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Objective: Lichenoid drug reactions (LDR) are a rarely known type of drug reaction that resembles lichen planus. The exact etiology of LDR is not known but it is thought to be caused by the triggering of all kinds of chemical substances. In this study; we aimed to investigate the clinical and demographic characteristics of the patients who were diagnosed with LDR. Material and Method: The files of 56 LDR patients who were followed in our outpatient clinic among 2011 - 2016 have been reviewed retrospectively. The demographic characteristics, the drugs considered to cause reaction, the presence of multiple drug usage, the duration between drug intake and appearance of the initial skin eruption, clinical findings, lesion locations, laboratory findings and associated diseases have been recorded. Results: Out of the 56 LDR patients, who were clinically and histopathologically diagnosed and followed, 36 were female and 20 were male. The average age was 52.8 (19-86 years of age). The duration of the symptoms was between 1-3 months in 58.9% of the patients, between 3-12 months in % 17.8, between 1 to 30 days in % 14.2 (n=8) and more than 1 year in 8.9% of the patients.48.2% (n = 27) of the lesions were on the extremities, 37.5 % were generalized, 7.1% were invers type. The most frequently accused drug groups were nonsteroidal anti-inflammatory drugs (NSAID) and antihypertensive. Conclusions: It has been found that the use of NSAID, and cardiovascular drugs on their own and / or in combination with other medications often led to lichenoid drug reactions.

Residues of veterinary drugs were investigated in fish samples from domestic farms in South Korea to highlight the changing trends in drug usage during aquatic food production. Samples (n = 958) were collected from 32 cities and 11 provinces. In total, 41 veterinary drugs were analyzed using an LC-MS/MS. The total detection rate of veterinary drugs in fish samples was 22.7% (n = 217). Enrofloxacin and oxytetracycline were mostly detected in fishery products. Moreover, 12 samples (1.3%) exceeded the maximum residue limit set by Korea. The detection rate for veterinary drug residues varied with fish species and water type. Additionally, our findings show that of the two or more residues in 87 samples, enrofloxacin was often detected in combination with ciprofloxacin, and other compound. Our results of this study suggested the need for an appropriate withdrawal period of fishery products are required to guarantee safe residue levels.

What is known and objective Omalizumab is effective as an add-on drug to treat severe persistent allergic asthma. However, delayed hypersensitivity reactions to omalizumab may deprive patients of its use. Rapid subcutaneous desensitization could be a solution. Case description A 61-year-old man developed a delayed allergy to omalizumab after the first injection. A 14-step desensitization procedure was applied to the patient and was successful. What is new and conclusion Delayed hypersensitivity reactions to omalizumab are rare, but they may cause the interruption of drug usage. Desensitization to omalizumab could be a possible solution.

Background: Recognition of drug usage patterns provides the basis for improving safety and plummeting risks associated with their use. Thus, this study was undertaken to explore the drug usage pattern in ophthalmology with an emphasis on antimicrobial use at a tertiary care teaching hospital. Materials and Methods: An observational study was conducted in the Department of Ophthalmology, Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard, New Delhi, India for 9 months. Newly registered patients visiting the Outpatient Department for curative complaints were included. All drugs prescribed were recorded, including dose, route, dosage form, frequency of administration, indications for prescription, and duration of therapy, and the data was audited using the indicators prescribed by the World Health Organization. Result: A total of 600 prescriptions were analyzed. The number of drugs prescribed was 1097 with an average drug per prescription being 1.8. The most common disorders diagnosed were infective conjunctivitis (21.5%) followed by stye (5.5%). Drugs were prescribed in different dosage forms with eye drops (72.6%) being the most common. Drugs were predominantly prescribed by brand name (100%). Antimicrobials (44.7%) were the most commonly prescribed drugs followed by lubricants (17.5%). Moxifloxacin (53.5%) was the most commonly prescribed antimicrobial agent. Of the antimicrobials prescribed, 89.6% were prescribed topically. Average total cost per prescription was 113 INR. Conclusion: The study concludes with an overall impression of rational prescription in terms of prescribing in consensus with the recommended treatment protocol of ocular diseases. Nevertheless, health-care professionals should be encouraged to prescribe by generic name. Creating awareness regarding selection of drugs from essential drug list to reduce the drug cost is the need of the hour. Last but not least, updating knowledge regarding appropriate antimicrobial use and the development of discreet strategies for their use should be implemented to steer clear of antimicrobial resistance.

A wealth of information is currently known about the epidemiology, etiology, and evaluation of drug and alcohol use across the life span. Despite this corpus of knowledge, much has yet to be learned. Many factors conspire to slow the pace of future advances in the field of substance use including the need for long-term longitudinal studies of often hard-to-reach subjects who are reporting rare and episodic behaviors. One promising option that might help move the field forward is integrative data analysis (IDA). IDA is a principled set of methodologies and statistical techniques that allow for the fitting of statistical models to data that have been pooled across multiple, independent samples. IDA offers a myriad of potential advantages including increased power, greater coverage of rare behaviors, more rigorous psychometric assessment of theoretical constructs, accelerated developmental time period under study, and enhanced reproducibility. However, IDA is not without limitations and may not be useful in a given application for a variety of reasons. The goal of this article is to describe the advantages and limitations of IDA in the study of individual development over time, particularly as it relates to trajectories of substance use. An empirical example of the measurement of polysubstance use is presented and this article concludes with recommendations for practice.

The benefits of closed-loop control of anesthesia in terms of drug usage, robustness to inter-patient variability and postoperative outcomes have been demonstrated in a number of clinical studies. However, to obtain regulatory approval for such systems to be employed as medical devices in operating rooms, patient safety must be demonstrated. This paper formalizes a previously published safety system for closed-loop anesthesia using formal model verification techniques. This safety system specifies safety constraints on the patient states based on the therapeutic window of propofol. To verify feasibility of the safety constraints in all situations, a finite number of simulation scenarios can be performed. However, the formal methods verify the feasibility problem for all possible admissible inputs and states without the need for simulation. The formalized safety system for closed-loop anesthesia guarantees that the patient states stay within safety constraints.

Ineffective medication management contributes to repeated hospitalisation and death among patients with heart failure. The meaning ascribed to medications and the influence of meaning on how patients manage medications is unknown. The purpose of this study was to explore the meaning and expectations associated with medication use in high-risk, non-adherent patients with heart failure.Patients ( n=265) with heart failure were screened for adherence to prescribed medication using the Morisky medication adherence scale (MMAS). Patients (MMAS score6; n=44) participated in semistructured interviews, analysed using qualitative content analysis. Of 17 initial themes (223 representative segments), the overarching theme 'unmet expectations' consisted of two subthemes 'working to be heard' by professionals and 'resignation' to both the illness and medications. Patients' expectations were challenged by unexpected work to communicate with providers in general (72 representative segments), and specifically regarding medications (118 representative segments) and feelings of resignation regarding the medication regimen (33 representative segments).These findings suggest that unmet expectations contribute to poor medication management. Improved listening and communication by providers, to establish a common understanding and plan for managing medications may strengthen patient beliefs, resolve feelings of resignation and improve patients' ability to manage medications effectively.

Research in clinical pharmacology covers a wide range of experiments, trials and investigations: clinical trials, systematic reviews and meta-analyses of drug usage after market approval, the investigation of pharmacokinetic–pharmacodynamic relationships, the search for mechanisms of action or for potential signals for efficacy and safety using biomarkers. Often these investigations are exploratory in nature, which has implications for the way the data should be analysed and presented. Here we summarize some of the statistical issues that are of particular importance in clinical pharmacology research.

Background Serratia is an opportunistic pathogen known to cause an array of infectious presentations including UTIs, pneumonia, wound infections, skin and soft tissue infections, surgical site infections and although rare, endocarditis and bacteremia. The aim of the proposed study is to identify the characteristics of patients with community-acquired Serratia blood stream infection over a five-year period within the TriHealth inpatient population within the Cincinnati, Ohio Region. The study will also examine antibiotic resistance patterns among patients with Serratia bloodstream infections. Methods This is a retrospective cohort study of 107 adult patients admitted to two community hospitals from January 2014 to December 2018 with a positive blood culture for Serratia species. A complete data set of 100 patients was analyzed for complications, antibiotic resistance, in-hospital mortality, 90-day mortality, readmission within 90 days and length of Hospital Stay (LOS). Descriptive statistics was performed using frequencies for discrete variables and median (IQR) for continuous variables. Results Patients admitted with a positive Serratia blood culture were 38% female with a median (IQR) age of 54.5 years (40.25–71.75) and predominantly white (85%). Forty percent had hepatitis C (HCV) infection and 42% had a history of IV drug use. Most patients were living at home (77%), 18% in long term care and 91% were infected with Serratia marcescens. The most common complications were endocarditis (12%) and osteomyelitis (10%). Extended spectrum beta-lactamase (ESBL) production was confirmed in 13%. In-hospital mortality was 2%, 90-day mortality 2%, readmission 23% and median (IQR) LOS 7(3.25–14.75). PATIENT CHARACTERISTICS AND OUTCOMES (part 1) PATIENT CHARACTERISTICS AND OUTCOMES (part 2) PATIENT CHARACTERISTICS AND OUTCOMES (part 3) Conclusion This study demonstrates that a high proportion of patients admitted with Serratia bacteremia are IV drugs users and that they have a high prevalence of coexistent HCV infection. Endocarditis and metastatic foci of infection are relatively common. Appropriate empiric antibiotic management should take into account the significant incidence of ESBL production resulting in a prolonged LOS and a high readmission rate. Disclosures All Authors: No reported disclosures

Background Dalbavancin is a lipoglycopeptide antibiotic active against gram-positive organisms. Its extended half-life allows for weekly dosing that can last 4 to 6 weeks with 2 doses. Although approved for treating skin and soft tissue infections, use for more complicated infections is appealing, particularly when daily intravenous antibiotics are impractical. S aureus is the most common cause of complex infections for which dalbavancin is considered at our institution, so we sought to better understand its use. Methods We conducted a retrospective study to describe dalbavancin use at our institution for infections caused by Staphylococcus aureus. We identified all patients ≥18 years who received ≥1 dose of dalbavancin. Infectious disease faculty reviewed charts for clinical characteristics and outcomes of the infections. Results Fifty-two patients with S. aureus infections (60% MRSA) were treated with at least a partial course of dalbavancin. Twenty-seven (52%) had a history of IV drug use (IDU) and the most common infections were bone and joint infection in 51% and bacteremia in 40% (Table 1). The most common dosing regimen was 1500 mg x 1 in 55% or 1500 mg weekly x 2 in 25% (Table 2). The most common reasons for use of dalbavancin were history of IDU in 48% and lack of a safe home environment in 21%. Suppressive oral antibiotics for the primary infection were prescribed to 3 patients after completing dalbavancin (2 received for other indications). Clinical outcomes include 15% of patients lost to follow-up, readmission due to infection recurrence or dalbavancin adverse effects in 12%, and overall infection recurrence or relapse by day 90 in 31% (Table 3). There were no severe dalbavancin-related adverse drug events. Table 1. Patient and Disease Characteristics Table 2. Dalbavancin Use Characteristics Table 3. Clinical Endpoints Conclusion While our results suggest dalbavancin is well tolerated, questions about relapse rates in the treatment of complicated S. aureus infections remain. Further research is needed to evaluate clinical outcomes for dalbavancin compared to standard of care antibiotics and to better elucidate whether relapses were related to true antibiotic failure versus other complexities of the S. aureus infections. Disclosures All Authors: No reported disclosures

Background Outpatient parenteral antimicrobial therapy (OPAT) programs are becoming a standard of care, however, program cost justification remains a challenge. One area of focus for institutions is facilitating timely discharge from the inpatient setting, and difficult to discharge patients are a group with which OPAT teams can be particularly impactful. Methods This retrospective review identified patients intervened upon by the Nebraska Medicine OPAT team during the initial nine months after program implementation (4/1/19 - 12/31/19) for which routine efforts at discharge by primary teams had failed. Patients were planned for extended inpatient stays to complete the full duration of parenteral antibiotic therapy due to discharge issues given the therapy plan initially recommended by infectious disease consult teams. Outcomes evaluated included inpatient days of therapy avoided, associated financial metrics, and 30-day readmission rates. A matched cohort of patients with similar lengths-of-stay, infectious disease indications, medication use, and lack of major complications was identified to calculate a cost per inpatient day avoided. Results A total of 17 difficult to discharge patients were intervened on by the OPAT team, leading to avoidance of 429 planned inpatient days. Based on calculation from internal matched cohort data, these OPAT interventions avoided an estimated $943,000 in total inpatient costs. All-cause 30-day readmission was 24% (4 of 17 patients). Additionally, 15 of these therapy courses were shifted to hospital-associated outpatient infusion centers. Facilitation of enrollment for 11 of these patients in pharmaceutical manufacturer patient assistance programs resulted in replacement of outpatient medication totaling over $28,000 in value. Reimbursements for two additional patients through either governmental or private insurance generated over $11,000 in margin for the health system. Conclusion Attention to complex discharge facilitation by OPAT programs can be a significant contribution to program cost justification, while also transitioning patients to therapy plans that lead to similar clinical outcomes when compared to the overall OPAT population. Disclosures All Authors: No reported disclosures

Background Studies using national administrative data suggest that hospitalizations for drug use-associated infective endocarditis (DUA-IE) have increased over the last ten years. However, drug use as a contributing factor to IE hospitalizations is often missed or not included in coding documentation, resulting in undercount of DUA-IE. We assessed whether missed drug use during IE hospitalizations was associated with higher levels of fragmented care and underestimation of DUA-IE burden. Methods We analyzed data from State Inpatient Databases and State Emergency Department Databases from six states (FL, GA, IA, NY, UT, VT) from 2011–2015. Patients older than 16 with ICD-9/10 codes for admissions with IE were included. IE was categorized as DUA using ICD-9/10 codes for drugs/conditions associated with injection drug use. We labeled IE cases as a “missed” DUA-IE case if they had no diagnosis of drug use during their index hospitalization but received a drug use diagnosis during an ED visit or inpatient stay in the calendar year of their index IE hospitalization. We compared “missed” DUA-IE cases to DUA-IE cases where drug use was identified in the index hospitalization and non-DUE-IE cases with respect to demographics, length of stay (LOS) and total charges. To assess care fragmentation, we stratified IE groups by whether the patient was admitted to 1 or >1 hospital within 90-days of the index IE admission. Results There were 52147 non-DUA-IE cases, 6872 DUA-IE cases, and 2676 “missed” DUA-IE cases identified by linking drug use across multiple encounters. Missed cases represented a 39% increase in total DUA-IE cases. Compared to DUA-IE cases identified at index hospitalizations, missed cases were more likely to be older, Black, insured by Medicare, and from rural areas. They also had higher 30-day readmission rate (23.2% vs 14.5%, p< 0.001) and higher charges (p< 0.001), with similar LOS. Fragmented care was most common among patients with missed DUA-IE (33.3%), followed by DUA-IE cases identified during index hospitalization (20.5%) and non-DUA-IE cases (13.7%). Table 1 Table 2 Conclusion Missed and/or unrecorded drug use and fragmented care are common features of DUA-IE. This results in underestimation of both DUA-IE prevalence and hospital utilization due to DUA-IE. Disclosures All Authors: No reported disclosures

Nivolumab has received regulatory approval to be given by weight-based or flat dosing every two weeks or by flat dosing every four weeks. However, flat dosing would lead to unnecessarily high doses for patients with lower body weight, increasing the drug usage and probability of toxicity. We review the rationale of using a four-weekly hybrid dosing strategy using weight-based and flat-dosing regimens adopted by some jurisdictions.

Introduction Cognitive Behavioral Therapy for Insomnia (CBTI) is the recommended treatment for insomnia in the United States, Europe and China. Individual, group and online formats are effective, with moderate to large effect sizes in treatment outcomes. Although the prevalence of insomnia is 15% in China, most individuals do not seek CBTI and often prefer TCM. This study investigated whether CBTI delivered to Chinese in Mandarin via group telehealth showed similar outcomes compared to other countries. Methods Chinese patients > 18 years with insomnia > 7 on the ISI were recruited from a sleep clinic in collaboration with Chongqing TCM Hospital in China. CBTI was delivered via 4-session telehealth group. Components included sleep education, sleep restriction, stimulus control, cognitive reframing, and relaxation. TCM use was extracted from medical records. Scores on self-report questionnaires assessing insomnia symptoms, sleep effort, sleep beliefs, and depression were compared pre- and post-treatment using paired sample t-tests with correction for multiple comparisons. Results All patients (N=34) completed pre-post measures. Mean age was 44 years, sample was 82% female, and 91% had a bachelor or advanced degree. Average insomnia duration was 4.1 years, and 80% of sample used TCM during CBTI. Post-treatment outcomes showed significant decreases in insomnia symptoms (ISI Mdiff=4.0, SDdiff=6.4, p=.001, ES=.63), sleep effort (GSES Mdiff=2.3, SDdiff=3.2, p=.000, ES=.72), and unhelpful sleep beliefs (DBAS Mdiff=5.4, SDdiff=5.4, p=.000, ES=1.0), along with significantly lower depression symptoms (PHQ9 Mdiff =2.6, SD=3.8, p=.000, ES=.68) and improvement in daytime functioning (PSQI Mdiff.=0.6 SDdiff =1.2, p=.008, SE=.50). Medication use also decreased significantly (PSQI Mdiff=1.5 SDdiff =1.6, p=.000). Conclusion Chinese patients with insomnia can be recruited successfully and treated effectively using CBTI via telehealth. Outcomes and effect sizes are similar to those seen with CBTI in other countries. Future comparison of CBTI with and without concurrent TCM could provide clinically relevant information. Support None

Introduction Childhood burns are extremely common and distressing for children and their parents. Pain is the most common complaint and often thought to be undertreated, disrupting care and increasing the risk of post-traumatic stress disorder. There is limited literature on the role of opioids and multimodal therapy in the treatment of burns in pediatric patients. We sought to evaluate the current use of multimodal therapy as well as the use, storage, and disposal of opioids in this patient population. Methods We prospectively surveyed parents of pediatric burn patients (0–18 years old) who presented to the burn clinic within two weeks of burn injury. Parents were surveyed regarding over-the-counter pain medication use and opioid medication use, storage, and disposal in the treatment of their child. Medians and interquartile ranges were used to describe continuous variables and frequencies and percentages were used for categorical variables. Results A total of 92 parents of burn-injured children were surveyed at a single institution in the outpatient burn clinic. The median age of burn-injured children was 3.1 years old, and 50% of patients were male. The majority had a TBSA of 1%. The hand was the most frequently burned location (45.7%). Acetaminophen (58.7%) and ibuprofen (69.6%) were the most common treatments for both constant and breakthrough pain. Approximately 28% (26/92) of patients were prescribed opioids, of which 18.5% (17/92) filled their prescription. Only 29% of patients (5/17) consumed their entire prescription, and a median of 3 doses of opioids remained for those who did not finish the entire prescription. Parents most commonly decided to give their children opioid pain medications because “my child is in severe pain” or “I give my child pain medications as scheduled (written on prescription).” Approximately 40% (7/17) of patients who filled opioid prescriptions stored them in a locked area, and only 35.3% (6/17) were educated on how to dispose of excess opioid pain medication. Conclusions Presently, multimodal therapy with over-the-counter pain medications is used to treat the majority of pediatric burns. This study demonstrates an increased need for education on opioid administration, storage, and disposal for parents of burn-injured children. Applicability of Research to Practice We aimed to evaluate what current trends in opioid use are in pediatric burn patients and areas for improvement in parent education for over-the-counter pain medication use, opioid use, opioid storage, and disposal. From the study, we were able to glean that the majority of patients are successfully managed with over-the-counter pain medications. However, parents and patients managed with opioids need additional education on appropriate administration of opioid pain medications, safe locked storage of opioids, and opioid disposal. This demonstrates an area for quality improvement inpatient and outpatient.

Introduction Our aim was to explore MV during the acute burn treatment and factors associated with successful extubation. Methods A retrospective review was performed on all burn patients that required MV in a reference burn center from December 2015 to April 2018. Patients successfully extubated or on trach collar (Group1) were compared to those that required re-intubation or died on MV (group2). The patients were also grouped depending on duration of MV, after excluding the patients that died under MV: Group A, 3 or less days; Group B, 4 or more days. A p 0.05 was considered significant. Results Out of a total of 104 burn patients on MV, 7 patients arrived intubated after coding on the field, were confirmed dead on the first 24 hours, and were excluded from the analysis. The mean expected mortality rate was 21.5±31%, 19 (19.5%) died during the admission. The patients remained intubated for 13±19 days, tracheostomy was performed in 20 (21%), after 26±15 days. Fifty-five (56.7%) of the patients were smokers or former smokers, 34 (35%) were illicit drug users, 16 (16.5%) had alcohol intoxication when burned. Inhalation injury was suspected in 80 (82.5%) of the patients, and confirmed in 41 (42.3%). Group 1 was younger: 48.42±18.66 vs 59.15 ± 21.38, p=0.032. Although a smaller rate of confirmed inhalation injury was seen among group1, it was not statistically significant (Group1: 25 (36.8%); group2: 16 (55.2%) (P=0.09). The TBSA burned was bigger on group 2: 18.4%±19.72 vs 34.39%±25.86, p=0.002. History of drug use was not associated with extubation success: group1: 26 (38%); group2: 8 (27.6%); (P=0.314). The expected mortality was significantly higher among group2: 10%±16.1% vs 48.54%±39.33%, p< 0.001. Group1 was associated with the use of less albumin and crystalloids on the first 24h and a bigger volume of urine on Day1 (Table1). A sub-analysis of the group that required re-intubation (n=10) and the successfully extubated showed an increased rate of psychiatric illness among the group requiring re-intubation: 18 (26.5%) vs 7 (70%), p< 0.001. The group that required a shorter time on the MV (GroupA) had a shorter length of stay, smaller percentage of TBSA, required fewer surgeries, and received less albumin and crystalloids on Day1 (Table2). Conclusions Lower expected mortality and age, and smaller %TBSA burned are associated with a successful extubation. Psychiatric illness may be associated with the need for re-intubation. Applicability of Research to Practice This study highlights the association of psychiatric illness and difficulty extubating the burn patient.

Background Given a significant proportion of women with inflammatory bowel disease (IBD) are of child-bearing age, the development of a pregnancy IBD decision aid would benefit patients and clinicians. Lack of IBD-specific reproductive knowledge has been associated with increased “voluntary childlessness” and may contribute to inappropriate medication changes during or after pregnancy. Decision aids support decision making in pregnancy in general, as well as in multiple other chronic diseases. However existing literature has not identified such a resource for women with IBD. Aims To develop a decision aid to improve decision making regarding preconception and pregnancy in IBD among women with IBD. Methods We followed the International Patient Decision Aids Standards (IPDAS). A steering committee of Canadian and Australian health care professionals with an interest in IBD management in pregnancy, in addition to patient representatives, was established. Themes chosen for discussion included inheritance, fertility, nutrition, medications, mode of delivery, breastfeeding, infant health. Initial patient and clinician focus groups were conducted and responses recorded with written/audio mediums. We developed an electronic PIDA draft that incorporates individualised information (type of IBD, pre-conception or pregnant, surgical history, medications) in personalized decision making. Further patient focus groups and interviews were conducted to obtain user opinion of the PIDA draft. Results In July 2017, patient and clinician focus groups were conducted at a Canadian site. Three patients (pre-conception) attended the focus group. Patient concerns - impact of disease and surgery on fertility and preterm delivery; impact of drug therapies on the fetus/ infant; impact of active disease on maternal and fetal/infant health. The clinician focus group included 3 IBD specialists, 2 IBD fellows, 2 IBD nurses, an obstetrician and a neonatal intensivist. Clinician concerns - absence of pre-conception counselling and lack of patient understanding about the impact of disease activity and IBD medication use in pregnancy. Additional patient feedback obtained through interviews (n=15) at two Canadian sites since March 2019 regarding the current electronic PIDA was positive, with comments about content, personalization, readability and unbiased presentation. Suggestions were made for inclusion of additional content such as impact of IBD on sexual function, laboratory changes during pregnancy, and timing of medications post-partum. Conclusions The pre and post PIDA design patient and clinician focus groups and interviews affirmed the role for PIDA. Main decisions considered necessary to address included ideal timing of conception pending disease activity, management of medications, and delivery methods. Ongoing user feedback will be obtained at Australian and Canadian sites during planned alpha testing. Funding Agencies WCHRI, Sinai Health System, UBC