“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
It seems like every entity that believes that they have some authority to interfere with the practice of medicine and opiate dosing… are attempting to put in their two cents and enacting some guidelines, laws and/or threatening some healthcare providers with having their accreditation withdrawn if they exceed a certain amount of MME/day on pts.
One group National Committee for Quality Assurance (NCQA),which is a agency that accredits different healthcare providers is putting forward daily MME and if prescribers exceed this arbitrary limit… the provider will have their accreditation revoked.
The Center for Medicare and Medicaid Services is coming forward with daily MME limits and is shifting some of the responsibility to enforce those limits to community pharmacists. Perhaps they approached this in this manner… so that they could wash their hands of any consequences caused by decisions of Pharmacists not to fill and deny care and override the prescriber’s wishes.
The CDC only put forth GUIDELINES… which did not bear the weight of law, but in fact has become de-facto standard of care and best practices for untold number of healthcare entities and providers.
Many states have passed laws that has MME/day limits and most are focused on those pts being treated with ACUTE PAIN…NOT CHRONIC PAIN.
This is a similar tactic that various state’s AG’s used against the company that brought a Hydrocodone ER (Zohydro) to the market. Because the company had to go to court in each state they were sued by the AG… and the company ended up in bankruptcy because of all of this nonsensical legal actions.
Those in the chronic pain community needs to make themselves of the various laws and guidelines… many of which can be in conflict or contradicting each other.
I am sure that a number of prescribers will tell pts that he/she is “forced” to comply with this-that law or guidelines. Many times these “limits” will be STATE LAW and I suspect that the prescriber will be misrepresenting what the context of the law really is. They may be observing their interpretation of the law and not the letter nor intent of the law.
I spoke with a chronic pain pt recently from Colorado. This pt’s prescriber was an employee of some corporation and that corporation was sold or merged with another corporation in FLORIDA… the FL corporation came down with a edit that NO OPIATES were to be prescribed. The prescriber started to wean down his pts… there was a edit from the FL corporation that all opiate pts were to be DISCHARGED IMMEDIATELY… cut off COLD TURKEY… I am not sure if the prescriber was fired and/or he quit… but.. he is no longer working for this corporation.
IMO, this is just the first of many such corporate decisions/mandates in how pts are provided care. This is where a class action law firm could be interested in pursuing… since a single corporate entity with “deep pockets” that he causing harm to hundreds or thousands of pts.
Unless chronic pain pts are aware of the rules/laws/guidelines that is being used to dictate their care… they will not be able to take legal action against the entity that is doing harm to them.
Remember, anytime that someone tell you that they are following some law/rule/regulation… simply ask them to furnish you with a copy of what they are following or the state statue number – so that you can look it up on the web… if they are unwilling/unable to provide you that information… It probably DOESN’T EXIST.
There should be consequences to those who violate our laws.
Chronic pain sufferers fear they could become casualties in the war on Ohio’s opioid overdose epidemic.
They say recent moves by Gov. John Kasich to fight the plague by restricting how many painkillers can be prescribed will add to their anguish — and could force them to go underground to find the relief they need to make it through a day.
“We are being punished for being in pain,” said Amy Monahan-Curtis, 44, who has been living in agony since 1993 due to condition called cervical dystonia that causes her neck muscles to contract involuntarily.
Monahan-Curtis, who lives in Cincinnati, said limiting painkiller prescriptions for adults to just seven days at a time, as Ohio now does, means “an additional financial burden is being placed on the pain patient if a primary doctor will write a prescription to pay for multiple scripts.”
“What these regulations are doing is forcing pain patients out of terror and extreme pain to the street, to find something to control their pain,” she said. “Legislators are making the drug problem much worse.”
Monahan-Curtis said she already follows strict rules laid out in the “narcotic contract” she signed when she enrolled in a pain management clinic, including having to submit to random urine samples.
“I can be called into the office at any time in between my monthly appointments, asked to bring in my narcotics bottle for a count to see if I have an appropriate amount left and am not selling them or taking too many,” she said.
And if her meds are lost or stolen, Monahan-Curtis said, “they will not be replaced.”
Kasich, when he made his announcement last week, said the new rules don’t apply to patients who already take painkillers for things like cancer or to treat dying patients receiving hospice care.
“We have tried to make it as clear as possible that this is not aimed at chronic pain sufferers,” said Cameron McNamee at Ohio’s state Board of Pharmacy.
A guide put out by Kasich’s administration clearly states that “the limits only apply to the treatment of acute pain.”
“I suspect what may have caused some confusion is that two pieces of legislation that do address chronic pain dropped a day before Gov. Kasich made his announcement,” McNamee said. “I can tell you with 100 percent certainty that the rules proposed by the governor are not aimed at persons who suffer from chronic pain. Those individuals will still be able to get their appropriate medications.”
Monahan-Curtis said she doesn’t believe it. She said the online message boards for chronic pain sufferers lit up after Kasich unveiled the restrictions.
“Doctors are already feeling this pressure not to prescribe pain medications,” she said. “What I am hearing is people are already being turned away. They are not getting medications. They are not even being seen. “
Ashley Marie MacDonald, who has been living in constant pain since a falling bookcase crushed her foot in 2011, echoed those concerns.
“I understand that there is a drug epidemic, but by doing this it is affecting people like me,” said MacDonald, 28, of Cincinnati.
MacDonald suffers from a malady called complex regional pain syndrome, that she says makes her feel “like I’ve been lit on fire and have barbed wire around my skin.” Workers’ compensation pays for her visit with a pain management specialist every 28 days.
But under Kasich’s order, MacDonald fears patients like her will have to make more frequent visits and pay $150 out of pocket every time. She said she’s got barely enough money now to survive. But the alternative is a horror she knows all too well.
“I had to recently go to court to fight for my medicine because workers comp got some doctor who never met me and said I don’t need my medicine,” she said. “So I went without for several days.”
What happened? “I could not get off the couch because the pain was unimaginable,” she said.
MacDonald said even before Kasich’s order pain patients were treated like criminals.
“You’re looked at suspiciously all the time,” she said. “You feel as if you are being treated like an addict. I don’t know how treating people like us like criminals will help stop the opioid epidemic. I’m not taking meds to get high, I am taking them to survive.”
“I do not believe that making it harder for people is going to solve this opiate crisis,” added 29-year-old Christa Whighstel of Columbus, Ohio, who suffers from the same syndrome as MacDonald.
Whighstel said the unintended consequence of Kasich’s rule is likely to be pain patients “jumping ship and getting addicted to the illegal stuff.”
“It will force people to go over to the other side,” she said. “They just want to live their lives without pain.”
While the deadly scourge of fentanyl-laced heroin cutting through Rust Belt states like Ohio has made headlines of late, the number of fatal overdoses from opioids that can be purchased with a prescription like oxycodone, hydrocodone, and methadone “have more than quadrupled since 1999,” according to the federal Centers for Disease Control and Prevention.
During that same time period, the amount of prescription opioids sold in the U.S. also quadrupled, according to the CDC.
In 2013 alone a quarter billion prescriptions were written, which equates to “enough for every American to have their own bottle of pills,” the agency reported.
Even if used correctly the CDC reported, “anyone who takes prescription opioids can become addicted to them.”
“In fact, as many as one in four patients receiving long-term opioid therapy in a primary care setting struggles with opioid addiction,” according to the CDC. “Once addicted, it can be hard to stop. In 2014, nearly two million Americans either abused or were dependent on prescription opioid pain relievers.”
Even before Kasich made his announcement, Ohio in January 2016 released new prescription painkiller guidelines recommending that people suffering short-term pain from surgery or injuries should be given alternatives whenever possible.
Among the alternatives suggested by Dr. Mary DiOrio, medical director for the state Department of Health, were ice, heat, wraps, stretching, massage therapy, acupuncture, physical therapy and non-addictive medicines like ibuprofen.
“Nobody wants to punish people with chronic pain,” Dr. Michael Kelley of the Ohio Health hospital system told NBC News. “But at the same time we don’t want to develop more addicts.”
Asked why the chronic pain community isn’t getting the message that they are not being targeted, Kelley said, “I don’t know for sure.”
“From the very start we were clear that doctors should responsibly treat people with chronic pain,” Kelley said. “But some doctors are starting to feel a little bit paranoid about the different laws. I think, sometimes, they’re over-concerned.”
Coming as early as September, Ohio will be able to offer chronic pain patients another alternative — medical marijuana.
“There is some evidence it works for chronic pain,” said Kelley. “There is also some evidence it may be a way to treat people who are addicted to opiates.”
Amy Monahan-Curtis, 44, of Cincinnati, Ohio, is among the many chronic pain sufferers who fear they will be hurt by painkiller restrictions imposed by politicians battling the opioid epidemic. Since 1993, she has been tortured by a condition called cervical dystonia which causes her neck muscles to contract involuntarily.
They are people who feel shut out from their pharmacies, by emergency rooms, and their doctors. Already struggling with chronic pain they feel “abandoned” by a system that is now focusing on a prescription drug epidemic that’s gripped the country.
Chronic pain patients have started forming their own support groups and are pleading for their voices to be heard.
“Everything is about addiction. Opioid overdoses, CDC statistics – but nobody is telling our side of the story and how this is affecting over 100 million patients in the United States,” said Barbi Ingle, President of iPain Foundation, and a chronic pain patient herself.
For many of these people life literally changed overnight. Whether it was an accident, a fall, a ruptured back disc, or medical malpractice – they now live gripped with pain everyday, not knowing when the “flare up” may hit.
If you ask them to describe the pain, the responses seem unbelievable.
“The pain in my back feels like, a banana clip that women wear in their hair,” Ingle said. “Only, make it out of heavy gauge steel, sharpen it even more, clamp it on my spine then tighten it up. Then add a 10 pound weight to it,” said Lauri Nickel, who suffers from chronic pain.
“My pain is a burning fire pain,” Ingle said. “As if someone put burning lighter fluid on me, lit me on fire, and I can’t put it out.”
They are people who have learned to live life and function – despite the suffering.
“When my back problems first started, my baby was 1 year old,” Nickel said. “I ended up toilet training him from lying down in hallway with my head in bathroom, to supervise him because I couldn’t sit up.”
Ingle said there were days she thought she wouldn’t survive the pain.
“There’s been days where I was bed bound I would think, ‘I’m going to die today,’ Ingle said. “My husband’s going to come home and he will find me dead.”
Part of the struggle for them, is also having to justify this pain to doctors and pharmacists, try to prove to them that they are not just another addict looking for pain pills.
“I do not understand how someone would take these pills for fun,” Ingle said.
For them, she added there was no “high.” There was just temporary relief.
Ingle said the iPain Foundation heard many stories from pain patients who said they were turned away from pharmacies who were unable to fill their prescriptions.
Some said they felt “criminalized” from the moment they walked into a pharmacy, and felt like they had to “prove their pain.”
“You have to prove so much even though you have medical records five inches deep,” said Nickel.
ABC15 took these concerns to the state pharmacy board.
Executive Director Kamlesh Gandhi said pharmacists were the front line in this war on prescription drugs. They had a huge responsibility and are constantly being trained to recognize prescription drug abusers.
Gandhi said law required pharmacists to check the “prescription monitoring program” database before filling prescriptions, and pharmacists were becoming more aware of the problem. He added that patients needed to maintain a good relationship with the pharmacy.
Rightway Pharmacy owner Ken Patel said pharmacies were also under scrutiny by many agencies, and had to be accountable for the number of opioids they prescribed to patients.
“Every pharmacist is quite cautious in filling opioid medication, it’s not that they don’t want to,” said Patel.
He added that all pharmacies have ordering limits imposed on them by drug companies, if they go over, they were also in fear of shutting down.
Patel said his first priorities were his loyal customers, and he usually knew what they needed every month, so knew how much to order.
In this age of addiction and abuse, establishing that trust was crucial.
“We want to take care of their health needs. That trust is very important. We want to understand what they’re going through so we can work with the doctor,” said Patel.
As for those living with chronic pain, all they wanted was to be understood, and treated with some dignity.
“We know we’re never going to be pain free. We just want to be able to function. We want to get out of bed. Take a shower more than twice a week,” said Nickel.
The Drug Enforcement sent us this statement in response to this story:
Prescription opioids undoubtedly have an important role in our society when used properly and under a doctor’s supervision. What we are dealing with as a society now involves balancing this legitimate need with preventing the diversion of these powerful substances outside of this doctor-patient relationship. The DEA has been and will continue to educate medical practitioners and pharmaceutical manufacturers about the regulatory system and ways to prevent this dangerous diversion. As our country is faced with an epidemic of overdose deaths from these substances, the American people would expect nothing less from the DEA.
With sales of its respiratory drugs doing well, GlaxoSmithKline has been spending hundreds of millions of dollars to expand manufacturing of several kinds of inhalers. But a glitch at one of its Ventolin inhaler plants has resulted in recalling nearly 600,000 units in the U.S.
According to an FDA Enforcement Report, GSK recently began recalling 593,088 Ventolin inhalers after discovering that an elevated number of the units were out of specification for leak rate, the company reported. The units were manufactured at its plant in Zebulon, North Carolina.
A GSK spokesperson pointed out this was not a consumer level recall, so patients can keep any Ventolin inhalers they have on hand. The voluntary recall is to the retail and wholesaler level so products are being removed from those channels.
About 15 months ago, GSK recalled nearly 130,000 inhalers over concerns that some canisters might not contain sufficient propellant to deliver the 200 doses its label said it can provide through the end of its shelf life.
GSK has been adding capacity for a number of its respiratory products after doubling down on that business several years ago. Last year it opened an $80.5 million (£56 million), 4,500-square-meter plant in Ware in the U.K. that will allow it to double production of its Ellipta inhalers to 37 million a year.
In February, the U.K.-based company informed local authorities it intended to build the $137 million four-story facility at its site in Scotland for the production of salbutamol, the API in Ventolin, a treatment for asthma and chronic obstructive pulmonary disease.
Product Description:
Ventolin HFA (albuterol sulfate) Inhalation Aerosol, 90 mcg per actuation, 200 Metered Inhalations, Net Wt. 18 g inhalers, Rx only, GlaxoSmithKline, Research Triangle Park, NC 22709, NDC 0173-0682-20.
Reason for Recall:
Defective Delivery System: Elevated number of units with out of specification results for leak rate.
Product Quantity:
593,088 inhalers
Recall Number:
D-0626-2017
Code Information:
Lot #: 6ZP9848, Exp 03/18; 6ZP0003, 6ZP9944, Exp 04/18.
However, the agency has modified a policy to ensure that high doses of opioids that are medically necessary can still be prescribed.
Like the CDC guideline, CMS is recommending a daily ceiling on opioid pain medication at 90 mgs of a morphine equivalent dose (MED). If a dose exceeds that level, Medicare insurers are expected to impose a “soft edit” that would automatically block the prescription from being filled until the edit is overridden by a pharmacist.
Under a previous proposal, insurance companies could also impose a “hard edit” that could not be overridden on prescriptions that exceed 200 mgs of MED. The modification allows a pharmacist to override the edit if the prescribing physician says the dose is medically needed.
“Point of sale edits are not intended to substitute physician judgment or dictate a prescribing limit. If a sponsor (insurer) chooses to implement a hard edit, CMS expects the sponsor to rely only on prescriber attestation that the MED is medically necessary to override the hard edit, and to not require additional clinical criteria,” a senior CMS official said in a news briefing.
“The edits are not to stop prescriptions. They’re to provide information to sponsors in real time as a preventative step, so that prescribers are aware of the amount of opioids that patients are receiving as well as that they may be receiving opioids from other doctors. They are not prescriber limits and they are not to substitute for prescriber judgement.”
CMS said there was a “significant number of comments” from the public about its opioid prescribing proposal. Some doctors and patient advocacy groups expressed concern that pain patients who are medically stable on high opioids doses would be forced to taper to lower doses.
“My tentative judgement, based on quickly looking at the documents today, is that CMS carefully stepped back from the absolute requirement that would have caused patients at over 200 (MED) mgs to have a sudden crisis in their care,” said Stefan Kertesz, MD, a practicing physician and Associate Professor at the University of Alabama at Birmingham School of Medicine.
“That doesn’t mean that they have foresworn this course of action in the future, but they clearly registered that they heard concerns from patients, doctors and others, and to me that is a hopeful sign.”
CMS is still moving ahead with plans to implement an opioid Overutilization Monitoring System (OMS) to identify physicians who prescribe high doses and the patients who receive them. Patients who receive opioids from more than 3 prescribers and more than 3 pharmacies during a 6 month period would also be red-flagged.
Insurers are expected to identify pharmacies, doctors and patients who do not follow CMS policies, and could potentially drop them from Medicare coverage and their insurance networks.
As PNN has reported, the insurance industry appears to have played a major role in drafting the OMS plan, which contains some of the same strategies suggested in a “white paper” prepared by the Healthcare Fraud Prevention Partnership, a coalition of insurers, law enforcement agencies, and federal and state regulators formed in 2013 to combat healthcare fraud.
The white paper goes far beyond fraud prevention, however, by recommending policies that will determine how a patient is treated by their doctor, including what medications should be prescribed. The white paper was drafted largely by insurance companies, including Aetna, Anthem, Blue Cross Blue Shield, Cigna, Highmark, Humana, Kaiser Permanente and the Centene Corporation.
CMS contracts with dozens of insurance companies to provide health coverage to about 54 million Americans through Medicare and nearly 70 million in Medicaid. CMS policy changes often have a sweeping impact throughout the U.S. healthcare system because so many insurers and patients are involved.
The human body’s peripheral nervous system could be capable of interpreting its environment and modulating pain, neuroscientists have established, after successfully studying how rodents reacted to stimulation.
Until now, accepted scientific theory has held that only the central nervous system – the brain and spinal cord – could actually interpret and analyse sensations like pain or heat.
The peripheral system that runs throughout the body was seen to be a mainly wiring network, relaying information to and from the central nervous system by delivering messages to the ‘control centre’ (the brain), which then tells the body how to react.
In recent years there has been some evidence of a more complex role for the peripheral nervous system, but this study by the Hebei Medical University in China and the University of Leeds highlights a crucial new role for the ganglia, a collection of ‘nodules’.
Previously these were believed to act only as an energy source for messages being carried through the nervous system. In addition, researchers now believe they also have the ability to act as ‘mini brains’, modifying how much information is sent to the central nervous system.
The five year study found that nerve cells within the ganglia can exchange information between each other with the help
of a signalling molecule called GABA, a process that previously believed to be restricted to the central nervous system.
The findings are published today in the Journal of Clinical Investigation and have potential future implications for the development of new painkillers, including drugs to target backache and arthritis pain.
Pain relief drugs
Current pain relief drugs are targeted at the central nervous system and often have side effects including addiction and tolerance issues.
The new research opens up the possibility of a route for developing non-addictive and non-drowsy drugs, targeted at the peripheral nervous system. Safe therapeutic dosage of these new drugs can also be much higher, potentially resulting in higher efficacy.
Whilst the study showed a rodent’s peripheral nervous system was able to interpret the type of stimulation it was sensing, further research is still needed to understand how sensations are interpreted and whether these results apply to humans.
In addition, the theory would need to be adopted by drug development companies and extensively tested before laboratory and clinical trials of a drug could be carried out. Should the findings be adopted, a timescale of at least 15-20 years might be required to produce a working drug.
Nerve arrangements
Neuroscientist Professor Nikita Gamper, who led the research at both universities, said: “We found the peripheral nervous system has the ability to alter the information sent to the brain, rather than blindly passing everything on to the c
entral nervous system.
“We don’t yet know how the system works, but the machinery is definitely in place to allow the peripheral system to interpret and modify the tactile information perceived by the brain in terms of interpreting pain, warmth or the solidity of objects.
“Further research is needed to understand exactly how it operates, but we have no reason to believe that the same nerve arrangements would not exist in humans.
“When our research team looked more closely at the peripheral system, we found the machinery for neuronal communication did exist in the peripheral nervous system’s structure. It is as if each sensory nerve has its own ‘mini-brain’, which to an extent, can interpret incoming information.”
Co-author of the study, Professor Xiaona Du from Hebei Medical University, added: “This dramatically changes our understanding of pain medication because in theory it is now possible to target drugs at the peripheral nervous system which could widen the type of treatments available.”
Professor Gamper believes the findings may present a challenge to the accepted ‘Gate Control Theory of Pain’. The theory holds that a primary ‘gate’ exists between the peripheral and central nervous systems, controlling what information is sent to the central system.
The study now suggests the transmission of information to the central nervous system must go through another set of gates, or more accurately a process similar to a volume control, where the flow of information can be controlled by the peripheral nervous system.
“Peripheral nerves have the ability to dial up or down the signal which goes through these gates to the brain”, said Professor Gamper. “Importantly, we believe that these gates can be exploited for therapeutic control of pain.”
Research Council support
Dr Kathryn Adcock, Head of Neurosciences and Mental Health at the Medical Research Council, which part funded the work, said: “These findings are an interesting step in advancing scientists’ understanding of the mechanisms
underpinning pain perception. We are committed to supporting work such as this to aid the continued search for new and better pain treatments.”
A view from industry
Lishuang Cao, head of Membrane Physiology at GlaxoSmithKline R&D in Shanghai commented on this research: “This interesting finding could pave the way for developing novel pain medicines by targeting the peripheral GABA signaling pathway and at the same time avoiding or reducing the side effects of many existing pain killers.
“Further work is needed to understand the physiological role of GABA in painful situations like inflammatory, neuropathic and chronic pain. More importantly we need to know if the same mechanism is present in human beings’ peripheral nervous systems.”
Manual blood pressure measurements may not be as accurate as the automatic devices that take multiple measurements.
If your doctor still uses a manual device to check your blood pressure, you risk being misdiagnosed, experts say.
This could lead to unnecessary treatment with medication for high blood pressure, not to mention dealing with the side effects and expense of those drugs.
In a new study published in the journal Canadian Family Physician, researchers estimated that about 20 percent of Canadians being treated for high blood pressure, or hypertension, don’t actually need medication because their blood pressure was measured incorrectly.
Researchers say this is due to more than half of family doctors in Canada still using manual devices to measure blood pressure.
Measuring someone’s blood pressure manually seems like a fairly straightforward procedure — put on the cuff, inflate it, and read the dial as the cuff deflates.
A lot can go wrong, though.
“It seems like blood pressure is easy to measure, but almost no one does it correctly,” said Dr. Sarah Woolsey, a family physician, and medical director with HealthInsight Utah.
Using the wrong size cuff can throw off the numbers. It can also happen if a person is fidgeting while having their blood pressure checked, or checking someone’s blood pressure right after they come into the office.
Manual measurement is acceptable if it’s properly done, but that’s often not the case.
Janusz Kaczorowski, Université de Montréal
Even just being in the doctor’s office can cause a person’s blood pressure to increase. This kind of “white-coat hypertension” is surprisingly common.
“The big message for us is that ‘white-coat hypertension’ is prevalent, and over-treatment may be prevalent and may lead to side effects of medication,” Woolsey told Healthline.
“Clinicians should use automatic devices. They are more expensive but more precise because they take several measurements,” Janusz Kaczorowski, PhD, a professor in the Department of Family and Emergency Medicine at Université de Montréal, and lead author of the Canadian study, said in a press release.
Automated blood pressure monitoring can also be done while the person is alone, which reduces some of the white-coat hypertension.
Does that mean manual measurements are always wrong? No, but their accuracy depends on how they’re done.
“Manual measurement is acceptable if it’s properly done, but that’s often not the case,” said Kaczorowski. “To take blood pressure the right way, a 12- to 15-minute period is required.”
This may not work with the typical 10-minute visit to a family doctor.
The blood pressure measurement that happens at a routine doctor’s visit is an initial screening.
If someone’s blood pressure is elevated, then a more thorough check is needed to properly diagnose high blood pressure.
This can be done in several ways.
“The gold standard is the 24-hour ambulatory monitor,” Woolsey told Healthline.
After that, the guidelines “suggest multiple measurements of blood pressure — and they give you the option of an automated office blood pressure, or out-of-office monitoring, or multiple in-office monitoring.”
We think the automated office blood pressure will be a good solution, especially for our smaller cities and smaller towns.
Dr. Sarah Woolsey, HealthInsight Utah
Ambulatory blood pressure monitoring devices are small, portable machines that measure a person’s blood pressure at regular intervals over 12 to 24 hours. This gives a more accurate picture of a person’s “real” blood pressure level.
However, these devices may be hard to come by, especially in rural areas.
A recent paper published by Woolsey and her colleagues in the Journal of the American Board of Family Medicine (JABFM) found that only a quarter of 123 primary care clinics in Utah that responded to a survey had access to ambulatory monitoring.
Researchers also discovered that clinics were not following all of the USPSTF guidelines.
At the high end, 93 percent of the clinics reported using an appropriately sized arm cuff.
But only 57 percent of clinics waited at least five minutes after the patient arrived at the office before checking blood pressure.
Woolsey thinks the situation may be similar in clinics throughout the United States.
Because of the lack of ambulatory devices in many areas and the challenges with manual blood pressure monitoring, automated devices may have an even bigger role to play in clinics.
“We think the automated office blood pressure will be a good solution, especially for our smaller cities and smaller towns,” said Woolsey.
People with high blood pressure often don’t feel sick until their pressure is really high or they develop another problem such as kidney disease, heart attack, or stroke.
That’s why high blood pressure is known as a “silent killer.”
This can be done using standard manual blood pressure cuffs or automated home devices.
For this to work well, though, people need to be properly trained — another area of improvement identified by Woolsey and her colleagues.
Slightly more than a third of the Utah clinics provided instructions to people on how to measure blood pressure accurately at home.
But once people know how to check their own blood pressure correctly, home monitoring can help them in more ways than one.
“I personally aspire to a day where we have diabetes without doctors, and hypertension treatment without doctors, because patients are so enabled in self-care,” said Woolsey. “Self-monitoring programs are good for patient engagement and patient self-awareness of their own conditions.”
Louisiana Attorney General Jeff Landry has teamed up with the Louisiana Ambulance Alliance and a pharmaceutical company to raise awareness about the growing opioid epidemic.
Landry on Wednesday announced the launch of the “End the Epidemic LA” campaign, which will include a website (EndTheEpidemicLA.org), advertisements and community outreach efforts.
The website includes information for users, parents, educators, employers and others in an effort to offer a “resource for anyone wishing to learn more about how to avoid opioid addiction, spot opioid addiction in others and treat opioid addiction.”
People can go to the site to request information or schedule a guest speaker on the dangers of opioid abuse.
In 2009, Cayce Badeaux McDaniel had just finished college at the University of Louisiana at …
“From the big cities to our rural towns, no community in Louisiana is immune to the opioid abuse epidemic,” Landry said in a statement. “Opioid abuse has taken the lives of too many of our children, parents, neighbors, and co-workers. We hope that End the Epidemic LA will assist in the reduction of opioid misuse, abuse, and overdose.”
The outreach effort is being paid for by Amphastar, a drug maker known for its generic naloxone, a drug that can quickly reverse opioid overdoses. Amphastar and other naloxone makers have come under scrutiny for the rising costs of their life-saving medication amid the rise of opioid abuse in recent months.
Louisiana has the sixth-highest opioid pain reliever-prescribing rate in the country, according to analysis from IMS Institute for Healthcare Informatics over a year-long period through June 30, 2016. It found that there were 102.3 opioid prescriptions for every 100 people, when counting new prescriptions and prescribed refills. The national average was 69.5 prescriptions for every 100 people during that period.
“When Attorney General Landry’s office brought this partnership opportunity to us, we immediately recognized the opportunity to deliver more pre-hospital care albeit in a non-traditional manner,” Ambulance Alliance CEO Donna Newchurch said in a news release. “The ultimate beneficiaries of this partnership are the citizens we serve daily.”
Legislation that aims to combat Louisiana’s growing opioid usage and linked overdose deaths …
The state’s drug overdose rate currently outpaces the national average, fueled by the rise in prescription opioid abuse and the use of illicit opioids, like heroin, and synthetic black-market opioids, like fentanyl. The Centers for Disease Control and Prevention placed Louisiana had the 19th highest age adjusted opioid OD rate in 2015.
For the first time in New Orleans’ history, deaths from accidental drug overdoses surpassed murders last year, attributed largely to the increase in the abuse of heroin and other opioids.
On Tuesday, Gov. John Bel Edwards, a Democrat, announced three anti-opioid abuse bills that are among his priority legislation for the session that begins Monday.
In a dramatic display that stretched across two committee hearings on Tuesday, Rep. Jason Chaffetz (R-Utah) subpoenaed the head of the Drug Enforcement Administration for documents on its confidential sources program.
Members of Congress have been seeking copies of the DEA’s informant guidelines since last year, following an eye-opening report by the Department of Justice watchdog. The agency’s inspector general detailed how the agency doled out more than $200 million to confidential sources with very little oversight.
Lawmakers have only been allowed to view the policy documents in-camera, meaning without staff or any means to make copies for themselves. Chaffetz blasted the arrangement, calling it inadequate.
“Congress has a right to have this material,” Chaffetz said, during an Oversight Committee hearing that he chaired on Tuesday morning. “It is unbelievable to me that you think we shouldn’t have a copy of it.”
Robert Patterson, the current Deputy Administrator of the DEA, responded by claiming that the DOJ was blocking the release of copies of the guidelines to lawmakers.
Chaffetz told Patterson that he was going to walk next door to the House Judiciary Committee — where DEA Administrator Chuck Rosenberg was testifying on separate matters — to issue a subpoena for the documents.
A few hours later, Chaffetz followed through on his promise, after taking his seat on the judiciary subcommittee down the hall.
“We are issuing a subpoena, and so I see no choice,” he then told DEA chief Rosenberg.
“The Department of Justice just doesn’t get to hide things from the United States Congress,” Chaffetz added. He said that there’s evidence of “massive problems” with the DEA confidential informant program.
“I will look at the subpoena carefully and I will have a further discussion with you,” Rosenberg responded.
According to the DOJ Inspector General’s findings last September, the DEA paid $237 million to more than 18,000 informants over the last five years, but the agency has not detailed if the sources’ information is reliable.
The loose oversight “exposes the agency to an unacceptably increased potential for fraud, waste, and abuse, particularly given the frequency with which DEA offices utilize and pay confidential sources,” the IG concluded.
“It seems like we should be able to review this,” Chaffetz said Tuesday.
The House Oversight Committee chair had the backing of many colleagues, including the panel’s ranking member, Rep. Elijah Cummings (D-Md.).
“I wholeheartedly support the chairman,” Cummings said. “We’re just trying to do our job.”
Companies of all kinds try to present their financial results in the best light possible to attract investors. One segment of the drug industry is bucking that trend, using an accounting method that narrows its profit margins.
The three big middlemen for prescription drugs, known as pharmacy benefit managers, or PBMs, had operating-profit margins last year of 4 percent to 7 percent, a level that lags the 16 percent average among S&P 500 companies. Were they to tally their revenue the way many middlemen in other industries do, their margins would more than double.
Several drug industry analysts said that booking revenue in a way that shows lower margins might have helped the companies deflect criticism of their pricing practices. “It hides a lot. It’s as simple as that,” said Ravi Mehrotra, a partner at the MTS Health Partners investment bank.
High margins are generally a lure for investors. But several analysts cautioned that very high margins in this industry could be unsustainable given the political pressure to control drug prices.
The PBMs’ method of counting complies with generally accepted accounting principles. Regulators haven’t expressed displeasure with the way these drug middlemen — namely the PBM units of CVS Health Corp., Express Scripts Holding Co. and OptumRx (part of UnitedHealth Group Inc.) — present their revenues, costs and margins.
It’s a judgment call and both approaches can be reasonably justified in this case, said Barry Epstein, a forensic accountant at Epstein + Nach in Chicago.
Representatives of the PBMs said the companies’ accounting treatment best reflects the nature of their business. They pointed to their annual reports, which describe their reasoning. Among other factors, the PBMs manage the process of getting prescription drugs to customers, take on credit risk and negotiate prices, they said.
“We believe gross accounting is appropriate as we are the principal in these transactions,” CVS spokeswoman Christine Cramer said by email.
Together, the three companies account for about 70 percent of the PBM market. Their shares have fluctuated this year as lawmakers have debated a health-care overhaul and investigated rising drug prices. So far this year, Express Scripts shares have lost 4 percent, while CVS has lost 0.5 percent. UnitedHealth is up 3.1 percent.
Drug Prices
The distinction between the accounting approaches is significant. The drug industry is receiving heavy criticism over spiraling prices. Consumer groups and lawmakers alike want to know who’s to blame, and President Donald Trump has threatened to get directly involved in setting drug prices.
Executives of the major drugmakers, forced to defend their practices to Congress, have tried to shift attention to the PBMs, which make their money as a go-between among drugmakers, retailers, insurers and consumers. Many drugmakers and pharmacists have alleged that PBMs aren’t transparent enough and that it’s hard to tell how they’re making their money.
The current system “allows these drug middlemen to extract enormous profits with limited oversight and transparency,” said Susan Pilch, vice president for policy and regulatory affairs at the National Community Pharmacists Association, which represents 22,000 independent pharmacies. The group’s members are participating in numerous lawsuits against the PBMs over fees and other contractual issues.
Agent or Principal?
The core question is what kind of business a PBM is. These companies help get products from providers to buyers. Sometimes they handle orders themselves via in-house mail-order services. Other times they use third-party retail pharmacy networks and therefore don’t take physical control of items like insulin vials or cholesterol-lowering capsules.
So are they an agent like, say, Expedia Inc. in travel or eBay Inc. in e-commerce? Or are they a principal like the retailer Walgreens Boots Alliance Inc.?
When Expedia books a $100 hotel room, it typically counts as revenue only the sum that it pockets through commissions and other fees, and calculates its profit margins from that. Walgreens and other retailers, by contrast, account for the full value of many of the goods they sell in their top-line figures because, among other factors, they take control of the goods before selling them.
For the most part, the big PBMs treat themselves as principals when they tally their sales — which means they book the entire value of drug transactions as revenue.
Often, the PBMs are indeed playing a textbook role as principal, taking ownership of drugs before dispensing them through their sizable in-house mail-order pharmacies. A Morgan Stanley analysis this month estimated that more than half of the revenues reported by the two biggest PBMs represented transactions in which they processed payments but didn’t handle products.
Specifically, this “pass-through revenue” accounted for 51 percent of the total recorded by Express Scripts and 62 percent at CVS’s PBM unit, Caremark, in 2016, the bank said. It wasn’t possible to analyze OptumRx because UnitedHealth doesn’t break out the results of its PBM unit in a comparable way.
Profit Picture
Strip out these pass-through revenues for Express Scripts and CVS, and their operating margins more than double to 15 percent and 10 percent respectively, according to Morgan Stanley. That’s higher than the 2 percent average for distributors and 8 percent average for retailers, making PBMs the most profitable operators in the health-care supply chain in 2015, according to another Morgan Stanley report.
“Pass-through revenues cloud the true economics of the PBM business,” the Morgan Stanley analysts wrote a year ago, without ascribing a motive.
Some middlemen in other industries use similar accounting methods. For example, C.H. Robinson Worldwide Inc., which uses third-party shipping companies to move freight for its clients, reported $13.1 billion in gross revenue in 2016. But its annual report also discloses net revenue of $2.3 billion and says it considers that figure its “primary performance measurement.”
By counting in their revenue and costs the value of the ingredients that go into the drug, the dispensing fee paid to the pharmacy and other pass-through items, the three big PBMs book enormous revenues — $277 billion combined in 2016 — and thin profit margins.
Public Perception
To counter claims that the PBMs are contributing to rising drug prices, industry lobbyists recently rolled out a promotional campaign aimed at Washington policy makers with the message that the PBMs are part of “drug benefit solutions.” The industry says it serves a vital role in the complex health-care ecosystem and helps keep drug prices in check, in part by forcing drugmakers with rival products to compete on price.
That’s partly true, said Bartholomew Clark, a pharmacy professor at Creighton University in Omaha, Nebraska, who has been researching the industry for 15 years and questions its accounting practices. “They have a good business model and do perform a useful service,” he said. “But the incomplete exchange of information makes it possible for profit to become egregious.”
It seems like every entity that believes that they have some authority to interfere with the practice of medicine and opiate dosing… are attempting to put in their two cents and enacting some guidelines, laws and/or threatening some healthcare providers with having their accreditation withdrawn if they exceed a certain amount of MME/day on pts. 
