In what it calls a "new paradigm," the FDA is suggesting that certain drugs normally requiring a prescription become available without one. In other words, the agency states, a pharmacist would be allowed to freely dispense them.
That proposal has drawn strong criticism from the American Academy of Family Physicians (AAFP), which contends that it could "seriously compromise" a patient's care and result in serious medication errors and other medical harm.
]]> "This proposed new paradigm would allow patients to receive powerful prescription drugs without the input of a physician," noted AAFP chairman Roland Goertz, MD, in a recent letter to the FDA.The FDA counters that its proposal would apply only to a limited number of drugs -- such as EpiPens and glucagon, used in life-threatening conditions and sometimes needed quickly by users -- and would have several salutary effects for the medical industry in general.
Included among those, say FDA officials, would be the following: better access overall to doctors by sicker patients, since fewer routine visits would be required by patients seeking "safe use" medications; easier and quicker access to drugs deemed safe through pharmacies; and a reduction in health care costs systemically, given the reduced burdens associated with fewer physician visits.
The American Medical Association also opposes any new drug classification. The American Pharmacists Association, unsurprisingly, favors the FDA proposal,
Source: MedPage Today, "AAFP says no to 'safe use' class of drugs," Emily P. Walker, May 1, 2012
]]>Specifically, they think about the National Transportation Safety Board (NTSB), an independent and politically insulated safety organization that has essentially rendered airline safety the envy of other industries throughout the world. Medical reformers almost unanimously voice their approval of widespread emulation of NTSB processes and practices, which have worked to reduce the risks of dying in an airplane crash to about a one-in-10-million chance.
]]> As has been widely noted, medical facilities have already profited from borrowing many ideas that were born in the aerospace industry. Those include simulation training, adverse incident-reporting systems and safety checklists.Critics and reformers alike, though, say that such implementation, while salutary, does not go nearly far enough to curb what should be unnecessary medical harm being visited upon patients across the country.
One problem is that critically important information -- e.g., what the source was for an infection problem at one hospital; why a serious medication error occurred at another facility -- is not systematically and in a high-profile manner disseminated to hospital administrators and doctors in all facilities across the country and openly discussed, debated and learned from.
That is the way it is done in the aviation industry, where improvements and flaws are rapidly conveyed and applied across the board.
"The NTSB has pioneered wonderful best practices that are public domain, and a similar idea could be implemented to keep doctors from having accidents," says one retired radiation oncologist whose father was an Apollo rocket scientist.
"We've just started to learn what we can learn from aviation," he adds.
Source: American Medical News, "Celebrities make pitch for patient safety panel," Kevin B. O'Reilly, May 14, 2012
]]>In fact, that is precisely the "analysis" that often underlies a physician's calculations regarding the dosing instructions for a child taking a medication. In a word: Guess.
]]> That contrasts mightily to the detailed dosing information that is readily available for virtually every medication on the market for adults. The reason for the difference is that the exhaustive studies and clinical trials associated with many drugs are tailored toward and tested upon adult -- not child - users. The result for adults is precise information about how much of a drug to take, how many times per day and for how long of a period.When it comes to kids, though, and owing centrally to a lack of such information, many doctors just proceed based on a child's age and weight. Indeed, a recent study carried out by Harvard researchers reveals that 80 percent of all children hospitalized in the United States are given medications that have never been tested at all in kids and are approved by the FDA only for adults.
And, note the experts, dosing by weight is far from a foolproof way of prescribing drugs for kids and avoiding medical error. The latter are not mini-adults, and their body organs can metabolize drugs far differently than is the case with adults.
A recent study by FDA researchers indicates that less than half of nearly 500 drugs studied that are listed in the Physicians' Desk Reference -- deemed "the bible of FDA-approved drug labeling" - have adequate dosing information for children.
What can be done about that?
Medical experts point to a number of things, but most centrally to the need for congressional reauthorization of recent federal laws. Those enactments require drug companies to test more on products that will be used in pediatrics and also reward them for testing by providing an additional period of exclusivity once a product hits the market.
Source: ABC News, "How do docs prescribe kids' meds? Guess," Carrie Gann, May 8, 2012
]]>For some patients, though, especially those with a history of or the potential to develop angioedema, a dangerous swelling in the face and neck, the inhibitors are more akin to a medication error that can bring about dire -- even fatal - medical harm.
]]> Angioedema is far from a common outcome for patients taking ACE inhibitors, but that fact has not stopped one Philadelphia doctor from calling its development in about one percent of all patients an "unrecognized epidemic."The reason why, says James R. Roberts, the director of emergency medicine at Mercy Philadelphia Hospital and Mercy Fitzgerald Hospital, is that one percent equates to a significant number when the overall popularity of inhibitors is considered.
In fact, scores of millions of patients in the United States take ACE inhibitor medications for heart disease, stroke, diabetes, hypertension, kidney disease and other ailments.
That results in persons being rushed into emergency rooms across the country with regularity, often displaying symptoms that are difficult to treat. No medication slows or reverses angioedema, and doctors must sometimes work quickly to insert a tube through a patient's nose, mouth or throat that allows the patient to breathe.
That effort is not always successful.
"I've seen a number of deaths because you just can't get the tube in," says Roberts.
Roberts wants the FDA to add a "black-box warning" on the inhibitors that alerts doctors about the dangers of angioedema.
He is not the first doctor to request this. Ten years ago, the agency declined to add the warning when it was petitioned by another physician to do so.
Interestingly, the FDA states that it is "not aware of any requests to add a boxed warning to ACE inhibitors about the risk of angioedema," even though information concerning the earlier request to do so and the agency's refusal to act appears on the FDA website.
Source: Philadelphia Inquirer, "ACE inhibitor blood-pressure drugs can have a severe side effect," Marie McCullough, May 2, 2012
]]>At first blush, many people might reasonably conclude that the matter must involve a claim of hospital negligence or medical malpractice, but what is actually alleged is bad faith on behalf of IU Health, which runs a number of hospitals in Indiana.
]]> Specifically, the charge against IU Health is that it engaged in differentiated billing practices based on whether patients were insured or uninsured. The two patients suing the medical group contend that they, as uninsured patients, were grossly overcharged for medical treatment. One patient paid close to $16,000 for care that she states would have cost an insured patient about $7,300. The other states that the hospital would have charged him "significantly less" if he had been insured.The matter was initially dismissed by a lower Indiana court, but then reversed on appeal. The medical group is seeking reversal from the state Supreme Court.
That might not happen. A central focus of the case is on long-established state law that requires a contract without a set price to be "reasonable," and one often-applied standard for that is what other consumers were charged for the same service.
A relatively new federal law now mandates that hospitals bill uninsured patients similarly to insured customers. IU Health claims that it fully complies with that duty, but the instant suit involves billings that preceded the change.
As such, patients can sue over past billing practices, and some people closely watching the IU Health case say that a pro-plaintiff ruling could open the door for many other uninsured patients to also file claims. Those claims could include multimillion-dollar class action filings against IU Health and other entities.
Source: Insurance Journal, "Lawsuit targets Indiana's largest hospital group," May 1, 2012
]]>A recent report from Massachusetts reveals how widespread the problem of compromised personal information has become, and why it is occurring. It commands instant relevance nationally for hospitals, banks, retailers and others who handle confidential data.
The report leads with this jaw-dropping statistic: About half of all Massachusetts residents have had their personal information either lost or stolen in data security breaches.
Initially, the health care industry seems to come across as being a bit more responsible than other industries. For example, there have been only 214 breaches of medical information reported in Massachusetts during the past four years, compared with nearly 1,000 incidents in the financial sector.
Numbers, though, can be deceiving, since health care breaches owing to hospital negligence tend to result in larger leaks and effect comparatively more people. Those 214 breaches, for example, compromised the personal data of nearly one million people.
And the problem is mushrooming with the advent of and constant push for a complete overhaul to electronic health record systems. Many administrators and technicians simply haven't learned yet how to properly protect confidential information through encrypting electronic devices.
Until they do, data-breach stories similar to what we describe in this blog post will continue to surface.
Source: Boston Globe, "3.2m in Mass. have had data lost, stolen," Jenn Abelson, April 24, 2012
]]>That especially concerns allegations of medical malpractice, in which surgeons and their medical facilities often respond to complaints of hospital negligence by quickly putting up a preventive barrier that isolates them from a complaining patient.
]]> That, says one critic, automatically ensures what most hospital administrators and their legal staffs want to avoid most. Specifically, that is an adversarial relationship in which a patient who strongly feels that he or she has suffered medical harm will become more likely to commence a lawsuit to obtain justice and a legal remedy.Medical administrators at the University of Michigan Health System implemented a new response system about 10 years ago to deal with alleged acts of medical error that is underscored by candid communication between a doctor and patient regarding the latter's complaints.
The system -- which encourages a dispassionate atmosphere, apology where one is deemed necessary, a change in treatment or remedial care when it is warranted, and the offer of a financial settlement in some instances to avoid protracted litigation -- flatly works, say those who implemented it.
A number of hospitals in Massachusetts are now taking a similar vein, with an initiative they call the "Road Map to Reform."
Not everyone is an unquestioning fan. One plaintiff malpractice attorney notes, for example, that some patients might get inadequate compensation compared to what they could receive through formal litigation. Many others doubtless agree with that view.
It is tempered, though, as one patient's advocate says, "if a patient's rights are not limited in any way." Further, there is wide agreement among those concerned with patients' rights that any medical response system that encourages open discussion and disclosure of errors rather than hiding the ball and cutting off communication with patients is a good thing.
Source: Boston Globe, "One doctor's take on malpractice policy that calls for disclosure, apology, and often a settlement, "Chelsea Conaboy, April 23, 2012
]]>First and foremost, it can yield exceedingly dangerous results, introducing medication errors that can be deadly in many instances.
Second, it is flatly fraudulent. Investigators from the U.S. Food and Drug Administration (FDA) have stressed several times in recent months their concerns that some doctors may be buying cheaper fake medicines from foreign markets for use on patients in the United States. Doing so allows them to bill insurers for the legitimate and more expensive medicines.
]]> That could be what is happening with the cancer drug Avastin, made by Roche Holding. Avastin is a widely popular injectable drug used to treat a multitude of cancers. A single 400-milligram vial of the real medicine costs about $2,400.A medicine that is made abroad, lacks FDA approval and looks -- at least superficially -- like Avastin costs just a fraction of that, which makes it alluring to unscrupulous medical practitioners and marketers who can realize substantial profits from substituting it for the real thing.
Doctors doing so unquestionably commit an egregious act of medical malpractice, as well as engage in outright criminal fraud. One California doctor has already pleaded guilty to ordering fake Avastin.
A new batch of the counterfeit drug already circulating in the United States is packaged in boxes labeled as Altuzan, the brand name for Avastin in Turkey.
The FDA states that lab tests confirm the drug lacks a critical ingredient present in Avastin, which prompts their strong concern that patients using the counterfeit medication "may not be receiving needed therapy."
Source: The Wall Street Journal, "FDA finds new batch of counterfeit Avastin," Jonathan D. Rockoff and Christopher Weaver, April 3, 2012
]]>As we noted in the earlier post, reform advocates argue that limiting harmed patients' access to courts and capping their damage recoveries actually benefits consumers as a group because it leads to lower insurance rates.
]]> The response to that bit of reasoning by The Center for Justice & Democracy (CJD) is essentially boiled down to a two-word response: "Say what?"The group suggests that persons "who still swallow this argument" take a studied look at what is presently going on in California, where the tort reform movement first spawned some 30-plus years ago after legislators there capped non-economic damages for malpractice victims of hospital negligence. Since then, a $250,000 ceiling has been a mantra and rallying cry for medical and insurance lobbies in states across the country.
But has it worked? Has it led to lower rates?
Precisely the opposite, say CJD commentators. In California, it has merely served to bloat and enrich the insurance industry, with insurers paying out only small amounts of premiums collected from doctors.
Dave Jones, California's feisty and proactive Insurance Commissioner, has noted that and is challenging the insurance industry in that state. Last year he demanded that the top six California malpractice insurers submit paperwork related to their rates, and then he rejected them as being excessive.
The result? Substantially lower rates are now being offered by five of those companies.
Moreover, there is now a proposed initiative on the California ballot to give the commissioner even greater power to challenge the insurance industry on behalf of consumers.
That is the kind of strong and in-your-face action that the CJD states is necessary to protect the public and drive down insurance costs.
The group states its hope that similar action "spreads like wildfire across the country."
Source: The Pop Tort, "The real world -- California (insurance)," April 13, 2012
Tags: medical malpractice, tort reform, hospital negligence
]]>The group's website -- Pop Tort -- can be eminently direct, acerbic and hard-hitting, and it brings in-depth research, statistics and strong conclusions to bear in its articles regarding matters that especially concern it.
Like medical malpractice, for instance. What has drawn the special attention of CJD is an argument that it flatly considers to be spurious and without any foundation, namely, this: The reason that health insurance premiums are inordinately high is because the courthouse door is left too far open to too many plaintiffs claiming that hospital negligence caused them harm. This leads in turn -- and where caps on recoveries are not firmly in place -- to outsized jury verdicts that require doctors to maintain malpractice insurance that costs them far too much and requires patients to cough up ever-more money to pay for premiums.
]]> The flip side of the argument, as stressed by medical groups and administrators: Shut the door more tightly on malpractice complaints and recoveries and the costs will go down. Insurers will be paying out less because insuring doctors' practices will become a significantly lower risk, and the monies saved will be passed along to consumers. In short, limiting patients' court access and legal recoveries for injuries suffered will actually benefit the system as a whole.That reasoning doesn't exactly resonate with CJD or any other consumer advocacy group in the country. Indeed, critics across a broad range find it disingenuous and directly inimical to consumers' best interests.
The CJD has a lot to say on the matter. We will delve into that into our next blog post.
Source: The Pop Tort, "The real world -- California (insurance)," April 13, 2012
]]>That is a question that is being asked a lot in the wake of a study by researchers of Johns Hopkins Bayview Medical Center in Baltimore. The research team examined how personnel at a 410-bed academic medical center interacted with a computerized provider order entry (CPOE) system over a recent one-year period.
The bottom line: Mostly, they just ignored it, which is a reaction fundamentally at odds with what is hoped for by hospital administrators, who see CPOE systems as strong safeguards against medication errors.
]]> What is the problem? Put another way, wherein lies the primary disincentive with working with the warning system to guard against patients' allergic reactions, bad interactions with other medications that a patient is taking, duplication error and other adverse events?The researchers cite "alert fatigue," that is, the simple fact that those ordering prescriptions get burned out by being consistently confronted by an electronic system that many of them say is difficult and frustrating to work with.
One problem with the system that the Johns Hopkins team scrutinized is that, following a drug order, every conceivable warning pops up on the same screen in undifferentiated -- in fact, in identical -- size and font. The person looking at the screen has no indication that one potentially adverse outcome might be any more common or dire than another.
Instances of medical error and harm will not be reduced, the researchers state, without revision of CPOE systems "to more clearly differentiate between types of warnings and, in particular, to distinguish the warnings that are most likely to have severe consequences."
Source: Medpage Today, "Drug warning alerts largely ignored," Nancy Walsh, April 6, 2012
]]>WellCare Health Plans Inc., a Florida insurer, has just found out how seriously the U.S. government views such wrongdoing. The insurer has just agreed to pay $137.5 million to the federal government and nine states to relieve itself of civil liability for its inflated billings and other illegal acts committed over a multi-year period.
]]> Trouble seems to follow WellCare. In 2009, the insurer was embroiled in a criminal investigation that led to charges against a number of executives at the company's highest level. WellCare ultimately paid $80 million to resolve those charges.The current settlement covers four separate lawsuits filed against the company under the U.S. False Claims Act. That legislation is often driven initially -- as was the case with WellCare -- by an individual whistleblower stepping up to inform the government of fraudulent acts committed internally at a company. In WellCare's case, those centrally involved bilking Medicare and Medicaid by overstating what the company paid for medical care and illegally retaining overpayments.
Four whistleblowers collected money for their roles in reporting the fraud. One of those persons received $20.75 million.
An added exaction on the company is that it will be forced to pay $35 million more if it engages in any change in control within the next three years.
Source: Bloomberg, "WellCare to pay $137.5 million to settle False Claims case," David Voreacos, April 3, 2012
]]>The history of the implants now tells a markedly different story and is manifest with tales of patients' pain and high failure rates.
The Johnson & Johnson DePuy hip replacement, for example, has now been embroiled for several years in a massive amount of medical malpractice and product liability litigation. Patients around the world are experiencing failure -- with often excruciatingly painful results and the need for remedial corrective surgeries -- at a rate far higher than what is experienced for implants made of other materials.
]]> That dismal track record and the many tragic stories that attend it have been a clarion call for federal regulators. In response to hundreds of thousands of patients with MoM prostheses who are being described as being "at elevated risk of device failure," the U.S. Food and Drug Administration (FDA) announced recently that it will convene an expert panel to take a comprehensive look at MoM technology -- risks, benefits, failure rates, marketing requirements, practitioners' recommendations -- in an upcoming two-day hearing to be held in late June.The discussion promises to be lively and, in some cases, wrenching. Evidence described as "strong" indicates that the metals in MoM implants cause toxicity to body organs and genetic damage in some patients. Long-term disabilities are not uncommon with MoM hip-replacement patients, with many suffering extensive damage to lymph nodes, kidneys, livers and spleens.
Source: Medscape News Today, "FDA to hold hearing on metal-on-metal hip replacements," Mark Crane, March 29, 2012
]]>The incident resulted in two deaths, with seven other people being injured, and the Allegheny County District Attorney says that a long and disturbing trail of clearly documented evidence indicates that John Shick, the shooter, should have been involuntarily committed at least a month prior to the tragedy.
Recent comments from Stephen A. Zappala Jr. and other law enforcement officials suggest that investigators are including hospital negligence, medical malpractice and even knowing disregard as potential causes for why Shick remained at large when he was manifestly dangerous to the community. Zappala referred to the "corporate criminal liability theories" existing in Pennsylvania criminal statutes during a press conference last week, and made reference to "knowing disregard or reckless conduct" that might have been displayed by medical officials.
]]> Indeed, the paper trail appears both lengthy and progressively alarming for the manner in which it presents a timeline sequence of unfolding events that arguably should have led UPMC doctors and administrators to take quick action to have Shick confined.A brief summary of developments indicates the following. First, Schick -- a graduate biology student -- was barred from Duquesne University last November for sexually harassing women. He was subsequently diagnosed by a Western Psych doctor with a depressive and anxiety disorder. Shick's mother informed the doctor that she was concerned with her son's behavior. Shick skipped multiple follow-up appointments at the facility and, from January, the appointments he did make were notable for being volatile and for Shick's expressed hostilities.
Shick twice threatened UMPC employees with a baseball bat. A doctor did follow up on that, seeking to have Shick involuntarily committed, but the matter was never carried through.
Zappala says that UPMC should have firmly acted at that point and that Shick "should have been taken to an emergency room on that basis."
The father of a young man killed by Shick says that he is simply angered by UMPC officials' failure to take action regarding Shick based on how much they knew about him.
"The more you think about it," he said, "the more it drives you crazy."
Source: Pittsburgh Post-Gazette, "Officials believe Shick should have been committed for an evaluation," Sean D. Hamil, Moriah Balingit," March 29, 2012
]]>Critics comprising a broad coalition of groups and interests -- including patient safety advocates, many state lawmakers, legal scholars, and individuals and organizations who want to ensure accountability in the medical industry and proper recourse against medical negligence and malpractice -- have a decidedly different response.
]]> One principal advocate for a national group focused on patient safety and justice fairly well sums up in one word the collective viewpoint of the vast opposition aligned against the bill.He calls it "obscene."
And, indeed, Gary M. Paul, the president of the American Association for Justice, readily elaborates on that assessment.
"Instead of focusing on patient safety, Congress voted to strip away the legal rights of injured patients, reduce accountability and leave Americans at risk for more injuries from negligent care," he says.
The bill was passed after proponents fought off more than two dozen amendments that sought to weaken certain of its provisions. Centrally, the legislation greatly dilutes court access and remedies available to persons harmed by medical error through tightly circumscribed caps on damage awards and by reducing the time in which an injured person can legally bring a claim.
Unsurprisingly, more than 100 medical organizations strongly backed the legislation.
The bill must still pass through the Senate, where close observers say it will face much harsher scrutiny and a more difficult path than it traversed in the House chamber.
Critics vow unrelenting resistance against the legislation.
Source: Sacramento Bee, "AAJ statement on House passage of H.R. 5," March 22, 2012
]]>