Examining the Impact of the World Health Organization 2022 Guidelines on Evaluation of Biosimilars for Non-Local Comparators in Biosimilar Studies on Middle East and North Africa Member States.

Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade.

Association of Pre-Pandemic Telehealth With Emergency Department and Telehealth Usage During the Pandemic.

Aims were to quantify the association of pre-COVID-19 pandemic telehealth use and separately: 1) likelihood of an emergency department (ED) visit, 2) likelihood of a telehealth visit in older people during the pandemic. A retrospective cohort study to measure odds ratios (ORs) of telehealth usage before the pandemic and likelihood of an ED visit and telehealth visit during the study period. Adults 65 years of age and older (N = 39,214) in the University of California COVID Research Data Set (UC CORDS).

Considerations on the Weight Loss-Associated Glucagon-like Peptide-1 Receptor Agonists for Older People.

Obesity rates for older people have increased around the world with rates tripling over the past four decades.² While previously considered a phenomenon of developed countries, the increased prevalence of obesity is now established in developing countries as well.³ Factors stimulating this epidemic include modifications in the global food supply chain, rise in consumption and availability of energy-dense, low-nutrient foods, sedentary occupations, expanding urbanization, changes in transportation means, as well as environmental components.

Exploring Concomitant Acetylcholinesterase Inhibitor and Overactive Bladder Anticholinergic Use and Risk of Hospitalization in Medicare and Dual-Eligible Medicare-Medicaid Populations in a Historic Database.

Overactive bladder prevalence increases in older adults often complicating the management of other comorbidities. The theoretical antagonism between the parasympathetic-blocking anticholinergic agent and the parasympathetic stimulatory agents concomitantly used by patients is only recently being explored. The primary aim was to determine the frequency of the annual use of acetylcholinesterase inhibitors, overactive bladder anticholinergics, and the use of both agents in the same year.

Effectiveness of letermovir for cytomegalovirus prophylaxis in allogeneic hematopoietic stem cell transplant recipients: A global systematic review.

Objective(s): Letermovir (LET), a novel antiviral, has largely supplanted more traditional preemptive therapy (PET) for cytomegalovirus (CMV) prophylaxis in allogeneic hematopoietic stem cell transplant (allo-HCT) patients. Use of LET demonstrated efficacy against placebo in phase III randomized controlled trials, but is considerably more expensive than PET. This review aimed to evaluate the real-world effectiveness of LET in preventing clinically significant CMV infection (csCMVi) for allo-HCT recipients and related outcomes.

Cost Effectiveness of Letermovir for Cytomegalovirus Prophylaxis Compared with Pre-Emptive Therapy in Allogeneic Hematopoietic Stem Cell Transplant Recipients in the United States.

Purpose: The aim of this study was to assess the cost effectiveness of letermovir prophylaxis with the option for subsequent pre-emptive therapy (PET) for the prevention of cytomegalovirus (CMV) infection compared with a PET-only scenario in adult allogeneic hematopoietic stem cell transplant (allo-HCT) recipients in the United States over a 10-year time horizon.

Materials And Methods: A publicly available decision tree model was constructed using a commercial third-party payer perspective to simulate an allo-HCT recipient's clinical trajectory in the first-year post-transplant, followed by entry to a Markov model to simulate years 2 through 10. Clinical inputs and utility estimates were derived from published literature.

The Critical Role of Pharmacists in Treating Older People in the Opioid Crisis.

Pharmacy-based Opioid Use Disorder (OUD) treatment has been identified as a central pillar in curbing the spiraling opioid epidemic that claimed more than 100,000 lives in the United States in a one year period for the first time. This epidemic is also partially responsible for the plummeting US life expectancy that began prior to the COVID-19 pandemic and has now claimed more than 500,000 lives since 1999 with more than 70% of the 70,630 overdose deaths in 2019 involved with an opioid. Older people are at increased risk of both OUD and OUD-related complications.

Minding the gap and the value of metrics: Count of working pharmacists in the United States.

Background: The Bureau of Labor Statistics (BLS) uses a single Standard Occupational Classification (SOC) code (29-1051) that reflects a traditional definition of pharmacist job functions. Pharmacists working in nontraditional roles would be categorized under other SOC codes and not included in the BLS pharmacist count. Knowing the magnitude of how many working pharmacists may not be included in the BLS pharmacist count would help determine whether the gap is a minor margin of error or a significant problem affecting pharmacist workforce projections.

Effects of financial toxicity on prescription drug use and mental well-being in cancer patients.

Background: In the US, medical costs for cancer patients have grown from $27 billion in 1990 to $174 billion in 2020. The increased financial strain that cancer patients and survivors endure is referred to as financial toxicity.

Objective: To quantify the relationship between indicators of financial toxicity and health utilization and quality of life in patients ever diagnosed with cancer.

Risk of Negative Health Outcomes and High Costs for People With Diabetes and Unmet Psychological Needs in the United States.

Measuring the population-level relationship between compromised mental health and diabetes care remains an important goal for clinicians and health care decision-makers. We evaluated the impact of self-reported unmet psychological need on health care resource utilization and total health care expenditure in people with type 2 diabetes. Patients who reported unmet psychological needs were more likely than those who did not to incur a higher annual medical expenditure, have greater resource utilization, and have a higher risk of all-cause mortality.

Examination of Medication Use Patterns by Age Group, Comorbidity, and Month in COVID-19 Positive Patients in a Large Statewide Health System During the Pandemic in 2020.

Understanding medication use patterns for patients with COVID-19 will provide needed insight into the evolution of COVID-19 treatment over the course of the SARS-CoV-2 pandemic and aid clinical management considerations. To systematically determine most frequently used medications among COVID-19 patients overall and by hospitalization status. Secondary objective was use measurement of medications considered potential therapeutic options.

Transferring Key Success Factors from Ambulatory Care into the Community Pharmacy in the United States.

In the United States, pharmacists' scope of practice continues to expand, with increasing opportunities for pharmacists in all practice settings to enhance health in society. In ambulatory care, pharmacists remain integral members on the healthcare team and have demonstrated positive impacts on patient care. Sharing similar characteristics as pharmacists in the community setting, a deeper look into common elements of a successful ambulatory care practice that can be applied in the community pharmacy setting is warranted.

Medication Use Patterns in Hospitalized Patients With COVID-19 in California During the Pandemic.

This cohort study examines trends in medication use among patients hospitalized for COVID-19–related treatment in a large US university health care system from the start of stay-at-home orders in March 2020 throughout the rest of the year.

When Can We Trust Real-World Data To Evaluate New Medical Treatments?

Concerns regarding both the limited generalizability and the slow pace of traditional randomized trials have led to calls for greater use of real-world evidence (RWE) in the evaluation of new treatments or products. RWE studies often rely on real-world data (RWD), including data extracted from healthcare records or data captured by mobile phones or other consumer devices. Global assessments of RWD sources are not helpful in assessing whether any specific RWD element is fit for any specific purpose.

DISCARDED MEDICATIONS IN VIALS ARE A SYMPTOM OF OUR HEALTH CARE SYSTEM: A CALL TO ACTION.

No funding was received for the writing of this letter. All authors were members of the National Academies study committee to which this letter refers, with Shortliffe as the chair. All committee members who contributed to the report were themselves vetted for potential conflicts of interest, as is described in the recently published version of the report.