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Sometimes, It’s the Little Things
August 19, 2020
Published by Nancy Globus
I often get my best inspiration for things I want to talk about by “mindlessly” scrolling on social media.
A few weeks back, I saw a Tweet from an anesthesiologist/patient safety advocate that spoke about how the “little things” add up to make great differences in patient care. And just today, I saw an article regarding the importance of identifying potential patient safety hazards during the construction of a healthcare facility. The article pointed out things like awkward placement of hand sanitizer dispensers and inconvenient storage of diagnostic equipment—things that most people probably wouldn’t give a second thought. This led me to think about the little things that go into the development process of a drug product that can ultimately affect the occurrence of errors with that product.
Error avoidance in the healthcare setting
In clinical practice, the causes of medication errors typically are multifactorial. Often, many of those factors are related to the systems that form the foundation of the healthcare setting. Typically, errors are not due to practitioner carelessness, nor are they typically due to faulty products or devices. Brief examples of systems-based causes of medication errors include:
- Lack of accurate patient information used to make treatment decisions (patient age, weight, diagnosis, comorbid conditions, laboratory values)
- Physical environment and distractions
- Faulty channels of communication of treatment orders
- Staffing fatigue and handoffs
I can tell you from my days working as a hospital pharmacist, that I experienced all these challenges continuously. The most frustrating situation was having the phone ring, a nurse at my door, an anesthesiologist at my OR [operating room] window, and written orders being sent via pneumatic tube from the nurses’ stations—all while trying to enter and verify medication orders in the computer system, and dispense those medications! Clearly, the process was not designed to be chaotic, but in practice, it often was, because all those things “added up.” This chaos was piled on top of the need to decipher poor handwriting and the struggle to choose the correct vial from my puny drug refrigerator (all additional factors in the causation of medication errors).
The Swiss Cheese
The best way to mitigate the risk of errors in a healthcare system is to put procedures into place that make it easy for practitioners to do things right and make it difficult to do things wrong. An additional safety-minded goal is to build redundancies into the system that will keep an error from reaching the patient and potentially causing harm. Using the drug use process as the system, James Reason’s “Swiss Cheese Model” can be adapted to show how active or latent failures (errors) can reach the patient if the “holes” in the system align.
This thought process can be applied to the design of any system, product, or process. Each hole in the Swiss cheese can be thought of as a “little thing.” Every hole that gets blocked will redirect a potential failure (indicated by the red “hazard” arrow in the above image) from continuing its journey through the process and reaching the patient.
But how do you know what the “holes” are? And where to find them?
First, even though medication errors are rare events, one must accept the fact that they do occur—and when they do, they can have serious or even deadly consequences. It is difficult to fathom that despite the best intentions and following of standards, mistakes will happen with any given practitioner, healthcare setting, or product. So, practitioners, healthcare facilities, patients, regulators, and the pharmaceutical industry must take actions to find the holes and prevent them from aligning.
Error Avoidance in Drug Product Development
How do these safety measures apply to drug product development? Many actions can be taken to minimize safety risks during drug product development—from the name of the product, to its label, to how the dosage form is presented. These are all variables that are in the control of the manufacturer.
Here are a few examples of how our risk-based approach to evaluation applies to the finding and blocking of the holes.
Example 1: What are the first few letters of the drug name and what other drug names start with those letters? Could this be a cause of confusion?
A common cause of product selection errors comes from typing just the first few letters of the drug name, as seen in the figure below. A “real life” example of this happened a few years ago and led to a patient’s death. The intended “Versed” was confused with “vecuronium” by typing “VE” into the system and choosing the wrong drug from the order entry screen.
Example 2: What colors are being used on the label? Can the strengths be confused? This picture shows look-alike labels within a product line, with numbers that look similar to each other (i.e., 60 and 80)
Example 3: Does the packaging and presentation of the dosage form fit with the route of administration?
In this example, the dropper bottle presentation of a topical solution for external use only could be confused with eye or ear drops.
In each of these examples, the highlighted characteristic (name, label, product presentation) doesn’t seem error-prone when examined individually. Each one can be thought of as a “little thing,” which, when placed into the complex healthcare system with other competing factors, may be a “hole” that needs to be blocked.
Little things aren’t so little if they mean preventing errors and harm to patients.
For more information about building error prevention into product development, please visit https://www.medicalaffairsspecialist.org/approve/ and for an FDA perspective, please visit https://www.fda.gov/drugs/drug-safety-and-availability/medication-errors-related-cder-regulated-drug-products.