Kendall Hall: So, Gina, can you just introduce yourself and describe your current role?

Gina Luchen: My name is Gina Galanou Luchen, and I am a pharmacist by training. I completed my undergraduate and Doctor of Pharmacy degrees at the University of Kansas School of Pharmacy. I then completed a postgraduate community-based pharmacy residency, followed by the ASHP [American Society of Health-System Pharmacists] Executive Fellowship in Association Leadership and Management. I am currently serving as the ASHP Director of Member Relations for the Section of Community Pharmacy Practitioners and Section of Pharmacy Educators. A little bit about my organization: the American Society of Health-System Pharmacists (ASHP) represents pharmacists serving as patient care providers both in acute and ambulatory care settings. We have nearly 58,000 members that work in pharmacy across the continuum of care with a goal to improve medication use, enhance patient safety, and advance pharmacy practice. In my role, I focus on community-based practitioners who are practicing within health systems or other community pharmacy settings. I am also highly involved with pharmacy education, supporting our members who educate student pharmacists and pharmacy residents and train the pharmacy workforce.

KH: Let’s talk about the training. Are there differences between how you train for working in an acute care facility versus in a community setting?

GL: That's a great question. When you graduate from a college or school of pharmacy, there are many postgraduate training opportunities. There are first- and second-year residency training programs. First-year pharmacy residencies are broken down into three major categories. One is what we consider the traditional pharmacy practice residency in an acute care setting. Residents usually train in a hospital or health-system environment, providing inpatient and outpatient pharmacy services within that institution. Second are community-based residencies, focusing on training within community pharmacies and ambulatory care clinics. Third are managed care residencies, and that's more specialized and looks at using clinical evidence and economics to optimize population health outcomes and medication benefits. There are also fellowship programs in research, policy, academia, nonprofit, industry, or other specialty practice areas.

KH: Thank you—that's very helpful for some context. To provide some clarity for individuals who may not be as familiar, what does it mean to be a community pharmacy, and what are the various operational types?

GL: When you think about a community pharmacy, most people bring to their mind their neighborhood pharmacy. But in the broad sense, community pharmacy is any healthcare setting that provides medication-related services to a patient within their community. The practice encompasses a large number of services and settings. You have the retail setting that can be found as stand-alone stores, both in smaller or larger chains, within grocery stores, or other retail settings. Then you have hospital or health-system outpatient pharmacies, which may serve patients of that particular institution or serve the larger public. And then you have clinic-based pharmacies that might be part of an ambulatory practice. For example, think of a specialized psychiatry clinic, or a primary care and multi-specialty physicians’ office, or assisted living facilities that may have community pharmacies embedded within them. Then you might have pharmacies that serve individuals who are homebound or provide home infusion therapy. Some pharmacies are designated as specialty pharmacies, and they provide specialized medications that treat complex conditions. There are also mail order pharmacies. And, if a patient requires nontraditional dosage forms or strengths of the medication, there are compounding pharmacies that handle custom compounded medications. In a nutshell, there are many settings in which community pharmacists practice and where community pharmacies can be found, but whenever you think of a patient condition that requires any type of medication therapy or any type of intervention within the community, you will likely find a pharmacy that helps to serve that patient and meet those needs.

KH: Wonderful. Thank you. I don't think we realized just how broad that term is and what it covers. With all of these different settings, what are the common and overarching goals of these community-based pharmacies?

GL: I think the goal of community-based practice is to support patients on an individual level not just in managing their medications, but also in managing their health, and to support public health in general. Outside of the traditional dispensing of medications, pharmacies in the community setting offer a variety of other services like medication counseling or disease state education. They assist patients in managing their entire medication therapy. Most community pharmacies today also provide immunizations, they provide point-of-care testing, and they provide consultations and other services needed within that population. There was a study that looked at accessibility for community pharmacies and found that nearly 90% of Americans live within 5 miles of a pharmacy.¹ This represents the tremendous opportunity that community pharmacists have to impact patient care, and that's why all these services that go beyond medication dispensing are so crucial to patients. When you think about the pharmacy’s responsibility, it's really to protect patients and to ensure that their therapy is optimal, safe, and effective. The pharmacist role within the community, and really across the continuum of care, is to increase medication optimization and safety, and ultimately to practice at the top of their license to help patients be healthier.

KH: Well, I think that's a great transition point to start talking about patient safety. What are some of the common patient safety events that can occur across these different settings? And what are some of the considerations that the pharmacist manages in order to protect the public?

GL: Pharmacists in the community manage safety similarly to how they would in any healthcare environment where patients are treated, and medications are handled. To start with, every pharmacist ensures that the services they provide encompass what we refer to as the “Five Rights,” and those are that the right drug makes it to the right patient, at the right dose, in the right route, and at the right time. Although these Five Rights are fundamental in establishing medication handling and dispensing, it's not always simple to ensure because, as we mentioned earlier, community-based pharmacists are part of a larger care continuum, and they provide services that are well beyond the dispensing process. So, when we're thinking about the safety considerations for a community pharmacy, we have to look at every single step, from the medication order to dispensing, the patient’s receipt of the medication, and the patient’s home.

The Institute for Safe Medication Practices (ISMP) released a report² about the key elements of a medication review system for community pharmacies, and they described a number of different elements within that process. But in summary, it starts with the procurement of the medication, so that's purchasing the medication, which includes navigating through drug shortages, verifying that the medication comes from reputable sources, accounting for the shelf life and the storage of the medication, and even keeping a quantity on hand of key medications that are needed in the community for immediate access. That’s all what we call part of the medication supply chain safety and integrity, and those are things that community pharmacists look at on a daily basis.

You then have the therapeutic considerations of safety—that is, ensuring that the medication prescribed is intended to treat or manage the patient’s disease appropriately. This can take into account pharmacists screening for medication duplications, omissions, allergy screenings that could interfere with the prescribed therapy, a new diagnosis that may have been added and needs to be accounted for, ensuring that the dose is appropriate, looking at drug interaction, etc. So there’s a whole therapeutic profile review that occurs in every medication that's dispensed in the community, and it requires a full understanding of the patient's medication profile and their health status. Sometimes verification requires picking up the phone and calling the prescriber or patient.

Then you move into the dispensing process. We mentioned those Five Rights, verifying that the interpretation of the prescription you're getting is appropriately entered and accurately dispensed and that you're filling the correct medication. Other factors would be operational workflow, staffing, technology, and the environment.

Two more things that people don't necessarily think about within the pharmacist’s realm of what we do to secure patient safety include the patient education component. This is ensuring that the patient understands the treatment provided to them. An example can be a pharmacist who is completing a medication review to ensure that the patient is comfortable with what they're taking, that they understand why they're taking their therapy, or counseling on controlled substance utilization or even opioid storage and safety. Lastly, care transitions. It's important to remember that community pharmacists are part of the overall healthcare team for a patient. Their role is crucial in reinforcing education after discharge, coordinating with the prescriber or multiple specialists, to ensure that everybody is on the same page as far as the medication profile for the patient, and preventing any duplications or omissions. The pharmacist is the last line of defense between the patient and that medication, and it's the last opportunity to protect the health of patients.

KH: Listening to you makes me realize that there's such an opportunity for the pharmacist in these settings to serve as a safety net or a double check to some of the things that go on both in the physician's office and at home. How do you take advantage of that? Is it the education piece with the patients?

GL: The community pharmacy, and pharmacy as a profession in general, has a really strong culture of safety. We realize how important our role is in protecting the public. If you look at the oath of the pharmacist, it starts by saying, “I'll consider the welfare of humanity and relief of suffering as my primary concerns” and then goes on to mention that assuring optimal outcomes for patients is really a top priority. You carry a lot of that responsibility as part of the overall culture of being a pharmacist. But the responsibility is with everyone. It starts with the pharmacy technician who takes the medication at the drop-off, to the pharmacist that provides the review, through to the collaboration between the pharmacist and the nurse or the physician to discuss any questions that may arise. From a culture standpoint, there are protocols in place for continuous evaluation and quality improvement within the pharmacy. Each institution has their own methods for ensuring that the staff is well-trained and comfortable performing their duties, that there's appropriate automation and technology, and the environment is distraction-free. And then, of course, there are tools that community pharmacies use to continue enhancing that safety culture. AHRQ [the Agency for Healthcare Research and Quality] has a community pharmacy survey, Community Pharmacy Survey on Patient Safety Culture, that's intended for pharmacy sites to evaluate their approach to safety. It is a self-critique of sorts and asks, “How can I learn from my staff? How can I learn from my patients?” For improving that safety process, ISMP has a self-assessment for community pharmacies as well, outlining different elements of the medication use system to help improve and prevent errors. Then there are even voluntary accreditations for pharmacies. ASHP has an accreditation standard for community and outpatient pharmacy practices with an entire section dedicated to medication safety, patient safety, and supporting continuous quality improvement. So, I think it's an ongoing process, regardless of your setting, establishing that culture to ensure that anyone who touches any aspect of care regards the patient’s safety as a top priority.

KH: So, what would you say are the biggest challenges to safety in the community pharmacy space?

GL: Every community pharmacy operates a little differently and the patient populations and services they offer also vary, but I think if you're speaking generally about common challenges we see in the community-based setting, I would say time available for conducting patient-related services. Again, ISMP has looked at errors that relate to the time the pharmacist has available to review and dispense the medication. and it's clear that pushing for higher volumes and faster dispensing and introducing multiple interruptions creates a risk. Another big challenge for community-based practitioners is that reimbursement is tied to the dispensing, not the clinical services that are so crucial to the safety. This means that the time the pharmacist spends conducting the therapeutic review, clarifying questions with the provider, and talking to the patient are not covered by reimbursement. This limits the availability that you have as a pharmacist.

Then you have interoperability concerns. Having access to patient information is extremely important for ensuring that community pharmacies are able to appropriately conduct a profile review, screen for allergies, do that therapeutic screening that we discussed earlier. If you're tied to a clinic or hospital, you might have access to the patient's direct chart or patient records, which allows you to do a more comprehensive review. However, unfortunately, that's not the case for most of our community pharmacies, who may have to piece it together and spend the extra time calling the nurse line and trying to get a hold of the physician, which I think brings us to a third challenge, which is access to the providers. This again affects the timing and safety of working with patients. In a clinic or health system, you might have a direct line of communication with providers when issues arise. That becomes more challenging in community settings where a pharmacist has to spend a significant amount of time trying to access the prescriber and there's no standard way to communicate with every provider. But overall, when you think about patient safety, it's important to remember it’s not just about the dispensing, it’s about the service provided, and it's about assessing the overall care and the overall system to ensure that safety is in place. Community pharmacies are great at continuous quality improvement as a gold standard. They keep looking at the issues and they keep evaluating what's going right and what's going wrong, in order to continue improving.

KH: You know, it seems that having continuity is something that I keep hearing in what you're saying in terms of having good communication with providers, with the patients. With transitions of care, could we talk a bit about those pharmacies that are part of health systems and their role in care transitions?

GL: I think every pharmacy has an extremely important role in care transitions. Ultimately, we talked about community pharmacies being the final safety net for that patient before they go home with a medication. But going back to the issues that we mentioned, interoperability is a huge component of being able to perform safe transitions. In an ideal world, what we would like to see is all community pharmacists having access to patient records and being able to review medication profiles, have access to providers, and document their interventions. Think about care as a feedback loop versus silos of care. Community pharmacies have a tremendous role to play because they often have the most touch points with the patient. At times they see patients on a weekly basis. So that's an opportunity for education, an opportunity for further clarification, an opportunity to look at the patient and evaluate, how's your adherence? Are you comfortable with your therapy? Can you afford your medication? These are all factors that play into patient safety. We could do everything right and then that patient goes home and doesn’t understand their therapy and doesn’t adhere to the therapy and then we're back to non-optimized use, not because anything went wrong with the diagnosis or anything went wrong with the actual care of the patient, but because they just didn't understand how to appropriately utilize their treatment. So, care transitions are critical in ensuring patient safety, and community pharmacies are really important in helping establish those relationships with providers and with patients and avoiding those mistakes.

KH: Are there any tools available for pharmacies that are not part of the system where the patient usually gets care? Or is it a reliance on the use of interoperable computer systems?

GL: There are definitely ways to ensure patient safety, no matter if you're part of an integrated system or a part of a stand-alone pharmacy. For a pharmacy provider who works in a community setting that may not have access to the electronic health record, or may not have direct access to the provider, there's still the responsibility of taking care of the patient. Professional education in these instances is so important, ensuring that you're up to speed with the latest treatment guidelines and understanding the appropriateness of therapy from your clinical expertise. The pharmacy team has the responsibility to serve as a patient advocate and communicate on behalf of the patient. The team also participates in quality reviews, looking at where errors happened, and collecting data that can be presented both to their institution, but also to collaborative organizations or collaborative practitioners and say, “Hey, we're seeing that these are the errors that are occurring, how can we work together to improve them? How can we collaborate better?” Most errors are related to system gaps, not individual providers, so constant reassessment of the processes is key.

Engaging patients in their own care is really important because ultimately, the patient can give you more information than anybody else. Maybe they can connect you directly to their provider, or maybe they can provide you more information about where the confusion arises. From the patient’s standpoint, they, or their caregivers, need to ensure they are actively involved in their own care and advocate for their own needs. Ensure that they understand why a medication change was made to their treatment. Sometimes patients are afraid to ask, but it's really important to talk with their pharmacist, talk with their provider, and understand why changes are being made so an error can be prevented, and medication use can be optimized. It also allows the development of trusting relationships with providers. We often hear the term “pharmacy hopping.” But it is important to establish long-term relationships with one pharmacist, one primary provider, and consistent specialists. This brings continuity to your care and goes a long way in preventing errors.  

KH: Are there formal mechanisms by which pharmacists and clinicians whose patients are coming to them can communicate about patterns or trends?

GL: It goes back to the ongoing patient safety monitoring and the error reports that pharmacists review. A really strong, ongoing safety program is documenting errors or near-misses. There are many different documentation forms out there- one is called Assess-ERR™, and it guides you through how to document the error or near-miss to understand what type of error was it? What kind of medication did it involve? What were the circumstances around it? So, when the pharmacist or administrator reviews these documents, they can look at trends and determine if something is a one-off mistake or a pattern.  Sometimes there could be a systems issue that requires staff education or updating a policy or process. Or it could be we're seeing a recurring misunderstanding from a provider warranting a call or clarification. So that's why that continuous quality improvement process is so important, because it looks at errors not only in an isolated incident, but trends over time, and identifies internal and external opportunities in a more formalized way.

KH: How is that feedback provided? Is it provided directly to those involved? Is it provided back to the safety group at the hospital? How do you to make sure that you get the information to the right people?

GL: It depends on the circumstances. If it's a prescribing or dispensing trend like we talked about earlier, then that would be a communication with the specific provider’s office or mak[ing] an internal change to the system or process. But if it is a transitions-of-care concern that you find, such as a medication missed at discharge, the pharmacist would call the discharge facility to confirm whether there was, in fact, an error or if it was intentional, and then make the changes with the provider. So, it's all on a case-by-case basis, depending on what type of error you're seeing. Overall, the complete medication review is that key component that happens before the patient goes home to ensure that all medications are correct.

KH: Is there anything that you think we should cover that we've missed or anything additional around patient safety in this setting?

GL: I think talking about some of the changes that are on the horizon that are helpful in planning for patient safety would be good to cover. From an operational standpoint, there's an effort to provide broader access to key providers and ensure that community pharmacists everywhere have access to the health information data that they need. CMS [the Centers for Medicare & Medicaid Services] is working to build out a roadmap for electronic exchange of data and e-prescribing to avoid errors and help with more communication and integration. There are also groups like the Pharmacy HIT [Health Information Technology] Collaborative that advocate for integrated networks of care. And then similarly, CPESN [Community Pharmacy Enhanced Services Network] is working to encourage community pharmacies’ involvement in providing enhanced patient care services. So, from an interoperability standpoint, there's a lot of action because we realize it's so important to communicate with one another. We're also seeing consistent use of technology to avoid errors, like barcode scanning and clinical decision support tools. These [technologies] catch errors that maybe the provider might not. We're also seeing innovative partnerships between settings to promote safety. For example, we're seeing partnerships between health systems and community-based pharmacies, creating collaborations for care transitions. Lastly, we mentioned some barriers with the time available for dispensing and clinical services, such as patient education. There is a push for regulatory change right now in recognizing pharmacists as providers and reimbursement for both dispensing and for other clinical responsibilities, such as counseling. The important thing to recognize is that community pharmacists do so much more than dispense medication.