DC Medical Malpractice & Patient Safety Blog

"Houston (and anywhere else there’s a compounding pharmacy) we have a problem." So says FDA Commissioner Dr. Margaret Hamburg, who wrote a blog on FDA Voice expressing concern about the lack of regulatory authority over the facilities that make customized, prescription medicines like the contaminated steroids that killed 53 and sickened 733 people last year. (See our blog post, “Drugs ‘Compounded’ by Pharmacies: A Disaster Waiting to Happen.”)

Despite resistance by compounding pharmacies, according to AboutLawsuits.com, state and federal agencies have been investigating them, and not liking what they see. Such pharmacies are supposed to fill a specific need: making customized drugs to order for local patients when the meds are not available commercially or in the right delivery system. But some, apparently, operate more like, as AboutLawsuits puts it, “stealth drug manufacturers, selling products nationwide in large amounts without any federal oversight.”

The New England Compounding Center (NECC), the outfit that allegedly caused the outbreak last autumn of fungal meningitis, shipped some 17,000 vials of injectable steroids across the country, and even employed sales representatives to promote it. If that’s not Big Pharma behavior, what is?

It’s cold comfort that NECC is facing criminal charges, lawsuits and bankruptcy—what’s needed, says Hamburg, is a bigger hammer of authority.

As reported by Reuters, Hamburg testified before Congress in November that the law was insufficient to enable the FDA to aggressively enforce rules and punish violators, noting that compounding pharmacies mostly are regulated by the states. Republican lawmakers countered that that the agency has authority but fails to use it properly.

Now, it seems, patient safety is the political football in a game between a divided Congress and the FDA. Last week, as reported by ABC News, House Democrats issued a report showing that most states are lax in their oversight of compounding pharmacies, and congressional investigators say state pharmacy boards lack the information and expertise to oversee them.

Of 49 states in the report, only Missouri and Mississippi provided the exact number of compounding pharmacies in their state. They were the only two that require permits or licenses for pharmacies that perform compounding. No state reported having tracked pharmacies that sell compounded drugs across state lines or in large quantities.

Many states, ABC reported, don’t keep inspection records of compounding pharmacies, and 22 don’t keep histories of problems like contamination, cleanliness and drug potency. For some states, record-keeping amounts to a combination of inspection reports, complaints and "staff recollections."

The average pharmacy board has five inspectors to visit all the pharmacies in the state. Only 19 states train inspectors to recognize problems with sterile compounding.

The next day, Republicans issued a report charging that the FDA’s sloth was the problem, not its authority. According to the Associated Press, the GOP said the agency should have closed NECC years earlier, and has always had the authority to do so. And lawmakers on both sides of the aisle called the FDA on carpet for its lack of aggressive action on compounding pharmacies generally.

In her blog, Hamburg said that the FDA has inspected 31 compounding pharmacies considered high risk and found objectionable conditions at 30 of them. Specifically, the FDA was investigating how well the facilities maintained sterile conditions and minimized the risk of contamination. You can read a summary of these inspections here.

In some cases, the feds had to get court warrants because the pharmacies delayed and resisted inspection, and U.S. marshals had to accompany the inspectors. Can you imagine a meat-processing plant engaging in such an act of defiance? An exotic flower importer turning away customs inspectors charged with keeping pests out of the country? And these people claim to be providing products people trust with their lives?

No wonder Hamburg seeks authority and resources for the FDA to police compounding pharmacies nationwide before there are violations, before someone else gets hurt or killed because the people who made their medicine took less care with hygiene than they would changing the fry oil at McDonald’s.

Gerontology is the study of health issues that go with old age and aging. It’s a medical specialty because, like the very young, older people have different biological, psychological and sociological needs. Medicare, the health insurance program that covers people in the U.S. starting at age 65, addresses many of the financial concerns of this population, but what about the hands-on care?

In a blog posted on KevinMd.com, Dr. Steven Reznick, an internal medicine physician, writes about his elderly parents residing in an assisted living facility. They are cognitively impaired, so he’s in contact with their personal physician, and lives nearby. They are lucky.

What if the circumstances were different? “What,” he asked, “would I look for in a physician for my elderly parents if they did not live close by?” Here’s his advice to older patients and their loved ones for choosing the right doctor.

• Find someone with experience in geriatric medicine. Such practitioners have training and certification from the American Geriatrics Society. A board-certified internist or family practitioner with experience in caring for the elderly also might be fine. Either specialist should be available by phone for questions and to see patients on the same day that they develop a problem requiring a doctor’s attention.


• The doctor should have hospital privileges at a local facility where patients might be taken by ambulance in an emergency. You want someone who can follow the patient into an acute care hospital if necessary. He or she also should have a professional relationship with a rehabilitation or skilled nursing facility so that patients can be treated in a rehab facility as they recover from an acute hospital stay.


• The doctor should be a compassionate individual; a great listener and energetic advocate for his or her patients. It’s all too common for elderly patients to be marginalized, to languish waiting for evaluation in the emergency department or when trying to make an appointment for a test or specialty visit. While a strong family member or other patient advocate (see our blog about patient advocates) can assume this responsibility, some older people lack such support, and the doctor is their last hope.

In addition, we would add that an elderly patient’s doctor should be very familiar with end-of-life issues. See our newsletter about who speaks for you when you can’t communicate your wishes.

Most of Reznick’s advice pertains pretty much to anyone seeking quality care from a doctor. Who doesn’t want someone compassionate, who doesn’t want someone available? But older people are among the weakest members of society, and often reluctant (or unable) to stand up for themselves. Qualities that are merely preferable for everyone might be critical for them.

To locate a suitable practitioner for an elderly patient:

• Search the Medicare referral site.


• Inquire at the local hospital medical staff office—those folks know who practices what and who’s accepting new Medicare patients.


• Ask people you know whose values are similar to yours.


• Inquire at local and county medical societies.


• Beware of Internet sites such as Yelp and other crowd-sourced referrals—everyone’s experience is different, and if a stranger is making the referral, how do you know your tastes and values are similar?


• Interview prospective doctors; if they decline because they’re too busy, they’re not good candidates.

From the meningitis outbreak, something good may come out of something bad. Earlier this month, U.S. Rep. Edward J. Markey of Massachusetts introduced a bill in Congress to boost the federal government’s authority to regulate compounding pharmacies.

As we’ve been reporting in the last several weeks (most recently last week), compounding pharmacies have been able to operate in often sketchy ways without the kind of oversight necessary to protect patients from harm. As reported on FDA Law Blog, Markey’s bill, the Verifying Authority and Legality in Drug Compounding Act of 2012 (VALID):

• Ensures that compounding pharmacies operating as drug manufacturers are regulated by the FDA as drug manufacturers (they do not currently fall under FDA scrutiny).


• Preserves state regulatory authority for traditional small compounding pharmacy activities and the requirement that drugs are compounded per each patient’s prescription. The FDA may waive this requirement in the event of a drug shortage or to protect the public health or well-being, but not for longer than one year unless the Secretary of Health and Human Services deems an extension necessary.


• Increases transparency to the public by requiring compounded drugs to include this statement: “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA at _____” (phone number and a website).

A “Do Not Compound” list of unsafe or ineffective drugs must be published within one year of enactment. State agencies responsible for regulating compounding pharmacies will receive the list, and it will be available on the FDA’s website.

Pharmacists and pharmacies compounding a drug product are required to report to the Secretary of Health and Human Services (HHS) any adverse event associated with the use of it within 10 days after becoming aware of it. If a pharmacist or pharmacy knows of any kind of contamination, chemical or physical change or deterioration of a drug that has been distributed and “could cause serious injury or death,” the pharmacist has five days to report it to the Secretary.

Some compounding operations are excused from some of the Act’s provisions, but not pharmacies required to be registered as drug manufacturers. Pharmacies or pharmacists might be waived if they: work within a hospital system compounding drug products exclusively for its patients; compound sterile drug products; compound drug products in limited quantities before receiving a valid prescription for an individual patient in their state.

As noted on FDA Law Blog, Markey, whose district is home to the New England Compounding Center (NECC) that distributed the contaminated steroid medicine that caused meningitis, said the VALID Compounding Act would close the “regulatory black hole.”

Additional developments in the NECC case were reported last week by the Boston Globe.

First, Massachusetts regulators ordered all the pharmacists and technicians employed by the NECC to stop working in the drug-compounding industry. That indicates, the paper said, that state regulators are concerned that the workers failed to follow proper procedures.

Duh. A letter from the Massachusetts Board of Registration in Pharmacy obtained by The Globe said that pharmacy staff “may present an immediate or serious threat to the public health, safety, and welfare and should immediately cease.”

The state board had already decided to seek surrender of NECC’s license. And the outfit shut down last month and recalled all of its products.

Later in the week, The Globe reported that the director of the state pharmacy board was fired and the board’s attorney placed on administrative leave for allegedly ignoring a complaint in the summer that NECC was distributing bulk shipments of drugs to hospitals in Colorado. That violates its state license.

NECC has long been a problem. As the Globe noted, The Colorado Board of Pharmacy issued a cease and desist order to the pharmacy in April 2011 after discovering its “unlawful distribution of prescription drugs.” This summer, when a Colorado hospital discovered a bulk shipment of a drug from NECC, Colorado authorities notified their Massachusetts counterparts.

They blew it off.

The House of Representatives’ Energy and Commerce Committee is convening public hearings Nov. 14 about the problems at NECC.

Even if you can’t read the fancy diploma posted on your doctor’s exam room wall, there’s comfort in knowing an authoritative institution has conferred a lofty status on the person you trust with your health.

But as a recent post on KevinMD.com by Dr. Christopher Johnson explains, certain terms denote different levels of medical accomplishment, and patients should know if their caregiver has the appropriate credentials to treat them.

“The terms ‘board certified’ and ‘board eligible,’ Johnson says, “are confusing to people not in the medical profession. It doesn’t help that more than a few doctors blur the distinctions to their own benefit.”

Anyone who has graduated from medical school is a physician, and is entitled to include the letters M.D. (doctor of medicine) or D.O. (doctor of osteopathic medicine) after his or her name. But those magic letters do not confer a license to practice medicine. Licenses are granted by each state only after a doctor has spent time in a residency program that provides additional training in a medical specialty (pediatrics, cardiology, internal medicine, etc.). Some specialties require longer post-graduate training than others.

On completion of residency, doctors must pass a test; if they pass, they are “board certified” in that specialty or specialties (you can be board certified in more than one field). But state licensing systems do not regulate what a doctor says about his or her specialist training. Many call themselves “specialists” because they are “board eligible.”

That status indicates a doctor has completed a residency program but hasn’t passed the test, either because he or she hasn’t taken it, or has done so and failed. Being board eligible restricts what the doctor is allowed to do in a hospital, but doesn’t prevent that person from practicing a specialty outside the hospital or from advertising services as a board eligible physician. It’s not wrong, but it can be misleading.

The American Board of Medical Specialties (ABMS) monitors these distinctions and recently implemented a rule forbidding doctors to claim that they’re board eligible for their entire careers. Now, there’s a time limit to pass the certification test after finishing a residency. If someone continues to use the “eligible” term beyond that threshold, sanctions can be imposed.

To find out if your doctor is certified in a given specialty, start at the ABMS website. It provides links to each specialty’s website, which tracks physician membership. And see our post about doctors with lifetime certification who are under no obligation to take re-certification exams.

It's been known for a while that Minnesota ranks dead last in the nation in the frequency with which its doctors are disciplined by the state licensing board for harming patients. Now we know why.

A new investigative series by the Minneapolis Star Tribune has some dizzying quotes from state officials who are charged with protecting the public.

For example, when asked why Minnesota so seldom took action against a doctor's license when authorities in another state had already done so, Ruth Martinez, supervisor of the board's complaint review unit, replied:

"What's the point of piling on?"

(Earth to Ms. Martinez: If your state is the only one that hasn't restricted a doctor's license to practice after some horrendous harm to patients, where do you think that doctor is going to end up practicing?)

Perhaps even more revealing are the words of the board's executive director, Robert Leach, who is quoted as follows by the Star Tribune:

"I'm satisfied the public is protected in Minnesota -- very satisfied. And remember that part of public protection is ensuring an adequate supply of health care practitioners to the public. You can't take everybody out of practice just because they had a problem. That's why we're not in the business of removing credentials unless absolutely necessary. We want to be remedial."

When the board declines to act against a doctor, patients have no way of finding out that that doctor might be a problem -- because by law in Minnesota, only public discipline is disclosable. So there's a real Catch 22 for patients trying to make sure they are seeing a top notch doctor.

Kudos to Public Citizen's Health Research Group for its compilation of the discipline statistics state by state, on which the Minneapolis newspaper report was based.

“Everyone’s a critic,” the saying goes. Applied to the practice of medicine, that sentiment might become “Everyone’s a cosmetic surgeon.”

And unless someone is board-certified in plastic/cosmetic surgery, that’s a far more threatening reality than the mere annoyance of opinionated people who can’t refrain from spouting off.

As reported in USA Today, only 21 states require that offices where doctors perform cosmetic surgery be accredited or licensed. Such practices must have certain life-saving emergency equipment and drugs, must adhere to strict safety procedures including record-keeping, anesthesia and cleanliness and must be subject to inspection.

The problem is known as “practice drift” — physicians who work outside of the areas in which they're trained and board-certified. As quoted in USA Today, "This is on the radar of many state boards," says Humayun Chaudhry, a physician and CEO of the Federation of State Medical Boards (FSMB). "What doctors should or shouldn't do when they change their area of focus is a concern for everyone."

As insurance payments to practitioners decline, many seek other avenues of income. Although insurance companies and hospitals generally prohibit doctors from practicing outside of their specialties, office surgery facilities are unregulated in more than half of states. And some clinics that do employ board-certified plastic surgeons have been accused of aggressively marketing less expensive alternatives to traditional plastic surgery, and minimizing their risks. We wrote about one such procedure, liposuction, that had tragic results for a client of our firm.

The spokeswoman for the North Carolina medical board told USA Today, "With cosmetic surgery, procedures are almost always done in the office, often without necessary and appropriate arrangements for emergencies. Doctors who drift typically do not have hospital privileges to do the procedures they are doing in the office [so] if complications do arise, the doctor often cannot even accompany the patient to the hospital."

The medical boards of individual states can discipline doctors for “unprofessional conduct” who practice medicine outside of their training and qualifications, or who put patients at risk because their facilities are insufficient. But most patient advocates say what’s really required to solve the problem are laws that codify what’s acceptable and what’s not. They say you can’t leave it open to interpretation.

Opponents say laws restricting practice drift could stifle doctors' abilities to innovate and impose unfair costs.

But when it comes to patient disfigurement or death, what cost is too high? As Dr. Sidney Wolfe, director of Public Citizens’ Health Research Group, points out, if a state doesn't have formal guidance or a law covering office-based surgery, "more people are going to get injured. States should want to expand their existing authority."

If you are interested in having, or are planning to have, cosmetic surgery, you should:

• Find out if your doctor is board certified in plastic surgery.


• Find out if your doctor is licensed and has any disciplinary actions on file.


• Locate accredited surgery facilities for your procedure.

The FSMB and/or your state’s medical board are resources that can answer your questions. Others include the American Association for Accreditation of Ambulatory Surgical Facilities, Inc. and the Accreditation Association for Ambulatory Health Care.

You can find more about cosmetic surgery malpractice, especially about the dangers of anesthesia in a non-hospital operating room, on our firm's website.

Last year we covered the outrageous spectacle in west Texas when two nurses who were appalled at a doctor's quackish and dangerous treatments of patients got into criminal trouble when they tried to report him to the state licensing board. Eventually the nurses were vindicated, but not before they lost their jobs. Now the doctor and the criminal authorities who did his bidding in Winkler County have had their comeuppance.

But still one question remains. How could this doctor, Rolando G. Arafiles Jr., have moved from town to town in Texas, inflicting harm on patients and ultimately moving on, and the authorities have taken so long to bring him to earth?

The answer exposes the perennial conflict-of-interest flaw in any professional self-disciplinary system, where the authorities bend over backwards to find some reason to let one of their fellow doctors keep practicing.

It's really not too different from the child sexual abuse scandal at Penn State, where a powerful authority figure, an assistant football coach, could continually inflict grievous harm on small children and his fellow football coaches like Joe Paterno looked the other way out of self-interest.

The Texas story is summed up in this Texas Observer story, which has this telling paragraph:

The more we dug into Arafiles' past, the more a troubling circular pattern emerged. In his wanderings across Texas—from Victoria to Crane to his wilderness years as a contract doctor to, finally, Kermit—Arafiles did the same things over and over, with the same results. He moved into town. He charmed the townsfolk. He began practicing medicine that can be charitably described as questionable; less charitably as dangerous. He peddled fringe treatments of dubious medical value. He tried to turn town authority figures against anyone who challenged him. He turned litigious when challenged. Eventually, he was stopped, but not punished. He left town, he moved on to somewhere else, and he did it all over again. And perhaps he would still be doing it today had two brave nurses in Kermit not put a stop to it.

A Kansas neurosurgeon who has been sued at least 16 times for malpractice has been able to enlist one important ally in protecting his privacy: the federal agency that runs the data bank that is supposed to keep track of dangerous doctors so they don't drift from hospital to hospital without their track record becoming known to hospitals who hire them.

The National Practitioner Data Bank (NPDB) is run by the U.S. Health Resources and Services Administration. It has both a public mission and a confidential one. The confidential mission is to allow hospitals to query the data base to obtain the track record of lawsuit payouts and disciplinary actions against doctors so they can make an intelligent decision about whether to bring a doctor onto their staff. The data bank also publishes aggregate data, without individual identifiers, about the doctors it keeps an eye on, so the public can see that it is doing its job.

A reporter for the Kansas City Star used the public data on the NPDB, among other resources, to figure out the lawsuit record of neurosurgeon Robert Tenny.

As shown by newly released documents, Dr. Tenny responded with a flurry of letters to the federal agency, which responded with:

* A threat against the newspaper reporter to punish him with fines for misusing the data bank. (This was later withdrawn.)

* Stern letters to all the 28 hospitals who had queried the data bank about Dr. Tenny to warn them that the information they had obtained on him was confidential and not to be disclosed.

* Shutting down the public access portion of the data bank.

The shutdown of all public data from the data bank has caused the most outcry, with a bunch of journalist organizations demanding that it be reinstated.

Senator Charles Grassley of Iowa released documents this week showing the cozy relationship between Dr. Tenny and the federal agency. You can read the documents by clicking here.

Article first published as Federal Health Agency Takes Side of Multi-Sued Surgeon on Technorati.

The Obama administration's decision to remove from the Web a database of physician discipline and malpractice activity shows how far this country is from giving the public ready access to information on who the most dangerous doctors are.

The National Practitioner Data Bank was set up in 1986 to provide a clearing house for hospitals and state licensing agencies to easily check out a doctor's prior history of malpractice claims and licensing discipline. From the start, the database has shielded from the public the names of the doctors in its data set. Only hospitals and licensing agencies could get the real goods. The idea was that by keeping the database confidential, health care providers would be encouraged to send in reports that would strengthen the quality of the information.

Each year, a public report of filings to the data bank is published, with all identifying information scrubbed out. The idea is to provide statistical trends.

But now there have been a few instances of enterprising journalists who have figured out from clues in the annual reports exactly which practitioners are among the heaviest sued or disciplined. And the data bank people don't like that. Hence the new move to take the whole thing down from any public access, even anonymized.

Three journalism organizations objected when the National Practitioner Data Bank was yanked by the Department of Health and Human Services (HHS) Sept. 1 from digital public access after neurosurgeon Robert Tenny, whose checkered professional history we profiled recently, complained.

As the New York Times reported, the data bank, created in 1986, is reviewed by state medical boards, insurers and hospitals, but recently, the public also could monitor claims against doctors, and their outcomes. As The Times said, the data bank “has provided valuable information for many years to researchers and reporters investigating oversight of doctors, trends in disciplinary actions and malpractice awards.”

In protesting the removal, ProPublica, Investigative Reporters and Editors and the Society of Professional Journalists noted that the Kansas City Star reporter who wrote the story about Tenny’s questionable competence received a letter from HHS warning him of liability for violating federal confidentiality laws. The document reads an awful lot like the kind of threat that chills free speech and the public’s right to know.

“Reporters across the country have used the public use file to write stories that have exposed serious lapses in the oversight of doctors that have put patients at risk,” Charles Ornstein told The Times. He’s president of the Association of Health Care Journalists and a reporter for the investigative outfit ProPublica. “Their stories have led to new legislation, additional levels of transparency in various states, and kept medical boards focused on issues of patient safety.”

A spokesman said the feds had been contacted by the doctor, who was concerned that The Star’s reporter had obtained information beyond that contained within the database’s public use file. He hadn’t.

Still, HHS is reviewing the public use file and might change it to further assure confidentiality before posting it back on the Web. The spokesman said he hoped it would be public again within six months.

Ornstein noted that The Star’s reporter, like many others across the country, had extensively researched courts, state agencies and hospital actions, “allowing them to connect the dots” to individual doctors. The federal database did not reveal identities.

As The Times’ pointed out, other recent notable articles based partly on the database have appeared in The Duluth News Tribune in Minnesota and The St. Louis Post-Dispatch, which published a series last year titled, “Who Protects the Patients?”

The answer to that question, in light of the HHS withdrawal of valuable information from public scrutiny, would have to be “not the government.”

If you're interested in more on this controversy, including the name and address of the government official responsible for the decision, check out this blog piece on the Kansas City Star affair.

Article first published as Database of Dangerous Doctors Gets Yanked from Public Eye on Technorati.

You have to wonder how in the modern world it is possible that a surgeon with 16 prior malpractice lawsuits for medical mistakes was allowed to operate on Maribeth Chase’s brain. She certainly was unaware the checkered history of Dr. Robert Tenny.

Her tortuous trip through medical misadventure and the system that enables it was told in a long story earlier this month in the Kansas City Star. The takeaway message from this shocking event is that a doctor’s history of alleged malpractice is often unknown to patients, and that doctors under such scrutiny often go undisciplined.

Here’s the cautionary tale.

Tenny’s Kansas medical license was in good standing and despite a history of malpractice claim payments, state licensing officials had never taken action against him.

In 2007, when Chase went under Tenny’s knife for the relatively simple procedure of draining blood from her brain, she didn’t know that Tenny’s poor care previously had left one patient dead, others paralyzed and yet others requiring remedial operations. She didn’t know he’d been denied clinical privileges by a local hospital.

Chase awoke from her surgery paralyzed on one side and unable to speak, the victim of a brain injury sustained during the operation. Her condition gradually deteriorated, and she died.

Tenny settled her family’s wrongful death suit for $1,010,000, a sum that brought the amount of malpractice payments made on Tenny’s behalf since the early 1990s to about $3.7 million. But that’s only part of the story.

Tenny denied causing Chase’s injury and continues to practice medicine, never mind that other disciplinary proceedings against him are pending and his Kansas license remains in good standing.

One week after Chase died, her daughter Claire filed a detailed complaint about Tenny with the Kansas medical licensing board. The board did not start formal disciplinary proceedings against Tenny until June 2010. More than a year later, the case is still not scheduled for a hearing.

It gets worse.

The Kansas City Star found 20 other doctors in Kansas and Missouri with clean, unencumbered licenses despite having lengthy histories of malpractice cases. “Some have been sued over patient deaths and serious injuries. Some allegedly operated on the wrong body parts, made incorrect diagnoses, delivered unnecessary treatment or left surgical materials inside their patients,” according to the paper.

None of their records reflects any discipline by state medical licensing boards.

Doctors and insurance companies in Kansas and Missouri must notify the boards about malpractice payments and the information also is collected by a federal agency, the National Practitioner Data Bank. State officials claim to review malpractice payments, but also say that a payout doesn’t necessarily mean there are grounds for disciplinary action. A financial settlement can be a business calculation, “a cost-benefit analysis of whether to go to trial,” one official told The Star.

The American Medical Association has reported that most doctors will be sued for malpractice by the time they retire, but most never face more than one lawsuit.

Doctors who are sued repeatedly and successfully are uncommon. According to The Star, “If you’re a doctor with more than two malpractice payments, you’re in a rare group,” said Russell Aims of the Massachusetts Board of Registration in Medicine.

The Star noted that the advocacy group Public Citizen recently released a nationwide analysis of the Data Bank. It found 14 states with physicians who had at least 10 malpractice payments plus at least one report by a hospital revoking or limiting clinical privileges, but who had not been disciplined by their state. One undisciplined doctor in New Mexico had 26 malpractice cases. One in Indiana had 20.

According to analyst Robert Oshel, formerly of the National Practitioner Data Bank, fewer than 2% of doctors nationwide have accounted for half of the reported $67 billion paid out for malpractice claims in the U.S. since 1990. “Taking that 2% of physicians out of practice would certainly make quite a difference,” Oshel told The Star.

“I wouldn’t necessarily recommend revoking the licenses of all the docs responsible for half of the payments,” Oshel said. “Some who have a single large payment are probably good, safe doctors. But all of them, especially those with multiple payments, would be good candidates for investigation by the licensing boards.”

After her mother’s ordeal, Claire Chase said, “I certainly at this point wouldn’t trust … (a) doctor without checking their history.”

If your state isn’t among the 17 that allow patients to view medical boards websites to find out about doctors’ malpractice histories, it’s time to let your legislators know that this is not acceptable. That this is a matter of life and death.

If you follow patient safety news, you've seen this headline before. Why should you care? Apart from retaining an attorney to represent you in the event of medical malpractice, what stands most prominently between medical consumers and the bad behavior of health-care providers is their states' medical boards.

These government agencies are charged with licensing medical practitioners, monitoring their practices and punishing those who make serious mistakes or who commit crimes. Sometimes, this oversight is lacking. We’ve written here before about states that fail to discipline doctors whose own hospitals find their behavior wanting, and about how one state—Washington—took the lead in addressing its board’s deficiencies.

A recent study by consumer watchdog Public Citizen has ranked states’ effectiveness in protecting their citizens from substandard physicians. Thanks primarily to shrinking budgets and also to flagging political will and leadership, residents of many states have a lot to be concerned about.

Most states, the study concludes, do not live up to their obligations to protect patients from doctors who practice substandard medicine.

The report analyzed data from the Federation of State Medical Boards on all disciplinary actions taken against doctors in 2010. It calculated the rate of serious disciplinary actions (revocations and surrenders of licenses, suspensions and probation/restrictions) taken by state medical boards. The rate was slightly lower than that in 2009 and “significantly” lower than the peak for the last 10 years.

Some of the worst states have been consistently poor performers. Nationally, in 2010 state medical boards took 2.97 serious actions per 1,000 physicians – down 3% from the last period and 20% from the peak rate of discipline in 2004 of 3.72 per 1,000 physicians.

Had the national rate of doctor discipline repeated the 2004 peak rate, there would have been 745 additional serious disciplinary actions in 2010 against U.S. physicians. “With a typical doctor having between 500 and 1,000 or more patients in their practice,” the report reads, “the positive impact of this on the large number of patients going to these doctors would be enormous.”

Minnesota was the worst state when it came to disciplining doctors. South Carolina and Wisconsin also have been consistently among the bottom 10 states for each of the last eight rankings. Connecticut has been in the bottom 10 for the last five rankings, and for the third consecutive ranking, Florida, at no. 7, is among the 10 states with the lowest rates of serious disciplinary actions. It’s a highly populated state with a lot of older people who use more health-care services than other demographic segments.

Filling out the bottom 10 are: Massachusetts, Rhode Island, New Hampshire, Utah and Vermont.

States whose rank has declined the most since their peak are: Vermont (8 to 42), Utah (10 to 43), Massachusetts (23 to 47), Montana (8 to 32) and Georgia (15 to 40).

Louisiana ranked highest in disciplining doctors, taking 5.98 serious actions per 1,000 physicians. Five states – Alaska, Arizona, Colorado, Ohio and Oklahoma – have been in the top 10 for all eight rankings. Other states in the top 10 are: Wyoming, North Dakota, New Mexico and Nebraska.

States whose rank has improved the most since their nadir: Hawaii (51 to 11), Delaware (50 to 13), Maine (46 to 19), North Carolina (41 to 16), Washington (42 to 18) and Arkansas (45 to 23). There are 51 rankings because the District of Columbia was also included (no. 37).

“One reason for medical boards’ declining rate of discipline is likely tighter state budgets,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The ability of certain states to rapidly increase or decrease their rankings … can only be due to changes in practices at the board level. The prevalence of physicians eligible for discipline cannot possibly change so rapidly.”

Most boards do not perform satisfactorily in disciplining physicians. Public Citizen called for legislative action and public pressure to kick them into action and, by extension, improve patient protection.

The organization said medical boards are more likely to address physician misbehavior if:

• they receive adequate funding (all money from license fees going to fund board activities instead of into the state’s general fund);


• they have adequate staffing;


• they engage in proactive investigations, rather than only reacting to complaints;


• they use all available/reliable data from other sources such as Medicare and Medicaid sanctions, hospital sanctions and malpractice payouts;


• they have excellent leadership;


• they have independence from state medical societies;


• they are independent from other state agencies; and


• a reasonable legal framework exists for disciplining doctors (the “preponderance of the evidence” rather than “beyond reasonable doubt” or “clear and convincing evidence” as the legal standard for discipline).

Too often, patients and families with a serious complaint about an incompetent or unethical medical doctor will write their concerns to the state licensing board and then see their case drop into a black hole. But now, thanks to the work of one crusading family, the state of Washington has a new law to make its board more responsive.

Consumers shuld hope that more of these disciplinary bodies around the country sign on for the basic changes in board conduct now required by the state of Washington. For instance, the new law requires the board to give families a report of the final disposition of any complaint, with reasons for the board's action.

These bodies are important upholders of patient safety because they have the legal power to pull or place restrictions on a doctor's or nurse's license to practice -- yet they seldom do.

In malpractice actions brought by the Patrick Malone law firm, we have often experienced the black hole first hand when we have tried to bring dangerous practitioners to the attention of state licensing authorities.

In one case, we sent a thick pile of medical records to a state licensing board about a plastic surgeon who overdosed a patient with so much local anesthetic that her heart stopped, causing her to go into a vegetative state.

The board responded a year later with a notice that the surgeon had been given a "private reprimand." When we asked them to explain what that meant, they said it was "private."

Oh.

In another case, we sent records, expert reports and other data to a state board demonstrating how a nurse had mishandled Pitocin, causing a woman's uterus to rupture with tragic consequences for her unborn baby. Two years later, we received a one-sentence notice that the board had decided not to do anything. The board advised us with pro forma language that we could send them more information. We pointed out in response that not knowing what else they might need, we felt stymied. The board said that was our problem.

Washington state has acted thanks to the efforts of Yanling Yu and Rex Johnson. Three years ago, Yu's father, Xingxun Yu, 81, died after being given a drug his daughter says triggered a fatal allergic reaction. They filed a complaint with the state's Medical Quality Assurance Commission about the doctor. When the board proved non-responsive, they enlisted the help of two state senators.

The new Washington law, which was signed by the governor a week ago, requires a disciplinary authority to promptly respond to inquiries about a complaint's status and provide the person complaining with a report on its final disposition. The law also gives family members the right to tell boards how a medical injury has affected them or their loved ones.

Yu told the Seattle Times: "I think it will make a difference, at least make them more responsive. I think it is a great step forward from what I call the dark ages in the process."

Lisa McGiffert, campaign manager for Consumer Union's Safe Patient Project, said she hoped the new Washington law would become a national model.

Article first published as Plugging the "Black Hole" in Medical Licensing Boards on Technorati.

Washington state lawmakers have proposed a bill that would give more rights to people who file licensing complaints alleging medical mistakes. Up to now, when something terrible happens to a patient in a hospital or under a doctor's care, families often file complaints with the Medical Quality Assurance Commission (MQAC) - the state's medical disciplinary board - but hear nothing for months or even years, only to finally be told that the official finding is "insufficient evidence" or "no cause for action." Not surprisingly, this leaves many families wondering if the physician and/or hospital have covered up what really happened to the patient.

Last year, nearly 1,400 Washington families filed complaints with the MQAC. Like most state medical boards, the MQAC typically closes most without action - of the 1,400 complaints, 950 were investigated and disciplinary action taken in only 94 cases, says its legal manager, Michael Farrell. Current Washington state law doesn’t require MQAC to divulge evidence during investigations or to detail its reasoning, Farrell says, and for the most part, it doesn’t.

But Lisa McGiffert, director of Consumers Union's Safe Patient Project, a national patient-safety effort, says that “many patients who file complaints end up getting frustrated because they feel like their report disappears into a bureaucratic black hole." Under the proposed law, which has already been passed by the House and is currently before a Senate committee, patients would have a "better opportunity to be heard."

The proposed law, which is being touted as model legislation for other states, would require a health profession's disciplinary board to promptly respond to complainants' queries about the status of an investigation, provide copies of files on request once a case is closed and, when deciding whether to reconsider its original finding because of new evidence, provide an explanation of its reasoning. For the first time, families would be given the right to tell board members how they've been affected - in writing or in person and before a case is closed - and recommend sanctions.

Source: The Seattle Times

Many women who went to Dr. Kermit Gosnell to end their pregnancies came away with life-threatening infections and punctured organs; some still had fetal parts inside them when they arrived at the ER of nearby hospitals. Though physicians at the University of Pennsylvania Health System, which operates two hospitals within a mile of the West Philadelphia abortion clinic, saw at least six of these patients — two of whom died – they failed to report their peer's incompetence, according to a grand jury report.

"We are very troubled that almost all of the doctors who treated these women routinely failed to report a fellow physician who was so obviously endangering his patients," wrote the Philadelphia grand jurors, who recommended a slew of charges against Gosnell and his staff in January.

The health system - in apparent contradiction of the grand jury report - released a statement saying that it had "provided reports to the authorities regarding patients of Dr. Gosnell who sought additional care at our hospitals" starting in 1999. However, attorneys for the health system could only produce a single report for the grand jury.

The grand jury also criticized Pennsylvania's health and medical regulators for taking no action against Gosnell, despite reports that he was harming patients. But the panel also said too many local physicians had shirked their professional and legal responsibilities to report him and thus protect the lives of future clinic patients.

Pennsylvania law requires doctors to report abortion complications to the state Health Department. And the American Medical Association says "physicians have an ethical obligation to report impaired, incompetent and unethical colleagues."

Prosecutors described Gosnell's clinic as "a house of horrors," where viable babies were killed with scissors, fetal remains were kept in jars and freezers, and dirty medical equipment was operated by unlicensed, often untrained and unsupervised employees. Gosnell himself was never certified in obstetrics and gynecology, only family practice.

Gosnell, 70, is jailed without bail and charged with eight counts of murder in the deaths of one patient and seven viable babies. Authorities say he also routinely maimed his clients, sometimes leaving them sterile and near death.

Source: Associated Press

State medical boards responsible for disciplining physicians have failed to do so in more than half of cases where hospitals have revoked or restricted a physician’s privileges.

A study conducted by Public Citizen, a non-profit consumer advocacy group, found that 63% of the doctors whose hospital privileges were restricted or revoked were not disciplined by the state's Board of Medicine, and 32 states didn’t even reprimand more than half of the offending physicians.

"Either state medical boards are receiving this disturbing information from hospitals but not acting upon it or, much less likely, they are not receiving the information at all,” says study overseer Dr. Sidney Wolfe, adding that either scenario is alarming.

The report was based on data from the National Practitioner Data Bank from 1990 to 2009. It examined the number of doctors whose hospitals barred — or put restrictions on — their practicing medicine there. Of the 10,672 U.S. physicians who faced hospital sanctions, 55 percent escaped any licensing action or discipline from their state medical board.

"In 20 years, only 10,000 doctors have ever been disciplined — which is an indictment of hospitals," Wolfe says. "But once hospitals take action, it's pretty serious. Of those, 5,800 were thrown off the staff of the hospital."

Yet in many cases, the state medical board did not discipline the doctor any further, and as a result, many are still practicing medicine, he says.

"It's a real indictment of medical boards," Wolfe says, because these cases are the most egregious and already have been investigated by the hospital. "It's like handing you a case on a silver platter. The investigation has been done."

State medical boards and hospital peer review are considered two of the three "legs" of the three-legged stool of patient safety and doctor discipline. The third leg that holds doctors and hospitals accountable is the availability of medical malpractice lawsuits for injured patients.

But that leg is under continual threat from medical industry advocates who complain, without good evidence, that the industry could do a better job of policing itself if state laws could make it harder for advocates for injured patients -- trial lawyers -- to file lawsuits.

Other Public Citizen report highlights include:

Of the 5,887 physicians who the state medical boards failed to discipline — many of whom also had a history of medical malpractice payments — 1,119 were disciplined for incompetence, negligence or malpractice; 605 were disciplined for substandard care; and 220 were identified as an immediate threat to health or safety.

Other categories of serious deviations of physician behavior and/or performance that resulted in the loss of hospital privileges included sexual misconduct; inability to practice safely; fraud including insurance fraud, fraud obtaining a license and fraud against health care programs; and narcotics violations. A total of 2,071 physicians were disciplined by their hospital employers for one or more of these violations.

3,218 physicians in the study lost their clinical privileges permanently, and an additional 389 physicians lost privileges for more than one year.

Source: The Los Angeles Times

You can read the complete study here.

The vast majority of medical devices recalled by the U.S. Food and Drug Administration (FDA) were subject to a less stringent regulatory process that requires only that the device prove that it's similar to something already on the market, according to a recently published study.

Of the 113 devices recalled from 2005 to 2009 because the FDA determined they could cause serious health problems or death, 80 (71%) were reviewed using the “510(k) process,” which is meant to assess devices deemed to involve low or moderate risk. Only 21 devices (19%) had been approved through the more rigorous premarket approval (PMA) process, which requires clinical testing and inspections. (Eight other devices were exempt from any FDA regulation.)

Cardiovascular devices, chiefly external defibrillators, made up nearly a third of the recalled medical products from 2005 through 2009, the time covered by the review. A 2006 study linked defibrillator failure to more than 300 deaths over a 10-year period.

Originally, the 510(k) process was specifically intended for devices with less need for scientific scrutiny, such as surgical gloves and hearing aids. It did not require clinical trials or manufacturing inspections to demonstrate safety and efficacy. Instead, it only required proof that the device was substantially equivalent in materials, purpose, and mechanism of action to another device that was already on the market, with the previous device serving as the “predicate” device with which the new device would be compared.

This approach was justified as a way to give manufacturers the opportunity to make small improvements on the devices already on the market and to allow companies with new products to compete with very similar devices without using the more extensive PMA process. If the FDA determined that the product was reasonably safe and effective according to the 510(k) review, it was said to be cleared for market rather than approved.

However, in 2002, Congress passed the Medical Device User Fee and Modernization Act, which shifted the regulatory standard to "the least burdensome approach in all areas of medical device regulation." This had the practical effect of making 501(k) the dominant mechanism for new device clearance, with the FDA now reviewing only 1% of medical devices using the more rigorous PMA process.

To decrease the number of high-risk recalls, the study recommends:

1. The FDA fully implements current law that subjects "life-saving and life sustaining" (Class III) devices to the PMA process.
2. The FDA's definition of a high-risk device takes into account the potential risks if the device fails.
3. The FDA expands the use of their authority to inspect the manufacturing of 510(k) devices just as they do for devices approved through the PMA process; and
4. The FDA strengthens their authority to use special controls for 510(k) devices as they do for PMA devices, such as postmarket surveillance, performance standards, and product-specific and general guidance documents.

Source: The Los Angeles Times

You can read the complete study here.

Former patients of an orthopedic surgeon in Dayton, Ohio, have petitioned a federal court to force a medical device company to stop selling him medical equipment. The complaint, filed in U.S. District Court against Roswell, Ga.-based Mylotec Inc., also seeks damages for 19 former patients of Dr. Lawrence Rothstein.

According to the complaint, Mylotec allegedly sold video-guided catheters to Rothstein, even though the catheters were not FDA approved for use with a laser. “Myelotec representatives were present during many of the spinal surgeries conducted in Ohio and knew or should have known that the company was placing patients at risk by promoting and permitting the alteration of its devices for non-FDA approved surgical use,” the complaint says.

Rothstein claims to have pioneered a non-invasive laser spine surgery called AccuraScope. The former patients allege Rothstein’s surgery left them with nerve damage, pain, weakness, numbness, paralysis and incontinence.

Rothstein declared bankruptcy in June 2010. At that time, there were 19 active malpractice cases against him. Previously, he had settled at least three cases and lost two trials, including a $5 million judgment for a Clark County woman who was left with permanent brain damage due to an overdose of pain medication. The bankruptcy case – which is still pending – halted the remaining malpractice cases.

Source: Dayton Daily News

Without a license to practice medicine or surgery or nursing or whatever, no health care practitioner can touch a patient. So the state licensing boards that issue -- and are authorized by law to take away -- licenses are important watchdogs for patient safety and accountability.

Which is why a year-long investigation by reporter William Heisel makes you want to cry.

He found ... well, let's borrow the introduction to his new article:

Medical boards from coast to coast are inconsistent, inefficient and ill equipped to monitor the hundreds of thousands of doctors licensed under their watch, Antidote’s investigation of every state board has found. There are some standouts, but, overall, they do a terrible job protecting patients and informing the public.

It bears repeating that most doctors do a great job and are focused on one thing: helping their patients heal and lead healthier lives. The mission of this tour was to explore what happens to that minority of doctors who don’t follow the rules.

One example in the story: Licensing boards that think they're doing a good thing when they restrict a doctor convicted of sexual molestation from seeing a certain age group of patients, naively failing to realize that the doctor will just "pivot his practice" to prey on a different age group.

Another issue: So many malpracticing doctors getting shunted to places where the patients are already vulnerable: poor towns, prisons, and addiction treatment centers.

Read the rest of his piece here.

A Louisiana neurosurgeon may face multiple lawsuits after the fund that normally handles malpractice claims in the state said it might not cover the cases.

Dr. Ravish Patwardhan already has had to surrender his surgical privileges in September over concerns about the speed of his surgeries, the number of surgeries he performed annually and the amount of followup care he provided. Now the state’s compensation fund says that if it decides Patwardhan intentionally caused harm to patients, he’s on his own.

In Louisiana, malpractice claims involving negligence or lack of medical skill are not filed against physicians directly. Instead, they are filed against the Louisiana Patients Compensation Fund, which physicians pay into in return for malpractice coverage. Such claims are capped at $500,000. However, the fund won’t cover cases if it determines that the physician intentionally harmed the patient. A panel of experts will review the claims made against Patwardhan, a process that could take as long as 2 years.

The case is unusual because usually people can sue only after a panel finishes its work. However, John Hammons, the attorney who is handling about 100 potential malpractice claims against Patwardhan, sued both Patwardhan and the fund directly after being notified that the claims might not be covered under Louisiana malpractice law.

Earlier this year, Hammons reported his concerns about Patwardhan to the Louisiana State Board of Medical Examiners, triggering an investigation that led to the board suspending Dr. Patwardhan's right to practice surgery.

Source: The Shreveport Times

Patient safety advocates and brand-name drug makers lined up against companies that make generic drugs over just how flexible the standards should be for the clinical testing of biosimilars.

These drugs, also known as biogenerics, follow-on biologics and subsequent entry biologics, are officially approved subsequent versions of biopharmaceutical products following patent and exclusivity expiration on the original product. Until now, only a handful of biosimilars have been approved in the U.S., but that is about to change.

At the hearing, patient safety advocates argued that the only way to be sure that a drug is safe is through extensive clinical trials, while generic biosimilar manufacturers and distributors maintained that dangerous and expensive clinical tests are not required because they will be based on drugs that are already proven safe.

But are they? Biosimilars exhibit high molecular complexity and may be sensitive to manufacturing process changes. In addition, the biosimilar manufacturer doesn’t have access to any of the information or substances (e.g. molecular clone or cell bank) that the originator used to create the drug. As a result, patient safety advocates worry that biosimilars might perform differently than the branded versions, and could have potentially serious health implications.

Amgen, a brand-name biopharmaceutical manufacturer, called for biosimilars to undergo rigorous testing and recommended that the FDA:

1. Use well-designed clinical trials to establish biosimilarity

2. Ensure the product manufacturer and lot number is known for all administered biologics

3. Set scientific and practical criteria for interchangeability.

Critics of a rigorous clinical testing standard say that in addition to the expense, there are ethical questions involved in repeating potentially dangerous trials in humans. To avoid repeating human trials, U.S. Senator Bernie Sanders has proposed require generics makers to pay a fee for access to clinical data used in the manufacture of the brand name biologic.

Source: Wall Street Journal blogs

You can get more information about the FDA hearing and view video of the proceedings here.

Tired of reading doctor report cards and not knowing which ones to believe? Now there's an organization that reviews the plethora of health care report cards available online in order to provide you with clear choices about the sites that really do provide accurate and useful information.

The Informed Patient Institute provides detailed analysis of online health report cards – covering nursing homes and physicians for now and other health areas in the future – to show consumers where they can find the best information.

An independent, non-profit organization funded by foundations and individual donors, IPI provides guidance to other consumer-focused organizations, such as Consumers Union, to “facilitate access to credible online information about health care quality and patient safety,” but not by rating individual health facilities or professionals. Instead, IPI evaluates the usefulness of the wealth of online report cards and advocates making more -- and more useful -- health care quality information available to consumers.

Among the best features of IPI's system:

1. It uses a clear rating system. Organizations can receive an A through F grade, with explanations for what each means. IPI always tells you “what we like” and “what we don’t like.” For example, the New York State Health Department’s Nursing Home Profile received one of the few A grades. IPI praises the site for providing a “wide range of information including state survey results, complaints and quality of care provided,” but also notes that it doesn’t “have information on costs, nursing home staffing, or resident or family satisfaction with the home.”

2. It allows for exceptions to the rules. If a site has “unique content” but doesn’t quite make the grade in other criteria, IPI gives the site a “U.”

3. It simplifies users’ options. If you click on a state like Alabama, you will see that the only option for you to click is “Physicians” because there is no nursing home content related to Alabama. California, by contrast has sites that cover both. All the areas that IPI hopes to cover in the future are included in the drop-down menu, but only the topics that have content are clickable.

4. It provides good context. For each state, on the right side of the screen, you will see a Top 10 ranking of the sites IPI has reviewed that contain content about that state.

Source: Reportingonhealth.org

To visit the Informed Patient Institute web site, click here.

A young health care journalist named William Heisel has put together a fascinating Google map of the United States highlighting case after case of state licensing boards going easy on doctors who abuse drugs, send fraudulent bills or engage in other misconduct. Check it out here.

For the latest news on Mr. Heisel's blog about dangerous doctors, see this story about a psychiatrist who has been welcomed to Maine by the licensing board there despite a checkered history including a fraud conviction, drug abuse, a competence inquiry, and some forgetfulness to mention much of this on his licensing application.

Piecing the story together about a doctor who has traveled from state to state, with multiple disciplinary actions, takes practically a Pulitzer Prize level journalistic inquiry.

Mr. Heisel rightly raises the question about why these publicly funded state licensing boards are so secretive and slow to divulge information even when they have taken concrete action. Among the boards he criticizes: Maryland, where the licensing board says only that the doctor once worked there. This is in keeping with the experience of malpractice lawyers like me who know that the Maryland Board of Medicine is slow to act and won't tell consumers much even when it has. (I discuss this in more depth in a chapter on "dangerous doctors" in my book: The Life You Save: Nine Steps to Finding the Best Medical Care -- and Avoiding the Worst.

Whose interest are these medical boards serving?

One routine piece of advice that many of us patient advocates give about scouting a new doctor is to make sure the doctor is certified by one of the boards under the umbrella of the American Board of Medical Specialties. But there's a "grandfather" issue that patients need to know about even with these boards. Doctors who were certified before 1990 have a lifetime certificate, and it's strictly voluntary whether they stay up-to-date by taking the re-certification exam every ten years.

Here is a guest column on this topic by John James, a patient safety advocate from Houston. I'm reprinting this with John's permission. John James is a NASA Ph.D. scientist who lost his son Alex to medical malpractice. Dr. James wrote a book: "A Sea of Broken Hearts -- Patient Rights in a Dangerous, Profit-Driven Health Care System." His description of the book:

This is the story of a father's journey through the healthcare that resulted in the death of his 19-year old son, and the incredible coverups of mistakes that were made. The reader is taught a little basic cardiology, and then invited to use those skills to solve "medical mysteries" that were missed by the boy's cardiologists. Chapters are devoted to understanding how physicians are educated and why current medical care is infested with errors - many of them lethal. The last chapter is a patient bill of rights that would enable patients to protect themselves from healthcare that is centered on making money and not patient safety.

The book is available from several on-line sources. Please go to http://PatientSafetyAmerica.com to read short reviews and learn about the sources.

And here is John James' column:

Does your Doctor Know?

Keeping up with new medical discoveries and applying them effectively to patients is a daunting task. One might suppose that physicians have developed an efficient and comprehensive way to capture new medical discoveries and disseminate these into the clinician community.

You would be wrong, perhaps dead wrong.

In a series of opinions from physicians published in the New England Journal of Medicine the woefully inadequate way physicians continue to learn is inadvertently revealed. That is not the intention of the opinions, but a little inspection discloses the problems. Besides their ongoing experience base, there are two major ways doctors can acquire new knowledge. The first of these is state-mandated continuing medical education (CME). Among the states, the mandated number of hours per year ranges from zero to fifty, but none is specifically required in the physician’s declared specialty. Is it any wonder that one of the articles, citing three studies, observes that CME does not improve physician performance or knowledge.5

The second way that physicians acquire new knowledge outside their practice experience is through board certification and periodic recertification. Surprisingly, a physician does not have to be board certified to represent himself as a specialist to the public. In addition, there are many second-rate board certifications appearing that are generally regarded as unable to give any assurance of competency.

What about the traditional and well-respected boards, such as those under the purview of the American Board of Medical Specialties. Can certification by these boards assure physician competency? There are two cases. One applies to physicians given limited certificates after 1990. They must periodically recertify. For example, internists must recertify every decade. Unfortunately, medical knowledge grows so quickly that information more than 5 years old may be well out of date. This approach is better than nothing, but it is clearly inadequate to ensure that your internist is up to speed on the latest findings.

Physicians that were board certified before 1990 trouble me most as a patient. These physicians were given lifetime certificates. This means that they do not have to recertify to continue to represent themselves to the public as board certified. However, these specialists can choose to voluntarily participate in maintenance of certification (MOC). This choice prompted the series I am reviewing here.

Two MDs make the case that internists with lifetime certificates should voluntarily recertify.5 They view MOC as a superior process to CME and cite several studies linking MOC to better physician performance. They note that physicians’ ability to self assess their learning needs is poor. Barriers to voluntary participation include costs and time. Of course, the fear of failure is another barrier. They note that there are flaws in the testing, but that these can be reduced by feedback from participants.

Three other MDs argue that a physician with lifetime certification should not voluntarily recertify.6 They note that very few physicians choose to recertify, which they interpret to mean that the specialists think the process is irrelevant to their practice. I would argue that it is more likely the cost, time, and fear-of-failure that limit voluntary MOC. They argue that there is not “definitive evidence” that recertification benefits patient care. They further argue that the recall of facts on the closed examination does not make an improvement in patient care.

As a patient I feel that physicians should demonstrate some level of competency through recertification or be required to disclose to all their patients when the last time was that they were subjected to a competency assessment. You might like to know that almost ¾ of cardiologists in a national survey admitted that they had not been evaluated for competency in the past 3 years.7

Citations:
5) Levinson, W and TE King, Jr. Enroll in the MOC program as currently configured. N Engl J Med 362:949-950, 2010

6) Goldman, L, AH Goroll, and B Kessler. Do not enroll in the current MOC program. N Engl J Med 362:950-952, 2010

7) Campbell, EG, S Regan, RL Gruen, et al. Professionalism in medicine: Results of a national survey of physicians. Ann Intern Med 147:795-802, 2007

If you would like to subscribe to John James' Patient Safety America Newsletter, send him an email at john.t.james@earthlink.net. I'm a subscriber, because John regularly provides valuable information about our broken health care system.