Part I: Reducing Medication Errors Through Packaging Design for Patient Safety
There are many moving parts, literally and figuratively, when it comes to packaging design for pharmaceuticals. The drivers of the design process, in addition to the obvious regulatory approvals, are patient safety and patient compliance. By keeping these drivers at the helm throughout, we can identify practices that lead to safe, effective, and creative packaging design.
Promoting Patient Safety: 3 Design Approaches
Patient safety in packaging boils down to making sure that nothing we initiate contributes to medication errors in the marketplace, whether administered in clinical or at-home settings. The FDA reports more than 100,000 medication errors occur annually in the U.S. alone. Further, more than 50% of patient harm (1:20 patients) is categorized as preventable, with half of that attributed to medication errors.
The World Health Organization reports that investing in patient engagement measures through product packaging and labeling “real estate” leads to fewer medication errors. Aside from the desirable safer outcomes, fewer errors then serve to generate cost savings for drug makers. With those outcomes in mind, what can be done at the packaging design level to foster patient engagement?
1. Design packaging that will educate users on correct administration of the drug. Most pharma teams make labeling and packaging decisions based on what constitutes the surest route to regulatory approval. The FDA’s templated guidance for labeling, prescribing information inserts, and patient-facing papers are what pharmaceutical companies typically rely on to educate the patient. Before required content is written, the design process starts with the packaging that holds the medicine and the outer materials that enclose and protect it. This is where I see a great opportunity for creative thinking.
Creativity applied to the packaging is somewhat restricted by the patient-safety priority, but not without reason, such as this FDA recommendation:
The package design should protect the consumer against incorrect use. Medications applied to the skin (topical) should not be packaged in containers that look like the containers usually associated with eye, ear, nasal, or oral products. Similar looking containers have resulted in people putting a topical product in the eye, ear, nose, and mouth.
If innovation cannot supersede end-user expectation, then we are left to deliver what the user expects. In the alternative, if we believe we are truly offering something better, then we must effectively educate them to ensure adoption of the change. Guidelines such as the one shown above are part of a growing body of evidence that supports the belief that while packaging and labeling directives can reduce medication errors, current practices have not eradicated errors or confusion. The FDA is reviewing standards regarding patient inserts. Even if new requirements result, I believe it will remain a powerful opportunity to incorporate helpful pictures, flaps, or other features of secondary packaging to guide the user in the moment. How we help the user know what to do with the product is where creativity can come into play. Design the surrounding package as a guide, a pathway that directs the experience step by step from holding the package to successful intake. Packaging “flaps,” visual cues (like stop signs, clock face, numbered steps), and verbiage function as sherpas for the correct path.
2. Prioritize clarity on dosing information. My experience confirms that at-home and clinical settings are equally vulnerable to patient safety concerns related to packaging. While nurses and technicians are clinically trained, they are still human, and in a busy setting with a constantly changing roster of patients. Those responsible for medication stocking and storing present yet another potential pitfall for misreading, lack of familiarity with a drug, etc. The FDA reviews new brand name drug nomenclature to minimize product name confusion. For every end user, we must ask what packaging features can we deploy to distinguish different strengths of the same medication, or make similar brand or chemical names jump off the label?
Dosing content is another common source of medication error found in FDA guidance. This article shows how labeling can create dosing confusion. A recent FDA article used an example of a liquid oral medicine with dosage in milliliters, yet the accompanying oral syringe or cup was marked in milligrams. What in our design process can be done to address potential misunderstandings such as these? This is where creative thinking comes into play, such as in this instance, can I place a graphic chart showing measuring equivalents to resolve this?
3. Design packaging with the patient in mind. As the physical packaging is concepted, be strategic about layout for the end user. Ask what is most important for this patient population to know at first glance. Generally, this would include the name of the drug, dosage/strength/timing details and what it treats. Different medicines and delivery systems may indicate other priorities.
Once a packaging concept is prototyped, it’s time to evaluate it and observe it in use in-house and ultimately by a human factors panel. These observations reveal the performance of the physical packaging and print messaging through the hands of your selected potential users.
The patient population for a medication should be prioritized at all phases of packaging design; could my grandmother figure this out? Senior patient populations face changes in dexterity, strength, vision impairment, color blindness and cognition. Know and design accordingly to ensure successful interaction with the packaging at each step: opening, dispensing, dosage control, taking, storing, remembering next dose.
On the opposite end of the spectrum, we have pediatric medications. This population needs different inputs. A perfunctory mindset can miss practical realities and unintentionally increase the risk of medication errors. While child safety closures ensure kids aren’t dishing out their own medicine, those who are dispensing include a wide-ranging, rotating group of medicine-givers. Parents, grandparents, school staff, and youth caregivers/babysitters all play a role in daily life of modern families. Has the design team addressed the complexity of engaging multiple “medicine givers”? Reaching consensus about medication-specific priorities for multiple knowledge levels should be explored. Identify and incorporate contingencies for changing caregiver scenarios. Identify and incorporate “must-haves” ahead of time so they are built into original packaging designs, rather than add-ons or late-comers that don’t make the final cut.
There are many patient population profiles with unique needs. Knowing and applying these conditions to packaging design will streamline packaging hiccups.
In summary, while repetitive packaging and delivery formats can reinforce user expectations for safer medicine administration, there are opportunities to build trust in the medications we package and reduce medication errors through comprehensively planned, patient-focused packaging design.
