Jessica M. Ogburn, PharmD Candidate

Health care—related mistakes happen every day, leading to worsened conditions, infection, injury, and even death. And whether the reason is negligence or unavoidable causes, health care professionals tend to respond with the traditional deny-and-defend approach, disclosing limited information to patients and families following a health care adverse event to protect themselves from malpractice litigation.

This malpractice system creates a tug of war. With malpractice insurance and claims increasing, health care organizations plead for providers to offer settlements to patients before errors are litigated. However, providers often remain silent because the admission of mistakes could lead patients to pursue legal action, ultimately resulting in a licensure revocation. This lack of transparency results in increased costs, missed settlement opportunities, prolonged processes for complete resolution, and significant stress. It also hinders quality-of-care improvement by slowing internal changes meant to avoid mistakes in the future. And most important, it impedes patient safety by withholding important health information.

As Jania Matthews, a spokesperson for Johns Hopkins Medicine, said, “When these medical errors result in unfortunate adverse clinical events, it is critical that patients receive information…[to] allow patients and their families to make informed decisions about their care and begin the rehabilitation and treatment processes as quickly as possible.” 

In 1986 Massachusetts made the first effort in the United States to improve error reporting and patient safety by enacting legislation permitting providers to apologize and prohibiting the use of certain statements against them in court.

More than 30 states have similar “apology laws” that prohibit certain statements from being used in court.

 However, they protect only expressions of regret. Any admission on the part of providers of something done wrong can still be used against them.

In 2001, Michigan developed the Communication and Optimal Resolution (CANDOR) program, a revised apology law. Its approach promotes a “culture of safety that focuses on caring for the patient, family, and caregiver” by providing freedom for providers to acknowledge an error without fear that the admission will be used against them in court.

Any investigation, disclosed information, or offered compensation is termed open discussion and is confidential and privileged. For these settlements to be protected under this act, the affected patient must be notified in writing within 180 days of the date on which the health care provider or organization knew or should have known that unexpected harm occurred, and the health care organization or provider must initiate the open discussion. Additionally, patients must be informed of their rights and granted the freedom to withdraw from CANDOR at any time. If providers follow the proper protocol, protected events are not required to be reported to state licensing boards.

 Since the CANDOR framework launched, medical claims at the University of Michigan Health System have dropped from 260 to 100 annually. Furthermore, average legal expenses per case have decreased by 50%.

On July 1, 2019, Colorado became the fourth state to enact its own CANDOR act, in hope of similar results. If all similar acts are successful, the United States may start to see more health systems adopt this culture of transparency. Nurses, pharmacists, physician assistants, physicians, and other licensed health care providers will be able to freely say, “I’m sorry.”

So what is the catch? The CANDOR framework relies on the goodwill of health care systems and providers to offer appropriate compensation to patients and their families. Some argue that this act of “candor” puts patients in a vulnerable position. Is the decrease in malpractice claims for health care systems the result of coercion of already emotionally strained patients? Is the smaller buyout a direct outcome of shortchanging patients who are unaware of all options under law?

Wayne Willoughby, immediate past president of the Maryland Association for Justice, said that his clients “are in emotional and financial straits when they come to meet me; their first impression is to jump on the first offer. I have to explain to them that they need to think about things like compensation for long-term health.”

If CANDOR is put into place solely for business benefits, clinical improvement and patient safety might be put into jeopardy once again.

Despite best efforts, mistakes happen. Allergies get overlooked, dilutions are miscalculated, and medications are dispensed incorrectly. Pharmacists take an oath when given their white coat to “embrace and advocate for changes that improve patient care.” 

 For patients to receive the best care, practitioners must first avoid mistakes and then admit to them when they occur. Only then can patients make decisions about how to heal, and only then can health systems fix internal processes to ensure the same mistake does not happen again. Many states have no apology law enacted to protect any health care provider’s admittance of error or expression of regret.

The moment that pharmacists become aware that they have made a mistake, they should contact a lawyer for guidance on how to navigate the next steps to protect themselves and the patient. The Canadian Medical Association Journal said it best: “Effective disclosure and apology is neither simple nor pain free.” 

 However, it is indispensable for patient safety and the quality of health care.

Patients put their trust in health care providers and expect them to be honest and put forth their best effort to help them in their time of need. That means owning up to mistakes, despite the possible lack of repercussions.

McDaniels AK. Doctors could admit to mistakes without facing liability in court under proposed legislation. 

. February 26, 2017. baltimoresun.com/health/bs-hs-hospital-mistakes-20170224-story.html. Accessed November 6, 2019.

Gallegos A. Candor laws growing, but are they effective? 

. 2016;17(3):1-18. doi: 10.1016/j.carage.2016.02.002.

Communication and optimal resolution (CANDOR). Agency for Healthcare Research and Quality website. ahrq.gov/patient-safety/capacity/candor/index.html. Updated April 2018. Accessed November 6, 2019.

The Michigan model: medical malpractice and patient safety at Michigan Medicine. University of Michigan website. uofmhealth.org/michigan-modelmedical-malpractice-and-patient-safety-umhs. Accessed November 6, 2019.

Boothman RC. CANDOR: the antidote to deny and defend? 

. 2016;51(suppl 3):2487-2490. doi: 10.1111/1475-6773.12626.

Oath of a pharmacist. American Pharmacists Association website. pharmacist.com/oath-pharmacist. Accessed November 6, 2019.

MacDonald N, Attaran A. Medical errors, apologies and apology laws. 

. 2009;180(1):11,13. doi: 10.1503/cmaj.081997.

Articles

Now in 4 states, the program allows providers to admit errors without worry about legal ramifications in the courtroom.