Understanding individual experiences with stick-built and modular cleanrooms: Lessons learned and a call to action.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: The purpose of this study was to assess the real-world experiences of cleanroom managers and specialists who have designed, installed, and maintained stick-built and/or modular cleanrooms, delineate the advantages and disadvantages of each type of cleanroom, and gather sterile compounding cleanroom design and installation advice and lessons learned. METHODS: This study was conducted via surveys and semistructured interviews of individuals with cleanroom experience in the previous 5 years. Qualitative analyses were conducted on participants' survey and interview responses to assess their satisfaction with each type of cleanroom and to determine what they perceive to be the pros and cons of each type based on their own experiences. Key lessons learned and advice from these individuals were also extracted from their survey and interview responses. RESULTS: Fourteen individuals from 13 US states completed the survey; twelve participated in follow-up interviews. Fifty percent of the participants (n = 7) had installed 5 or more cleanrooms in the previous five years and over half (n = 8; 57%) had 7 or more years of cleanroom experience. The average satisfaction scores for each type of cleanroom, on a 1 to 10 scale, was 5.3 for stick-built (n = 11) and 9.3 for modular (n = 4). The pros of stick-built cleanrooms included greater design and material flexibility and lower up-front costs. The pros of modular cleanrooms included the cleanroom experience and expertise of modular vendors, quick and easy installations, guaranteed certification, and high-quality and durable design features and materials. Additionally, modular cleanrooms had fewer long-term maintenance issues, greater long-term flexibility, and lower indirect and long-term costs than stick-built cleanrooms. Key pieces of advice from the participants included the following: do your homework before beginning a cleanroom project; make sure heating, ventilation, and air conditioning system(s) and air handlers are adequate for your needs; and remember that the ultimate purpose of a quality cleanroom is patient safety. Participants also advocated for industry-wide cleanroom standards that go beyond USP regulations. CONCLUSION: The findings of this study confirm many of the purported pros and cons of each type of cleanroom, with further insight gained into the relative quality and costs of each type. Modular cleanrooms were considered by most participants to be a better long-term option, based on quality and lifetime costs, if feasible to install. Study participants also emphasized that designing and installing pharmacy cleanrooms is a complex and time-intensive process that often comes with a steep learning curve. While there are federal and state cleanroom standards available and consultants for hire, a comprehensive resource or manual that could provide guidance, insight, and collective lessons learned on cleanroom design and installation is needed.

An assessment of exposed syringe inner walls as a route of exposure from hazardous drugs.

INTRODUCTION: Maintaining safe working environments for health care personnel, especially for those who regularly handle hazardous drugs (HDs), is of utmost importance. Studies have shown that when closed system transfer devices (CSTDs) are used with standard open barrel syringes, cyclophosphamide (CP), a commonly used HD, is transferred to the syringe plunger during compounding or administration processes. This contamination can then be transferred to the work environment, endangering workers. PURPOSE: The purpose of this study was to quantify HD contamination of the inner surface of standard open barrel syringes and to compare contamination levels between three commonly used HDs: 5-fluorouracil (5-FU), CP, and ifosfamide (IF). METHODS: Each HD was transferred from a vial to an intravenous (IV) bag using a standard open barrel syringe and Becton, Dickinson and Company (BD) PhaSealTM CSTD connectors. Samples were taken from the inner surface of each of the syringe barrels to measure the amount of HD contamination. Each drug was tested 15 times and compared to a positive control. RESULTS: Significant amounts of each drug were transferred to the inner surfaces of the syringes. The average amounts of each drug measured were: 5-FU, 1327.7 ng (standard deviation [SD] = 873.6 ng); CP, 1074.8 ng (SD = 481.6 ng); and IF, 1700.0 ng (SD = 1098.1 ng). There was no statistically significant difference between the three drugs (p = 0.14). CONCLUSION: This study underscores the presence of HD contamination on standard open barrel syringe inner surfaces after transfer of drug from vial to syringe to IV bag. Such contamination could be spread in the working environment and expose health care workers to harm.

Patient Perceptions of Opioids and Benzodiazepines and Attitudes Toward Deprescribing.

BACKGROUND: Opioids and benzodiazepines (BZDs) pose a public health problem. Older adults are especially susceptible to adverse events from opioids and BZDs owing to an increased usage of opioids and BZDs, multiple comorbidities, and polypharmacy. Deprescribing is a possible, yet challenging, solution to reducing opioid and BZD use. OBJECTIVE: We aimed to explore older adult patients' knowledge of opioids and BZDs, perceived facilitators and barriers to deprescribing opioids and BZDs, and attitudes toward alternative treatments for opioids and BZDs. METHODS: We conducted 11 semi-structured interviews with patients aged 65+ years with long-term opioid and/or BZD prescriptions. The interview guide was developed by an interprofessional team and focused on patients' knowledge of opioids and BZDs, perceived ability to reduce opioid or BZD use, and attitudes towards alternative treatments. RESULTS: Three patients had taken opioids, either currently or in the past, three had taken BZDs, and five had taken both opioids and BZDs. Generally, knowledge of opioids and BZDs was variable among patients; yet facilitators and barriers to deprescribing both opioids and BZDs were consistent. Facilitators of deprescribing included patient-provider trust and slow tapering of medications, while barriers included concerns about re-emergence of symptoms and a lack of motivation, particularly if medications and symptoms were stable. Patients were generally unenthusiastic about pursuing alternative pharmacologic and non-pharmacologic alternatives to opioids and BZDs for symptom management. CONCLUSIONS: Our findings indicate that patients are open to deprescribing opioids and BZDs under certain circumstances, but overall remain hesitant with a lack of enthusiasm for alternative treatments. Future studies should focus on supportive approaches to alleviate older adults' deprescribing concerns.

A descriptive analysis of primary care providers' interest in clinical pharmacy services.

Background: Various clinical pharmacy services exist to improve the health outcomes of patients. However, there are numerous barriers to their implementation and execution, especially in outpatient settings. As pharmacists design and implement clinical pharmacy services in outpatient settings, they often do not consider the needs of providers until after service development. Objectives: The purpose of this study was to assess primary care providers' (PCPs') perceptions of clinical pharmacy services and their clinical pharmacy support needs. Methods: A web-based survey was distributed via email to PCPs across North Carolina (NC). Survey dissemination was completed in two phases. Data analysis consisted of mixed methods - quantitative and qualitative. Descriptive statistics were used to analyze demographic differences within each phase as well as the ranking of medication classes/disease states by providers. Qualitative data analysis through inductive coding was done to assess provider perceptions of clinical pharmacy services. Results: The response rate of the survey was 19.7%. Providers with previous experience with a clinical pharmacist rated overall services as positive. 62.9% of PCPs (N = 80) provided their perception of the positive attributes (pros) of clinical pharmacy services. 53.5% of PCPs (N = 68) provided their perception of the negative attributes (cons) of clinical pharmacy services. The top three medication classes/disease states that providers indicated they would value clinical pharmacy services for were: comprehensive medication management (CMM), diabetes medication management, and anticoagulation medication management. Of the remaining areas assessed, statin and steroid management ranked the lowest. Conclusions: The results from this study demonstrated that clinical pharmacy services are valued by PCPs. They also highlighted how pharmacists can best contribute to collaborative care in outpatient settings. As pharmacists, we should aim to implement the clinical pharmacy services that PCPs would value most.

Patterns and disparities in prescribing of opioids and benzodiazepines for older adults in North Carolina.

BACKGROUND: We characterized real-world prescribing patterns of opioids and benzodiazepines (BZDs) for older adults to explore potential disparities by race and sex and to characterize patterns of co-prescribing. METHODS: A retrospective evaluation was conducted using electronic health data for adults ≥65 years old who presented to one of 15 primary care practices between 2019 and 2020 (n = 25,141). Chronic opioid and BZD users had ≥4 prescriptions in the year prior, with at least one in the last 90 or 180 days, respectively. We compared demographic characteristics between all older adults versus chronic opioid and BZD users. We used logistic regression to identify characteristics (age, sex, race, Medicaid use, fall history) associated with opioid and BZD co-prescribing. RESULTS: We identified 833 (3.3%) chronic opioid and 959 chronic BZD users (3.8%) among all older adults seen in these practices. Chronic opioid users were less likely to be Black (12.7% vs. 14.3%) or other non-White race (1.4% vs. 4.3%), but more likely to be women (66.8% vs. 61.3%). A similar trend was observed for BZD users, with less prescribing among Black (5.4% vs. 14.3%) and other races (2.2% vs. 4.3%) older adults and greater prescribing among women (73.6% vs. 61.3%). Co-prescribing was observed among 15% of opioid users and 13% of BZD users. Co-prescribing was largely driven by the presence of relevant co-morbid conditions including chronic pain, anxiety, and insomnia rather than demographic characteristics. CONCLUSIONS: We observed notable disparities in opioid and BZD prescribing by sex and race among older adults in primary care. Future research should explore if such patterns reflect appropriate prescribing or are due to disparities in prescribing driven by biases related to perceived risks for misuse.

A pilot study on the use of the nominal group technique to refine core pharmacy roles and to determine what competencies may be missing from pharmacy education.

INTRODUCTION: To describe the use of the nominal group technique (NGT) to refine pharmacy core roles and to compare these roles with current pharmacy outcomes and other literature to highlight potential deficiencies. METHODS: The NGT process was used for this proposal review. The process was conducted in four key stages: silent generation, round-robin, clarification, and voting. A convenience sampling of five pharmacy faculty and administrators that have researched the areas of practice-readiness and pharmacy competencies formed the panel of participants for the NGT process. RESULTS: Study findings offer seven core roles that define pharmacists' scope of practice: knowledge, patient care skills, professional, scholar, system-based practice/manager, collaborator, and advocate/health promoter. Development of these core roles revealed several missing pharmacy competencies or ones only covered in optional learning objectives: conflict management, professional advocacy, scholarship, empathy, personal health, transitions of care, health outcomes, quality improvement, and health insurance. CONCLUSIONS: The development of pharmacy roles is one way to ensure students are adequately prepared for pharmacy practice following graduation. Mapping of competencies to core professional roles would allow schools/colleges of pharmacy to have one cohesive document to guide pedagogical and assessment practice. More research and consensus building will be needed before these core roles could be disseminated more broadly.

Primary-Care Prescribers' Perspectives on Deprescribing Opioids and Benzodiazepines in Older Adults.

PURPOSE: Opioids and benzodiazepines (BZDs) are frequently implicated as contributing to falls in older adults. Deprescribing of these medications continues to be challenging. This study evaluated primary-care prescribers' confidence in and perceptions of deprescribing opioids and BZDs for older adults. METHODS: For this study, we conducted a quantitative analysis of survey data combined with an analysis of qualitative data from a focus group. A survey evaluating prescriber confidence in deprescribing opioids and BZDs was distributed to providers at 15 primary-care clinics in North Carolina between March-December 2020. Average confidence (scale 0-100) for deprescribing opioids, deprescribing BZDs, and deprescribing under impeding circumstances were reported. A virtual focus group was conducted in March 2020 to identify specific barriers and facilitators to deprescribing opioids and BZDs. Audio recordings and transcripts were analyzed using inductive coding. RESULTS: We evaluated 61 survey responses (69.3% response rate). Respondents were predominantly physicians (54.8%), but also included nurse practitioners (24.6%) and physician assistants (19.4%). Average overall confidence in deprescribing was comparable for opioids (64.5) and BZDs (65.9), but was lower for deprescribing under impeding circumstances (53.7). In the focus group, prescribers noted they met more resistance when deprescribing BZDs and that issues such as lack of time, availability of mental health resources, and patients seeing multiple prescribers were barriers to deprescribing. CONCLUSION: Findings from quantitative and qualitative analyses identified that prescribers were moderately confident in their ability to deprescribe both opioids and BZDs in older adults, but less confident under potentially impeding circumstances. Future studies are needed to evaluate policies and interventions to overcome barriers to deprescribing opioids and BZDs in primary care.

A deprescribing medication program to evaluate falls in older adults: methods for a randomized pragmatic clinical trial.

BACKGROUND: Opioids and benzodiazepines (BZDs) are some of the most commonly prescribed medications that contribute to falls in older adults. These medications are challenging to appropriately prescribe and monitor, with little guidance on safe prescribing of these medications for older patients. Only a handful of small studies have evaluated whether reducing opioid and BZD use through deprescribing has a positive impact on outcomes. Leveraging the strengths of a large health system, we evaluated the impact of a targeted consultant pharmacist intervention to deprescribe opioids and BZDs for older adults seen in primary care practices in North Carolina. METHODS: We developed a toolkit and process for deprescribing opioids and BZDs in older adults based on a literature review and guidance from an interprofessional team of pharmacists, geriatricians, and investigators. A total of fifteen primary care practices have been randomized to receive the targeted consultant pharmacist service (n = 8) or usual care (n = 7). The intervention consists of several components: (1) weekly automated reports to identify chronic users of opioids and BZDs, (2) clinical pharmacist medication review, and (3) recommendations for deprescribing and/or alternate therapies routed to prescribers through the electronic health record. We will collect data for all patients presenting one of the primary care clinics who meet the criteria for chronic use of opioids and/or BZDs, based on their prescription order history. We will use the year prior to evaluate baseline medication exposures using morphine milligram equivalents (MMEs) and diazepam milligram equivalents (DMEs). In the year following the intervention, we will evaluate changes in medication exposures and medication discontinuations between control and intervention clinics. Incident falls will be evaluated as a secondary outcome. To date, the study has enrolled 914 chronic opioid users and 1048 chronic BZD users. We anticipate that we will have 80% power to detect a 30% reduction in MMEs or DMEs. DISCUSSION: This clinic randomized pragmatic trial will contribute valuable evidence regarding the impact of pharmacist interventions to reduce falls in older adults through deprescribing of opioids and BZDs in primary care settings. TRIAL REGISTRATION: Clinicaltrials.gov NCT04272671 . Registered on February 17, 2020.

Pharmacist interventions to deprescribe opioids and benzodiazepines in older adults: A rapid review.

BACKGROUND: Many older adults are prescribed opioids and benzodiazepines (BZDs), despite increased susceptibility to adverse events. Challenges of deprescribing include fragmented care and lack of knowledge or time. Pharmacists are well-positioned to overcome these challenges and facilitate deprescribing of these medications. OBJECTIVES: We sought to evaluate interventions utilizing pharmacists to deprescribe opioids and BZDs in older adults. METHODS: We conducted a rapid review following a comprehensive literature search to identify interventions with pharmacist involvement for deprescribing opioids and BZDs in older adults. Studies were included based on: (1) inclusion of patients ≥ 65 years old receiving BZDs and/or opioids, (2) evaluation of feasibility or outcomes following deprescribing (3) pharmacists as part of the intervention. We included randomized, observational, cohort, and pilot studies. Studies that did not report specific results for BZD or opioids were excluded. RESULTS: We screened 687 abstracts and included 17 studies. Most (n = 13) focused on BZD deprescribing. Few studies focused on opioids (n = 2) or co-prescribing of opioids and BZDs (n = 2). The most common intervention was educational brochures (n = 8), majority being the EMPOWER brochure for deprescribing BZDs. Other interventions included chart review with electronic notes (n = 4), pharmacist-led programs/services (n = 2), and multifactorial interventions (n = 3). Many studies were underpowered or lacked suitable control groups. Generally speaking, interventions utilizing educational materials and those in which pharmacists engaged with patients and providers were more effective. Interventions relying on electronic communication by pharmacists were less successful, due to low acceptance or acknowledgement. CONCLUSIONS: We identified a number of feasible interventions to reduce BZD use, but fewer interventions to reduce opioid use in older adults. An optimal approach for deprescribing likely requires pharmacists to engage directly with patients and providers. Larger well-designed studies are needed to evaluate the effectiveness of deprescribing interventions beyond feasibility.

Transitioning Focus Group Research to a Videoconferencing Environment: A Descriptive Analysis of Interactivity.

The COVID-19 pandemic disrupted face-to-face interactions in healthcare research, with many studies shifting to video-based data collection for qualitative research. This study describes the interactivity achieved in a videoconferencing focus group of seven primary care providers discussing deprescribing opioids and benzodiazepines. Researchers reviewed video footage of a focus group conducted via Zoom and assessed interactivity using Morgan's framework for focus group communication processes. Two reviewers categorized the type of exchanges as sharing information, comparing experiences, organizing, and conceptualizing the content, as well as validating each other or galvanizing the discussion with "lightning strike" ideas. The conversation dynamics in this focus group included clear examples of interactivity in each of the categories proposed by Morgan (validating, sharing, comparing, organizing, conceptualizing, and lightning strikes) that were observed by two different reviewers with demonstrated high interrater reliability. Conducting focus groups with a skilled moderator using videoconferencing platforms with primary care providers is a viable option that produces sufficient levels of interaction.

Assessing the Impact of Comprehensive Medication Management on Achievement of the Quadruple Aim.

Nonoptimized medication regimens cost patients and payors in the United States more than $528 billion in additional health care expenses each year. Comprehensive medication management is a patient-centered approach to medication optimization delivered by a clinical pharmacist working with the patient, physicians, and other members of the health care team. Comprehensive medication management ensures medications are assessed for appropriateness, effectiveness, and safety given the patient's clinical status, comorbidities, and other medications, as well as the patient's ability to take the medications as intended and adhere to the regimen. This article reviews the growing body of literature demonstrating the value of comprehensive medication management in achieving the quadruple aim of health care: better care, reduced health care costs, an improved patient experience, and provider well-being.

Integrating targeted consultant pharmacists into a new collaborative care model to reduce the risk of falls in older adults owing to the overuse of opioids and benzodiazepines.

Using central nervous system (CNS)-active medications increases older adults' risk for falls and fall-related injuries. Opioids and benzodiazepines are among the most widely used CNS-active medications and because of their addictive potential and widespread use for common ailments such as chronic pain, anxiety, or sleep, are also among the most difficult to deprescribe. Reducing the dose burden of these 2 medication classes in older adults-to balance safety with efficacy-is a challenge that requires persistence and strategic support structures to be successful. We propose a novel care model that uses the support of targeted consultant pharmacist services to help primary care providers reduce the unnecessary use of opioids and benzodiazepines in their patients who are older adults. This care model holds promise to not only offer providers additional time-saving clinical support but to help their practices improve patient outcomes, such as a reduction in medication-related falls and excess opioid use.

Implementation of a Student-Developed, Service-Based Internship for Pharmacy Students.

PURPOSE: This article describes the development, implementation, and impact of a student-created pharmacy internship program with aspects of service-learning, professional development, and ambulatory care pharmacy practice. PROGRAM DESCRIPTION: As the pharmacy profession continues to evolve, pharmacy internships present valuable opportunities for student pharmacists to explore career pathways and develop personal and professional skills. While internships in clinical and industry settings support interns' professional development, service-based internships provide additional benefits to student pharmacists by promoting cultural awareness, community engagement, and commitment to serving underserved patients. Student leaders from the Student Health Action Coalition (SHAC) at the University of North Carolina Eshelman School of Pharmacy created a service-learning, ambulatory carefocused pharmacy internship for fellow student pharmacists. Two rising third-year students were selected to participate in the internship in the summer of 2018. Over the two-month program, the interns participated in various program components including direct patient care activities, faculty-led workshops and topic discussions, and quality improvement projects. In addition to supporting the interns' academic and professional growth, this program also furthered the mission of SHAC to promote positive health outcomes for underserved populations. SUMMARY: The SHAC Ambulatory Care in Underserved Populations Internship represents an innovative initiative by pharmacy student leaders to develop a service-focused internship for fellow student pharmacists. Participation in the internship provides unique opportunities not often available in conventional pharmacy curricula, including engagement with underserved patient populations and exploration of strategies to mitigate health disparities. Crafted by students for fellow students, this internship provides opportunities for personal and professional growth for both student developers and interns to carry into their future pharmacy careers.