Patients are imperiled by avoidable drug errors and hit with pricing ploy

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Patrick Malone & Associates P.C. | DC Injury Lawyers

Big Pharma has made the nation so pill-obsessed that prescription drugs pose big risks to the safety of the seriously sick and injured and the finances of retirees.

Recent news stories have warned, for example, that:

The grievous harms created by hospital medication errors arose anew as a major, systemic institutional menace with infuriated nurses’ reaction to the criminal conviction of RaDonda Vaught, R.N., for giving a patient a lethal dose of a drug in error. She admitted her mistake and had her license revoked. But prosecutors asserted her actions were so egregious that they charged her with felonies and won a conviction against her for gross neglect of an impaired adult and negligent homicide.

The case caused a national nursing furor because practitioners said medical staffers need to be allowed to own up to errors, so they can be prevented, particularly if they are systemic. Her defenders say they cannot understand why prosecutors intervened in Vaught’s case, which more typically might have been handled in civil lawsuits or settlements. They also said Vaught’s mix-up was all too common — entering incorrect information and pulling from a secure, “computerized medicine cabinet” a wrong drug, a powerful paralyzing agent, rather than a sedative, and dosing a patient with it.

Such incidents occur with distressing frequency, the independent, nonprofit Kaiser Health News service reported, following up on the nurses’ concerns and Vaught’s conviction. Brian Kelman reported this for KHN:

“Computerized cabinets have become nearly ubiquitous in modern health care, and the technological vulnerability that made Vaught’s error possible persists in many U.S. hospitals. Since Vaught’s arrest in 2019, there have been at least seven other incidents of hospital staffers searching medication cabinets with three or fewer letters and then administering or nearly administering the wrong drug, according to a KHN review of reports provided by the Institute for Safe Medication Practices, or ISMP. Hospitals are not required to report most drug mix-ups, so the seven incidents are undoubtedly a small sampling of a much larger total.

“Safety advocates say errors like these could be prevented by requiring nurses to type in at least five letters of a drug’s name when searching hospital cabinets. The two biggest cabinet companies, Omnicell and BD, agreed to update their machines in line with these recommendations, but the only safeguard that has taken effect so far is turned off by default. ‘One letter, two letters, or three letters is just not enough,’ said Michael Cohen, the president emeritus of ISMP, a nonprofit that collects error reports directly from medical professionals. ‘For example, [if you type] M-E-T. Is that metronidazole? Or metformin?’ Cohen added. ‘One is an antibiotic. The other is a drug for diabetes. That’s a pretty big mix-up. But when you see M-E-T on the screen, it’s easy to select the wrong drug.’”

Kelman detailed how three-letter drug mix-ups have occurred even since Vaught’s conviction might have made hospitals and medical staff more aware and cautious:

“The seven drug mix-ups identified by KHN, each of which involved hospital staff members who withdrew the wrong drug after typing in three or fewer letters, were confidentially reported by front-line health care workers to ISMP, which has crowdsourced error reports since the 1990s. Cohen allowed KHN to review error reports after redacting information that identified the hospitals involved. Those reports revealed mix-ups of anesthetics, antibiotics, blood pressure medicine, hormones, muscle relaxers, and a drug used to reverse the effects of sedatives.

“In a 2019 mix-up, a patient had to be treated for bleeding after being given ketorolac, a pain reliever that can cause blood thinning and intestinal bleeding, instead of ketamine, a drug used in anesthesia. A nurse withdrew the wrong drug from a cabinet after typing in just three letters. The error would not have occurred if she had been required to search with four. In another error, reported mere weeks after Vaught’s arrest, a hospital employee mixed up the same drugs as Vaught did — Versed, a sedative, and vecuronium, a dangerous paralytic. Cohen said ISMP research suggests requiring five letters will almost entirely eliminate such errors because few cabinets contain two or more drugs with the same first five letters.”

If this precaution, indeed, can be so effective, why hasn’t it been put in effect at more hospitals? Here is what KHN reported of steps by the two major medication cabinet makers:

“Omnicell [product shown above, as used in British health service video] added a five-letter search with a software update in 2020. But customers must opt into the feature, so it is likely unused in many hospitals. BD, which makes Pyxis cabinets, said it intends to make five-letter searches standard on Pyxis machines through a software update later this year — more than 2½ years after it first told safety advocates the upgrade was coming. That update will be felt in thousands of hospitals: It will be much more difficult to withdraw the wrong drug from Pyxis cabinets but also slightly more difficult to pull the right one. Nurses will need to correctly spell perplexing drug names, sometimes in chaotic medical emergencies.”

This, in turn, can create its own challenges, the news services reported:

“Michelle Lehner, a nurse at a suburban Atlanta hospital that activated the five-letter search last year, said she believed hospitals would be better served by isolating dangerous medications like vecuronium, instead of complicating the search for all other drugs. Five-letter search, while well-intentioned, might slow nurses down so much that it causes more harm than good, she said.

“As an example, Lehner said that about three months ago, she went to retrieve an anti-inflammatory drug, Solu-Medrol, from a cabinet with the safety feature. Lehner typed in the first five letters of the drug name but couldn’t find it. She searched for the generic name, methylprednisolone, but still couldn’t find it. She called the hospital pharmacy for help, but it couldn’t find the medication either, she said. After almost 20 minutes, Lehner abandoned the dispensing cabinet and pulled the drug from a non-powered, ‘old school’ medication carts the hospital normally reserves for power outages. Then she realized her mistake: She forgot the hyphen. ‘If this had been a situation where we needed to give the drug emergently,” Lehner said, ‘that would have been unacceptable.’”

A prescription drug list that suddenly changes prices

While lawmakers in Congress continue to dawdle and poke around the idea that the federal government should use its giant clout to negotiate with drug makers over the costs of prescription medicines, Medicare recipients have found themselves struggling with what critics call a pricing flim-flam.

For seniors, too many of whom barely get by on fixed budgets, the problems with their federal insurance drug benefits roll up during their year-end, annual open enrollment period. That is when beneficiaries can choose plans or switch them — and a key consideration for many of the insured focuses on the long lists of drugs that are covered and at what cost to patients.

Here’s the way, though, that patients get a financial knifing, with a twist, during their crucial, deadline-driven, policy decision-making period, Kaiser Health News reported, quoting critics:

“A recent analysis by AARP, which is lobbying Congress to pass legislation to control drug prices, compared drugmakers’ list prices between the end of December 2021 — shortly after the Dec. 7 sign-up deadline — and the end of January 2022, just a month after new Medicare drug plans began. Researchers found that the list prices for the 75 brand-name drugs most frequently prescribed to Medicare beneficiaries had risen as much as 8%. Medicare officials acknowledge that manufacturers’ prices and the out-of-pocket costs charged by an insurer can fluctuate. ‘Your plan may raise the copayment or coinsurance you pay for a particular drug when the manufacturer raises their price, or when a plan starts to offer a generic form of a drug,’ the Medicare website warns. But no matter how high the prices go, most plan members can’t switch to cheaper plans after Jan. 1, said Fred Riccardi, president of the Medicare Rights Center, which helps seniors access Medicare benefits.

“Drug manufacturers usually change the list price for drugs in January and occasionally again in July, ‘but they can increase prices more often,’ said Stacie Dusetzina, an associate professor of health policy at Vanderbilt University and a member of the Medicare Payment Advisory Commission. That’s true for any health insurance policy, not just Medicare drug plans.”

As KHN found, seniors not only must work through a jarring price hike after the enrollment period closes, they also must find their way through a thicket of complex designations by insurers affecting the prices of prescription medications they need for their health, depending on their chosen drug plans:

“When [the Center for Medicare and Medicaid Services] approves plans to be sold to beneficiaries, the only part of drug pricing it approves is the cost-sharing amount — or tier — applied to each drug. Some plans have as many as six drug tiers. In addition to the drug tier, what patients pay can also depend on the pharmacy, their deductible, their copayment or coinsurance — and whether they opt to abandon their insurance and pay cash.”

Throw in the challenges for patients in figuring out list prices, co-payments, and subsidies for those less well off, and, critics say, seniors too often find themselves far from a fundamental, optimal situation of getting to budget well for their drug costs.

Not good. In my practice, I see not only the harms that patients suffer while seeking medical services, but also the damage that can be done to them and their loved ones by dangerous and costly drugs.

It is unacceptable that hospitals fail to take maximal steps to prevent mistakes, especially when they are systemic, and cause patients to receive harmful and even fatal doses of prescribed drugs. In pre-pandemic times, medical errors claimed the lives of roughly 685 Americans per day  — more people than died of respiratory disease, accidents, stroke and Alzheimer’s. That estimate came from a team of researchers led by a professor of surgery at Johns Hopkins. It meant that medical errors ranked as the third leading cause of death in the U.S., behind only heart disease and cancer. As hospitals and medical staff have been overwhelmed by the coronavirus pandemic, patient safety issues likely have only grown, experts warn.

This underscores the importance of institutions adopting and improving helpful patient safety advances, including system modifications that require medical staff to double- and triple-check, and check again, the medications they administer to the sick and injured.

If emergency care requires fast and accurate prescribing, hospitals can make adjustments, including, as KHN reported, posting signs, if needed, to ensure key meds are spelled correctly, or in providing specialized staff to assist. It also may be past time for great minds to reconsider the complex system under which drugs get generic and brand names, the latter having become all but nonsensical (see the direct-to-consumer drug advertisements that blanket the airwaves).

As for Big Pharma and drug prices, well, where to begin? Congress and the White House must heed the ever-rising public clamor to deal with prescription drug prices, pronto, especially because the only certainty in this area is that meds will skyrocket in cost.

C’mon, folks in this business have a right to make reasonable profits from their products. But we have much to do to ensure the safety, affordability, and access to prescription drugs.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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