so.
The Walgreens settlement gives a significant boost to the attorney general’s youth education fund. That was good news for Kat Allen, coordinator of the Communities that Care Coalition of Franklin County and the North Quabbin, one of 120 grant applicants. The attorney general expects to select the grant recipients in a few weeks.
Allen said her group is seeking $20,000 to expand a program that teaches social and emotional skills, such as how to cope with anger and anxiety and how to resolve conflicts. The program is offered in seven public middle schools; the grant would expand it to elementary and high schools. She said the program has proven its effectiveness over years of research.
“When kids have those kinds of strong social skills and emotional skills, they’re way less likely to turn to substances,” Allen said.
PALO ALTO, Calif. — For Thomas P. Yacoe, the word is “terrifying.”
Leah Hemberry describes it as “constant fear.”
For Michael Tausig Jr., the terror is “beyond description.”
All three are patients struggling with chronic pain, but what they are describing is not physical agony but a war inside the medical community that is threatening their access to painkillers — and, by extension, their work, their relationships, and their sanity.
Two years after the United States saw a record 27,000 deaths involving prescription opioid medications and heroin, doctors and regulators are sharply restricting access to drugs like Oxycontin and Vicodin. But as the pendulum swings in the other direction, many patients who genuinely need drugs to manage their pain say they are being left behind.
Doctors can’t agree on how to help them.
“There’s a civil war in the pain community,” said Dr. Daniel B. Carr, president of the American Academy of Pain Medicine. “One group believes the primary goal of pain treatment is curtailing opioid prescribing. The other group looks at the disability, the human suffering, the expense of chronic pain.”
Pain specialists say there is little civil about this war.
“There’s almost a McCarthyism on this, that’s silencing so many people who are simply scared,” said Dr. Sean Mackey, who oversees Stanford University’s pain management program.
“The thing is, we all want black and white. We don’t do well with nuance. And this is an incredibly nuanced issue.”
Nuance does not matter to people like Tausig, 43, who has been unable to work or socialize since 2008, when the last of his five spinal reconstruction surgeries left him in constant pain.
He last got a taste of life without opioids a few years ago, when his pharmacy’s corporate parent imposed opioid-distribution limits, forcing him to find a new one.
“Those three days were among the worst of my life,” he said. “I wandered the house at night, legs shaking like a whirling mass of putty, sleepless and without respite from the pain.”
Now, with regulators and health industry leaders continuing to bear down on opioids, and the arrival of a new president whose statements indicate that he might further restrict opioid distribution, Tausig’s worries have deepened.
“It’s put the fear of God in me.”
Elizabeth D. Herman for STATMichael Tausig has been unable to work or socialize since 2008, when the last of his five spinal reconstruction surgeries left him in constant pain.
The medical community’s battle over painkillers burst out into the open in late 2015, when the New England Journal of Medicine published a commentary in which two doctors argued that chronic pain patients should focus not on reducing the intensity of their pain, but on their emotional reactions to it.
The authors, Dr. Jane C. Ballantyne, the president of Physicians for Responsible Opioid Prescribing, and Dr. Mark D. Sullivan, argued patients should pursue “coping and acceptance strategies that primarily reduce the suffering associated with pain and only secondarily reduce pain intensity.”
The pair argued that patients who mainly focus on pain intensity tend to escalate their doses of opioids and worsen their quality of life.
On NEJM’s website, the comments section devolved to a flame war more suited to YouTube than the staid pages of the nation’s top medical journal, with some accusing the authors of a lack of compassion, and others lauding them for a sane approach to public health and addiction prevention.
But the comments also laid bare a fundamental problem in the debate over opioid treatments: Neither side has much evidence about the benefits or consequences of long-term use because almost no such studies exist.
A few studies have identified a litany of side effects beyond addiction. One survey, by palliative care doctors Mellar P. Davis and Zankhana Mehta, pointed to symptoms including increased risk of depression, anxiety, cognitive impairment, and sleep apnea, among other issues. Patients with lung disease were also more likely to die when their treatment included opioids, according to the survey’s authors, who practice at Geisinger Health System.
Stanford’s Mackey said those risks are important to recognize. But, he said, nearly 15,000 people die a year from anti-inflammatory medications like ibuprofen. “People aren’t talking about that,” he said.
Elizabeth D. Herman for STATMackey says doctors being trained at Stanford’s pain center have grown increasingly fearful about prescribing opioids.
On a Monday morning last month, Mackey entered an exam room to greet one of his patients who uses opioids: an 81-year-old physician with a bad back.
The doctor, who agreed to be interviewed on condition of anonymity, said he’d routinely cycled to work until relatively recently, when a degenerative spinal condition worsened. Surgery in October failed to help, and now, he told Mackey, he can only get out of bed if he takes five opioid pills at dawn and sleeps another half-hour before rising.
The doctor wanted to find a way to address his back problem without the painkillers, which, he said, cloud his thinking.
Mackey spent nearly 30 minutes with him, talking about scans, symptoms, and previous treatments. He planned a follow-up consult in January, when another set of test results would arrive.
Over lunch, Mackey reviewed the case.
“Do you get any sense from him of drug-seeking behavior?” he asked. “Is he selling this stuff on the street or trying to score some synthetic fentanyl or heroin? No. All he wants to do is be more functional so he can see patients and be relevant and have a life.”
Mackey also wasn’t sure the opioids were causing the cloudiness. The patient’s cognitive issues could be the result of non-opioid medications he takes before sleeping, so dialing down the opioids without first exploring other options might harm him more. Without them, his pain would be so severe he would be relegated to bed.
“If you’re 81 and you stop getting out of bed, it’s a slippery slope,” he said.
Mackey, a past president of the American Academy of Pain Medicine, has built Stanford’s pain center into one of the nation’s most comprehensive and well-funded pain research operations. But he said doctors being trained there have grown increasingly fearful about prescribing opioids.
“In many cases that can be healthy, but I’d like to see a thoughtful, balanced approach,” he said. “Opioids are a tool — they’re more often a fourth- or fifth-line option for me.”
Mackey recalled the case of a patient who had crushed his foot in an accident and undergone 10 surgeries that failed to diminish his “burning, terrible pain.” The patient now relies on opioids.
“People will say, ‘This guy’s on way, way too much opioid medication, you have to take him off,’” Mackey said. “But guess what: He gets up every morning and goes to work and does his job, and he’s been on the same regimen for years and years and tried everything else first.”
Even some of Mackey’s colleagues have issues with that kind of thinking.
Lembke believes that long-term opioid use can cause patients to perceive pain even after the original cause of pain has cleared. Some patients, she said, find themselves free of pain only once they have endured the often agonizing effects of opioid withdrawal.
“That’s what we’re seeing again and again,” she said.
Lembke believes people with chronic pain who have taken opioids daily for long periods may never be able to break their dependence on the drugs, and may need permanent doses of medications like Suboxone, which is commonly given to people with opioid addictions.
But chronic pain patients who have not yet started on opioids, she said, should only take them intermittently — “like every three days or so” — to avoid addiction.
The American culture has grown too intolerant of pain, Lembke said.
“Whether it’s surgery or women going into childbirth, there’s an alarmist reaction to pain, and it’s contagious and makes more people anxious, which makes the pain worse,” she said. “We’re terrified to experience pain.”
Elizabeth D. Herman for STATMackey has built Stanford’s pain center into one of the nation’s most comprehensive and well-funded pain research operations.
Those who experience chronic pain say these views embolden clinicians, pharmacists, and others to treat them like addicts and criminals.
Hemberry, a 36-year-old multimedia specialist in Leavenworth, Wash., suffers from a connective-tissue disorder called Ehlers-Danlos syndrome and trigeminal neuralgia, an often-excruciating nerve condition for which she occasionally takes opioids.
She heard Lembke interviewed on NPR recently and was bereft. “Every pain patient is now an addict and a failure,” Hemberry said.
Last March, the Centers for Disease Control and Prevention issued guidelines for opioid prescriptions. Those guidelines focused on addiction prevention, opioid trafficking, and medication diversion, and included stern cautions against using the drugs for chronic pain.
To Hemberry, the guidelines seemed reasonable. “But many doctors and administrators have taken a hard-line ‘no opiate’ stance,” she said, and go to absurd lengths to enforce it.
“What people forget is, those who end up on opioid pain management have usually tried everything else unsuccessfully.”
Thomas P. Yacoe, who suffers from chronic migraines
Earlier this winter, Hemberry recalled, she went to the emergency room with a migraine headache, a frequent symptom of her medical conditions. She was seeking a saline drip — one of the few treatments that has helped her pain — and said she wasn’t seeking opioids.
The nursing staff nonetheless grilled her on her medications and chided her for taking too many pills, even though her daily medications are non-narcotic. She turned her head at one point and started sobbing.
Others report a similar lack of empathy.
“What people forget is, those who end up on opioid pain management have usually tried everything else unsuccessfully,” said Yacoe, 61, who suffers from chronic migraines. “I stayed away from opioids for decades. It was really and truly a last resort.”
Elizabeth D. Herman for STATA patient room at the Stanford University Center for Back Pain.
Some clinicians trace the early roots of the opioid crisis not to the pharmaceutical industry’s marketing of controlled-release morphine pills, but to a 1986 study of 38 non-cancer patients performed by palliative care doctors at Memorial Sloan Kettering Cancer Center.
Most were treated with oxycodone, methadone, or levorphanol in small daily doses — less than half the surgeon general’s current recommended starting dose — and 24 reported acceptable or adequate pain relief, while two patients developed “management” problems with the drugs. (Both had histories of substance abuse.)
According to Carr, of the American Academy of Pain Medicine, the conservative opioid treatment approach used in the study, and the modest benefits reported, reflect the current practices and expectations of many doctors.
But a growing number, he said, are being pressured into a zero-tolerance policy.
“Because if one isn’t anti-opioid enough, there’ll be protests,” said Carr, who is also founding director of Tufts University’s Pain Research, Education, and Policy Program.
Other experts note that, as opioid restrictions tighten, the medical system and insurance industry have done little to support opioid-withdrawal efforts, help more physicians learn how to help patients manage pain, or enable access to alternative therapies.
In some cases, patients seeking to treat their pain have turned to street drugs like heroin or synthetic fentanyl, while others have instead chosen suicide. (In one high-profile case recently, a man who committed suicide left behind notes saying he could find no help for his chronic pain; at least two of the roughly 20 patients interviewed for this article said they had considered suicide because of their pain.)
Everyone wants the number of opioid overdoses to fall. But patients like Tausig don’t want to be made to suffer.
Tausig, a single father of two teens, said that every month he needs to fill a prescription, he’s fearful it will be denied.
Whenever he thinks he might meet with a new pharmacist or clinician, he dresses neatly to hide his tattoos. He said he thinks they can cause people to rush to judgment or even stigmatize him as an addict.
“You’ve got the wars on the medical side, but then you’ve got the governmental people stepping in, who have no idea,” Tausig said. “All they know is drugs: bad.
“They don’t see a struggling single dad in the most expensive place in the US who’s just trying to get through the day.”
A man who suffers from high blood pressure sued a Wal-Mart pharmacy in Cahokia, Illinois, claiming the pharmacist provided him with the incorrect prescription.
Leroy Turner filed the lawsuit in St. Clair County Circuit Court on August 25, 2015. He alleged Wal-Mart Inc. and pharmacist Christopher L. Hurtte were negligent in providing him with the wrong prescription. Pharmacist Laura Drouis was added as a defendant later in an amended complaint.
According to the lawsuit, Turner went to the Walmart pharmacy with a prescription for Cardura in February 2015. Hurtte allegedly gave Turner Warfarin without his knowledge or consent. Cardura is used to treat high blood pressure while Warfarin is a blood thinner. Blood thinners are contraindicated for patients with high blood pressure.
Turner claimed he suffered extreme fatigue and bruising on his back, shoulders, arms and thighs after taking Warfarin for several weeks. Concerned, he called his doctor, who instructed him to “double up” on the medication. The doctor did not know his patient was taking the wrong drug by mistake.
After following his doctor’s orders, Turner allegedly experienced additional, more severe symptoms for around a week before realizing he was taking the incorrect medication. He is seeking more than $50,000 in damages against each defendant, in addition to court costs.
If you suffered an injury or illness as a result of a medication error due to negligence or medical malpractice, you should consult the medical malpractice attorneys at Briskman Briskman & Greenberg.
While we ponder our choices (or lack of) awaiting open enrollment, an assault on the American Dream is being waged against small pharmacies in Florida.
“Work hard, play by the rules and prosper” is a nightmare for our independent, or indie, pharmacists. The playing field has never been level, but now these stand-alones are largely out of network in privatized Medicaid plans. They’re required to pay Medicaid taxes but can’t fill Medicaid prescriptions. This is troubling.
Indies offer a plethora of goods and services large chains can’t, don’t or just won’t. Indies meet your eyes when you arrive. They know your health profile like the back of their hand. They fill hundreds of prescriptions a day, as opposed to thousands. For the housebound, they’ll home deliver. There’s on-site compounding, diabetic supplies, free health magazines, etc. Whatever you need they’ll order. That’s the point, to treat the whole patient, not just fill a prescription.
Gov. Rick Scott’s privatization of Medicaid was supposed to be about free enterprise. That’s just a guise.
Here’s an example of why I need my indie: When he caught wind of a price hike on one of my prescriptions, he stocked up, and gave me a 90-day heads up. Can you imagine that happening with an hourly worker at a supermarket chain?
Behemoths have their benefits, like being open 24/7. That’s not helpful if you’re really sick, live hours away or don’t drive. They have databases, but a computer won’t pick up on the pallor or sudden weight loss of a patient. For that, you need a human being.
Corporate outfits claim lower prices negotiated by their powerful Pharmacy Benefit Managers (PBM), who claim to be part of the solution. But the top three PBM’s have three-quarters of the market share. They profit from every transaction and also can own drugstore chains. This gives them incentive to drive patients toward their stores by any means possible. It’s the American way, right?
Not in this case. We need to outlaw closed pharmacy networks and insist on fair play for the corner mom-and-pop shop. Small businesses drive our economy.
Seven U.S. senators sharply criticized the Drug Enforcement Administration on Wednesday for failing to answer questions about enforcement actions against pharmaceutical companies accused of violating laws designed to prevent painkillers from reaching the black market.
“We received an insufficient response that ignored those questions almost entirely and recited boilerplate information about the DEA’s mission,” said the letter to the acting DEA administrator, Chuck Rosenberg.
The DEA did not immediately respond to a request for comment.
The senators first sent the questions to the DEA in October after The Washington Post reported that the agency had slowed its enforcement efforts in the face of the opioid epidemic, which has cost nearly 180,000 lives since 2000. In 2015 alone, about 16,000 people died of prescription opioid overdoses, according to the Centers for Disease Control and Prevention.
The Post reported that beginning in 2013, DEA lawyers at headquarters started to delay and block enforcement efforts against large opioid distributors and others, requiring investigators in the field to meet a higher burden of proof before they could take action.
Five former supervisors from the DEA’s Diversion Control Division told The Post in on-the-record interviews that they had become increasingly frustrated by the sharp drop in enforcement actions. They said their civil cases were suddenly being subjected to a higher standard of proof, similar to that required in criminal cases.
The supervisors’ concerns were confirmed by reports filed by the DEA’s chief administrative law judge, who found that the number of cases approved at headquarters was “stunningly low for a national program.”
DEA officials have declined to publicly explain why the agency’s enforcement efforts have plummeted and why cases made by the agency’s field offices against pharmaceutical companies have languished, in some cases for years.
On Dec. 2, DEA officials held an off-the-record briefing for the senators. But the lawmakers said in the letter sent Wednesday that the session was not a “substitute for written responses to our questions.”
The senators said they wanted to know whether civil filings had fallen and if so, why. They also asked whether the Department of Justice played a role in policy changes that have affected the DEA’s enforcement efforts.
“Since we wrote to you, the Centers for Disease Control and Prevention (CDC) has released new data showing that the U.S. opioid epidemic is growing and that prescription and illicit opioids remain a driving force,” the senators wrote Wednesday. “Especially in light of this new data, Congress and the American people deserve an explanation of how the DEA is enforcing laws that could help address this public crisis.”
The letter was signed by Democratic Sens. Edward J. Markey (Mass.), Richard J. Durbin (Ill.), Joe Manchin III (W.Va.), Amy Klobuchar (Minn.), Tammy Baldwin (Wis.) and Richard Blumenthal (Conn.) and independent Bernie Sanders (Vt.).
“We do not yet know if the DEA is doing its job to prevent deadly prescription opioid painkillers from getting into the wrong hands as a result of decreased enforcement efforts against wholesale pharmaceutical distributors,” Markey said in a statement Wednesday.
Sens. Patrick J. Leahy (D-Vt.) and Ron Wyden (D-Ore.) sent a similar letter to Rosenberg and U.S. Attorney General Loretta E. Lynch after the Post stories. Wyden said Wednesday the response was insufficient.
“The DEA’s response to our inquiry was totally inadequate given the life-and-death nature of the opioid crisis,” he said.
The National Academy of Sciences has released a report challenging the Schedule 1 classification of marijuana by the Drug Enforcement Agency. The NAS report found that marijuana has medical benefits, but the public health risks that need to be researched are impeded by the Schedule 1 classification.
According to the PBS NewsHour, Schedule 1 substances are deemed illegal because they are both highly addictive and have no demonstrable medical application. Drugs classified as such include heroin and LSD.
A judge looked this inmate straight in the eyes and said something that left the entire courtroom in tears:
“Schedules 2 through 5 are for [drugs] with demonstrated medical benefit to a fairly high standard of demonstration,” Mark Kleiman, a public policy professor at NYU, added. “The DEA could have decided 30 years ago, ‘Lots of oncologists think that cannabis helps their patients with nausea. That’s accepted medical use. We’re going to treat it as accepted medical use.’ But they decided the other way, so that’s the current definition of the law that the courts have upheld. And that leaves no place in the law for a drug of moderate abuse potential and no [proven] medical use.”
According to Forbes, the NAS study advocates for new “political and non-political strategies to resolve regulatory barriers to cannabis research, an objective and evidence-based analysis of cannabis policy is necessary.”
“The DEA has actually admitted that cannabis is not a gateway drug and does not cause long-term brain damage, psychosis, and other alleged harms, yet they keep distributing this false information anyway, despite the reality these claims are not based on scientific fact,” noted Beth Collins, Senior Director of Government Relations and External Affairs for Americans for Safe Access. “It’s illegal for the government to disseminate inaccurate information and the DEA must be held accountable.”
But as President-elect Donald Trump’s administration approaches, with anti-marijuana advocate Jeff Sessions on deck to be next U.S. Attorney General, decriminalizing and deregulating marijuana use stands on shaky ground.
#Costco to pay $11.75M over handling of opioids and other drugs
100,000+ Demand DEA Stop Spreading Lies About Medical Marijuana
