“All we want to do is help our patients, but what they don’t teach us in medical school is that there are so many ways to do harm.” I picked up that bit of wisdom on The Resident, a new medical show on Fox. In fact, a 2012 study from the U.S. Department of Health and Human Services (a much more official source than any TV medical drama) reported: “More than one in four Medicare beneficiaries experience some degree of harm while hospitalized.” That’s a staggeringly large number.
About one-third of the adverse events reported in this study were related to medication, resulting in excessive bleeding, delirium, hypoglycemic events, kidney failure, hypotension, respiratory complications, severe allergic reactions and lesser issues. Put yourself in the patient’s hospital slippers; you come to the healthcare facility to be cured, not harmed. These adverse events are things you neither want nor expect nor deserve to experience.
What is an Adverse Drug Event?
An adverse event describes harm to a patient as a result of medical care. Specifically the National Coordinating Council for Medication Error Reporting and Prevention says that an adverse drug event (ADE) or medication error “is any preventable event that may cause or lead to inappropriate medication use or patient harm while the medication is in the control of the health care professional, patient, or consumer.”
This holistic definition includes medication management and prevention of errors not only in the hospital, but also after the patient has returned home and is continuing to take prescribed medications or is using over-the-counter drugs. It’s a large scope because the potential for medication error can occur anywhere along the path of patient treatment.
Typical Medication Errors
A British team defined medication errors as occurring in the buckets of knowledge, rule, action, and memory on the part of healthcare professionals. Wrong drug, wrong dose, wrong timing, and wrong patient are a few of the medication error types that can happen. Allergic reactions and medication interactions that happen even when each of these elements is “right” for the diagnosis can still result in a “wrong” for the patient.
You can also look at broad buckets by out-patients taking too much, taking too little, taking the wrong medication, mixing medications, mixing drugs with food or drink, or taking medications in an incorrect manner.
Read a few magazine drug ads without relying on your many years of medical training. Understanding what ailment the drug treats and even remembering the name can be very difficult. What if the patient is prescribes sertraline (for depression) instead of cetirizine (for allergies) or she buys Zertec (for allergies) instead of Zantac (for heartburn)? The Institute for Safe Medication Practices maintains a list of more than 500 drugs with names that look alike or sound alike.
At home, patients may disregard the warning to abstain from alcohol while taking certain medications; they may simply forget whether they’ve taken their meds that day and underdose or overdose; they may assume that if one pill helps, five will work even better.
Why Do Medication Errors Happen?
Each error has a root cause. Each error is probably preventable. James Reason has described a person approach and a system approach for dealing with errors in the medical field. The person approach identifies human flaws of forgetfulness, inattention, poor motivation, carelessness, negligence, and recklessness and puts countermeasures in place. However, these actions are often not effective in driving sustained improvement. They deal with trying to reduce human error and variability by retraining (even multiple times), disciplinary measures and other approaches that blame the individual, usually someone who simply got caught in a bit of “system” quicksand.
One of the big issues with the person approach is that these negative consequences put pressure on individuals to hide mistakes. Dysfunctional behavior after a medication error may include not reporting the error, falsifying records, blaming others, and simply misrepresenting timing or other elements of the problem so that the truth is never known. The quicksand remains, just waiting to catch the next unwitting person to make the same human error.
On the other hand the system approach indicates that “although we cannot change the human condition, we can change the conditions under which humans work,” again, a recommendation from James Reason. In the manufacturing world we describe this as “Fix the process; don’t blame the person.”
Dealing With Medication Errors Using Process Improvement Tools
The system approach to addressing medication errors focuses on application of root cause problem solving tools, mistake proofing, and fail-safing. Your safety and quality team might use fishbone diagrams, five whys or other tools to get to underlying causes. Then applying mistake proofing makes it difficult for the error to happen again and fail-safing mitigates impact so that if it does happen the patient harm is reduced.
Beyond these reactive efforts, a proactive approach can include a healthcare failure mode and effects analysis (HFMEA). This process assigns risk by looking at a potential failure mode (i.e. how could the process go wrong?) and assessing the severity of an incident and the probability of occurrence to create a hazard ranking or prioritization. From here resources continue root cause analysis and identify and implement system improvements that will quickly and permanently prevent specific errors before they can happen. A follow-up step verifies that the enhancements identified actually happen.
Remember Murphy’s Law? “Whatever can go wrong will go wrong.” The application of mistake proofing, fail-safing and HFMEA is a positive corollary. By fixing possible root causes, whatever CAN’T go wrong WON’T go wrong. The more potential mistakes are identified and addressed, the fewer mistakes will happen.
This type of proactive system thinking has resulted in many process changes to minimize medication errors, such as tallman lettering in drug names, single-dose distribution, enhanced communications, electronic medication records maintenance, medication and patient barcoding, automatic flags of blood test results, standardized processes, daily minders for at-home meds, and many other improvements.
Reporting Medication Errors
The hospital needs to assign accountabilities for internal reporting and root cause analysis and follow-up for any medication issue. It’s important that this work is aligned with a culture of reinforcement rather than punishment. You want hospital staff to report errors rather than hiding them under a bedpan. You want staff engaged in constructive improvement efforts rather than pointing fingers of blame or saying “I’ll try not to do it again.”
Besides the internal reporting, adverse drug events are reported for nationwide analysis. This can take a path through the FDA’s voluntary Medwatch program or the National Coordinating Council for Medication Error Reporting and Prevention (NCC MERP), Institute for Safe Medication Practice (ISMP). Other state or federal reporting systems may be in place as well. Until reporting evolves to one approach nationwide, standardize within your organization, assign roles and utilize data collection forms to ensure full reporting and avoid redundant activities.
Existing multi-hospital data collection efforts are already identifying and communicating drug side effects and other issues that will benefit the patient. Ideally, in the long run, “big data” analysis of input from across the nation or even around the globe through World Health Organization efforts (WHO) will provide even greater and earlier understanding of medication issues and opportunities.
Utilizing process improvement efforts to do problem solving on medication errors and take preventive action to prevent more issues is a large and rewarding opportunity. This doesn’t have to be complex; it’s not coming up with a cure for cancer. However, good work to understand the reasons for medication errors and implement simple and lasting improvements can eliminate harm to patients and even save lives.
For more help with this topic, get in touch with EON, your go-to partner for continuous improvement in healthcare efficiency and effectiveness.