Medical Form Research Articles

An Access-Focused Patient-Centric Value Assessment Framework for Medication Formulary Decision-Making in Immune-Mediated Inflammatory Diseases.

The healthcare system in the United States (US) is complex and often fragmented across national and regional health plans which exhibit substantial variability in benefit design and formulary policies for accessing medications. We propose an access-focused value assessment framework for formulary decision-making for medications to manage immune-mediated inflammatory diseases (IMIDs), where patients are at the center of this framework. Formulary decision-making for IMID medications can be a challenging, even daunting, task with continuously evolving and enhanced treat-to-target goals. Given the complexity of the US healthcare system, patients and their caregivers need assurance from formulary decision-makers that rapid, predictable, and sustained access to both well-established treatments and innovative therapies will be a priority, with a particular emphasis on continuity of effective care. This access-focused patient-centric (APAC) value assessment approach encompasses three "value components"-higher therapeutic goals, better health-related quality of life, and improved work productivity-the monetization of which can be derived using data from clinical trials when real-world data are yet to become available. Measures and assessment approaches are outlined to serve as a pragmatic tool for decision-makers in the US to ensure timely delivery and sustained access of clinically indicated therapies aimed to improve patient outcomes, enhance equity, and increase efficiency.

Disease-modifying therapies as positive predictors of quality of life for Sudanese patients with multiple sclerosis: a cross-sectional study

BackgroundMultiple sclerosis (MS) is an immune-mediated, neurodegenerative disease with devastating, disabling, and negative impacts on the patients’ quality of life (QoL). Although MS was not known in Sudan, it seems to be rising in recent years. This is a cross-sectional, hospital-based study aimed at assessing the impact of MS medications on patients’ QoL in neurology clinics in Khartoum City. Sixty-four patients diagnosed with MS were recruited. SF-36 questionnaire was used to assess the patients’ QoL. Data were collected from patients’ records in addition to the hand-delivered questionnaire. Data were analyzed using ANOVA test and logistic regression; p ≤ 0.05 was considered statistically significant.ResultsThe majority of patients were females from north Sudan (92.2%). The mean age was 28.2 ± 6.5. Relapsing–remitting was the most diagnosed MS type (65.6%). Fatigue and urinary incontinence were the most observed symptoms. All patients had vitamin D deficiency (5–20 ng/ml). Disease-modifying therapies (DMTs) were prescribed to 37.5% of patients.The overall mean QoL was 53.9 ± 14.7 with fair physical and mental health (51.8 ± 19.2 and 57.0 ± 10.9, respectively). Patients on DMTs showed a significantly good QoL compared to azathioprine (p ≤ 0.01), corticosteroids (p ≤ 0.01.), and no medications (p ≤ 001). Azathioprine (OR = 0.12; p ≤ 0.05), corticosteroids (OR = 0.14; p ≤ 0.05) and no treatment (OR = 0.01; p ≤ 0.001) negatively affected MS patients’ QoL when compared to DMTs. Vitamin D supplementation was significantly (p ≤ 0.01) associated with good QoL.ConclusionsMS was prominent in young females’ descendants of Sudanese northern tribes. DMTs improve the devastating effect of MS on patients’ QoL, and vitamin D supplementation was significantly associated with good QoL of MS patients.

Evolving Utilization of Topical Budesonide Following Endoscopic Sinus Surgery.

Topical budesonide irrigations are frequently prescribed after endoscopic sinus surgery (ESS) to manage mucosal inflammation. However, this off-label indication may conflict with health insurance formularies. We sought to quantify the relative frequency of postoperative budesonide prescriptions to determine if this could be considered common practice after ESS. We extracted and analyzed postoperative prescription data for patients undergoing ESS from 2016 to 2022 within our health care system. Overall, among 8157 ESS patients, 15.9% and 22.1% received topical budesonide prescriptions within 30 or 180 days postoperatively, respectively. On a year-over-year basis, budesonide prescription frequency increased significantly over time, culminating at 20.3% and 24.9% in 2022. Conversely, postoperative oral corticosteroid (OCS) prescriptions showed a decreasing frequency over the same time period (P < .001). Our results show topical budesonide irrigations are increasingly frequently prescribed after ESS and may offset postoperative OCS requirements. This argues for coverage of topical budesonide as a formulary medication after ESS.

Institutional practices for charitable medication access for uninsured patients.

To identify the most frequently prescribed medications, the location where prescriptions were filled, and whether a voucher was utilized among patients enrolled in a charitable care program within an academic medicalcenter. This was a retrospective cohort study analyzing electronic health record and pharmacy dispensing information at a medical center's outpatient pharmacies. Patients included in this analysis were enrolled in a charitable care program and had at least 1 ambulatory encounter in a primary care clinic from March 1, 2019, to June 30, 2021. The study identified frequently prescribed medications, prescription payment methods, the overall cost of prescriptions if available, and the percentage of patients who filled their prescription at a medical center's outpatient pharmacies vs external outpatient pharmacies. Descriptive statistics were used to describe the results. This study included 511 patients, 87% of whom were Spanish speaking. A total of 8453 prescriptions were identified, and more than half of the prescriptions were sent to external outpatient pharmacies. The most common medications prescribed were for cardiovascular disease, diabetes, and pain treatment. Forty-seven percent of all prescriptions were sent to the medical center's outpatient pharmacies. The medical center's charitable care program covered the costs of 44% of the prescriptions sent to internal pharmacies, assisting 148 unique patients and incurring a cost of $111,052 for the medical center. Overall, this study was able to characterize patient demographics, historical costs related to charitable care coverage, and the utilization of health care services among this population. This information can be used to support the development and implementation of a charitable medication formulary, with the aims of improving quality of care for this population and reducing medical center costs.

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Background: Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. Methods: We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. Results: The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. Conclusion: Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.

Modeling the Effects of Formulary Exclusions: How Many Patients Could Be Affected by a Specific Exclusion?

Background: Medication formularies, initially designed to promote the use of cost-effective generic drugs, are now designed to maximize financial benefits for the pharmacy benefit management companies that negotiate purchase prices. In the second-largest pharmacy benefit management formulary that is publicly available, 55% of mandated substitutions are not for generic or biosimilar versions of the same active ingredient and/or formulation and may not be medically or financially beneficial to patients. Methods: We modeled the effect of excluding novel agents for atrial fibrillation/venous thromboembolism, migraine prevention, and psoriasis, which all would require substitution with a different active ingredient. Using population data, market share of the 2 largest US formularies, and 2021 prescription data, we calculated how many people could be affected by such exclusions. Using data from the published literature, we calculated how many of those individuals are likely to discontinue treatment and/or have adverse events due to a formulary exclusion. Results: The number of people likely to have adverse events due to the exclusion could be as high as 1 million for atrial fibrillation/venous thromboembolism, 900 000 for migraine prevention, and 500 000 for psoriasis. The numbers likely to discontinue treatment for their condition are as high as 924 000 for atrial fibrillation/venous thromboembolism, 646 000 for migraine, and 138 000 for psoriasis. Conclusion: Substitution with a nonequivalent treatment is common in formularies currently in use and is not without substantial consequences for hundreds of thousands of patients. Forced medication substitution results in costly increases in morbidity and mortality and should be part of the cost-benefit analysis of any formulary exclusion.

Exploring the complexities of drug formulation selection, storage, and shelf-life for exploration spaceflight.

Medications have been a part of space travel dating back to the Apollo missions. Currently, medical kits aboard the International Space Station (ISS) contain medications and supplies to treat a variety of possible medical events. As we prepare for more distant exploration missions to Mars and beyond, risk management planning for astronaut healthcare should include the assembly of a medication formulary that is comprehensive enough to prevent or treat anticipated medical events, remains safe and chemically stable, and retains sufficient potency to last for the duration of the mission. Emerging innovation and technologies in pharmaceutical development, delivery, quality maintenance, and validation offer promise for addressing these challenges. The present editorial will summarize the current state of knowledge regarding innovative formulary optimization strategies, pharmaceutical stability assessment techniques, and storage and packaging solutions that could enhance drug safety and efficacy for future exploration spaceflight missions.

Trends and site-level variation of novel cardiovascular medication utilization among patients admitted for heart failure or coronary artery disease in the US Veterans Affairs System: 2017-2021

We assessed trends in novel cardiovascular medication utilization in US Veterans Affairs (VA) for angiotensin receptor-neprilysin inhibitors (ARNI), sodium-glucose cotransporter-2 Inhibitors (SGLT2i), and glucagon-like peptide-1 receptor agonists (GLP-1 RA). We retrospectively identified cohorts from 114 VA hospitals with admission for prevalent 1) systolic heart failure (HF, N=82,375) or 2) coronary artery disease and diabetes (CAD+T2D, N=74,209). Site-level data for prevalent filled prescriptions were assessed at hospital admission, discharge, or within 6 months of discharge. Variability among sites was estimated with median odds ratios (mOR), and within-site Pearson correlations of utilization of each medication class were calculated. Site- and patient-level characteristics were compared by high-, mixed-, and low-utilizing sites. ARNI and SGTL2i use for HF increased from <5% to 20% and 21%, respectively, while SGTL2i or GLP-1 RA use for CAD+T2D increased from <5% to 30% from 2017 to 2021. Adjusted mOR and 95% confidence intervals for ARNI, SGTL2i for HF, and SGTL2i or GLP-1 RA for CAD+T2D were 1.73 (1.64-1.91), 1.72 (1.59-1.81), and 1.53 (1.45-1.62), respectively. Utilization of each medication class correlated poorly with use of other novel classes (Pearson <0.38 for all). Higher patient volume, number of beds, and hospital complexity correlated with high-utilizing sites. Utilization of novel medications has increased over time but remains suboptimal for US Veterans with HF and CAD+T2D, with substantial site-level heterogeneity despite a universal medication formulary and low out-of-pocket costs for patients. Future work should include further characterization of hospital- and clinician-level practice patterns to serve as targets to increase implementation.

Barriers to access to psychiatric medications in Missouri county jails.

Objectives of this study were to characterize barriers to receiving psychiatric medications for people who are incarcerated, to compare barriers before competency restoration to those after competency restoration, and to characterize psychiatric medication formularies. A survey of county jails in Missouri was completed between October 2021 and February 2022. Survey questions were answered by medical department personnel, nurses, or a person responsible for medication oversight. Formularies were requested. Of 97 jails contacted, 51 completed the survey (53%). Most jails allowed patients to supply their own medications and reported they were "often" or "always" able to continue home medications. Inability to provide home medications was frequently attributed to cost. Notably, only 57% of jails were able to provide long-acting injectable antipsychotics (LAIA), 22% charged a fee for administration of medications, and 31% would not adjust medication times based on food requirements. No major differences existed precompetency and postcompetency for any question. Jail policies varied; thus, medication access for patients should be approached at the individual level. Potential areas to target to improve access are medication administration times, LAIA access, and removal of medication administration fees.

Advancing health equity through medication formulary policy.

Awareness of the presence and significance of disparities in American health outcomes is growing. Equitable access to appropriate medication-pharmacoequity-is foundational to equitable health care, with medication formularies representing a key determinant of medication access. Critical formulary design elements include clinical criteria, prescription processes, and patient access policies. Facets of each can be refined to ensure more equitable access to medications, including avoidance of prior authorization requirements, awareness of the complex determinants of human behavior, streamlined authorization processes, and optimized costs and convenience for patients. Optimizing these factors for proven treatments of conditions disproportionately borne by vulnerable communities is especially critical in the pursuit of equitable access. For policy makers at payer and pharmacy benefit manager organizations to successfully pursue corresponding changes in formulary policy, it is critical that teams educate leadership regarding the importance of policy change, invest in comprehensive patient data, and engage community members in their efforts.

169-OR: SGLT2 Inhibitor Prescribing Discrepancies in Patients with Diabetes Mellitus Type 2 and Heart Failure at an Academic Medical Center

With new indications for SGLT-2 inhibitors (SGLT2i) and efforts to minimize cardiovascular risk, there are concerns about equitable and timely distribution of SGLT2i. Inpatient initiation of SGLT2i is an important opportunity to optimize medical therapy. To better understand current prescribing practices, we compared patients started on a SGLT2i at time of discharge across two hospital sites in the 15 months after inclusion in the inpatient medication formulary. A retrospective chart review from February 2021 to May 2022 was performed of patients admitted to UC San Diego and discharged with a SGLT2i. Diagnosis was determined by ICD-10 code, and/or A1c during admission 6.5%. This cohort was compared to all patients admitted with an ICD-10 diagnosis of heart failure and/or DMT2. We examined patient demographics including age, gender, race/ethnicity, and differences between hospital sites (H1, H2). An SGLT2i was prescribed for 178 patients out of 1160 total admissions for CHF and 52,291 total admissions of individuals with DMT2. Of those who received an SGLT2i, 105 (58%) had diabetes, 151 (85%) had CHF and 82 (46%) had both. Between hospitals, 22% of patients with CHF at H1 v. 5% at H2 received an SGLT2i, and 0.22% of patients with diabetes at H1 and 0.17% at H2. The average age of those prescribed compared to the eligible population was 59 v. 64 for CHF and 60 v. 47 for DMT2. Women were less likely to be prescribed than men in both the heart failure (7% v. 16%) and DMT2 groups (0.1% v. 0.32%). The percentage of recipients (CHF, DMT2) by ethnicity was Asian (6, 0.08%), American Indian 0%, Black (7, 0.23%), Hispanic (19, 0.23%), Pacific Islander (26%, 0.81%), White 10, 0.17%). This analysis of SGLT2i initiation at hospital discharge indicates there are likely key differences in prescribing frequency between gender, ethnicities, and hospital sites. Continued collaboration amongst specialties and attention to implicit bias in prescribing practices is warranted. Disclosure J.Hansen: None. K.Kulasa: None. T.Santos cavaiola: Consultant; 9am Health.

Comparison of Sodium Zirconium Cyclosilicate to Sodium Polystyrene Sulfonate in the Inpatient Management of Acute Hyperkalemia

Background: Oral potassium binders have a role in the management of acute hyperkalemia among hospitalized patients. However, with therapeutic additions to this class, there is insufficient evidence between potassium binders to support a standard of care recommendation for use in this acute setting. Objective: The purpose of this study was to compare the acute potassium lowering effects of sodium zirconium cyclosilicate (SZC) and sodium polystyrene sulfonate (SPS). Methods: A retrospective review of admitted patients who received SZC or SPS was conducted after exemption from the Institutional Review Board. Patients with baseline potassium values less than 5.1 mmol/L or factors contributing to potentially false report of serum potassium were excluded. The primary outcome was the average change in potassium from baseline to 24 hours following potassium binder administration. Secondary outcomes compared changes to potassium from baseline to various time periods after administration, presence of electrolyte changes, and documentation of serious adverse events. Results: A total of 246 patients were included, with 128 receiving SZC and 118 receiving SPS. Mean change in serum potassium (mmol/L) at 24 hours was not significant between binders (−.78 vs −.91; P = .22). Secondary efficacy and safety outcomes were also similar between groups. A total of 5 serious adverse events were reported, occurring only in the SPS group. Conclusion: SZC and SPS have comparable effects in acute potassium reduction, with serious gastrointestinal adverse events documented only in SPS patients. Health systems may consider this data in determining medication formularies or during order set development.

More Than Meets the Eye: A Closer Look At Demyelinating Diseases In Zambia (P4-8.015)

<h3>Objective:</h3> Describe demographic and clinical characteristics of Zambian adults with MS and neuromyelitis optica (NMO). <h3>Background:</h3> MS and other demyelinating diseases are reportedly rare in sub-Saharan Africa and remain understudied. <h3>Design/Methods:</h3> Adults diagnosed with either MS, NMO, NMO spectrum disorder (NMOSD), or clinically isolated syndrome (CIS) at the only neurology outpatient clinic in Zambia were eligible to participate from October 2019 to February 2022. An MS-trained nurse administered structured questionnaires regarding sociodemographic characteristics, and each participant also underwent a comprehensive neurological history and examination by a neurologist. Finally, plasma 25-hydroxyvitamin D levels were obtained. For analysis, the cohort was dichotimized into a MS/CIS disease group and NMO/NMOSD disease group. Descriptive statistics of the cohort are presented and compared between both groups. <h3>Results:</h3> Amongst the 34 participants, mean age was 36 + 9 years, 65% (n=22) were female, 90% were Black-African, 10% were of Southeast Asian decent, 50% had MS/CIS, and 50% had NMO/NMOSD. The average age was 34 + 11 years in the MS/CIS group and 37 + 7 years in the NMO/NMOSD group (p=0.28). Females constituted 65% (n=11) of both disease groups. Median time to diagnosis was 242 days (interquartile range IQR: 91–974) and did not differ significantly between the groups. The majority (82%) of the NMO/NMOSD group presented with bilateral optic neuritis. Among the MS/CIS group, median EDSS was 4 (IQR: 2.25–4.25), median Disease Steps were 2 (IQR: 1–2), and 59% (n=10) had an abnormal gait at enrollment. Median 25-hydroxyvitamin D level was 29 (IQR: 24–46) ng/mL in the overall cohort but did not differ by disease group or supplementation status. <h3>Conclusions:</h3> In this sub-Saharan African cohort of adults with demyelinating diseases, MS and NMO were equally prevalent. Delays in diagnosis resulted in high levels of disability in both groups. <b>Disclosure:</b> Dr. Mortel has nothing to disclose. Dr. Braun has received research support from Zambart. Dr. Chishimba has nothing to disclose. Dr. Chomba has nothing to disclose. Dr. Mutete has nothing to disclose. NALUCA MWENDAWELI has nothing to disclose. Dr. Namangala has nothing to disclose. Dr. Zimba has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

MOG Antibody-Associated Bilateral Optic Neuritis Associated with Johnson and Johnson COVID-19 Vaccination (P12-3.009)

<h3>Objective:</h3> To describe a case of bilateral optic neuritis associated with MOG Antibodies following vaccination with Johnson and Johnson (J&amp;J) COVID-19 vaccine. <h3>Background:</h3> Cases of MOG Antibody Disease (MOGAD) following infection or vaccination have been reported, including in association with both COVID-19 infection and vaccination. However, no cases have been reported in Africa, associated with the J&amp;J vaccine or presenting with bilateral optic neuritis. <h3>Design/Methods:</h3> NA <h3>Results:</h3> A 37-year-old Zambian woman presented two weeks after vaccination with the J &amp; J COVID-19 vaccine with progressive vision loss and headache associated with eye movement. Loss of color vision developed a week later and progressed over four days to complete blindness. On examination, she had no light perception in both eyes, dilated pupils with sluggish light reflex, and bilateral papilledema. The remainder of her examination was normal. Baseline investigations were unremarkable, and MRI and MRV of the brain were normal. Orbital MRI was not available in our setting. OCT showed bilateral thickening of the retinal nerve fiber layer with nasal depression of the macular ganglion cell inner plexiform layer. Serum aquaporin-4 antibodies were negative, and serum MOG antibodies were positive. The patient received a 5-day course of pulse-dose steroids followed by 1mg/kg oral prednisolone tapered over 8 weeks. She experienced full recovery of her visual acuity within 10 days of pulse-dose steroids and remained relapse free for six months. <h3>Conclusions:</h3> This case of MOG-antibody associated bilateral optic neuritis triggered by J&amp;J COVID-19 vaccine in a Zambian woman is unique in that the diagnosis was made in a resource limited setting, necessitating a high index of suspicion, reliance on clinical skills and highly targeted testing. This case further highlights the need for surveillance for similar cases and it adds literature of cases of MOGAD associated with various COVID-19 vaccines. <b>Disclosure:</b> Dr. Mutete has nothing to disclose. NALUCA MWENDAWELI has nothing to disclose. Dr. Asukile has nothing to disclose. Dr. Serenje has received research support from Orbis International. Willard Mumbi has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Multiple Sclerosis Research Across the African Continent: A Systematic Review (P5-3.002)

<h3>Objective:</h3> To summarize the contemporary state of MS research across the African continent and to identify knowledge gaps from the current research landscape. <h3>Background:</h3> MS remains considered a rare neurological disorder among African populations, despite the fact that original MS research based in African countries is extremely limited or non-existent. <h3>Design/Methods:</h3> Boolean searches on the PubMed, SCOPUS and Embase databases were conducted for articles published from 1990 to February 2022. Two reviewers evaluated the title and abstract of each identified record for inclusion based on pre-defined eligibility criteria. Discrepancies between reviewers were resolved by discussion until consensus was reached. Full-text review and data extraction were conducted by a single reviewer for all articles which passed the initial title and abstract screening process. <h3>Results:</h3> After removal of duplicates, 2491 records were initially identified and underwent screening. 332 records were then selected for full-text review and 251 were deemed eligible for inclusion. The majority of included studies were from the Northern African region (<i>n</i>=204; 81%), particularly from Egypt (<i>n</i>=166; 66%), and had a case-control study design (<i>n</i>=145; 58%). Studies based in Egypt, Tunisia and South Africa accounted for ≥90% of included studies. Over 50% (<i>n</i>=150) of selected studies were published from 2016–2022, highlighting the substantial increase in research output in recent years. Studies investigating the utility of diagnostic tools (i.e. blood/serum biomarkers and neuroimaging technology) were most common (<i>n</i>=105; 42%), followed by studies investigating MS risk factors (<i>n</i>=41; 16%). <h3>Conclusions:</h3> The majority of MS research from the African continent comes from only a few countries with virtually no data from the majority of African countries. Notable gaps and barriers in our knowledge of the burden of MS in Africa remain, and further efforts to promote clinical and epidemiological MS research in sub-Saharan Africa are needed to improve our understanding of the burden of MS amongst African patients. <b>Disclosure:</b> Mr. Hwang has nothing to disclose. The institution of Dr. George has received research support from Biogen. Dr. Garcia-Dominguez has nothing to disclose. Dr. Salasky has nothing to disclose. The institution of Dr. Vishnevetsky has received research support from National MS Society. The institution of Dr. Vishnevetsky has received research support from NIH (NeuroNext). Dr. Miskin has nothing to disclose. Andy Tran has nothing to disclose. Dr. Chiluba has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Parkinsonism in a Zambian Man with an unusual occupational exposure (P3-4.002)

<h3>Objective:</h3> Describe a case of Manganism encountered in Zambia. <h3>Background:</h3> Manganism is a neurodegenerative syndrome due to manganese toxicity and its excessive accumulation in the brain. <h3>Design/Methods:</h3> Case presentation <h3>Results:</h3> A 37-year-old man presented with a four-month history of mild, intermittent headache and three-month history of chest pain, dry cough and symmetrical distal-predominant paresthesias. He developed progressive cognitive decline associated with slowness in talking, low volume speech and difficulty completing activities of daily living two months prior to presentation. He reported fever and night sweats. Past medical history was unremarkable. Social history only notable for working as a manganese smelter for the past eight years. Neurological exam revealed memory and language deficits with psychomotor slowing, subtle left upper motor neuron facial weakness, hypomimia, bradykinesia and had a hyperkinetic tongue and upper limb tremor with normal tone and power in all limbs. Deep tendon reflexes were normal, but frontal release signs and an applause sign were present. Small and large fiber length-dependent sensory loss was noted with a cock-walk gait. MRI brain with gadolinium showed non-enhancing symmetric T1 hyperintensities in the globus pallidum and midbrain with corresponding T2 hypointensities in the same areas. <h3>Conclusions:</h3> A diagnosis of Manganism was made based on clinical history, strong occupational exposures, and neurological examination and imaging findings. Blood manganese levels and other heavy metals could not be obtained due to unavailability of tests in our setting, although blood manganese levels are often normal when obtained in cases of Manganism. The cough, headache, chest pain and fever were ascribed to metal fume fever and improved after a three-month withdrawal of manganese exposure, though neurologic symptoms did not improve during this period. This case demonstrates the importance of thorough history (including social history), examination, and correlation with limited investigations in diagnosing even rare diseases in resource-limited settings. <b>Disclosure:</b> Dr. Munkombwe has nothing to disclose. Dr. Asukile has nothing to disclose. Dr. Schwab has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Evaluation of Three Cohorts of the First Neurology Postgraduate Training Program in Zambia (P4-8.001)

<h3>Objective:</h3> Identify strengths, areas for improvement and perceptions of a new neurology training program in Zambia. <h3>Background:</h3> The first Zambian neurology training program commenced in 2018. We report its first programmatic evaluation. <h3>Design/Methods:</h3> All current and former neurology trainees, internal medicine (IM) trainees who rotated with neurology in the past year, all IM faculty, and all international visiting providers from the past four years were sent electronic surveys. Neurology trainees and graduates, IM rotators, international faculty who had visited for at least three months, and one hospital administrator were invited to focus groups or semi-structured interviews. Participants were asked what they perceived as the “most significant change” at the hospital since program implementation. <h3>Results:</h3> 62/78 (80%) completed surveys, 17 contributed to focus groups and interviews. Neurology trainees noted protected didactic time, emphasis on bedside teaching, and one-on-one attending exposure were program strengths and requested more exposure to outpatient subspecialties and electrophysiology training. When asked about the “most significant change”, participants noted providers in other specialties across the hospital also seemed to be learning neurologic examination and diagnostic skills, leading to widely improved neurologic care. Additionally, they noted a stronger research emphasis among trainees, even those outside neurology. <h3>Conclusions:</h3> The Zambian neurology training program has created positive department-wide changes in teaching and research. Other training programs in resource-limited settings may benefit from prioritizing one-on-one bedside teaching and protected didactics. Similarly, trainees in resource-limited settings may benefit from the development of regional collaborations to provide better exposure to subspecialty clinical experiences and mentors that may be limited at single institutions. Our study employed a comprehensive, mixed-methods approach to program evaluation in this resource-limited setting that identified strengths and actionable solutions to areas for improvement. This program evaluation method could provide valuable insights in other training settings, regardless of available resources. <b>Disclosure:</b> Dr. DiBiase has nothing to disclose. Edford Sinkala has nothing to disclose. Dr. Jonathan has nothing to disclose. The institution of Sean Tackett has received research support from NIH. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Evaluating the Experience of Visiting International Providers on Local Neurology Trainees in a Resource-Limited Setting (P4-8.007)

<h3>Objective:</h3> Assess the impact of visiting international neurology attendings and trainees on local neurology trainees in Zambia. <h3>Background:</h3> Interest in global neurology is increasing among U.S. neurology residents. Global health electives improve clinical skills, commitment to underserved populations, and cost-effective decision-making practices among neurology trainees from high-income settings. However, existing literature focuses primarily on the experiences of Canadian and U.S. trainees, with formal research on the perspective of local neurology trainees lacking. <h3>Design/Methods:</h3> The Zambian neurology training program, which graduated its first class in 2018, frequently hosts visiting neurology attendings and residents from high-income settings. Current trainees and graduates of the program completed surveys and participated in focus groups to assess their experiences with visitors and the impact on their training. <h3>Results:</h3> 100% of current trainees (n=5) and program graduates (n=4) participated. All participants rated the experience of working with international visitors positively (56% rated 5/5 (most positive), 44% rated 4/5). Specific positive aspects included exposure to different teaching styles and clinical approaches, awareness of neurologic practice in different parts of the world, expertise in subspecialties less available locally, and expanded academic networking opportunities. Local trainees appreciated the clinical contribution to busy inpatient and outpatient services, the ability to compare themselves to an “international standard”, and the cultural exchange with visitors. Challenges of working with visitors included occasional discrepancies in expectations, prolonged patient encounters due to language barriers, incomplete understanding by visitors of cultural differences and resource limitations, and physical workspace constraints. <h3>Conclusions:</h3> Local trainees in Zambia reported an overall positive experience with visiting providers from high-income countries. Our results provide support for expanding global health electives and faculty opportunities in Zambia and, potentially, similar settings. Orientation sessions for visiting clinicians to review cultural differences, resource limitations, and training expectations may improve the experience for visitors and hosts alike. <b>Disclosure:</b> Dr. Salasky has nothing to disclose. Dr. DiBiase has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Patient Feedback for a Neurology Specialty Clinic with a “Provider Continuity” Model in Lusaka, Zambia (P4-8.012)

<h3>Objective:</h3> Assess patient satisfaction with the only neurology clinic in Zambia. <h3>Background:</h3> Zambia’s only outpatient neurology clinic operates two mornings weekly with approximately 50 patients seen each day on a first come-first served basis. In 2018, neurology residents were incorporated as providers within the clinic. Formal feedback has not been previously solicited from patients. <h3>Design/Methods:</h3> We distributed surveys in English, Nyanja and Bemba to patients in the neurology clinic over four weeks. No identifying information was collected, and participant responses were entered into a Qualtrics database. <h3>Results:</h3> 191 patients participated. Since attending the clinic, 46% reported understanding of their diagnoses improved, 20% reported medication modifications, 18% motor improvement or re-gained ambulation, and 14% better seizure control. The majority were at least “somewhat satisfied” with competence (89%) and communication skills (86%) of clinic doctors, time spent with the physician (90%), and with their follow-up plan (82%). When asked to compare the neurology clinic to other clinics they attended, patients reported superior diagnostics and treatment options, better physician bedside manner, and more time spent with patients. Half of participants were at least “somewhat unsatisfied” with wait times to be seen after arriving at the clinic. Still, most (56%) preferred to see the same neurologist each visit, while 17% preferred to see the first available provider and the rest were undecided/ambivalent. <h3>Conclusions:</h3> The Zambian neurology clinic provides diagnostic clarity for patients and better satisfaction with treatment plans and patient/doctor relationships than other clinics. Despite prolonged wait times, most patients preferred provider continuity over expedited care. Thus, hospitals in resource-limited settings should consider introducing specialist public sector clinics whenever possible and replacing “first available provider” models with “provider continuity” models to improve clinical care and patient satisfaction. Providing formal appointment times in lieu of a first come-first served appointment model may also improve patient satisfaction. <b>Disclosure:</b> Dr. DiBiase has nothing to disclose. The institution of Dr. Chiwaya has received research support from National Institute of Health . Mr. Giauque has nothing to disclose. The institution of Dr. Saylor has received research support from National Institutes of Health. The institution of Dr. Saylor has received research support from National Multiple Sclerosis Society. The institution of Dr. Saylor has received research support from American Academy of Neurology. The institution of Dr. Saylor has received research support from United States Department of State. Dr. Saylor has a non-compensated relationship as a Member of multiple committees and task forces focused on improving access to MS medications to people across the world with Multiple Sclerosis International Federation that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the Neurology and COVID19 committee with World Health Organization that is relevant to AAN interests or activities. Dr. Saylor has a non-compensated relationship as a Member of the International Outreach Committee, Junior and Early Career Membership Committee, and Educational Innovation Commitees with American Neurological Association that is relevant to AAN interests or activities.

Clinical Relevance of Drug-Drug Interactions With Antibiotics as Listed in a National Medication Formulary: Results From Two Large Population-Based Case-Control Studies in Patients Aged 65-100 Years Using Linked English Primary Care and Hospital Data.

This study evaluated drug-drug interactions (DDIs) between antibiotic and nonantibiotic drugs listed with warnings of severe outcomes in the British National Formulary based on adverse drug reaction (ADR) detectable with routine International Classification of Diseases, Tenth Revision coding. Data sources were Clinical Practice Research Databank GOLD and Aurum anonymized electronic health records from English general practices linked to hospital admission records. In propensity-matched case-control study, outcomes were ADR or emergency admissions. Analyzed were 121,546 ADR-related admission cases matched to 638,238 controls. For most antibiotics, adjusted odds ratios (aORs) for ADR-related hospital admission were large (aOR for trimethoprim 4.13; 95% confidence interval (CI), 3.97-4.30). Of the 51 DDIs evaluated for ADR-related admissions, 38 DDIs (74.5%) had statistically increased aORs of concomitant exposure compared with nonexposure (mean aOR 3.96; range 1.59-11.42); for the 89 DDIs for emergency hospital admission, the results were 75 (84.3%) and mean aOR 2.40; range 1.43-4.17. Changing reference group to single antibiotic exposure reduced aORs for concomitant exposure by 76.5% and 83.0%, respectively. Medicines listed to cause nephrotoxicity substantially increased risks that were related to number of medicines (aOR was 2.55 (95% CI, 2.46-2.64) for current use of 1 and 10.44 (95% CI, 7.36-14.81) for 3 or more medicines). In conclusion, no evidence of substantial risk was found for multiple DDIs with antibiotics despite warnings of severe outcomes in a national formulary and flagging in electronic health record software. It is proposed that the evidence base for inclusion of DDIs in national formularies be strengthened and made publicly accessible and indiscriminate flagging, which compounds alert fatigue, be reduced.