Moving beyond Technical Issues to Stakeholder Involvement: Key Areas for Consideration in the Development of Human-Centred and Trusted AI in Healthcare.

Discussion around the increasing use of AI in healthcare tends to focus on the technical aspects of the technology rather than the socio-technical issues associated with implementation. In this paper, we argue for the development of a sustained societal dialogue between stakeholders around the use of AI in healthcare. We contend that a more human-centred approach to AI implementation in healthcare is needed which is inclusive of the views of a range of stakeholders. We identify four key areas to support stakeholder involvement that would enhance the development, implementation, and evaluation of AI in healthcare leading to greater levels of trust. These are as follows: (1) aligning AI development practices with social values, (2) appropriate and proportionate involvement of stakeholders, (3) understanding the importance of building trust in AI, (4) embedding stakeholder-driven governance to support these activities.

Adherence and discontinuation of prescription cannabidiol for the management of seizure disorders at an integrated care center.

OBJECTIVE: Evaluate adherence, discontinuation rates, and reasons for non-adherence and discontinuation of prescription CBD during the 12-months post-initiation period at an integrated care center. METHODS: This was a prospective study of patients prescribed CBD by a neurology clinic provider with initial prescription fulfillment through the center's specialty pharmacy from January 2019 through April 2020. Baseline demographics and reasons for non-adherence and/or discontinuation were collected from the electronic health record and pharmacy claims history was used to calculate adherence using proportion of days covered (PDC). Patients were included in the PDC analysis if they had at least 3 fills during the study period. Non-adherence was defined as a PDC < 0.8. Descriptive statistics were used to summarize data with categorical variables represented as frequencies and percentages and continuous variables as medians and interquartile ranges (IQRs). RESULTS: We included 136 patients with a median age of 14 years (IQR 9 - 21). Most patients were white (n = 115, 85%), with a diagnosis of intractable epilepsy (n = 100, 74%). Among the 128 patients with 3 or more fills, the median PDC was 0.99 (IQR 0.95 - 1.00) with non-adherence seen in 6% (n = 8) of patients. The most common reason for non-adherence was side effects (n = 2, 25%). Prescription CBD was discontinued by 23% (n = 31) of patients with a median time to discontinuation of 117 days (IQR 68 - 216). The most common reason for discontinuation was major side effects (n = 12, 39%). The most common side effects leading to discontinuation were agitation/irritability (n = 4), mood changes (n = 4), aggressive behavior (n = 3), and increased seizure frequency (n = 3). CONCLUSION: Adherence to prescription CBD at an integrated care center was high with approximately 94% of patients considered adherent. Providers and pharmacists may improve adherence and discontinuation rates by educating patients on the timeline of response, potential side effects, and potential for dose adjustments.

Public Preferences for Digital Health Data Sharing: Discrete Choice Experiment Study in 12 European Countries.

BACKGROUND: With new technologies, health data can be collected in a variety of different clinical, research, and public health contexts, and then can be used for a range of new purposes. Establishing the public's views about digital health data sharing is essential for policy makers to develop effective harmonization initiatives for digital health data governance at the European level. OBJECTIVE: This study investigated public preferences for digital health data sharing. METHODS: A discrete choice experiment survey was administered to a sample of European residents in 12 European countries (Austria, Denmark, France, Germany, Iceland, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the United Kingdom) from August 2020 to August 2021. Respondents answered whether hypothetical situations of data sharing were acceptable for them. Each hypothetical scenario was defined by 5 attributes ("data collector," "data user," "reason for data use," "information on data sharing and consent," and "availability of review process"), which had 3 to 4 attribute levels each. A latent class model was run across the whole data set and separately for different European regions (Northern, Central, and Southern Europe). Attribute relative importance was calculated for each latent class's pooled and regional data sets. RESULTS: A total of 5015 completed surveys were analyzed. In general, the most important attribute for respondents was the availability of information and consent during health data sharing. In the latent class model, 4 classes of preference patterns were identified. While respondents in 2 classes strongly expressed their preferences for data sharing with opposing positions, respondents in the other 2 classes preferred not to share their data, but attribute levels of the situation could have had an impact on their preferences. Respondents generally found the following to be the most acceptable: a national authority or academic research project as the data user; being informed and asked to consent; and a review process for data transfer and use, or transfer only. On the other hand, collection of their data by a technological company and data use for commercial communication were the least acceptable. There was preference heterogeneity across Europe and within European regions. CONCLUSIONS: This study showed the importance of transparency in data use and oversight of health-related data sharing for European respondents. Regional and intraregional preference heterogeneity for "data collector," "data user," "reason," "type of consent," and "review" calls for governance solutions that would grant data subjects the ability to control their digital health data being shared within different contexts. These results suggest that the use of data without consent will demand weighty and exceptional reasons. An interactive and dynamic informed consent model combined with oversight mechanisms may be a solution for policy initiatives aiming to harmonize health data use across Europe.

Therapy outcomes associated with prescription cannabidiol use at 12 months post-initiation.

OBJECTIVE: This study evaluated prescription cannabidiol (CBD) outcomes during the first 12 months of therapy. METHODS: A single-center, prospective cohort study was performed including patients prescribed CBD from January 2019 - April 2020, excluding clinical trial patients and those using external specialty pharmacy services. The primary outcome wasepilepsy-related emergency healthcare service (EHS) use within 12 months of initation. Secondary outcomes included prescription CBD discontinuation rate and reason and concomitant anti-seizure medication (ASM) use. A multiple logistic regression model evaluated the odds of EHS use, adjusting for initial concomitant ASM count, age, and insurance type. RESULTS: The 136 patients included were 85% white, 50% female, and 68% pediatric. EHS utilization occurred in 37% (n = 50) of patients; 29 patients (21%, n = 20 pediatric, n = 9 adult) had at least one emergency department (ED) visit, 9 patients (7%) had two or more; 30 patients (22%, n = 22 pediatric, n = 8 adult) had at least one hospitalizaion. Median time to first ED and hospitalization was 69 (IQR 31-196) and 104 (IQR 38-179) days, respectively. Prescription CBD was discontinued in 31 patients (23%, n = 18 pediatric, n = 13 adult), due to major side effects (n = 12, 39%), common side effects (n = 11, 36%), and unsatisfactory response (n = 11, 36%). There was no significant change in concomitant ASM use. CONCLUSION: Despite potential benefits of prescription CBD, many patients utilize EHSs in the first 12 months of treatment with minimal changes in concomitant ASM use.

Insurance Approval Delay of Biologic Therapy Dose Escalation Associated with Disease Activity in Patients with Inflammatory Bowel Disease.

BACKGROUND: Dose escalation of self-injectable biologic therapy for inflammatory bowel diseases may be required to counteract loss of response and/or low drug levels. Payors often require completion of a prior authorization (PA), which is a complex approval pathway before providing coverage. If the initial PA request is denied, clinic staff must complete a time and resource-intensive process to obtain medication approval. AIMS: This study measured time from decision to dose escalate to insurance approval and evaluated impact of approval time on disease activity. METHODS: This was a single-center retrospective analysis of adult patients with IBD prescribed an escalated dose of biologic therapy at an academic center with an integrated specialty pharmacy team from January to December 2018. Outcomes included time to insurance approval and the association between approval time and follow-up C-reactive protein (CRP) and Short Inflammatory Bowel Disease Questionnaire (SIBDQ) scores. Associations were tested using linear regression analyses. RESULTS: 220 patients were included, median age 39, 53% female, and 96% white. Overall median time from decision to dose escalate to insurance approval was 7 days [interquartile range (IQR) 1, 14]. Approval time was delayed when an appeal was required [median of 29 days (IQR 17, 43)]. Patients with a longer time to insurance approval were less likely to have CRP improvement (p = 0.019). Time to insurance approval did not significantly impact follow-up SIBDQ scores. CONCLUSION: Patients who had a longer time to insurance approval were less likely to have improvement in CRP, highlighting the negative clinical impact of a complex dose escalation process.

Pharmacology and Therapeutic Potential of Benzothiazole Analogues for Cocaine Use Disorder.

Pharmacological targeting of the dopamine D4 receptor (D4R)─expressed in brain regions that control cognition, attention, and decision-making─could be useful for several neuropsychiatric disorders including substance use disorders (SUDs). This study focused on the synthesis and evaluation of a novel series of benzothiazole analogues designed to target D4R. We identified several compounds with high D4R binding affinity (Ki ≤ 6.9 nM) and >91-fold selectivity over other D2-like receptors (D2R, D3R) with diverse partial agonist and antagonist profiles. Novel analogue 16f is a potent low-efficacy D4R partial agonist, metabolically stable in rat and human liver microsomes, and has excellent brain penetration in rats (AUCbrain/plasma > 3). 16f (5-30 mg/kg, i.p.) dose-dependently decreased iv cocaine self-administration in rats, consistent with previous results produced by D4R-selective antagonists. Off-target antagonism of 5-HT2A or 5-HT2B may also contribute to these effects. Results with 16f support further efforts to target D4R in SUD treatment.

Multicenter Study of Nonadherence to Self-Injectable Biologic Therapy in Patients With Inflammatory Bowel Disease: Risk Factors and Outcomes.

Background and Aims: This study aimed to evaluate adherence to subcutaneous biologic therapy and impact of nonadherence including risk factors and outcomes in academic centers with integrated specialty pharmacies for patients with inflammatory bowel disease (IBD). Methods: This was a multicenter, retrospective cohort analysis of patients aged ≥18 years receiving care in 3 tertiary care outpatient IBD clinics with integrated specialty pharmacies. Subjects were prescribed injectable anti-TNF therapy (adalimumab, certolizumab, golimumab) or anti-IL 12/23 therapy (ustekinumab) with at least 3 consecutive prescription claims. The primary outcomes were medication possession ratio (MPR), percent achieving optimal adherence (MPR > 0.86); in addition, we sought to verify a prior risk factor model including smoking status, narcotic use, psychiatric history, and prior biologic use. Secondary outcomes included emergency department visits (ED) and IBD-related hospitalizations. Statistical analysis was performed using Wilcox rank sum test, Pearson's Chi-squared test, and logistic regression model as an unordered, factor variable to flexibly estimate the probabilities of adherence. Results: Six hundred eight subjects were included. Overall median MPR was 0.95 (interquartile range 0.47, 1) and adherence was 68%-70%. When the number of risk factors for nonadherence increased, the likelihood of nonadherence increased (P < .05). In unadjusted and adjusted analysis, nonadherence increased the likelihood of ED visits [rate ratio 1.45 (95% confidence interval 1.05, 1.97)] and hospitalizations [rate ratio 1.60 (95% confidence interval 1.16, 2.10)]. Conclusion: Academic centers with integrated pharmacies had high adherence. Prior risk factors for nonadherence remained significant in this multicenter model. Nonadherence was associated with higher likelihood of hospitalizations and ED visits.

Specialty pharmacy integration and the role of an advanced certified pharmacy technician in prescription cannabidiol access.

BACKGROUND: Insurance requirements that limit access to prescription cannabidiol (CBD), an adjunct therapy for uncontrolled seizure disorders, may lead to treatment initiation delays. Integrated health-system specialty pharmacies (IHSSPs) use pharmacists and advance certified pharmacy technicians (CPhTs) to help navigate prescription CBD access requirements. OBJECTIVE(S): Evaluate time from initial specialty pharmacy referral to prescription CBD shipment. METHODS: This was a single-center, retrospective analysis of patients prescribed CBD from January 2019 to April 2020 by the outpatient neurology clinic and dispensed by the center's IHSSP. The primary outcome was the time to prescription CBD access, defined as days between the specialty pharmacy completing an initial patient assessment and first medication shipment. Secondary outcomes were percentage of patients requiring financial assistance and days between key steps in the access pathway. Data were collected from electronic health records and the specialty pharmacy patient management database. The CPhT was responsible for completing most portions of the access pathway under supervision of the clinical pharmacist. RESULTS: After screening, 136 patients were included: 50% male, 85% white, 60% insured by Medicaid, and median age 14 years (interquartile range [IQR] 9-21). The most common indication was Lennox-Gastaut syndrome (n = 117, 86%). Of the 129 patients (95%) who required a prior authorization (PA), 92% were approved (n = 119). Median time from initial assessment to first shipment was 7 days (IQR 4-13). Of patients for whom the CPhT helped obtain financial assistance (n = 14, 10%), all had $0 costs after assistance. Median times for secondary outcomes led by the CPhT in days were as follows: initial assessment completion to benefits investigation (BI) = 0 (IQR 0-0), BI to PA submission = 0 (IQR 0-0), and PA denial to appeal submission = 4 (IQR 1-7). CONCLUSION: IHSSP teams, particularly advanced CPhT roles, helped patients afford and initiate prescription CBD quickly.

Exploring healthcare providers' experiences with specialty medication and limited distribution networks.

Integrated health-system specialty pharmacies (IHSSP) have shown high medication access, adherence, and provider satisfaction. The goal of this study was to explore healthcare providers' experiences with specialty medications distributed via Limited Distribution Networks (LDN) that do not include IHSSPs. We investigated healthcare providers' perceived impact of LDNs on clinic workflow, clinical practice, and patient outcomes. Interviews and focus groups were conducted with fourteen healthcare providers from four outpatient specialty clinics at an academic health system with an IHSSP. Qualitative analysis using an iterative inductive/deductive approach of coded transcripts was used to identify themes. Participants discussed requirements and barriers to communicating with insurance providers, drug manufacturers, and external pharmacies; time and effort required to navigate LDNs and impact on workload and clinic workflow; financial awareness of medication costs and methods for communication about financial information with patients; and advocating for patients to ensure access to necessary therapy and avoid missed doses or treatment lapse. Participants reported barriers to navigating LDNs that can interfere with clinic workflow and patient care. IHSSPs may reduce clinic burden by helping patients access, afford, and remain on therapy.

Cancer multidisciplinary team meetings: impact of logistical challenges on communication and decision-making.

BACKGROUND: Multidisciplinary teams (MDTs) are widely used in cancer care. Recent research points to logistical challenges impeding MDT decision-making and dissatisfaction among members. This study sought to identify different types of logistical issues and how they impacted team processes. METHODS: This was a secondary analysis of a cross-sectional observational study. Three cancer MDTs (breast, colorectal, and gynaecological) were recruited from UK hospitals. Validated observational instruments were used to measure decision-making (Metrics of Observational Decision-making, MDT-MODe), communication (Bales' Interaction Process Analysis, Bales' IPA), and case complexity (Measure of Case Discussion Complexity, MeDiC), including logistical challenges (Measure of Case Discussion Complexity, MeDiC), across 822 case discussions from 30 videoed meetings. Descriptive analysis and paired samples t tests were used to identify and compare frequency of different types of logistical challenges, along with partial correlations, controlling for clinical complexity of cases, to understand how such issues related to the MDT decision-making and communication. RESULTS: A significantly higher frequency of administrative and process issues (affecting 30 per cent of cases) was seen compared with the frequency of equipment issues (affecting 5 per cent of cases; P < 0.001) and the frequency of the attendance issues (affecting 16 per cent of cases; P < 0.001). The frequency of the attendance issues was significantly higher than the frequency of equipment issues (P < 0.001). Partial correlation analysis revealed that administrative and process issues, including attendance, were negatively correlated with quality of information (r = -0.15, P < 0.001; r = -0.11, P < 0.001), and equipment issues with the quality of contribution to meeting discussion (r = -0.14, P < 0.001). More questioning and answering by MDT members was evident with the administrative and process issues (r = 0.21, P < 0.001; r = 0.19, P < 0.001). Some differences were observed in teams' socioemotional reactions to the administrative and process issues with the gynaecological MDT showing positive correlation with positive socioemotional reactions (r = 0.20, P < 0.001), and the breast cancer MDT with negative socioemotional reactions (r = 0.17, P < 0.001). CONCLUSION: Administrative and process issues were the most frequent logistical challenges for the studied teams. Where diagnostic results were unavailable, and inadequate patient details provided, the quality of decision-making was reduced.

Droxidopa management by an integrated health-system specialty pharmacy team.

BACKGROUND: Droxidopa, indicated for the treatment of symptomatic neurogenic orthostatic hypotension, can be challenging for patients to access owing to manufacturer and payer restrictions, and requires close monitoring to ensure safety and effectiveness. OBJECTIVE: This practice report describes the development and outcomes of an integrated neurology specialty pharmacy team for droxidopa management. PRACTICE DESCRIPTION: An integrated health-system specialty pharmacy (HSSP) connected to an academic institution with integrated specialty pharmacists working in collaboration with the providers in both the neurology and autonomic disfunction clinic. PRACTICE INNOVATION: In May 2017, the integrated HSSP developed droxidopa management services. Based on clinic-identified needs, the specialty pharmacy team completed droxidopa access requirements (insurance approval and affordability), provided comprehensive medication education at droxidopa initiation, and developed and executed droxidopa titration and monitoring plans in collaboration with providers. While patients were on droxidopa therapy, specialty pharmacist staff (pharmacists and technicians) monitored patients for safety and response to therapy and communicated with the health care team through the shared electronic health record. EVALUATION METHODS: We performed a retrospective cohort analysis of adult patients with at least 3 fills of droxidopa using the integrated specialty pharmacy services from May 2017 to April 2020. Outcomes included persistence (defined as lack of 60-day gap in treatment), adherence (calculated using pharmacy claims and proportion of days covered [PDC]), and number and type of pharmacist interventions after droxidopa initiation. RESULTS: Of the 83 patients reviewed, 60 patients (72%) were persistent on droxidopa therapy over the study period. The median PDC was 0.98 (interquartile range 0.90-1.00). Over 36 months, the specialty pharmacist performed 60 interventions after droxidopa initiation, most related to dose changes, drug-drug interaction management, and medication reconciliation. CONCLUSION: The development of integrated specialty pharmacy services for patients prescribed droxidopa resulted in high droxidopa persistence and adherence. Interventions from the specialty pharmacist ensured droxidopa remained safe and appropriate for patients.

Prescription cannabidiol for seizure disorder management: Initial drug-drug interaction management by specialty pharmacists.

PURPOSE: To describe the presence, type, and management of drug-drug interactions (DDIs) at prescription cannabidiol (CBD) therapy initiation. METHODS: We conducted a single-center, retrospective study of patients prescribed CBD from a medical center's neurology clinic for seizure management from January 2019 through April 2020. Patients were excluded if they were enrolled in a CBD clinical trial or the insurance approval or medication fulfillment process was not completed by the center's specialty pharmacy. The primary outcomes were the numbers, types, and management of DDIs identified at the time of CBD prescribing. RESULTS: Of the 136 patients included, 109 (80%) had a DDI identified at baseline. Of the 260 DDIs, 71% (n = 184) were pharmacodynamic and 29% (n = 76) were pharmacokinetic in nature. Management of the 260 DDIs detected included counseling only (89% [n = 232 interactions]), discontinuation of the interacting agent [9% (n = 22 interactions]), and dosage change for the interacting agent [2% (n = 6 interactions]). Clobazam was the most commonly identified interacting medication (n = 63, 24%), while valproic acid accounted for 10% (n = 26) of the DDIs. The population was predominantly white (n = 115, 85%), 18 years of age or younger (n = 92, 68%), and had an indication for prescription CBD treatment of Lennox-Gastaut syndrome (n = 117, 86%). CONCLUSION: This study provides new information on the role that integrated specialty pharmacists can play in identifying and managing initial DDIs in patients starting prescription CBD.

A cross-sectional analysis of persistence to disease-modifying therapies in treatment naïve and experienced patients with relapsing multiple sclerosis at a health-system specialty pharmacy.

BACKGROUND: Patients with relapsing multiple sclerosis (RMS) are maintained on disease-modifying therapy (DMT) to prevent disease progression. Reported persistence rates to DMTs are varied and concerningly low. Limited data exists on long-term persistence rates and reasons for DMT discontinuation in patients with RMS. This study evaluated long-term DMT persistence, rates and reasons for DMT discontinuation or switch, specialty pharmacist involvement in DMT treatment transitions, and predictors associated with non-persistence in treatment naïve and experienced patients. METHODS: We performed a single-center retrospective, cross-sectional review of patients with RMS and ≥3 fills of DMT from a health-system specialty pharmacy (May-October 2017). Patients were followed for 3 years to determine DMT persistence, defined as the time a patient remained on index DMT. Descriptive statistics were used to summarize sample characteristics and outcomes. The Kaplan-Meier estimation method was used to estimate the probability of remaining persistent and we used the Cox proportional hazards regression model to analyze the primary outcome. Rates and reasons for DMT discontinuation were identified via pharmacy claims and confirmed via chart review of the electronic health record. RESULTS: The study included 540 patients, of which 41 (7.6%) were treatment naïve. Over 3 years, 193 (36%) patients remained on index DMT. The probability of remaining persistent for 3 years was 0.51 (95% confidence interval [CI] 0.47-0.56) and median time on index DMT was 642 days (interquartile range 317-1096). For the 347 patients that did not continue index DMT: 91 (26%) discontinued, 136 (39%) switched to a new DMT, 92 (27%) transferred care to a new specialty pharmacy or provider, 21 (6%) were lost to follow-up, and 7 (2%) died. Common reasons for DMT discontinuation or switch were insurance formulary change, side effects, clinical decline, and stable disease. Specialty pharmacists initiated 6 (7%) DMT discontinuations and 49 (36%) DMT switches. A strong non-linear relationship existed between age and risk of non-persistence (p = 0.003). Patients on an injectable index DMT were 1.5 times more likely to be non-persistent than those on an oral DMT (95% CI 1.1-2.1, p = 0.012) and patients with non-commercial insurance were 1.4 times more likely to be non-persistent (95% CI 1.02-2.0, p = 0.040). CONCLUSIONS: Long-term persistence to DMTs is low, with many patients switching or discontinuing DMT treatment. Specialty pharmacists identify the need for DMT discontinuation or switch and are uniquely positioned to assist during therapy transitions.

Primary medication nonadherence to oral oncology specialty medications.

BACKGROUND: Patients prescribed specialty oncology medications face logistical and financial challenges to medication procurement, leading to primary medication nonadherence (PMN). Limited research has evaluated rates and reasons for PMN within a specialty oncology population. Addressing PMN is essential to ensuring patient access and uptake and realizing benefits of these therapies. OBJECTIVES: The objectives of this study were to compute the rates of and reasons for PMN in patients prescribed oral oncology medications at an integrated health-system specialty pharmacy (IHSSP). METHODS: We performed a single-center, retrospective analysis of specialty oncology prescriptions electronically prescribed between January and December 2018. Data were extracted from electronic health record (EHR) and pharmacy claims databases. Prescriptions were PMN eligible if none of the following were met: fill of any cancer medication within the previous 180-day lookback window, duplicate prescription, cancellation within 30 days, rerouting to an external pharmacy within 30 days of prescribing, filled through alternate method, or nononcology or hematology condition. PMN was calculated by dividing eligible prescriptions unfilled during the study period by all eligible prescriptions. Reasons for a lack of prescription fulfillment were assessed via EHR review. Data were analyzed using descriptive statistics. RESULTS: We evaluated 4482 prescriptions from 1422 patients, resulting in 861 PMN-eligible prescriptions. Most PMN-eligible prescriptions (n = 668, 78%) were filled within 30 days, leaving 193 prescriptions as potential instances of PMN. After EHR review, 158 prescriptions met the exclusion criteria, resulting in a PMN rate of 4%. Of PMN prescriptions (n = 35), most were caused by clinical reasons (n = 22, 63%); however, 10 prescriptions were unfilled owing to patient decision, 2 owing to unaffordable treatment, and 1 owing to inability to reach the patient. Patients with PMN had a median age of 72 years and were mostly male (60%), with a median Charlson comorbidity index score of 7. CONCLUSION: Low rates of PMN to prescribed anticancer medications were found among electronic prescriptions intended to be filled at an IHSSP.

Primary medication nonadherence calculation method specifications impact resulting rates.

BACKGROUND: Previous literature has illustrated a wide range of primary medication nonadherence (PMN) rates due to inconsistent calculation methods and parameters, but the impact of parameter specifications on PMN rates has not been assessed. OBJECTIVES: The objective of this study was to evaluate the impact of lookback window (LBW), duplicate window (DW), and fill window (FW) specifications on PMN rates in patients prescribed specialty self-administered oncology medications. METHODS: This was a single-center, retrospective cohort analysis. Patients receiving a new electronic specialty oncology prescription January-December 2018 were included; excluded if re-routed to an external pharmacy within 2 days, fell within a DW, or cancelled within a FW. Twenty-four methods were used to calculate PMN based on combinations of the following parameters: (i) absence of prior specialty self-administered oncology medication fill within LBW (90, 180 days); (ii) absence of a duplicate prescription within DW (2, 7, 30 days); and (iii) sold status within FW (14, 30, 60, 90 days). For each method, PMN was calculated as the number of unsold prescriptions within the FW divided by all eligible prescriptions. RESULTS: We evaluated 4,482 prescriptions, resulting in PMN ranging from 16% to 23%. Patients were commonly male (53%) and white (83%), with a median age of 64 years (interquartile range, IQR, 54, 72). Increasing the LBW from 90 to 180 days resulted in exclusion of 72 (2%) prescriptions and minimally impacted PMN rates. Most duplicate prescriptions (87%) occurred within two days of original prescription and PMN rates were minimally affected by DW. Most fulfilled prescriptions were filled within FW 30 days, 98% with a method of LBW 180, DW 2, and FW 30. Adjusting the FW consistently impacted PMN rates. CONCLUSIONS: Because various PMN definitions can significantly impact results, a thorough explanation of all parameter specifications should be reported in research using PMN.

Specialty pharmacist integration into an outpatient neurology clinic improves pimavanserin access.

INTRODUCTION: Access to pimavanserin, the only Parkinson disease-related psychosis treatment approved by the FDA, is restricted by insurance requirements, a limited distribution network, and high costs. Following initiation, patients require monitoring for safety and effectiveness. The primary objective of this study was to evaluate impact of specialty pharmacist (SP) integration on time to insurance approval. Additionally, we describe a pharmacist-led monitoring program. METHODS: This was a single-center, retrospective study of adults prescribed pimavanserin by the neurology clinic from June 2016 to June 2018. Patients receiving pimavanserin externally or through clinical trials were excluded. Pre- (June 2016 to December 2016) and post-SP integration (January 2017 to June 2018) periods were assessed. Proportional odds logistic regression was performed to test association of approval time with patient characteristics (age, gender, insurance type) postintegration. Interventions were categorized as clinical care, care coordination, management of adverse event, or adherence. RESULTS: We included 94 patients (32 preintegration, 62 postintegration), 80% male (n = 75) and 96% white (n = 90) with a mean age of 73 years. Median time to approval was 22 days preintegration and 3 days postintegration. Higher rates of approval (81% vs 95%) and initiation (78% vs 94%) were observed postintegration. Proportional odds logistic regression suggested patients with commercial insurance were likely to have longer time to approval compared with patients with Medicare/Medicaid (odds ratio 7.1; 95% confidence interval: 1.9, 26.7; P = .004). Most interventions were clinical (51%, n = 47) or care coordination (42%, n = 39). CONCLUSION: Median time to approval decreased postintegration. The SP performed valuable monitoring and interventions.

Development, implementation, and evaluation of a health outcomes and research program at an integrated health-system specialty pharmacy.

PURPOSE: Health-system specialty pharmacies (HSSPs) provide high-quality, efficient, and collaborative care to patients receiving specialty therapy. Despite proven benefits of the integrated model, manufacturer and payer restrictions challenge the viability and utility of HSSPs. Vanderbilt Specialty Pharmacy developed a health outcomes and research program to measure and communicate the value of this model, drive improvement in patient care delivery, and advocate for recognition of HSSP pharmacists' role in patient care. The purpose of this descriptive report is to describe the development and results of this program. SUMMARY: The health outcomes and research program began as an initiative for pharmacists to evaluate and convey the benefits they provide to patients, providers, and the health system. Early outcomes data proved useful in communicating the value of an integrated model to key stakeholders and highlighted the need to further develop research efforts. The department leadership invested resources to build a research program with dedicated personnel, engaged research experts to train pharmacists, and fostered internal and external collaborations to facilitate research efforts. As of March 2021, the health outcomes and research program team has published 33 peer-reviewed manuscripts, presented 88 posters and 7 podium presentations at national conferences, and received 4 monetary research awards. Further, the program team engages other HSSP teams to initiate and expand their own health outcomes research in an effort to empower all HSSPs in demonstrating their value. CONCLUSIONS: The health outcomes and research program described has pioneered outcomes research among HSSPs nationwide and has proven valuable to specialty pharmacists, the health system, and key specialty pharmacy stakeholders.

Tofacitinib Adherence and Outcomes in Refractory Inflammatory Bowel Disease.

Background: Tofacitinib has been approved for moderate-to-severe ulcerative colitis and studied in Crohn's disease. Understanding medication adherence to oral medications in severe disease is essential. Methods: We retrospectively reviewed adherence and real-world outcomes of inflammatory bowel disease patients who initiated tofacitinib at a single care center. Adherence was measured by proportion of days covered. Results: Sixty-three patients were identified. All patients failed at least one prior biologic therapy. Mean proportion of days covered was 95.7% for ulcerative colitis and 93.1% for Crohn's disease. Significant clinical and endoscopic response was seen. Conclusion: Adherence was high in a cohort with highly refractory disease.

Preferences of the Public for Sharing Health Data: Discrete Choice Experiment.

BACKGROUND: Digital technological development in the last 20 years has led to significant growth in digital collection, use, and sharing of health data. To maintain public trust in the digital society and to enable acceptable policy-making in the future, it is important to investigate people's preferences for sharing digital health data. OBJECTIVE: The aim of this study is to elicit the preferences of the public in different Northern European countries (the United Kingdom, Norway, Iceland, and Sweden) for sharing health information in different contexts. METHODS: Respondents in this discrete choice experiment completed several choice tasks, in which they were asked if data sharing in the described hypothetical situation was acceptable to them. Latent class logistic regression models were used to determine attribute-level estimates and heterogeneity in preferences. We calculated the relative importance of the attributes and the predicted acceptability for different contexts in which the data were shared from the estimates. RESULTS: In the final analysis, we used 37.83% (1967/5199) questionnaires. All attributes influenced the respondents' willingness to share health information (P<.001). The most important attribute was whether the respondents were informed about their data being shared. The possibility of opting out from sharing data was preferred over the opportunity to consent (opt-in). Four classes were identified in the latent class model, and the average probabilities of belonging were 27% for class 1, 32% for class 2, 23% for class 3, and 18% for class 4. The uptake probability varied between 14% and 85%, depending on the least to most preferred combination of levels. CONCLUSIONS: Respondents from different countries have different preferences for sharing their health data regarding the value of a review process and the reason for their new use. Offering respondents information about the use of their data and the possibility to opt out is the most preferred governance mechanism.

Patient Safety Education 20 Years After the Institute of Medicine Report: Results From a Cross-sectional National Survey.

OBJECTIVES: Educating healthcare professionals in patient safety is essential to achieving sustainable improvements in care. This study aimed to identify the key constituents of patient safety education alongside its facilitators and barriers from a frontline perspective. METHODS: An electronic survey was sent to 592 healthcare professionals and educators in patient safety education in the United Kingdom. Two independent reviewers conducted a thematic analysis of the free-text data. Themes focused on effective content, learning practices and facilitators and barriers to patient safety education. RESULTS: Of 592 individuals completing the survey, 545 (92%) submitted analyzable responses. Interrater reliability of coding was high with Cohen k value of 0.86. Participants endorsed experiential and interactive learning as ideal modalities for delivery and expressed a need for content to be based on real clinical cases and tailored to the needs of the learners. The most commonly mentioned facilitators were standardization of methods and assessment (49%), dedicated funding (21%), and culture of openness (20%). Staffing problems and high workload (41%) and lack of accessibility of training (23%) were identified as primary barriers of efficacy and uptake. CONCLUSIONS: This study identified key factors to the success of patient safety education in terms of content and delivery alongside facilitators and barriers. Future curricula developers and interventions should improve standardization, funding, culture, and access so as to optimize education programs to enhance patient safety.