- June 29, 2016
The recent controversies at the National Institute of Health (NIH) Clinical Center are every hospital administrator’s worst nightmare. According to a June 2, 2016 article in the Wall Street Journal a Bethesda, Maryland hospital, recognized for its cutting-edge medical research, has an unsafe pharmacy dosing program for patients.
In 2015, Federal Drug Administration (FDA) inspectors found what they termed “serious manufacturing problems” with the hospital pharmacy. Then, in April 2016, an outside group of experts concluded that the two laboratories drug production for clinical studies on patients did not comply with safety standards.
The unflattering piece in the Journal noted that “Eight high-ranking physicians and researchers – seven department heads, plus the winner of the prestigious Lasker Award in medicine – sent a scathing letter to NIH Director Dr. Francis Collins.” They agreed that there were important safety related issues with the hospital but disagreed with the method of dealing with these issues.
This inferno of controversy was started by a spark of human error in the hospital’s pharmacy. Now, administrators from around the country are wondering if this could happen in their hospital. The CEO of Monarch Medical Technologies, Stuart Long is convinced these types of dosing errors happen all too often.
It’s a Common Problem
“This problem is common,” Long said. “We’ve heard this from clients for years. As a matter of fact, in the state of California there is a program called Medical Error Reduction Plan and we receive phone calls from facilities that are being investigated and penalized by that organization because they are finding errors in the dosing of insulin.
“These hospitals are trying to establish a dosing regimen from a paper protocol and are not able to adapt the dosing to how a patient is responding. A patient’s response to insulin can vary wildly and there is a very high probability that these types of inadvertent errors are occurring everywhere, among every hospital size. No facility is immune to this.”
The Data Suggest a Big Problem
“Errors and adverse events with insulin are dangerous and insulin is the top one of the most dangerous drugs in the world,” Long said.
“There is a large quantity of data that points to the effects of insulin being drawn incorrectly. One can look back over 50 years and the error-rates have grown. We’ve seen the increase in dosing errors rise because of the sheer number of patients requiring insulin. We’ve also seen a rise of hypoglycemia over the incidences of hyperglycemia and this is the result of overdosing while attempting to reduce a patient’s glycemic level to target ranges, and inevitably stacking insulin doses.”
EndoTool is Revolutionary
The glucose management software, EndoTool ™, from Monarch Medical Technologies uses Model, Predict, and Control technologies for inpatient insulin therapy recommendations. It is designed to help physicians and nurses provide a personalized insulin treatment plan while reducing the complexities that result in dangerous human errors. How does this work?
“Every human being is unique, and in a hospital, the patient’s physiologic state can change on a moment’s notice, perhaps based on something as basic as stress” Long said. “We take into account a number of clinical variables that are specific to the patient’s current physiologic state. Kidney function also has an impact on a patient’s individual insulin dose, so EndoTool also looks at serum creatinine (sCr) levels and glomular filtration rate (GFR).”
“EndoTool creates a model that will get that patient into control quickly and safely. The software takes into account the current and previously administered insulin that may still be ‘on board’ during intravenous therapy and adjusts future dose recommendations to accommodate the residual insulin; in a paper-based or linear world, this simply cannot be accounted for. By predicting the future blood glucose levels, the software is able to detect the probability of the patient approaching a hypoglycemic or a hyperglycemic event, thus reducing what’s known as ‘glucose variability’ or ‘glucose cycling.’
“Trending the patient’s response is the key to bringing the patient into control quicker while reducing the burden for the patient and nurse. We can reduce the number of ‘sticks’ to the patient by almost 50 percent, which is very important to the nurse’s workload and the patient’s comfort.”
“We are able to do this while using lower ‘goal ranges,’” Long said. “A normal glucose range for any person who does not have diabetes is 70 to 99, and up to 140, during or after a meal. In a hospital setting, you can see a patient come in with a blood glucose running well over 600.
“Anytime a patient’s glucose level drops below 70, it is called ‘mild hypoglycemia’ and if it drops below 40, it is termed ‘severe hypoglycemia’ and mortality becomes a concern. That is why we are very focused on the statistical elimination of severe hypoglycemia.
“Hospitals have set ‘goal ranges’ for the patient while they are hospitalized. Ideally, this means keeping the patient’s blood glucose level between 100 and 140. Unfortunately, with linear insulin protocols, there is a high risk of the patient getting closer to that mild hypoglycemia range. Because of the residual insulin from the previous doses, the patient can very easily be over-dosed on insulin. This causes an increase in the incidence of hypoglycemia, dropping the levels too low.
“After the NICE-SUGAR study was published in 2012, hospitals began to raise the ‘goal ranges’ as a method to prevent the hypoglycemia. With higher targets, there is less risk of dropping blood glucose levels to a lower level. The challenge with this is that the hospital is now running the patients at higher glycemic levels and the associated complexities that come with that are not abated. Therefore, the problems continue to rise at growing rates.”
Healthcare Moves Slowly
Many hospital organizations are hesitant to invest in an innovative technology like the EndoTool because of a large amount of internal business process re-engineering, even though it can potentially save lives and money. What can these hospital administrators learn from the problems related to dosing errors at the NIH?
“There’s an interesting conundrum in healthcare today,” Long noted. “I heard an anecdote from a physician who looks at these types of issues. He said that it takes 17 years from the first published article in a medical journal that proves an outcome, until it gets implemented into healthcare – we’re only about 10 years in for glucose management technology.
“For some reason, healthcare is slow to adopt new technology. It’s not that facilities aren’t willing to pay for patient care. They are already paying for it. But, by putting in an electronic solution, it can actually cost less and save a significant amount of money on treatment. Plus, this doesn’t take into account the extraordinary clinical outcomes that are realized.
“The challenge of this technology is that it touches almost every aspect of the hospital – from the emergency room, to the general ward bed, to the pharmacy, to the supply-chain. It is a work-flow change for an organization to take on and competes heavily with other IT related projects going on. The standard operating procedure of most healthcare facilities is that current methods are ‘good enough’ for the time being.
“However, there are a number of facilities who have made the decision to make the bold change and adopt this technology. It involves getting everyone in the organization to make the commitment and have confidence that this piece of software can make these very complicated calculations.”
Learn more about how your hospital can reduce dosing errors and save money on quality patient care.