Can Pill Color Prompt a “Nocebo” Response?

What’s the opposite of a placebo? An active drug, of course. But what’s the opposite of a placebo response? That would be a “nocebo” response, in which placebos produce adverse side effects.

 

“It’s somewhat hypothetical, but you can imagine that if somebody feels they will get better, they will get better, and if they feel that they’re taking something that’s not good for them, they might get worse,” according to Dr. Allan Krumholz, professor of neurology and director of the Maryland Epilepsy Center, Baltimore.

Image courtesy of Dr. Tricia Y. Ting

Pill color and appearance have been identified as a potential source of “nocebo” response, and differences in appearance between brand-name and generic drugs have been postulated to explain why some patients experience increased adverse events when they switch from brand-name to generics.

In response to this growing concern, in August 2010 the Food and Drug Administration solicited proposals for bioequivalence studies of the impact of switching from brand-name antiepileptic drug lamotrigine (Lamictal) to generic among patients with epilepsy in the outpatient setting.

This is a new way of conducting such trials. “Pharmacokinetics trials across all areas of medicine have traditionally been highly controlled single-dose studies in healthy volunteers dosed in the laboratory setting,” said lead investigator Dr. Tricia Y. Ting, a neurologist who works with Dr. Krumholz at the UMD epilepsy center.

Because the brand-name Lamictal and its generic counterparts look very different, the investigators decided to over-encapsulate the pills with identical coverings in order to “blind” the patients to which formulation they were taking.

But in order to do that, they first needed to determine whether the color of the pill would impact the patients’ perception of safety and efficacy. A group of 80 adult epilepsy patients were shown standard AA size capsules in five “global colors” (white, yellow, gray, caramel, maroon) and asked to select any color(s) considered “unacceptable” and to rank their preferences.

More patients deemed gray, caramel and maroon colors “unacceptable” (21%, 19%, and 20%, respectively) compared with the white and yellow (5% and 4%, respectively). There was a clear preference for white and yellow pills over the other, darker colors, without much difference between white and yellow.

But, there were patients who selected maroon as their “preferred” color. “Some people didn’t have any preference. Some had a very strong preference. One patient, an artist, liked the darker colors. It was different for different people,” noted Dr. Karen M. Aquino, a neurology fellow who worked on the nocebo study.

So what pill color will the bioequivalence study use? “To optimize drug adherence, white colored capsules will be used for over-encapsulation,” Dr. Ting wrote in her poster, which was presented at the American Epilepsy Society’s annual meeting in Baltimore. Dr. Krumholz and Dr. Aquino presented the pill color preference data in a separate poster at the meeting. The bioequivalence results are expected in 2013.

-Miriam E. Tucker (@MiriamETucker on Twitter)

Is Abstinence Contraception?

For many women, abstinence is a reliable way to prevent unwanted pregnancy. But is it a valid form of contraception for young women who are taking the powerful teratogenic drug isotretinoin?

Courtesy Wikimedia Commons user Diacritica

Advisers to the Food and Drug Administration danced around that topic at a meeting examining whether the risk management program for isotretinoin — called iPLEDGE — was effectively reducing the number of pregnancies in women of child-bearing age who take the drug.

Isotretinoin is indicated for a severe, scarring form of acne, but is used off-label for other types of acne, as well.

iPLEDGE began in 2006. As part of the program, young women who are capable of getting pregnant are required to have monthly pregnancy tests during their course of treatment, and to use two methods of birth control. But it’s left up to the women to decide what they will use. According to data submitted to the FDA by isotretinoin maker Mylan Pharmaceuticals, after birth control pills, abstinence was the top choice for all women as a primary method of birth control.

About 13% of women who became pregnant on the program were using abstinence as their primary method, with no back-up contraception. Twenty-five percent of women in the program who were not pregnant used abstinence and no back-up, and another 10% used abstinence as their primary method, with oral contraceptives as the secondary method.

Among isotretinoin-using pre-teen and teenaged girls, abstinence was listed as the primary method. It was the second most popular contraceptive technique for 20- to 29-year-olds.

Mylan reported that there have been 836 pregnancies in the 5 years since iPLEDGE began. Four hundred women chose to end their pregnancies, possibly because of the risk of birth defects. The company does not know the outcomes in 282 of the pregnancies. There were 45 live births; of those there were 8 children born with congenital anomalies.

Pregnancies are declining, though, as reported in our news coverage of the meeting. But even Mylan said in its background materials that, “the most common reason for iPLEDGE pregnancy as reported by the prescriber and the patient, was failure to comply with the iPLEDGE contraceptive requirements (e.g., did not use two forms of birth control, did not use contraception on the date of conception, unsuccessful at abstinence).”

How many pregnancies could be avoided with more specific education for prescribers and for young women about which birth control methods are the most effective?

The FDA advisers heard from Dr. Eleanor B. Schwarz, a University of Pittsburgh ob.gyn., who pleaded for the iPLEDGE program to make a strong recommendation for young women to use IUDs or contraceptive implants.

Some members of the advisory committees agreed that perhaps it was time to provide a more comprehensive guide to the effectiveness of various contraceptive techniques.

FDA officials were largely silent on that matter. And it’s hard to imagine them — or the isotretinoin makers — weighing in on such a dicey topic as which birth control method young women should be using.

What do you think? Should the iPLEDGE program be giving young women more evidence-based information about contraceptives?

—Alicia Ault (@aliciaault on Twitter)

Approved or not Approved? That is a Good Question.

In a move last month that apparently took at least two device manufacturers completely by surprise, one center of the Food and Drug Administration recommended against an intended use of their products, despite the products’ approval and licensure by another FDA center.

PharmaJet's Stratis is used to vaccinate a Cambodian child against measles. Photo courtesy of Heather Potters.

Recent jet injector models, including Bioject’s ZetaJet and Biojector 2000 and PharmaJet’s Stratis, were approved and licensed by the FDA’s Center for Devices and Radiological Health (CDRH) as needle-free alternatives for injecting vaccines and injectable medications. Both companies had been marketing their devices for influenza immunization in the current flu season.

On October 26th, the FDA’s Center for Biologics Evaluation and Research (CBER) issued a notice  advising healthcare professionals that inactivated influenza vaccines should be administered only with a sterile needle and syringe. The reason: “Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.” However, CBER said, individuals who have already received a flu vaccine with a jet injector do not need to be revaccinated.

Currently, only the measles-mumps-rubella vaccine is approved and specifically labeled for administration by jet injector.

So what’s the concern with influenza vaccine? “A jet injector subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered,” according to the CBER document.

Evidently this information had not been previously communicated to the manufacturers. “We were provided no notice by FDA of any concerns about Jet Injectors or FDA’s statement. To our knowledge, no other needle-free injection manufacturer received notice or an opportunity to discuss this matter with FDA,” PharmaJet said in a statement.

Bioject’s President and CEO Ralph Makar was similarly taken aback by the FDA notice. “The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices…are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other injectable drugs,” he said in a statement.

In a public comment at the October meeting of the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices, PharmaJet Inc’s chairman Heather Potters said, “Last year we scaled up to provide several hundred thousand syringes, and this season we were expecting to sell several million. Now, our domestic sales have virtually stopped, except for [investigational trials].”

The companies are expected to meet with the FDA in early January to work this out. According to Mr. Makar, “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”

-Miriam E. Tucker (@MiriamETucker on Twitter)

TAVI Trek Begins

It took just two days after the Nov. 2 FDA approval of the Edwards SAPIEN transcatheter aortic valve for New York-Presbyterian Hospital/Columbia University Medical Center to claim bragging rights as the first center in the United States to implant the device as an FDA-approved standard of care.

The center will be one of four sites to train U.S. doctors in the procedure, and is promising to lead a live demonstration tomorrow (Nov. 9) at the annual Transcatheter Cardiovascular Therapeutics symposium in San Francisco for those eager to get a front row view of transcatheter aortic valve implantation (TAVI).

Courtesy Edwards Lifesciences

The FDA approval also put the U.S. in the rare position of following the footsteps of some 40 countries that have already approved the SAPIEN valve including Latvia, Iran, and Russia. This fact elicited a good laugh at the recent Heart Valve Summit 2011 in Chicago, but also prompted much dialogue about some of the thorny ethical and economical consequences that still lay ahead.

“Is anyone at the government talking about rationing of care?” asked Dr. Stephen Strelec, an anesthesiologist at University of Pennsylvania Medical Center, at the summit. It’s not just the 92-year-old who says “I want to live,” but the younger patient facing a valve procedure who decides they don’t want to be on anticoagulants and undergo surgery because they can afford this expensive new transcatheter valve in 2 years. “There’s an economic consequence to that decision as well,” he said.

Dr. Robert Bonow, director of the center for cardiovascular innovation at Northwestern, said the issue is being looked at by federal agencies and insurers, but added that it is “one of the biggest hot-button items about this whole technology because it’s not going to be cheap.”

Dr. David Adams, chair of cardiothoracic surgery at Mount Sinai Medical Center, said they’ve already had their share of 90-year-olds wheeled in from the nursing home by family members who read about TAVI in the newspaper and want mom to stay alive.

The suggestion was made that surgeons and interventional cardiologists will have to hone their skills in making the very specific diagnosis of medical futility, and that a board-certified palliative care physician will be one of the most valuable members of the multidisciplinary teams treating these patients.

“Every PARTNER site looking back over their patients can name patients that they wish they didn’t enroll in the trial and done the valve on,” said Dr. Howard Herrmann, director of interventional cardiology and cardiac catheterization at the Hospital of the University of Pennsylvania. “The question is how to recognize them up front.”

Edwards Lifesciences and the FDA are setting up an intensive training program with simulations, an expert review of cases and a proctoring system. Still, the challenge for Edwards and other companies that will follow will be enormous in terms of launching this technology outside the clinical trial setting, said Dr. Adams, co-principal investigator of Medtronic’s CoreValve trial.

“You can not overestimate the amount of company support you’re going to need to do these things safely,” he said. “This is not a new widget you can pick up in one or two tries like a new ring or new stent…It’s a whole new process.”

The European experience, albeit the initial experience, suggests there’s a distinct learning curve to TAVI. A meta-analysis of 12 TAVI trials presented at this summer’s European Society of Cardiology Congress, reported a flattening of mortality curves 8 years after the first human case in 2002, with procedural mortality decreasing from 16.7% in 2004 to 0.0-0.6% in 2010 and 30-day mortality plummeting from 67% to 11% over the same time period. The authors, led by Dr. Pablo Salinas, University Hospital La Paz, Madrid, credit technical improvements in the devices, better patient selection and on-site case proctoring as helping to shorten the learning curve.

—by Patrice Wendling

Is Your Phone Smart Enough to Cure Acne?

The Federal Trade Commission (FTC) says no, definitely not.  On Sept. 8, the agency announced that it had reached settlements with two companies that were claiming that their apps could cure acne. It is the first time the FTC has pursued any company making a health claim for an app.

“AcneApp” and “Acne Pwner” both claimed to be able to treat acne with colored lights that come out of the phone when the app is activated. Purchasers were told to hold the screen next to the affected area of skin for few minutes daily.

The agency was having none of it. “Smartphones make our lives easier in countless ways, but unfortunately when it comes to curing acne, there’s no app for that,” said FTC Chairman Jon Leibowitz, in a statement.

Acne Clear app. Photo by Alicia Ault

According to the FTC, there were 3,300 downloads of AcnePwner, for sale in the Android Marketplace for 99 cents. AcneApp was downloaded 11,600 times from the iTunes store at a cost of $1.99 each. 

The AcneApp makers claimed that the app was developed by a dermatologist and that its technology was backed up by a study in the British Journal of Dermatology. Nope, not true, said the FTC.

The settlements bar the app makers from making acne-treatment claims and they were ordered to pay nominal fines. Koby Brown and Gregory W. Pearson, doing business as DermApps, have to pay $14,294, and Andrew N. Finkle, doing business as Acne Pwner, was ordered to pay $1,700.

The trade journal mobihealthnews reported that both apps had been removed from retail earlier this year or late last year.  Mobihealthnews also noted that the New York Times gave the AcneApp some press in late 2009. Gregory Pearson is identified in that story as a Houston-area dermatologist.

Apps that claim to offer curative powers were the subject of a two-day workshop that the Food and Drug Administration just wrapped up.  The agency has been mulling over how and when to regulate mobile apps.  It looks like the FTC may have beaten it to the punch.

But there are likely to be plenty more apps to scrutinize in the future.

A quick check of the Android marketplace today from my smartphone found, “Acne Clear,” from United Holdings Group, being sold at 99 cents.  It supposedly “uses a specific sound frequency and a blue color wavelength from the Lapis Lazuli gemstone to help clear and detox the skin.”  United also markets a “Skin Cleanser” app that supposedly uses a sound frequency and “a yellow color wavelength from the Imperial Topaz gemstone to help clean the skin of dark spots, sun spots, and acne scars.”  It’s 99 cents.

There’s also “SkinApp” from M&R Selected, which is free. and advises that it allows you to do “color light therapy on the go.” It is listed as having 10,000 to 50,000 downloads. The reviews are full of testimonials that it works, but also that it is just plain “bad.”

What kind of review would you give these apps? Should patients download them, or are they better off keeping their 99 cents?

— Alicia Ault (on Twitter @aliciaault)

Can Crowdsourcing Speed Diabetes Drug Discovery?

When it comes to finding treatments and cures for complicated conditions such as diabetes, why not cast the widest net possible for new ideas? That’s the thinking behind the Juvenile Diabetes Research Foundation’s new collaboration with an organization called Innocentive to seek innovative proposals from the general public for a novel glucose-responsive insulin drug. The “Challenge,” which offers a $100,000 reward, is an example of crowdsourcing in drug discovery, a recent concept that has been gaining momentum.

manbeastextraordinaire (Jake Brown) / Wikimedia Commons

“Originally, crowdsourcing was defined as a mechanism by which specific problems are communicated to an unknown group of potential solvers in the form of an open call, usually via the Internet; the community (the “crowd”) is asked to provide solutions and the ‘winners’ are rewarded,” Dr. Monika Lessl and Dr. Khusssru Asadullah, of Global Drug Discovery Bayer Healthcare Pharmaceuticals, Berlin, wrote earlier this year in Nature Reviews/Drug Discovery.

Eli Lilly was the first company to introduce the crowdsourcing concept in drug discovery by establishing the InnoCentive platform in 2001. Now an independent organization, InnoCentive has a “solver” community of more than 200,000 experts from 20 countries. In Innocentive’s “Challenge Platform” model, intellectual property (IP) is transferred from the solver to the “seeker” in return for a financial reward. In contrast, with Bayer Healthcare’s Grants4Targets, IP remains fully with the applicants initially, and subsequent collaborative agreements are negotiated for promising agents. In yet another crowdsourcing model sponsored by the UK’s Medical Research Council, IP is jointly owned and revenue is split between the parties.

Drs. Lessl and Asadullah write that in order for drug discovery crowdsourcing to be successful, “it is critical that the questions or challenges to be addressed are suitable, precisely defined and clearly presented, and that what is expected from potential solvers and offered by the searching organizations is clearly communicated.” Indeed, the expectation is clearly spelled out for the JDRF/InnoCentive initiative: “What we need is a sophisticated insulin that will take the guesswork out of managing diabetes by working the same way insulin works in people without diabetes,” Aaron Kowalski, Ph.D., assistant vice president of Treatment Therapies at JDRF, said in a press statement.

This isn’t JDRF’s first support of research on glucose-responsive insulin. Back in 2008, JDRF formed a $1 million partnership with a company called SmartCells, Inc. to advance the preclinical development of a product called SmartInsulin. SmartCells has since been acquired by Merck, which is continuing the product’s development. As Dr. Kowalski told me, “JDRF remains interested and excited in the clinical development of SmartInsulin by Merck.”

Photo by Miriam E. Tucker

So why is JDRF now simultaneously crowdsourcing the concept? Again, it’s about that wide net. First, Dr. Kowalski said, there may be multiple innovative ways to design glucose-responsive insulins. Second, it’s possible that not all insulin-dependent diabetes patients would respond the same way to a single type of insulin. “Therefore, we aim to stimulate more approaches that we hope will provide multiple options to patients with diabetes.”

Third, because the approval process for new drugs is highly variable, “The more options that are available, the more likely it is that one of them will make its way through the regulatory process.” Bottom line: “Insulin-dependent diabetes remains an urgent, unmet medical need, and it is important for JDRF to take a multi-pronged approach to tackle this challenge.” By opening up the challenge to the entire world, crowdsourcing would seem to be the ultimate “multi-pronged” approach.

Anyone with a solution that fits the proposed criteria is eligible to enter the Challenge, which requires only a written proposal. Submissions will be accepted through November 9, 2011.

—Miriam E. Tucker (@MiriamETucker on Twitter)

Cruising the Kaplan-Meier Curve

Perhaps you’ve heard that biostatistician Paul Meier, co-developer of the Kaplan-Meier survival analysis, died on August 7 at age 87.  A pair of illuminating obits on his life ran during the past week in The Washington Post and The New York Times.

A quartet of Kaplan-Meier curves. Source: The New England Journal of Medicine © 2007

Like all medical reporters, I see Kaplan-Meier survival curves for dozens, possibly hundreds of study reports that I cover at medical meetings each year. It’s such a  staple of the medical trial landscape that I’ve heard some speakers introduce their slide that shows the curve with a touch of irony in their voice, their secret handshake with the audience that here comes the study’s punchline. And I’ve heard the shuffle of chairs and feet around me as a Kaplan-Meier curve showing a negative result for some drug or procedure comes onto the screen, causing part of the audience to bail from a suddenly less interesting talk.

Kaplan-Meier survival estimates date from a 1958 paper that proposed a novel way to calculate overall survival rates when the items enrolled in a study remain in it for varying periods of time.  Remarkably, while Meier approached this issue from the perspective of patients in clinical trials, his collaborator,  Edward L. Kaplan, was a mathematician at Bell Labs who was interested in the lifespan of vacuum tubes in buried telephone cables.

Paul Meier’s obituaries made clear that the survival curve he lent his name to was not the only piece of biostatistical bedrock for which he should be remembered. It turns out that he also was critically important in establishing patient randomization as the gold standard for clinical trials.The randomized controlled trial–the RCT–is as much of a biomedical icon as the Kaplan-Meier curve, and this man was integral in the creation of both.

In an interview that Meier did in 2004 with Harry M. Marks, a medical historian from Johns Hopkins, Meier fails to put an exact date on when he began advocating randomization as part of trial design, but says “I started doing that quite early,” before the Salk Polio Vaccine field trials in 1954. Meier also said: “When I said ‘Randomize’ in breast cancer trials I was looked at with amazement by my medical colleagues.”

Later in the interview, when asked what in his career he was most proud of, Meier adds: “It would have to be my promoting of randomization. For a long time randomization was not thought of so highly. I defended randomization every chance I got, and I had a fair number of chances. Two years ago [in 2002] a very distinguished statistician told me that I had a major influence on the Food and Drug Administration’s policies on RCTs. I don’t know how true that was, but if so, it would be something of which I am very proud.”

It’s hard today to imagine the world of major clinical trials without randomization or Kaplan-Meier survival estimates. It’s quite a legacy.

—Mitchel Zoler (on Twitter @mitchelzoler)

New Engl J Med 2007;356:1503-16

Immunizing in the Inpatient Setting

August is National Immunization Awareness month, which means back-to-school physicals and likely a new round of pseudoscience stirred up by the antivaccine crowd. Perhaps some have forgotten the consequences of failing to vaccinate our children.

Credit: National Institutes of Health

Pediatricians and family practitioners haven’t, and based on new data presented at the Pediatric Hospital Medicine 2011 meeting in Kansas City, nor have their hospitalist colleagues.The Children’s Hospital of Wisconsin in Milwaukee has developed a process to identify and immunize hospitalized children prior to discharge. Milwaukee County lags significantly behind national and Wisconsin child-immunization rates, with just 47% of 2-year-old inpatients fully immunized, compared with about 83% in all of Wisconsin and 81% nationally, Dr. Anjali Sharma explained at the meeting.

“We did the study because we felt an obligation,” she said.  “With so many patients that are obviously not able to get it done at their primary physicians for whatever reason, we really wanted to get them immunized and see if there are other avenues to eliminate these missed opportunities.”

The four-pronged process includes printing an immunization record from the Wisconsin Immunization Registry (WIR) at admission, having nurses screen for vaccine contraindications using the CDC tool, educating physicians about the importance of ordering immunizations and true immunization contradictions, and developing a standardized order set to immunize children at discharge.

During the prospective, pilot project test period, 414 children were admitted to the hospital, with 142 eligible for vaccines.

Only 13, or 9%, of these children were fully immunized, leaving 129 patients with missed vaccine opportunities, Dr. Sharma said.

Moreover, 60% of the 129 patients remained not fully immunized 6 months after discharge.

“It’s obvious we want to get more kids immunized in the hospital because those really, truly were missed opportunities because they didn’t get immunized later,” she said.

Contrary to popular belief, true contradictions to immunization occurred in just 5% of cases. Other reasons for the missed opportunities include WIR records not being reviewed, screening tools going uncompleted because of nursing disinterest and physician error.

Since the study, Children’s Hospital has begun a 5-year immunization initiative to address this issue.  Changes include linking hospital electronic health records to the WIR, process improvement, and education of staff at all levels, according to the authors of the study, led by pediatric hospitalist Dr. Angela Bier at the Medical College of Wisconsin, also in Milwaukee.

— By Patrice Wendling

What Would Jeff Spicoli Do?

If chronic pot smokers present to your office with recurrent episodes of tummy trouble, consider a diagnosis of cannabinoid hyperemesis syndrome.

Image courtesy Flickr user Torben Bjorn Hansen via Creative Commons License.

First reported in Australia in 2004, cannabinoid hyperemesis syndrome (CHS) is marked by “horrible abdominal pain, but mostly nausea, and vomiting” in chronic pot smokers, Dr. Walter J. Coyle said at a conference on primary care medicine sponsored by the Scripps Clinic.

Symptom relief comes only after patients take a hot bath or shower. Patients who experience CHS tend to be males who have been smoking “at least two bongs a day for a long time—months and months,” said Dr. Coyle, who, with Dr. Emily Singh, published the first clinical report of the syndrome in the United States. “The treatment is to quit the weed.”

 Sometimes patients take baths or showers with water so hot that it causes scald marks on the skin, Dr. Coyle said. Others refuse to curb their pot smoking. In fact, one patient told him “thanks for telling me [about CHS]. I’m not gonna stop.”

According to a 2009 article from the American Journal of Gastroenterology, the suggested pathogenesis of CHS includes “toxicity due to marijuana’s long half-life, lipophilicity, delayed gastric motility, and dysfunction of thermoregulatory and autonomic effects on the limbic system and hypothalamus secondary to the effect its active ingredient, Tetrahydrocannabinol, on the endogenous Cannabinoid receptors CB1 and CB2.”

If the fictional character Jeff Spicoli from the 1982 film “Fast Times at Ridgemont High” were to visit his physician with telltale signs of CHS, one wonders how that dialogue might go.

 SPICOLI: Gnarly stomach trouble, Doc. Really cramping my style. Can’t surf. Can’t impress the ladies.

SPICOLI’S DOCTOR: The only way you’ll get better is if you quit smoking pot. Is that something you’ll consider?

SPICOLI: Um, dude. I don’t think so.

SPICOLI’S DOCTOR: But if you quit you’d be able to master the ocean waves and you’d have good breath for the ladies.

SPICOLI: I didn’t think of that. You’re smart, Bud. Let’s party!

— Doug Brunk (on Twitter@dougbrunk)

Medical Errors Hurt Doctors, Too

Doctors and nurses make mistakes, some of which hurt patients. To err is human. In fact, that’s the name of a 2000 Institute of Medicine report aiming to decrease errors in health care.

Calcium chloride photo by Markus Brunner (Wikimedia Commons)

The Institute for Safe Medication Practices (ISMP), a non-profit that focuses the bulk of its work on improving patient safety, also recognizes that a patient injured by a medication error isn’t the only one hurting after the mistake. A recent newsletter and press release draw attention to the so-called “second victims” of medication errors — the healthcare workers who are involved in the error.

Healthcare workers may react with feelings of sadness, fear, anger, and shame, and be haunted by the incident. They may lose confidence, become depressed, and even develop PTSD-like symptoms.

A case in point: Kimberly Hiatt, a pediatric critical care nurse with 27 years of experience, made a mathematical error that resulted in an overdose of calcium chloride in a fragile infant. The baby died. Hiatt’s life went into a tailspin. She felt consumed by guilt. She lost her job and, despite obtaining extra training, she was unable to find work. Seven months later, she committed suicide in April 2011.

The ISMP says a culture of silence and lack of support surrounds medication errors in healthcare, and it points healthcare workers to resources to change that culture. For example, you can watch a free webinar about the second victims of medical error, produced by the Texas Medical Institute of Technology. A toolkit for building a support program for clinicians and staff is available from the Medically Induced Trauma Support Services.

If you’re a healthcare worker, what’s it like at your institution when medication errors happen? Does anyone ever hear about them? Are there mechanisms in place to learn from mistakes? Is there any structural support for healthcare workers who make a mistake?

Have you ever had to deal with a medication error or other medical error of your own? How did you cope?

Leave a comment and let us know.

—Sherry Boschert (on Twitter @sherryboschert)