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

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.

Wellbeing of Frontline Health Care Workers After the First SARS-CoV-2 Pandemic Surge at a Neuroscience Centre: A Cross-sectional Survey.

BACKGROUND: The coronavirus disease 2019 (COVID-19) pandemic has affected people of all ages, races, and socioeconomic groups, and placed extraordinary stress on health care workers (HCWs). We measured the prevalence of burnout and assessed wellbeing and quality of life (QoL) in HCWs at a single UK neuroscience center after the first pandemic surge. METHODS: A 38-item electronic questionnaire was disseminated through local team email lists between May 22 and June 7, 2020, to HCWs in a university neurosciences center. Burnout was measured using the single-item Emotional Exhaustion and Depersonalization scales, and wellbeing and QoL assessed using the Linear Analogue Self-Assessment Scale and the EuroQol-5 Dimension instrument. RESULTS: The response rate was 57.4% (n=234); 58.2% of respondents were nurses, 69.4% were women and 40.1% were aged 25 to 34 years. Overall, 21.4% of respondents reported burnout assessed by the Emotional Exhaustion scale; burnout was higher for nurses (23.5%) and allied health care professionals (22.5%) compared with doctors (16.4%). HCWs from ethnic minority groups reported a higher rate of burnout (24.5%) compared with white HCWs (15.0%). There were no differences in reported wellbeing or QoL between professional groups, or HCW age, sex, or race. Nurses (36.8%) and staff from ethnic minority groups (34.6%) were more fearful for their health than others. CONCLUSIONS: Our findings highlight the prevalence of HCW burnout after the first surge of the pandemic, with an increased risk of burnout among nurses and staff from ethnic minority groups. Both nursing and staff from ethnic minority groups were also more fearful for their health. With ongoing pandemic surges, the impact on HCW wellbeing should be continuously assessed to ensure that local strategies to support staff wellbeing are diverse and inclusive.

Olfactory and taste dysfunction among mild-to-moderate symptomatic COVID-19 positive health care workers: An international survey.

OBJECTIVES: To determine the prevalence of olfactory and taste dysfunction (OD; TD) among COVID-19 positive health care workers (HCWs), their associated risk factors and prognosis. METHODS: Between May and June 2020, a longitudinal multicenter study was conducted on symptomatic COVID-19 PCR confirmed HCWs (COVID-19 positive) in London and Padua. RESULTS: Hundred and fourteen COVID-19 positive HCWs were surveyed with a response rate of 70.6% over a median follow-up period of 52 days. UK prevalence of OD and TD was 73.1% and 69.2%, respectively. There was a male to female ratio of 1:3 with 81.6% being white, 43.7% being nurses/health care assistants (HCAs), and 39.3% being doctors. In addition, 53.2% of them worked on COVID-19 wards. Complete recovery was reported in 31.8% for OD and 47.1% for TD with a 52 days follow-up. The job role of doctors and nurses negatively influenced smell (P = .04 and P = .02) and taste recovery (P = .02 and P = .01). Ethnicity (being white) showed to positively influence only taste recovery (P = .04). Sex (being female) negatively influenced OD and TD recovery only in Paduan HCWs (P = .02 and P = .011, respectively). Working on a COVID-19 ward did not influence prognosis. CONCLUSIONS: The prevalence of OD and TD was considerably higher in HCWs. The prognosis for OD and TD recovery was worse for nurses/HCAs and doctors but working on a COVID-19 ward did not influence prognosis. Sixty-eight percent of surveyed HCWs at 52 days continued to experience OD or TD requiring additional future medical management capacity. LEVEL OF EVIDENCE: 4.

An Exit Strategy for Resuming Nonemergency Neurosurgery after Severe Acute Respiratory Syndrome Coronavirus 2: A United Kingdom Perspective.

INTRODUCTION: Substantial healthcare resources have been diverted to manage the effects of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, and nonemergency neurosurgery has been effectively closed. As we begin to emerge from the crisis, we will need to manage the backlog of nonemergency neurosurgical patients whose treatment has been delayed and remain responsive to further possible surges of SARS-CoV-2 infections. METHODS: In the present study, we aimed to identify the core themes and challenges that will limit resumption of a normal neurosurgical service after the SARS-CoV-2 pandemic and to provide pragmatic advice and solutions that could be of utility to clinicians seeking to resume nonemergency neurosurgical care. We reviewed the relevant international policies, a wide range of journalistic and media sources, and expert opinion documents to address the stated aims. RESULTS: We have presented and discussed a range of factors that could become potential barriers to resuming full elective neurosurgical provision and important steps that must be completed to achieve pre-SARS-CoV-2 surgical capacity. We also explored how these challenges can be overcome and outlined the key requirements for a successful neurosurgical exit strategy from the pandemic. CONCLUSION: The performance of nonemergency neurosurgery can start once minimum criteria have been fulfilled: 1) a structured prioritization of surgical cases; 2) virus infection incidence decreased sufficiently to release previously diverted healthcare resources; 3) adequate safety criteria met for patients and staff, including sufficient personal protective equipment and robust testing availability; and 4) maintenance of systems for rapid communication at organizational and individual levels.