Here’s an interesting clinical dilemma brought to my attention by another physician.
She was asked to refill a prescription for a drug called domperidone to help a patient with lactation. Domperidone is not FDA approved in the United States for any indication. However, in Europe and in Canada it is approved as a promotility agent for patients with a condition called gastroparesis, which causes the stomach to empty very slowly and results in chronic nausea and vomiting. As a side effect the drug is also known to increase the production of prolactin, a hormone that stimulates milk production. In the case of this physician’s patient, she had adopted a child and found that the medication had effectively enabled her to produce milk and nurse, with seemingly no untoward effects. It’s unclear who had initially prescribed the drug, but various online lactation support forums discuss it as an option for women who have trouble with lactation.
The questions: Is it legal, ethical or good medical practice for a physician in the United States to write a prescription for domperidone for a patient who has been using it for lactation with good results? How about for gastroparesis? Where does one get the drug? Is it even legal to sell the drug in the United States?
I’ve cared for at least two patients who have used domperidone. In both instances it was ordered by prescription from an overseas source by a local gastroenterologist. In these two cases my patients had tried just about everything on the market in the United States for gastroparesis and were still struggling with debilitating symptoms. In one case, my patient had required hospitalizations and ultimately a feeding tube because of intractable vomiting. The drug was ineffective in both patients and it was eventually discontinued.
Continue reading “Should a Doctor Prescribe Drugs that are Unapproved by the FDA?”
Filed Under: Physicians, THCB
Tagged: alternative therapies, doctor/ patient relationship, domperidone, FDA, Juliet Mavromatis, prescription drugs
Aug 26, 2013
The original Hipoocratic Oath states:
I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.
One modern version reads:
I will not be ashamed to say “I know not,” nor will I fail to call in my colleagues when the skills of another are needed for a patient’s recovery.
The idea here is that a doctor needs to recognize when another practitioner has a skill that they do not, and that they must refrain from “practice” when another person has demonstrable expertise in that area of practice.
It is now 2013. It is time for doctors to stop “writing their own EHR” from scratch. They need to bow out of this in favor of people who have developed expertise in the area.
I just found out about another doctor who has decided to write his own EHR, because he has not been able to find one that supports his new direct pay business model adequately. In the distant past I encountered a doctor who believed that his “Microsoft Word Templates” qualified as an EHR system. This is a letter to any doctor who feels like they are comfortable starting from-scratch software development for an EHR in 2013 or later.
You might believe yourself to be an EHR expert.
Are you sure about that? Are you sure that you are not just an EHR expert user?
This difference is not unlike your relationship with your favorite thoracic surgeon. Or for that matter, your relationship with the person who built your car. The fact that you are capable of expertly evaluating and using EHR products does not mean you are qualified to build one. Just like the fact that you are qualified to treat a patient who has recently had heart surgery or to discern when a patient might need heart surgery does not make you qualified to perform that heart surgery. Similarly, the fact that you can drive, or even repair your automobile, does not provide you with the expertise you need to build a car from scratch.
The ethical situation that you are putting yourself in by developing your own EHR is fairly tenuous. Performing heart surgery without being a heart surgeon, building and driving your own car without being an automotive engineer and a doctor coding their own EHR system from scratch all have the same fundamental problem: You might be smart enough to pull it off, but if you don’t you can really mess up another person’s life. Make no mistake, you can kill someone with a shoddy EHR just as easily as by performing medical procedures that you are not qualified for or by driving a car that is not road-safe.
Continue reading “Why Doctors Should Stay Out of the Business of Building EHRs”
Filed Under: Physicians, Tech, THCB
Tagged: Design, EHR, Fred Trotter, HIT, Patient Safety, Physicians, practice of medicine
Aug 26, 2013
For better or worse, Twitter can change the world. I got a whiff of that potential last spring,while participating in a regular Twitter chat (#eldercarechat), someone raised (Tweeted?) the question of what we want government to do to improve thelives of the nation’s 60 million caregivers, and added that weneeded something like a PeaceCorps for family caregivers. That idea resonated with me—and with what I myself need at thisjuncture in my life. My young adult children, five between the ages of 19 and 23, struggle to find work—regular work, much less meaningful work—so that they can pay their bills, including college tuition and loans.
My 92-year old grandmother has moved to Alaska to be with my aunt, and spends many of her days alone, her mind still longing for human connections, her body unable to gether there. What if we could buildsomething akin to the Peace Corps,a national program that could simultaneously address a spectrum of issues, such as workforce development, economic security, intergenerational respect, skillbuilding, and national service?
What if a program existed that could, for instance, employ my 20-something kids, rely on the skills and experience of retirees, like my own 69-year-old parents,and provide companionship to mygrandmother?What if we had a CaregiverCorps? I tweeted. Within a day, I had launched a petition to the White House calling for Americato create such a Corps. Within a month, the New Old Age blog of The New York Times had featured the idea.
Even now, late summer, the idea continues to be discussed: mentioned in the Times, and talked about online. Moving from something as ephemeral as a Tweet to somethingas enduring as a national program, of course, will take more than a season. To that end, I have spent subsequent months writing about the idea for various online platforms, and networking with individuals and organizations who are intrigued by the possibility. Anne Montgomery, my colleague at the Center for Elder Care and Advanced Illness at Altarum Institute and a veteran Hill staffer, has done the same.
Continue reading “Caregiver Corps: Tapping a Nation of Caring People”
Filed Under: OP-ED, THCB
Tagged: Altarum Institute, Caregiver Corps, elder care, Janice Lynch Schuster
Aug 26, 2013
Why aren’t people in hospitals more attentive to the needs of patients?
In a recent post, Dr. Ashish Jha raises this issue as he relates his own story of coming to an ED with a very painful dislocated shoulder. Unsurprisingly, prompt treatment of his pain was deferred while staff diligently completed registration, sent him for an xray, and waited for a physician to see him.
On the bike path where Jha took his initial tumble, people went out of their way to respond to his injury with attention and concern. But as he lay moaning on a gurney in the hospital corridors, waiting for an xray and not yet treated for pain, people avoided his eyes and even walked by a little faster.
What gives? Why aren’t people in the hospital more empathetic and attentive? Is this a “wonderful people, bad system” issue?
In reflecting on his experience, Jha remarks that people seem to leave their humanity at the door when they arrive at the hospital for work, and posits that we get desensitized to suffering. He notes that some workers were able to “break out of that trap,” and responded to him more empathetically when he directly solicited their help and attention.
“It is the job of healthcare leaders to create a culture where we retain our humanity despite the constant exposure to patients who are suffering,” writes Jha.
Culture change is necessary but not sufficient
Culture is important. Yes I’ll admit that I’m usually a bit skeptical when I hear of a plan to tackle a problem through culture change. In my own experience, this has consisted of leaders trying to “create culture” by describing to front-line staff what they should be doing, and repeatedly exhorting them to do it. (And maybe giving out gold stars to those who do it.)
This, of course, is never enough. Talking the talk does not mean people start to walk the walk, especially if the walk involves a slog uphill rather than an easier stroll down a path of lesser resistance.
If we – whether healthcare leaders or just concerned citizens who want to see healthcare improve – really want healthcare workers to demonstrate more compassion and empathy while on the job, then here is what we need to do:
- We should take seriously the task of understanding what might be interfering with this compassion and engagement. This means not only studying workflow, but also the behavioral psychology of individuals as well as groups.
- We should then be serious about creating the conditions that would allow regular human beings to reliably produce the desired behaviors.
Why it can be hard to help people in the hospital
What interferes with showing compassion and engagement? In reading Jha’s piece, I reflected on my own hospital days. Here are the obstacles that I remember, and the impact on me.
Continue reading “Creating Conditions for Humanity in Hospitals”
Filed Under: Physicians, THCB
Tagged: caregivers, culture of healthcare, emergency room visit, Hospitals, Leslie Kernisan, patient engagement, Patient Safety
Aug 25, 2013
The dangers of texting while driving recently received renewed attention thanks to a public service video produced by German film director Werner Herzog. The National Highway Traffic Safety Administration estimates that driver distraction results in approximately 3,000 deaths per year, as well as an additional 400,000 injuries. Experts have estimated that the risk of a crash may increase by more than 20 times when texting, exceeding the risk associated with intoxication.
Texting while driving is just one example of a larger phenomenon of our age, often referred to as multitasking. The term was coined by IBM engineers in the 1960s to refer to the ability of a microprocessor to perform multiple tasks at once. Today the term is more often applied to human beings attempting to do more than one thing, such as simultaneously watching television and folding laundry, or answering emails while talking on the phone. Many health professionals pride themselves on their multitasking.
In fact, however, the term multitasking is a bit of a misnomer, even in the domain of computing. At least where one microprocessor is concerned, a computer does not so much multitask as it switches back and forth between tasks at such a high rate of speed that it appears to be doing multiple things at once. Only more recently, with the advent of multicore processing, has it become possible for computers genuinely to multitask.
The same thing applies to human beings. Health professionals and others who think they are multitasking are typically switching back and forth between different tasks over short periods of time. And in most cases, multitaskers are not able to perform any of the activities in which they are engaged as well as they could if they concentrated on them one at a time. It takes time and effort to re-focus on each task at hand, and this tends to degrade the effectiveness and efficiency of each.
To be sure, multitasking is not impossible. In one sense, simply remaining alive requires us to multitask all the time. Our hearts are continuously pumping, lungs exchanging gases, kidneys filtering the blood, immune system fighting infections, and all the while we are also digesting our last meal. Add to this the ceaseless multitasking of the brain, which is monitoring the environment and maintaining our posture while simultaneously walking and chewing gum, and the complexity multiples.
Continue reading “The Perils of Multitasking”
Filed Under: THCB
Tagged: culture of health, multitasking, Patient Safety, public health, Richard Gunderman, texting
Aug 24, 2013
The wellness emphasis in the Affordable Care Act is built around the Centers for Disease Control and Prevention’s (CDC) 2009 call to action about chronic disease: The Power to Prevent, the Call to Control. On the summary page we learn some shocking statistics:
“Chronic diseases cause 7 in 10 deaths each year in the United States.”
“About 133 million Americans—nearly 1 in 2 adults—live with at least one chronic illness.”
“More than 75% of health care costs are due to chronic conditions.”
Shocking, that is, in how misleading or even false they are. Take the statement that “chronic diseases cause 7 in 10 deaths,” for example. We have to die of something. Would it be better to die of accidents? Suicides and homicides? Mercury poisoning? Infectious diseases? As compared to the alternatives, it is much easier to make the argument that the first statistic is a good thing rather than a bad thing.
The second statistic is a head-scratcher. Only 223 million Americans were old enough to drink in 2009, meaning that 60% of adults, not “nearly 1 in 2 adults,” live with at least one chronic illness — if their language is to be taken literally. Our suspicion is that their “133-million Americans” figure includes children, and the CDC meant to say “133-millon Americans, including nearly 1 in 2 adults, live with at least one chronic illness.” Sloppy wording is not uncommon at the CDC, as elsewhere they say almost 1 in 5 youth has a BMI > the 95th percentile, which of course is mathematically impossible.
More importantly, the second statistic begs the question, how are they defining “chronic disease” so broadly that half of us have at least one? Are they counting back pain? Tooth decay? Dandruff? Ring around the collar? “The facts,” as the CDC calls them, are only slightly less fatuous. For instance, the CDC counts “stroke” as a chronic disease. While likely preceded by chronic disease (such as hypertension or diabetes) and/or followed by a chronic ailment in its aftermath (such as hemiplegia or cardiac arrhythmias), a stroke itself is not a chronic disease no matter what the CDC says. Indeed it is hard to imagine a more acute medical event.
They also count obesity, which was only designated as a chronic disease by the American Medical Association in June–and even then many people don’t accept that definition. Cancer also receives this designation, even though most diagnosed cancers are anything but chronic – most diagnosed cancers either go into remission or cause death. “Chronic disease” implies a need for and response to ongoing therapy and vigilance. If cancer were a chronic disease, instead of sponsoring “races for the cure,” cancer advocacy groups would sponsor “races for the control and management.” And you never hear anybody say, “I have lung cancer but my doctor says we’re staying on top of it.”
Continue reading “The Biggest Urban Legend in Health Economics–and How It Drives Up Our Spending”
Filed Under: THCB
Tagged: Al Lewis, Body Mass Index (BMI), Cancer, CDC, chronic disease, Obesity, overdiagnosis, Overtreatment, prevention, Vik Khanna, Wellness
Aug 24, 2013
Dear Mr. President:
I served in your White House; to do so was among the highest honors of my life and an incomparable professional opportunity.
Since 2009, I’ve sought to return the favor by building on a decade as a journalist to write about the unsung innovation I saw happening beneath the public’s radar. (The federal government has never been great about describing its positive achievements, but this unintentional “humility” is worsened by too much media reliance on muckraking to generate cheap content.) The prize for some of your Administration’s improvements will be billions of dollars’ worth of process efficiency and an ability to retain social-good programs while slashing redundancy and phasing out archaic ways of doing business. All politics aside, I watched these mechanisms with my own wide eyes.
But if one is to deliver praise like I just did, then one must also be willing to highlight dangerous errors in the path ahead, especially when the potholes are avoidable. As a subject matter expert on emergency medical technologies, I have a patriotic duty to point out correctible overstatements and oversimplifications that, if left uncorrected, could undermine your Administration’s objective to bolster the public’s senses of safety, security and comfort—especially as it simultaneously emphasizes the danger of man-made and natural disasters.
On July 9, 2013, your White House sent out a “marketing” email entitled “President Obama’s Plan for Using Technology to Make Government Smarter.” The email contained the following three bullets:
- Increasing efficiency and saving money. CHECK: A worthy goal, and one that I had the chance to see put in action from the inside-out, as part of the project team that relaunched USAJOBS.gov—the so-called “face of federal hiring.” The White House email cited cost reductions of our $2.5 billion; that seems reasonable, considering how extensive an effort went into collapsing duplicative data silos and databases, and modernizing the federal government’s technical infrastructure. Vivek Kundra, the visionary former federal Chief Information Officer, should be a central figure in every conversation about government’s meaningful gravitation toward efficiency; he earned more credit than he gets (but that’s not why people work in government).
- Opening government data to fuel innovation and problem-solving: CHECK: The Administration claims that it is opening “huge amounts of government data to the American people, and putting it on the internet for free.” There are many ways in which this is true, ranging from Data.gov to the Blue Button Initiative, to a (relative) simplification of the grant-making process. (The latter is better than it was, but it still is eons from intuitive or fair.) Much controversy now swirls around actions that the government still keeps secret, but that cannot detract from the fact that a veritable cornucopia of information has been released, and it is indeed spurring creativity. Unfortunately, my own firm uncovered a challenging corollary problem that goes hand-in-hand with the release of oodles of data: at least some of those data are bad, faulty or incomplete, yet when we tried contacting the appropriate agency to close the gap and strive for accuracy, we were met with silence.
The last bullet in the White House’s email, however, does not deserve a “CHECK.” Rather, it is concerning and arguably more dangerous than whoever drafted the outreach piece likely realized. It also touches on something I know a bit about.
Filed Under: OP-ED
Tagged: digital health, Disaster relief, Emergency Medicine, EMS technology, FEMA, HIT, Jonathon Feit
Aug 23, 2013
In the wake of the National Coordinator’s announcement that he is departing, there has been a flurry of tweets, blog posts, impromptu online polls, and conjecture about the most likely successor. To date, none of these conversations has resulted in a thoughtful assessment of the set of characteristics that would represent the ideal candidate, nor has there been any thorough review of the most likely candidates in the context of these attributes. The need for a rapid transition to a successor is well understood by all – yet there has been no indication that the Obama administration is in a hurry. Let’s hope that we can evolve them toward a greater sense of urgency. The fragility of ONC – and the importance of its health – can’t be overlooked.
Let’s consider some history:
The first two National Coordinators, David Brailer and Rob Kolodner, were appointed before ARRA. The agency was small, focused largely on certification (through CCHIT), standards (through HITSP) and policy. When ARRA arrived, David Blumenthal, a thoughtful, deliberate, policy-savvy internal medicine physician from Boston was brought in to lead the rapid expansion of health IT that was facilitated by the HITECH Act.
ONC expanded under Blumenthal from a team of ~ 30 people to a team of >100 in the two years that he was at the helm, and the agency published the 2011 certification criteria regulations, and collaborated with CMS to publish the regulations that defined stage 1 of the Meaningful Use incentive program. The policy foundation was that the three-stage program – to be implemented over six years – would evolve the nation’s care delivery system by causing adoption of EHR technology (stage 1) and then exchange of clinical information electronically (stage 2) and finally improved clinical outcomes (stage 3).
Farzad Mostashari, who joined Blumenthal as the Deputy National Coordinator early in Dr Blumenthal’s tenure, was quickly named as Blumenthal’s successor when Blumenthal announced his resignation in the Spring of 2011. Both Mostashari and Blumenthal pushed hard for Mostashari’s appointment – so that the consistency, focus and forward momentum of the organization could be maintained.
And so it was. Under ARRA, adoption of EHRs has skyrocketed. The CMS MU Stage 2 regulations and the ONC 2014 certification regulations were published, and the size of the agency has doubled to over 150 people. Recognizing the need for experienced partners to assist him in leading a larger agency – and growing national reliance on health IT and an essential component of the care delivery ecosystem – Mostashari hired David Muntz as the “Principal Deputy” (essentially the COO of the agency), Jacob Reider as Chief Medical Officer (leading a team of clinicians focused on quality and safety) and Judy Murphy as the Deputy National Coordinator for Programs and Policy (adding internal coordination support for ONC programs).
Continue reading “Replacing Farzad”
Filed Under: OP-ED, Tech, THCB
Tagged: ARRA, CMS, EHR, Farzad Mostashari, HHS, HIT, HITECH Act, Meaningful Use, ONC, Physicians, software
Aug 22, 2013
Stealthily, AHRQ has acquired a new head, but the ax still hovers over it.
Very quietly, researcher Richard Kronick, PhD was named by the Department of Health and Human Services (HHS) to be the new director of the Agency for Healthcare Research and Quality (AHRQ). He joins an organization that remains squarely on the House GOP’s chopping block and with few friends strong enough to ward off the blow.
Last fall, when a House appropriations subcommittee voted to eliminate all AHRQ funding, I wrote that the agency’s execution went almost unnoticed: it didn’t even rate a separate mention in the committee’s lengthy press release.
Back then, the House GOP’s big target was Big Bird, a/k/a funding for public broadcasting. Since then, the rampaging Republican right-wing has decided it won’t approve subsidies to farmers unless it can also slash food stamps to the poor and that undocumented immigrants are mostly a law-and-order problem, not a human one. That these positions contradict views held by many conservative Republican senators, governors and party leaders has had little to no effect.
Enter Kronick, after a months-long search to replace Dr. Carolyn Clancy, who’d held the top AHRQ post since February, 2003. Oddly, the announcement by HHS Secretary Kathleen Sebelius wasn’t posted on the HHS website or even the AHRQ one. Searching Kronick’s name simply turned up press releases from his current position as deputy assistant secretary for health policy. According to MedPage Today, the naming of Kronick was made “in the department’s daily electronic afternoon newsletter.”
Why? My guess: politics.
Clancy was known for good relations with policymakers of both parties; she was upgraded from “acting director” to permanent status during the George W. Bush administration. Her predecessor, Dr. John Eisenberg, enjoyed a similar bipartisan rapport. Of course, that was before conservatism gave way to crusaders. Kronick, by contrast, has a background almost tailor-made to tick off Tea Partyers.
Continue reading “In a Quiet Move, Washington Replaces the Head of AHRQ. Is It Too Late to Save the Agency?”
Filed Under: OP-ED, THCB
Tagged: AHRQ, Carolyn Clancy, GOP, HHS, Michael Millenson, Richard Kronick
Aug 22, 2013
The hype over mobile health is deafening on most days and downright annoying on some. So it is with some reluctance that I admit that mobile has the potential to be a game-changer in health. I’ve professed enthusiasm before, but that was largely around the use of wireless sensors to measure physiologic signals and SMS text as a way to deliver messages to patients and consumers. For several years, the industry has been awash with smartphone apps (by a recent count more than 40,000). At the Center for Connected Health, we started looking at mobile health as far back as 2008 and could not justify the excitement around smart phones and apps at that time, mostly because our patient population did not demonstrate significant enough adoption of smartphones to justify development in this area.
I felt very unpopular at all of the major conferences. I talked about our success with text messaging as a tool for engaging pregnant teens in their prenatal care and helping patients battling addiction to stick with their care plan, while others were touting the virtues of their various apps.
It’s worth noting that our primary focus at the Center for Connected Health has been patients with chronic illness. As such, we are every bit as concerned about the 85 year old with congestive heart failure as we are about the young professional with hypertension. However, across the population of people with chronic disease, smartphone adoption has lagged. I felt like our strategy was vindicated when my friend Susannah Fox published research showing that folks with two or more chronic illnesses (independent of other variables such as age and socioeconomic status) use technology in the context of their health less than others.
The world of patient care appears to be catching up to the rest of mobile. Not that I would ever endorse the irrational exuberance shown for mobile health apps in general, but some recent data points that changed my thinking are worth noting.
Continue reading “Could Mobile Health Become Addictive?”
Filed Under: Tech, THCB
Tagged: Apps, Joseph Kvedar, mHealth, Mobile health, public health, Smartphones
Aug 22, 2013