Understanding the problem of digital medication inventory visibility in health systems.

PURPOSE: This project describes and quantifies the perceived degree of digital visibility to medication inventory throughout 6 large health systems. METHODS: In this project, 6 large health systems evaluated their physical medication inventory for digital visibility, or the degree to which physical medication inventory information is viewable in electronic systems, during a 2-year period (2019-2020). Inventory reports included medication items with either a National Drug Code (NDC) or a unique institutional identifier. Physical inventory reports contained the medication item name and a corresponding NDC or identifier, the quantity on hand, and the physical locations and the storage environments of the inventory items at the time of the audit. Investigators independently reviewed physical inventory reports and categorized medication line items by degree of digital visibility: (1) no digital visibility, (2) partial digital visibility without accurate quantities, (3) partial digital visibility with accurate quantities, or (4) full digital visibility. Data were anonymized, aggregated, and analyzed to characterize the degree of digital visibility across the health systems and to identify locations and storage environments where the greatest improvement is needed. RESULTS: Overall, less than 1% of medication inventory was judged to have full digital visibility. The majority of the evaluated inventory items were categorized as having partial digital visibility, with or without accurate quantities. Analysis by both units of inventory and inventory valuation indicated that only 30% to 35% of inventory had full digital visibility or partial digital visibility with accurate quantities. CONCLUSION: Most of the medication inventory within 6 large academic centers is either not digitally visible or partially digitally visible but without accurate quantities. Full digital visibility of inventory is rare. Better digital visibility can minimize disruption from recalls and decrease waste. Technology vendors and health systems must collaborate to develop improved automation and systems to make medications on hand more digitally visible.

Pharmacist biosimilar survey reveals knowledge gaps.

BACKGROUND: Biosimilars are of increasing significance to pharmacy practice, with the potential to improve patient access to biologic therapies and help reduce overall health care costs. OBJECTIVES: This web-based survey assessed pharmacists' understanding of biosimilars, including interchangeability. METHODS: WebMD LLC fielded a survey including true or false and Likert-type questions to the Medscape pharmacist and certified pharmacy technician (CPT) panel in March 2021. Those practicing in community, home care or infusion, hospital or health system, managed care, outpatient, or specialty pharmacy settings and currently providing prescription services, or formulary or benefit management related to biologic products were included, to a quota of 500 responses. Results were analyzed descriptively. RESULTS: Data are reported for 507 of 992 respondents (265 did not meet eligibility criteria, 220 responded after the survey closed), including 498 pharmacists and 9 CPTs. These respondents worked in a community setting (66%), outpatient or ambulatory or other setting (16%), hospital or health system setting (14%), or managed care (5%). Overall, 87% and 91% of respondents knew that the biosimilar had equivalent efficacy and safety, respectively, to its reference product. Only 20% understood that a pharmacist can substitute a Food and Drug Administration-approved interchangeable without approval of the prescriber. However, 53% responded that they felt it was appropriate for a pharmacist to dispense an interchangeable in place of its reference product without authorization from the prescriber if consistent with state law; a numerically smaller proportion of community pharmacists understood this concept than the other groups (50% vs. 54%-61%). Only 11% of respondents knew that no biosimilars were designated as interchangeable at the time of the survey, with a numerically greater proportion of managed care pharmacists showing awareness than other groups. Slightly more than 50% of respondents felt that they were moderately or very comfortable in responding to patients' biosimilar questions. CONCLUSION: Gaps remain in pharmacists' understanding and comfort with key concepts about biosimilar products, including interchangeability, suggesting the need for further education.

Factors associated with naloxone availability and dispensing through Michigan's pharmacy standing order.

Background: Pharmacy standing order policies allow pharmacists to dispense naloxone, thereby increasing access to naloxone. Objectives: To describe pharmacy standing order participation and associations of pharmacy and community characteristics that predict naloxone availability and dispensing across eight counties in Michigan. Methods: We conducted a telephone survey of 662 standing order pharmacies with a response rate of 81% (n = 539). Pharmacies were linked with census tract-level demographics, overdose fatality rates, and dispensing data. County maps were created to visualize pharmacy locations relative to fatality rates. Regression models analyzed associations between pharmacy type, neighborhood characteristics, fatality rates, and these outcomes: naloxone availability, having ever dispensed naloxone, and counts of naloxone dispensed. Results: The prevalence of standing order pharmacies was 54% (n = 662/1231). Maps revealed areas with higher fatality rates had fewer pharmacies participating in the standing order or lacked any pharmacy access. Among standing order pharmacies surveyed, 85% (n = 458/539) had naloxone available and 82% had ever dispensed (n = 333/406). The mean out-of-pocket cost of Narcan® was $127.77 (SD: 23.93). National chains were more likely than regional chains to stock naloxone (AOR = 3.75, 95%CI = 1.77, 7.93) and to have ever dispensed naloxone (AOR 3.02, 95%CI = 1.21,7.57). Higher volume of naloxone dispensed was associated in neighborhoods with greater proportions of public health insurance (IRR = 1.38, 95%CI = 1.21, 1.58) and populations under 44 years old (IRR = 1.24, 95%CI = 1.04, 1.48). There was no association with neighborhood overdose fatality rates or race in regression models. Conclusion: As deaths from the opioid epidemic continue to escalate, efforts to expand naloxone access through greater standing order pharmacy participation are warranted.

The global landscape on interchangeability of biosimilars.

INTRODUCTION: Biosimilars hold the potential to be an integral healthcare component that can significantly improve affordability and thereby accessibility of the otherwise expensive biotherapeutic products. Regulators, payors, and policymakers, each have a major role to play in successful adoption of biosimilars. One of the issues that has been a point of frequent discussion is that of interchangeability of biosimilars. AREAS COVERED: This article aims to review the position that the major regulatory bodies have taken on interchangeability of biosimilars. Key issues that remain are also discussed. Adalimumab and etanercept have been chosen as real-world case studies to demonstrate interchangeability considerations. The need for gaining global harmonization on interchangeability is highlighted. EXPERT OPINION: A global harmonization on the interchangeability can likely accelerate biosimilar adoption and result in better accessibility to biologics. Experience gained with real-world studies supports switching to biosimilars from originators however post-marketing pharmacovigilance should be in place to assess the risk-benefit profile of biosimilars in the long run.

An analysis of hospital pharmacy practice in Namibia, based on FIP's Basel Statements.

BACKGROUND: Sub-Saharan Africa, a region faced with a double challenge of infectious and non-communicable diseases requires strengthening of hospital pharmacy practice to improve treatment outcomes and patient safety. OBJECTIVES: The objectives of this study were to assess the current state of pharmacy practice in hospitals in Namibia and to identify opportunities for expanding pharmacists' role in addressing public health challenges and improving medicines use outcomes. METHODS: A survey utilized FIP's self-assessment tool to evaluate current hospital pharmacy practice in Namibia against best practices articulated in the Basel Statements. The study was conducted among hospital pharmacists across Namibia. Quantitative and qualitative data were analysed using descriptive statistics and thematic analysis. KEY FINDINGS: The study was conducted in 24 hospital pharmacies across Namibia, the majority of which were public facilities (67%). Overall, current hospital pharmacy practice activities are focused on medicine procurement, preparation and distribution. The main barriers to optimal hospital pharmacy services are associated with limited human resources and collaboration across healthcare providers, as well as policy gaps. CONCLUSIONS: There is a strong desire among hospital pharmacists to expand their contributions to improving medicines outcomes and solving public health problems. Namibia's pharmacy educational system is a strength and should be utilized to continue advancing hospital pharmacy practice and medicines use. Therapeutics committees are usually part of each hospital's structure and can be very effective for hospital-based policy change. The opportunity exists to optimize pharmacists' contributions by utilizing the local therapeutics committees in combination with the educational system to advance hospital pharmacy practice in Namibia.

Considerations related to comparative clinical studies for biosimilars.

Introduction: Biosimilar medicines have transformed the healthcare landscape by providing improved access to life-saving medicines at a lower cost. Biosimilars are a distinct category of biologic therapeutics that enter the market after patent expiration of a reference molecule. Regulatory bodies worldwide have developed guidance to expedite the approval and entry of these drugs to the market. Biosimilar approval is based on a totality of the evidence approach, demonstrating similarity between the biosimilar and the originator in terms of physicochemical properties, quality characteristics, biological activity, safety, and efficacy.Areas covered: This article provides an overview of the biosimilar regulatory guidelines and discusses the importance and considerations of comparative clinical studies that are performed during biosimilar development. Two review assessment reports, one each from the EMA and the FDA, are presented.Expert opinion: The discussed case studies illustrate the importance of pharmacokinetic and pharmacodynamic studies in the regulatory approval of biosimilars. It is crucial for biosimilar developers to judiciously determine clinical parameters including biomarkers, endpoints, and acceptance criteria before executing clinical studies.

Implementing a specialty pharmacy course within a professional pharmacy curriculum.

BACKGROUND AND PURPOSE: Specialty pharmacy is an important area of pharmacy practice where patients who are prescribed a growing number of specialty drugs receive specialized care, including: benefits investigation, financial support, side effect management, and adherence assessment. As these specialty medications continue to emerge, it is important for pharmacy students to have knowledge of this specialized practice and awareness of the opportunities that exist in this area. The objective is to describe the development of a specialty pharmacy elective course to meet this educational need. EDUCATIONAL ACTIVITY AND SETTING: A one-credit specialty pharmacy elective course was created for second and third-year pharmacy students. Content experts with a variety of clinical and administrative specialty pharmacy expertise led student lectures and topic discussions. Students were assessed for baseline specialty pharmacy knowledge, knowledge at the completion of the course, and satisfaction with the course. FINDINGS: Student knowledge of specialty pharmacy practice increased 27.7% when comparing baseline to post-course test scores. Students evaluated the new course positively with recommendations that the course could benefit by being expanded by an additional credit. SUMMARY: The development of a specialty pharmacy elective course within a college of pharmacy curriculum improved student knowledge of specialty pharmacy practice and was well-received by students who enrolled in the course. Given the complexity and growing importance of specialty pharmacy in practice, this type of course should be considered by other colleges of pharmacy.

Evaluating a handheld decision support device in pediatric intensive care settings.

OBJECTIVE: To evaluate end-user acceptance and the effect of a commercial handheld decision support device in pediatric intensive care settings. The technology, pac2, was designed to assist nurses in calculating medication dose volumes and infusion rates at the bedside. MATERIALS AND METHODS: The devices, manufactured by InformMed Inc., were deployed in the pediatric and neonatal intensive care units in 2 health systems. This mixed methods study assessed end-user acceptance, as well as pac2's effect on the cognitive load associated with bedside dose calculations and the rate of administration errors. Towards this end, data were collected in both pre- and postimplementation phases, including through ethnographic observations, semistructured interviews, and surveys. RESULTS: Although participants desired a handheld decision support tool such as pac2, their use of pac2 was limited. The nature of the critical care environment, nurses' risk perceptions, and the usability of the technology emerged as major barriers to use. Data did not reveal significant differences in cognitive load or administration errors after pac2 was deployed. DISCUSSION AND CONCLUSION: Despite its potential for reducing adverse medication events, the commercial standalone device evaluated in the study was not used by the nursing participants and thus had very limited effect. Our results have implications for the development and deployment of similar mobile decision support technologies. For example, they suggest that integrating the technology into hospitals' existing IT infrastructure and employing targeted implementation strategies may facilitate nurse acceptance. Ultimately, the usability of the design will be essential to reaping any potential benefits.

Board of Pharmacy Practices Related to Medication Errors and Their Potential Impact on Patient Safety.

State boards of pharmacy are generally responsible for the governance of the practice of pharmacy. While the regulatory process and methods for accomplishing this task may vary by state, all boards of pharmacy must address medication errors committed by pharmacists. The National Association of Boards of Pharmacy (NABP) has recommended that state boards of pharmacy implement best practices and enforcement actions that are aimed to promote patient safety and reduce medication errors. The current study was designed to identify and compare current corrective action practices among boards of pharmacy in response to medication errors. An electronic survey regarding board policies and anticipated board actions in response to hypothetical medication error scenarios was sent to boards of pharmacy for completion. Approximately 45% of pharmacy boards responded. Survey responses demonstrated that corrective actions and consequences were levied against pharmacists inconsistently among state boards. Corrective action plans and process improvement components were lacking in a majority of state board of pharmacy practices. Medication safety education for pharmacists and for members on boards of pharmacy was insufficient in many states. Responses to hypothetical error scenarios indicated that most board actions are educational and punitive in nature, rather than focusing on systems improvement.

A Review of Best Practices for Intravenous Push Medication Administration.

In 2015, the Institute for Safe Medication Practices (ISMP) released safe practice guidelines for adult intravenous (IV) push medications. ISMP's most recent set of guidelines has added to a growing list of recommendations from professional groups on the safe use of IV medications. These recommendations and guidelines vary with regard to their audience, scope, and terminology. In some ways, these variations may contribute to confusion and delayed adoption of the standards. This report attempts to provide clarity about the rationale and background regarding the need for practice improvement, discussion of various guidelines, and practice mitigation strategies to improve patient safety.

Biosimilars: Practical Considerations for Pharmacists.

OBJECTIVE: To review the scientific and regulatory aspects of biosimilar development and practical considerations for the use of biosimilars that are relevant to pharmacists. DATA SOURCES: Literature searches of PubMed and congress abstracts for publications pertaining to biosimilars were conducted from January 2016 to January 2017. Individual drug company web pages and governmental, regulatory, and other agency websites were also reviewed. STUDY SELECTION/DATA EXTRACTION: Published articles, regulatory guidelines, and other sources covering biologic/biosimilar development and approval, reporting results of biosimilar studies or survey research, and/or identifying biosimilars in development or approved for use in Europe or the United States were reviewed and included. DATA SYNTHESIS: Biologic therapies have revolutionized the treatment of serious diseases, including hematological or autoimmune disorders and cancers. A biosimilar is highly similar to a licensed biologic (ie, reference or originator) and has no clinically meaningful differences in safety, purity, and potency. Unlike small-molecule drugs, biologics are large, complex proteins that cannot be exactly replicated, so the concept of a generic equivalent cannot be applied to biologics. Regulatory agencies have provided a framework for biosimilar approval, but there are many practical considerations for pharmacists, including interchangeability, substitution, naming, indication extrapolation, product labeling, therapeutic drug monitoring, manufacturer attributes, logistics of product use, and reimbursement. CONCLUSIONS: Pharmacists will play a key role in managing the introduction of biosimilars into health care systems. Understanding the principles of biosimilar development and evolving regulatory guidelines relevant to their use will allow pharmacists to make informed decisions regarding formulary inclusion and educate patients and other health care providers about biosimilars.

Oseltamivir for pandemic influenza preparation: Maximizing the use of an existing stockpile.

With the threat of significant morbidity and mortality following an influenza pandemic, stockpiling of antiviral agents such as oseltamivir is recommended. Shelf-life extension was explored to maximize use of an existing stockpile. This analysis demonstrated that oseltamivir retains potency defined by United States Pharmacopeia acceptance criteria beyond the labeled expiration date.

Cost Analysis of Implementing Matrix-Assisted Laser Desorption Ionization-Time of Flight Mass Spectrometry Plus Real-Time Antimicrobial Stewardship Intervention for Bloodstream Infections.

Studies evaluating rapid diagnostic testing plus stewardship intervention have consistently demonstrated improved clinical outcomes for patients with bloodstream infections. However, the cost of implementing new rapid diagnostic testing can be significant, and such testing usually does not generate additional revenue. There are minimal data evaluating the impact of adding matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) for rapid organism identification and dedicating pharmacy stewardship personnel time on the total hospital costs. A cost analysis was performed utilizing patient data generated from the hospital cost accounting system and included additional costs of MALDI-TOF equipment, supplies and personnel, and dedicated pharmacist time for blood culture review and of making interventions to antimicrobial therapy. The cost analysis was performed from a hospital perspective for 3-month blocks before and after implementation of MALDI-TOF plus stewardship intervention. A total of 480 patients with bloodstream infections were included in the analysis: 247 in the preintervention group and 233 in the intervention group. Thirty-day mortality was significantly improved in the intervention group (12% versus 21%, P < 0.01), and the mean length of stay was reduced, although the difference was not statistically significant (13.0 ± 16.5 days versus 14.2 ± 16.7 days, P = 0.44). The total hospital cost per bloodstream infection was lower in the intervention group ($42,580 versus $45,019). Intensive care unit cost per bloodstream infection accounted for the largest share of the total costs in each group and was also lower in the intervention group ($10,833 versus $13,727). Implementing MALDI-TOF plus stewardship review and intervention decreased mortality for patients with bloodstream infections. Despite the additional costs of implementing MALDI-TOF and of dedicating pharmacy stewardship personnel time to interventions, the total hospital costs decreased by $2,439 per bloodstream infection, for an approximate annual cost savings of $2.34 million.

Biologics, Pharmacovigilance, and Patient Safety: It's All in the Name.

The most appropriate naming convention for biologics and biosimilars has been an area of significant debate. The ultimate decision will have an impact on patient safety, pharmacovigilance program effectiveness, and, potentially, the overall adoption of biosimilars in the United States. This article reviews some of the advantages and disadvantages of various naming approaches. For clarity in communication, optimal pharmacovigilance, and patient safety, it is recommended that biosimilars be named with a common USAN (United States Adopted Name) with the reference product, along with a suffix that is memorable, such as one associated with the original manufacturer of the product. This approach supports the FDA's mission of protecting patient safety and public health, while minimizing the possibility of inadvertent switching of products and facilitating effective pharmacovigilance. DISCLOSURES: No funding supported the writing of this article. Stevenson reports consulting fees from Amgen, Inc., AbbVie, and Pfizer and is employed by Visante. Green is employed by and owns stock in Amgen, Inc. Article concept was contributed primarily by Stevenson, along with Green. The manuscript was written and revised primarily by Stevenson, along with Green. Both authors contributed equally to data interpretation.

Standardization of compounded oral liquids for pediatric patients in Michigan.

PURPOSE: The development, dissemination, and adoption of standard concentrations for compounded oral liquids for pediatric patients in Michigan are described. SUMMARY: A baseline assessment of current practices in Michigan revealed significant variations in the concentrations of commonly used oral liquid medicines for pediatric patients. A statewide collaborative initiative in Michigan was created to standardize the concentrations of compounded oral liquids for pediatric patients. Standard concentrations were proposed and adopted by key stakeholders. These standards were then disseminated across the state to prescribers and pharmacists, with encouragement to voluntarily adopt the standards as a patient safety measure. A follow-up survey was conducted to evaluate adoption of the standards. A total of 263 pharmacists responded to the survey. Standardization of the concentrations of compounded oral liquids in Michigan was welcomed by most pharmacies and is perceived to have reduced the risk for errors at transitions of care for children receiving compounded oral liquids. Awareness of the standardization initiative was acknowledged by 77% of survey respondents, and adoption of the standards was observed to some degree by 57% of survey respondents. In addition, 70% of survey respondents agreed or strongly agreed that adoption of the standards has improved patient safety in Michigan. CONCLUSION: Standard drug concentrations for compounded oral liquids were developed for pediatric patients in Michigan. A survey after dissemination of the recommended standards confirmed general awareness of the initiative and adoption of the standards by a substantial proportion of respondents. Most respondents indicated a belief that creation of the standards improved patient safety.

Revision of the International Pharmaceutical Federation's Basel Statements on the future of hospital pharmacy: From Basel to Bangkok.

PURPOSE: The processes used to revise the 2008 Basel Statements on the future of hospital pharmacy are summarized, and the revised statements are presented. METHODS: The process for revising the Basel Statements followed an approach similar to that used during their initial development. The Hospital Pharmacy Section (HPS) of the International Pharmaceutical Federation (FIP) revised the 2008 FIP Basel Statements in four phases, including a survey of hospital pharmacists worldwide, an internal review, online forums, and a face-to-face "World Café" workshop in Bangkok, Thailand. RESULTS: The global survey on the initial Basel Statements included input from 334 respondents from 62 countries. The majority of respondents agreed that most of the initial Basel Statements were acceptable as written and did not require revision. In total, 11 statements were judged by more than 10% of respondents as needing revision or deletion. The FIP HPS executive committee used the survey results to develop 69 initial revised draft statements. After an online discussion with the international hospital pharmacy community, including individuals from 28 countries representing all six World Health Organization regions, a final set of draft statements was prepared for the live discussion involving participants from 20 countries. The final 65 revised Basel Statements were voted on and accepted. CONCLUSION: Systematic revision of the FIP Basel Statements resulted in an updated reflection of aspirational goals for the future of hospital pharmacy practice. While this revision reflects the development of new goals for hospital pharmacy practice, the core principles of the Basel Statements remain an essential foundation for the discipline.

Comparison of barcode scanning by pharmacy technicians and pharmacists' visual checks for final product verification.

PURPOSE: The results of an evaluation of barcode verification by pharmacy technicians as an alternative to visual checking by pharmacists in the final stage of the dispensing process are reported. METHODS: A two-phase study was conducted to compare error rates with pharmacist visual checks versus technician-operated barcode scanning for final verification of prepackaged unit dose medications dispensed from a satellite pharmacy of a large hospital. In phase 1 of the research, potential errors detected by technician barcode scanning after pharmacist visual checking and approval to dispense were measured over two weeks; in phase 2, dispensing errors not detected through technician scanning that were subsequently detected by pharmacist visual check were measured over three weeks. A time study was conducted to assess the amount of pharmacist time required for visual checks. RESULTS: A total of 2015 medication doses dispensed during the study period were included in the analysis. Technician barcode scanning was found to be superior to visual checking by a pharmacist in detecting dispensing errors. The calculated time for a pharmacist to check unit doses averaged 5.93 seconds per check. The additional technician time required for barcode scanning versus pharmacist verification was not measured directly, but subjective analysis indicated that the increase in technician time was comparable to the corresponding decrease in pharmacist time. CONCLUSION: The use of pharmacy technician barcode checking is a safe alternative to a pharmacist's visual check and, in appropriate cases, can allow reallocation of pharmacist time to clinically oriented patient care services.