Medication safety risks to be managed in national implementation of automatic substitution of biological medicines : a qualitative study

Peer reviewe

Is There Any Research Evidence Beyond Surveys and Opinion Polls on Automatic Substitution of Biological Medicines? A Systematic Review

Background Biosimilars are expected to decrease growing health care expenditures. Given that uptake of biosimilars has been modest, automatic substitution has been suggested to increase their use, but the practice is not yet allowed or implemented in many jurisdictions. Methods A systematic review was performed by searching databases Scopus, Medline (Ovid), CINAHL, and Web of Science. Peer-reviewed, original studies written in English and published during the period January 1, 2006 to April 24, 2021 reporting any interventions, pilots or any other studies including experiences or perceptions of any relevant stakeholders on automatic substitution of biologics were included without limitation by setting or geography. The quality of the included studies were evaluated by pre-determined criteria. Results Altogether, 27 studies fulfilled the inclusion criteria, of which 23 were surveys, and four semi-structured interviews reporting mainly stakeholders' perceptions on automatic substitution. Most of the studies (56%, 15/27) were from Europe. Studies were conducted among prescribers (n = 12), pharmacists (n = 5), patients (n = 4), payers (n = 1), and mixed stakeholders (n = 5). The primary objective of the majority (81%, 22/27) of the studies was to investigate some other biosimilar topic than automatic substitution. The reported perceptions of substitution were mainly negative. Studies evaluating risks, safety or effectiveness, or reporting real-life experiences of biologic substitution were lacking except one intervention and two prospective risk management studies. The overall quality of the studies was low to moderate, and the results were not generalizable due to convenience sampling not representing the populations of interest, and low response rates. Conclusions The current research evidence on the automatic substitution of biologics is scarce and of low to moderate quality, reflecting low stakeholder knowledge and their cautious attitude towards biosimilars. The safe and efficient implementation of automatic substitution requires well-designed practices, pilot studies, and evolving legislation.Peer reviewe

Closed-Loop Medication Management with an Electronic Health Record System in U.S. and Finnish Hospitals

Many medication errors in the hospital setting are due to manual, error-prone processes in the medication management system. Closed-loop Electronic Medication Management Systems (EMMSs) use technology to prevent medication errors by replacing manual steps with automated, electronic ones. As Finnish Helsinki University Hospital (HUS) establishes its first closed-loop EMMS with the new Epic-based Electronic Health Record system (APOTTI), it is helpful to consider the history of a more mature system: that of the United States. The U.S. approach evolved over time under unique policy, economic, and legal circumstances. Closed-loop EMMSs have arrived in many U.S. hospital locations, with myriad market-by-market manifestations typical of the U.S. healthcare system. This review describes and compares U.S. and Finnish hospitals’ EMMS approaches and their impact on medication workflows and safety. Specifically, commonalities and nuanced differences in closed-loop EMMSs are explored from the perspectives of the care/nursing unit and hospital pharmacy operations perspectives. As the technologies are now fully implemented and destined for evolution in both countries, perhaps closed-loop EMMSs can be a topic of continued collaboration between the two countries. This review can also be used for benchmarking in other countries developing closed-loop EMMSs

Number needed to treat and cost of recombinant human erythropoietin to avoid one transfusion-related adverse event in critically ill patients* LEARNING OBJECTIVES

A recent study suggests that the use of 40,000 units weekly of recombinant human erythropoietin (EPO) in critically ill patients reduces the need for allogeneic blood transfusions (1). Patients who were randomized to receive EPO were less likely to undergo a transfusion than those who received placebo (50.5% vs. 60.4%, respectively LEARNING OBJECTIVES On completion of this article, the reader should be able to: 1. Describe the benefits of using erythropoietin. 2. Explain the potential adverse events related to red cell transfusions. 3. Explain the cost of erythropoietin required to avoid one transfusion adverse event. The authors have disclosed that they have no financial relationships or interests in any commercial companies pertaining to this educational activity. The authors have also disclosed that they will be discussing unlabeled/investigational uses of erythropoietin, a commercial product, and will disclose this to the audience. Visit the Critical Care Medicine Online website (www.ccmjournal.com) for information on obtaining continuing medical education credit. Objective: To calculate the absolute risk reduction of transfusion-related adverse events, the number of patients needed to treat, and cost to avoid one transfusion-related adverse event by using erythropoietin in critically ill patients Design: Number needed to treat with sensitivity analysis. Setting: Teaching hospital. Patients: Hypothetical cohort of critically ill patients who were candidates to receive erythropoietin. Interventions: Using vs. not using erythropoietin to reduce the need for packed red blood cell transfusions. Measurements and Main Results: We used published estimates of known transfusion risks: transfusion-related acute lung injury, transfusion-related errors, hepatitis B and C, human immunodeficiency virus, human T-cell lymphotropic virus, and bacterial contamination, stratified by severity. Based on the estimated risk and frequency of transfusions with and without erythropoietin, we calculated the absolute risk reduction of transfusion-related adverse events, the number needed to treat, and cost to avoid one transfusion-related adverse event by using erythropoietin

Risperidone, Haloperidol and Clozapine in the South Carolina Medicaid Program: A Comparative Analysis of Utilisation and Expenditure

Objective: To determine whether the increased acquisition costs associated with the atypical antipsychotic risperidone are offset by reductions in other mental health care utilisation and expenditure. Design and setting: The study was population-based and used South Carolina Medicaid claims data to determine changes in mental healthcare utilisation and expenditures related to schizophrenia. Changes in mental health-related utilisation and expenditures over time were calculated; total mental health-related expenditures and utilisation were disaggregated into pharmaceuticals, inpatient hospitalisations, and ambulatory and inpatient physician services [Health Care Financing Administration (HCFA) 1500 claims]. Groups of patients were compared for two 6-month periods preceding the initial prescription (pre1 and pre2), and two 6-month periods following the initial prescription (post1 and post2). Costs were discounted to the index date. Perspective: Payor (South Carolina Medicaid). Patients: Those patients with schizophrenia who received initial prescriptions for risperidone (n = 862), haloperidol (n = 325) or clozapine (n = 66) between February 1994 and June 1995 (index date). Main outcome measures and results: The mean increase in level of expenditure per person for pharmaceuticals from the pre- to the post-treatment period was significantly greater in the risperidone [751 US dollars ($US)] and clozapine ($US1423) groups than in the haloperidol group ($US6). However, the change in mean level of total mental healthcare expenditure per person was not significantly different for the risperidone group ($US832) compared with the haloperidol group ($US540) over the same time period, but the increase in the clozapine group was significantly higher ($US2500.23; pAntipsychotics, Clozapine, Cost analysis, Drug utilisation, Haloperidol, Pharmacoeconomics, Risperidone, Schizophrenia