Medical Error/Harm

One in five patients incur harm while receiving care in hospitals in OECD countries.

In his book “MISTREATED “ Dr.Robert Pearl gives a riveting account of his father Jack Pearl’s medical care. Dr. Robert Pearl led Kaiser Permanente for years and is a renowned teacher at Stanford University Medical School. His brother, Ron, also at Stanford Medical School, is Chairman of Anesthesiology, at Stanford University. Jack, a retired dentist and a US decorated Veteran in excellent health, was visiting his sons in California. While there he suddenly collapsed one morning and he was in the ICU at Stanford followed by prolonged rehabilitation. The cause of his collapse was fulminating pneumococcal sepsis. His recovery was slow and it seemed he “aged an entire decade” after fighting this devastating illness.  In previous history, Jack had acquired hemolytic anemia and had to have a splenectomy to maintain normal red blood cell counts. He had been dividing his time between New York and Florida in his retirement. Between his doctors in New York and Florida, everybody(primary care, hematologist, surgeon, etc)  assumed that pneumococcal vaccination was administered by someone else. Still, he never received a pneumococcal vaccine in a fragmented healthcare system. Jack’s family came to know of this mishap after his Stanford hospitalization and after his debilitating long recovery from pneumococcal sepsis!!  With Jack’s frailty and advancing age, he developed lower back pain after his car was rear-ended in New York a few years later. As his lower back pain persisted, he was taken off anticoagulants for his chronic atrial fibrillation so that he could receive an epidural steroid injection (ESI ). There was no discussion of alternative approaches for managing chronic LBP as taking him off anticoagulants for ESI was a significant risk, nor was there a discussion for bridge anticoagulant therapy at the time of the ESI procedure. Soon after he had a fatal massive brain clot and he died at the age of 83 years.Jack received his care at Stanford, where his two sons are highly acclaimed medical professionals. Even under the best circumstances, Jack’s physicians couldn’t avert medical errors in Jack’s care.

In a study by Martin Makary M.D., D.P.H and Michael Daniel of Johns Hopkins the researchers examined four separate studies that analyzed medical death rate data from 2000 to 2008, including one by the U.S. Department of Health and Human Services Office of the Inspector General and the Agency for Healthcare Research and Quality. Then, using hospital admission rates from 2013, they extrapolated that based on a total of 35,416,020 hospitalizations, 251,454 deaths stemmed from a medical error, which the researchers say now translates to 9.5 percent of all deaths each year in the U.S.

Medical errors are the third leading cause of death after heart disease and cancer.!

Makary defines a death due to medical error as one that is caused as below:

*inadequately skilled staff

*error in judgment or care

*a system defect or preventable adverse effect 

-computer breakdowns 

-mix-ups with the doses or types of medications administered to patients

-surgical complications that go undiagnosed

Patients in the U.S. are more likely than those in comparable countries to experience a medical error at some point during their care, according to a survey by the Commonwealth Fund. In this case, medical errors include being given the wrong medication or dose or experiencing delays or errors in laboratory test results. In 2016, 19% of patients in the U.S. experienced a medical error compared to 12% of patients in similar countries(OECD countries).

Dr. Danielle Ofri has written a highly readable book.She is a talented medical writer and is the auhor of the book- Medical Errors- “WHEN WE DO NO HARM”– with stories of medical errors in different settings. The most impressionable sections in my reading were the harrowing  2 case histories where enormous harm occurred.  In the first case Jay, a very healthy middle-aged executive was diagnosed with Acute Myeloid leukemia with poor prognostic markers. He developed MRSA (methicillin-resistant staphylococcal aureus bacteria) from a central venous line in the neck. He died from ARDS (Acute Respiratory Distress Syndrome). There was overreliance on laboratory data and imaging while ignoring clinical context which Jay’s wife  Tara RN pointed out repeatedly to all the resident doctors, attending doctors, and nurses to no avail. Tara suffered from PTSD  following Jay’s tragic death and after 5 years of exhausting malpractice lawsuits, she accepted an undisclosed settlement from a high-profile hospital system on the east coast.

In the second case Glenn, another extremely healthy middle-aged male incurred 30 % burns in an accident in a farming community in middle America. He was rushed to a local community hospital. Instead of transferring him immediately to a Regional Burn Center, he was treated overnight in ICU with wrong fluid management, over sedation, etc and he got transferred in extremis to the Burn Center (after an overnight stay in the local hospital ) where he died subsequently. His wife Nancy and daughter Melissa spent years seeking redress with an enormous toll on their lives.

She points out that checklists have been very helpful in reducing errors in surgical procedures but they have not been helpful in medical conditions where there is a lot of uncertainty about diagnosis and implementation of checklists is very poor.

EMR ( Electronic Medical Records ) is the future with significant benefits as compared to old paper records. Yet it has brought its problems. Our clinic in Milwaukee, Aurora Health Center, was a pioneer in EMR with Epicare when they rolled out their program for ambulatory care. When Dr.Ofri writes about encountering many alerts and clicks needed to close an encounter it immediately strikes a chord. Older physicians of my generation used to joke about the number of clicks we had made at the end of the day’s schedule. Most of the alerts and clicks were ignored- it was impossible to take care of patients’ needs in a 15-minute visit, particularly older patients with multiple complaints and multiple co-morbidities. Similarly, a huge number of alarms(warnings) in the ICU don’t draw the focus and attention of nurses and physicians in most instances. There is an ALERT and ALARM fatigue.

She has prescient advice to hospitalized patients and their families- have a CONCISE MEDICAL HISTORY ready, KNOW YOUR MEDICATIONS and doses. Either the patient or a family member will have to observe all interventions and medications given to the patient and ask questions of caregivers. Highly trained doctors and nurses try hard to deliver diligent care, but avoiding error in a highly complex system is nearly impossible. Patients or patient advocates must be as informed as possible to minimize error and harm.

Dr.Robert Wachter is Chairman and Professor of Medicine at the University of Southern California and he wrote a book in March 2017 titled Digital Doctor: Hope, Hype and Harm at Dawn of Medicine’s Computer Age. His wife Katie Hafner is a highly accomplished journalist in the field of Science and Technology. I listened to a fascinating interview with Dr.Wachter on 9/9/2017 recorded on YouTube. What prompted Dr.Wachter to write this book is a devastating incident of a huge medication error given to a patient at UCSF. He interviewed many people to try and understand how the error escaped detention. The patient was a 16-year-old young man who had a rare  NEMO syndrome with chronic autoimmune problems. He was used to taking a lot of medications daily for chronic ailments including skin infections. The young patient’s body weight was around 38 kg. He was taking Septra (antibiotic) 160 mg twice a day for chronic skin infections. Because of the patient being in the pediatric age group and because his weight was lower than 40 kg the computer generated the order as 160 mg per kg. 

As Fate would have it the computer program generated an order with rounding a dose of  6160 mg!! 

This turned out to be 39 tablets 6160 mg divided by 160 mg tablet instead of 1 tablet!! As mentioned above by Dr.Afri, an average physician gets 20-30 alerts, the majority of which are clinically unimportant -an example would be Tylenol may interact adversely with alcohol- and the physician ignored the alert. It should be pointed out that the new computer program would have the same alert if the dose was a mere 10% over normal as the alert here when the dose was 4000% over normal dose! The physician had a glancing view at the screen which showed the number 6160 (highlighted for emphasis), ignored the alert and the order went through to a pharmacist and pharmacy technician.  The pharmacist was extremely busy with refills for potent chemotherapeutic agents used in pediatric cancer. Since Septra was a common antibiotic, a “soft “alert did not jolt the pharmacist and the order went on to dispensing by a newly acquired robot. The robot duly sent the tablets to the floor. The patient’s mother in the meantime had to see the patient’s brother on another floor who was in the hospital at the same time. This brother had the same rare syndrome and he was sicker than the patient under discussion here. The mother was not in the patient’s room when the nurse came in to give medications to her son. She had prepared the son that he would most likely get” a lot of stuff” given to him by which she meant he would have to drink colon prep liquids etc. The nurse was a junior and was working as a float nurse. The senior nurse had gone on a break so she was therefore not easily available for the junior nurse.  The nurse felt uneasy with several tablets but did not summon up the courage to call the pharmacist or the doctor. She felt reassured when she swiped the barcode for prescribed tablets when there was no rejection -the tablets were correct and for the right patient.! When the patient took all those tablets, he thought he had a weird illness (he was used to taking 18 tablets per day daily ) and as per his conversation with his mother, he did not question the nurse either. (The mother felt guilty later that she was not there when her son was given Septra tablets as she would have immediately questioned it ). Moments after taking the tablets patient felt extremely jittery, had seizures subsequently, and had to stay in ICU for 9 days.  Fortunately, he recovered fully without permanent harm. 

So this story illustrates the perils of care delivery in a highly complex hospital environment. Even though the computer system improved upon so many previous prescription problems with illegible handwriting, unreadable decibel points, etc,  a grave error occurred in one of the best hospitals in the US.

Dr.Pearl  ( Author of MISTREATED ) writes that “HIGH TECH Care has to be delivered with “HIGH TOUCH”. A high-quality Integrated healthcare delivery system has indeed made significant advances in this regard with better coordination and efficient teamwork, yet providers  need to oversee all aspects of the complex care.

The same advice is pertinent in outpatient settings. Too often medications and their doses are not accurately updated and patients have to be particularly alert about highly risky medications like blood thinners and the doses and their likely interactions when new medications are introduced. ( Coumadin or Warfarin is a notorious example).

Here is what WHO has to say on patient safety:  The simplest definition of patient safety is the prevention of errors and adverse effects on patients associated with health care. Every 10th patient in Europe experiences preventable harm from adverse events in the hospital, causing suffering and loss for the patient, their families, and healthcare providers, and taking a high financial toll on healthcare systems. Among its many recommendations to enhance safety, an important one was empowering and educating patients and the public, as partners in the process of care.

Institute for Healthcare Improvement defines Medical Harm: as “unintended physical injury resulting from or contributed by medical care ( including the absence of intended medical treatment), that requires additional monitoring, treatment or hospitalization, or that results in death”. Common Medical Errors/Adverse events in hospitals are Health Care -Acquired or Associated Infections like MRSA and C difficile infections, surgical errors, medication errors, adverse events associated with medical devices like some hip implants and surgical mesh and wrong diagnoses about 10% to 20% of the time. As per the Consumers Association estimate as reported on the American Hospital Association website, in 2013 1 in 4 patients was harmed during hospitalization. As to the number of deaths due to medical error in the USA, there are widely varying numbers and controversies. Many of the harmed patients have severe coexisting morbidities. The extract below gives a fair glimpse of the prevalence of medical harm in the Medicare patient population.

In his testimony to the US Senate, Dr.Ashish Jha said that in a November 2011 report on adverse events in hospitals, the Office of the Inspector General (OIG) in the Department of Health and Human Services found that 13.5 percent of Medicare patients suffered an injury in the hospital that prolonged their stay or caused permanent harm or death. An additional 13.5 percent of Medicare patients suffered temporary harm such as an allergic reaction or hypoglycemia. Together, the data suggest that more than one in four hospitalized Medicare beneficiaries suffers some sort of injury during their inpatient stay, much higher than previous rates. In a different report, the OIG at HHS found that 22 percent of Medicare beneficiaries in skilled nursing facilities (SNF) suffered a medical injury that prolonged their stay or caused permanent harm or death. An additional 11 percent suffered temporary medical injury.  The OIG report is particularly alarming given that about 20 percent of hospitalized Medicare patients go to a SNF after discharge. He also said that US is about average as regards adverse events when compared to other OECD countries.

It behooves us to remind ourselves of the Hippocratic Oath:” First, do no harm.”