Bone-Chilling Mistakes Hospitals Make And Why They Don't Want You To Know

Claire* was detained by security at the airport when the metal detector went off. Guards couldn’t figure out why. Eventually, they let her board the flight, but when she arrived home she immediately asked her doctor to order an X-Ray. The result: There in Claire’s abdomen, clear as day, was a retractor, a surgical instrument the size of a crowbar, somehow left behind from her recent surgery.

This story is not as unusual as we would all hope. Indeed, the story is instructive enough that it appears in the leading textbook on patient safety, “Understanding Patient Safety” by Bob Wachter. There’s even a well-vetted medical term for this kind of error: “foreign objects retained after surgery,” one among many scary mishaps labeled as “serious adverse events.” The Leapfrog Group, my nonprofit which represents employers and other purchasers of healthcare, has another name for these outrageous errors: “never events” – mistakes that should never happen, no excuses. Surgical never events – Claire’s experience, plus some other errors you don’t want to hear about during lunch, occur about 11 times a day, according to a study from Johns Hopkins. There is a host of grisly mishaps known to happen beyond the surgical suite in the walls of a hospital, from excruciating and fully preventable Stage 3 or 4 bedsores to collapsed lungs. When you count all the non-surgical and surgical never events, they happen about 200 times a day to Medicare beneficiaries alone.

Here’s the kicker: Though I don’t know Claire, I bet the offending hospital billed her for the surgery to remove the crowbar. They probably weren’t brazen enough to bill her to replace the missing retractor in the operating room, but stranger things have shown up on hospital bills.

Employers and other purchasers have long been outraged by these astonishing misadventures in hospitals, and they are tired of paying for them. In recent years, they’ve adopted a set of purchasing principles that include refusing to pay for never events and demanding an apology to the patient. It’s amazing that we even needed to establish such guidelines in the first place. But according to the Leapfrog Hospital Survey, while the majority of reporting hospitals committed to adhere to our guidelines, hundreds more refused.

A few years ago, after many battles, Medicare finally started requiring hospitals to publicly report on some of them, including the following nine events:

Foreign object retained after surgery

Air embolism

Pressure ulcers, Stage 3 and 4

Trauma and falls

Collapsed lung due to medical treatment

Breathing failure after surgery

Postoperative PE/DVT (a preventable and often deadly blood clot)

Wound split open after surgery

Accidental cuts or tears from medical treatment

We used these nine measures in our Hospital Safety Scores – letter grades assigned to more than 2,500 general hospitals warning consumers of their propensity for deadly mistakes. We found that some hospitals have many more of these never events than others. And the public deserves to know which hospitals protect patients best.

But the American Hospital Association (AHA) and its lobbyists disagree. They did not want hospital data on these never events, as well as some other terrible measures, publicly reported. They acknowledge these events happen, but they say the government wasn’t measuring them in a way that’s perfectly fair to hospitals.

Purchasers continually fight this effort to suppress reporting. The best-known and most well-respected national coalition of employers, unions and consumer advocates, the Consumer-Purchaser Disclosure Project, pleaded in a letter last year to Secretary of Health and Human Services Kathleen Sebelius, “When it comes to patient safety, we simply cannot afford – in either human or financial terms – to delay or derail progress toward greater transparency and accountability. Nor can we wait until the arrival of perfect measures before addressing patient safety gaps in our health care system.”

The hospital lobbyists nearly won suppression of never events. Last fall, the Centers for Medicare & Medicaid Services (CMS), the agency that runs Medicare, announced they would stop reporting the never events listed above, plus other key measures. However, the agency recently told us they do, indeed, plan to continue reporting these measures, at least through 2013, so we’ll keep working with them to continue the level of transparency the public deserves.

The good news is that the administration has taken steps to identify other measures of patient safety for public reporting and pledges to tie Medicare payment to performance on those measures in the future. These are new measures of infection, errors and accidents. Just last month, CMS put out for public comment a proposed rule to make a number of important new safety measures public.

Last week, the hospital lobby submitted a 58-page comment letter complaining (among other things) that these measures aren’t perfect enough, but consumer and purchaser organizations responded, saying the measures, in fact, meet the requirements of good science and give the public the information we need to protect ourselves and our families.

Our advocates ask for reporting on more critical measures, faster and with more detail. AHA asks for fewer measures, reported later instead of now, and reported in generalities so you can’t discern among hospitals using the data. For instance, Leapfrog wants to end the exemption of Maryland, Puerto Rico and Guam from public reporting. We ask for data to be reported for each and every facility that calls itself a hospital; currently, CMS only reports data by hospital system, and a system can have several hospitals in a wide geographical area. (Patients care about their individual hospital, not what corporate system it belongs to. And we have found major differences among hospitals in the same network).

Meanwhile, before the ink was dry on its letter to CMS complaining about the imperfection of measures and requesting delays, AHA was quick to submit testimony to the Senate about its commitment to public reporting — as long as it’s on its own terms. AHA’s testimony asks for fewer measures to be publicly reported, and although the lack of progress nationally on patient safety is well established, the testimony reports glowing achievements by some of its member hospitals in improving on several important measures of performance. Ironically, the important measures it touts to Congress are among the same ones it tells CMS aren’t good enough for public reporting.

We can only hope for bipartisan common sense to prevail when hospitals ask to suppress information from the public that they themselves use to improve their performance. While we’re hoping for the right response from Congress, consumer and purchaser advocates will need all the support we can get to protect patients — and protect our right to know.

_______________________________________
Source: Forbes (Binder, 7/15)

Daughters say patient safety compromised at Dallas VA Hospital

Patient safety at the Dallas Veterans Administration Hospital is again being called into question.

Considered to be the agency's worst facility in 2004, the Dallas VA Hospital has received more than 30 certification agency complaints in the last three years.

And now, there are two more.

Two daughters agreed to discuss the deaths of their fathers and the conditions they say no veteran should have to endure.

The Veterans Administration is the largest health care system in the nation, serving more than eight million veterans a year. VA officials in Washington D.C. pledge “to never compromise the safety, security or well-being of veterans."

Sydney Schoellman says the government has shattered that pledge.

Her father, Korean War veteran Gary Willingham, trusted his care to doctors at the Dallas VA hospital. In November 2010, Willingham went to the VA for what his daughter believed would be a short operation to remove a tumor from his neck.

But six hours after surgery began, Schoellman said two doctors finally emerged. "They never really admitted that anything went terribly wrong,” she said. "They kind of just padded around that."

Schoellman said what they did tell her is that her father had lost a lot of blood, and that they had accidentally clamped off his carotid artery for six minutes.

When she and her family were allowed to see Willingham, she said she was in shock.

"What we saw wasn't the man we grew up with," Schoellman said. "That wasn't the man that we'd seen how many hours earlier." With his carotid artery clamped and his brain starved of oxygen, Willingham had, in effect, suffered a debilitating stroke. Schoellman's once-energetic father was now bedridden and would spend the next year before he died unable to eat or drink on his own. Outraged, Schoellman started to dig, asking for the detailed surgical notes from the day of the operation.

"I was informed by one of the employees at the Dallas VA that I should get those records before they disappeared," she said. Deep in the surgical notes Schoellman said she found a disturbing revelation: The carotid artery had been clamped not for six minutes — as she said she was told — but for 15 minutes.

"If we had known it was 15 minutes, we wouldn't have allowed the things that went on. We would have let him end his life with dignity and the grace he lived it with before the surgery," Schoellman said.

Willingham's family has since filed a formal complaint and a legal claim against the Dallas VA for improper care. Tammie Wilson has also filed a complaint with the Dallas VA, saying her father — decorated Vietnam vet Gary McGrew — was stripped of his dignity as well.

Admitted to the Dallas VA this past February with two broken arms, Wilson said her father agonized for hours without pain medicine. "They just dawdled and dawdled, and it might have been six hours in-between," Wilson said. "I would just keep going out to the nurses' station saying, "Please, please!' They would respond slowly, if at all."

Wilson said no one seemed to be aware that her father was in his final stages in a fight with cancer. She said nurses were still trying to feed him in the minutes he was taking his last breaths.

"Here comes this nurse, stirring up the same pills and the same apple sauce he had spit out the night before because he couldn't even take a drink of water," Wilson said.

Administrators at the Dallas VA have declined to discuss either of the complaints with News 8, saying they either can't due to pending legal action or to lack of proper authorization.

They also say the complaints filed against them with the Joint Commission, the hospital accreditation agency, have been investigated and closed. They said the VA "maintains a safe and sanitary environment" and "invite families to discuss their concerns and complaints ... through several means available to them."

Schoellman said the only means left for her family is the courts, along with her ability to speak out for the veterans who cannot. "These are some of the greatest national treasures that we have, and they walk in every day, and these families are blindsided by the pain and the agony of losing someone at the hands of people who are never held accountable," Schoellman said.

Last fall, News 8 investigated complaints about quality of care at the Dallas VA. The Inspector General with the Veterans Administration last fall also found excessive wait times and irregularities with referrals and appointments.

Rep. Eddie Bernice Johnson (D-Dallas) said her office has also received complaints.

"While I am unable to comment directly on any information I have received from my constituents, many of these complaints pertain directly to the quality and timeliness of patient care," Johnson said. "The VA’s own Inspector General reports — which are public record — bear out the delays and shortcomings in patient care."

“I have repeatedly expressed my concerns to the VA in Dallas and in Washington D.C., in direct response to those complaints," the congresswoman added. "The single most important responsibility of the VA is to meet the health challenges that our veterans face. While I have worked directly with [VA] Secretary [Eric] Shinseki's office on numerous occasions within the past year, the VA at the local and federal levels have not responded impartially to these complaints. It has always been my hope that the leadership at the VA would have taken their own initiative to address these issues. I will do everything necessary to address the concerns of my constituents and patients of the VA North Texas Healthcare System. So long as the VA’s ability to meet those challenges remains in question, I will not rest until these issues are resolved.”

____________________________________________

Source: WFAA (AP, 6/10)

Texas Supreme Court rules against Fort Worth family whose dog accidentally euthanized

The Texas Supreme Court ruled against a Fort Worth family who sued for the sentimental value of their dog after it was mistakenly euthanized at a Fort Worth animal shelter.

The case was being watched by animal advocates, pet product manufacturers and veterinary groups after the 2nd Court of Appeals in Fort Worth that said owners can claim sentimental value for their deceased pets, overturning a 120-year-old state Supreme Court decision stating that a person can only sue for the market value of a pet.

But the court, in a unanimous decision from the court, stood by its earlier precedent and said that a pet owner's attachment to their family pet, while unquestionable, is also uncompensable.

"Throughout the Lone Star State, canine companions are treated -- and treasured -- not as mere personal property but as beloved friends and confidants, even family members," wrote Justice Don Willett. "Given the richness that companion animals add to our everyday lives, losing "man's best friend" is undoubtedly sorrowful. Even the gruffest among us tears up (everytime) at the end of Old Yeller."

"We acknowledge the grief of those whose companions are negligently killed. Relational attachment is unquestionable. But it is also uncompensable. We reaffirm our long-settled rule..."

Kathyrn and Jeremy Medlen sued a Fort Worth animal shelter employee after their dog, an 8-year-old Labrador mix named Avery, was mistakenly euthanized several years ago.

Avery had escaped from Kathryn and Jeremy Medlens' back yard during a thunderstorm. The next day, Jeremy Medlen went to the animal shelter to get his dog, but found out he had to pay $80 in order for the shelter to release Avery. Medlen didn't have the cash on hand but was told he could come back to claim Avery.

He returned to the shelter the next day, but matters were complicated even more when he learned that a veterinarian would have to implant a microchip in Avery's ear. A "hold for the owner" sign was placed on the dog's cage to prevent the dog from being put down.

But when Medlen returned to the shelter with money to claim Avery, he learned that his pet had been euthanized by mistake.

Initially, their lawsuit was dismissed in a Tarrant County civil district court because the family sued for the sentimental value and not the market value of their dog, but the Medlens appealed, and the Fort Worth appeals court issued its ruling in favor of the family.

An attorney representing the former animal shelter employee, Carla Strickland, in her appeal, said pet owners can already sue for reasonable damages if their animal is killed accidentally.

The attorney said that the Fort Worth appeals court ruling would also have a "devastating" effect on the economy, forcing veterinarians to pay more for malpractice insurance and pet owners to pay more for vet visits.

Previously -  Texas court asks: Is man’s best friend priceless?

_______________________________________
Source: Star Telegram (Campbell, 4/5)

Mass. pharmacy recalling some compounded products

BOSTON— A Massachusetts pharmacy issued a voluntary recall Monday of some of its sterile compounding products after "foreign matter" was found in drug vials during an unannounced inspection by state and federal officials.

Pallimed Solutions Inc., of Woburn, was also ordered by the state board of pharmacy to stop all sterile compounding activities until further notice.

Most of the recalled items were used to prepare erectile dysfunction treatments for patients who have difficulty taking drugs orally. The company said fewer than 800 patients were involved.

The company described the recall as a precautionary measure and said it had received no reports of any illnesses or injuries. It also said it would continue with nonsterile compounding.

The Massachusetts Department of Public Health said it requested the recall after a joint inspection on Friday by the state pharmacy board and the U.S. Food and Drug Administration.

"The cease and desist was issued after foreign matter was observed in vials of injectable drugs," the Department of Public Health said in a statement.

Pallimed also was ordered to place all its compounded sterile products into quarantine while the investigation continued.

The company said there was no indication the products were tainted or unsafe. The state also said there were no reports of any patient harm.

A message was left with the FDA.

Massachusetts stepped up unannounced inspections of compounding pharmacies after a deadly fungal meningitis outbreak last year was linked to an injectable steroid produced at another Massachusetts company, New England Compounding Center.

That outbreak was responsible for 720 illnesses in 20 states, including 48 deaths, according to the most recent update from the Centers for Disease Control and Prevention.

Framingham-based NECC ceased operations in October and surrendered its license to the Massachusetts board.

Pallimed Solutions is a 7-year-old company that does business as Pallimed Pharmacy and has about 15 employees, according to its website. It said it regretted any impact on customers and that patient safety was its top priority.

"By undertaking this recall action, Pallimed will move forward to ensure that our products always meet the highest standards of safety and customer expectations," the company said in its statement.

On Nov. 27, the state ordered Pallimed to temporarily stop production of sildenafil citrate — the active ingredient in Viagra — for human use after inspectors found it had been prepared with improper components. The company said those issues were administrative in nature and had been resolved, and Monday's announcement was unrelated.

The state said the earlier order was still in place, pending the board's acceptance of a corrective plan.

___________________________
Source: WFAA (AP, 3/25)

Compounding pharmacies have been linked to deaths, illnesses and safety failures for years

 Shoddy practices and unsanitary conditions at three large-scale specialty pharmacies have been tied to deaths and illnesses over the past decade, revealing that the serious safety lapses at a Massachusetts pharmacy linked to last fall’s deadly meningitis outbreak were not an isolated occurrence, records and interviews show.

The series of safety failures happened long before national attention focused on the New England Compounding Center, whose contaminated steroid shots were linked to 45 deaths and 651 illnesses.

A Washington Post analysis found that state and federal authorities did little to systematically inspect and correct hazards posed by specialty pharmacies, which custom-mix medications for individual patients, hospitals and clinics. In the lightly regulated industry, pharmacies were rarely punished even when their mistakes had lethal consequences.

The Post reviewed hundreds of records, including lawsuits and Food and Drug Administration documents, and interviewed dozens of government and industry officials. The review found serious problems at three of 15 large-scale compounding pharmacies that dominate the industry. These multimillion-dollar companies mass-produce medications and ship them across state lines, often without individual patient prescriptions.

Three of the firms, in addition to the NECC, have experienced significant safety problems over the past decade that were tied to at least 39 illnesses. Two companies’ missteps were linked to at least six deaths. The problems included medications that were too potent or laced with bacteria.

One of the three firms identified by The Post — the California-based Central Admixture Pharmacy Services — is under investigation at its Massachusetts facility by the FDA, according to industry and government officials.

Executives at CAPS, a pioneer and among the largest manufacturing-style compounders, declined to comment on the investigation, which has not been previously disclosed. Federal officials would not discuss the probe, which was triggered by their ongoing investigation of the NECC and a sister company, Ameridose.

Illinois-based PharMEDium Services and Texas-based ApotheCure also had serious deficiencies, records show.

Officials at CAPS, PharMEDium and ApotheCure said their companies produce high-quality products and are continuously upgrading operations to make them safe.

But when regulators have visited the firms after patient illnesses or deaths, they have sometimes found alarming conditions.

“The things they saw, they would chill your bones,” said cardiologist John Armitage, regarding the FDA’s 2005 investigation of several CAPS facilities after some of his patients died or became gravely ill.

Today, compounders supply about 40 percent of all intravenous medications used in hospitals, up from 16 percent a decade ago, according to industry estimates. They make some of the highest-risk drugs available, including steroid injections like the ones linked to the meningitis outbreak. Yet they are not required to follow the safety rules that apply to commercial drugmakers.

Government regulators have failed to rein in reckless operators. State pharmacy boards, which have the primary responsibility for policing the industry, have an uneven enforcement record.

The FDA’s attempts to use its power have been thwarted by companies relying on gaps in the law and conflicting court rulings. The companies have fought enforcement orders and kept the agency out of their facilities. Some members of Congress have sought to beef up the agency’s authority, but the industry has successfully killed those efforts.

“You are seeing a bunch of people trying to do their best in a system that is legally and factually complicated,” said Howard Sklamberg, director of compliance for the FDA’s Center for Drug Evaluation and Research.

The FDA is again pressing Congress for greater powers.

CAPS In 1991, health-care entrepreneur Jim Sweeney became one of the original architects for the modern compounding industry when he persuaded a Southern California hospital to outsource some of its pharmacy work to him.

Across the country, nurses had made fatal errors mixing solutions in patients’ rooms, and hospital pharmacies were struggling with bacterial growths in their own drug therapies. Hospitals adopted new safety standards, but they were costly. At the City of Hope hospital, officials turned to Sweeney and CAPS “strictly to save money,” said Dale Adams, chief pharmacy officer.

Sweeney outfitted a double-wide trailer in the hospital parking lot, hired a team of pharmacists and began making intravenous nutritional supplements for its cancer patients. Before long, CAPS was expanding to other hospitals and making intravenous drugs.

“We typically would approach hospitals and ask, ‘What are the high-risk things you are making? How would you like us to do that for you?’ ” said Eric Steen, whom Sweeney hired from the drugmaker Baxter and made president. Sweeney sold the company in 1994.

One of the drugs in big demand was cardioplegia, a solution used in open-heart surgery to stop and restart the heart. The drug often is made from ingredients that are not sterile, so compounders must successfully sterilize them so it can be safely injected into the coronary arteries.

The pharmacies, however, cannot be compelled to test each lot or batch to check for sterility and proper potency.

In 2004, the company’s Pittsburgh facility prepared cardioplegia for Alycia Hartzell, a 2-year-old who was undergoing open-heart surgery. According to a 2007 lawsuit filed against CAPS by Children’s Hospital of Pittsburgh, the active ingredients and the sodium strengths were too strong and “the use of the CAPS cardioplegia solution led to a brain bleed, and severe permanent injuries.”

Daniel Stefko, a lawyer for the hospital, said the FDA never investigated the episode. “I remember being sort of surprised to find that there was this phenomenon out there, where if I ordered something from Pfizer, it was FDA-regulated, but if I ordered basically the same thing from a compounding pharmacy, the rules were not there.”

CAPS settled with Children’s Hospital for an undisclosed amount. The Hartzell family, which sued the hospital, settled with it for an undisclosed amount. The girl’s mother, Amanda Hartzell, said she could not comment because of a confidentiality agreement. CAPS and parent company B. Braun Medical declined to comment.

A year later, CAPS shipped batches of cardioplegia from its facility in Lanham, Md., to Mary Washington Hospital, a hospital in Fredericksburg, records show.

Shortly thereafter, two patients who had undergone open-heart surgery had a devastating infection and died. Nine other heart patients ended up in the intensive-care unit for extended stays.

“It’s normal for people to have an inflammatory response following open-heart surgery, but to have a severe response that results in multi-organ failure — that’s rare,” said John Armitage, who ran the cardiac unit and now lives in Oregon. “We started changing everything we could think of. Nothing seemed to work.”

In September 2005, cardiovascular specialists staged a mock surgery and found the cardioplegia was contaminated with bacteria, according to a hospital analysis.

They repeated the mock surgery to make sure no other factors were contributing to the crisis. This time, the full cardiac team joined in, scrubbing their hands, slipping on sterile gowns, masks and gloves as they walked through each step of an operation while the hospital’s infection-control staff watched. The only thing missing was a patient.

The cardioplegia seemed to be the only problem, the state health department concluded.

When the FDA was notified, Armitage said, it took days for investigators to arrive, and they wouldn’t tell the hospital what they were finding out about the CAPS Lanham facility.

“They said, ‘We are not a police agency,’ ” Armitage said. The hospital filed a Freedom of Information Act request and received the FDA inspection report about six months later.

The FDA found 17 safety violations at the Lanham facility. Cardioplegia was tainted with the species of bacteria that matched those found at Mary Washington. Internal tests showed “the presence of bacteria in a water container used for cleaning. . . . Likewise, sterility testing demonstrated similar bacteria in its drug products.” The Maryland Board of Pharmacy suspended the Lanham facility’s license for two months.

The FDA also found dozens of problems at CAPS’s facilities in Alabama, Pennsylvania and Missouri.

Steen, who left CAPS last year to start his own medical consulting firm, said the cause of the illnesses remains a “mystery.” He noted that the facility sent the drug to a number of other hospitals that didn’t have any problems.

That might have been because Mary Washington had ordered a special formula, said Diane Woolard, director of the Division of Surveillance and Investigation with the Virginia Health Department. “It may have been a contaminated element in those ingredients,” she said.

Officials at CAPS, which has 25 locations and $500 million in annual sales, would not comment on the 2005 event. In an e-mail statement, Mike Koch, a vice president, said, “CAPS is committed to offering the highest quality admixture service to our customers and their patients.”

PharMEDium Services

In 2007, a team of investigators from the Centers for Disease Control and Prevention issued an unusually blunt warning to hospitals and doctors: Compounded drugs had a higher risk of contamination than commercially manufactured drugs, and compounding pharmacies had “generally lower quality-control standards than pharmaceutical manufacturers.”

The warning, which appeared in a medical journal, stemmed from a 2005 multi-state outbreak involving another big compounder, PharMEDium Services of Lake Forest, Ill.

In January 2005, six cardiac patients at Kaiser Permanente Los Angeles Medical Center came down with a rare bacterial infection. Doctors suspected contaminated magnesium sulfate made by PharMEDium. The intravenous solution is widely used to steady the heartbeat after surgery and to treat a life-threatening condition of pregnancy called pre-eclampsia.

But neither the hospital nor PharMEDium’s Houston plant that made the drug had any solution left to test. Compounders are not required to keep samples for testing later on in case patients get sick.

Federal officials were stymied until they learned five heart patients in New Jersey had developed the same infection, also after receiving magnesium sulfate made by PharMEDium. The New Jersey hospital had bags of solution left, and tests confirmed the rare bacterial strain in the bags matched that of all patients in Los Angeles and New Jersey.

“It was almost luck that we were able to make this match,” said Esther Tan, part of the CDC team that investigated the outbreak.

Investigators said the contamination could have come from the hands of technicians who made the bags of solution. No source was identified.

One patient, Joe Chacon, a heavy-equipment operator in Los Angeles, said he was infected Jan. 12, 2005, at the Kaiser hospital during heart surgery. He became feverish, required a ventilator to breathe and eventually needed to have his pacemaker removed because of concerns about a recurrence of infection, according to his civil suit against PharMEDium.

“I was in the hospital for quite a while,” said Chacon, now 59. He said he wasn’t able to go back to work. The company settled for $25,000, his wife, Rachelle Chacon, said.

All told, at least 18 people in five states were sickened.

From 2005 to 2011, hospitals and patients raised other concerns about PharMEDium medications. In 2006, the company recalled pain medication after human error led to mislabeled drugs at its Mississippi plant, according to FDA records and company officials. An Arizona man lost consciousness after receiving morphine sulfate rather than the less powerful fentanyl citrate. In 2009, a similar incident occurred at the same plant, according to FDA records.

After the bacterial outbreak, the FDA inspected the Houston plant and found staff had failed to fully investigate nine instances in the months before the outbreak where PharMEDium’s own monitoring showed higher-than- allowed levels of “viable microorganisms,” according to FDA records.

The company increased environmental testing and training, officials said in an interview. The firm also developed a special bar-code-scanning technology to minimizes manual errors, the company said. The company said that it’s not practical to keep samples because it makes small batches of drugs with short expiration dates.

Founded in 2003, PharMEDium has four plants and annual sales of more than $100 million, officials said. The company says it uses only sterile, FDA-approved ingredients for the intravenous and epidural medications it supplies to more than 2,000 hospitals, including Johns Hopkins Hospital.

Company President Rich Kruzynski said the incidents are a fraction of the “tens of thousands of batches” provided to hospitals. The record, he said, demonstrates PharMEDium’s commitment to be the industry’s “gold standard” for quality, patient safety and regulatory compliance.

ApotheCure

While many compounding pharmacies were focusing on hospitals, others were catering to physicians who practiced experimental medicine.

One of the rising stars was Texas-based ApotheCure, which was cited by celebrity Suzanne Somers in her 2005 bestselling book, “The Sexy Years,” which extolled the anti-aging benefits of customized hormone therapies.

About the same time, ApotheCure’s owner, Gary Osborn, was quoted in alternative magazines and wrote on his company’s Web site about the benefits of using gout medication for pain relief and using lipids in “fat-dissolving” solutions. He also promoted chelation therapy, which removes heavy metals from the body, as a treatment for autism.

As ApotheCure branched out, nearly doubling its $6 million in annual sales during the mid- to late 2000s, patients began getting ill after using some of its products. FDA records from a 2007 inspection show ApotheCure did not alert the agency about many of the incidents.

However, the FDA was notified by local health officials about a 2004 episode in which nine people in Pennsylvania got sick after receiving infusions of an ApotheCure solution that the pharmacy said would dissolve fat, records show. Symptoms included abdominal pain, nausea, vomiting and renal complications, according to state health records.

When FDA officials showed up to investigate the Dallas facility that had made the solution, owner Osborn turned them away, saying they needed an inspection warrant, FDA and court records show. They never returned with one, the records show.

FDA officials said that although they did not secure a warrant, they worked with Texas State Board of Pharmacy officials who inspected the facility. The state board did not take any disciplinary actions, said Allison Benz, the board’s director of professional services.

In 2005, a 5-year-old autistic boy died after being treated with ApotheCure’s chelation compound. Using this treatment for autism “is not evidence-based, and it has the potential for being very toxic and fatal,” said FDA’s Janet Woodcock, director of the agency’s Center for Drug Evaluation and Research.

The company kept promoting chelation therapy, records show. Osborn did not make any public statements about the incident at the time and did not respond to The Post’s requests for comment.

Two years later, three patients at an Oregon pain clinic died after injections of ApotheCure-compounded colchicine, a medication for gout marketed by alternative compounding pharmacies for neck and back pain. The solution was eight times as strong as what was ordered by the treating physician, records show.

The Oregon state attorney general’s office investigated the company after the three deaths. David Hart, who prosecuted the case against ApotheCure for the attorney general’s office, said he thinks the FDA missed a critical opportunity in 2004 when it didn’t get the search warrant.

“Arguably, if action had been taken earlier by the FDA, this could have been prevented,” he said.

When the FDA was notified of the 2007 deaths, this time the agency got a warrant for the facility. The agency identified 13 deficiencies and Texas authorities found 80 deficiencies and violations, records show.

In its report, the FDA noted that products were not tested for potency prior to shipping — something that could have prevented the deaths. But that didn’t violate the law because testing for potency and sterility is not required of compounders, noted ApotheCure attorney James J. Doyle III in a written comment.

The agency’s and state board’s findings became the backbone for state complaints in Texas and Oregon and a Justice Department lawsuit filed against Osborn and his company, state and federal records show.

At the time of the fatal incidents, Osborn told the Associated Press that the colchicine mishap was due to “human error.” Osborn declined interview requests from The Post. His attorney, Lawrence J. Friedman, said he thinks his client was unfairly singled out.

“They decided to make an example out of ApotheCure,” Friedman said.

After the 2007 incident, Friedman said, his client hired consultants and “doubled, even tripled,” safety precautions.

However, a Dec. 20, 2010, internal audit of ApotheCure, obtained by The Post, showed that three years after the FDA investigated, the pharmacy was still riddled with unsanitary conditions.

Insect body parts were found in “clean rooms” where sterile products were compounded. A suspended ceiling, with exposed pipe, wiring and duct work, allowed “contaminants to flow over the sterile suite and fall through the suspended ceiling.”

The Texas pharmacy board returned last year and found a few minor problems. All of them have since been corrected, said Gay Dodson, the board’s executive director.

In 2012, Osborn pleaded guilty to misdemeanor criminal violations of the federal Food, Drug and Cosmetic Act for the colchicine-related deaths. Osborn was ordered to pay a combined $400,000 in fines to settle the DOJ, Texas and Oregon complaints directed at him and his company. The terms of settlements with victims’ families are confidential.

Osborn’s company — which has about $10 million in annual sales — is still in operation.

“People make mistakes, but there is nobody watching over these people,” said Christopher Long, whose 56-year-old mother died after receiving the toxic colchicine made by ApotheCure. “The regulatory piece of this, nothing has changed. I realize it takes a long time to rein things in, but my mother is dead, ApotheCure is still in operation and people have died again.”

___________________________________
Source: Washington Post (AP, 2/7)

Meningitis due to tainted steroids

The meningitis outbreak that has sickened at least 119 people and killed 11 of them has laid bare a disturbing lack of regulatory oversight of pharmacies that mix drug compounds and ship them around the country. Unless Congress passes legislation to strengthen the hand of the Food and Drug Administration, the public will continue to be at risk from contaminated products.

The outbreak has been linked to a steroid made by the New England Compounding Center in Framingham, Mass., that was shipped to 23 states. The steroid was almost certainly contaminated by a fungus, although final laboratory results are not yet in. Some 13,000 patients may have had the tainted steroid injected near their spines to ease back or neck pain. The center has shut down, surrendered its license and recalled all of its products, not just the steroids, while state and federal investigations try to pin down exactly what went wrong.

How could this happen? As Denise Grady, Andrew Pollack and Sabrina Tavernise explained in The Times, these pharmacies fall into a legal no man’s land between the Food and Drug Administration and 50 state pharmacy boards, most of which have little expertise and limited resources to ensure the safety of these products.

Years ago, compounding pharmacies were small-scale operations that mixed ingredients to meet the special needs of patients who couldn’t take the standard drugs, perhaps because they were allergic to a particular ingredient or couldn’t swallow a pill and needed a liquid form instead. Such pharmacies still exist, often inside a hospital, where they custom-make mixtures in accord with prescriptions written by the patients’ doctors.

Over the past decade or more, however, some pharmacies have morphed into miniature drug companies that compete with big pharmaceutical firms and produce compounds that essentially mirror drugs already on the market. Doctors and hospitals have turned to these pharmacies because their prices are often much lower than those charged by major manufacturers or because the standard drugs are in short supply.

Therein lies an element of risk. Compounded drugs have not gone through the same rigorous tests for safety and effectiveness required of standard drugs and are not made in plants inspected by the F.D.A. to ensure good manufacturing practices. There have been several incidents in recent years in which compounded drugs have caused injury. Some critics complain that the F.D.A. and state regulators should have intervened in this case sooner and more forcefully, which may well be true. But conflicting court decisions have left unclear what powers the F.D.A. has to regulate these pharmacies.

Congress can and should clarify matters with legislation. The legislation ought to grant the F.D.A. any powers it thinks it needs to inspect compounding pharmacies, monitor their nationwide sales and judge the safety or effectiveness of their products. It should also empower the F.D.A. to block pharmacies from making drugs (such as injectable steroids) that require a higher degree of sterility than many of them can meet. The goal is to ensure that there are no further calamities in this lightly regulated market.

_____________________

Source: The New York Times (10/9)

Study: tort reform has not cut health care costs in Texas

A new study found no evidence that health care costs in Texas dipped after a 2003 constitutional amendment limited payouts in medical malpractice lawsuits, despite claims made to voters by some backers of tort reform.

The researchers, who include University of Texas law professor Charles Silver, examined Medicare spending in Texas counties and saw no reduction in doctors' fees for seniors and disabled patients between 2002 and 2009. A 2003 voter campaign in Texas, and some congressional backers of Texas-style tort reform in every state, however, argued that capping damage awards would not onlycurb malpractice lawsuits and insurance costs for doctors, it would lower costs for patients while boosting their access to physicians.

Tort reform is a controversial topic likely to be resurrected by Republicans and doctors' groups who hoped to make it part of the 2010 federal health care law.

[visit Texas Injury Lawyers' website]

The researchers' findings come after a report last fall in which the Ralph Nader-founded consumer group Public Citizen said it found Medicare spending in Texas rose much faster than the national average after tort reform. Critics of that study said that tort reform leaders never promised health care spending would decline and noted that caps on damage awards brought steep drops in malpractice insurance rates for doctors and large increases in new doctors coming to Texas.

Another study yet to be published on physician supply and tort reform, also by Silver's group, agrees that malpractice suits and payouts sharply dropped after tort reform. But that study strongly disputes claims of a mass exodus of Texas doctors before tort reform and huge increases afterward.

On the question of health care costs, Silver's group focused on the federal government's Medicare program, which makes up 20 percent of the $2.5 trillion spent on U.S. health care.

That group — consisting of two Republicans, a Democrat and a foreign national, according to the researchers — analyzed data at the county level in Texas, said Tom Baker, author of a 2005 book, "The Medical Malpractice Myth," and a professor of law and health sciences at the University of Pennsylvania.

"This is a very highly regarded study, and this team is highly regarded," Baker said. The study was paid for by the researchers' universities, Silver said, and the paper was published this month in the Journal of Empirical Legal Studies.

"Their results didn't surprise me at all," Baker said.

[read full story at Statesman.com here]

____________________
source: Statesman (Roser, 6/20)

Medical Malpractice Caps Hurt Patients

The U.S. House is set to consider on the Republicans' Jobs Through Growth Act, which contains a section aimed at reforming medical malpractice by imposing caps on economic and non-economic damages similar to those in place in Texas. Texas limits non-economic and exemplary (punitive) damages in all cases, and limits what relatives can get in cases of wrongful death. An obvious disturbing consequence is that caps reduce compensation to severely-injured individuals. Caps would hurt consumers in a second way -- lower damage awards would reduce medical professional liability insurers' financial incentives to reduce practice risk.

Much of the protection consumers have against irresponsible and negligent behavior on the part of health care providers hinges on oversight and incentives created by the medical professional liability insurance industry. A nationwide shift to caps could result in more cases of negligence and substandard care.

Support for caps comes from individuals who see the medical malpractice system as broken, largely based on anecdotal observations. Everyone seems to have heard a story of a high verdict to a plaintiff whose claim was not valid. Yet, careful studies suggest these cases are anomalies, and the court system generally works. While there are no statistics for the country as a whole, based on the existing evidence, we can say confidently that a good chunk of initial claims (likely more than three-quarters) do not move forward because no negligence was involved. The vast majority of cases that do move forward settle.

This means that court signals from earlier trials are clear. If court awards were random, one would expect many more cases to go to court as there would be an expectation of an award even where there was no negligence. Many cases go to court because plaintiffs think they have a case when they do not. We know this because plaintiffs rarely win; less than a quarter of all cases that go to court are resolved in favor of the plaintiff. At least one study found court findings of negligence lined up with assessments by impartial reviewing physicians.

Critics of the legal system point out that many cases of negligence are not reported or adjudicated. However, every review has found claims are concentrated among a very small subset of physicians; less than five percent of physicians are responsible for the overwhelming share of claims. Even if a large percentage of negligent actions are not reported, it would seem that the present system works in identifying physicians whose practice patterns put patients at risk.

For the system to work to reduce practice risk, malpractice premiums must be experience rated -- physicians who exhibit risky behaviors must face higher malpractice insurance premiums than their less-risky peers. The conventional wisdom among health policy experts has been that experience rating does not occur. But this is not true: high-risk physicians pay up to 500% more for insurance than their less-risky peers.

Insurance companies specialize. Some only insure physicians with spotless records. Others, the surplus lines carriers, specialize in underwriting the highest-risk physicians -- at any given time between two and ten percent of practicing physicians. As one broker put it, because it is so costly, being forced into the surplus lines market gets a physician's attention and motivates efforts to reduce practice risk.

New procedures are often left to surplus lines carriers to underwrite, adding a layer of oversight to the introduction of new procedures such as Lasik eye surgery and laparoscopic gallbladder surgery. On rare occasions, carriers deny coverage, which precludes affiliation with most hospitals and health maintenance organizations -- which effectively means these really risky physicians are forced out of practice, which is exactly the desired result.

Beyond individual underwriting to identify at-risk physicians, the medical professional liability insurance industry makes significant contributions to risk reduction in other ways. Companies offer premium discounts to physicians who take risk management seminars. The Physicians Insurers Association of America's Data Sharing Project identifies risky practice patterns. High insurance premiums motivated anesthesiologists to evaluate the risk associated with their practice patterns. As a result, anesthesiology is much safer than it used to be. Some insurers visit physician offices to evaluate safety and risk.

In 1992, when Congress tried to "help" community and migrant health centers by taking on their malpractice risk, many of the health centers resisted, lamenting the loss of the risk-management services the private carriers supplied.

Under the current system, liability motivates these efforts to reduce risk. Reducing liability, as caps do, is rarely a good idea in any situation. Placing caps would reduce malpractice insurers' incentives to oversee physician practice patterns and reduce incentives to manage risk in our health care system, and make health care that much riskier for all of us.

___________
source: Huffington Post (Svorny, 11/23)