Heather J. Ipema

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.

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 antipsychotio–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, place bo-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 counteracting 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 antipsychotio–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.

ASHP Guidelines on the Pharmacist’s Role in Providing Drug Information

The provision of drug information (DI) is among the fundamental professional responsibilities of all pharmacists. Recent practice trends, including increased provision of medication therapy management services and efforts to obtain provider status, have placed pharmacists in increasingly complex

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 K1 (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.

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-con trolled 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 μg/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.

Medication Repurposing: New Uses for Old Drugs:

Background: Medication repurposing, the practice of using old drugs in new ways, is becoming more common. Old drugs that had previously fallen out of favor due to safety concerns, lack of efficacy, or development of more desirable therapeutic alternatives have been resurfacing in the literature and on pharmacy shelves. Developing new uses for old drugs may provide patients with access to helpful therapies but may also present challenges and risks. Objective: To explore the rationale for, and historical context of, the developing trend of recycling existing drugs for new, innovative uses, and to provide pharmacy practitioners with information about how to find clinical evidence regarding these new uses. Data Synthesis: The process of obtaining marketing approval for new drugs can take an average of over 10 years and exceed

Intravenous Push Administration of Antibiotics: Literature and Considerations:

1 billion. Repurposing old drugs (both approved and unapproved) for new uses requires considerably fewer resources since information about production needs, pharmacology, and pharmacokinetics is already known. Other advantages of using old drugs include faster availability for patient use and known safety concerns for the original indication. Disadvantages of new uses for old drugs may include lack of clinical evidence, unknown safety for the new clinical context, limited availability of information about new uses, and liability or legal concerns. Several methods of identifying potential new uses exist, including the observance of previously unknown desirable pharmacologic effects during clinical use, new knowledge of a mechanism of action leading to exploration of innovative therapeutic areas, or screening compound libraries for targeted clinical activity. Conclusions: There are many examples of recycling existing medications for new purposes. Pharmacy practitioners should be aware of this developing trend and know how to find information about utilizing old drugs in new ways.

Drugs to be used with a filter for preparation and/or administration

Intravenous (IV) push administration can provide clinical and practical advantages over longer IV infusions in multiple clinical scenarios, including in the emergency department, in fluid-restricted patients, and when supplies of diluents are limited. In these settings, conversion to IV push administration may provide a solution. This review compiles available data on IV push administration of antibiotics in adults, including preparation, stability, and administration instructions. Prescribing information, multiple tertiary drug resources, and primary literature were consulted to compile relevant data. Several antibiotics are Food and Drug Administration–approved for IV push administration, including many beta-lactams. In addition, cefepime, ceftriaxone, ertapenem, gentamicin, and tobramycin have primary literature data to support IV push administration. While amikacin, ciprofloxacin, imipenem/cilastatin, and metronidazole have limited primary literature data on IV push administration, available data do not support that route. In addition, a discussion on practical considerations, such as IV push best practices and pharmacodynamic considerations, is provided.

Survey of drug information activities of ASHP-accredited pharmacy practice residency programs.

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 re...

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

ASHP has established accreditation standards for postgraduate year 1 (PGY1) pharmacy practice residency programs, as well as required and elective program outcomes, goals, and objectives.[1][1] One pharmacy practice area addressed by the ASHP outcomes, goals, and objectives is drug information (DI