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The coronavirus disease 2019 (COVID-19) pandemic caused by the severe acute respiratory syndrome coronavirus 2 has challenged health systems to find innovative ways of delivering patient care while protecting staff from infection with the virus As the COVID-19 pandemic has continued to evolve establishing ?hot spots? in various areas of the country, clinicians have learned more about caring for these patients This has required the Department of Pharmacy at Thomas Jefferson University Hospital to constantly update the approach it has taken during this time, and the guidance which is provided for the pharmaceutical care of these patients Because Philadelphia was in the initial stages of the pandemic within the United States, operations within the Department of Pharmacy at Thomas Jefferson University Hospital needed to be redesigned This brief report provides an example of the swift changes that were made in the pharmacy practice model at a large academic medical center Herein we describe the impact of the pandemic on the Department of Pharmacy at Thomas Jefferson University Hospital with a focus on clinical and operations aspects The areas that will be highlighted in this report represent areas that required rapid and transformational change to the operations and/or clinical care in order to protect the health of pharmacists and allow them to continue to provide the necessary level of patient care This article is protected by copyright All rights reserved

Purpose The application of lean methodology in an initiative to redesign the formulary maintenance process at an academic medical center is described. Summary Maintaining a hospital formulary requires clear communication and coordination among multiple members of the pharmacy department. Using principles of lean methodology, pharmacy department personnel within a multihospital health system launched a multifaceted initiative to optimize formulary management systemwide. The ongoing initiative began with creation of a formulary maintenance redesign committee consisting of pharmacy department personnel with expertise in informatics, automation, purchasing, drug information, and clinical pharmacy services. The committee met regularly and used lean methodology to design a standardized process for management of formulary additions and deletions and changes to medications’ formulary status. Through value stream analysis, opportunities for process and performance improvement were identified; staff suggestions on process streamlining were gathered during a series of departmental kaizen events. A standardized template for development and dissemination of monographs associated with formulary additions and status changes was created. In addition, a shared Web-based checklist was developed to facilitate information sharing and timely initiation and completion of tasks involved in formulary status changes, and a permanent formulary maintenance committee was established to monitor and refine the formulary management process. Conclusion A clearly defined, standardized process within the pharmacy department was developed for tracking necessary steps in enacting formulary changes to encourage safe and efficient workflow.

Propofol has reduced healthcare costs in coronary artery bypass graft (CABG) surgery patients by decreasing post-operative duration of mechanical ventilation. However, the US shortage of propofol necessitated the use of alternative agents. This study sought to evaluate clinical and economic implications of substituting dexmedetomidine for propofol in patients undergoing CABG surgery. This was a retrospective cohort study. Patients undergoing isolated, elective CABG surgery and sedated with either propofol or dexmedetomidine during the study period were included. The cohorts were matched 1:1 based on important characteristics. The primary outcome was the number of patients achieving a post-operative duration of mechanical ventilation ≤6 h. Secondary outcomes were post-operative intensive care unit (ICU) length of stay (LOS) ≤48 h, total post-operative LOS ≤5 days, the need for adjunctive opioid therapy and associated cost savings. Variables recorded included patient demographics, co-morbid medical conditions, health risks, sedation drug doses, post-operative medical complications and sedation-related adverse events. Univariate and multivariate analyses were completed to examine the relationship between these covariates and post-operative LOS. The cost analysis consisted of examination of the net financial benefit (or cost) of choosing dexmedetomidine versus propofol in the study population, with utilisation observed in the study converted to costs using institutional data from the Premier database. Eighty-four patients were included, with 42 patients per cohort. Mechanical ventilation duration ≤6 h was achieved in 24 (57.1 %) versus 7 (16.7 %) in the dexmedetomidine and propofol cohorts, respectively (p

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.

Perioperative pain management has drastically evolved over the years to satisfy current unmet needs. Intermittent delivery of drugs has been replaced by continuous delivery systems involving oral, neuraxial, and peripheral nerve block routes of administration. One current standard of perioperative pain management is an epidural injection of an opioid such as morphine, fentanyl, or hydromorphone, with or without the addition of a local anesthetic, such as bupivacaine. Although this method is extremely effective in controlling pain during the most critical 48-hour period postoperatively, it also has its disadvantages. Risks associated with indwelling epidural catheters include infection, adverse effects, and spinal hematoma. The development of extended- and controlled-release drug delivery systems has revolutionized perioperative pain management. This class of drugs comprises MS Contin (Purdue Pharma LP, Stamford, CT), OxyContin (Purdue Pharma LP), Opana ER (Endo Pharmaceuticals, Chadds Ford, PA), and DepoDur (Endo Pharmaceuticals). There are also phase II trials in progress examining controlled-release formulations of local anesthetics. This review discusses extended- and controlled-release agents administered perioperatively.

A therapeutic-interchange (TI) program for oral histamine H2-receptor antagonists at a hospital is described. In 1992 the pharmacy and therapeutics committee at a large teaching hospital accepted cimetidine as the preferred oral H2 antagonist. However, the program to promote cimetidine met with little success. The manufacturer of nizatidine then offered the hospital that drug at a reduced cost relative to all other members of the drug class. The committee recommended including nizatidine on the formulary; implementing a TI program so that when an order for an oral H2 antagonist was written nizatidine would be dispensed; deleting cimetidine and ranitidine tablets from the formulary; and retaining cimetidine and ranitidine oral liquid and i.v. formulations. The program was approved by the medical executive committee and was implemented in August 1994. Extensive efforts to inform the pharmacy, medical, and nursing staffs about the program were undertaken, and the pharmacy established mechanisms for monitoring compliance. Two months into the program, 97% of eligible patients were receiving nizatidine. Actual cost savings in the first four months exceeded $40,000. In July 1997 the same program was applied to famotidine, which had replaced nizatidine as the most cost-effective H2 antagonist. A successful TI program for oral H2 antagonists was achieved by gaining physician support for the program, educating providers, monitoring compliance, and responding to changes in drug costs.

The Drug Use Policy and Medical Information Service of Thomas Jefferson University Hospital conducted a survey of industry- and academic-based drug information centers to examine the types of Internet-based resources provided and used, demographics of the centers, and electronic mail and World Wide Web usage. A total of 464 surveys were sent (293 to industry sites and 171 to academic sites), with a response rate of 29%. Results indicated that medical information specialists in industry- and academic-based drug information centers use the Internet daily. Most centers have access to e-mail and the World Wide Web. Fewer that 25% of the respondents provided a homepage for their center. Internet usage in many centers has increased from the previous year.

Hydroxyurea was approved by the Food and Drug Administration for the treatment of adults with moderate to severe sickle cell anemia and sickle-β0-thalassemia. Its major side effect is myelotoxicity, which is reversible upon discontinuation of the drug. Other side effects that have been described in animal studies but unconfirmed in humans include its teratogenic and carcinogenic potential. Additionally, hydroxyurea has idiosyncratic side effects that occur in some individuals and this may be a genetic or epigenetic phenomenon. We report three idiosyncratic side effects of hydroxyurea in four patients with sickle cell anemia (SS). Desquamating rash, decreased libido and partial complex seizures have not been previously described in patients who are hydroxyurea responders. Although these reactions are rare, they can be serious in some patients.

A survey of U.S. bone marrow transplantation (BMT) programs was conducted to determine the role of pharmaceutical services in those programs and the pharmacy department resources allocated to support them. Surveys were sent to 92 U.S. BMT programs to solicit the following information: characteristics of the institution and the BMT program, extent of pharmacist involvement in the BMT program, and pharmacy resource allocation to the program. Fifty-five responses were received (60% response rate). BMT pharmacists were employed by 53 of these institutions (a total of 66 pharmacists). BMT pharmacists at 49 of the 53 institutions (92%) received their salary from the department of pharmacy. Common BMT pharmacist responsibilities included managing adverse effects (100% of respondents), adjusting medication doses (96%), providing drug information (94%), participating in BMT team rounds (87%), maintaining medication profiles (85%), and developing medication protocols (81%). Inpatient BMT-related drug costs (reported by 37 respondents) averaged 12% of the pharmacy's annual inpatient drug budget. One or more pharmacists were members of the BMT team at 46 of 53 institutions. BMT-related drug costs accounted for 12% of the total inpatient drug budget at the 37 institutions reporting cost data.

This article reviews and describes the formulary decision-making process in an academic medical centre. The pharmacy and therapeutics (PT) committee is the organisational nucleus of the drug use control process in the institutional environment. Thomas Jefferson University Hospital (TJUH), a 720-bed academic medical centre in an urban locality in the US, is used as a model representative of how most of these committees function. Survey responses collected from 29 peer academic medical centres are presented to compare and contrast the structure and function of the PT committee at TJUH with corresponding procedures in other university hospitals in the US. TJUH is typical of the institutions which comprise the University Hospital Consortium (UHC). The PT committee of TJUH is composed of 29 members, meets once per month for 10 months of the year, and has a network of 13 subcommittees. TJUH has an intermediately controlled (mixed) formulary, and uses both restricted drugs and treatment guidelines. Of the 29 UHC member institutions responding to the survey, the average PT membership is 18, the average meeting frequency is 11 times per year, and 83% of these committees have a network of subcommittees. None describe their formulary system as open, 86% have a closed formulary and 14% have a mixed formulary system. There is a restricted drug programme in 76% of the institutions, 79% utilise treatment guidelines, 76% practice therapeutic interchange and all employ generic substitution. Specific areas addressed in this review include the history of the formulary system, the structure and function of the PT committee, types of formularies, cost containment and the formulary decision-making process, the impact of organisational culture on physician decision making, the role of the pharmacy department, the role of pharmaceutical sales representatives and their impact on prescribing habits, the impact of the Joint Commission on Accreditation of Healthcare Organisations (JCAHO) Agenda for Change on the formulary process, and future challenges.

OBJECTIVE:To review published abstracts, case reports, and journal articles and evaluate data examining the use of systemic corticosteroids as adjuvant treatment for Pneumocystis carinii pneumonia (PCP) in patients with AIDS.DATA SOURCES:Computerized online databases, peer-reviewed journals from January 1986 through September 1991, and personal communication with a National Institutes of Health correspondent.STUDY SELECTION:The authors identified 13 reports pertinent to this review. By author consensus, five studies were selected for analysis based on sample size, controlled study design, and clinical outcome measures. Recommendations of an expert panel from the National Institutes of Health and the University of California also are discussed.DATA EXTRACTION:Data are presented based on the methodologic strength of the studies reviewed. Studies are assessed on sample size, inclusion criteria, comparative cohort populations, specific patient outcome measures, and statistical analysis.DATA SYNTHESIS:Results of the study analysis support the use of systemic corticosteroids as early adjunctive therapy for AIDS patients with moderate-to-severe PCP who have an initial arterial oxygen partial pressure of 35 mm Hg on room air. Improved outcomes included decreased mortality, respiratory failure, and deterioration of oxygenation. Data evaluated have shown that adjuvant corticosteroid therapy is most effective when initiated within 72 hours of beginning specific antipneumocystis therapy. A small, but sometimes significant, increased rate of infection in steroid-treated patients was noted.CONCLUSIONS:Based on the literature reviewed, early systemic adjuvant corticosteroid therapy can benefit patients with moderate-to-severe AIDS-related PCP. The steroid regimen used in the largest controlled trial and recommended by the expert panel is prednisone 40 mg bid (days 1–5), then 40 mg/d (days 6–10), then 20 mg/d (days 1–21).

Evidence from the literature strongly supports that high doses of TMP, as used in the treatment of PCP in AIDS patients, have the propensity to cause hyperkalemia by inhibiting sodium channels in the distal nephron, thereby impairing potassium secretion. The mechanism of TMP-induced hyperkalemia is believed to be similar to that of triamterene and amiloride because of the structural similarity of these agents. It is also possible that declining renal function, which is a natural progression of HIV disease, may contribute to the hyperkalemia seen in this patient population. In addition, patients with AIDS also may exhibit a defect in adrenal function, potentiating the hyperkalemic effect of TMP therapy. Therefore, it is crucial for clinicians to monitor closely the serum potassium concentration in this patient population, especially during therapy with high doses of TMP.

The intravenous immune globulin (IGIV) preparations are reviewed with respect to method of preparation, pharmacokinetics, clinical uses (with emphasis on the labeled indications), and adverse reactions; a brief review of the immune system also is provided. IGIV preparations are approved for the treatment of hypogammaglobulinemia, recurrent bacterial infections due to B-cell chronic lymphocytic leukemia, and idiopathic thrombocytopenic purpura (ITP). The mechanism of action in the first two indications is passive replacement of antibodies, but in ITP the mechanism is not clearly established. The clinical literature on the use of IGIV for these indications is summarized. In patients with ITP, platelet counts return to safe levels and the number of infections is reduced in patients with primary humoral immunodeficiency treated with IGIV. The use of IGIV in pregnant women and premature infants is controversial. Adverse reactions are primarily related to infusion rate, activation of complement, and anaphylactic reactions to a component of the product. There is minimal to no risk of viral transmission with IGIV therapy. IGIV also has been administered safely on an outpatient or homecare basis. This has led to a feeling of greater control by patients over their chronic illness. Other uses of IGIV are under investigation. As our understanding of the immune system and the pharmacology of immune globulin increases, the uses of IGIV will expand.

Intravenous immune globulin (IV-IgG) is approved for use in substitution therapy of immunodeficiency syndromes and treatment of idiopathic thrombocytopenic purpura (ITP). The initial dose for substitution therapy is 0.2 g/kg body weight repeated monthly. If necessary, the dose may be increased to 0.3 g/kg and the frequency to every 2-3 weeks. The approved dosage for ITP is 0.4 g/kg daily for 2 to 5 consecutive days. Repeat doses of 0.4 g/kg have been used as maintenance therapy. The initial infusions of IgG to immunodeficient patients who have not been treated during the previous 8 weeks or never treated at all should proceed with caution. These patients are at risk of potentially serious complement-mediated adverse reactions. Adverse reactions due to IgG administration are less frequent and less severe for patients with ITP. Currently available preparations are contraindicated in patients with a selective IgA deficiency and detectable IgA antibodies.

We reviewed the records of 49 patients who had 55 episodes of Pneumocystis carinii pneumonia (PCP) from January 1984 to January 1987. Thirty-three patients had acquired immunodeficiency syndrome (AIDS), with the risk groups being homosexual/bisexual practices (26), hemophilia (6), and blood transfusion (1). Fourteen patients had a history of malignancy or chemotherapy and two underwent organ transplantation. Overall response to therapy of PCP was 75% (77% of patients with AIDS, 68% of those with other conditions). All six relapses occurred in patients with AIDS. Both trimethoprim-sulfamethoxazole (TMP-SMX) and pentamidine were associated with a higher rate of toxicity in those patients than in patients with other conditions. A 30% rate of failure due to side effects occurred when TMP-SMX was used as initial therapy, but the combination is considered effective and should be given an adequate therapeutic trial. Pentamidine was an effective alternative for patients who failed with TMP-SMX and for those who failed therapy due to side effects, but was associated with serious toxicities. Our experience was similar in some respects to previous published results from New York and California.

Idiopathic thrombocytopenic purpura (ITP) is a disorder characterized by a low platelet count and purpura. Identification of an antiplatelet antibody suggests that this is an autoimmune disease. Corticosteroids and splenectomy have been the major therapies for many years. High-dose intravenous immune globulin (IV-IgG) has been very successful in the management of ITP and has recently received FDA approval for this condition. It was also successful when administered to a few patients with autoimmune neutropenia. The exact mechanism of action of IV-IgG in autoimmune disorders is poorly understood. Currently, high-dose IV-IgG has a definite place in the management of ITP. Its role in therapy includes emergency treatment, preoperative preparation, the postponement of splenectomy in young children, and treatment of ITP during pregnancy.