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.

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.

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.

Building a business case for an outpatient pharmacy.

To be successful, an outpatient prescription pharmacy service built and operated by a hospital should be run as a competitive business, not in the manner of an inpatient operation. The outpatient pharmacy should not be a siloed entity that operates separately from the inpatient pharmacy. A hospital may miss a significant margin opportunity if it runs the pharmacy strictly as a safety net for uninsured or underinsured patients.

Demonstrating the value of antimicrobial stewardship programs to hospital administrators.

The movement away from fee-for-service models to those that emphasize quality of care and patient outcomes affords a unique opportunity for antimicrobial stewardship programs to expand their value for hospital administration. Antimicrobial stewardship participants must collaborate with administrators and key stakeholders to position themselves to improve economic, process, and outcomes measures. This will allow the establishment of antimicrobial stewardship programs as essential components of the present and future healthcare quality journey.

Variability in compounding of oral liquids for pediatric patients: a patient safety concern.

OBJECTIVE: To determine the degree in variation of oral liquid pediatric compounding practices in Michigan pharmacies. DESIGN: Cross-sectional survey study. SETTING: All types of inpatient and outpatient pharmacies across the state of Michigan, excluding nuclear pharmacies and long-term care facilities. PARTICIPANTS: 244 Michigan pharmacies. INTERVENTION: An online survey tool was used to assess the current compounding practices of 147 oral liquid pediatric medications. The survey was e-mailed or faxed to hospitals, chain pharmacies, and independent pharmacies. Pharmacists were also mailed a follow-up postcard, and the Michigan Pharmacists Association publicized the project through its journal and annual meeting. MAIN OUTCOME MEASURES: Pharmacy demographics; number of compounding pharmacies; number of medications compounded; awareness of compounding errors; results of compounding errors; and number of concentrations compounded per medication. RESULTS: The majority of respondents were from outpatient pharmacies, but inpatient and other types of pharmacies were also represented. The majority of participating pharmacies compound fewer than five oral liquid medications per week. Awareness of errors was low overall, with no errors believed to result in permanent harm or death. The number of concentrations compounded per medication ranged from 1 to 9, with the majority of pharmacies compounding more than 3 concentrations per medication. CONCLUSION: There is a considerable degree of variation in current oral pediatric liquid compounding practices in Michigan pharmacies. This variability poses a significant risk to patient safety.

Measuring Change in Health-System Pharmacy Over 50 Years: "Reflecting" on the Mirror, Part II.

The Director's Forum guides pharmacy leaders in establishing patient-centered services in hospitals and health systems. 2013 marked the 50th anniversary of the publication of the Mirror to Hospital Pharmacy, which was a comprehensive study of hospital pharmacy services in the United States. This iconic textbook was co-authored by Donald Francke, Clifton J. Latiolais, Gloria N. Francke, and Norman Ho. The Mirror's results profiled hospital pharmacy of the 1950s; these results established goals for the profession in 6 paradigms: (1) professional philosophy and ethics; (2) scientific and technical expansion of health-system pharmacy; (3) development of administrative and managerial acumen; (4) increased practice competence; (5) wage and salary commensurate with professional responsibilities; and (6) health-system pharmacy as a vehicle for advancing the profession as a whole. This article critically reviews our progress on the last of 3 goals. An understanding of the profession's progress on these goals since the seminal work of the Mirror provides directors of pharmacy a platform from which to develop strategies to enhance patient-centered pharmacy services.

Formulary Selection Criteria for Biosimilars: Considerations for US Health-System Pharmacists.

Pharmacists will play a key role in evaluating biosimilars for formulary inclusion in the United States. As defined by US law, a biosimilar is a biologic that is highly similar to its reference product, notwithstanding minor differences in clinically inactive components, and should not have clinically meaningful differences from its reference product in safety, purity, and potency. We review biosimilars and the current European Union and US regulatory pathways for biosimilars. Furthermore, we propose a checklist of considerations to ensure that US pharmacists thoroughly evaluate future biosimilars for formulary inclusion. Included in the checklist are considerations related to the availability of preapproval and postapproval safety and efficacy data; differences in product characteristics and immunogenicity between the biosimilar and reference product; manufacturer-related parameters that can affect a reliable supply of quality products; health-system and patient perspectives on product packaging, labeling, storage, and administration; costs and insurance coverage; patient education; interchangeability and differences in the range of indications; and evaluation of institutions' information technology systems.

Profiles in Leadership: Donald E. Francke, MSc, DSc (Hon).

The Director's Forum series is designed to guide pharmacy leaders in establishing patient-centered services in hospitals and health systems. August 2013 marked the 50th anniversary of the publication of the Mirror to Hospital Pharmacy, the results of a federally funded comprehensive study of pharmacy services in the United States. The late Don E. Francke, MS, DSc, was the lead author of the Mirror and the principal investigator for the US Public Health Service grant W-45. To celebrate the anniversary of the Mirror, the Director's Forum is profiling the leadership styles of Drs. Latiolais and Francke. September's article highlighted Dr. Clifton J. Latiolais; this month's Director's Forum reviews Dr. Francke's biography and key career accomplishments, describes his leadership philosophy, and translates that philosophy to today's health care challenges. Don's influence on health system pharmacy serves as an example of effective leadership. This historical perspective provides directors of pharmacy a valuable leadership view as they develop strategies to enhance patient-centered pharmacy services.

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.

A case study on the safety impact of implementing smart patient-controlled analgesic pumps at a tertiary care academic medical center.

BACKGROUND: As with the use of any therapy involving opioids, patient-controlled analgesia (PCA)-related errors can lead to overdose and even death. "Smart" (computerized) pumps have medication safety enhancements, particularly those related to operator errors during administration, to improve overall safety and efficacy. After the occurrence of PCA-related errors that occurred at a tertiary care academic medical center, an analysis of PCA errors was conducted. The introduction of smart pumps was identified as a possible solution, and the medical center adopted the technology in 2006. A study was conducted to investigate the impact of implementation. METHODS AND RESULTS: The study had three primary objectives: (1) to evaluate history logs stored in the smart PCA pumps to characterize the nature of hard and soft stop alerts and identify potential errors that may have been averted, (2) to examine the impact of smart PCA pumps on voluntarily reported PCA therapy-related errors, and (3) to assess nursing perceptions regarding the improvement in safety due to the introduction of smart PCA pumps. The smart pumps potentially prevented 159 errors for the January-June 2007 period; upper hard limits had the most number of alerts, representing avoidance of errors with the greatest potential to be detrimental to the patient. In addition, pump-programming errors due to wrong concentration were eliminated after implementation. Finally, nursing staff perceived smart pumps to be valuable in improving patient safety. CONCLUSIONS: Smart PCA pumps had an important positive impact on PCA-related patient safety at the medical center. Other facilities should adopt PCA devices with additional safety features such as bar-code verification of the drug and concentration, as well as dosage limits, to prevent pump-programming errors.

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.

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.

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.

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.

Darbepoetin alfa: an effective treatment with flexible and simplified dosing for anemia in patients with cancer.

Anemia is common in patients with cancer or myelodysplastic syndrome. Erythropoietic therapy offers an effective way to manage anemia by increasing hemoglobin levels, decreasing transfusion requirements, and alleviating symptoms. We reviewed data showing the feasibility and effectiveness of treatment with the erythropoiesis-stimulating protein darbepoetin alfa at extended dosing intervals to treat anemia in patients with cancer receiving multicycle chemotherapy. We also explored the darbepoetin alfa's potential for treating anemia in patients with myelodysplastic syndrome. Data from clinical studies and drug therapy evaluations confirm that darbepoetin alfa administered weekly, every 2 weeks, and every 3 weeks corrects and maintains hemoglobin levels in patients with chemotherapy-induced anemia. In addition, the data demonstrate that both weight-based and fixed dosing with darbepoetin alfa are effective, and that early intervention to treat anemia has clinical benefits. Darbepoetin alfa also is an effective treatment for anemia in patients with cancer not receiving chemotherapy, at extended dosing intervals of at least 3 weeks. Extended dosing for anemia treatment can provide benefits for patients, caregivers, and clinicians because it reduces the number of clinic visits needed and permits synchronizing anemia treatment with chemotherapy cycles. Data from recent studies suggest that darbepoetin alfa is effective for treating anemia in patients with myelodysplastic syndrome; this potential use is being investigated further in ongoing studies. Thus, darbepoetin alfa is an attractive therapy option for patients with chemotherapy or cancer-induced anemia. It allows increased flexibility and simplified dosing and may offer some benefit in the treatment of anemia in patients with myelodysplastic syndrome.