Programming errors led to overdoses with pain-medicine pumps

Building off a state health department report showing that, as The Morning Call’s Tim Darragh wrote, “Nurses at St. Luke’s Hospital three times in 2010 and 2011 improperly programmed patient-controlled pumps to deliver pain medication, causing patients to overdose themselves,” Darragh dug deep into each incident, uncovering patient details and adding perspective to the errors, which were severe enough that the feds decided the hospital’s patients were in “immediate jeopardy” until steps were taken.

In each of those cases and in three others, the nursing staff failed to document the errors properly, state investigators found.

Employees told the investigators that St. Luke’s did not require annual competency training on the pumps. Unnamed employees offered conflicting statements about when and whether all the staff had received retraining in 2010.

For their part, hospital officials say they have bought new patient-controlled pumps, developed a restricted dosage plan and retrained staff.

“When St. Luke’s nursing staff members identified the dosing pump programming issues, the events were promptly reported to all the appropriate individuals and regulatory agencies as outlined in our Network Patient Safety Plan,” said Carol Kuplen, chief nursing officer for St. Luke’s Hospital & Health Network.

“There was complete transparency in these events,” she said in an interview Thursday.

Related

Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, appeared at a newsmaker briefing at Health Journalism 2010 to announce an FDA initiative to reduce risks associated with infusion pumps. Log in to the AHCJ website to see his presentation and listen to his announcement.

• Press release: FDA Launches Initiative to Reduce Infusion Pump Risks
• FDA page on infusion pumps and FDA’s new safety initiative
• White Paper: Infusion Pump Improvement Initiative
• Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions
• Letter to Infusion Pump Manufacturers
• Public Meeting: Infusion Pump Workshop, May 25-26, 2010
• Generic Infusion Pump Project

Leaded aviation fuel a threat to public health, children

KUOW’s John Ryan used federal data and a few key sources to delve deep into issues surrounding one of the few remaining sources of airborne lead in the United States, a leaded aviation fuel known as “avgas.” In the process, he reveals damage that even low levels of lead exposure could be doing to children.

Avgas accounts for less than 1 percent of the nation’s liquid fuel use. Yet enough piston–engine planes fly enough miles on avgas to belch out half of all the lead going into the nation’s air.

Lead paint in old buildings remains a bigger threat, but even low levels of childhood exposure, one source tells Ryan, can manifest itself in “Decreases in IQ, changes in test scores, changes in attention, hearing threshold, all sorts of things like that.”

Earlier this month (January), an expert panel advising the Centers for Disease Control and Prevention cut in half the levels of lead in children that should alarm parents or doctors. Researchers have yet to find any level of lead exposure that doesn’t cause harm.

Michael Kosnett, a medical toxicologist at the University of Colorado, told Ryan, “In any one child, it’s not something that’s going to necessarily cause them to display any kind of signs and symptoms. But if you can lower the lead exposure of a population of children, you’re going to give that population more of an opportunity to have gifted children and to have children who have higher IQs, and that’s certainly a desirable public health goal.”

Marie Lynn Miranda, an environmental health scientist and a dean at the University of Michigan, points out that “Living close to an airport can increase your blood lead level anywhere from 2 to 4 percent,” acknowledging that is a small amount but that evidence indicates even small amounts of lead are bad. She also notes that “lead is especially a problem for the low–income families that are most likely to live near airports.”

Pilots who still use avgas say their businesses would be dead in the water if they couldn’t get the leaded fuel, an argument Ryan contrasts with quotes from a Europe-based lead-free avgas producer, who sells it for 40 cents less a gallon, but hasn’t been able to break into the U.S. market “Because no one thinks that there will be demand for an unleaded–grade aviation gasoline.”

The federal database Ryan used, The National Emissions Inventory, is posted online by the EPA.

Investigation delves into Wash.’s prescription drug problem

Everything time we think prescription drug abuse stories have peaked, something comes along to push the story further. This time, InvestigateWest’s Carol Smith sets herself apart by starting from square one and clearly explaining the origins and dimensions of Washington’s particularly nasty drug issues, tracing back each facet of the problem to its source and spotlighting what makes the Evergreen State unique.

Washington has been one of the hardest hit states in the country, in part because of aggressive prescribing practices. That, coupled with lack of oversight of doctors who over-prescribe, has led to the spectacular run-up in the number of deaths from prescription overdoses.

The backdrop for her work is an epidemic that shows no signs of abating, despite a recently implemented state law Smith calls “a bold attempt to reduce overdose deaths by launching the first-ever dosing limits for doctors and others who prescribe these medicines.”

Prescription drug abuse is at epidemic levels throughout the state, and elsewhere in the country, despite lawmakers’ attempts to get a grip on it. Washington now has one of the highest death rates in the nation. Deaths from prescription drug overdoses in this state have skyrocketed nearly twenty-fold since the mid-1990s, and now outstrip those from traffic accidents.

Why caused it to leap so quickly? Smith tracks down several key tipping points. “There’s plenty of blame to go around for what caused the epidemic,” she writes. “Aggressive marketing of opiates by drug companies, nonexistent tracking of overprescribing, lack of insurance coverage for alternative treatments for pain, and demand by patients for quick fixes, to name a few.”

She drills down into many of those causes, with my personal favorites being two key origin stories:

• How marketing by OxyContin maker Purdue Pharma led to relaxed guidelines for chronic pain treatment and a “1999 law specified ‘No disciplinary action will be taken against a practitioner based solely on the quantity and/or frequency of opiates prescribed,’” both of which helped cause a jump in prescriptions.
• How “the rise in the death rates of Medicaid patients tracks along with the state’s cost-saving decision to move many of its poorest residents to the cheapest, most potent pain reliever available: Methadone.”

See the upper right-hand sidebar for more stories from the six-month investigation.

NYT series digs into overprescription and developmentally disabled adults

In the series Abused and Used, New York Times reporter Danny Hakim and a host of his colleagues have been investigating how public resources are used to treat developmentally disabled New Yorkers. The series is ongoing, but hit an inflection point with the publication of Hakim’s piece on the few-strings-attached use of very powerful drugs to treat some of the state’s most vulnerable adult residents.

Developmental disabilities, Hakim writes, often manifest themselves in ways that are easily mistaken for mental illness, and these misdiagnoses can lead to unnecessary or improper medication. “In fact,” Hakim writes, “developmentally disabled residents of group homes in New York are more likely to be given Ativan, an anti-anxiety drug that has a tranquilizing effect, than multivitamins, the records show.”

Hakim’s reporting is rich with both anecdotes and data. These paragraphs from the series will give you an idea of how he approached the issue.

Tens of thousands of powerful pills created to treat serious mental illnesses like schizophrenia are given to developmentally disabled people in the care of New York State every day.

…a review by The Times of previously unreleased records, as well as interviews with state employees, clinicians, family members and outside experts, reveals that the psychotropic medications, which alter the brain’s chemistry, are often dispensed sloppily, without rigorous or regular review, by general practitioners with little expertise in the area.

And low-level workers at state group homes are frequently given discretion to increase the medication “as needed,” despite their lack of significant training.

Psychologists who have worked inside the system describe a culture in which the drugs are used to control the disruptive behavior of the developmentally disabled — people with conditions like autism, Down syndrome and cerebral palsy — an approach increasingly discredited in the field.

Reuters shows how shell companies hide Medicare fraud in plain sight

Reporting for Reuters, Brian Grow and Matthew Bigg used an analysis of public data to investigate the practice of using shell companies to defraud Medicare of millions while staying a step or two ahead of federal investigators.

While the specific damage inflicted by shell companies has not been tracked, “Last year, ‘improper payments’ resulted in $48 billion in losses to the Medicare program, nearly 10 percent of the $526 billion in payments the program made, according to a Government Accountability Office report last March.”

“Simply by reviewing the incorporation records of Medicare providers in two buildings” in Miami, they write, “reporters uncovered information that one government official said could prompt “a serious criminal investigation” of some of the companies.”

The fraud rings merge stolen doctor and patient data under the auspices of a shell company and then bill Medicare as rapidly as possible. Other shell companies are often layered on top to camouflage the fraud, law enforcement officials say.

Some of the shells purport to be billing companies; they form a buffer between the sham clinics and Medicare. Others pay kickbacks to doctors and patients who sign off on bogus medical claims or sell their Medicare ID numbers to enable the shell company to bill the government. Still other shells act as fronts to launder the profits.

The key to this kind of fraud, known as a “bust-out” scheme, is for each of the fake companies to bill as much as possible before authorities catch on. Shell companies become a tool that helps keep the crooks ahead of the cops.

The Armenian crime ring whose fraud made headlines last year used 118 shell companies in 25 states and bilked the feds out of at least $100 million. Varying incorporation rules make state-hopping and obfuscation “easy,” they write, especially since states don’t check to see if records are legit before they allow a company to incorporate. The reportes found that even a few simple safeguards would go a long way to detecting the boldest frauds.

In Florida, FBI agents say almost every Medicare fraud scheme involves shell companies. There, Reuters scrutinized incorporation documents for firms located in two buildings near the Miami International Airport. In a building with dimly lit corridors, a rickety elevator and almost no one in sight, a host of companies purport to provide services to Medicare recipients. But telltale signs of fraud abound.

Many of the 26 companies in the buildings had replaced corporate officers at least once in the last four years. Some had changed ownership, or their corporate executives represented more than one medical-related company. Law enforcement officials consider such activities to be red flags for fraud.

For its part, CMS told the reporters it simply didn’t have the resources necessary to conduct the widespread audits needed to catch fraud, though the $350 million allocated to such efforts under the 2010 health reform law should help.

Health journalists who will certainly want to review the “methodology” subheading at the end of the story.

AHCJ opposes taking taxpayer-funded research out of public’s reach

Congress should not roll back public access to taxpayer-funded research reports, AHCJ wrote in a letter to members of Congress (PDF).

AHCJ is opposing the Research Works Act (H.R. 3699), which would remove the public’s access to medical journal articles about publicly funded research. They are currently available for free to the public no more than 12 months after their publication in a medical journal.

“Our board of directors believes strongly that more transparency, not less, is vital for the public to assess how funds are spent and to benefit from and learn about the research underwritten by the government,” board president Charles Ornstein wrote in a letter to the House Committee on Oversight and Government Reform. “The recently introduced Research Works Act is a step in the wrong direction.”

In the letter, AHCJ rebutted medical publishers’ assertions that the current system doesn’t work.

“We understand the objections of such publishers, who contribute editorial support and fear loss of income,” Ornstein wrote. “But it’s worth noting that much of that support comes from unpaid peer reviewers. And publishers still maintain a year of exclusivity, enabling them to reap profits during the time when interest in research is highest.”

In 2010, AHCJ voiced concerns about a similar bill, which did not become law.

Project looks at problems in how deaths are investigated

The results of a yearlong joint investigation of the American autopsy system by ProPublica, Frontline and NPR show that problems in the death investigation system throughout the country have led to innocent people being sent to prison, “allowed the guilty to go free and left some cases so muddled that prosecutors could do nothing.” When autopsies aren’t done, diagnostic errors go undetected and opportunities to learn more about medicine are lost.

One story of patient rights and legal wrangling sports the remarkable headline “Why Can’t Linda Carswell Get Her Husband’s Heart Back?” It hinges, among other things, on the simple fact that “Even though the Institute of Medicine has reported that medication errors affect an estimated 1.5 million patients per year, it is not typical to conduct toxicology tests as part of clinical autopsies. They are routine in forensic autopsies.”

Another piece takes a broader view, exploring the reasons behind and consequences of the fact that autopsies are performed on only about one in 20 patients who die in hospitals when, 50 years ago, the rate was one in two.

Hospitals aren’t required to perform autopsies – the Joint Commission hasn’t included autopsy rates in its accreditation process since 1971 – and neither Medicare nor private insurers reimburse hospitals for the procedures, which Allen found cost about $1,275 each. The implications of these financial disincentives, combined with related factors such as some physicians’ confidence that new diagnostic tools such as MRIs and CT scans provide such accurate results that they obviate the need for postmortem work, are far-reaching.

Diagnostic errors, which studies show are common, go undiscovered, allowing physicians to practice on other patients with a false sense of security. Opportunities are lost to learn about the effectiveness of medical treatments and the progression of diseases. Inaccurate information winds up on death certificates, undermining the reliability of crucial health statistics.

Furthermore…

A 2002 review of academic studies by the federal Agency for Healthcare Research and Quality found that when patients were autopsied, major errors related to the principle diagnosis or underlying cause of death were found in one of four cases. In one of 10 cases, the error appeared severe enough to have led to the patient’s death.

Other stories in the project report that suspicious deaths of the elderly are rarely investigated and that the deaths of children “pose special technical challenges for forensic pathologists.”

Watch the full episode. See more FRONTLINE.

Journalism organizations ask HRSA to clarify how it will exercise restrictions

The Association of Health Care Journalists and five other journalism organizations asked federal health officials this week to specify how they plan to enforce new rules governing access to the public version of the National Practitioner Data Bank.

In a letter to Mary Wakefield, administrator of the Health Resources and Services Administration, the groups continued to express disappointment in the agency’s restrictions on the data bank’s Public Use File. In the past, reporters have used the file to expose faulty oversight of doctors by state medical boards.

The Health Resources and Services Administration removed the public file from its website in September after a complaint from a doctor who complained information on him was used inappropriately. The agency republished the data last month but put in place restrictions on how the data could be used.

Among the restrictions is a provision that bars users from matching data in the Public Use File with other data sources to identify physicians. If journalists or others are found to have violated the provision, they could be required to return the data and be barred from receiving it in the future.

In the letter to Wakefield, sent Wednesday, the groups asked for answers to several questions:

1. What process will HRSA follow to determine whether a reporter has violated the agreement? If a reporter identifies a doctor in a story and also had access to the Public Use File, how will the agency find out whether the reporter used the file to identify the doctor or got the information from another source? Will HRSA ask to see notes and talk to sources? What will the agency do if reporters decline to discuss their reporting methods beyond what appears in their stories?
2. What recourse will reporters have if they believe they have been unfairly barred from future access to the file?
3. If you ask a reporter to return data, will you take any steps to ensure the data hasn’t been copied or saved elsewhere? If so, what will those steps be?
4. How will HRSA address stories written based on copies of the Public Use File downloaded before Sept. 1? Such files are available without restriction on the websites of journalism organizations, and reporters do not need to sign any agreement to access them. Will reporters face penalties if they use the information in a way that HRSA objects to?

AHCJ president Charles Ornstein said he continues to believe that the new restrictions are both ill-advised and likely unconstitutional. But he added, “If HRSA intends to stick to them, it’s imperative that journalists understand how they will be enforced before deciding whether to use this information.”

Other groups signing the letter were Investigative Reporters and Editors, the Society of Professional Journalists, the National Association of Science Writers, the Reporters Committee for Freedom of the Press and the National Freedom of Information Coalition.

Investigative Reporters and Editors, working with AHCJ and the Society of Professional Journalists, has posted the data for download, free to the public.

For more background, please see AHCJ’s Right to Know page or this timeline.

Related

• Secrecy around data bank protects ‘Practitioner No. 222117′
• Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
• Agency’s restrictions on data about disciplined doctors continue to get attention
• Journalism groups protest HRSA restrictions to Sebelius

Secrecy around data bank protects ‘Practitioner No. 222117′

Alan Bavley of The Kansas City Star provides us with a stark illustration of why new restrictions on the use of the National Practitioner Data Bank are not in the public interest.

In the most straightforward example yet, Bavley reports on “Practitioner No. 222117,” a doctor whose medical licenses have been revoked or suspended by 20 states, who was banned from billing Medicaid or Medicare and whose license to prescribe was yanked by the Drug Enforcement Administration. Bavley learned all of that from perusing the data bank’s Public Use File.

The NPDB includes reports on malpractice payments and disciplinary actions involving health care professionals. Hospitals and state medical boards can use the data when deciding to grant staff privileges or when reviewing license applications, though AHCJ found state medical boards do that less than you might expect. The NPDB’s Public Use File, available for download on a public website, removes identifying information. Bavely’s article explains more about how they de-identify the data.

Despite all we know about Practitioner No. 222117, we don’t know if he or she is still practicing medicine. The public, including journalists, is restricted from using the data to identify this doctor.

In the past, reporters have used information in the Public Use File, in combination with other records, to identify to flesh out their reporting on troubled doctors and show the failure of medical boards to act against doctors with multiple malpractice awards.

That ended on Sept. 1, when the U.S. Health Resources and Services Administration, which runs the database, removed the public use file because one doctor complained about stories that Bavley was writing.

AHCJ, along with other journalism groups and patient-safety advocates, decried the database’s removal. In November, HRSA restored the Public Use File – but with restrictions on how it can be used. Reporters and researchers have to agree not to connect any individual to information in the database. Reporters can be barred from future access to the database if HRSA decides they have violated the rules. For more background, please see AHCJ’s Right to Know page or this timeline.

Florida hospitals sidestep state constitution, keep records under wraps

Writing for BrowardBulldog.org, an independent investigative news site serving South Florida, Amber Statler-Matthews reports that hospitals are going to what one man called “extraordinary lengths” to prevent patients from accessing records that, according to the Florida constitution’s “Patient’s Right to Know Act,” should be made available.

Seven years ago, Florida voters overwhelmingly approved a Constitutional amendment that gave patients who had been hospitalized the right to see reports dealing with botched medical procedures and poor care. While the amendment could be used to give patients vital information before a medical mistake is made, its practical and more much publicized purpose was to give aggrieved patients more power in court by opening up malpractice complaints and confidential internal reviews of doctors and hospitals.

In the years since the amendment, the state’s courts have been pressed on both sides, with hospitals dedicating considerable resources to throwing up “roadblocks and legal challenges to block access to patient records,” Statler-Matthews writes. “In response, patients across Florida are using the law to ask judges to pry open reports about medical errors.”

For more on how the battle has evolved and details on how Florida hospitals are circumventing the constitution, see Statler-Matthews’ full piece.

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