We interviewed 20 clinicians. Participants included 3 hospitalists, 5 inpatient pharmacists, 1 infectious disease physician, 2 anti-microbial stewardship pharmacists, 4 primary care providers, 2 outpatient pharmacists, 2 resident physicians, and a nurse case manager for the allergy service. We should note that the outpatient clinicians we interviewed for this study did not participate in the previous quality improvement based initiatives at our facility. Therefore, they had not received any penicillin allergy education and were not provided access to the CDST prior to our outpatient interviews. However, given the need for future involvement of our outpatient healthcare team, we recruited them to gather preliminary data surrounding possible and perceived barriers to expanding penicillin allergy de-labeling interventions to outpatient settings.
The factors that contributed to barriers to penicillin allergy evaluation and de-labeling were classified under six TDF domains spanning both individual and system-level determinants. In our study, we found that the factors related to knowledge, skills, beliefs about capabilities, beliefs about consequences, environmental context and resources, and professional role and identity were the most prominent barriers to penicillin allergy evaluation (Fig. 2).
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Inpatient Setting
Knowledge, skills, beliefs about capabilities and consequences
All inpatient clinician groups were aware of the scientific evidence supporting the penicillin allergy evaluation. Specifically, participants were familiar with data showing increased risk for comorbidities in patients labeled as penicillin allergic. However, they reported a need for further education on de-labeling benefits and reassurance for its safety. Health care professionals in all groups cited apprehension about inducing an allergic reaction with test dose challenges and having inadequate skills and resources to treat a possible allergic reaction. Despite this, both inpatient pharmacists and hospitalist physicians were amenable to gaining the skills to identify low-risk patients and perform test dose challenges in low-risk patients in the future. In addition, pharmacists and hospitalists felt that they needed frequent practice to maintain familiarity and comfort with the process.
When asked questions regarding using the CDST available to aid history taking, risk stratification and de-labeling of penicillin allergic patients, clinicians in all groups reported a lack of knowledge on where the CDST could be found within the EMR or how to apply it. Upon reviewing the penicillin allergy algorithm (Appendix 1b), residents and pharmacists noted that the tool was straightforward. “I think [the] algorithm is really helpful. I think the biggest barrier is if [patients] don't remember the reaction, or can't get enough information to feel confident, but the algorithm itself is very straightforward” (Resident 1).
However, despite this positive feedback about the CDST, infrequent engagement and lack of practice with the task diminished clinicians’ beliefs about their self-efficacy to effectively participate in the penicillin de-labeling process. Infrequent engagement with de-labeling also influenced a perception that identifying suitable patients took a lot of time. Participants stated that they would need to hone their skills to navigate the EMR system and access the patient history and lists of previous and current medication lists. A lack of self-confidence in their skills with risk stratification and treating possible adverse reactions were noted as specific barriers. For example, a resident said they are not very comfortable with treating patients who may have adverse reactions during the drug challenges: “I know drips and epinephrine things. I just haven't had the opportunity to treat many patients with an acute reaction” (Resident 2).
Even though most participants acknowledged the positive consequences of removing allergy labels from patient records, the fear of erroneous de-labeling and patients having a serious allergic reaction as a consequence prevented clinicians from engaging in the de-labeling process. For example, hospitalists were worried that adverse reactions would add complexity to patients’ clinical care or extend their hospital stay. Pharmacists raised concerns regarding disciplinary action following an error. Several pharmacists noted that if there was evidence in the EMR that a patient was prescribed penicillin in the past, they felt confident to update EMR with a note that the patient tolerated penicillin in the past. However, they were still reluctant to de-label without consulting the patient’s hospitalist, primary care doctor or an allergy specialist, suggesting a lack of confidence or trust in interpreting allergy data in the EMR. “I think it is really tough to take that allergy off the chart unless the patient gets that specific antibiotic while they're here, we have the discussion with the providers that the patient tolerated it just fine and are comfortable that documenting that we're pulling it off the chart completely” (Pharmacist 5).
Professional Role and Identity
As demonstrated in Fig. 1, penicillin evaluation and de-labeling is a multidisciplinary process requiring a collaborative approach. The interdependent nature of the process requires high levels of coordination and communication within and among teams. When a patient is admitted to the hospital, the pharmacy team (either inpatient pharmacist or antimicrobial stewardship pharmacy) usually initiates the de-labeling process by identifying patients with penicillin allergy and conducting a medication reconciliation based on patient’s medical records. In the next step, the patient is risk stratified and direct drug challenge is recommended if the patient is low risk. In the current workflow, the Allergy Consult service evaluates and de-labels the patient, although ideal future workflows would empower inpatient pharmacists and hospitalists to fulfill this role for low-risk patients. Currently, pharmacists and hospitalists expressed that they needed the Allergy service’s approval to de-label a patient especially if there is disagreement among teams.
“There's sometimes a little bit of disagreement with the history taking and the one that comes up all the time is, did the patient really have hives or true urticaria? And then almost always in that situation, we default to the most conservative or safest option, [between] skin testing, getting allergy involved, or doing an oral test dose” (Hospitalist 1).
Clinicians noted that obscurity on which teams would take the lead on de-labeling created barriers to developing robust workflows in clinic. In addition, discomfort with the tasks that did not clearly fall under a specific specialty – such as ordering of the test dose and monitoring the patient during oral challenge – discouraged clinicians from engaging in the de-labeling process. Specifically, neither pharmacists nor hospitalists felt that removing the allergy labels from patient records fell within the inpatient teams’ current professional roles. Because there was not a point person or a group who clearly championed the initiative, the task ended up “bouncing” among teams and fell through the cracks (Table 2). This, in combination with other environmental stressors, resulted in inconsistent clinical workflows and variable application of the penicillin allergy CDST.
“I guess it's a little unclear [who takes the lead on de-labeling]. Um, I think that, you know, teams, individual medical teams do try to do something. It is certainly not very systematic amongst the teams” (Hospitalist 2).
Environmental stressors, resources, and organizational culture
Pharmacists, hospitalists, and specialty consult services described an organizational culture where workload and competing priorities prevented implementation of penicillin allergy protocols in the inpatient setting. The teams’ abilities to focus on patients who are penicillin allergic were hindered by the need to prioritize other competing quality measures and exacerbated by the limited inpatient bed availability.
“I think from an inpatient perspective, it's probably the culture that ‘we need to address the things that need to be addressed as an inpatient, and the rest can be pushed to outpatient world.’ So that tends to be a general thought process. And it's sometimes appropriate, and sometimes it isn't, and penicillin allergy falls in that bucket. So, I think that is probably something in the organizational culture” (ID MD1).
Participants also said that using an alternative antibiotic was easier than evaluating the allergy. This perception was reflected in workflows, especially in times of stress and periods of competing priorities where individuals defaulted decision making to prioritize discharging of patients. “In terms of time to evaluation and treating the patients effectively, a lot of times using an alternative antibiotic is the path of least resistance if there is an alternative there. But if we're kind of stuck between a rock and a hard place, and we need that one antibiotic, maybe that is the way to go then. But I feel like I've just seen so far that a lot of times a different antibiotic is picked just to steer clear of that allergy for the time being” (Pharmacist 5).
With easy access to alternative antibiotics, clinicians prioritized other competing tasks and postponed de-labeling to an unspecified time or deferred to an allergist. Although allergists assumed a leadership role by becoming the point person for patients with complex histories, insufficient resources such as staffing and clinical space prevented them from consulting with all potentially eligible patients. Overall, emphasis on rapid discharge workflows interrupted the momentum and often led to patients being discharged before evaluation.
“I think de-labeling is important but right now, the hospital is completely full every day. We are getting messages on the screen, ‘discharge your patients as fast as you can.’ So, everything becomes secondary to getting the inpatient work done and getting the patients out of the hospital as quickly as we can” (Hospitalist 1).
Team members described how the priority to discharge patients quickly predisposed them to dismiss tasks that may delay discharge. This was exacerbated by time constraints and the precedence to make beds available in case of an urgency, especially during Covid surges. The inpatient healthcare team often deferred penicillin allergy evaluation to a later, undefined future patient encounter: “We can't be here every hour. You're kind of having to pass the buck to somebody else to take care of it” (Pharmacist 3). One exception that facilitated allergy evaluation was if the penicillin allergy specifically affected the patient’s current hospital course.
The lack of adequate staffing to complete daily tasks was also a major barrier to de-labeling. Several clinicians pointed out that shortages of critical team members such as LPNs, and variable hospitalist schedules created barriers to standardizing and implementing de-labeling processes. In addition, inpatient pharmacists were co-assigned to two teams at once, which impeded following a patient through their entire hospital stay and prevented inpatients from being identified early enough in their hospital stay to allow time for an oral challenge. If a pharmacist or ID physician sent an alert to the inpatient team toward the end of a patient’s hospital stay, the team often deferred the task to a later time to avoid discharge delay.
“I think there's always an inherent time limitation, the admission pharmacy med rec isn't put on the chart sometimes for, like, 24 or 48 hours after admission… By the time you hit 48 hours, we're already planning to get [patients] out of the hospital at that point.” (Hospitalist 1)
Within the busy inpatient workflow process, ineffective communication systems further impeded the implementation of penicillin allergy evaluations. Specifically, the inability to quickly identify eligible patients within the EMR upon admission delayed risk stratification of the patients and subsequent decision making about whether the inpatient could be challenged and de-labeled by the inpatient team. Pharmacists, residents, and hospitalist physicians cited difficulties finding the CDST within the EMR due to the unintuitive nature of the system. Small errors such as not updating the history within the allergy field and indicating the relevant clinical encounter often buried important information in the clinical record, limiting data accessibility. Residents pointed out additional challenges with accessing patient history in the system, especially if they were accessing allergy records from a different institution.
Clinicians discussed a number of factors related to the culture of the organization. The decrease in staffing due to COVID and inpatient COVID surges resulted in siloed teams and reduced opportunities for multidisciplinary discussions. For example, pharmacists noted that they no longer rounded with the teams. Multidisciplinary communications were reduced to Teams messages, which made it harder to provide the team with recommendations about de-labeling and to initiate the process. Both pharmacists and hospitalists described how increasing reliance on asynchronous messaging led to ambiguity in recommendations and created the perception that recommendations to challenge patients were less urgent than recommendations that were given in person. Similarly, suggesting penicillin challenges through CPRS notes was considered as “noncommittal,” as notes were a passive form of communication, compared to recommendations conveyed over a phone call or in person. Hospitalists acknowledged that they did not always prioritize ID recommendations documented in CPRS.
“I think it is a much more passive form of communication of just assigning people to notes. It's very noncommittal by the signature that you've received that, whereas, you know, if you had a phone call, it may convey more importance” (Hospitalist2).
Table 2
Representative quotes demonstrating perspectives of inpatient and outpatient clinicians.
| Domain | Constructs | Quotes from inpatient clinicians | Quotes from outpatient clinicians |
| Knowledge | Knowledge (scientific rationale) | I think a lot of people would be convinced by the data out there about long term benefits to doing this. And people are probably not super aware of the data. So I think the data would be a good selling point overall (Resident 1) | Probably the majority of providers don't know that de-labeling of something that is actually a viable thing that we can do a lot of times historically or otherwise. (PCP 4) |
| Procedural knowledge | I think a big barrier is just that we have SharePoint, we have all these other folders, there’s different sites. I'm sure I could find [the CDST] if I went to go look for it, but we have so many different places to start looking that it's just hard to find where everything is, and how updated it is, because we have old versions of stuff and new versions. Our file organization system isn't the best. (Pharm 4) | I am aware that there are kind of protocols to look at history and things like that to delabel and then a paradigm or an algorithm to go through. But I don't think the majority of primary care doctors are. (PCP 4) |
| Skills | Skills | In terms of evaluating their risk for an actual activation of the allergy, I wouldn't feel extremely comfortable, especially doing that on my own. I feel like it's always been a discussion with the team and then if ID needs to get involved in evaluating from that standpoint of group collaboration of what do we think, when was this reaction? …But in terms of actually assigning a risk to it, I don't feel too comfortable at this point doing that on my own. (Pharm 5) | I think I'd be somewhat worried about the volume. I could just see getting trained initially and then we do this for one patient a month and no one has a reaction for 2 years. And then someone does have a reaction and we don't feel as comfortable anymore. (PCP 3) |
| Beliefs about Capabilities | Perceived competence | We rarely do antibiotic test doses. So there may be a lot of concerns about doing that inpatient. So I think familiarity and comfort level across the disciplines is probably one of the barriers. Again, if we do this maybe four times a year, that's really quite infrequent that we're challenging patients. (Hospitalist 2) | Without having been there in the initial moment when they had the reaction, I think it's hard sometimes to be able to, to sort of distinguish and feel confident and questioning whether it was a true allergy. PCP#? |
| Beliefs about Consequences | Outcome expectancies | I feel like if they had penicillin allergy on their chart, but maybe you didn't think it was all that severe, so you give penicillin anyway and having them have an anaphylactic reaction and possibly bad outcome. I think that's probably my biggest fear or barrier to removing the label or giving someone penicillin when they have a documented allergy. (Resident 2) | I haven't done the direct or, the ordering provider, the administrator, the monitoring provider. So I think without experience in that, it would be relatively unsafe and then we don't have any protocols for monitoring after things outside of a few minutes after a vaccination in clinic, we don't have a structure in place to have somebody actively monitor for longer. (PCP 2) |
| Professional Role and Identity | Professional role | It’d be nice to know who is ultimately going to lead the charge, because I feel like a lot of times, we might see it first, because the pharmacy technician put it in med rec. And then if we reach out to the team, I feel like, then sometimes it gets bounced from the team to ID. And if ID recommends getting allergy involved, and it kind of seems like it's always the next person who will be looking into it. And a lot of times I feel like that's where it falls through the cracks. So, if we knew who is going to take charge of it from the beginning, because by the time all those things have happened, the patient might be ready for discharge and then this falls through the cracks anyways, they've already selected a different antibiotic and are being discharged on something else. So, just kind of knowing who ultimately is in charge of that follow up. (Pharm5) | I guess historically part of the problem has been sort of ownership of that and kind of a belief that once it's on the chart, it's gold and we're not going to re diagnose a patient or kind of delve too much into that…so unless someone is prompting us to do that, it’s not something we're necessarily going to go into. (PCP 4) I guess we would wonder what standard of care is, if it's standard for primary care to be doing this or if it's standard for allergy to be doing it…. I would just wonder if it's kind of outside the typical realm of what primary care would be doing to actually administer the trials…. I think there's a lot of very specific primary care things like healthcare maintenance type things that we don't have time to complete all of that. And so I would wonder if adding something that was more specialty driven is the best use of primary care resources but, but not impossible. (PCP 2) |
| Environmental Context and Resources | Environmental stressors | You get done with a long day at the hospital and it's like 6pm and you're ready to go home. You could always ask yourself, could I go talk to this patient some more about penicillin allergy de-labeling? The answer is yes, there's always time there, but is there time within reasonably normal working hours that isn't going to burn the inpatient team out? (Hospitalist 1) It's hard right now, the way the model is, when you're a pharmacist, you have two medical teams essentially that you're covering. And so usually they round at the same times and so you can't be in two places at once. (Pharmacist 2) | If primary care does all the preventative care that it’s supposed to do for each patient that comes in, that's going to take seven hours out of the day. Plus all the acute care needs that patients are bringing up and things they have to address and paperwork and other things. And so eventually the day just kind of runs out of time and, you know, we kind of struggle to do the things that typically fall under the umbrella of primary care in the way the system is currently set up. (PCP 4) A lot of times when I'm seeing a new patient, there's so much to get done. There's so much medical history that when I'm entering the allergies, I'm kind of trying to go as fast as I can and it does ask, what the reaction was, but sometimes they're just like, ‘oh, I don't know.’ And I'm just like, okay ‘unknown, next.’ [Laughs] So, I think probably just general primary care time constraints is the big one. (PCP 3) |
| Resources / material resources | Eventually a lot of these patients need to be sent to the allergy clinic for testing or could get tested in the hospital. And we don't have FTE either here or in the allergy clinic to do that... But we have limited ability to do that because of [Allergy’s] space, their FTE and then our FTE. So that that's probably the biggest barrier. (AMSPh1) | At our community based outpatient clinics, I don't know if I would want to do this if a patient had a reaction, so if this would be done at the main hospital where, if something did happen, we've got the emergency department, we've got inpatient services right there… I could see some hesitancy with doing this procedure in some of our community based outpatient clinics or clinics that just aren't as well supported to navigate an issue if it arose. (Outpatient Pharm 2) |
| Organizational culture /climate | I think a lot of conversations now happen by Microsoft Teams. I think the lack of an in-person communication probably impacts that, like you don't want to bother them as much by sending them yet another Teams message, or your point might not necessarily get across in the electronic communication. I think a lot of times, often it’s just easier to have that face to face conversation, and really not having that with the physician teams, like I almost never see the physicians in person anymore, when I'm staffing on the floors, I guess I should say. (AMS Ph2) | For a procedure that takes 90 minutes, I feel like that might be a tough sell to have the team available…. that could be overwhelming if there's a lot of those coming through…. we're in a workforce shortage right now within primary care providers, LPNs, nurses… That, I think is something else to note, work availability of personnel to be able to implement it. (Outpatient Pharm 1) |
Insert Table 2here
Inpatient to Outpatient Transitions
When the inpatient pharmacists and physicians could not de-label a patient during their hospital stay for reasons such as competing priorities, or workflow issues or pressures, they deferred the de-labeling tasks to outpatient care. However, outpatient pharmacists and primary care providers (PCP) in our study expressed several concerns with taking on penicillin de-labeling as a responsibility.
Barriers to de-labeling in primary care settings
PCPs and outpatient pharmacists echoed the barriers described by inpatient clinicians related to knowledge, skills, beliefs about capabilities, beliefs about consequences, and professional role (Table 2). Because these clinicians had not participated in previous quality improvement-based initiatives surrounding penicillin allergy de-labeling, they expressed hesitation about their level of knowledge and training surrounding risk stratification and oral challenges. They reported that they would need reassurance about the safety of the procedures through practical guidance and protocols on risk assessment, while ensuring that only low-risk patients would be de-labeled. They also expressed that even with updated training, they may still feel ill equipped to safely address patients’ potential allergic reactions during oral challenges because of infrequent practice. Several PCPs noted that assessing the accuracy of a penicillin label in patient records had not been part of their workflow in the past so they “[did] not think to assess it.” Additionally, because PCPs did not regularly prescribe antibiotics, they did not always remember to refer patients to the allergy clinic: “I think recognition is probably the biggest thing. It hasn't been part of my workflow in the past to look for penicillin allergy and then to think to assess whether it's real” (PCP2). While the PCPs thought they could play a role in patient identification by increasing their exploration of patients’ allergy history and referring patients to allergy for further assessment, they expressed that conducting oral challenges would fit better into a specialty role rather than primary care.
Outpatient clinicians also described barriers related to environmental stressors, organizational culture, and resources, and pointed out how those barriers would make it challenging for them to incorporate penicillin de-labeling into their workflows. In particular, they expressed that primary care already has so many other tasks they must cover in each appointment, that discussing and addressing penicillin allergy is a lower priority given their time constraints. Because “identifying low-risk patients and having them go through a 90-minute test might be a tough sell to have the team available” (Outpatient Pharmacist 1), they preferred de-labeling tasks to be performed in the allergy clinic or by the inpatient team. Additionally, they felt that lack of emergency resources at community clinics to treat potential allergic reactions, lack of space to conduct challenges, and lack of support from nursing staff due to staff shortages were significant hurdles. Outpatient pharmacists also noted that the CPRS system could be “clunky,” making it difficult to find protocols and access accurate patient history.
“We're also struggling with space concerns at the facility where I work. I just don't think the building management would like to have people sitting around for 2 hours when we don't have enough rooms as it is” (PCP 1).
