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.
Photo by Felix42 via Flickr.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
Reporters find heart devices skipped FDA’s more rigorous approval process
Deborah L. Shelton and Jason Grotto of the Chicago Tribune couldn’t help but wonder: How does a medical device get implanted into patients without first getting FDA approval?
Tricuspid valve in a model heart. (Photo by robswatski via Flickr)
That question led to their two-day series in late May that reported for the first time that certain heart valve repair devices had been “down-classed” from class III to class II, a regulatory category that required that they undergo less scrutiny, even though the devices are permanently implanted and life-sustaining.
One of the annuloplasty rings had been stitched into the hearts of at least 700 patients in Chicago and elsewhere without going through proper channels. In fact, even though the company could have submitted both rings for clearance through a less rigorous regulatory pathway, it didn’t even do that. In these two cases, the process was skipped in its entirety.
In this article for AHCJ members, the pair explains how they reported the story, including finding documents and persuading affected patients to speak on the record.
Journal Sentinel details public health investigation into tainted alcohol wipes
Last week we shared the story of how MSNBC.com reporter JoNel Aleccia uncovered the FDA’s failure to take action on contaminated products manufactured by a Wisconsin company.
Shanoop and Sandra Kothari of Houston claim tainted alcohol prep wipes led to the death of their son, Harrison Kothari, 2. (Photo courtesy of MSNBC.com)
One couple believes alcohol prep pads used on their son were tainted with a bacterium, leading to his death. Aleccia shared with AHCJ members how she covered each step of the story, including what documents were useful and how she got them, to find that the FDA had known about problems in the manufacturer’s plant as early as 2009.
Now, Raquel Rutledge and Rick Barrett of the Milwaukee Journal Sentinel have written a detailed narrative about the FDA’s oversight of the Triad Group and H&P Industries, as well as the death of 2-year-old Harry Kothari and illnesses at the Children’s Hospital in Aurora, Colo.
Their narrative tells of the public health investigation, with FDA investigators visiting the factory day after day for weeks, children in Colorado getting sick and epidemiologists trying to find the source, the role of purchasing groups, Kothari’s death and the FDA’s heavily redacted inspection reports.
Beat reporter uncovers FDA’s failure to take action on contaminated products
Filed under: Government, Public health, Public records
What happens when health care products that are supposed to protect against infection and illness turn out to be contaminated with potentially deadly bacteria?
Shanoop and Sandra Kothari of Houston claim tainted alcohol prep wipes led to the death of their son, Harrison Kothari, 2. (Photo courtesy of MSNBC.com)
Even worse, what happens when the federal agency that’s supposed to oversee the safety of the products concludes that shoddy sterilization and known contamination don’t pose “an imminent health hazard?”
JoNel Aleccia, an MSNBC.com health reporter, unraveled the dual threads of human harm and regulatory mistakes.
In this article, she shares with AHCJ members how she covered each step of the story as it unfolded, including what documents were useful and how she got them.
Potential changes in regulation of medical devices would likely impact health care costs
As the medical device industry ramps up its campaign against further government regulation, Merrill Goozner takes stock of the regulatory and business environment in that arena and explains what is at stake. The key battleground at present is possible modifications to the 1976 law which allows devices to bypass some rigorous testing as long as they’re similar to something that has already been approved for market. The problem? That similarity doesn’t always mean they’re safe, as Goozner points out.
Photo by AlishaV via Flickr
A study published earlier this year in Archives of Internal Medicine found that of 113 major product recalls between 2005 and 2009, only 19 percent had gone through the more rigorous clinical trial testing required for new products, while 71 percent had used the follow-on process. There had been only 49 major recalls in the prior five years.
Despite slipping onto market through the similarity provision, many of these new products claim to be improvements over their predecessors and thus come with commensurately higher price tags. According to Goozner and his sources, this little disconnect has done quite a bit to increase the cost of health care in America.
“Requiring evidence of benefit of effectiveness for patients before device approval would prevent billions of dollars from being spent on technologies that are not helpful for patients and are even harmful,” said Rita Redberg, editor of the Archives of Internal Medicine and a cardiologist at the University of California, San Francisco. “There are many examples, such as vertebroplasty and kyphoplasty for back pain [compression fractures], on which Medicare spends approximately $1 billion annually. After they were FDA-approved, randomized clinical trials showed they were no more effective than a sham procedure in relieving symptoms.”
The device industry, often cited for its red-hot growth rates in the past, now posts numbers that, while huge, still lag behind the health sector at large. That may be why the industry is stepping up political pressure to reduce its regulatory burden and to sidestep a 2.3 percent excise tax that was passed as part of recent health care reform efforts. For more on the money and politics involved, see Goozner’s full piece, which was also published in The Fiscal Times.
Related
- Medical device investigation unearths conflicts, regulatory issues
- House Committee on Oversight and Government Reform hearing: FDA Medical Device Approval: Is There a Better Way?, June 2, 2011
FDA creates embargo policy in response to reporter concerns
The Food and Drug Administration has adopted a policy on embargoes that permits reporters to share embargoed information with outside sources, provided the sources agree to uphold the embargo.
The policy explicitly supports embargoes as a way for reporters to add depth and detail to their stories, and conforms to common practice among medical journals and other sources of complex information.
The policy was shared with AHCJ this week after complaints from the organization earlier this year. In January, the FDA barred reporters from interviewing experts about new regulations on medical devices until the embargo lifted. AHCJ wrote to the FDA that such an approach created obstacles to serious journalism.
In an embargo, the group releasing information chooses the time and date that it will be made public, and reporters get an advance look as long as they agree to delay publication or broadcast until that time. Reporters are willing to do this because it allows time digest the information and seek comments from experts.
In a letter this week to AHCJ, the FDA outlined its policy going forward:
“A journalist may share embargoed material provided by the FDA with non-journalists or third parties to obtain quotes or opinions prior to an embargo lift provided that the reporter secures agreement from the third-party to uphold the embargo.”
The letter, from Meghan H. Scott, FDA’s acting associate commissioner for external affairs, said the FDA did not previously have a policy on embargoed news. After AHCJ’s inquiry, she wrote, the media staff met with AHCJ members, other journalists, and editors of medical and scientific journals as it worked to develop a policy.
“The FDA is committed to a culture of openness in its interaction with the news media and the public,” Scott wrote to Charles Ornstein, AHCJ president, and Felice Freyer, chair of AHCJ’s Right to Know Committee.
She specified that the FDA may provide embargoed information when:
- the issue is not related to regulatory or enforcement issues and does not contain confidential, commercial information; and
- the subject is complex or technical and early access to materials and subject matter experts will help reporters prepare their articles in a timely, accurate manner with the context needed to understand the material.
“We’re grateful that the FDA media staff took the time to study the issue and develop a suitable policy,” Freyer said. “The results are clear rules that are reasonable and workable – and a step forward in improving relations between the FDA and the media.”
VA centers in 30 states, D.C. used recalled wipes
JoNel Aleccia of MSNBC.com continues her reporting on tainted and recalled alcohol prep pads, finding that “A quarter of the nation’s Veterans Health Administration medical centers and the agency’s outpatient mail-order pharmacy used recalled alcohol prep pads and other products …”
The FDA has identified problems with contamination and sterilization at the plant where the products were manufactured and hundreds of millions of products were recalled because of the threat of bacterial contamination.
The VA says “38 of the country’s 152 major veterans medical centers in 30 states and the District of Columbia removed recalled wipes, pads and other products from use” and “products were removed from the Consolidated Mail Outpatient Pharmacy, which provides more than 97.4 million prescriptions a year to veterans.”
Previously, the FDA the company that manufactured the wipes refused to identify which hospitals used the products, but Aleccia has obtained and published a list of the affected VA facilities.
Recalled povidone iodine prep pads from the same company also have been included in first aid kits intended for animals, such as this equine first-aid kit.
Previous coverage:
- Parents blame toddler’s death on tainted wipes
- FDA knew of problems at plant that made tainted wipes
- FDA defends actions on tainted wipes
- Colo. hospital blew whistle on tainted wipes
- Pressured firm closes line that made tainted wipes
- Infection risk triggers new recall of wipes
- Two-thirds of alcohol wipes contaminated
- FDA asks maker of tainted wipes to stop production
- Senators question FDA’s response to tainted wipes
- Wipe-maker shuts doors after U.S. Marshals arrive
- Feds seize $6 million in products from wipe-maker
Presidents of AHCJ, SPJ call for more openness from Obama administration
The presidents of the Association of Health Care Journalists and the Society of Professional Journalists published an op-ed in The Washington Post this morning, criticizing the lack of openness within the Obama administration and calling on officials to improve the flow of information to journalists and the public.
Charles Ornstein
“Democrats criticized the Bush administration for not making decisions based on the best science,” wrote AHCJ’s Charles Ornstein and SPJ’s Hagit Limor. “But the Obama administration now muzzles scientists and experts within federal agencies. When they are allowed to talk about important public health issues, a chaperone often supervises every word. These constraints keep the public from learning whether decisions are science-based or politically motivated.”
AHCJ has been very active in advocating for government openness, including a recent series of meetings in Washington, D.C., with officials from the U.S. Department of Health and Human Services and its related agencies. The organization has urged the FDA to re-examine a policy that prohibits reporters from sharing embargoed materials with sources before the embargo lifts for the purpose of obtaining outside comment and context. Board members from AHCJ also have worked with state health directors to encourage dissemination of more information during public health outbreaks.
“We remain hopeful that our ongoing conversations with HHS and its agencies will help improve the current climate, which isn’t working for journalists or the public,” Ornstein said. “Our members are interested in timely, meaningful responses to their questions, additional access to scientists and health experts, and speedier responses to their Freedom of Information Act requests.”
Skyrocketing drug price is chance to examine manufacturing, FDA approval process
St. Louis Post-Dispatch reporter (and Midwest Health Journalism Program Fellow) Jim Doyle has put together a series of stories on KV Pharmaceuticals that read like a primer on the confounding economics of drug manufacture and FDA approval. In the stories, especially the first and last installments, Doyle presents the big picture and helps readers understand why the systems work they way they do.
The first story shows how FDA approval could end up sending the price of a prenatal drug skyrocketing 16-fold and earn piles of money for a local pharmaceutical company. The second involves a U.S. District judge condemning a former head of that same company for “greed, abuse of power, recklessness.” Finally, he ends his tour of pharmaceutical avarice with a stern warning about the potential longterm costs, both monetary and medical, that could result from the fast-track approval of the drug whose approval formed the basis of the first story. For lots more about KV Pharmaceuticals, be sure to check the “Related Reading” box on this page.
Further reading
If you’re looking for more on KV Pharmaceuticals and the Orphan Drug Act, check out Ed Silverman’s post on Pharmalot. There, he interviews a nonprofit advocate who helps explain how KV’s manipulations were possible, how it could happen again and how the act should be modified.
AHCJ leaders hold series of media access meetings with government officials
Filed under: Government, Health journalism, Public health
AHCJ representatives held a series of meetings in Washington, D.C., last week to press for government openness at the state and federal levels.
AHCJ President Charles Ornstein and board member Felice Freyer (chair of the 
organization’s Right to Know Committee) met with representatives of the Health and Human Services Department, the Food and Drug Administration and the Centers for Medicare & Medicaid Services, as well as 12 newly appointed state health directors organized by the Association of State and Territorial Health Officials.
The federal officials professed a commitment to openness, within limits, and promise to look into specific requests to further that goal. The state health officials, who heard a panel presentation about working effectively with reporters, were receptive and eager to talk with AHCJ about building relationships at the state level.
Read more for details from each meeting …
Related
Freyer will moderate a panel on this topic, “Right to know: Getting information from government agencies,” at Health Journalism 2011. The panel features Peter Ashkenaz, director of communications, FDA Office of Regulatory Affairs; Lisa Chedekel, senior writer and co-founder, Connecticut Health I-Team; Lucy A. Dalglish, executive director, Reporters Committee for Freedom of the Press; and Lilian Peake, M.D., M.P.H., director, Thomas Jefferson Health District, Virginia Department of Health.
- Reporter runs into wall requesting public records from FDA
- AHCJ asks FDA to re-evaluate embargo policy
- Health officials, journalists agree information is key in public health crisis
- Journalists, officials discuss information released in public health emergencies
- Committee works to improve access to experts, officials
- Health journalists cite uneven disclosure of H1N1 deaths across country
- Major journalism groups demand agency end newsgathering constraints
- AHCJ objects to federal agencies’ handling of story embargo
- AHCJ calls on new administration to improve access to federal experts
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- Tips for print, online journalists to embrace broadcast opportunities
- Numbers reveal how often, or how rarely, states check doctors’ disciplinary records
- How I did it: Falsified charts in nursing homes linked to patient care
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- Transparency & medical errors: Public reporting of patient harm is a potent force
