Enhanced recovery after surgery (ERAS® ) Society abdominal and thoracic surgery recommendations: A systematic review and comparison of guidelines for perioperative and pharmacotherapy core items.

INTRODUCTION: Worldwide, ERAS® Society guidelines have ushered in a new era of perioperative care. The purpose of this systematic review is to compare published core elements and pharmacotherapy recommendations embedded within ERAS® Society abdominal and thoracic surgery (ATS) guidelines. Determining whether a consensus exists for pharmacological core items would make future guideline preparation for similar surgeries more standardized and could improve patient care by reducing unnecessary protocol variations. METHODS: From the ERAS® Society website as of May 2023, 16 current ERAS® published ATS guidelines were included in the analysis to determine consensus and differing statements regarding each ERAS® perioperative and pharmacotherapy-related item. The aims were to (a) determine whether a consensus for each item could be derived, (b) identify gaps in ERAS® protocol development, and (c) propose potential research directions for addressing the identified gaps in the literature. RESULTS: Core items with consensus included: preoperative smoking and alcohol cessation; avoiding bowel reparation and fasting; multimodal preanesthetic, perioperative analgesia, and postoperative nausea and vomiting regimens; low molecular weight heparins for in-hospital and at-home venous thromboembolism prophylaxis; antibiotic prophylaxis; skin preparation; goal-directed perioperative fluid management with balanced crystalloids; perioperative nutrition care; ileus prevention with peripherally-acting mu receptor antagonists; and glucose control. CONCLUSION: While consensus was found for aspects of 21 current ERAS® guideline core items related to pharmacotherapy choice, details related to doses, regimen, timing of administration as well as unique aspects pertaining to specific surgeries remain to be researched and harmonized to promote guideline consistency and further optimize patient outcomes.

Medication Management Through Collaborative Practice for Children With Medical Complexity: A Prospective Case Series.

OBJECTIVE: Care coordination for children and youth with special health care needs and medical complexity (CYSHCN-CMC), especially medication management, is difficult for providers, parents/caregivers, and -patients. This report describes the creation of a clinical pharmacotherapy practice in a pediatric long-term care facility (pLTCF), application of standard operating procedures to guide comprehensive medication management (CMM), and establishment of a collaborative practice agreement (CPA) to guide drug therapy. METHODS: In a prospective case series, 102 patients characterized as CYSHCN-CMC were included in this pLTCF quality improvement project during a 9-month period. RESULTS: Pharmacists identified, prevented, or resolved 1355 drug therapy problems (DTP) with an average of 13 interventions per patient. The patients averaged 9.5 complex chronic medical conditions with a -median length of stay of 2815 days (7.7 years). The most common medications discontinued due to pharmacist assessment and recommendation included diphenhydramine, albuterol, sodium phosphate enema, ipratropium, and metoclopramide. The average number of medications per patient was reduced from 23 to 20. A pharmacoeconomic analysis of 244 of the interventions revealed a monthly direct cost savings of $44,304 ($434 per patient per month) and monthly cost avoidance of $48,835 ($479 per patient per month). Twenty-eight ED visits/admissions and 61 clinic and urgent care visits were avoided. Hospital -readmissions were reduced by 44%. Pharmacist recommendations had a 98% acceptance rate. CONCLUSIONS: Use of a CPA to conduct CMM in CYSHCN-CMC decreased medication burden, resolved, and prevented adverse events, reduced health care-related costs, reduced hospital readmissions and was well-accepted and implemented collaboratively with pLTCF providers.

Effect of Pharmacoprophylaxis on Postoperative Outcomes in Adult Elective Colorectal Surgery: A Multi-Center Retrospective Cohort Study within an Enhanced Recovery after Surgery Framework.

BACKGROUND: The application of enhanced recovery after surgery principles decreases postoperative complications (POCs), length of stay (LOS), and readmissions. Pharmacoprophylaxis decreases morbidity, but the effect of specific regimens on clinical outcomes is unclear. METHODS AND MATERIALS: Records of 476 randomly selected adult patients who underwent elective colorectal surgeries (ECRS) at 10 US hospitals were abstracted. Primary outcomes were surgical site infection (SSI), venous thromboembolism (VTE), postoperative nausea and vomiting (PONV), pain, and ileus rates. Secondary outcomes included LOS and 7- and 30-day readmission rates. RESULTS: POC rates were SSI (3.4%), VTE (1.5%), PONV (47.9%), pain (58.1%), and ileus (16.1%). Cefazolin 2 g/metronidazole 500 mg and ertapenem 1 g were associated with the shortest LOS; cefotetan 2 g and cefoxitin 2 g with the longest LOS. No SSI occurred with ertapenem and cefotetan. More Caucasians than Blacks received oral antibiotics before intravenous antibiotics without impact. Enoxaparin 40 mg subcutaneously daily was the most common inpatient and discharge VTE prophylaxis. All in-hospital VTEs occurred with unfractionated heparin. Most received rescue rather than around-the-clock antiemetics. Scopolamine patches, spinal opioids, and IV lidocaine continuous infusion were associated with lower PONV. Transversus abdominis plane block with long-acting local anesthetics, celecoxib, non-anesthetic ketamine bolus, ketorolac IV, lidocaine IV, and pregabalin were associated with lower in-hospital pain severity rates. Gabapentinoids and alvimopan were associated with lower ileus rates. Acetaminophen, alvimopan, famotidine, and lidocaine patches were associated with shorter LOS. CONCLUSIONS: Significant differences in pharmacotherapy regimens that may improve primary and secondary outcomes in ECRS were identified. In adult ECRS, cefotetan or ertapenem may be better regimens for preventing in-hospital SSI, while ertapenem or C/M may lead to shorter LOS. The value of OA to prevent SSI was not demonstrated. Inpatient enoxaparin, compared to UFH, may reduce VTE rates with a similar LOS. A minority of patients had a documented PONV risk assessment, and a majority used as-needed rather than around-the-clock strategies. Preoperative scopolamine patches continued postoperatively may lower PONV and PDNV severity and shorter LOS. Alvimopan may reduce ileus and shorten LOS. Anesthesia that includes TAP block, ketorolac IV, and pregabalin use may lead to reduced pain rates. Acetaminophen, alvimopan, famotidine, and lidocaine patches may shorten LOS. Given the challenges of pain management and the incidence of PONV/PDNV found in this study, additional studies should be conducted to determine optimal opioid-free anesthesia and the benefit of newer antiemetics on patient outcomes. Moreover, future research should identify latent pharmacotherapy variables that impact patient outcomes, correlate pertinent laboratory results, and examine the impact of order or care sets used for ECRS at study hospitals.

How Compounding Pharmacies Fill Critical Gaps in Pediatric Drug Development Processes: Suggested Regulatory Changes to Meet Future Challenges.

Drugs administered to children in the United States fall into two broad categories: (1) those that have followed the US Food and Drug Administration (US-FDA) pediatric drug approval process and are marketed as finished dosage forms with pediatric labeling; and (2) all others, many of which are used "off-label". The use of most drug products in pediatrics is still off label, often requiring special preparation, packaging, and, in some cases, compounding into preparations. The latter category includes compounded preparations that incorporate either a US-FDA approved finished dosage form (e.g., a sterile solution, sterile powder, nonsterile capsules, oral solution, crushed tablets, etc.), or rely on bulk active pharmaceutical ingredients (APIs). Compounded preparations are prepared for individual patients in 503A pharmacies, or on a larger scale and not just for specific patients, in licensed 503B establishments. Critical gaps in the current drug approval process for finished dosage forms have created a proverbial "Gordian knot" that needs to be untangled thoughtfully to facilitate increased production and approval of vitally needed medications for pediatric patients. This opinion will describe current regulatory processes pertaining to pediatrics-only drug approval in the United States. Additionally, discussed are steps required for a product to acquire pediatric labeling. Gaps in regulatory approval pathways for both manufactured and compounded pediatric drugs will be identified, especially those that complicate and slow development and availability to patients. Finally, suggestions for regulatory modifications that may enhance pediatric product development strategies for both manufacturers and compounders are suggested.

Pediatric Perioperative Clinical Pharmacy Practice: Clinical Considerations and Management: An Opinion of the Pediatrics and Perioperative Care Practice and Research Networks of the American College of Clinical Pharmacy.

Pediatric perioperative clinical pharmacists are uniquely positioned to provide therapeutic and medication management expertise at a particularly vulnerable transition of care from the preoperative space, through surgery, and postoperative setting. There are many direct-patient care activities that are included in the role of the pediatric perioperative pharmacist, as well as many opportunities to develop effective, optimized, and safe medication use processes. This article outlines many of the areas in which a pediatric perioperative clinical pharmacist may intervene.

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.

Compounded Nonsterile Preparations and FDA-Approved Commercially Available Liquid Products for Children: A North American Update.

The purpose of this work was to evaluate the suitability of recent US Food and Drug Administration (US-FDA)-approved and marketed oral liquid, powder, or granule products for children in North America, to identify the next group of Active Pharmaceutical Ingredients (APIs) that have high potential for development as commercially available FDA-approved finished liquid dosage forms, and to propose lists of compounded nonsterile preparations (CNSPs) that should be developed as commercially available FDA-approved finished liquid dosage forms, as well as those that pharmacists should continue to compound extemporaneously. Through this identification and categorization process, the pharmaceutical industry, government, and professionals are encouraged to continue to work together to improve the likelihood that patients will receive high-quality standardized extemporaneously compounded CNSPs and US-FDA-approved products.

Pharmacotherapeutic prophylaxis and post-operative outcomes within an Enhanced Recovery After Surgery (ERAS®) program: A randomized retrospective cohort study.

BACKGROUND: Pharmacotherapy prophylaxis embedded in Enhanced Recovery After Surgery (ERAS®) protocols is largely unknown because data related to agent choice, dosing, timing, and duration of treatment currently are not collected in the ERAS Interactive Audit System (EIAS®). This exploratory retrospective randomized cohort study characterized pharmacologic regimens pertaining to prophylaxis of surgical site infections (SSI), venous thromboembolism (VTE), and post-operative nausea and vomiting (PONV). MATERIALS AND METHODS: The records of 250 randomly-selected adult patients that underwent elective colorectal (CR) and gynecologic/oncology procedures (GO) at an ERAS® site in North America were abstracted using REDCap. In addition to descriptive statistics, bivariate associations between categorical variables were compared. RESULTS: Rates of SSI, VTE, & PONV were 3.3%, 1.1%, and 53.6%, respectively. Mean length of stay (LOS) for CR was 6.9 days and for GO, 3.5 days (p < 0.001). The most common antibiotic prophylaxis was one-time combination cefazolin 2 g and metronidazole 500 mg between 16 and 30 min preoperatively after chlorhexidine skin preparation. The most frequent VTE prophylaxis was tinzaparin 4500 units SC daily continued for at least 7 days after hospital discharge in oncology patients. PONV was related to longer LOS in both groups. Total morphine milligram equivalents (MME) was positively related to PONV and LOS in both CR & GO groups. CONCLUSION: Guideline-consistent pharmacologic prophylaxis for SSI and VTE for both CR and GO patients was associated with low complication, LOS, and readmission rates. LOS in both groups was highly influenced by total MME, incidence of PONV and multi-modal anesthesia.

Positive Patient Postoperative Outcomes with Pharmacotherapy: A Narrative Review including Perioperative-Specialty Pharmacist Interviews.

The influence of pharmacotherapy regimens on surgical patient outcomes is increasingly appreciated in the era of enhanced recovery protocols and institutional focus on reducing postoperative complications. Specifics related to medication selection, dosing, frequency of administration, and duration of therapy are evolving to optimize pharmacotherapeutic regimens for many enhanced recovery protocolized elements. This review provides a summary of recent pharmacotherapeutic strategies, including those configured within electronic health record (EHR) applications and functionalities, that are associated with the minimization of the frequency and severity of postoperative complications (POCs), shortened hospital length of stay (LOS), reduced readmission rates, and cost or revenue impacts. Further, it will highlight preventive pharmacotherapy regimens that are correlated with improved patient preparation, especially those related to surgical site infection (SSI), venous thromboembolism (VTE), nausea and vomiting (PONV), postoperative ileus (POI), and emergence delirium (PoD) as well as less commonly encountered POCs such as acute kidney injury (AKI) and atrial fibrillation (AF). The importance of interprofessional collaboration in all periprocedural phases, focusing on medication management through shared responsibilities for drug therapy outcomes, will be emphasized. Finally, examples of collaborative care through shared mental models of drug stewardship and non-medical practice agreements to improve operative throughput, reduce operative stress, and increase patient satisfaction are illustrated.

The Perioperative Surgical Home in Pediatrics: Improve Patient Outcomes, Decrease Cancellations, Improve HealthCare Spending and Allocation of Resources during the COVID-19 Pandemic.

Cancellations or delays in surgical care for pediatric patients that present to the operating room create a great obstacle for both the physician and the patient. Perioperative outpatient management begins prior to the patient entering the hospital for the day of surgery, and many organizations practice using the perioperative surgical home (PSH), incorporating enhanced recovery concepts. This paper describes changes in standard operating procedures caused by the COVID-19 pandemic, and proposes the expansion of PSH, as a means of improving perioperative quality of care in pediatric populations.

Where are the Ambulatory Care Pediatric Pharmacists?

This editorial describes the purposes and content of the Special Issue for the development of a national pediatric pharmacotherapy collaborative practice network. A collaborative practice network from a population health perspective is needed to better manage the medication-related needs of children with special health care needs and medical complexity (CSHCN-CMC). Over the last 25 years, the pharmacy profession has been engaged in organized efforts both to elevate practice and educational standards for pediatric pharmacy practice and to design medication management systems that benefit children and their families and caregivers. Moreover, alignment with pediatric clinical pharmacologists will aid in the development of new practice-based research paradigms that can be applied in the clinical setting. Formalized multi-disciplinary collaboration (CPAs) with new approaches to specialized electronic medication systems and comprehensive medication management (CMM) is necessary to improve the pharmacotherapy outcomes of pediatric patients.

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.

Clinical pharmacist perspectives for optimizing pharmacotherapy within Enhanced Recovery After Surgery (ERAS®) programs.

One of the most durable approaches to perioperative enhanced recovery programming has culminated in the formation of perioperative organizations devoted to improvements in the quality of the surgical patient experience, such as the Enhanced Recovery After Surgery (ERAS®) Society. Members of the American College of Clinical Pharmacy (ACCP) Perioperative Care Practice and Research Network (PRN) and officials from the ERAS® Society present an opinion that: (1) identifies therapeutic options within each pharmacotherapy-intensive area of ERAS®; (2) generates applied research questions that would allow for comparative analyses of pharmacotherapy options within ERAS® programs; (3) proposes collaborative practice opportunities between key stakeholders in the surgical journey and clinical pharmacists to manage drug therapy problems and research questions; and (4) highlights examples of pharmacist-led cost savings attributed to ERAS® implementation. Clinical pharmacists, working in this manner with the perioperative team across the care continuum, have optimized pharmacotherapy towards measurable outcomes improvements, and stand ready to partner with inter-professional stakeholders and organizations to advance the care of our mutual patients.

Lecture 2-What Is a Formulary, Anyway? (Or the Cliff Notes Version of Drug Stewardship and Expense Control).

A formulary is the product of an evaluative process, the formulary system, conducted by an expert panel that both sanctions and guides the selection, prescription, administration, and monitoring of pharmaceuticals and related items for a given environment. An expert panel, often called the Pharmacy and Therapeutics Committee (P&T), is a group of pharmacists, physicians, nurses, and administrators assembled for the purpose of providing guidance and validation for pharmaceutical utilization in a given organization. Expert panels became prominent because of qualitative and quantitative changes in drug production and marketing strategies employed by industry, the expansion of public health sector medicine, and organized, macro-level drug control systems. It could be argued that, as a clinical instrument, the formulary is predicated on the role pharmacy is perceived to play in actual direct patient care. In this lecture, the concept and defining characteristics of a formulary (the perspective of an expert panel, differences in the environment of application, and interprofessional relationships), the modifiers used to describe a formulary, which modifiers enhance or distract from its meaning, and the outlook for comprehensive and objective evaluation through the formulary mechanism are discussed.

What Is a Formulary, Anyway? Part 2.

This paper is a continuation of the first paper on drug formularies. It details the various types of formularies, and speculates on the future of formularies as an instrument for improving rational drug therapy.

Current Trends and Emerging Priorities in Compounded Preparations for Children.

The problems related to pediatric pharmacotherapeutics and medication management are not unique to any particular country, as drug therapy problems are common causes of emergency department visits. Over the past 20 years, there were only sporadic scientific and commercial efforts to develop unique oral nonsterile dosage forms with a potential for mass production and standardization that would address the needs of pediatric patients under the age of four years with chronic diseases. This article raises awareness of the issues encountered in pharmacy pediatrics practice surrounding compounded nonsterile preparations. Current trends and emerging priorities at the interface between the use of these preparations and patient safety will be discussed. Trends in compounded nonsterile preparations preparation for children include standardization of nomenclature, formulation, dose, re-purposing old medications, reformulating older drugs, increasing federal oversight of pharmacy compounding, and changes to broaden the scope of indications in the product's label. Among the emerging priorities for safe pediatric compounded nonsterile preparations use include creation of new formulations for expanding pediatric diagnoses, improved quality-control processes described in United States Pharmacopeia Chapter <795>, closing the patient safety gap with changes to the prescription fulfillment systems, and employment of board-certified pediatric pharmacy specialists within the fulfillment process. In particular, an emerging opportunity to close the good clinical practice-good manufacturing practice gap at the pharmacy or point-of-care level with application of reverse-engineering concepts and other novel solutions have the potential to improve a pharmacist's ability to produce quality pediatric compounded nonsterile preparations. A systems approach (Formulation, Information, Collaboration, and Innovation) to the design of an integrated prescription generation and medication management system for children, including a simulation functionality, would include validation of small batch compounded nonsterile preparations, provision of complete information necessary to verify a prescription order, establishment of models of collaboration between board-certified pediatric clinical pharmacists and pediatricians, and performance of pragmatic clinical trials regarding compounded nonsterile preparation use in children.

Lecture 3-Measuring Pharmacy's Work in the 21st Century.

The importance of developing a thoroughly shared understanding of mission, vision, and values is highlighted in reference to the creation of meaningful and sustainable key performance indicators (KPIs). A review of clinical practice KPIs (cpKPIs) and operational KPIs (opKPIs) is provided using work load measurement activities from Canada, its province of Alberta, and the United Kingdom. In order for Singaporean pharmacy clinicians and leaders to embrace a unified KPI system, the natural tendency to measure what is easy and available, instead of what matters to patients, is difficult but must be overcome.

Briefing Note: Proceedings of the Singapore National Clinical Pharmacy Colloquium-Health Manpower Development Planning.

The nation of Singapore highly values its health service as well as the component of healthcare delivery that includes clinical pharmacy and administration. The Ministry of Health (MOH) engaged the services of Dr. Richard Parrish to better understand the relationship between the Singaporean citizenry and its clinical pharmacists. Through a series of five lectures, structured from the national to local unit level, four roundtables, two hands-on sessions, and three workshops, clinical pharmacists and administrative leadership participated in “open-mic” style lectures, discussed the issues facing Singapore pharmacy in its current provision of healthcare services, and deliberated on the future resources required to meet projected healthcare needs. From three distinct perspectives, these discussions were very frank, transparent, and passionate about what practitioners and administrators thought Singaporean health leadership needed to address in terms of (1) what programs and practices to continue; (2) what ones to start; and (3) what ones to evaluate. Each of the areas below will be framed using these three perspectives in order to clearly reflect the ideas and suggestions expressed in each of the 14 group sessions. These recommendations are forwarded to MOH pharmacy leadership for consideration and action. In addition, we met with MOH leaders regarding non-medical prescribing (NMP), and discussed strategies and tactics that seemed successful as well as unsuccessful in other jurisdictions when adopting expanded scope models for clinical pharmacists and other qualified healthcare providers that include prescribing of medications.

Lecture 1-Justification of the Value of Clinical Pharmacy Services and Clinical Indicators Measurements-Introductory Remarks from a Traveler on a 40-Year Wayfaring Journey with Clinical Pharmacy and Pharmaceutical Care.

Without question, health care delivery, and clinical pharmacy’s purpose in it, is changing rapidly all over the world. Pharmacy’s place in the new health care environment is ensured only to the extent that the purpose of pharmaceutical care is understood and transmitted to the global structures of these developing organizational patterns and paradigm shifts. While the current trend toward commodification of illness and treatment seems to be driving efforts to consolidate the economic factors of pharmaceutical distribution, a new type of practice—patient-driven health care—has continued to shape the interactions of pharmacists and patients all over the world. A thorough understanding of the above factors involved in pharmacy’s history, present, and future are necessary for clinical practice preparation, as well as for value justification. How clinical pharmacy will succeed in this kind of social and economic milieu is precisely why this series of lectures and roundtables will help us embrace many of the vexing issues that clinical pharmacy administrators and practitioners face in daily practice.