Showing posts with label its. Show all posts
Showing posts with label its. Show all posts

Thursday, March 27, 2014

FDA Warns LifeScan About Its Meters

On December 7, the FDA sent a warning letter to LifeScan, Inc. concerning possible incorrect measurements on its blood glucose monitors. The letter was posted on the FDAs site on December 20. You can read it here.

The letter was a culmination of correspondence between LifeScan and the FDA which began in April when the FDA sent inspectors to LifeScans California plant. Shortly after that inspection began, LifeScan posted a press release discussing possible issues with its meters:

If you use a OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash®, or SmartScan® Meter, we want to make you aware of two possible issues regarding these products.
  1. Your meter is designed to show results in two different units of measure. When setting your meters date and time, it is possible for you to accidentally change the unit of measure.
  2. Very rarely, an event such as dropping your meter while in use can cause a brief power loss. As a result, the meter may unexpectedly change the unit of measure and/or the code number.
- LifeScan Press Release, April 14, 2005

If youd like to check your meter, visit LifeScans site for more information including correct device settings. Youll find a list of contact phone numbers and an email response form there too.

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For the FDAs warning letter:
LifeScan, Inc. Warning Letter

For LifeScans page on how to check your meter:
URGENT: MEDICAL DEVICE CORRECTION -- OneTouch® Ultra®, OneTouch® FastTake®, InDuo®, EuroFlash® and SmartScan®

Some news summaries:
FDA Warns About Faulty Blood Sugar Monitors
FDA Warns Maker of Blood-Sugar Monitors

Sunday, February 16, 2014

Questions Surrounding Avandia� and its Effect on Bone


A small study to be published in an upcoming issue of the Journal of Clinical Endocrinology & Metabolism found that postmenopausal women who took Avandia® (rosiglitazone) at 8mg/day for 14 weeks had greater reductions in hip bone density than women in a control group:
  • - Total hip bone density fell in the Avandia group by 1.9%
  • - Total hip bone density fell in the placebo group by 0.2%
Leading authors to conclude:
"Short-term therapy with rosiglitazone exerts detrimental skeletal effects, by inhibiting bone formation."

A reduction in bone density could increase the risk of fractures. That wont be welcome news to women with diabetes who already experience an increased risk of fractures - a finding reported by this journal last year.

Reuters reported:
"Morgan Stanley said in a note that an osteoporosis warning was now "very likely" to be added to the drugs label."

________

Avandia study, free author manuscript (pdf):
The peroxisome-proliferator-activated receptor-gamma agonist rosiglitazone decreases bone formation and one mineral density in healthy postmenopausal women: a randomized, controlled trial

Avandia study, abstract:
The peroxisome-proliferator-activated receptor-gamma agonist rosiglitazone decreases bone formation and bone mineral density in healthy postmenopausal women: a randomized, controlled trial

Reuters news summary:
New study fuels bone fears over Glaxos Avandia

JCEMs diabetes and bone fracture study, abstract:
Risk of Fracture in Women with Type 2 Diabetes: the Women’s Health Initiative Observational Study

Tuesday, February 11, 2014

An Update On Population Health Management Its Working!

CMS, MA Plans & Disease Management?
Its a good day when Health Affairs has nice things to say about population health management (PHM).  After all, Health Affairs is one of the bedside reading options for inside-the-beltway health care elites. So, when hostility to Ver. 1.0 disease management turns into a reasoned summary of Ver. 2 PHM, thats not only evidence of PHMs success but waning anti-vendor ideology. While the ultimate success of PHM is a function of market demand, this kind of endorsement cant hurt.

Using the Care Continuum Alliances definition of PHM, researchers from Americas Health Insurance Plans (AHIP) and Brandeis University conducted a written and then telephonic survey of 42 out of 72 larger Medicare Advantage (MA) Plans. While the results were interesting, what caught the Disease Management Care Blogs eye was that.....

Disease and case management are "routinely used." These programs are made up of nurse hotlines, telephone visits, increasing access to social services, meeting patients psychosocial and providing care coordination. An accompanying infographic says "100%" offer "teaching chronic disease self-management."

Health risk assessments are also used "universally" and target self-identified individuals with outreach designed to educate and/or enroll in programs that reduce risk factors.

Care managers for the frail elderly are available in "100%" of plans. A second infographic points out that home safety, in-home visits and community services errals are among the top used interventions. And, as testimony to a lingering sense of skepticism over remote home monitoring, the infographic says that was only used in 56% of plans.

Unlike Medicare fee-for-service (FFS), hospital readmissions have been a top concern of the MA Plans for years. They know there is no single "silver bullet" and have long relied on a combination of nursing, social services, home-health visits, medication reconciliations, follow-up care coordination programs and home visits. Survey respondents were convinced their programs were "effective."

In other examples of MA Plans being light-years ahead of Medicare FFS, if providers need data, MA Plans will make it available. If payment orm is necessary, MA Plans will make deals involving global risk arrangements, bundled payments and shared savings.

Evidence? Regretfully, say the authors, there is a lack of "systematic evidence" supporting PHMs effectiveness.  They also believe that there is conflicting evidence on whether MA Plans achieve better outcomes versus Medicare FFS.

The Disease Management Care Blogs take:

While skeptics continue to believe that Medicare Health Support "proved" that "disease management" doesnt work, the MA Plans correctly surmised that MHS only proved that early versions of disease management in Medicare FFS settings doesnt work.  The MA Plans have figured out how to improve on disease management.

While published data may be lacking, the people who run MA Plans are not dunces.  They have internal data showing that it works, or they wouldnt be using it.

While the Medicare Advantage program is controversial, the Health Affairs post suggests the MA Plans are useful laboratories for seeing what can be of benefit in the care of Medicare-eligible seniors.  If ACOs flop, perhaps CMS will go back to the future with their MA Program for ideas on what can work.

Tuesday, January 28, 2014

If It Can Be Digitized Its Transport Can Be Commoditized Implications for Health Care Providers

Navy telemedicine, coming
to a clinic near you
The Disease Management Care Blog is not only a simultaneously superb and humble physician, its a needy and impatient patient.  In the course of recently seeing one of its doctors, it endured having to arrive early (waiting room), getting past the dreary check-in line (confirming my zip code again?), answering all the the nurses inane questions (no, I dont have pain), seeing the doc ("Yup! Everything is fine!") and getting out (with an after-visit summary). It was a time consuming hassle that ate up half of a day.

The time is ripe for some disruptive technology.

Enter this highly interesting video by futurist Edie Weiner, who illuminates the underestimated links between "digitization" and "commoditization." While Ms. Weiners point had more to do with the generalities of mainstream data processing, the DMCB thinks there are parallels in health care that have important downside implications for the industrys knowledge workers.

And the most vulnerable of those knowledge workers are the primary care physicians, because, thanks to digitizing of patient information, a lot of physician office visits will be going away.  Thats not only a lot of disruption, thats a lot of income.

The DMCB explains:

Recall that a "commodity" is any market good or service that is supplied without qualitative differentiation. Classic examples include wheat, copper and oil, which are bought and sold on the basis of upstream supply and downstream product demand (such as bread, computers and gasoline).

What does this have to do with health care?  While the physician DMCB is not saying that humans are the same as wheat, copper and oil, that doesnt mean that their symptoms and treatment cant be digitized.

Before you scoff, recall that the management of upper respiratory illness can be distilled down to a fairly simple algorithm. The same is arguably true for other myriad conditions such high blood pressure, diabetes mellitus and even heart attack.  "Inputs" including age, gender, concurrent conditions, disease severity, medications and other factors can be digitized.  This, in turn, can be informatically processed to create evidence-based treatment recommendations from afar.

Until now, the new paradigms associated with health care orm still rely on the assumption that patients with their colds, hypertension, diabetes and chest pains will continue to personally bring their medical problems to the doctors office.  Whats supposedly "new" is that advances like the teaming of a medical home, the decision support of an electronic record or the incentives of value-based insurance designs would make the office visit a more rewarding, efficient, effective and less costly affair. All well and good says the DMCB, but even with a new wrapper, its still destined to remain a dreary and time-consuming office visit.

Thanks to Edie Weiner, the DMCB suggests that that business model and all those caully laid policy assumptions could blow up.

Heres why.

Our clinic-based and see-the-doctor approach to care is being eclipsed by an approaching "perfect storm" made up of four key ingredients:

1. Highly organized electronic databases.  Not to be confused with electronic health records, this is the access of updated and easily accessible patient information, plus

2. Networked patient monitoring systems. This is periodic assessments of, for example, blood pressure, glucose levels and EKGs in persons with hypertension, diabetes and heart disease, plus

3. Artificial intelligence-backed decision support. While this may not be ready for prime time in the average doctors office or via a voice-activated smart phone, the recent broadcast of the game show Jeopardy featuring IBMs Watson showed us just whats possible, plus

4. A tipping point of consumer acceptance of informatics. The DMCBs spawn have applied their mobile devices to every part of their lives, why not their health care?

In a traditional care setting, patients assemble their concerns (the "data") and personally transport them to the doctor (the "processor"), who renders a treatment plan. Thanks to the four-fold perfect storm described above, the digitization of patient information will enable patients like the DMCB to avoid the high opportunity costs of a usual-care office vist.  The DMCB will be able to use the network. In effect, its the transport of the DMCBs information that will, in a round-about way, be "commoditized."

In some respects,its already begun. Because patient problems can be be digitized, packaged and transported just like all the worlds other data that are described by Edie Weiner, video physician visits, decision support-backed nurses and touch-screen kiosks are now processing the information and rendering treatment recommendations outside the office visit.

What will this mean?  Many diagnoses can be made remotely. Treatment plans can be adjusted without need for a face-to-face visit. Oversight can be provided by non-physicians.

In tomorrows post, the DMCB will review the implications and what it means for primary care physicians.