Creating Data Standards to Support the Electronic Transmission of Compounded Nonsterile Preparations (CNSPs): Perspectives of a United States Pharmacopeia Expert Panel.

The perspectives of the Compounded Drug Preparation Information Exchange Expert Panel of the United States Pharmacopeia (CDPIE-EP) on the urgent need to create and maintain data standards to support the electronic transmission of an interoperable dataset for compounded nonsterile preparations (CNSPs) for children and the elderly is presented. The CDPIE-EP encourages all stakeholders associated with the generation, transmission, and preparation of CNSPs, including standards-setting and informatics organizations, to discern the critical importance of accurate transmission of prescription to dispensing the final product and an urgent need to create and adopt a seamless, transparent, interoperable, digitally integrated prescribing and dispensing system benefiting of all patients that need CNSPs, especially for children with special healthcare needs and medical complexity (CSHCN-CMC) and for adults with swallowing difficulties. Lay summary: Current electronic prescription processing standards do not permit the complete transmission of compounded nonsterile preparations (CNSPs) from a prescriber to dispenser. This lack creates multiple opportunities for medication errors, especially at transitions of care for children with medical complexity and adults that cannot swallow tablets and capsules. The United States Pharmacopeia Expert Panel on Compounded Drug Preparation Information Exchange aims to reduce this source of error by creating ways and means for CNSPs to be transmitted within computer systems across the continuum of care. Twitter: Digitizing compounded preparation monographs and NDC-like formulation identifiers in computerized prescription systems will minimize error.

US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty?

Recently, the US Food and Drug Administration (FDA) issued emergency use authorization (EUA) for convalescent plasma (CP) for the treatment of hospitalized patients with coronavirus disease 2019 based on a non-peer-reviewed, open-label, observational study. Issuance of an EUA without a proven randomized, controlled trial (RCT) sets a dangerous precedent since the premature action drives healthcare providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recent debacle related to the rescinded EUA of hydroxychloroquine and chloroquine, which were approved initially based on an anecdotal report. The FDA process for determining efficacy and safety must be based solely on data from RCTs in order to sustain public and professional trust for future treatment and vaccine efforts to be successful.

Minimizing Medication Errors from Electronic Prescription Transmission-Digitizing Compounded Drug Preparations.

Lack of standardization related to compounded drug preparations, especially in the transition of care situations, threatens patient safety by facilitating medication error. This paper outlines progress to-date from the United States Pharmacopeia (USP) Expert Panel on the Exchange of Compounded Drug Preparation Information in Health IT Systems. The work plan developed for the group is focused on proposing a set of encoding rules that would govern how compounded nonsterile drug preparations (CNSPs) are digitized and exchanged, including patient electronic health records (EHR), pharmacy systems, e-prescribing (eRx), and other Health IT (HIT) systems to ensure a seamless compounding process tailored to the needs of an individual patient. Included in this work are identifying authorized compounding monographs, surveying provider and end-user groups for information about data specificity during e-prescribing, and generating guidelines for the development of a compatible data model for clinical formulation identifiers (CF-IDs). This paper will also discuss how evolving nomenclature standards for CNSPs within HIT systems are part of a quality assurance system for comprehensive medication management (CMM) in children, thereby minimizing medication errors across the continuum of care. Finally, a network approach for the design of medication management systems for children and their families/caregivers is proposed.

Impact of the Pharmacy Practice Model Initiative on Clinical Pharmacy Specialist Practice.

This paper describes the goals of the American Society of Health-System Pharmacists' Pharmacy Practice Model Initiative (PPMI) and its recommendations for health-system pharmacy practice transformation to meet future patient care needs and elevate the role of pharmacists as patient care providers. PPMI envisions a future in which pharmacists have greater responsibility for medication-related outcomes and technicians assume greater responsibility for product-related activities. Although the PPMI recommendations have elevated the level of practice in many settings, they also potentially affect existing clinical pharmacists, in general, and clinical pharmacy specialists, in particular. Moreover, although more consistent patient care can be achieved with an expanded team of pharmacist providers, the role of clinical pharmacy specialists must not be diminished, especially in the care of complex patients and populations. Specialist practitioners with advanced training and credentials must be available to model and train pharmacists in generalist positions, residents, and students. Indeed, specialist practitioners are often the innovators and practice leaders. Negotiation between hospitals and pharmacy schools is needed to ensure a continuing role for academic clinical pharmacists and their contributions as educators and researchers. Lessons can be applied from disciplines such as nursing and medicine, which have developed new models of care involving effective collaboration between generalists and specialists. Several different pharmacy practice models have been described to meet the PPMI goals, based on available personnel and local goals. Studies measuring the impact of these new practice models are needed.

Bupivacaine liposomal versus bupivacaine: comparative review.

Bupivacaine liposomal injection was recently approved by the US Food and Drug Administration (FDA) as a local anesthetic for use in management of postsurgical pain in adults. When compared to placebo, bupivacaine liposomal decreases postoperative pain and opioid use. This review examines the efficacy of bupivacaine liposomal when compared to conventional bupivacaine ± epinephrine using published and unpublished data provided to the FDA by the manufacturer.

Compounding pharmacy conundrum: "we cannot live without them but we cannot live with them" according to the present paradigm.

Compounding pharmacies serve a critical role in modern health care to meet special patient care needs. Although the US Food and Drug Administration (FDA) has clearly delineated jurisdiction over drug companies and products manufactured under Good Manufacturing Practice (GMP) regulations to ensure quality, potency, and purity, compounding pharmacies are regulated by the State Boards and are not registered by the FDA. In recent years, some compounding pharmacies acted like a manufacturer, preparing large amounts of injectable drugs with interstate activities. Multiple outbreaks have been linked to compounding pharmacies, including a recent outbreak of fungal meningitis related to contaminated methylprednisolone, exposing > 14,000 patients in multiple states. This tragedy underscores the urgency of addressing safety related to compounding pharmacies. There is a call for action at the federal and state levels to set minimum production standards, impose new labeling conditions on compounded drugs, and require large-scale compounders be regulated by the FDA. "Industrial" compounding must come under FDA oversight, require those pharmacies to meet GMP standards, and ensure quality and safe products for patient use. Moreover, compliance with the Institute for Safe Medication Practices 2011 recommendations that any type of sterile compounding must be in compliance with the United States Pharmacopoeia chapter 797 guidelines will reduce the risk of patient harm from microbial contamination. Finally, other critical factors that require close attention include addressing injectable products compounded in hospitals and other outpatient health-care centers. The FDA and State Boards of Pharmacy must be adequately funded to exercise the oversight effectively.

Antibiogram compliance in University HealthSystem Consortium participating hospitals with Clinical and Laboratory Standards Institute guidelines.

PURPOSE: The degree of compliance with antibiogram guidance among University HealthSystem Consortium (UHC) hospitals was analyzed. METHODS: The UHC Pharmacy Council Pharmacy Practice Advancement Committee conducted a survey to evaluate hospital policies regarding the generation, reporting, and utilization of antibiograms among UHC hospitals. The survey was distributed via a UHC online survey tool to pharmacy directors at 237 UHC hospitals. Responses were collected from April 13 to May 14, 2010. RESULTS: Of the 237 hospitals to which surveys were sent, 49 hospitals (21%) from 28 states submitted survey responses. Forty-eight hospitals reported that they routinely generated antibiograms, and 36 reported that they adopted all or most of the standards recommended by the 2009 guidelines on antibiograms published by the Clinical and Laboratory Standards Institute (CLSI). The compliance rates to the four key CLSI recommendations were as follows: 98% reported data at least annually, 89% eliminated duplicate isolates, 83% did not include surveillance isolates, and 64% required at least 30 isolates for each reported species. Thirty-eight hospitals had an antimicrobial stewardship program; 35 of them formally reviewed antibiograms and 19 implemented new programs based on the antibiogram data. In 16 hospitals, formulary changes were made as a consequence of antibiogram results. In 30 hospitals, pharmacists had significant involvement in compiling, reviewing, and reporting antibiograms. CONCLUSION: Among respondents from 47 UHC hospitals, the compliance rates to four key CLSI recommendations for antibiograms ranged from 64% to 98%. Respondents from 30 hospitals reported significant involvement of pharmacists in compiling, reviewing, and reporting antibiograms.

A national survey on hospital formulary management processes.

PURPOSE: In light of formulary management guidelines from the American Society of Health-System Pharmacists (ASHP), and discussion of pharmacies' noncompliance with recent Joint Commission accreditation requirements, the University HealthSystem Consortium conducted a formulary management survey to determine member institutions' standard of practice. METHODS: An electronic survey was distributed to 227 institutions. Questions pertained to formulary structure, policies and procedures to manage formulary processes, tracking nonformulary medication use, pharmacoeconomic assessment, and Food and Drug Administration (FDA)-approved versus off-label medication use. RESULTS: Fifty-two institutions across the United States provided responses. Most institutions maintain written policies for how medications are requested (94%) and reviewed (88%) for formulary addition; 92% of institutions have a nonformulary medication process. Nonformulary medication use is tracked at 88% of institutions, and 85% of institutions conduct pharmacoeconomic analyses. Regarding The Joint Commission's requirement to approve drugs for specific indications, 40% of institutions approve drugs for all FDA-approved indications; 35% of institutions have not formally addressed this requirement. Approximately 31% of the institutions have a policy for approving a medication for an off-label indication. CONCLUSION: Portions of the ASHP guidelines have been implemented by most institutions, while 35% of institutions have yet to address The Joint Commission's clarification to approve drugs for specific indications.