“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
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.”
Before the Subcommittee on Crime, Terrorism, Homeland Security, and Investigations
Committee on the Judiciary
U.S. House of Representatives
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We strive faithfully to execute that mission with excellence and integrity at all levels and are continually looking for ways to further improve our operations.
More than 20 percent of patients who sought a second opinion at one of the nation’s premier medical institutions had been misdiagnosed by their primary care providers, according to new research published Tuesday.
Twelve percent of the people who asked specialists at the Mayo Clinic in Rochester, Minn., to review their cases had received correct diagnoses, the study found. The rest were given diagnoses that were partly in line with the conclusions of the Mayo doctors who evaluated their conditions.
The results are generally similar to other research on diagnostic error but provide additional evidence for advocates who say such findings show that the health-care system still has room for improvement.
“Diagnosis is extremely hard,” said Mark L. Graber, a senior fellow at the research institute RTI International and founder of the Society to Improve Diagnosis in Medicine. “There are 10,000 diseases and only 200 to 300 symptoms.”
Graber was not involved in the Mayo Clinic research, which appears in the Journal of Evaluation in Clinical Practice.
In 2015, the National Academy of Medicine reported that most people will receive an incorrect or late diagnosis at least once in their lives, sometimes with serious consequences. It cited one estimate that 12 million people — about 5 percent of adults who seek outpatient care — are misdiagnosed annually. The report also noted that diagnostic error is a relatively under-measured and understudied aspect of patient safety.
According to previous research cited in the new study, diagnostic errors “contribute to approximately 10 percent of patient deaths” and “account for 6 to 17 percent of adverse events in hospitals.” Graber estimates that the rate of misdiagnosis, although difficult to determine, occurs in 10 percent to 20 percent of cases.
“Diagnostic error is an area where we need more research, more study and more information,” said James M. Naessens, a professor of health services research at the Mayo Clinic, who led its study. “The second opinion is a good approach for certain patients to figure out what’s there and to keep costs down.”
The researchers looked retrospectively at 286 patients who had seen primary-care physicians, physician assistants and nurse practitioners in 2009 and 2010. Nearly two-thirds were younger than 64, and most were female.
With or without the help of their initial provider, those people sought additional advice from the Mayo Clinic’s internal medicine department. That makes the group somewhat different from the general population, Naessens said, because their conditions were serious enough to merit another look by some of the best physicians in the country.
“It’s not going to be 20 percent wrong every time” a patient goes to see a doctor, Naessens said.
In 62 cases (21 percent), the second diagnosis was “distinctly different” from the first, the researchers reported. In 36 cases (12 percent), the diagnoses were the same. In the remaining 188 cases, the diagnoses were at least partly correct but were “better defined/refined” by the second opinion, according to the study.
Naessens and Graber said a second opinion is valuable any time a patient is told he or she has a serious condition, such as cancer, or needs surgery — even if an extra visit initially means more expense. In the long run, additional advice can save lives and money, they said.
“Doctors are humans, and they make the same cognitive mistakes we all make,” Graber said. “If you are given a serious diagnosis, or you’re not responding the way you should [to medication], a second opinion is a very good idea. Fresh eyes catch mistakes.”
CMS (Centers for Medicare and Medicaid Services) has implemented a FIVE STAR RATING SYSTEM for all those providing care to those pts covered by Medicare/Medicaid/Medicare Advantage.
More STARTS means that the vendor GETS HIGHER REIMBURSEMENTS. Pts file GRIEVANCES to CMS ( www.cms.gov or 800-MEDICARE) about poor/unacceptable service will lower the vendor’s star rating… They get LESS MONEY !
There are a few disease states that CMS is focused on “helping” pts manage and part of that “management” is to make sure that you regularly take your medication. http://pqaalliance.org/measures/cms.asp
Barb was getting supper ready and HER CELL PHONE RANG and so I answered it… the woman on the other end ask to speak to me… and identified herself as working for our Part D provider.
All she asked for ID verification from me was the YEAR I was born in… not exactly EXTREME VETTING .. since she was going to discuss medication that I was taking.
She asked me if the number she called was a good number.. I told her NO.. since it was my wife’s cell phone .. which she seldom answers… you would think that she would then ask me a BEST NUMBER… but NOT HER…
She proceeded to inform me that one particular medications was DUE FOR A REFILL and named the pharmacy that we use. I knew that I had a few weeks worth of medication on hand and told her such… We normally get 90 days supply of chronic medication and the rules of this part D provider is that you can refill a prescription when 80% of the previous fill would have been taken… meaning that you can refill a prescription 18 days early.
It is normal for me if Barb has some refills… if I have some medications within the 18 day window… I will go ahead and refill them.. I did however look at the prescription bottle that they were referring to and technically I would not be out of medication for ANOTHER WEEK…
I find it hard to believe that this Part D provider really cares about my health, but more interested in their FIVE STAR RATING and their bottom line… since I have used this Part D provider for nearly FIVE YEARS and this is the first time that I have received a call from them about getting my prescription(s) refill on time.
My money is on that it would have to snow in July before they called me about refilling a controlled substance.
To me, this demonstrates how important it is for pt with Medicare/Medicaid/Medicare Advantage that they should file GRIEVANCES with CMS when they do not receive proper care from a hospital, prescription, Part D insurance, pharmacies and others. Remember healthcare is nothing more than a FOR PROFIT BUSINESS and putting “dings” on their FIVE STAR RATING … that will lower their reimbursements… is the only leverage a pt has.
