To share information stored in the internal database, a DI Frequently Asked Questions (FAQs) Database was created to be accessible by pharmacy staff. The database is intended to provide concise information about FAQs as well as hospital-specific clinical practice, information required in emergent situations, and information not readily available. The database is designed to be searchable by category (eg, Cleveland Clinic policy and procedures, crush/administration, vaccines, immunoglobulins) or keyword. At first, only the DI staff submitted questions to be added to the database. However, as the database has gained more popularity and has been more widely used, staff pharmacists have contacted the DI Center with FAQs and responses to be added.
Each response is written in a concise format and is referenced with the most current information and/or reflects standard clinical practice at the Cleveland Clinic. Responses are added to the DI FAQ Database after a peer-review process in which 2 DI pharmacists verify the validity and accuracy of the information. To ensure the DI FAQ database is used as a reference and not in place of a clinical decision-making process, there is a disclaimer that states: “This Frequently Asked Questions (FAQ) Database is intended for use as a REFERENCE ONLY. It is specific to adult patients (ie, >18 years) unless specified in the response. Patient-specific factors (eg, age, weight, renal or hepatic function, comorbid conditions, concomitant medications) should ALWAYS be taken into account, along with the most current drug information, medical literature, and standards of practice.”
In addition to having all sources listed in each response, the date when the response was added and the last-updated date are included. This information was included to assist the pharmacist in making a judgment call on whether there may be more up-to-date information available or if the DI Center should be contacted. All of the responses are given internal numbers for indexing and are in an annual rotation to be reviewed and updated with new information.
Dabigatran (Pradaxa, Boehringer Ingelheim) capsules should be swallowed whole and should NOT be broken, chewed, or opened before administration. The bioavailability of dabigatran etexilate increases by 75% when the pellets are taken without the capsule shell.
Pradaxa (dabigatran etexilate mesylate) capsules for oral use [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals, Inc; November 2011.
Duloxetine (Cymbalta, Lilly) delayed-release capsules contain enteric-coated pellets that should be swallowed whole and should NOT be chewed, crushed, or opened. The contents should NOT be sprinkled on food or mixed with liquid because doing so may affect the enteric coating. Duloxetine is listed on the “Do Not Crush” list by the Institute for Safe Medication Practices, Lexicomp, and Micromedex.
The pellets should NOT be administered via feeding tube because that has not been studied and could potentially clog the feeding tube.
Caution: There is an in vitro study that determined a 20-mg duloxetine capsule maintained its potency, purity, and dissolution when mixed with applesauce and apple juice (pH ~3.5). The efficacy and safety for oral administration was NOT tested. However, if this method is to be used, it is important that the pellets maintain their integrity and are NOT crushed, chewed, or broken. This study also found that the duloxetine pellets did NOT maintain potency, purity, and dissolution when mixed with chocolate pudding (pH ~5.5-6.0).
Cymbalta (duloxetine) delayed-release capsules for oral use [package insert]. Indianapolis, IN: Lilly USA, LLC; September 2011.
Mitchell JF. Oral dosage forms that should not be crushed. Institute for Safe Medication Practices. Oct 2011. http://www.ismp.org/tools/donotcrush.pdf. Accessed December 19, 2011.
Lexicomp Online, Lexi-Drugs Online. Hudson, Ohio: Lexicomp, Inc; December 2011. (Search “crush.”)
Micromedex Healthcare Series [Internet database]. Greenwood Village, CO: Thomson Reuters (Healthcare) Inc. Updated periodically.
Wells KA, Losin WG. In vitro stability, potency, and dissolution of duloxetine enteric-coated pellets after exposure to applesauce, apple juice, and
chocolate pudding. Clin Ther. 2008;30:1300-1308.
Gammagard Liquid 10% (IV immunoglobulin [IVIG]; Baxter) is dosed by ideal body weight (IBW) due to standard Cleveland Clinic Foundation clinical practice. Adjusted body weight should be used if the total body weight is more than 30% to 40% of the IBW.
IVIG has a low volume of distribution (0.09-0.13 L/kg) and is believed to stay primarily in the intravascular space with little distribution into the fat. There is limited published information available on dosing IVIG by IBW because the original studies used total body weight. However, several sources recommend using adjusted body weight in the obese population and suggest dosing with IBW may be an option for IVIG therapy.
Standard Cleveland Clinic Foundation Clinical Practice.
Immune Globulin Monograph. Lexicomp Online, Lexi-Drugs Online. Hudson, Ohio: Lexicomp, Inc; January 2012.
Siegel J. Immunoglobulins and obesity. Pharmacy Practice News. 2010;37:8-9.
Herman. Safe administration of intravenous immune globulin (IVIG). World of Drug Information. 2004;15.
Khan S, Grimbacker B, Boecking C, et al. Serum trough IgG level and annual intravenous immunoglobulin dose are not related to body size in patients on regular replacement therapy. Drug Metab Lett. 2011;5:132-136.
Rand K, Gibbs K, Derendorf H, Graham-Pole J. Pharmacokinetics of intravenous immunoglobulin (Gammagard) in bone marrow transplant patients. J Clin Pharmacol. 1991;31:1151-1154.
The Zostavax (zoster vaccine live) vaccine should be given subcutaneously
in the deltoid region of the upper arm and not injected intravascularly or intramuscularly. However, if Zostavax is given intramuscularly, it does NOT need to be readministered.
Department of Health and Human Services Centers for Disease Control and Prevention. Herpes zoster vaccination for health care professionals. http://www.cdc.gov/vaccines/vpd-vac/shingles/hcp-vaccination.htm. Accessed August 14, 2012.
Zostavax (Zoster Vaccine Live) suspension for subcutaneous injection [package insert]. Whitehouse
Station, NJ: Merck & Co., Inc.; June 2011.
A postdural puncture headache (PDPH) is a complication of spinal anesthesia or unintentional dural puncture. A PDPH usually is treated with IV caffeine/sodium benzoate (500 mg in 1,000 mL normal saline administered over 1 hour, followed by 1,000 mL normal saline infused over 1 hour); a second course of caffeine can be given for unrelieved headache pain in 4 hours. The 500-mg dose of caffeine and sodium benzoate contains 250 mg of
anhydrous caffeine and 250 mg of sodium benzoate, which helps increase the solubility of the caffeine.
When caffeine/sodium benzoate is not available, 300 mg of oral anhydrous caffeine as a single dose can be used. Caffeine citrate oral solution is available as 20 mg/mL and contains 10 mg/mL of caffeine base. Therefore, 30 mL of caffeine citrate 20 mg/mL oral solution contains 300 mg of anhydrous caffeine.
Lexicomp Online, Lexi-Drugs Online. Hudson, Ohio: Lexicomp, Inc; February 2012; February 15, 2012.
Drug Evaluation: Caffeine. In: Hutchison TA, Shahan DR, Anderson ML, eds. Drugdex System [internet database]. Greenwood Village, CO: Thomson Healthcare; 2012. Updated periodically.
Caffeine and sodium benzoate–caffeine injection, solution [package insert]. Shirley, NY: American Regent, Inc.; September 2008.
Caffeine Citrate–caffeine citrate injection, solution [package insert]. Shirley, NY: American Regent, Inc.; September 2011.
Camann WR, Murray RS, Mushlin PS, Lambert DH. Effects of oral caffeine on postdural puncture headache. A double-blind, placebo-controlled trial. Anesth Analg. 1990:70:181-184.
Choi A, Laurito CE, Cunningham FE. Pharmacologic management of postdural puncture headache.
Ann Pharmacother. 1996;30:831-839.
Imovax (human diploid cell rabies vaccine, Sanofi Pasteur) and RabAvert
(purified chick embryo cell rabies vaccine, Novartis) are generically
equivalent and are considered interchangeable. If available, the same brand should be used for the entire vaccination series. However, vaccination should NOT be deferred due to unavailability of the brand used for previous doses.
A 2-year comparative study showed that the immunogenicity and
reactogenicity of the 2 products are comparable. The dose, route, and
indications of the 2 products are the same, but their origins, excipients, and side-effect profiles are different.
Grabenstein JD. ImmunoFacts: Vaccines and Immunologic Drugs–2012 (37th revision). St. Louis, MO: Wolters Kluwer Health; 2011.
Dreesen DW, Fishbein DB, Kemp DT, Brown J. Two-year comparative trial on the immunogenicity and adverse effects of purified chick embryo cell rabies vaccine for pre-exposure immunization. Vaccine. 1989;7:397-400.
Manning SE, Rupprecht CE, Fishbein D, et al. Human rabies prevention–United States, 2008: recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2008;57:1-28.
Imovax Rabies (rabies vaccine, HDCV) [package insert]. Swiftwater, PA: Sanofi Pasteur, Inc.; December 2005.
RabAvert (rabies vaccine) [package insert]. Emeryville, CA: Novartis Vaccines and Diagnostics, Inc.; March 2010.
The zoster vaccine live (Zostavax, Merck) and the pneumonia vaccine
(Pneumovax 23, Merck) can be given to a patient on the same day.
Although the manufacturer suggests that prescribers should consider
administering Zostavax and Pneumovax 4 weeks apart, the Advisory
Committee on Immunization Practices (ACIP) and the FDA support the
administration of the 2 vaccines concomitantly.
The vaccines should be administered using separate syringes at different anatomic sites.
Zostavax (Zoster Vaccine Live) suspension for subcutaneous injection [package insert]. Whitehouse
Station, NJ: Merck & Co, Inc; June 2011.
Centers for Disease Control and Prevention. Prevention of herpes zoster: recommendations of the Advisory Committee on Immunization Practices (ACIP)–early release. MMWR Recomm Rep. 2008;57:e1-e31.
Baylor NW. Letter to the editor: Perspective of the U.S. Food and Drug Administration on concomitant administration of Zostavax and Pneumovax. Vaccine. 2011;29:8771.
National Center for Immunization and Respiratory Diseases. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2011;60:8-9, 38.
The most appropriate dose, duration, route, and form of copper supplementation in copper-deficient patients (acquired copper deficiency,
copper deficiency myelopathy) have not been studied. It is recommended to first discontinue any zinc therapy and use oral copper therapy, if needed, rather than IV therapy. However, IV therapy may be needed if the oral absorption of copper is blocked or if there is an urgent need due to the patient’s clinical condition.
The preferred route is oral; 2 mg per day of elemental copper is usually
sufficient, although doses as high as 9 mg per day have been used. Some sources recommend starting with 6 to 8 mg per day of elemental copper for 1 week, then decreasing the dose by 2 mg each week. Additionally, some sources recommend periodic reassessment of the serum copper level to
determine if replacement therapy is adequate, and dose adjustment as needed.
Oral therapy recommendations: Over-the-counter multivitamins are an option for oral therapy. The pharmacy usually stocks Therapeutic M (multivitamins, therapeutic with minerals PLUS IRON tablet [THEREMS-M]) tablets, which contain 2 mg of copper. It is important to read product labels to determine the amount of copper in the product. For example, Centrum Kids complete chewable tablets contain 2 mg copper per tablet, whereas Centrum Silver tablets contain 0.5 mg copper per tablet. There are no FDA-approved single-ingredient products available, and, per hospital policy, dietary supplements that are not FDA-approved will not be ordered, stocked, or dispensed.
IV therapy recommendations: 2 mg per day of elemental copper infused
over 2 hours for 5 days, then periodically thereafter. IV copper is available as single-entity cupric sulfate (0.4 mg elemental copper/mL) and cupric chloride (0.4 mg elemental copper/mL), with the primary indication for use as an
additive in parenteral nutrition. Verify with the IV room that an IV product
is available because both products recently have been in short supply.
Kumar N. Copper deficiency myelopathy (Human Swayback). Mayo Clin Proc. 2006;81(10):1371-1384.
Jaiser SR, Winston GP. Copper deficiency myelopathy. J Neurol. 2010;257:869-881.
Product Information. Therems-M vitamin and mineral supplement. Rugby Laboratories, Inc.
http://www.watson.com/products/product-database-detail.asp?currentPage=2&group=alpha&c=T. Accessed May 31, 2012.
Centrum.com. Accessed December 20, 2011.
Cleveland Clinic Pharmacy. Policy Number 03-055. Dietary Supplements: Formulary. Effective Date 02/08/07, Dates Revised 02/23/10, 04/02/12.
The FAQ DI Database is used frequently by the DI staff and was accessed by pharmacy staff more than 2,000 times over a recent 6-month period.
The FAQ DI Database would not be possible without the help of Mandy Leonard, PharmD, Janine Douglas, PharmD, Matthew Miller, CIS, and the drug information pharmacist peer reviewers: Marigel Constantiner, RPh, Meghan Lehmann, PharmD, Mandy Leonard, PharmD, Amy Martin, PharmD, Kara Sink, RPh, Christopher Snyder, RPh, and Marcia Wyman, PharmD.