Complex medication packaging
How can we improve usability for patient safety?
OVERVIEW
An evaluation of advanced prototypes.
Our pharmaceutical client was about to release a drug that would require patients to take a different combination of tablets from a single package at different times in the day. We were tasked with iterating on their current packaging design and assessing the usability of the instructions before it went on the market.
THE PROBLEM
Here’s a worst case scenario:
It starts with being diagnosed with a serious condition.
The patient is prescribed a costly medication to treat this condition. When she picks it up from the pharmacy, she is told how to administer the medication and it is complex. Each dose over the first few days and weeks is comprised of a different combination of different colored tablets.
When she wakes up the next morning to start her regimen, she realizes she no longer remembers what her doctor and pharmacist told her about how to take the medication. She must rely on the drug packaging.
Visual and graphic instructions are a critical line of defense against incorrect or off-label use of medication and can prevent PATIENT under- and over-dosing.
RESEARCH OBJECTIVE
A pharmaceutical client was coming out with a groundbreaking drug that could improve the lives of over 3 million people in the United States. The FDA had just started allowing pharmaceuticals to co-package drugs (different drugs in a single package) and asked us to design two versions of packaging such that in a worst case scenario, individuals would know how to administer the drug properly using only the packaging for instructions. This is an iterative design-research project to improve medication instructions-for-use (IFUs) for patient safety.
* My role * In the first phase of this study, I was a designer-researcher responsible for creating rapid prototypes and in the second phase, I was research lead: I led a team of researchers, submitted IRB protocols, and ultimately wrote the 510(k) report to the FDA.
RESEARCH METHOD
Rapid Iterative Testing and Evaluation (RITE) usability study
30 participants diagnosed with the condition or a similar condition (15 participants for each design)
Part of the original design. Spot the usability issues.
PROTOCOL
Every session would started off with the moderator asking the participant, a few background questions to put the participant at ease and build rapport.
The moderator would then place the prototype medication packaging in front of the participant and prompt:
“Imagine it is the day immediately following that appointment with your physician, and you are just starting your day at home by yourself. It is 7 am, and it is time to start your new medication. Go ahead and show me how you would do that...”
Testing schedule. We ran two simultaneous sessions to tackle the two designs with built-in time for design iteration.
More than half of the participants in the first day failed to indicate that they would properly administer their morning dose. We probed for a root cause in the error to understand how we could make the instructions on the packaging clearer and got to work...
prototypes: before and after
Original design
After first iteration
Final on-the-market design
IMPACT: increased success rates
Task Success Rate
Both versions of the packaging saw increased task success rates!
BONUS: avoiding test artifacts USING Confederates
A drawback to in-lab simulation studies is that participants may behave according to the test environment as opposed to their natural environment.
In order to combat this disconnect, after the first phase of testing, we decided to construct a “skit” in which the participant was administered warm-up questions and given a pharmacy bag with the prototype packaging within by a confederate wearing a white coat. This provided literal and figurative immersion into the scenario. The result: fewer task failures that were due to the simulated environment.