The Opioid Epidemic: How Bad and Whose Fault?

The Opioid epidemic is making headlines, and it is easy to think that the situation is a media-generated headline to keep the talking heads busy.  Unfortunately, nothing could be further from the truth, The misuse of and addiction to opioids—including prescription pain relievers, heroin, and synthetic opioids like fentanyl—is a serious national crisis. The Centers for Disease Control and Prevention estimates that the total economic burden of prescription opioid misuse alone in the United States is $78.5 billion a year, including the costs of healthcare, lost productivity, addiction treatment, and criminal justice involvement.

Every day, more than 115 Americans die after overdosing on opioids. In 2015, more than 33,000 Americans died because of an opioid overdose, including prescription opioids, heroin, and illicitly manufactured fentanyl.

Here are some equally troubling statistics from the National Institute on Drug Abuse:

 

  • Roughly 21 to 29% of patients prescribed opioids for chronic pain misuse them.
  • Between 8 and 12% of these develop an opioid use disorder.
  • An estimated 4 to 6% of those who misuse prescription opioids transition to heroin.
  • About 80% of people who use heroin misused prescription opioids first.
  • The Midwestern region saw opioid overdoses increase 70 percent from July 2016 through September 2017.
  • Opioid overdoses in large cities increased by 54 percent in 16 states.

 

There is evidence the crisis has yet to peak. Emergency room visits for suspected opioid overdoses rose by 30% throughout the U.S. in a year, according to the CDC. The analysis, appearing in a new Vital Signs report, was based on about 91 million ED visits in 52 jurisdictions within 45 states from July 2016 to September 2017 from the CDC’s National Syndromic Surveillance Program (NSSP) Biosense Platform.

 

So, what is the government doing about it?

 

In response to the opioid crisis, the U.S. Department of Health and Human Services (HHS) is focusing its efforts on five major priorities:

  • improving access to treatment and recovery services
  • promoting use of overdose-reversing drugs
  • strengthening our understanding of the epidemic through better public health surveillance
  • providing support for cutting-edge research on pain and addiction
  • advancing better practices for pain management

 

The National Institutes of Health, a component of HHS, is the nation’s leading medical research agency and is helping by focusing on discovering new and better ways to prevent opioid misuse, treat opioid use disorders, and manage pain. To accelerate the progress, NIH is exploring formal partnerships with pharmaceutical companies and academic research centers to develop safe, effective, non-addictive strategies to manage chronic pain as well as treat addictions and deal with overdoses.

 

The U.S. Department of Justice plans to hold providers accountable via a new large-scale effort to tackle the opioid crisis. It is certainly easy to hold those writing the prescriptions accountable—at least at first blush. Doctors and other providers are quick to point out that they have been the subject of manipulation by pharma for quite some time. Adriane Fugh-Berman, MD, a Georgetown University professor who leads the PharmedOut initiative, asserts that “the pharmaceutical industry is almost completely responsible for this epidemic”.  She went on to cite misleading advertising and pharma’s practice of hiring “thought leaders” to shame providers into prescribing more opioids. These individuals told physicians they were “torturing our patients” by not issuing painkillers whenever they complained of pain.  This has been a tactic that I have seen in action, and is deeply troubling. Since the 1990s, physicians who have been reluctant to dole out opioids to those with chronic pain have been label “cruel”, those I always thought the only situation where addiction should not be a concern would be those battling the pain of terminal illness.   I was in the minority though.

 

As they have in other instances, Pharmaceutical companies “spun” the literature by consistently citing small-scale studies and research letters as evidence for supporting opioid prescriptions and publishing ghostwritten articles in medical and consumer publications.  Prescribers bear some responsibility also, often writing for doses of opioids that are too high for too long a duration; and though pharma helped ingrain those habits, it is up to providers to be more cautious with the use of such drugs. Fortunately, many physicians are starting to ask themselves hard questions about their own prescribing practices, and states and professional societies are beginning to issue guidelines.

 

This is a crisis that needs to be addressed, but it is historically marked by extremes.  I hope we can address the root causes, without leaving behind those in chronic pain who have no other options.

 

Further reading:

 

https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis

 

https://www.medpagetoday.com/neurology/opioids/71580?xid=nl_mpt_DHE_2018-03-07&eun=g1218653d0r&pos=2&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-03-07&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days

 

https://www.medpagetoday.com/publichealthpolicy/opioids/71661?xid=nl_mpt_DHE_2018-03-10&eun=g1218653d0r&pos=0&utm_source=Sailthru&utm_medium=email&utm_campaign=Daily%20Headlines%202018-03-10&utm_term=Daily%20Headlines%20-%20Active%20User%20-%20180%20days

 

Is Medicine Dangerous? Are Hospitals Dangerous?

Physicians have always striven to provide patients with the best care and outcomes.  Yet over the past forty years healthcare has become progressively more complex, dependent on technology, and reliant on increasingly large teams.  The physician is still the “captain,” but more than a dozen staff members, including nurses, social workers, therapists, and trainees at various levels, may care for a patient on an obstetrics service over numerous work shifts.  Opportunities for error have increased along with the complexity of care, and as we have improved our ability to deal with complex diseases we have also raised the stakes for failure. At the same time, the expectations of federal and local regulatory bodies, employers, the insurance industry, the public, and individual patients have never been higher.

While the idea of keeping patients safe and improving outcomes is certainly not new, turning these ideas into tangible practice has taken center stage in the healthcare industry.

Nevertheless, we have been trying to solve patient safety issues for more than 20 years, an effort many have dubbed “the patient safety movement.” The origin of the patient safety movement can be traced to the Annenberg Conference, a 1996 meeting convened in the wake of a series of highly-publicized medical mishaps, which brought together leaders from the American Association for the Advancement of Science, the American Medical Association (AMA), and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) to discuss errors in health care (Leape, Woods et al. 1998). This launched organizations such as the National Patient Safety Foundation and the Institute for Healthcare Improvement (IHI), as well as efforts like the VA’s Patient Safety Initiative, the IHI’s 5 Million Lives Campaign, and the JCAHO’s Sentinel Event reviews, all of which attempt to tackle the various issues that relate to unanticipated adverse outcomes and quality of care delivery in medicine.

Three years after the Annenberg Conference, the Institute of Medicine published a landmark report assessing the prevalence and impact of medical errors in the United States, estimating that a staggering 44,000-98,000 patients die each year due to medical errors (Kohn, Corrigan et al. 2000). Concluding that a majority of medical errors are caused by correctable faults, this report was a wake-up call to improve quality and deliver care more safely.  You did not misread that number – every week, at minimum, the human equivalent of two full 747 jetliners die in hospitals, yet it doesn’t make the headlines plane crashes do.

We have not made the progress we should have made in the past 20 years. A study by researchers at Johns Hopkins Medicine says medical errors are the third leading cause of death in the United States.  Based on an analysis of prior research, the Johns Hopkins study estimates that more than 250,000 Americans die each year from medical errors. On the CDC’s official list, that would rank just behind heart disease and cancer, which each took about 600,000 lives in 2014, and in front of respiratory disease, which caused about 150,000 deaths.

Medical mistakes that can lead to death range from surgical complications that go unrecognized to mix-ups with the doses or types of medications patients receive.

But no one knows the exact toll taken by medical errors. In significant part, that’s because the coding system used by CDC to record death certificate data doesn’t capture things like communication breakdowns, diagnostic errors and poor judgment that cost lives, the study says.  In a hospital setting, the Joint Commission has long established that communication failure is the leading cause of serious adverse outcomes.

One might rightly argue that the problem has not worsened—-we are just getting better at identifying and reporting mistakes.  There is some truth in that; many healthcare organizations have worked hard to create a non-punitive environment where mistakes are brought forward so they can be learned from – thereby creating a “culture of reporting”, and that is laudable.

I still think hospitals are dangerous places.  Perhaps far better than in the 1920’s, but we still have a long way to go.

 

Further reading:

Kohn, L., et al., Eds. (2000). To Err is Human:  Building a Safer Health System. Washington, D.C., National Academy Press.

Leape, L. L., et al. (1998). “Promoting patient safety by preventing medical error.” Jama 280(16): 1444-1447.

http://www.bmj.com/content/353/bmj.i2139

 

Academic Medicine, at Risk for Extinction?

Is academic medicine at risk for extinction? To answer that question, let’s take a deeper dive and look at how the average medical school funds itself.

 The data from the AAMC show that only about 4% of medical school budgets is covered by tuition, which may be surprising to those of you still paying off your student loans. Most medical school funding comes from clinical revenue, be it hospital contracts or faculty practice collections.

 The real take-home message is that the clinical practice cross-subsidizes the research and education mission in academic medicine. So, when the clinical mission catches a cold, the rest of the academic medical center gets pneumonia. The big problem is we’re now in perennial flu season. And why is that? Well, let’s look at how much we spend as a nation on healthcare.

 By 2018 or 2019, about 20 cents of every dollar in the U.S. economy is going to be spent on healthcare.  To put this in real-world terms, if you drink Starbucks coffee, you already shell out more for the cost of employee healthcare in each cup of coffee than you do for the cost of the coffee to brew it. If you drive a General Motors car, you pay more for the cost of employee healthcare than for the cost of the steel to make it.

 The American people as well as employers (who shoulder the majority of healthcare costs), are saying, “Enough is enough; we want more value for our money.” And that encapsulates the shifting healthcare landscape we are all experiencing – whether you’re in academic medicine or not. It is a shift from fee-for-service to a greater emphasis on value. That is, improving outcomes while holding costs steady or even reducing them.

 So what does this mean for the average physician? First off, it means that we are going to get paid less for many things at baseline, and will only see a raise if we can measurably improve outcomes. We’re going to be assessed in ways that we never dreamed of before, and certainly in ways that we haven’t been exposed to in medical school and residency.

 We’re going to get scorecards from our hospitals, or other partners, about how much our average hospital admission costs, what our average length of stay is, how much we consume in supplies, and how often our patients are readmitted.

 And we’re going to be judged more on the total continuum of care, rather than quality in acute hospitalization. It isn’t just enough to get our patients safely out of the hospital — they or their employers will judge us by how soon these patients get back to work and resume a normal quality of life.

So, is academic medicine at risk for extinction?

 Well, I think the answer to that question is largely in our hands. We’re going to have to change our behaviors, pay attention to what the American people expect of us, and be willing to change.

 

(This piece originally appeared in Opinion Makers, a new MedPage Today video exclusive weekly series, presenting leaders from all areas of medicine offering their views on current topics in clinical care, research, and policy.

https://www.medpagetoday.com/publichealthpolicy/healthpolicy/53928)

 

How You Shop for Groceries and Safer Hospital Care Have a Lot in Common

While it is hard to admit sometimes, the human memory is quite fallible.  This is the reason many of us keep a calendar of important events, even for things you think you would never forget, like a spouse’s birthday.  It is also the reason why many of us write down a grocery list, even if you are going out for just a few things—we have all gotten home only to realize we forgot something important a few minutes before.

Well, things in medicine are no different, although the stakes involved in forgetting to buy bananas are much lower than forgetting to remove an embedded needle.  But medicine took a long time to appreciate this human failing, and it took the aviation industry to make healthcare sit up and take notice. While hospitals can be dangerous places, the medical equivalent of a grocery list has been proven to make a difference.

 

Checklists in Medicine and Surgery

The use of checklists to improve quality and safety dates to the 1930s and the first flight tests of the B-17 bomber.  Nicknamed the “Flying Fortress”, this airplane was significantly larger, faster, and had a longer range than any prior bomber in the US Army Air Corps. Resultantly, it required a much higher skill level of its crew, who were forced to cope with a quantum leap in the complexity of the controls and procedures required to fly safely.  One of the very first flights ended soon after takeoff, in a fiery crash that killed two of the five-man crew. The crew forgot to release the airplane’s “gust lock,” a device that held the bomber’s movable control surfaces in place while the plane was parked on the ground. After takeoff, the plane climbed, stalled, and nosedived in the ground.  Subsequent investigations into the accident showed no mechanical failures but rather, ‘pilot error’. Experts of the day wondered if it was “too much plane for one man to fly.” (Gawande 2007). In response, rather than increasing pre-flight training or reducing the complexity of the technology, the test pilots introduced a system of checklists to simplify the processes of takeoff, flight, and landing.  From that moment, pilots guided the B-17 bomber through 1.8 million flights without a single accident, and aviation adopted the checklist as a critical tool for all aspects of defense and civil aviation (Gawande 2007).

 

Medicine has adopted the checklist concept to simplify systems that have grown to enormous levels of complexity.  Checklists aim to improve care quality and reduce adverse outcomes in medicine via two strategies. First, they aim to implement evidence-based and best-practice strategies in a systematic fashion, making their use routine and universal.  Second, they attempt to improve the function of a team by creating a shared set of standards and goals.

 

The first application of checklists tested as an intervention to improve outcomes is attributed to work in the intensive care unit of Johns Hopkins Hospital.  There, investigators implemented a checklist for the insertion and care of central line catheters; at the end of the study, the unit that did not use checklists had no change in catheter-related bloodstream infections whereas the intervention unit showed a decrease from 11 to 0 per 1000 catheter days, with an estimated savings of 43 catheter related infections, 8 lives, and nearly $2 million dollars over one year (Berenholtz, Pronovost et al. 2004). When expanded to programs within the entire state of Michigan, this same checklist reduced infections by 66%, saving over 1500 lives and $175 million over just 18 months (Pronovost, Needham et al. 2006). What is most remarkable is that the checklist involved only five steps:  hand washing, using sterile draping, cleaning the skin with chlorhexidine, avoiding the femoral site, and removing any other unnecessary or redundant catheters.

Application of this work to the surgical specialties has shown further remarkable results.  A WHO program implemented a 19-item surgical safety checklist in operating room facilities over one year in 8 hospitals among a diverse range of healthcare settings (Haynes, Weiser et al. 2009). Complication rates decreased from 11% to 7% (p<0.001) and death rates were reduced by nearly 50% (1.5% to 0.8%, p=0.003).  The impact of simple checklists on world health should not be underestimated.

Checklists will not solve all of medicine’s potential dangers, but they are an important tool in a more comprehensive set of solutions.

 

Further Reading:

 

Berenholtz, S. M., et al. (2004). “Eliminating catheter-related bloodstream infections in the intensive care unit.” Crit Care Med 32(10): 2014-2020.

Gawande, A. A. (2007). The Checklist. The New Yorker: 86-101.

Haynes, A. B., et al. (2009). “A surgical safety checklist to reduce morbidity and mortality in a global population.” N Engl J Med 360(5): 491-499.

Pronovost, P., et al. (2006). “An intervention to decrease catheter-related bloodstream infections in the ICU.” N Engl J Med 355(26): 2725-2732.

 

How to Have a Productive Doctor’s Appointment

In decades past, the relationship between physician and patient was based on long-earned trust on both sides.  Often, a patient and a doctor would work together for thirty years or more, and knew a great deal about each other’s families, stresses, and social lives.  Now that insurance plans change frequently, often requiring a patient to find a new doctor in their plan, and with physicians practicing in large groups, that level of intimacy has diminished.  Compounding the problem is that many physicians are under intense pressure to “produce”, with the number of visits and procedures directly tied to what a doctor is paid. Return visits are often scheduled for no more than 15 minutes, and sometimes as little as eight.  When you go to the doctor, it is easy to feel like you just got on an assembly line.

There are some things that can help you get the most out of your visit, and your precious time with the doctor:

 

  1. Be prepared before you go:  If you have seen this same doctor within the past two years, he or she has ready access to your medical history.  Focus on what you think are the major changes in your health or lifestyle since the last visit, don’t feel the need to start from the beginning.

 

If you are seeing a physician or a group of physicians that are new to you, doing some advance preparation is crucial.  It may help you to use a checklist, and a very good one can be found as part of the information here: http://myphr.com/Resources/MX10172%20Patient%20Resource%20Guide_FINAL.pdf.  At the very least, it would be helpful to write down the following:

  • Your major medical issues and how long you have had each
  • The medications you are taking, including the dose and how often you take them
  • A list of surgeries you may have had
  • A list of any diseases that seem to run in multiple members of the family
  • A list of any allergies you have and what triggers them

 

It can be especially useful, especially if you are changing doctors or going for a consultation from a specialist, to bring records from your other doctors.  If you have an issue with your heart, bones, joints, or spine, it would also be crucial to bring along copies of things like X-rays, ultrasounds, CT scan or MRIs.

 

 

  • Bring along a pen and notepad, or a friend that can help take notes for you: As we discussed, your time with the doctor may not seem long enough, so it will be helpful for you to take notes, or better yet, while you focus on working with your doctor, have a trusted person with you who can take notes for you.
  • Bring a list of questions: In a visit, it is not uncommon for a patient to get “stage fright” and be so overwhelmed by the exam and process that they forget things that they have wanted to ask for a long time.  I would suggest that this list not be too long, but have it include what is most important to you.
  • Help your doctor remember to plan for your future health:  At the end of the visit, there are some questions you may always want to ask:
  • Anything about my blood pressure of weight that concerns you?
  • Are there are vaccinations I need, especially because of my age?
  • Do I need any screening tests, especially because of my age or family history? (For example, a colonoscopy after age 50)
  • If applicable, do I need a change in my prescriptions?
  • When should I be seen next?

 

 

Lastly, if you are having some tests done at the end of the visit of in the days following, ask your doctor how you will learn about results.  Will they call you? Should you call if you have not heard within a certain period of time, like a week? Do they call with all results, or only abnormal ones?  These are the sorts of things that may vary from office to office, so knowing the reporting process will help ease anxiety and make sure you get a satisfactory level of information.  Tests done in a lab or radiology center outside of your doctor’s office will likely not be reported to you directly, they will be reported to your doctor’s office.

Like a lot of things lately, a doctor’ appointment is usually marked by a lot to do and not enough time in which to do it.  With a little forethought and advanced preparation, these tips will help you make sure you get the best care you can.

Helping an Elderly Relative or Friend Get the Most from a Doctor’s Visit

Even when you are young, it is no small challenge to come away from a doctor’s visit feeling like you covered all the ground that you wanted to, and are clear on the next steps.  It gets even more difficult as we get older. Chronic conditions mount, memories are not what they used to be, and people often develop defensive pride in their independence and ability to manage things unaided.

Before you go any further, I would suggest you read my post “How to Have a Productive Doctor’s Appointment” PLEASE INSERT LINK.  Many of the same strategies apply, but some are more important than others.

First and foremost, BE PREPARED.  If you are accompanying a friend or relative to a visit, have a conversation beforehand.  Come to an agreement on:

  • Whether you will be in the room for the visit, possibly including the physical exam
  • What the main issues to be addressed are
  • Whether it is ok for you to bring up things that concern you, or changes in health or cognition that you have observed.  For instance, many elderlies may deny having falls or balance issues, and may deny it even more strongly if you surprise them and bring it up in front of them for the first time while they are with the doctor.

 

At the very least, it would be helpful to write down the following:

  • Your relative’s major medical issues and how long he/she has had each
  • The medications he/she are taking, including the dose and how often they are taken
  • A list of surgeries he/she has had
  • A list of any diseases that seem to run in the family
  • A list of any allergies he/she have and what triggers them

 

Of all of these things, I would urge you, first and foremost, to maintain a constantly up to date list of your relative’s medications.  Write the drug names, doses, and how often they are taken on an index card, and make a copy for yourself and your loved one. Put it in his or her wallet in as visible place a possible, and use red ink if you can.  In an emergency, even if your elderly relative cannot remember or communicate their conditions, having medication information provides powerful clues as to what the major medical issues are, and what may be wrong. This information alone can be lifesaving.

 

It may also be helpful to bring along a pad and pen to take notes, or if the doctor agrees, record the counseling on your phone at the end of the visit.  Also, take the time to write down a list of questions that are important to both or you. You will be surprised at how easy it is to forget some crucial questions in the heat of the moment, especially if you get unexpected news.

If the elderly relative is a parent, it may be especially hard to try to assert yourself, as old habits die hard in parent/child relationships.  Do your best, but also remember that as long as your parent is mentally competent, they still have the final say in these situations unless other legal arrangements have been made.

Further reading:

 

https://www.aarp.org/caregiving/health/info-2017/doctor-visit-bjj.html

Healthcare Mega-Mergers: What is Going On?

The year 2017 was marked by mergers of all sorts, and 2018 is looking to eclipse it in terms of both size and volume of transactions.

 

Mergers took place across the entire industry, from national hospital systems to vertical integrations like retail pharmacy CVS Health and insurer Aetna. They are about achieving scale, and turning that into a financial and competitive advantage.  They also should be about achieving efficiencies, but history has proven that this is difficult to achieve, probably because it does not offer the immediate payoff that the former advantage offers.

 

At the end of 2017, the following intentions were announced:

 

  • Catholic Health Initiatives and Dignity Health seeking to create a giant system with 139 hospitals and $28.4 billion in revenue. 
  • Advocate Health Care and Aurora Health Care creating a $10 billion enterprise
  • The CVS-Aetna transaction: The deal is valued at $77 billion. This includes approximately $69 billion in cash and stock, as well as the assumption of Aetna’s debt.
  • The acquisition of the Healthcare Partners division of DaVita by the Optum Health division of UnitedHealth.

 

Writing in Forbes, Robert Pearl M.D. dissects the CHI-Dignity merger, which may be emblematic of many others. “In fiscal 2017, Dignity Health experienced a $66.8 million operating loss, worse than in the previous year. Meanwhile, CHI saw operating losses grow from $371.4 million in 2016 to $585.2 million last year. Put these numbers in front of a group of MBA students (or most CEOs working outside the healthcare industry), and they’d all come up with the same M&A strategy: (1) close or combine under-performing facilities, (2) eliminate duplicate clinical services, and (3) reduce administrative overhead.

Instead, Dignity and CHI appear poised to do the opposite. The San Francisco Chronicle reports, “There are no current plans to close any facilities,” and by inference, no job cuts among the health system’s 159,000 employees. Further, the organization announced it will retain co-CEOs, a move that’s almost always more politically expedient than operationally effective. If the Dignity/CHI merger proves to be less about improving efficiency through consolidation –  more about negotiating higher prices with insurers – they wouldn’t be alone.”

In early March of 2018, Cigna, a larger insurer that failed to merge with competitor Anthem last year, announced it had agreed to buy Express Scripts, the nation’s largest pharmacy benefit manager, in a $52 billion deal that could further morph the healthcare industry.  Anthem has been a large Express Scripts customer, but had previously announced they were ending their association and would be creating their own capabilities in this area.

 

This consolidation has serious implications for consumers.  If the merging hospitals were in the same state but at least 30 minutes apart, prices increased by about 7% to 10%, according to a study conducted by Northwestern University, Harvard University and Columbia University and cited by Modern Healthcare.  Why would this be the case?  There are two major drivers of the risk to consumers

 

  • Mergers result in fewer choices, which means less competition on price and quality
  • Larger organizations have more negotiating clout with those that pay for healthcare—insurers, employers and consumers.

 

These were among the reasons that antitrust regulators broke up AT&T in 1982 and Standard Oil about 70 years prior to that.

 

What the ultimate effect of the merger trend in healthcare will ultimately have remains to be seen.  Advocates, such as Michelle Napier, chief revenue officer at Orlando Health, says the consolidation of a major pharmacy chain like CVS with an insurance company could make information more accessible for consumers.The ease of the electronic tools of information that those companies bring, they’ve both invested a lot of time, energy and resources in electronic tools for the consumer,” she told Healthline (https://www.healthline.com/health-news/what-the-latest-healthcare-mergers-mean-for-consumers#3).  “So having them come together really does set the stage for many consumers having much more transparent access to information than they have today. To have the combination of medical care and prescription care, all the way through your specialty pharmacy, is pretty attractive.”

 

While I do agree there is promise in greater information sharing and consumer convenience, I remain dubious that the average patient will come out of this trend with his or her wallet intact.

 

Further reading:

 

http://www.modernhealthcare.com/article/20171226/NEWS/171229957

 

https://www.forbes.com/sites/robertpearl/2018/01/16/hospitals/#34840ab44b03

 

https://www.healthline.com/health-news/what-the-latest-healthcare-mergers-mean-for-consumers#3

Flying Fortresses and Medical Checklists: How a World War II era bomber can save patient lives today

Paradoxically, while the patient safety movement has been increasingly embraced by Ob/Gyns, our efforts to create a safer environment grow more challenging each year as the healthcare industry becomes increasingly complex. During her hospital stay, a patient is likely to interact with staff from numerous hospital departments (e.g., nurses, therapists, social workers, and diagnostic imaging staff, not to mention admitting personnel and ward clerks) in addition to her physician. Medical imaging provides us with increasingly detailed but often irrelevant data. The result is a veritable deluge of records and documentation, with little time to sort through it all to obtain a global view of the patient’s condition. Worse, even when such a global view can be obtained, testing and treatment algorithms change frequently based as on the results of latest clinical trials, and about 25,000 controlled clinical trials are published each year(1). Thus, we are in the age of “information overload”. To practice medicine conscientiously in the 21st century means walking around in angst, wondering “Did I forget something?” and worse yet, “Did I forget something crucial?”

Modern physicians are not the first to suffer such anxiety in high-stakes situations. Imagine how the technicians at the Three Mile Island Nuclear Generating Station felt when the alarms started sounding 30 years ago. In fact, imagine being a pilot in the U.S. Army Air Corps in 1935. A year earlier, that service had requested designs for a bomber capable of carrying a significant bomb load at an altitude of 10,000 feet for 2000 miles(2). The resultant design was the Boeing Model 299, which excelled in an early test flight. However, development came to a screeching halt in October 1935, when during a second test flight the crew forgot to release the airplane’s “gust lock,” a device that held the bomber’s movable control surfaces in place while the plane was parked on the ground(3). After takeoff, the plane climbed, stalled, and dove nose-first in the ground. An investigation concluded that the increased complexity of the new bomber had resulted in a pilot error, and the “talking heads” of the day wondered if it was “too much plane for one man to fly.” The solution was remarkably simple: the pre-flight checklist. The Model 299 became the B-17 Flying Fortress and went on to contribute significantly to our victory in World War II. But its greatest legacy may be its prompting of one of the first great human factor engineering improvements – the safety checklist.

As Atul Gawande has elegantly asserted, “Medicine today has entered its B-17 phase. Substantial parts of what hospitals do—most notably, intensive care—are now too complex for clinicians to carry them out reliably from memory alone”(4). Checklists are now being adopted to guide staff through complex procedures that require systematic and comprehensive approaches. The use of checklists seems especially promising in surgery. Haynes and colleagues recently published the impact of implementing a 19-item surgical safety checklist designed to improve team communication and consistency of care and, thus, reduce surgical complications and mortality(5). Between October 2007 and September 2008, eight hospitals in eight cities participated in the WHO’s Safe Surgery Saves Lives program. Pre-intervention data were collected on clinical processes and outcomes from 3,733 consecutively enrolled patients 16 years of age or older undergoing non-cardiac surgery. These findings were compared to 3,955 consecutively enrolled patients following introduction of the checklist. The primary metric was occurrence of complications, including death, during hospitalization and within the first 30 post-operative days. The authors reported that mortality dropped from 1.5% before the checklist was introduced to 0.8% post-intervention (P=0.003). Inpatient complications occurred in 11.0% of patients at baseline and in 7.0% after checklist introduction (P<0.001).

Similar work is just beginning in obstetrics. Clark and colleagues developed a checklist-based protocol for oxytocin administration(6). Following a retrospective chart review of the last 100 patients receiving oxytocin before implementation of the checklist and the first 100 patients receiving oxytocin after protocol implementation, the authors reported that significantly fewer newborns with any index of adverse outcome in the post-checklist period (31 vs 18, P < 0.05). System-wide implementation of this program was associated with a decline in the rate of primary cesarean delivery rate from 23.6% to 21.0%. While the salutary effects of the checklist are difficult to isolate from those accruing use of a more conservative (lower dose and frequency of increase) oxytocin infusion strategy, the results are promising.

Medical checklists are indispensable tools in condensing large quantities of knowledge in a concise fashion, to reduce errors of omission and commission and to maintain up to date best practices(7). They are particularly crucial in high acuity settings during the performance of low frequency, complex procedures as found in intensive care settings, administration of anesthesia in operating rooms (and Labor and Birth) and providing acute emergency department care(7). Recognizing that general anesthesia is now rarely given for cesarean delivery except in emergent situations, Hart and Owen compiled a list of 40 items they believed were crucial to preparing to administer general anesthesia using expert opinion(8). The resultant electronic checklist system with voice prompts was tested on 20 anesthesiologists using a high-fidelity anesthesia simulator. The authors found that physicians omitted to check a median of 13 (range, 7-23) of the 40 items. Among the omissions: not checking that the difficult intubation trolley was available and not confirming maternal left lateral tilt(8). The authors rightly underscore the fallibility of human memory, especially under stress.

Checklist use in intensive care settings has led to statistically significant improvements in compliance with various key best practices, like increased administration of aspirin for myocardial infarctions in the emergency department (21.4%; 95% CI; 7.3–32.7%) (9). However, in Ob/Gyn this movement is still in its infancy and there are, as yet, only a few studies like those cited above, showing efficacy. Furthermore, a standard method to create reliable checklists is still lacking. Hales et al., offer practical guidance to constructing checklists based on an exhaustive analysis of the published literature(7). They point out that there are multiple types of checklists, including laundry lists to verify availability of equipment, sequential lists to insure proper order and flow of tasks, and iterative checklists that that require repeated reviews to obtain valid results before proceeding in dynamic settings. Table 1 presents some of their suggested steps in checklist development combined with a few of my own ideas. Keys include utilization of pre-published guidelines, formation of expert panels, and repeat pilot-testing of preliminary checklists.

Most of us recognized the fallibility of memory years ago, though maybe not consciously, the day we bought our first Washington Manual (or similar book) to slip into the pocket of our white lab coats. Many of us have moved to fancier tools, and our tattered paper “pocket brains” have been replaced by PDAs. But our brains clearly need some help, be it in the form of reference tools or prompts in the form of checklists. I believe that this is a medical tool whose time has come, and we have the B-17 to thank.

Table 1: Format for Creating Medical Checklists.
Determine need for a checklist! Is it really mission-critical, will it likely be cost-effective, can you get universal buy-in?
Identify the goal of, and audience for, the checklist.
Develop content from professional organizations’, state departments of health’s, and federal agencies’ guidelines and best practices, from available published expert opinion, or from your own local experts’ opinions. (Be sure to use UpToDate and Contemporary Ob/Gyn’s web site and other electronic sources to validate that these opinions are truly current). Be sure to involve physicians from other disciplines where appropriate (e.g., infectious disease, surgery, and anesthesiology)
Design should consider practicality as well as completeness, particularly in acute care settings. Lists must be readability, concise, clear and in a logical order. Avoid jargon and abbreviations must be avoided.
Pilot the checklist multiple times until all the “bugs” are worked out – balance completeness with practicality. Use realistic simulations for rare events.
Obtain any required approval (e.g., hospital medical board, state department of health, federal agency).
Conduct regular simulations for rarely-used checklists involving acute care settings to maintain relevance and utility.
Regularly review and update checklists – and avoid checklist proliferation!

References:
1. Gluud C, Nikolova D. Likely country of origin in publications on randomised controlled trials and controlled clinical trials during the last 60 years. Trials. 2007; 8:7
2. Goebel, Greg (2005). “Fortress In Development: Model 299”. The Boeing B-17 Flying Fortress. Wikipedia, the free encyclopedia. Retrieved on March 23, 2009.
3. Wikipedia, B-17 Flying Fortress, Retrieved March 24, 2009.
4. Gawande, Atul (2007). The Checklist. www.newyorker.com/reporting/2007/12/10/071210fa_fact_gawande?currentPage=all. Retrieved March 24, 2009.
5. Haynes AB, Weiser TG, Berry WR, Lipsitz SR, Breizat AH, Dellinger EP, Herbosa T, Joseph S, Kibatala PL, Lapitan MC, Merry AF, Moorthy K, Reznick RK, Taylor B, Gawande AA; Safe Surgery Saves Lives Study Group. A surgical safety checklist to reduce morbidity and mortality in a global population. N Engl J Med. 2009; 360:491-9.
6. Clark S, Belfort M, Saade G, Hankins G, Miller D, Frye D, Meyers J. Implementation of a conservative checklist-based protocol for oxytocin administration: maternal and newborn outcomes. Am J Obstet Gynecol. 2007; 197:480.e1-5.
7. Hales B, Terblanche M, Fowler R, Sibbald W. Development of medical checklists for improved quality of patient care. Int J Qual Health Care. 2008; 20:22-30.
8. Hart EM, Owen H. Errors and omissions in anesthesia: a pilot study using a pilot’s checklist. Anesth Analg. 2005; 101:246-50.
9. Wolff AM, Taylor SA, McCabe JF. Using checklists and reminders in clinical pathways to improve hospital inpatient care. Med J Aust. 2004; 181:428–31.

Economics of Patient Safety

While the primary impetus behind patient safety efforts is quality care and the elimination of harm, one cannot ignore economic considerations in today’s healthcare environment.  Few of these efforts can be provided at no cost, though their simplicity and widespread effects create appealing cases for favorable returns on investment. One study reports that the elimination of excess costs related to adverse events could save up to 5.5% of total inpatient costs in the U.S. (Jha, Chan et al. 2009), while an Australian study estimates that adverse events represent nearly 16% of the total expenditure on direct hospital costs (Ehsani, Jackson et al. 2006).

An economic analysis based on the 18 AHRQ Patient Safety Indicators demonstrated that in my own discipline, the three obstetrics-specific indicators (obstetric traumas related to cesarean delivery, spontaneous vaginal delivery, and operative vaginal delivery) were not associated with significant additional costs or lengths of stay, though many of the other nonspecific indicators (e.g. pulmonary embolus, postoperative hemorrhage or infection, retained foreign body) that were significant are often seen during obstetrical adverse events (Zhan and Miller 2003). Unfortunately, however, there is little evidence to guide an economic cost-benefit calculation of patient safety programs (Schmidek and Weeks 2005).

A business case can be designed to appeal to a healthcare organization or liability carrier.  As an example, one comprehensive safety effort involved the support of a malpractice liability carrier which compensated the cost of outside expert review, a patient safety nurse, and initial training in crew resource management.  Initial costs of this program were estimated at $210,000, with ongoing yearly costs of $150,000. This investment is dwarfed by the average payment ($500,000-1,900,000) for one single obstetrical claim; the program effectively pays for itself if it is able to avert at least one malpractice settlement every 5 years (Barbieri 2006).

In 2008, preventable harm was estimated to cost the United States $19.5 billion, in addition to the incalculable human cost. The bulk ($17 billion) of this cost was directly associated with additional medical expenses, followed by increased mortality rates ($1.4 billion) and loss of worker productivity ($1.1 billion). When indirect costs are accounted for, the estimated economic impact skyrockets to nearly $1 trillion annually.

 

It should not be hard to create patient safety interventions that make both ethical and economic sense.