Talking Medication Safety in Specialty Pharmacy with ISMP | NASP Specialty Pharmacy Podcast

In this episode, Sheila Arquette, President & CEO of NASP, speaks with Rita Jew, PharmD, MBA, President of the Institute for Safe Medication Practices (ISMP), about what it takes to keep specialty medication use safe. They discuss the distinct risks of specialty medications and detail ISMP's mission to prevent medication errors, providing drug-specific risk assessments, resources, and interactive tools that help pharmacies uncover gaps between policy and practice.

• 0:05Speaker 00

  You are listening to the global network of podcasters dedicated to the pharmacy profession. Welcome to the pharmacy podcast network.

• 0:26Speaker 01

  You're listening to the NASP Specialty Pharmacy Podcast, a collaboration between the National Association of Specialty Pharmacy and the Pharmacy Podcast Network. Each episode dives deep into trends, challenges, innovations, and patient centric practices shaping the future of this dynamic and rapidly evolving industry. Whether you're a pharmacist or healthcare provider, patient advocate, or industry leader, you'll hear expert insights, real world evidence, and thought provoking discussion that highlights all that makes specialty pharmacy special.

• 0:59Speaker 00

  In support of NASP's mission to empower specialty pharmacy stakeholders to advance the standard of patient care, NASP supports a free market healthcare system in which all specialty pharmacies compete on the same fair and level playing field because that is in the best interest of the patients we collectively serve. NASP is committed to working with all stakeholders and policymakers to ensure that all patients have access to the life-saving medications they need and the high-touch patient care and support services they deserve from the pharmacy of their choosing.

• 1:29Speaker 02

  Hello, my name is Sheila Arkat, and I am the President and CEO of the National Association of Specialty Pharmacy. I am delighted to welcome my special guest, Dr. Rita Jew, to this episode of the NASP Podcast. Dr. Rita Jew is President of the Institute for Safe Medication Practices, or ISMP, where she leads national efforts to prevent medication errors. She brings more than 25 years of advancing medication safety in pharmacy operations, guiding hospitals through automation, sterile compounding, and clinical transformation. She has held various leadership positions, including Director of Pharmacy at UCSF Health, Executive Director of Pharmacy and Clinical Nutrition Services at CHOC Children's, and

• 2:14Speaker 02

  Clinical Manager at Children's Hospital of Philadelphia. Her expertise spans medication safety, pharmacy operations, healthcare technology and automation, and pediatric pharmacy services. A widely published author and sought-after speaker, Dr. Jew has presented extensively on clinical pharmacy topics and held adjunct faculty appointments at multiple schools of pharmacy and nursing. She earned her Pharm D from the University of California, San Francisco, completed her residency at Thomas Jefferson University Hospital, and holds an MBA from the Wharton School at the University of Pennsylvania. She is a board-certified pediatric pharmacy specialist. Rita, thanks so much for joining me today.

• 2:54Speaker 03

  Of course. It's my pleasure to join you here.

• 2:58Speaker 02

  So many of our listeners may have heard of ISMP but may not know much about the organization. Can you tell us who is IMP and what is its mission?

• 3:08Speaker 03

  Of course, yes. ISMP stands for the Institute for Safe Medication Practices. We are an independent nonprofit organization that is devoted entirely to medication safety. And then in 2020, we became part of ACRI, which is another nonprofit organization that is more focused on patient safety in general and device safety. Our mission is very simple, but powerful. It is advancing patient safety worldwide by empowering the healthcare community to prevent medication errors. We are founded and rooted in medication error reporting.

• 3:50Speaker 03

  For more than 30 years, ISMP, through our medication error reporting program, has identified medication use risk. And then we analyze a lot of these errors that came into our reporting portal and then help develop practical strategies to help prevent patient harm. So really, collecting and analyzing the medication error report is just one big thing that we do, but we then publish these kind of learnings in our newsletter. We also share these information through educational programs with healthcare professionals.

• 4:32Speaker 03

  And most importantly, what we do is we collaborate with our stakeholders, whether it's healthcare organizations, or pharmaceutical industry, or even the government agencies or accreditation agencies to help them implement safe medication use practices. And so throughout the work that we do, we are all about advocating for safer medication use systems. And then our biggest thing is that we are unique in the sense that we focus on understanding why errors happened and then offering practical solutions to help organizations redesigning the systems to make things safer.

• 5:16Speaker 03

  And then in the last five years, we really have placed more focus on the ambulatory care settings, including community and specialty pharmacies, just because, as we all know, more and more care is moving to the ambulatory settings.

• 5:32Speaker 02

  Yeah, I remember when I was practicing a long, long time ago, I remember a couple campaigns that came out of analyzing medication errors, like the look-alike, sound-alike, right? The ways to try to make sure dispensing the right medication, and this is before e-prescribing, but then writing out some of, you know, the common abbreviations, right? Like units and milligram and things like that so that there weren't errors made like that.

• 5:55Speaker 03

  Yep, definitely. That's what we are all about. A lot of those items that you talked about, guidelines and tools that ISMP publish to try to improve the system and make things safer. Yeah.

• 6:08Speaker 02

  So tell me why medication safety should be a top priority in the specialty pharmacy practice setting?

• 6:13Speaker 03

  Well, I think a lot of people think about specialty medications and they think high cost. I think specialty medications is not besides the high cost. It also has a lot of risk involved in that. So it's also a high-risk medications and process in a lot of ways, right? Medications these days, a lot more potent drugs than when I was in school, I still remember, when I first started practice, everyone would tell you oral medications are not going to be killing people. So meds that patients are taking in general from the community pharmacies are not, less likely to cause harm. It's no longer the case in here, right?

• 6:58Speaker 03

  And more and more of these specialty medications also have a lot of drug interactions. They may have narrow therapeutic index or very complex dosing. We've seen a lot of those. And all this means is these high complexity really require specialized handling and onboarding, and a lot of times it's also ongoing monitoring and patient support. And coupled with this complexity is also the workflow of specialty pharmacy. I don't think I need to belabor this with the audience for this podcast, the fact that

• 7:38Speaker 03

  the specialty pharmacy workflow is very complex, includes prior authorization, co-chain management, dispensing, shipping, administration coordination, detailed patient education, and on and on, right? I guess the problem is every single one of these steps, an error could happen that can result in patient harm. And that's why we believe that specialty pharmacies can also work on building a reliable systems that is consistently safeguarded against human errors. That's what ISMP is about, and that's what we believe in the specialty pharmacy world.

• 8:22Speaker 03

  This is a high priority thing to help protect patients receiving these very complex medications.

• 8:30Speaker 02

  Now, the patients themselves are oftentimes complex, right? And very vulnerable.

• 8:35Speaker 03

  Absolutely. And the environment they are in, the whole environment they are in, is also something that we need to take into considerations, right? Because when you're in the hospital, you know you have a set environment, but when you have, when you're shipping drugs out to patients who potentially could be living in very different conditions, whether they have refrigeration or not, if this is a refrigerated medication, are all important items to consider.

• 9:05Speaker 02

  Absolutely. Or even, like I tell people this all the time, because I think you're right, there is that misconception that just because it's a pill, it can't hurt you. I'm like, we're treating people now with, you know, cancer medications at home, right? And without any real healthcare provider interaction like they would have had like 10 or 15 years ago, had they gone into a clinic or the doctor's office, right? An infusion center. So I think you're right. I mean, the propensity for something to go wrong is high.

• 9:31Speaker 03

  Right. And the fact that a lot more these days, patients are self-injecting medications at home, right? And making sure that they understand how to drop the right dose if they have to do that, and how to make sure that they are injecting the medication in a sterile manner, that they're not contaminating things and causing themselves an infection. Those are all important items that they need to get educated. And we need to ensure that they actually understand that, not just we are delivering that education, but getting reassurance that they can handle the complex therapy is important.

• 10:14Speaker 02

  Absolutely. What are some of the most common medication safety challenges ISMP sees across specialty pharmacy practice?

• 10:23Speaker 03

  Well, a lot of the risks that we see in specialty pharmacy practice is similar to those found in other areas in healthcare or just inpatient practices, like communication breakdowns, workflow interruptions, technology issues, or the failure to properly utilize or implement technology, and human factors vulnerabilities are all similar in that setting. However, specialty pharmacies definitely face additional challenges because these are, a lot of them are new therapies that are entering the market. They have very complex dispensing processes. We talk about those all the time.

• 11:05Speaker 03

  Every time when a new specialty medication is ready to come out, the ISMP team started looking into that and talking through some of these complexities with dispensing processes. There may be different payer requirements and coordination. It really does require coordination across multiple providers and multiple care setting. And that adds to the challenge. And in addition to that, these days, we are also hearing about some accreditation agencies or payer's requirement that require specialty pharmacies either monitor or report medication errors rate.

• 11:47Speaker 03

  And that is one area that ISMP is very passionate about. We discourage benchmarking or trending of medication error rates, mainly because in our current system, in our healthcare system, all of these error voluntary reports. So I oftentimes tell people who are really into medication error rates to say, to basically tell them, you know, if you want, if you really think that a low medication error rate is a good thing, all you have to do is to tell people to stop reporting, and you'll have zero errors. That is not good, right?

• 12:28Speaker 03

  Because we advocate for building a strong culture of safety, and that is hand in hand with encouraging reporting of errors and near misses because that's how we can identify and reduce risks, right? If we don't know about something, we just kind of put our hands on our eyes and say, I don't want to see it, or put our hands on our ears and say, don't want to hear about it because that affects our metrics of error rate. Then we'll never learn about what are some of the existing risks that we can work on preventing, right? So we really do have to look beyond these error rates and focus on systems vulnerabilities

• 13:12Speaker 03

  and looking at these close calls. Hopefully, they are close calls and not actual errors that happen to a patient. So, and really use that as opportunities for process improvement. So I think I have not, as we have been working in medication safety for quite a long time now, we have chipped away this whole notion that people have on medication error rates and, you know, lower rate is better. And now we're coming into a new space where people are started talking, have been talking about medication error rates and wanted low rates. And so that is a challenge that we kind of want to work with specialty pharmacies

• 13:55Speaker 03

  to overcome as well because that is important to build a very strong culture of safety and eventually a process improvement.

• 14:04Speaker 02

  Sure. So shipping and delivery are critical components of specialty pharmacy care. What has ISMP learned about shipping and delivery errors? And what can organizations do to reduce their risk?

• 14:17Speaker 03

  What we learned is shipping and delivery errors are very common. As a matter of fact, we are working, currently working on an article in our ambulatory and community newsletter. And one of the specialty pharmacies shared with us that shipping and delivery-related errors accounts for almost half of the internally reported errors. That is, that's kind of scary because if you made errors in delivery, that could have a huge impact. So anywhere from patients receiving the wrong medications to medications getting shipped to the wrong address, or just delay in the delivery of inpatients getting their therapy

• 15:02Speaker 03

  or missed doses are all common things that we see. And as we're looking at some of the contributing factors, I think this is where things get really complex. In a regular community pharmacy, when patients are coming in to pick up their medications, you have your store to worry about that you can create processes. So there is internal system-based processes that we need to make sure that the right patient is picking up the right medication. When you're shipping this out, you do have to deal with internal systems, which is complex because we've seen how work is being done in specialty pharmacies.

• 15:40Speaker 03

  Anywhere from, it could be in just not confirming that the current patient address to the fact that you may have the right patient address, but somehow if the systems are not connected, that you still ended up coming up with a packing label for, or delivery label that has the wrong address on it. There's all kinds of issue, internal system-based challenges that we have seen. And then now we have the external third-party carrier challenges of delivering to an incorrect address or delay or lost packages, right?

• 16:20Speaker 03

  We all know how all of these things happen to our usual Amazon deliveries, for example. Now, that becomes more important when you're talking about sometimes a life-saving medication for your patients, when it was lost, it was delivered to, you know, the neighbor down the street or something that you can't track is something that we've seen challenges are. Our recommendation is, I'm telling you, that we're drafting a newsletter article that kind of focused on some of the strategies. Some of our recommendations include making sure that you confirm the shipping. Simple thing that, you know, we want to make sure that we call it out loud, confirm

• 17:05Speaker 03

  the address with the patient. And also make sure that while you're still engaged with the patient, that's one of the first few things that you do, right? You make sure that you have the right patient address, deleting out all the outdated addresses, reducing interruptions during this whole order setup is always a good thing to do, and making sure that there is some kind of independent comparison between the prescription label, shipping label before things are shipped out is important. More importantly, sometimes is overlooked, is having an adequate workspace. Some state board of pharmacies have mandated certain square footage of counter space

• 17:49Speaker 03

  you need for dispensing drugs, but people have not really think about the counter space, for example, for shipping. You can, when there is clutter around, you can see how easily it can contribute to swapping of shipping labels and all those kinds of things. So ideally, what we believe is if a pharmacy system can be integrated with the shipping label system, like, because in a lot of places now they're separate. If those two systems can integrate and we can use technologies such as Varko scanning to drive the population of a delivery address and also be real-time tracking your package

• 18:33Speaker 03

  to make sure the patient is receiving it, that will be the ultimate, right? And so I'm imagining a world where almost all of the specialty medications should have a very strong co-chain control and monitoring of those products that require co-chain control, and also in RFID technology that we can easily track where the item is. Now, I have to tell you, as I was preparing for this podcast, I was talking to Jennifer Young, one of our specialists, about shipping in general, like all the challenges.

• 19:13Speaker 03

  Between the article we're writing and the fact that we are talking about this here in this podcast, one thing came up is that I get, every so often, I get shipments of fish, fish, not medications, from Atlanta. And it's amazing. One day, I literally was looking at my package and I was, I was sitting there going like, wow, this is what we do. Now, let me tell you what they do. They make sure that there is no dry ice in the package and a lot of padding to make sure that the fish is always stays frozen. And comes to find out, my nerdy husband noticed that the shipping label actually has embedded

• 19:57Speaker 03

  an RFID in there. Well, he's just nerdy because he wants to make sure that it is being disposed of properly and everything. But that really gets me to think about our specialty medication. Now, I have to tell you, my box of fish is not that expensive, definitely not in comparison to some of these specialty drugs that are thousands of dollars, they're like a hundred dollars, right? And if they can do all these things to make sure that my fish comes to me frozen in the right condition and tracked, we should be able to do something similar with our specialty medications, right? So this is how passionate we are about specialty medications and the whole mailing and delivery

• 20:42Speaker 03

  say. And to this end, we are actually considering adding a best practice to our targeted medication safety best practices for community pharmacy. And the great news is we are also incorporating specialty pharmacy in these targeted medication safety best practices. So we are changing the name of these best practices to be the targeted medication safety best practices for community and specialty pharmacies. And we are looking to publish an update, an updated best practice at the end of this year.

• 21:19Speaker 02

  Well, that's awesome. We do have, you know, we have a big, growing subset of our membership that focuses on the cold chain management and logistics coordination and protective packaging, right? Making sure, and they partner with specialty pharmacies to make sure that somebody is tracking that drug shipment, right? And it's going where it's supposed to be going and it doesn't become distressed and it's, you know, maintains the temperature that it's supposed to throughout the entire period of transit. So you're right, I mean, it is, it is a huge area of concern.

• 21:47Speaker 03

  Yeah.

• 21:49Speaker 02

  So what does ISMP help specialty pharmacy move from identifying risks to actually improving safety?

• 21:58Speaker 03

  Well, we do a lot of things. We, as I say, we focus on practical and action oriented resources and plans to make sure that a lot of our recommendations are actionable and practical. And so we do have a specialty pharmacy membership, medications, proper name is Medication Safety Specialty Pharmacy Membership, where we provide quite a few different resources. First and foremost, we provide drug specific proactive risk assessments. And with that assessment, right now, we have over 350 drugs and biosimilars that is in

• 22:39Speaker 03

  our library of specialty drug proactive risk assessment. The goal is really to help our members be safe and also meet and support their accreditation readiness. So these assessments, and we know that folks all are doing their own self-assessment a lot of times as new drugs come out. And the great thing is we work proactively to look at what is being approved by the FDA and worked on these self-assessment so that instead of every single specialty pharmacy is going, working, looking at the assessment, you can use our templated assessment that

• 23:23Speaker 03

  we have already looked from the safety lens, what are some of the issues that folks needs to put their thoughts in and then use that template to create the action plan in their individual specialty pharmacies. And so these are on our website, easily downloaded, and it has standardized risk assessment questions that folks needs to think through as they think through every single one of the drugs. So that is huge resources. It takes a lot of time on our end, but what we hope is that it will eventually take less time collectively in the specialty pharmacy community because we do it once and we can share it with everyone.

• 24:03Speaker 03

  The other resource we have is the medication safety self-assessment for specialty pharmacy. And this is specific for pharmacies. And this is where we have this interactive self-assessment online that folks can take online. And the great thing about the assessment is we don't just ask one person to fill out the form and answer the questions. We have different, we wanted to have specialty pharmacies with staff that is a different role, like your administrator can fill out the assessment and answer the questions, your pharmacist, the frontline pharmacist maybe can fill this out, and your technicians, for example, your pharmacy technician can fill this out.

• 24:47Speaker 03

  And here we kind of compile the results of that and really give organizations a good view of where they stand. And also, if there's any discrepancies between different roles of people, you can then identify those discrepancies and understand why there's this discrepancy. Because I can tell you, as a pharmacy director in my previous life, there are times when I think something is, is the practice, because that's the policy we put out, but then the actual practice could be very different. So the self-assessment can really uncover some of those disconnect and help folks can fix the system's issue.

• 25:25Speaker 03

  Now, so these are all self-assessment that, oh, and by the way, this pharmacy assessment also can help members visualize, de-identify aggregated data from other member pharmacies. So you can kind of see if there's an area that you feel like you're not doing as well, you can kind of see, oh, the rest of the specialty pharmacy community also struggle with that, or is there some area that it's different in your perspective organization that you can reach out and ask for help from other organizations? Obviously, those information is de-identified, you don't know where they're coming from, but people can reach out to their colleagues.

• 26:07Speaker 03

  And really, the goal of this pharmacy self-assessment is to help folks develop a safety forward strategic plan. And a lot of times, this could be a few years' plan on how you can reach some of these goals. And then, of course, we help you identify your risks. We also want to make sure that we help you close the safety gap. So like I say, we have best practices that will be coming out to help with closing the gap. We have educational programs and, of course, we have our Medication Safety Newsletter that comes out from all the work that we do in analyzing errors that are coming in that we distribute to all of our members.

• 26:51Speaker 03

  And on a quarterly basis, we aggregate a lot of the issues that we see in the, in those previous newsletter and came up with an action agenda where folks can look at an aggregated list of potential risks that they can evaluate the specialty pharmacy against and decide on what action plans they have to put in place for their own specific specialty pharmacies.

• 27:18Speaker 02

  So if listeners remember only one thing from today's conversation, what would you want them to take away about medication safety in specialty pharmacy?

• 27:27Speaker 03

  I think the one most important thing they need to know is that most medication errors stem from system weaknesses and not individual failures. So the greatest opportunity for improvement really comes from identifying and strengthening those systems. And ISMP is committed to support and partner with the specialty pharmacy community to advance medication safety across the community.

• 27:59Speaker 02

  Well, thank you, Rita, for chatting with me today and for sharing such valuable information.

• 28:04Speaker 03

  Thank you, it's my pleasure.

• 28:07Speaker 02

  As a reminder, NASP corporate members are invited to be my guest on one complimentary podcast per year. For more information about this or other NASP membership benefits and events, please feel free to reach out to [email protected] or visit our website at www.naspnet.org. Until next time, have a great day.