Limitations of pharmaceutical drugs and biologics for chronic diseases (e.g., medication non-adherence, adverse effects, toxicity, or inadequate efficacy) can be mitigated by mobile medical apps, known as digital therapeutics (DTx). Authorization of adjunct DTx by the US Food and Drug Administration and draft guidelines on “prescription drug use-related software” illustrate opportunities to create drug + digital combination therapies, ultimately leading towards drug–device combination products (DTx has a status of medical devices). Digital interventions (mobile, web-based, virtual reality, and video game applications) demonstrate clinically meaningful benefits for people living with Alzheimer’s disease, dementia, rheumatoid arthritis, cancer, chronic pain, epilepsy, depression, and anxiety. In the respective animal disease models, preclinical studies on environmental enrichment and other non-pharmacological modalities (physical activity, social interactions, learning, and music) as surrogates for DTx “active ingredients” also show improved outcomes. In this narrative review, we discuss how drug + digital combination therapies can impact translational research, drug discovery and development, generic drug repurposing, and gene therapies. Market-driven incentives to create drug–device combination products are illustrated by Humira® (adalimumab) facing a “patent-cliff” competition with cheaper and more effective biosimilars seamlessly integrated with DTx. In conclusion, pharma and biotech companies, patients, and healthcare professionals will benefit from accelerating integration of digital interventions with pharmacotherapies.

Digital Therapeutics for Improving Effectiveness of Pharmaceutical Drugs and Biological Products: Preclinical and Clinical Studies Supporting Development of Drug + Digital Combination Therapies for Chronic Diseases

Cytomegalovirus (CMV) is a common opportunistic infection in patients after liver transplant (LT). Guidelines recommend 900 mg daily of valganciclovir; however, valganciclovir commonly causes dose‐dependent hematologic toxicities. Use of a low‐dose valganciclovir (450 mg) has been used to prevent these adverse effects, but the data regarding this dosing strategy are not as robust in a steroid sparing LT center.

Incidence and risk factors for the development of cytomegalovirus viremia in a steroid sparing liver transplant center

Comparable drug levels and immunogenicity in patients with axial spondyloarthritis treated with adalimumab originator and biosimilar: A retrospective study from two centers of China.

BACKGROUND
Low-dose valganciclovir (VGC) for cytomegalovirus (CMV) prophylaxis post-transplant has been employed due to cost and safety. The incidence of CMV disease in CMV intermediate-risk liver recipients at 1-year after standard-dose prophylaxis is approximately 5%. However, there are limited data on outcomes after using a "true" low-dose VGC prophylaxis regimen in liver and dual-abdominal transplant recipients as VGC was not dose-adjusted in all patients with impaired renal function in prior studies.


OBJECTIVE
The objective was to assess the incidence of CMV associated with low-dose VGC prophylaxis in CMV intermediate-risk liver, simultaneous pancreas-kidney (SPK), and simultaneous liver-kidney (SLK) recipients with creatinine clearance (CrCl) >60 mL/min.


METHODS
This was a retrospective review of CMV intermediate-risk liver, SPK, and SLK recipients with CrCl >60 mL/min transplanted January 2018 to June 2022 who received VGC 450 mg daily for prophylaxis. The primary outcome was incidence of CMV infection 6-months post-transplant.


RESULTS
Ninety-nine transplant recipients were included (79 liver, 11 SPK, 9 SLK). The primary outcome occurred in 13% of patients (liver 10%, SPK 36%, SLK 10%), including 1 case of CMV disease and 3 breakthrough infections. In addition, 6 patients experienced CMV infection between 6-months and 1-year. Recurrence occurred in 3 patients. There was no evidence of CMV resistance. Thirty patients experienced neutropenia within 1-year, 32 were prescribed granulocyte-colony stimulating factors, and 5 experienced thrombocytopenia. Two patients died due to graft-vs-host disease.


CONCLUSION AND RELEVANCE
Low-dose VGC prophylaxis led to comparable CMV infection rates at 6-months in CMV intermediate-risk liver and SLK recipients. However, as SPK recipients displayed higher rates of CMV infection, low-dose VGC should be avoided in this population.

Low-Dose Valganciclovir Prophylaxis Against Cytomegalovirus in Intermediate-Risk Liver and Dual-Abdominal Transplant Recipients.

Recent developments and controversies in organ transplantation necessitate the reaffirmation and application of foundational ethical norms as the laudable goal of increasing viable organs for transplantation is pursued. The physician's primary duties are to individual patients under the physician's care. For physicians of prospective donor-patients, the "bright line" between serving the best interests of donor-patients and their families and serving potential recipient-patients and the public interest can become blurred in ethically problematic ways. This paper provides ethical guidance for clinicians involved in organ transplantation as well as for patients, families, the public, policymakers, and others to help maintain trust and encourage participation in this life-saving enterprise. It clarifies the duties and roles of care teams of prospective donor-patients, recipient-patients, and organ procurement teams, reaffirming that end-of-life decision making for prospective donor-patients must center on the best interests of donor-patients and their families independent of organ donation potential. It also emphasizes the importance of truly informed consent for organ donation and advocates for prioritizing equity and transparency in transplantation processes. 

Ethical Issues in Organ Transplantation: A Position Paper From the American College of Physicians

DISCLAIMER
In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.


PURPOSE
The impact of the market entry of adalimumab biosimilars on clinical practices and specialty pharmacies is explained. A roadmap is also provided for how pharmacists can successfully navigate this landscape.


SUMMARY
Biosimilars have previously been introduced as a mechanism to help curb biologic expenditures, with biosimilars undergoing an abbreviated regulatory approval process that focuses on biosimilarity and generating product competition. Adalimumab is currently the leading product in the biologics market, generating approximately $20 to $30 billion in sales worldwide consecutively from 2019 to 2021. Many adalimumab biosimilars are slated to enter the market in 2023 and become available for patient use. However, compared to other biosimilars, adalimumab biosimilars have several unique considerations, such as interchangeability and concentration, that will impact pharmacy practices and workflows. Because pharmacists embedded in clinical practices and specialty pharmacies will be significantly involved in the processes relating to adalimumab biosimilar implementation, adoption, and use, a primer on understanding the various adalimumab biosimilar products available and considerations surrounding these products with regard to workflow and patient use is critical. Several resources are also provided to help pharmacists successfully navigate the adalimumab biosimilar landscape.


CONCLUSION
The biosimilar landscape continues to evolve, and 2023 will see the launch of several adalimumab biosimilar products, which vary with regard to formulation, concentration, and interchangeability status. Pharmacists are well positioned to educate providers and patients about this landscape and help implement an efficient workflow to support adalimumab biosimilar adoption and use.

Preparing for the market entry of adalimumab biosimilars in the US in 2023: A primer for specialty pharmacists.

Biologics have become the forefront of medicine for management of autoimmune conditions, leading to improved quality of life. Many autoimmune conditions occur in solid organ transplant (SOT) recipients and persist following transplant. However, the use of biologics in this patient population is not well studied, and questions arise related to risk of infection and adjustments to induction and maintenance immunosuppression. Guidelines have been published highlighting management strategies of biologics around the time of elective surgical procedures, but this is not always feasible in urgent situations, especially with deceased donor transplantation. The aim of this review is to summarize the current literature regarding the use of these agents in solid organ transplant recipients, and specifically address induction and maintenance immunosuppression, as well as the need for alternative infective prevention strategies to create a practical reference for the frontline clinician, when faced with this complex clinical scenario.

The use of non‐transplant biologics in solid organ transplant recipients: A practical review for the frontline clinician

In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time.

Health-system specialty pharmacies do the heavy lifting for hospital electronic medication prior authorizations.

Audience Our reusable low-cost peritonsillar abscess simulator (PTA) simulator is designed to train emergency medicine (EM) residents, fellows, and medical students. Trainees who are interested in otolaryngology (OTL) or this specific disease may also benefit from this simulator. Introduction Peritonsillar abscess is one of the most common deep infections 1 of the head and neck, accounting for 7589 consultations and 11069 hospital bed days in the UK between 2009–2010.1,2 Emergency medicine physicians commonly treat this pathology with surgical and medical modalities. Not only is this a common diagnosis, but there is a significant cost associated with the evaluation and management of primary PTA. 3 Demands for high-volume patient care and good patient outcomes are increasing in a medical climate of limited financial resources and resident work hours. Given these complexities, medical education is viewing simulation training, with proven success in various surgical specialties, as a valuable addition to resident education and patient safety. 3–5 The PTA is the collection of pus in the space between the palatine tonsil and its capsule. Successfully locating the abscess is crucial because it prevents the unwanted damage of nearby vascular structures, patient discomfort, and failure to treat the infection. Management of peritonsillar abscess is primarily surgical and includes incision and drainage (I & D), needle aspiration, or Quinsy tonsillectomy. The simulator provides a realistic characteristic of typical PTA presentations, such as uvula deviation, swelling, trismus, and purulence during aspiration. While learning to drain a PTA, trainees must locate the infection with a needle without injury to the surrounding structures of the oral cavity and deep structures of the neck. The discomfort caused during this procedure can be unsettling for both physician and patient. Simulation use and testing enable the trainee to develop familiarity with handling instruments, increase comfort with the sequence of a procedure, and improve confidence in the ability to perform a procedure safely.6,7,8 Simulators provide improved patient outcomes and increased EM residents' comfort level. Educational Objectives By the end of this training session, learners will be able to: 1) locate the abscess, 2) perform needle aspiration, and 3) develop dexterity in maneuvering instruments in the small three-dimensional confines of the oral cavity without causing injury to local structures. Educational Methods Our PTA simulator was fabricated with a low-cost, non-degradable material and is the first known PTA simulator that used a validated survey for fidelity assessment. The simulator was fabricated using a silicone mold to mimic the oral cavity and oropharynx. A simulated abscess pocket consisting of saline encased in balloon material was placed in the proper anatomic location, allowing for abscess simulation on either side of the oropharynx model. The time to fabricate the model averaged 20 hours. The simulator was manufactured with low-cost materials at an expense of 45 USD and could be easily reproduced by any EM residency program. Research Methods Twenty-one participants were instructed to expose and drain the simulated abscess. The model was evaluated using The Michigan Standard Simulation Experience Scale (MiSSES).7 Participants scored the simulator in five categories: Self-efficacy, fidelity, educational value, teaching quality, and the overall rating on a 5-point Likert scale of simulator. Overall rating and global evaluation scores were compared by groups (Group 1, Group 2) between training level (residents and attendings), specialty (emergency and otolaryngology), and previous experience (<5 or ≥5 drainages). Convenience sampling was used to determinate the sample. Variables were summarized using the mean and standard deviation for continuous variables and percentages and frequencies for categorical variables. The MiSSES was scored as previously described in the literature.7 The Kolmogorov-Smirnov test was used to test for normal distribution of the variables. T-test for independent samples was performed to determinate if there exists a difference between groups in perception of a PTA simulator. The statistical analyses were performed using SPSS version 20.0 Armonk, NY: IBM. Results Twenty-one participants were enrolled in the study: residents (n=15) and attending (n=6) from OTL and EM departments. The simulator’s plasticity allowed multiple attempts of needle aspiration and drainage without degradation and received high ratings on teaching quality, fidelity, and educational value. This PTA simulator achieved high fidelity ratings in the standard simulator’s assessment survey for realism of environment, simulation of trismus, uvular deviation, and realism of the mucosal surfaces. On the MiSSES, the model received positive ratings (range 3.6 to 4.9). The highest rating was on teaching quality (4.9), fidelity (4.6), and educational value (4.5) (Table 1). We found that self-efficacy and teaching quality sections were rated higher for those who had less experience (≥5 PTA drainage), while fidelity was rated higher for OTL. The overall rating average was 4 and was higher of attendings, OTL, and those with less experience. All comparisons between groups were not statically significant (Table 2). About 76% of participants found that the simulator can be used in training with slight improvement or no improvement needed. (Table 3) Discussion With favorable participant ratings and comments, we believe that this tool can offer high-fidelity simulation at a low cost. Widespread use may be possible, allowing training of EM residents in performing instrumentation of PTA in a controlled simulation environment. We have created a reusable low-cost PTA simulator that achieved a high score fidelity in a standard simulator’s assessment survey. Topics Peritonsillar abscess, oropharynx, emergency medicine residency, otolaryngology residency training.

Peritonsillar Abscess Simulator: A Low-Cost, High-Fidelity Trainer

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