Compounding the Problem?

Here’s a question to get you thinking this Friday morning.  What has been called the “worst public health crisis” in the US in decades?  Is it:

(a)  HIV

(b)  Obesity

(c)  Healthcare.gov

(d)  Heart Disease

(e)  None of the above

While there’s no doubt options (a) through (d) challenge our healthcare system, the correct answer is in fact (e). What’s more, this public health crisis may have gone unnoticed by many. What we’re referring to is the fungal meningitis outbreak that was traced to the New England Compounding Center. So far, there have 751 reported cases, including 64 deaths.

Indeed, most Americans had never heard of compounding pharmacies until the now-shuttered New England Compounding Center was blamed for making tainted steroid injections that killed and sickened people in 20 states.

Since then, the FDA has issued more than 60 reports of compounding pharmacies that had one or more quality or sterility issues. Five compounding pharmacy testing labs received similar reports.

Now, after months of negotiating, the US Senate has finally passed legislation that was drafted in the wake of the scandal.  The Drug Quality and Security Bill will give the FDA greater oversight of compounding pharmacies and also creates a national system for tracking prescription medicines from factory to pharmacy. The bill, which was already passed by the US House, is designed to bolster the pharmaceutical supply chain, and now goes to President Obama for his signature

The bill will create a new class of compounding pharmacies, as suggested by the FDA. The agency believes that traditional compounders – those who mix or alter ingredients for individual patients on an as-needed basis, should be distinguished from ‘non-traditional’ compounders – those that sell high volumes and ship out of state because these activities may pose a higher risk.

“We know more from a barcode on a gallon of milk than we do from a barcode on a bottle of prescription drugs, which could mean the difference between life and death,” says US Senator Michael Bennet. “Whether it’s a stronger drug supply chain or better oversight for compounded drugs, this commonsense bill will help restore confidence in our prescription drugs and protect our families from potential health risks.”

The bill also creates a voluntary category for so-called office compounding of sterile medications. These operations would voluntarily register with the FDA and submit to GMP, or good manufacturing practices, compliance and pay fees in exchange for the right to ship product without a prescription. But there is no criteria concerning interstate shipping or the percentage of production involved.

The legislation “leaves regulation of this vital and long-accepted practice by independent community pharmacies to state boards of pharmacy, where it should be,” says the National Community Pharmacists Association.

But not everyone agrees.

Rosa DeLauro, a Democratic Congresswoman from Connecticut, says the “voluntary approach will continue to expose patients to potentially unsafe, mass-produced compounded drugs that are not approved or evaluated by the FDA.”

Similarly, the International Academy of Compounding Pharmacists released a statement saying that “a voluntary category of outsourcing facilities is not the answer” and warned that another potentially deadly New England Compounding Center type of scandal could still occur.

Some health policy experts have even said they fear the new bill will make drugs, less, rather than more, safe.

Critics say that by giving compounding pharmacies the option whether or not to register with the Food and Drug Administration and adhere to stricter guidelines for testing, quality and sterility, does not go far enough.

“It makes what is now illegal legal,” said Dr. Michael Carome, who directs the health research group at Public Citizen, a think tank.

Carome said he opposes the bill because it allows large scale compounding without individual prescriptions and with no requirement to follow the strictest quality and sterility guidelines that drug manufacturers must adhere to.

“It makes no sense to have two different tiers of drug manufacturers – one that has to meet all the manufacturing guidelines and one that only has to meet some of them. We believe in a level playing field.”

What do you think of this legislation?  Has it gone far enough?  We’d love to hear from you.

Geriatric Medicine?

Picture this…a distinguished vascular specialist in his 80’s performs surgery, then goes on vacation, forgetting he has patients in the hospital; one subsequently dies because no doctor was overseeing his care.

Or imagine this? An internist who suffered a stroke gets lost going from one exam room to another in his own office.  Crazy? Unbelievable?? Well how about the beloved general surgeon with Alzheimer’s disease who continues to assist in operations because hospital officials don’t have the heart to tell him to retire.

No, these aren’t plots from a new medical drama, they are all real-life examples, exemplifing an emotionally charged issue that is attracting the attention of patient safety experts and hospital administrators.

About 42% of the nation’s 1 million physicians are older than 55.  21% are older than 65. And their ranks are expected to increase as many work past the traditional retirement age of 65, for reasons both personal and financial.

Unlike commercial airline pilots, who by law must undergo regular health screenings starting at age 40 and must retire at 65, doctors are subject to no such rules. And while most states require continuing education credits to retain a medical license, “you can sleep through a session, and if you sign your name, you’ll get credit,” observes Ann Weinacker, chief of the medical staff at Stanford Hospital.

“The public thinks that physicians’ health and competence is being vigorously monitored and assessed. It isn’t,” said geriatrician William Norcross, 64, founding director of a program at the University of California at San Diego that performs intensive competency evaluations of doctors referred by state medical boards or hospitals. The program, known as PACE, (Physician Assessment and Clinical Education) is one of about 10 around the country.

Norcross, who evaluates 100 to 150 physicians annually, estimates that about 8,000 doctors with full-blown dementia are practicing medicine. And as if that in itself isn’t worrying enough, studies have found, that approximately one-third of doctors don’t even have a personal physician, who might be on the lookout for deteriorating hearing, vision and motor coordination, or the cognitive impairment that precedes dementia.

Although doctors are not immune to the effects of aging, those with cognitive and neurological problems almost never have insight into their problems many deny that anything is wrong.

While few experts would argue that age alone should control who can continue to practice, some studies suggest that doctors’ skills tend to deteriorate over time. A 2006 report found that patient mortality in complex operations was higher among surgeons older than 60 than among their younger colleagues.

“Colleagues have a code of silence,” says New Hampshire health-care consultant Jonathan Burroughs who spent 30 years as an emergency department physician. During his career, Burroughs said he followed several elderly doctors around, quietly correcting their orders to prevent mistakes. According to him, such experiences are nearly universal in medicine. But that kindness can backfire, subjecting patients to potentially disastrous consequences such as serious injury or death, and the faltering physician to a malpractice suit or the loss of a medical license.

Although an older doctor can be a font of wisdom and experience, their skills have not necessarily kept pace; meaning that although they claim they’re practicing state-of-the-art care it’s maybe 20 or 30 years out of date.

Even so, rheumatologist Ephraim Engleman, who will turn 102 in March, said he plans never to quit. One of the nation’s oldest practicing physicians, Engleman drives from his San Mateo home to the medical campus of the University of California at San Francisco three days a week. There he sees about eight longtime patients per week.  “I’m very much opposed to retirement,” said Engleman, “As long as I’m able intellectually and physically, I’m going to continue.” His only impediment, he said, is severe spinal stenosis, which has left him stooped and dependent on a cane. “I walk like an old man,” he said.

Informed that Stanford, his undergraduate alma mater, has recently begun requiring doctors older than 75 to be tested, he quipped, “I’m glad they don’t do it here.”

So next time you catch yourself thinking cops are looking younger, maybe you should start taking a closer look at your healthcare provider.

Physician, Heal Thyself!

An unwavering work ethic is a hallmark of many health professionals. But a new survey finds that when a doctor is sick, such dedication to duty can have serious consequences.

A poll of 150 attendees of an American College of Physicians meeting in 2010 revealed that more than half of resident physicians had worked with flu-like symptoms at least once in the last year and one in six reported working sick on three or more occasions during that time.

The survey conducted by researchers at the University of Chicago Medicine and Massachusetts General Hospital also asked the doctors whether they believed they’d ever directly transmitted an illness to a patient.  Shockingly, nearly 10 percent of respondents answered yes, and more than 20 percent believed other residents had passed on an illness to a patient. So much for the Hippocratic Oath and the promise to do no harm!

The results published in the Archives of Internal Medicine are further evidence of a culture of self-sacrifice long prevalent in medicine. Researchers say a physician’s sense of loyalty to already-overwhelmed peers, along with a commitment to patient care, often conflicts with an ethical stance against exposing patients and staff to an illness or compromised performance.

“Resisting the pressure to work when ill can be particularly difficult for young doctors,” said study author Anupam B. Jena, MD, PhD,. “A work-first, self-second attitude is often seen as ideal among peers, superiors and even patients.”

In the first known account of the reasons for presenteeism among doctors-in-training, more than half of respondents cited obligation to colleagues who’d be forced to cover their duties or an obligation to patient care as the top reasons for not taking a sick day.

Far fewer, a mere 12%, indicated they’d worked when ill due to concerns their colleagues would think they were “weak” and 8% came to work sick because they felt pressured to repay colleagues for coverage.

Seniority appeared to be a factor in the results. Second-year residents were more likely than first-years to select responsibility to patient care as a reason for presenteeism. Gender differences were also brought to light with female residents more likely to work sick and cite patient care as the reason. Female residents were also more likely to report fear of being perceived as weak as a motive for not taking time off.

While time away from the office carries a similar stigma in other high-pressure professions, a business  executive showing up sick to the boardroom is significantly less worrisome than a doctor with flu treating patients. An otherwise healthy doctor can often recover quickly, but an infected patient with an already-compromised immune system may not.

Clearly it’s time for doctors to stop playing superheroes.  Presenteeism needs to be addressed and eliminated. Given the intellect of most doctors it shouldn’t be too difficult for them to understand that refraining from work while ill is the most professional way to ensure responsible and safe care for patients.

A word to my doctors – if  what you’ve got is contagious or makes you so sick that your judgment is clouded – STAY HOME!

Reckless Research Race, Results in Rising Retractions. Reform Required?

As our regular readers know, SRxA’s Word on Health loves nothing more than a good alliteration to start the day!  Although the blog post title may rank as one of our more classic tongue twisters, there is nothing amusing about the content.  As involved as we are in medical communications and peer-reviewed, scientific publishing, we are saddened to report on the rise of a recent trend of falsified research. An unsettling pattern is emerging. The rate at which articles are retracted (meaning the study was published, only to later be dubbed unfit for print — typically due to either deliberate misconduct or an honest scientific mistake) is increasing. To our knowledge, at least three scientific journals have published articles over the past two years warning of the rise in retractions and misconduct by researchers who have fudged results.

Last year Nature reported a tenfold increase in retractions over the past decade even though the number of published papers only increased by 44%. Before that, the Journal of Medical Ethics published a study in 2010 that said a rise in recent retractions was the fault of misconduct and “honest scientific mistakes.” It calculated that the number of retractions had more than tripled from 50 in 2005 to 180 in 2009.

The latest publication to highlight this issue is Infection and Immunity. In the fall of 2010, Dr. Ferric C. Fang, editor in chief of the journal made an unsettling discovery – one of his authors had doctored several papers. The journal wound up retracting six of the papers from the author, Naoki Mori of the University of the Ryukyus. It soon became clear that Infection and Immunity was hardly the only victim of Dr. Mori’s misconduct. Since then, according to the blog Retraction Watch, other scientific journals, including the International Journal of Cancer  have retracted another 24 of his papers. This was a new experience for Fang. Prior to this incident Infection and Immunity had only retracted nine articles over a 40-year period. “Nobody had noticed the whole thing was rotten,” said Fang, a professor at the University of Washington School of Medicine. Dr. Fang became curious how far the rot extended. To find out, he teamed up with a fellow editor at the journal, and before long they reached a troubling conclusion: not only that retractions were rising at an alarming rate, but that retractions were just a manifestation of a much more profound problem.

Dr. Fang’s colleague, Dr. Arturo Casadevall, said he feared that science had turned into a winner-take-all game with perverse incentives that led scientists to cut corners and, in some cases, commit acts of misconduct. Last month, in a pair of editorials in Infection and Immunity, the two editors issued a plea for fundamental reforms. While no one claims that science was ever free of misconduct or bad research, the new raft of retractions appears to be a mix of misconduct and honest scientific mistakes. Several factors are at play here, scientists say. One may be that because journals are now online, bad papers are simply reaching a wider audience, making it more likely that errors will be spotted. But other forces are more pernicious. To survive professionally, scientists feel the need to publish as many papers as possible, and to get them into high-profile journals. And sometimes they cut corners or even commit misconduct to get there. To measure this claim, Drs. Fang and Casadevall looked at the rate of retractions in 17 journals from 2001 to 2010 and compared it with the journals’ “impact factor,”  – a score based on how often their papers are cited by scientists. The higher a journal’s impact factor, the higher its retraction rate. The highest “retraction index” in the study went to one of the world’s leading medical journals, The New England Journal of Medicine.

The scramble to publish in high-impact journals may be leading to more and more errors. Each year, every laboratory produces a new crop of Ph.D.s, who must compete for a small number of jobs, and the competition is getting fiercer. In 1973, more than half of biologists had a tenure-track job within six years of getting a Ph.D. By 2006 the figure was down to 15 percent. In such an environment, a high-profile paper can mean the difference between a career in science or leaving the field. The scramble isn’t over once young scientists get a job. “What people do is they count papers, and they look at the prestige of the journal in which the research is published, and they see how many grant dollars scientists have, and if they don’t have funding, they don’t get promoted,” Dr. Fang said. “It’s not about the quality of the research.”

With all this pressure on scientists, they may lack the extra time to check their own research. Instead, they have to be concerned about publishing papers before someone else publishes the same results. Adding to the pressure, thousands of new Ph.D. scientists are coming out of China and India, countries that offer cash rewards to scientists who get papers into high-profile journals. Dr. Fang worries that the situation could be become much worse if nothing happens soon. To change the system, Fang and Casadevall say graduate students need a better understanding of science’s ground rules. They would also move away from the winner-take-all system, in which grants are concentrated among a small fraction of scientists by putting a cap on the grants any one lab can receive. A little bit of old fashioned honesty wouldn’t hurt either!

20/20 on the Vanishing American Hospital

Most Americans are born in hospitals. Hospitals also provide care during many other intimate and extraordinary circumstances in our lives – serious injuries, severe sickness and mental breakdown. Hospitals are also, by and large where we go to die.

As such, hospitals serve as a cornerstone of our communities and our very existence.

According to the American Hospital Association, there are 5,754 registered hospitals in the U.S. In 2011, almost 37 million people were admitted to a hospital in the U.S. – that’s more than 1:10 people.

Yet despite all this history, hospitals are in the midst of massive and disruptive change.

Even knowing this, SRxA’s Word on Health was shocked to read an article suggesting that by 2020 one in three hospitals will close or reorganize into an entirely different type of health care service provider.

Writing on KevinMD.com, a leading physician voice blog, authors David Houle and Jonathan Fleece suggest that that there are four significant forces and factors are driving this inevitable and historical shift.

First, America must bring down its crippling health care costs. The average American worker costs their employer $12,000 annually for health care benefits and this figure is increasing more than 10 percent every year. U.S. businesses cannot compete in a globally competitive market place at this level of spending. Federal and state budgets are getting crushed by the costs of health care entitlement programs, such as Medicare and Medicaid. Given this cost problem, hospitals are vulnerable as they are generally regarded as the most expensive part of the delivery system for health care in America.

Second, statistically speaking hospitals are just about the most dangerous places to be in the United States. Three times as many people die every year due to medical errors in hospitals as die on our highways — 100,000 deaths compared to 34,000.

The Journal of the American Medical Association reports that nearly 100,000 people die annually in hospitals from medical errors. Of this group, 80,000 die from hospital acquired infections, many of which can be prevented. Given the above number of admissions that means that 1 out of every 370 people admitted to a hospital dies due to medical errors.

In other words, hospitals are very dangerous places.  It would take about 200 747 airplanes to crash annually to equal 100,000 preventable deaths. Imagine the American outcry if one 747 crashed every day for 200 consecutive days in the U.S. The airlines would stand before the nation and the world in disgrace.

Currently in our non-transparent health care delivery system, Americans have no way of knowing which hospitals are the most dangerous. We simply take uninformed chances with our lives at stake.

Third, hospital customer care is abysmal. Recent studies reveal that the average wait time in American hospital emergency rooms is approximately 4 hours. Name one other business where Americans would tolerate this low level of value and service.

Fourth, health care reform will make connectivity, electronic medical records, and transparency commonplace in health care. This means that in several years, and certainly before 2020, any American considering a hospital stay will simply go on-line to compare hospitals relative to infection rates, degrees of surgical success, and many other metrics. Isn’t this what we do in America, comparison shop? Our health is our greatest and most important asset. Would we not want to compare performance relative to any health and medical care the way we compare roofers or carpet installers? Inevitably when we are able to do this, hospitals will be driven by quality, service, and cost — all of which will be necessary to compete.

So hospitals are about to enter the open competitive marketplace. And as we know there will be winners and losers.  According to Houle and Fleece a third of today’s hospitals will fall into the latter category.

Will your hospital be among them?  Let us know what you think.

e-prescribing: e-fficient, but still e-lusive?

Electronic prescribing or e-prescribing, has multiple potential benefits, including helping to reduce the risk of medication errors caused by illegible or incomplete handwritten prescriptions.  However, according to a study funded by the U.S. Department of Health and Human Services’ (HHS) Agency for Healthcare Research and Quality (AHRQ),  neither prescribers, pharmacists or indeed patients are getting the full benefit of the technology.

The study, published online in the December issue of the Journal of the American Medical Informatics Association focused on a key aspect of e-prescribing: the electronic exchange of prescription data between physician practices and pharmacies. This practice can save time and money by streamlining the way in which new prescriptions and renewals are processed. The study showed that while physician practices and pharmacies were generally positive about electronic transmission of new prescriptions and prescription renewals, connectivity between physician offices and mail-order pharmacies continue to pose problems. Additionally problematic is manual entry of certain prescription information by pharmacists, for example, the drug name, dosage form, quantity, and patient instructions.

“Physicians and pharmacies have come a long way in their use of e-prescribing, and that’s a very positive trend for safer patient care and improved efficiency,” said AHRQ Director Carolyn M. Clancy, M.D. “This study identifies issues that need attention to improve e-prescribing for physicians, pharmacies, and patients.”

Researchers at the Center for Studying Health System Change, conducted 114 interviews with representatives of 24 physician practices, 48 community pharmacies and three mail-order pharmacies using e-prescribing. Physician practices and pharmacies used e-prescribing features for electronic renewals much less often than for new prescriptions. More than a quarter of the community pharmacies reported that they did not send electronic renewal requests to physicians. Similarly, one-third of physician practices had e-prescribing systems that were not set up to receive electronic renewals or only received them infrequently.

Physician practices reported that some pharmacies that sent renewal requests electronically also sent requests via fax or phone, even after the physician had responded electronically. At the same time, pharmacies reported that physicians often approved electronic requests by phone or fax or mistakenly denied the request and sent a new prescription.

The study noted that resolving e-prescribing challenges will become more pressing as increasing numbers of physicians adopt the technology in response to federal incentives. Physicians can qualify for Medicare and Medicaid electronic health record incentive payments by generating and transmitting more than 40% of all prescriptions electronically.

The study concludes that a broad group of public and private stakeholders, including the federal government, e-prescribing standard-setting organizations, vendors and others will need to work together to address these issues.

Do you have any experience, good or bad with e-prescribing?  Let us know.

What’s In A Name?

Many words sound alike but mean different things when put into writing. Think “accept” – a verb meaning to receive or agree and “except” – a preposition meaning other than. While such confusion may cause grammar teachers to lose sleep and their student’s grades to suffer, the consequences are generally minimal. When it comes to drugs, however, it’s a different matter. The existence of confusing drug names is one of the most common causes of medication error and is of concern worldwide.  Many drug names look or sound like other drug names. Contributing to this confusion are illegible handwriting and similar packaging or labeling.

Recently, the Institute for Safe Medication Practices (ISMP) warned pharmacists and other healthcare providers about mix-ups of a prescription eyedrop solution and a wart-removal drug with similar-sounding names after receiving reports describing situations in which nurses and pharmacists confused Durezol, a prescription corticosteroid eyedrop solution used to treat inflammation and pain following ocular surgery, and Durasal, a prescription wart remover. Both products are packaged in small applicator bottles.

In a case that led to a lawsuit against Walgreens earlier this year, a pharmacist allegedly misread a doctor’s prescription for Durezol eyedrops and instead dispensed Durasal wart remover. The patient put the wart remover into his eye, suffered “grievous personal injury,” and filed a $1 million lawsuit against Walgreens.

SRxA’s Word on Health has learned that this is not an isolated mix-up.  The ISMP has published a list of hundreds of drugs with sound alike names that have come to light because mix-ups have occurred. So, before you inadvertently put wart remover in your eyes…or worse, we strongly recommend that you read the labels and patient information leaflets before taking any new medication.

Hospital errors affect 1:3 patients

How common are hospital errors?

A shocking new study suggests that the number of “adverse events” befalling patients in U.S. hospitals may be 10 times higher than previous estimates.

If the authors are correct, this would mean that medical mistakes affect one in three people hospitalized  in the US. The study, published in the journal Health Affairs involved a review of almost 800 patient charts at three U.S. hospitals. Using a review technique known as the “global trigger tool,”  researchers detected a whopping 354 adverse events. Scarier still,  that figure might actually understate the enormity of the problem as it was based on potentially incomplete medical records rather than on direct observation in real time.

Dr. David C. Classen of the University of Utah believes his study gives a more reliable tally of hospital errors than other studies, including a 1999 landmark study from the Institute of Medicine entitled To Err is Human showing that hospital errors caused up to 98,000 Americans each year.

So what sorts of events were uncovered in the new review? According to Classen, there were three big ones:

• Medication errors, including getting the wrong drug the wrong dose of the right drug
• Surgical errors, such as having an operation done on the wrong site or gaffes that result in bleeding or infection;
• Hospital-acquired infections

The question many are now asking: is the new estimate accurate?

“It is hard to know that to make of the trigger tool,” admits Dr. Peter J. Pronovost, a Professor in the Johns Hopkins University School of Medicine (Departments of Anesthesiology and Critical Care Medicine, and Surgery) and Medical Director for the Center for Innovation in Quality Patient Care.

However, “Far too many patients suffer preventable harm in the U.S.” he added.

Other recent studies appear to confirm Classen’s findings.

Earlier this month the US government released data for the first time, showing how often patients are injured by certain medical errors in hospitals.  However, only eight types of serious, preventable errors were included in the comparison.

They were: air in the bloodstream, falls, bedsores, transfusions with the wrong blood type, urinary tract infections, blood infections, uncontrolled blood-sugar levels and foreign objects left in the body after surgery.

Other serious events, including wrong-site surgeries and medication errors, were not included.

And late last year, the Office of Inspector General for the U.S. Department of Health and Human Services said 180,000 Medicare recipients die each year from hospital mistakes. That’s more people than are killed every year in car crashes, or from diabetes or pneumonia.

Without doubt, health care has improved over the past decade, but it’s clear that there is still a great deal of work to do in order to achieve a health care system that safe, effective, patient-centered, efficient, timely, and devoid of disparities based on race or ethnicity.

Until then, SRxA’s Word on Health advises that if you think something is amiss or wrong with your hospital care, speak up.