Light-Sensitive Injectable Prescription Drugs-2022.

This chart is an update to the 2014 article published in Hospital Pharmacy on injectable drugs that require protection from light. To update the chart, an online search of the FDALabel database was performed from inception through July 31, 2022 using the terms "protect" OR "light." After filtering out drugs with non-injectable routes of administration, the list of generic drug names was combined with the 2014 list and duplicates were removed. The resulting list of drugs was then reviewed to determine whether the drugs require protection from light during storage, preparation, or administration. The reader should always consult the Food and Drug Administration-approved prescribing information for the most up-to-date information regarding the need for protection from light.

Drugs to Be Used With a Filter for Preparation and/or Administration-2019.

This chart is an update to the 2012 article published in Hospital Pharmacy on injectable drugs to be used with a filter. To update the chart, drugs approved from December 2011 to April 2019 were reviewed to determine if they require filtration and drugs included in the 2012 table were reviewed for accuracy. Readers are urged to review national standards of practice for information about clinical situations that warrant the use of a filter for medication preparation or administration, independent of the drug being given, and the reader should consult the Food and Drug Administration (FDA)-approved prescribing information for the most up-to-date information.

Formulary Considerations for Insulins Approved Through the 505(b)(2) "Follow-on" Pathway.

OBJECTIVE: To summarize formulary-relevant issues for follow-on insulins approved through the Food and Drug Administration (FDA) 505(b)(2) approval pathway (Basaglar and Admelog). DATA SOURCES: A search of the MEDLINE database was performed for articles pertaining to clinical and formulary considerations for follow-on insulin products through July 2018. STUDY SELECTION AND DATA EXTRACTION: All clinical trials used in the 505(b)(2) approval process for follow-on insulin glargine and insulin lispro products were included and summarized. DATA SYNTHESIS: Follow-on insulin glargine and insulin lispro products have been recently approved as the first lower-cost alternatives to innovator insulin products. The follow-on insulins were approved via the 505(b)(2) pathway, making them neither generics nor biosimilars. Current data do not suggest any clinically relevant differences between the follow-on insulins and their respective innovator products. Clinicians should be aware that follow-on insulins will be reclassified as biologic products in the year 2020. Relevance to Patient Care and Clinical Practice: This article provides information about currently available follow-on insulin products that were approved through the 505(b)(2) pathway, including product characteristics and efficacy and safety data. These products will likely be considered for both clinical use and formulary placement because of their potentially lower cost compared with innovator products. CONCLUSIONS: Follow-on insulin products approved through the 505(b)(2) pathway are supported by robust efficacy and safety data. As new follow-on insulins are approved and the regulatory change that will occur with these products in 2020 approaches, formulary decisions and clinical policies (eg, substitution) will continue to be revisited.

Use of oral vitamin K for prevention of late vitamin k deficiency bleeding in neonates when injectable vitamin K is not available.

OBJECTIVE: To evaluate the literature describing use of oral vitamin K(1) (phytonadione) to prevent late vitamin K deficiency bleeding (VKDB) in neonates when injectable vitamin K preparations are not available. DATA SOURCES: Articles were retrieved through MEDLINE (1946-February 2012) using the terms vitamin K, vitamin K deficiency bleeding, newborn, neonate, and prophylaxis. Reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All articles published in English on the use of prophylactic oral vitamin K in neonates were evaluated. The largest epidemiologic studies discussing the efficacy of continuous oral vitamin K prophylaxis were reviewed. Individual, smaller clinical trials were not reviewed. DATA SYNTHESIS: For prevention of early, classic, and late VKDB, use of intramuscular vitamin K 1 mg is preferred over oral administration because of superior efficacy. Single oral doses protect against early VKDB, but multiple oral doses are needed for late VKDB prophylaxis, especially in exclusively breast-fed neonates. Continuous oral dosing regimens used in the literature vary; European epidemiologic data suggest the lowest rates of late VKDB with oral vitamin K 1 mg at birth followed by 25 µg daily for 13 weeks, or 2 mg at birth followed by 1 mg weekly for 3 months. Limited data describe the use of oral prophylactic vitamin K in high-risk patients (eg, premature neonates, biliary abnormalities). CONCLUSIONS: While there are data supporting effective oral vitamin K dosing regimens for prevention of late VKBD in exclusively breast-fed neonates, lack of an appropriate oral dosage form prevents routine use of this technique in the US. In times of drug shortage, injectable vitamin K preparations should be reserved for use in neonates. If injectable vitamin K is not available, clinicians should choose the most practical method of administering oral vitamin K based on the oral products available.

Use of topical tranexamic acid or aminocaproic acid to prevent bleeding after major surgical procedures.

OBJECTIVE: To evaluate the literature describing topical use of tranexamic acid or aminocaproic acid for prevention of postoperative bleeding after major surgical procedures. DATA SOURCES: Literature was retrieved through MEDLINE (1946-September 2011) and International Pharmaceutical Abstracts (1970-September 2011) using the terms tranexamic acid, aminocaproic acid, antifibrinolytic, topical, and surgical. In addition, reference citations from publications identified were reviewed. STUDY SELECTION AND DATA EXTRACTION: All identified articles in English were evaluated. Clinical trials, case reports, and meta-analyses describing topical use of tranexamic acid or aminocaproic acid to prevent postoperative bleeding were included. DATA SYNTHESIS: A total of 16 publications in the setting of major surgical procedures were included; the majority of data were for tranexamic acid. For cardiac surgery, 4 trials used solutions containing tranexamic acid (1-2.5 g in 100-250 mL of 0.9% NaCl), and 1 trial assessed a solution containing aminocaproic acid (24 g in 250 mL of 0.9% NaCl). These solutions were poured into the chest cavity before sternotomy closure. For orthopedic procedures, all of the data were for topical irrigation solutions containing tranexamic acid (500 mg-3 g in 50-100 mL of 0.9% NaCl) or for intraarticular injections of tranexamic acid (250 mg to 2 g in 20-50 mL of 0.9% sodium chloride, with or without carbazochrome sodium sulfate). Overall, use of topical tranexamic acid or aminocaproic acid reduced postoperative blood loss; however, few studies reported a significant reduction in the number of packed red blood cell transfusions or units given, intensive care unit stay, or length of hospitalization. CONCLUSIONS: Topical application of tranexamic acid and aminocaproic acid to decrease postsurgical bleeding after major surgical procedures is a promising strategy. Further data are needed regarding the safety of this hemostatic approach.

A primer on ocular viscosurgical devices.

PURPOSE: To provide pharmacists with an overview of ocular viscosurgical devices (OVDs) and a comprehensive resource describing characteristics of commercially available agents. SUMMARY: OVDs are substances that are injected into the eye during ophthalmic procedures, such as cataract surgery, to reduce injury to the endothelium that may result from surgical manipulation. Currently available OVDs are composed of one or more of the following active ingredients: sodium hyaluronate, sodium chondroitin sulfate, and hydroxypropylmethylcellulose. Rheologic properties of OVDs, such as viscosity, elasticity, pseudoplasticity, and cohesion, affect the products' function and performance. Based on rheologic properties, OVDs can be generally classified as cohesive or dispersive. Given each products' unique characteristics, OVDs are not interchangeable. An understanding of OVD characteristics and role in practice allows for improved product selection, which varies based on patient characteristics and procedure. Availability of OVD information and literature is generally lacking since OVDs are regulated by the US Food and Drug Administration (FDA) as medical devices. This primer includes an overview of relevant ophthalmic surgical practices and the landscape of comparative efficacy and safety literature to assist in formulary decision-making. This review also provides a comprehensive guide to commercially available OVDs and a discussion on practical considerations for the pharmacist. CONCLUSION: Pharmacists may be tasked with handling OVDs in institutional settings. Knowledge about OVD rheologic properties, product characteristics, role in practice, and available literature is necessary for managing formularies and ensuring optimal product selection.

Removal of Anti-Thymocyte Globulin by Plasma Exchange in ABO-Incompatible and Positive Crossmatch Kidney Transplant Recipients.

BACKGROUND: Recipients of ABO-incompatible (ABOI) and positive crossmatch (PXM) kidney transplants are at high risk for antibody-mediated acute rejection. Despite aggressive immunosuppression in high-risk patients, the incidence of acute rejection remains considerably higher than in other groups. No published studies have examined plasma concentrations of anti-thymocyte globulin (ATG) in patients undergoing plasma exchange. The objectives of this study were to compare plasma ATG concentrations before and after plasma exchange in ABOI and PXM kidney transplant patients to determine the amount removed. MATERIALS AND METHODS: This prospective pharmacokinetic evaluation enrolled 10 patients undergoing ABOI or PXM kidney transplant at an academic medical center. Blood and waste plasma samples from 5 patients were assayed for total and active ATG concentrations. Patient records were monitored for renal function and rejection rates in the first 6 months post-transplant. RESULTS: Total ATG concentrations decreased a mean of 59.78 ± 13.91% after each plasma exchange session, and active ATG levels decreased a mean of 56.8 ± 17.08%. Mean daily concentrations reflect a lack of expected ATG accumulation. Only 1 of 4 patients had detectable ATG concentrations after 30 days. After 6 months, the incidence of acute rejection in this sample was 44% and graft survival was 89%. CONCLUSIONS: This is the first study to show that plasma exchange removes a substantial amount of ATG in high-risk kidney transplant patients. Based on these results, we believe these high-risk patients have been traditionally underdosed.

Efficacy of metformin and topiramate in prevention and treatment of second-generation antipsychotic-induced weight gain.

OBJECTIVE: To review the literature describing the efficacy of metformin and topiramate for the treatment of second-generation antipsychotic-induced weight gain. DATA SOURCES: Articles were identified by searching the MEDLINE database (from 1949 through January 2010) using the key words metformin, topiramate, antipsychotic, weight, weight gain, and obesity. STUDY SELECTION AND DATA EXTRACTION: All randomized, placebo-controlled trials of metformin and topiramate were selected for review. DATA SYNTHESIS: Weight gain due to second-generation antipsychotic use is a concern due to the risk of long-term metabolic and cardiovascular effects with these agents. These effects include obesity, hyperglycemia, and insulin resistance, all of which may contribute to diabetes and cardiovascular disease. Second-generation antipsychotics vary in the degree to which they cause weight gain, and dietary and lifestyle changes may not be feasible or sufficient in counter-acting this weight gain. Although other pharmacologic agents may be beneficial to prevent and treat antipsychotic-induced weight gain, metformin and topiramate have been the most extensively studied in this setting. Metformin acts peripherally to cause weight loss, while topiramate acts centrally. Review of 11 randomized, controlled trials demonstrates beneficial effects of metformin and topiramate in prevention and treatment of weight gain. Metformin is generally well tolerated and has been studied in pediatric patients, while topiramate is associated with more drug interactions and may possibly interfere with control of schizophrenia. CONCLUSIONS: Data for the use of metformin and topiramate in the treatment and prevention of second-generation antipsychotic-induced weight gain are limited. Both may be effective in helping patients lose weight via mechanisms that have yet to be clearly defined. The use of metformin results in greater weight loss than topiramate, and topiramate is associated with more risks and may compromise the treatment of schizophrenia. Treatment of antipsychotic-induced weight gain with metformin may be an option after lifestyle and dietary changes have failed.

Survey of drug information centers in the United States-2018.

PURPOSE: To provide a current directory of drug information centers (DICs) in the United States and present information about their characteristics, activities and services, and networking activities. METHODS: In February 2018, an electronic 23-question survey was delivered to 118 contacts on a distribution list compiled from previous directories of DICs, responses to listserv messages, and an Internet search. DICs, defined as formal centers dedicated to providing drug information services, including but not limited to responding to drug information requests, were asked questions about their characteristics, activities and services, drug information requests, and networking activities. RESULTS: The response rate was 79% (93 of 118 DICs). Of the 93 respondents, 82 (88%) met the definition of a DIC and were included in the directory. Of the 82 included DICs, 37 (45%) belonged to a university or college, while 36 (44%) belonged to a medical center or hospital. Seventy percent of the DICs (n = 57) had been in existence for more than 20 years. Of the 81 respondents reporting activities performed at the DICs, precepting pharmacy students (n = 79, 98%) and training pharmacy residents and/or fellows (n = 68, 84%) were most commonly reported. Nearly 90% reported that answering drug information questions was central to the DIC operations. Most DICs (n = 52, 65%) indicated receiving an average of 50 requests or less on a monthly basis. DICs reported a variety of electronic means of communicating with the DIC community, although 16 (21%) of the 77 respondents reported no need to do so. CONCLUSION: The survey identified 82 DICs that collectively provide a variety of services to their clienteles. The DIC directory published herein should facilitate networking among DICs.

Romiplostim management of immune thrombocytopenic purpura.

OBJECTIVE: To review the pharmacology, pharmacokinetics, efficacy, and safety of romiplostim, the first drug approved for use in patients with immune thrombocytopenic purpura (ITP). DATA SOURCES: Articles were identified through searches of MEDLINE (1966-January 2009) and International Pharmaceutical Abstracts (1970-January 2009) using the key words romiplostim and AMG 531. Searches were limited to articles published in English. The manufacturer was contacted for additional data. STUDY SELECTION AND DATA EXTRACTION: Clinical trials and pharmacokinetic data were selected for review. DATA SYNTHESIS: Romiplostim is a second-generation thrombopoietic receptor agonist that exerts its therapeutic effect by stimulating megakaryopoiesis. Subcutaneous therapy results in a dose-dependent increase in platelets; however, interindividual variability exists. Time to peak concentration is approximately 14 hours, and the elimination half-life is approximately 3.5 days (range 1-34). Romiplostim undergoes endothelial recirculation and is eliminated by the reticuloendothelial system. The results of 2 Phase 3, randomized, double-blind, placebo-controlled trials have demonstrated the efficacy of romiplostim for increasing platelet counts in patients with ITP refractory to other therapies, including splenectomy. Effects on platelets were transient and decreased within 2 weeks of discontinuing the drug. Interim results of an open-label extension study revealed that romiplostim has sustained efficacy and tolerability for up to 156 weeks at a dosage range of 1-17 microg/kg/wk (mean 5.9 +/- 3.9). The most common adverse effects include headache, fatigue, epistaxis, and contusion. Romiplostim is also under investigation for treatment of thrombocytopenia associated with myelodysplastic syndrome. The drug must be ordered directly from the manufacturer through a limited access program, and weekly subcutaneous injections are given in the clinic setting. CONCLUSIONS: Romiplostim is effective for the management of ITP in adults refractory to other therapies, including splenectomy.