Inspired To Heal
Stories of clinicians, educators, innovators, and researchers who built or led programs of excellence in government health institutions. Each guest has excelled in clinical medicine, program building, or public health. They persevered and succeeded through a clear vision, collaboration, and a passion for the mission of government-run health systems. Their stories will inspire those seeking change in their own organizations.
Inspired To Heal
Drug Packaging Protects Patients
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Join us for an exploration into product design, FDA history, and healthcare safety with Professor Laura Bix, Director of the renowned School of Packaging at Michigan State University. As a leader in medical packaging solutions, Professor Bix explores how design impacts patient health.
We trace the regulatory and engineering response to two historical crises: the mid-century child aspirin poisoning epidemic and the infamous 1980s Chicago Tylenol cyanide contamination crisis. Learn how public health agencies, corporate manufacturers, and academic innovators collaborated to invent child-resistant and tamper-evident packaging.
This episode explores an essential field, proving their motto true: “It's the industry that no one thinks about, but saves lives.”
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Inspired to Heal, Season 2, Public Health Stories. In this season, we recount important public health advances, whether through outbreak investigations, policies, or program building. In each story, government agencies play critical roles. I'm Bill Trick, your host for Inspired to Heal. Today I'm excited to host Professor Laura Bix, the Associate Dean for Graduate Programs, and the Director at the School of Packaging at Michigan State University. There are two salient, catastrophic public health events that led me to Professor Bix's work. Children dying of aspirin toxicity during the 1940s and 50s, and the intentional contamination of Tylenol with cyanide in the 1980s. An interesting aspect of the Tylenol murders is that the recognition of foul play resulted from a public health nurse who was asked to investigate the home of three people who had died. She found and was concerned about an open bottle of Tylenol and relayed this information to the Cook County Medical Examiner's office, where they identified cyanide as the contaminant. Subsequently, Tylenol was removed from stores. Professor Bicks, the burden on prevention programs such as yours is that it's difficult to prove and quantify that which has not occurred. Which leads me to your department's slogan.
SPEAKER_01Thank you for having me. I'm delighted to be here. I am from the School of Packaging at Michigan State University. And before I go into kind of the details of what I do, I find that it's always good to kind of explain how packaging can be a discipline at a research-intensive institution. People frequently go to pizza boxes for some reason. And absolutely, pizza boxes are a form of packaging, but there are far more than that. And it's it's kind of the ubiquitous tool that nobody thinks about until there's a problem. So when I was looking for a major as a high school graduate, I found this field largely because my father had worked in it, but then also because I was a food science major and my professor's husband was in packaging and he came over to guest lecture. And it's, I think it's really, really a very appealing field as an 18-year-old who's trying to choose a pathway without feeling railroaded into one thing. It is an interdisciplinary science that really combines science, think material science, think chemistry, engineering. You deal with shock and vibration, distribution dynamics, protective qualities for the products that you're getting shipped. Think art, graphic design, and structural design from a form and function perspective. My team is even a little different than most of the people at the school. Most of the people at the school work on maximizing or optimizing the form and function related to the product. Can we fill it effectively? Can we protect the product? Can we extend the shelf life? Those types of things. My team looks at the other side of the container, if you will. We look at what from a human factors perspective can we do to design in ways that facilitate appropriate choices, that facilitate appropriate doses in the case of medications and motivate the behaviors that we're looking for. And we try to really develop data that informs both policy and design in ways that make products easier, better, and more appropriately used by patients primarily. As you mentioned, my team focuses on the healthcare side of things with a very specific focus on what can packaging do about those problems. So things like medication error, what can we do from a design perspective to mitigate the likelihood of a look-alike, sound-alike mix-up? If you have aceta hexamide and acetazolamide sitting next to each other when you're in a critical situation and your mind is very limited in terms of the things that can process because of the adrenaline, how can we as designers help facilitate the crack choice? We look at things like how can we encourage appropriate use of medications when you're managing many, many complicated regimens and you may be at a point in your life where that is very difficult for you to do? You may be facing cognitive declines, mild dementia. What as designers can we do to help intuit your way through those complexities? We look at the interesting design paradox of how can we disable increasingly adept toddlers from getting into the package or getting into a medication while we enable people that are frail or weak because of age, disease, injury, things that are going on. And we look at what we can do in an operating theater to facilitate the transfer of a sterile device to the sterile field without contacting a non-sterile surface, which is a potential vector for germs, which nobody wants.
SPEAKER_03Quite a broad amount of work, even beyond what I thought I would encounter when I read about your work and read about those historic events that led me to you. You mentioned all those disciplines that you work with. How many are in your team? And then how often is it that you collaborate across departments within your university or outside of your university?
SPEAKER_01The vast majority of my collaborators come from outside my college, let alone outside of my discipline. We collaborate, obviously, with the healthcare system. So with nursing, with human medicine, with vet medicine. We collaborate with ergonomics personnel, cognitive psychology and cognitive neurology to understand from a very applied perspective, what can we do, you know, in terms of design that that really cues on the way that perceptive and cognitive systems work. We collaborate with mechanical engineering to look at kinematics and kinetics and how do the how does a design influence the movement of the bones or the muscles that are engaged in terms of opening studio art to look at how are the people in our lab able to replicate or design things that we can test in realistic fashion? And so really I can't think of too many fields that someone in packaging hasn't collaborated with, honestly.
SPEAKER_03Do you think of a discipline that you have found that you have a weakness or a gap in your knowledge? And you're like, oh, thank God that the graphic design people are here or the engineers.
SPEAKER_01Oh, that happens that happens all the time. I I think to me, the the greatest innovations, the greatest progress occurs at disparate intersections. I can think like me. I've been trained like me. I don't need to sit with a bunch of other people that were trained and think like me. I need to sit with people that are different from me, that have different training, that have different experience, that have different background. And to me, it is those disparate intersections, those maybe unexpected intersections where the biggest leaps in understanding come from. My longest standing collaborator is a cognitive neurologist, which you might go, wow, a packaging person, a cognitive neurologist. But he understands the link between the vision system and the cognition, and really understands a lot of fundamental basics about the way the eye and the brain work, which is really helpful in terms of if you're trying to design things, labels or or even forms that you want attended, you want components to be visually salient. And so he and I have collaborated over 25 years, and it's probably not a combination that is common or that most people would put together.
SPEAKER_03If you can get a way for people to read a package insert in a medication, you know, that would be miraculous, I think.
SPEAKER_01Yeah.
SPEAKER_03Maybe there are people who do it, but uh Yeah.
SPEAKER_01Well, I think, you know, there's a lot of problems with those. That extraneous information interferes with the information that the individual really needs. So I mean one time I was watching my son take an over-the-counter medication and he just took it out and took two. And I was like, oh my gosh, my entire career, I have been trying to create labels that drive attention, that you will process, that you know, you will attend to, you will understand, you will comply with. And you're one of those people. And he said, Mom, I don't, I'm 18 years old. I don't have any allergies, I don't have any other conditions, I don't, you know, I don't need any of the information. I have the directions committed to memory. And it occurred to me, really, what we need is much like we do in personalized medicine, we really need personalized labeling. And so one of the things that my team has been working on is is it possible to enter your health information into an app and then use something like augmented reality, kindred to the Pokemon Go where you know you're finding little animals. And that augmented reality will float either a stop sign, a check mark, or caution sign based on your own individual needs. Because really the information you need is specific to you. And all of the extraneous information that we put in labeling in a one size fits all stagnant, static format interferes with your ability to get to what you need.
SPEAKER_03Wow. That that's very innovative. And I hope that works out because it it sounds like a really big advantage to have personalized, customized advice, the medication that or the whatever it is that they're picking up. Pizza, maybe.
SPEAKER_02Yeah, could be.
SPEAKER_03Back to the pizza box, sorry. You mentioned that toddlers now have skills that we didn't have or prior generations.
SPEAKER_01Did I mishear that, or have they become more inquisitive or Yeah, well, I'm I'm not a child development expert, but I can tell you in the 1970s, when I was a a preschooler into toddler, my mother would throw me out the back door and I come home at lunchtime. So I was primarily focused on my gross motor skills. My own sons, who are now, you know, approaching college age, when when they were toddlers, they went to things like computer tots, where they would line up arrows. They would problem solve on computers using keys on the keyboard. And so I think that their fine motor skills are more advanced than probably the children of the 1970s. They're on iPads and iPhones and tablets and different sort of computer gaming systems at very, very early ages. And so I think their ability to do things like line up the arrows and turn, or line up the arrows and push, or even even read directions is beyond maybe what we were, I was doing. Now that said, I've I've tested a lot of children of that age. They're still not rational thinkers. They don't understand, they may be able to do the fine motor things, but they don't understand the ramifications. At the same time, we're living longer, too, and increasingly doing things like rehabbing in home health environments. And so all of that, I think, suggests that we should be revisiting child-resistant closures and child-resistant mechanisms and making improvements. One of the things that the CDC did quite a while ago, probably 10 years ago, more than 10 years ago, is they formed an organization called Protect and Protect RX. Basically, what they were seeing was they were seeing increases in morbidity in children less than five due to unintentional ingestion of medications in home environments. And they looked at automotive morbidity in this same population. They found that the automotive morbidity had come down significantly since the 1970s. But at the same time, morbidity due to these unintentional ingestions was going up. So Dan Budnitz at the CDC at the time actually started these initiatives to try to figure out why and what could be done. And when they looked at the automotive industry, they found huge advances, huge leaps in terms of air curtains, airbags, latch system, car seats had dramatically changed. But when they looked at the technology affiliated with child-resistant packaging, it was largely the same as it had been in the 1970s, which is, at least in the US, the ubiquitous push and turn closure. And so this group, Protect and Protect R X, was an industry, academe, government, NGO consortium intended to look at what we can do about this enhanced or increasing morbidity.
SPEAKER_03One of the aspects that I think government plays a critical role in public health or other agencies is being the nexus around which those other partners can gather and historically has been a trusted partner. So CDC could convene industry, academics, and and other government agencies and bring them together to solve problems. Can you speak a little bit to the to the role of government in protecting the population, the agencies that have been involved?
SPEAKER_01Yeah, well, I I think, you know, the CDC initiative to me was just has been, because it's still ongoing, has been one of the most rewarding endeavors of my career. I I think the benefit of having the CDC convene it, one is, you know, they don't have a dog in the fight other than public safety. And so they are a powerful convener. Generally, when they call, whether you're an academic or an industry partner, you want to be involved. You want to be part of that solution, part of what's happening. And so the people that they could put together were just amazingly different, amazingly motivated, and all worked together around this common sort of cause that they had identified very scientifically with data. The data was very clear that the morbidity rates were rising. And what it turned out, I think, to be was an early harbinger of the opiate epidemic. The other thing that they did was they provided a really nice framework, this really nice scaffolding, which we could think about the problem and potential solutions. I think they called it the three E's. It was enforcement. What could they convince other agencies or their agency partners to do in terms of enforcement? So CPSC or the Consumer Product Safety Commission was there, FDA was also there, the Food and Drug Administration. So enforcement was one of the legs that they used. Engineering, what could we do from an engineering perspective with regard to packaging to improve on or make more impactful child-resistant features beyond what was on the market at the time? And education. What could we do with regard to educating the public about the importance of storing medications properly in a way and out of sight of children? What could we do about educating them that they needed to reclose things properly or resecure, not transfer products to other containers that didn't have child-resistant features, or even simple things like putting your medications in your purse and leaving your purse on the floor where they're easily accessible? The working groups were largely divided around these three E's. Each worked on different and varied aspects of the problem. As I said, it's been one of the most rewarding things that I've done in my career.
SPEAKER_03In a prior episode on microwave safety, they touched on the engineering and the education aspects of product safety, and really felt that education was unfortunately such a difficult and active, you have to reach out to each individual. Whereas the engineering, you can you put it in place and make dramatic improvements.
SPEAKER_01Well, and engineering was one of the big wins, I think, that we've had in the group. If you look at liquid formulations containing acetaminophen for both pediatric and infant formulations, it was not required, but McNeil, Johnson ⁇ Johnson Company was one of the members at the table. They led the way in applying a flow restrictive device into their liquid formulations that contained acetaminophen. So if you've ever dosed a child and needed one of those little syringes, one of those dosing syringes to put it through that little device in the neck of the vial and draw out the dose, that was largely done in the Protect and Protect RX initiatives. And when somebody like the Johnson ⁇ Johnson companies do something like that, their competitors tend to follow suit. So even though it's not a requirement, you'll find that many, many of those products on the market have that added hurdle. So if the child resistant closure comes off of those, there's the added hurdle of that flow restrictive device there that prevents the child from accessing a large portion unless they absolutely crush that package.
SPEAKER_03So it's wonderful to hear cases where industry comes voluntarily to the table and creates the solutions because they're in business to make money. They have to have a profit. And if there's a solution that puts them out of business, no one benefits. What has your experience been with industry? And I guess a corollary to that question is is it necessary to have those government agencies? Do you think those partnerships would be certainly not as robust, but still be possible?
SPEAKER_01I think all the players are needed, honestly. Not only did McNeil come to the table, but also uh many of the pharmacies were there as well. And Walmart was one of the partners in the Protect and Protect RX initiatives. And they printed on their bags the messaging about the importance of using, of storing things up in a way and out of sight. So they echoed the educational component. I don't think government could do it alone. I don't think industry will do it alone. And so I, to me, a healthy ecosystem involves all of those players sitting together working toward a common goal. And I do think that sometimes things won't happen without enforcement as well. I don't think that industry is innately evil. I don't think that they're innately totally capitalist, but they do have different missions, goals, and stakeholders that they have to answer to than other members at the table. And so having us all there, I think, is important.
SPEAKER_03Yeah. As I hear about all the work that you do, I'm thinking that when you go to the store, it probably takes you like five times longer to get what you need. You know, as you walk even through a drugstore or a grocery store, it's probably hard not to get distracted. Is that true? And do kids recognize that?
SPEAKER_01Yeah, I think especially at first, when you first discover the discipline, it's that way. When you're working on projects, I think you get keyed into them. But I guess. One of the benefits of being old is getting numb to the newness of it all and things like that. Mostly what I attend to now are egregious examples that I've found where I'm like, oh my gosh, how could someone have done this? This was such a bad idea. I remember one time every every line of OTC or most lines of OTCs are exempted from the requirements for a child resistant closure on one size. OTC just is OCC over-the-counter medication.
SPEAKER_03So things that you can get without a prescription.
SPEAKER_01Yep, without a prescription. One size can be exempted from the requirement for a child-resistant closure, provided that it is conspicuously labeled with the idea that it's not for households with young children. So you need to warn people that there's no child-resistant closure on it. I was in the grocery store one time, and one of the manufacturers, I will not name who it was, but they had actually a promotional matchbox car that was a NAS car that was attached to their product that did not have the child-resistant closure on it. So those types of things catch my eye when I'm in the store.
SPEAKER_03You did not need the cognitive neurologist to figure that one.
SPEAKER_01No, no, no. Yes, exactly.
SPEAKER_03And I I think I imagine sometimes people have trouble, you know, parents have trouble getting their kids. Hey, could you run an errand? Could you go to the store for me? Probably like, if you're not going, Mom, I'm happy to help you.
SPEAKER_02Yeah.
SPEAKER_03Do it myself.
unknownYeah.
SPEAKER_03And they come home with a new NASCAR matchbox.
SPEAKER_02Yeah. Yeah.
SPEAKER_03So there are some definitions that I think would be nice to hear you talk about. Could you describe to us there's tamper resistant, tamper evident? Yeah, what are the big categories and what do they mean?
SPEAKER_01Yeah, well, you're talking about things that are defined in the Code of Federal Regulations. So they all have official definitions that are defined by the government in various pieces of legislation and subsequent regulations. But tamper resistant was largely the term that was used shortly after the Tylenol incidents happened. And Tylenol or what happened with that product catalyzed people to start thinking about, oh, we need to have some kind of barriers so that people can't tamper these products and not have it be noticed. When they first started, I think, with the idea, they called it tamper resistant because the idea was they were holding people out in some way. But in reality, you really can't hold people out if they want to get into things. I mean, we by definition, we need to be able to get into that product and use it. And so it has to be accessible. Over the years, they've shifted the language and the nomenclature to be more, if they do get into it, you need to be able to detect or it needs to be evident that somebody has accessed that product. And so, really, the the older term is tamper resistant and the newer term is tamper evident. Now, the challenge is people don't always behave the way that you want them to. I would guess that if you polled a lot of people and asked them if they ever looked at the tamper-evident features to investigate, has somebody gotten into this, probably a majority of people, if they were answering you honestly, would say they don't look at it. We've held groups with experts, people that are well versed in tamper evidence and tamper resistance and know about what happened in Chicago. We've asked them, have you ever had things that have appeared with an induction seal, which is at the top of the closure, should be intact and you have to kind of peel it off and sometimes they're a pain. We asked them, have they ever had a feature not intact and still used a product? And most of them said yes. And we asked them, Oh, well, you know, you know about this. You know that it shouldn't be used. Why are you using it? And they're like, Well, I figure it's probably a seal failure, or maybe it shook loose in distribution. I don't want to go back to the store. I've already gone to the hassle of getting it. I don't want to have to return it. And so even people that know sometimes explain these things away. I think people behave much differently than is sometimes rational. Working with people, they're incredibly variable in their behaviors and many times just do things uh way differently than you would expect or or seems reasonable. The lesson that we've tried to convey to some of the manufacturers that we've worked with is if we can cut the consumer out of the decision making, like if we could have the barcode, for instance, disappear or become blacked out if the headspace in the container changes and stop the product from being sold to begin with, that's a far better solution than relying on consumers to behave in a way that you would like them to.
SPEAKER_03I've heard before about the irrationality of human behavior. So we've talked about over-the-counter medications having the tamper-evident packaging. What else is there that has tamper evident packaging and why certain products and not others?
SPEAKER_01Yeah, so the the over-the-counter medications were the direct result of what happened in 1982, the poisonings that you have discussed related to Tylenol, and then many copycats that followed after that. And so the government does regulate, does require at least two tamper evident features on over-the-counter medications. The other two products that it's required on are milk and alcohol. Milk, I think, is largely because it is such a staple in the American diet and can also be a vehicle for terrorism, quite honestly. Alcohol comes from a very different place. After prohibition was repealed, the Department of Commerce actually was assigned as the overseer of alcohol regulations. There was a lot of concern about people not getting what they were paying for, people getting ripped off, if you were, with watered-down alcohol, not getting the proof that you were actually purchasing. The tamper evident feature on alcohol is largely about not getting it watered down on its way to the consumer.
SPEAKER_03So that was actually an industry-motivated.
SPEAKER_01Maybe.
SPEAKER_03So I think that was a particularly salient event, and one in which drove this this tamper evidence packaging. Could you speak a little to that? And did I get the history right?
SPEAKER_01So, yeah, other than it wasn't really driving the tamper evidence, it was driving the child resistant piece. The Tylenol drove the tamper evidence. Aspirin, as you mentioned, was introduced with flavor for children. I was a child of the 1970s, and I can remember, I thought it was very delicious. And apparently I was not alone because the children that preceded me had been ingesting it to the point where it again caught the attention of the regulators who convened several different groups to start to look at what could be done about these unintentional ingestions. A limited number of researchers that produced or ideated around what could we do with packaging to reduce the chances that children ingested these unintentionally. And it took until 1970. So the problem was recognized in the late 40s, early 50s. It took until 1970 to get the piece of legislation produced, but that was the Poison Prevention Packaging Act of 1970, which authorized at the time that it authorized the FDA to start to define test standards for what it meant to be a child-resistant package. I think it was 1972 the CPSC, the Consumer Product Safety Commission, was created, and they became the regulatory authority for those standards. And to this day, they oversee a test standard for both child resistance and senior friendliness that manufacturers must pass if they have a regulated product that they're distributing in the United States.
SPEAKER_03If you could choose one item to put into your public health bag to make a difference, literal or figurative, what would that be?
SPEAKER_01Well, I think we're at an interesting point in time right now. One thing that I could change or accentuate right now, it would be helping the public to understand the role, their role in government oversight and government regulation, that they are able to participate in the process, that they are able to have an active voice in the process, and that that ability makes this country a very, very special place. We are at a point, I think, where people are not fully appreciating that and not fully taking advantage of that. And so one thing that I try to impress on my students is not only the difference that we can make with our disciplinary expertise, but the difference that we can make as citizens.
SPEAKER_03Very well said. It was a pleasure talking to you.
SPEAKER_01Yeah, you too. Thank you for asking me.
SPEAKER_03Many thanks to our guests for sharing their words, but more importantly, their acts of service. Please email us your inspiring governmental health care or public health stories at info at inspired to heal.net. Thank you for listening.
SPEAKER_00Inspired to Heal podcasts are for informational purposes only and should not be considered as health or professional advice. You're not responsible for any losses, damages, or liabilities that may arise from the use of this podcast. The views expressed do not necessarily represent those of the host or the guest's current or past employers.
