Quantitative and qualitative survey feedback of pharmacists regarding current and prospective licensure models.

BACKGROUND: Despite variation in licensure requirements and models for pharmacy practice nationwide, there is little published data within the United States regarding pharmacist perspectives. OBJECTIVES: The purpose of this study was to identify the demographics, awareness, and perceptions about current pharmacist licensure models. METHODS: A fifteen-question mixed-methods survey was created and distributed via Qualtrics-XM Survey to all Utah licensed pharmacists (n = 4154). Data collection was August 22-September 22, 2022. Before survey distribution, pilot feedback was sought from the Utah Board of Pharmacy and pharmacists at the 118th National Association of Boards of Pharmacy (NABP) national conference. Exempt status was granted by Roseman University Institutional Review Board. Quantitative and qualitative data analysis allowed for descriptive statistics and thematic content identification. RESULTS: The survey collected 972 responses for a response rate of 23% and a completion rate of 94%. Respondents self-identified 36 practice areas. Distribution of years in practice was well dispersed between the predefined ranges. Primary state of licensure was Utah (80%), with additional representation from all 50 states and Guam. The survey showed a variation in awareness regarding other healthcare professional licensing models with 40.83% "aware," 40.62% "unaware," and 18.55% "unsure". A majority showed awareness of the NABP Verify program (55.8%), but unawareness of the Electronic Licensure Transfer Program program (56.14%). Respondents agreed with increased license portability for medically underserved and rural areas (71.79%) and preference for having a law exam (56.72%). Pharmacists (n = 405) noted concerns regarding multistate renewal requirements, fees, and continuing education. CONCLUSION: This study provided baseline data on a topic that is missing in existing literature. Results illustrated a high completion rate, a diversity of demographics including well dispersed age ranges, years in practice, and qualitative responses. The quantitative data shed light on a variety of pharmacist perspectives and varied awareness about NABP licensure programs and compacts.

Effectiveness of an educational intervention to improve antibiotic dispensing practices for acute respiratory illness among drug sellers in pharmacies, a pilot study in Bangladesh.

BACKGROUND: Inappropriate dispensing of antibiotics for acute respiratory illness (ARI) is common among drug sellers in Bangladesh. In this study, we evaluated the impact of an educational intervention to promote guidelines for better ARI management among drug sellers. METHODS: From June 2012 to December 2013, we conducted baseline and post-intervention surveys on dispensing practices in 100 pharmacies within Dhaka city. In these surveys, drug sellers participated in 6 standardized role-playing scenarios led by study staffs acting as caregivers of ARI patients and drug sellers were blinded to these surveys. After the baseline survey, we developed ARI guidelines and facilitated a one-day educational intervention about ARI management for drug sellers. Our guidelines only recommended antibiotics for children with complicated ARI. Finally, we conducted the six month post-intervention survey using the same scenarios to record changes in drug dispensing practices. RESULTS: Only 2/3 of participating pharmacies were licensed and few (11%) of drug sellers had pharmacy training. All the drug sellers were male, had a median age of 34 years (IQR 28-41). For children, dispensing of antibiotics for uncomplicated ARI decreased (30% baseline vs. 21% post-intervention; p = 0.04), but drug sellers were equally likely to dispense antibiotics for complicated ARI (15% baseline vs. 17% post-intervention; p = 0.6) and referrals to physicians for complicated ARIs decreased (70% baseline vs. 58% post-intervention; p = 0.03). For adults, antibiotic dispensing remained similar for uncomplicated ARI (48% baseline vs. 40% post-intervention; p = 0.1) but increased among those with complicated ARI (44% baseline vs. 78% post-intervention; p < 0.001). Although our evidence-based guidelines recommended against prescribing antihistamines for children, drug sellers continued to sell similar amounts for uncomplicated ARI (33% baseline vs. 32% post-intervention; p = 0.9). CONCLUSIONS: Despite the intervention, drug sellers continued to frequently dispense antibiotics for ARI, except for children with uncomplicated ARI. Pairing educational interventions among drug sellers with raising awareness about proper antibiotic use among general population should be further explored. In addition, annual licensing and an reaccreditation system with comprehensive monitoring should be enforced, using penalties for non-compliant pharmacies as possible incentives for appropriate dispensing practices.

Enhanced responsibilities for pharmacy interns at a teaching hospital.

OBJECTIVE: To describe the implementation of a pharmacy intern distribution coordinator position and its impact on the intern's professional development. SETTING: Tertiary academic medical center. PRACTICE DESCRIPTION: In 2009, our institution implemented a pharmacy intern distribution coordinator position, which was previously staffed by a pharmacist. Interns, who are in their first through fourth professional year, take the lead in the medication distribution process while under the direct supervision of a pharmacist. The intern adjudicates the medication distribution process by ensuring proper processing, filling and timely delivery of the medications, as well as triaging inventory issues and maintaining open communication with the pharmacists about any medication issues. Additionally, the intern can make clinical interventions during the various checkpoints in the final verification process and answer drug information questions for fellow medical professionals. PRACTICE INNOVATION: Pharmacy intern resources and development are maximized via staffing in a medication distribution coordinator position previously staffed by a pharmacist. By adapting to the role of pharmacist early on in one's career, pharmacy interns are provided with a valuable opportunity to grow professionally. The position can foster the development of pharmacotherapy knowledge, communication skills, leadership experience, time management, and critical thinking by allowing pharmacy interns to practice at the top of their licensure. CONCLUSION: Our pharmacy intern distribution coordinator position provides interns with a professional development opportunity by assuming enhanced roles and responsibilities in a hospital pharmacy department. The expansion of the pharmacy intern's role can increase pharmacy department resources and provide a valuable platform for their development. Institutions should seek to maximize the opportunities for pharmacy interns to work at the peak of their licensure.

Falling NAPLEX pass rates are cause for concern.

INTRODUCTION: First-time pass rates of the North American Pharmacist Licensure Examination (NAPLEX) have declined 7% from 2019 to 2022 with more than a third of schools experiencing a decline of ≥10%. COMMENTARY: The cause of the decline is likely multifactorial and extends beyond the impact of the COVID-19 pandemic. Changes to the NAPLEX blueprint in 2021, curricular revisions in response to the implementation of Accreditation Council for Pharmacy Education Standards 2016, and changes to prerequisite course requirements in response to declining enrollment must also be evaluated as potential causes. IMPLICATIONS: The academy must respond to this decline by scrutinizing admissions, curriculum, and assessment processes. We urge the National Association of Boards of Pharmacy to provide access to student-level data on NAPLEX performance and increase transparency in passing standard practices to inform this process.

NAPLEX Preparatory Perceptions from Recent Graduates at One College of Pharmacy.

OBJECTIVES: The current study assessed how students prepared for the North American Pharmacist Licensure Examination (NAPLEX), and examined factors associated with first-time pass rates. In addition, updated information on student perceptions of several currently available NAPLEX preparation resources was collected. METHODS: A survey was administered to 2022 graduates from 1 school, which collected data on student demographics, and NAPLEX-related items regarding when the exam was taken and how students prepared, including resources used. The association between first-time success (pass, no pass) and grade point average (GPA), timing of test date after graduation, effort toward exam, and number of hours studied was examined. In addition, student ratings of NAPLEX preparation resources in terms of usefulness, representativeness to actual examination, and monetary value were reported. RESULTS: A total of 52 individuals completed the survey. Pharmacy GPA over 3.5, taking the NAPLEX within 60 days of graduation, and exerting moderate to extensive effort to pass the NAPLEX were all associated with higher first-time pass rates. All students reported using at least 1 RxPrep resource, which students rated highly and suggested the school provide as a resource for NAPLEX preparation. CONCLUSION: This study found that taking the NAPLEX examination within 60 days of graduation, contributing moderate to extensive effort to pass the examination, as well as a cumulative GPA of 3.5 (out of 4) or above were related to success on the NAPLEX. Additionally, students reported high satisfaction with RxPrep resources.

A Description of Required NAPLEX Preparation Courses Among US Pharmacy Programs.

OBJECTIVE: One of the final tasks for pharmacy graduates to enter practice is passing the North American Pharmacist Licensure Examination (NAPLEX). Given the recent national declines in pass rates, programs are making significant investments of time and money in NAPLEX preparation. The objective is to characterize the structure and content of required NAPLEX preparation courses. METHODS: A survey on NAPLEX preparation practices was developed and distributed to all Accreditation Council for Pharmacy Education-accredited pharmacy schools. NAPLEX preparation course syllabi were also collected as part of this survey. Syllabus information was summarized into 4 elements: course structure, content, resources, and assessment strategies. RESULTS: Of 144 colleges/schools of pharmacy, 100 responded to the survey, 87 reported having a NAPLEX preparation program, and 47 reported having a NAPLEX preparation course. Twenty syllabi were collected. Most courses (14) were longitudinal through the Advanced Pharmacy Practice Experiences year, 16 were credit-bearing, and 19 included a vendor NAPLEX preparatory product. Fourteen courses were hybrid delivery, and 12 focused on licensure preparation and included test-taking strategies, calculations practice, case-based discussions, etc. All 20 courses reported using unproctored timed quizzes and practice examinations, half conducted proctored timed assessments, and 11 included written reflections and/or continuous professional development activities. Most courses were pass/fail (15), and high stakes (16) were defined by delayed or withheld graduation as a consequence for failure. Only 3 of 20 NAPLEX preparation courses were mapped to NAPLEX competencies. CONCLUSION: Although required NAPLEX preparation courses focus on assessments, the content is infrequently mapped to NAPLEX competencies. This project provides some information on how schools might create their own NAPLEX preparatory courses.

The North American Pharmacist Licensure Examination (NAPLEX) Pass Rate Conundrum.

As first-time pass rates on the North American Pharmacy Licensure Examination (NAPLEX) continue to decrease, pharmacy educators are left questioning the dynamics causing the decline and how to respond. Institutional and student factors both influence first-time NAPLEX pass rates. Pharmacy schools established before 2000, those housed within an academic medical center, and public rather than private schools have been associated with tendencies toward higher first-time NAPLEX pass rates. However, these factors alone do not sufficiently explain the issues surrounding first-time pass rates. Changes to the NAPLEX blueprint may also have influenced first-time pass rates. The number of existing pharmacy schools combined with decreasing numbers of applicants and influences from the COVID-19 pandemic should also be considered as potential causes of decreased first-time pass rates. In this commentary, factors associated with first-time NAPLEX pass rates are discussed along with some possible responses for the Academy to consider.

Student pharmacists' perceptions of a NAPLEX preparation module in the pharmacy curriculum at one United States college of pharmacy.

BACKGROUND AND PURPOSE: To investigate final-year student pharmacists' experiences of a new module for North American Pharmacist Licensure Examination® (NAPLEX®) preparation at one college of pharmacy in the United States. EDUCATIONAL ACTIVITY AND SETTING: All student pharmacists enrolled in a new Spring 2023 module for NAPLEX preparation (n = 118) were invited to complete an electronic questionnaire and participate in a semi-structured interview. The questionnaire investigated the perceived helpfulness, grading, importance, prioritization, structure, and timing of the module in the curriculum, as well as assignment choices, confidence building, and time management using a six-point Likert scale. Semi-structured interviews investigated experiences with NAPLEX modules, time management, and course format. Questionnaire data were descriptively analyzed; interview data were thematically analyzed. FINDINGS: Forty-one completed questionnaires and seven interviews were analyzed. Median scores for questionnaire items were six (denoting strongly agree) for three items, five (denoting agree) for seven items, and four (denoting somewhat agree) for two items. Twenty-three (56%) students desired an online self-directed (asynchronous) course structure. Seventeen (42%) students desired a mixture of short and long course assignments with a greater proportion of short course assignments while another 17 (42%) desired only short course assignments. Two themes were constructed from interviews: timing (when to study for NAPLEX) and structure (how to study for NAPLEX). SUMMARY: Study findings indicated typically positive perceptions of a module for NAPLEX preparation among final-year student pharmacists at a college of pharmacy in the United States. Recommendations from students can be used to improve the module in future years.

High Total Failures of the North American Pharmacist Licensure Examination (NAPLEX) Warrant Monitoring of Professional Pharmacy Programs.

From 2021 to 2023, 7978 graduates of pharmacy programs failed the North American Pharmacist Licensure Examination on the first attempt. Presently, the Accreditation Council for Pharmacy Education monitors programs with a passage rate of ≥ 2 SDs below the national mean pass rate. In 2023, this should lead to monitoring 7 programs that produced 140 failures out of the total of 2472 failures (5.7 %). In our view, this is neither equitable nor demonstrative of sufficient accountability. Analysis of failure counts among the 144 programs reported by the National Association of Boards of Pharmacy demonstrates a distribution curve highly skewed to the right. The evaluation of average failure counts across all programs suggests that schools with absolute failures ≥ 2 SDs higher than the average number of failures should be identified for monitoring, in addition to those falling ≥ 2 SDs below the national mean pass rate. Based on the 2023 data, this additional criterion corresponds to ≥ 35 failures/program. This threshold would prompt monitoring of 18 programs and 36.5 % of the total failures. Of the 7 programs that will be monitored based on the current Accreditation Council for Pharmacy Education criteria, only 1 would be captured by the ≥ 35 failure method of selection; the remaining 6 contribute 85 total failures to the pool. Thus, if both criteria were to be applied, ie, ≥ 35 failures and ≥ 2 SDs below the national mean pass rate, a total of 24 programs would be monitored (16.6 % of the 144 programs) that contribute 987 of the total failures (39.9 %).

NAPLEX Preparation Program Characteristics and Resources Associated With First-Time Exam Pass Rates.

OBJECTIVE: Pharmacy colleges and schools invest substantial faculty effort and financial resources in North America Pharmacist Licensure Exam (NAPLEX) preparation, including vendor products purported to improve NAPLEX pass rates. The objective of this project was to examine NAPLEX preparation program characteristics associated with first-time pass rates. METHODS: A national survey investigated which pharmacy schools provided a formal NAPLEX preparation program in the 2021/2022 academic year, and what resources students were required to use. Pharmacy school characteristics and the unique resources provided in NAPLEX preparation programs were separately analyzed for association with 2022 NAPLEX first-time pass rates. RESULTS: The survey response rate was 71% (100 pharmacy schools). Of the 6 pharmacy school characteristics analyzed, offering a formal NAPLEX preparation program and private status were both weakly correlated with a decrease in the 2022 NAPLEX pass rate, while founding year of 2000 or earlier was weakly correlated with an increase in the pass rate. In a generalized linear model, a decrease in 2022 NAPLEX pass rate was associated with offering a formal NAPLEX preparation program (-5.90% [-11.55 to -0.23]) and with a 3-year accelerated curriculum (-9.15% [-15.55 to -2.75]). Of 12 resources required in NAPLEX preparation programs, 3 were weakly correlated with a decrease in 2022 pass rate: a vendor question bank, vendor review book/materials, and a live, synchronous faculty-led review. In a generalized linear model, a decrease in 2022 NAPLEX pass rate was associated with a live, synchronous faculty-led review (-6.62% [-11.16 to -2.08]). Among schools without a formal preparation program, NAPLEX pass rates consistently exceeded the national average in 2020, 2021, and 2022, while the proportion of schools with NAPLEX preparation programs and first-time pass rates above the national average dropped from 59% in 2021 and 58% in 2020 to 44% in 2022. CONCLUSION: Simply implementing a NAPLEX preparation program is insufficient to overcome other systemic/programmatic influences of successfully passing the NAPLEX; programs should invest earlier resources to address NAPLEX competencies.

Monitoring of schools and colleges of pharmacy based on NAPLEX passage rate.

INTRODUCTION: We have evaluated two approaches of monitoring schools and colleges of pharmacy based on North American Pharmacist Licensure Examination (NAPLEX) passage rates. Historically, the Accreditation Council for Pharmacy Education (ACPE) has cited programs for passage rate ≥2 SD below the national average. Since the National Association of Boards of Pharmacy (NABP) no longer reports scores, this procedure is being reconsidered. Our supposition is that the failure rate of ≥2 SD below the average should be retained, but now be based on the national average passage rate rather than score. Yet, we further suggest this is not sufficient due to major variations in class size. COMMENTARY: We suggest the establishment of a "maximum acceptable failure count," likely in the range of 20 to 25 failing graduates per class. Analyses of data from 2017 to 2019 indicate that this approach would lead to monitoring approximately 15% of existing programs that graduate approximately 40% of individuals failing NAPLEX vs. monitoring only 5% of programs that graduate approximately 9% of individuals failing NAPLEX. IMPLICATIONS: The historical method of monitoring pharmacy programs with NAPLEX passage rates ≥2 SD below the national average is not sufficient, primarily due large variations in class size. Since accreditation standards are currently being revised ("Standards 2025"), this would be an ideal time to update methods for selecting programs that warrant monitoring based on inadequate NAPLEX passage rates. We suggest the concept of "maximum acceptable failure count" should be considered when identifying programs to be cited.

Frequency of Course Remediation and the Effect on North American Pharmacist Licensure Examination Pass Rates.

Objective. Remediation is a tool that allows students to correct an academic deficiency after earning an unsatisfactory grade. There is a lack of data on remediation processes and their impact on future academic performance. This study aimed to evaluate the impact of remediation frequency on North American Pharmacist Licensure Examination (NAPLEX) performance.Methods. The primary analysis was the relationship between the NAPLEX first-time pass rate and the frequency of course remediations (no remediations, one remediation, and two or more remediations). Additional analyses included the correlation between the NAPLEX scaled score and the number of course remediations and characteristics of the course remediated.Results. A total of 116 students with NAPLEX data were included for analysis. Compared to students who never remediated, NAPLEX first-time pass rates were similar among those who remediated only one course; however, students who remediated two or more courses had significantly lower NAPLEX pass rates. Remediation in courses mapped to Pharmacy Curriculum Outcomes Assessment (PCOA) area 4.0 (clinical sciences), and courses with mixed PCOA content areas were negatively correlated with NAPLEX scaled scores. A significant negative correlation existed between remediation in students' second or third years in pharmacy school and the NAPLEX scaled score, but this correlation was not significant for students in their first year.Conclusion. Multiple course remediations are negatively correlated with NAPLEX scaled scores and a reduced first-time NAPLEX pass rate, but a single course remediation has no effect. Institutions should aim to evaluate their current remediation practices and assess whether additional support should be provided to students with multiple course remediations.

Association Between Accreditation Era, North American Pharmacist Licensure Examination Testing Changes, and First-Time Pass Rates.

Objective. To estimate whether first-time pass rates on the North American Pharmacist Licensure Examination (NAPLEX) have been influenced by the number of pharmacy programs founded since 2000, the programs' accreditation era, and the changes to the blueprint as well as changes to the testing conditions and passing standards implemented by the National Association of Boards of Pharmacy (NABP) beginning in 2015.Methods. This was a retrospective, observational cohort study using publicly published data. The number of programs and pass rates were collected from 2008 to 2020. Programs reporting pass rates from 2016 to 2020 were eligible. Accreditation era was defined as programs accredited before or after 2000. Pass rates were categorized into NAPLEX tests administered before or after 2015. Statistical analyses were conducted for comparisons.Results. Pass rates were initially found to decline as the number of programs rose. First-time pass rates of programs accredited before 2000 were higher than pass rates of programs accredited after 2000 every year after 2011. Only 40% of the programs accredited after 2000 exceeded the national average between 2016-2020. Blueprint changes implemented in 2015 and the changes to testing conditions plus passing standards implemented in 2016 had a greater effect on pass rates than the number of programs or applicants.Conclusion. Programs accredited after 2000 generally had lower first-time NAPLEX pass rates. Even so, blueprint changes and changes to the testing conditions plus passing standards instituted by the NABP were more important predictors of the decline of first-time NAPLEX pass rates. Stakeholders should collaborate and embrace best practices for assessing practice-ready competency for licensure.

Assessing quality in pharmacy education in an era of rapid expansion.

OBJECTIVES: To describe measures used to evaluate the quality of U.S. pharmacy graduates in an era of rapid increases in the number of pharmacy colleges and schools (CS) and students and to assess if the expansion has influenced such measures. SETTING: United States. PRACTICE INNOVATION: Institutional research used by CS and the pharmacy accrediting organization in evaluating the knowledge, skills, and abilities of pharmacy graduates. MAIN OUTCOME MEASURES: Scores on the North American Pharmacist Licensure Examination (NAPLEX) and survey data from CS graduates, faculty, and preceptors. RESULTS: Mean first-time NAPLEX pass rates over time are comparable for older and newer CS and for main versus branch campuses. Graduates, faculty, and preceptor survey results affirm that faculty, preceptors, and students perceive the quality of pharmacy education to be very high. CONCLUSION: The increase in pharmacy programs and graduates has not thus far affected educational quality based on available objective and subjective measures.

Supporting pharmacy students' preparation for an entry-to-practice OSCE using video cases.

BACKGROUND AND PURPOSE: Objective structured clinical examinations (OSCEs) are widely used, including in licensure examinations. OSCEs assess diverse skills in a structured manner, but can be stressful for students and have a significant organisational burden for faculty. Case-based video OSCE preparation resources were developed for students preparing for a licensure OSCE. The study aimed to examine student engagement, compare scores awarded by students to performances at specific competence standards with faculty scores, and examine usability, usefulness, and acceptability of the video cases. EDUCATIONAL ACTIVITY AND SETTING: Final year pharmacy students (n = 149) enrolled in an integrated master of pharmacy programme in Ireland were invited to participate. Six sets of recorded OSCE-based video cases were developed, comprising multiple recordings of the same case scenario, with each pitched at a different level of performance. Students watched and scored the video cases. Usability, usefulness, and acceptability were evaluated via questionnaire. FINDINGS: One or more video cases were accessed by 70.5% of students. Score ratings awarded by the students, when compared to faculty ratings, showed an overall trend towards inter-rater agreement between students and faculty. Students felt positively in terms of the usability, usefulness, and acceptability of the videos. SUMMARY: Video cases designed to support OSCE preparation for a high-stakes national pharmacy licensure examination were widely used by students and were perceived to be usable, useful, and acceptable. Such video cases may be a feasible alternative to additional mock OSCEs to support student preparation.

Association Between NAPLEX Preparation Program Characteristics and First-Time Pass Rates.

Objective. The objectives of this study were to (1) describe characteristics of preparation programs for the North American Pharmacist Licensure Examination (NAPLEX) that are currently used by colleges and schools of pharmacy and (2) evaluate these program characteristics in relation to first-attempt NAPLEX pass rates.Methods. This cross-sectional study was based on an online survey administered between February and March 2020. Assessment leads from 143 PharmD programs were invited to answer questions on their schools' PharmD program characteristics and various aspects of NAPLEX preparation programs. The study included regression analyses to investigate associations between the NAPLEX first-attempt pass rates and PharmD demographic characteristics as well as between first-attempt pass rates and various aspects of the NAPLEX preparation programs. Finally, common themes from open-ended questions were identified.Results. Fifty-eight participants completed the survey out of 132 successfully delivered email invitations (response rate = 44%). Fifty participants (86%) indicated that their PharmD program offers a NAPLEX preparation program. Our data indicate that offering a NAPLEX preparation program was not significantly associated with higher NAPLEX first-attempt pass rates. The analysis identified possible explanations for this lack of association, including student concerns with balancing a preparation program with advanced pharmacy practice experiences (APPEs) and the faculty workload associated with delivering such programs.Conclusion. The current findings show no association between offering a NAPLEX preparation program and NAPLEX first-attempt pass rates. Future research should continue to examine the impact of these programs on individual school pass rates and factors that may enhance student motivation to engage in these programs.

Healthcare professional experiences and attitudes on unlicensed/off-label paediatric prescribing and paediatric clinical trials.

OBJECTIVES: To investigate the knowledge and views of a range of healthcare professionals (consultant paediatricians, general practitioners (GPs), community pharmacists and paediatric nurses) regarding the use of unlicensed/off-label medicines in children and the participation of children in clinical trials. METHODS: A regional study in which a survey instrument with 39 items was issued to 500 randomly selected GPs, all community pharmacists (n = 512), 50 hospital consultants and 150 paediatric nurses in Northern Ireland. RESULTS: Approximately half (46.5%) of the 1,212 healthcare professionals approached responded to the questionnaire. The majority of respondents indicated their familiarity with the term unlicensed (82.9%) or off-label (58.6%) prescribing with the most frequently quoted reason for such prescribing being younger age (33.6%). Apart from community pharmacists, most respondents reported having gained their knowledge through personal experience. Even though a large percentage of respondents expressed concerns about the safety (77.8%) or efficacy (87.9%) of unlicensed/off-label prescribing in children, only 30.7% reported informing parents/guardians of these concerns on the use of such medicines in children. In addition, only 56% of respondents believed that unlicensed/off-label medicines should undergo clinical trials in children. Overall, 28.4% of respondents (20.1% of GPs, 41.4% of community pharmacists, 27.7% of paediatric nurses and 94% of consultant paediatricians) indicated their willingness to be actively involved in, and recruit their patients for paediatric clinical research. CONCLUSION: The use of unlicensed and off-label medicines remains a major issue in paediatric medicine. Until such times as more licensed medicines are available for children, clear guidance should be developed to allow consistency in practice across the spectrum of healthcare professionals who are involved with such medicines in their routine practice.

Investigation of Factors Associated With Immunogenicity Labeling Updates and Characteristics of Biologics License Applications.

Immunogenicity, the potential to elicit an antidrug immune response, is a critical concern in developing biological products, but its consequences are difficult to predict with animal studies. The aims of the present study are to investigate the evolution of immunogenicity information in labeling and to identify attributes associated with immunogenicity labeling updates. Biologics License Applications (BLAs) approved by the Center for Drug Evaluation and Research, US Food and Drug Administration between 2008 and 2017 were studied. A majority of BLAs described the incidence/prevalence of antidrug antibodies (ADAs) (94.9%) and neutralizing antibodies (NAbs) (68.4%) in their original labeling documents. However, less than one third of the BLAs mentioned the impact of ADAs/NAbs in the original (20.3%) and most recent (29.1%) labeling documents. BLAs with a priority review status (57.4% vs. 33.3%), orphan designation (61.5% vs. 34.2%), or a mention of ADA impact in the latest label (69.6% vs. 38.9%) had higher percentages of applications with postmarketing requirements (PMRs) directly related to immunogenicity concerns in comparison with applications without those characteristics. Among the BLAs with updated immunogenicity information, the mean time to the first update was 1,077 days, while that for BLAs with accelerated approval was shorter (709.1 ± 492.2 days vs. 1173.8 ± 661.8 days). The results suggest that there is a substantial amount of critical information lacking in the original labeling documents and an overdependence on PMRs for more evidence. Additional efforts should be made to investigate the impact of ADAs to provide timely information for improved patient care.

Compliance With Cannabis Act Regulations Regarding Online Promotion Among Canadian Commercial Cannabis-Licensed Firms.

Importance: As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media. Objectives: To evaluate compliance among licensed firms with the Cannabis Act and analyze trends among violations regarding promotional material. Design, Setting, and Participants: This cross-sectional study evaluated cannabis-licensed firms after cannabis legalization. Data were extracted from online public platforms, including company websites, Facebook, Instagram, and Twitter, from October 1, 2019, to March 31, 2020. Descriptive statistics, Poisson regression, and logistic regression were used to analyze the associations of covariates with promotion violations. Main Outcomes and Measures: The primary outcome was characterization of type and prevalence of promotion violations. Secondary outcomes were the role of various covariates (namely, licensed firm characteristics and online platforms) in the frequency and probability of violations. Hypotheses were formulated before data collection. Results: Among 261 licensed firms, 211 (80.8%) had an online platform, including 204 (96.7%) with websites, 128 (60.7%) with Facebook, 123 (58.3%) with Instagram, and 123 (58.3%) with Twitter. Of all licensed firms with an online platform, 182 (86.3%) had at least 1 violation. Compared with websites, the risk of violations was significantly higher on Facebook (rate ratio [RR], 1.24; 95% CI, 1.11-1.39) and Instagram (RR, 1.19; 95% CI, 1.05-1.34). The most common violations included lack of age restrictions, brand glamorization, and omission of risk information. With websites as the reference group, lack of age restrictions was approximately 15 times more likely to occur on Facebook (odds ratio [OR], 14.76; 95% CI, 8.06-27.05); the odds of an age restriction violation were also higher on Instagram (OR, 2.48; 95% CI, 1.43-4.32) and Twitter (OR, 4.03; 95% CI, 2.29-7.09). For unsubstantiated claims, the odds of violations were significantly decreased on Facebook (OR, 0.23; 95% CI, 0.11-0.48) and Instagram (OR, 0.28; 95% CI, 0.14-0.57). The odds of glamorization were associated with an increase on Instagram (OR, 2.90; 95% CI, 1.72-4.88). Conclusions and Relevance: In this cross-sectional study, widespread violations were observed in online Canadian cannabis promotion. To protect public health and safety amid legalization, decision-makers should make explicit federal regulation and enforcement regarding promotional activities of cannabis retailers. These results suggest that policy and enforcement of cannabis promotion in Canada would have an international impact, from ease of access to online media and downstream consequences of unregulated promotion.