THE PHARMACY ADVISOR A Publication of the Beth Israel Deaconess Medical Center Department of Pharmacy and Pharmacy & Therapeutics Committee Volume 1, Issue 1 July 2002 From the Editors: The Pharmacy Advisor is a new publication of the Department of Pharmacy and the Pharmacy & Therapeutics Committee. This monthly newsletter will feature articles regarding medication use at Beth Israel Deaconess Medical Center and in addition will include relevant topics in pharmaceutical care. Included in each publication will be updates from the Pharmacy and Therapeutics Committee including formulary additions, therapeutic drug class reviews, medication-related policies and prescribing guidelines, targeted medication use evaluations and medication safety and adverse drug reaction reports. Informational bulletins will update caregivers to current drug shortages and will provide recommendations for alternate therapies. Clinical Pharmacy Pearls will be included to provide information on topics such as drug interactions, pharmacokinetic considerations in drug prescribing and general drug information. Articles relating to pharmacoecomonics will provide insight on the economic impact of the pharmaceutical care we provide. Your comments and suggestions for future articles and topics are welcome. INSIDE THIS ISSUE 1 Formulary Update: Famotidine is selected as the preferred parenteral H2 Receptor Antagonist on the BIDMC Inpatient Formulary Formulary Additions: Cefepime (Maxipime™); Zoledronic Acid (Zometa™); Darbepoetin (Aranesp™); Tenofovir (Viread™); Valganciclovir (Valcyte™) 2 POE: Top 10 hints to improve medication ordering 3 Medication Safety: Safety concerns with transcription and the use of abbreviations 4 Drug Shortages The Pharmacy Advisor is a publication of the Department Of Pharmacy and the Pharmacy & Therapeutics Committee at the Beth Israel Deaconess Medical Center, Boston, MA 02215 Writing/Editorial Board: Katherine Giampietro, PharmD Christopher McCoy, PharmD Lisa Saubermann, PharmD Diane Soulliard, PharmD Bruce Bistrian, MD, Co-Chair P&T James Heffernan, MD, Co-Chair P&T Francis P. Mitrano, M.S., RPh P&T Formulary Update Famotidine Selected as the Preferred Parenteral H2Receptor Antagonist on the BIDMC Formulary H2 receptor antagonists (H2RA) are indicated in the therapy and treatment of duodenal ulcer, gastric ulcer, control of gastric pH in critically ill patients, symptomatic relief in gastritis, gastroesophageal reflux, active benign ulcer, and pathological hypersecretory conditions. Four H2RA s are currently used in the United States, three of which (cimetidine, famotidine and ranitidine) are available for parenteral administration. The pharmacodynamic and therapeutic properties of the H2RAs suggest that these agents are equally effective for all indications and the available parenteral formulations should be considered therapeutically equivalent, as should the oral formulations. Based on famotidine’s favorable safety profile, minimal drug interactions, once or twice daily parenteral administration and competitive cost, the Pharmacy & Therapeutics Committee (P&T) voted to replace parenteral ranitidine with famotidine as the preferred parenteral H2RA on formulary. In alignment with the outpatient PSN formulary, ranitidine will remain as the preferred oral H2RA on formulary. Treatment with oral or enteral medication is recommended for clinically stable patients with a functional GI tract. For those patients requiring parenteral therapy, the usual dose of IV famotidine is 20mg IV q12 hours. Parenteral famotidine is available in premixed minibags containing 20mg famotidine in 50ml iso-osmotic sodium chloride. Each dose is administered over 15-30minutes. Higher doses may be required in some hospitalized patients with pathological hypersecretory conditions or intractable ulcers. Dose adjustment for patients with renal impairment: CrCl: >50 ml/minute: 20mg IV q12h CrCl: < 50 ml/minute: 20mg IV q24h Some newer references suggest that further dose reduction to 20mg q48h is warranted for CrCl < 30ml/minute. The following IV dose conversion will be utilized: Cimetidine IV Ranitidine IV Famotidine IV 300mg q6h 50mg q8h 20mg q12h 900mg /day continuous infusion 150mg /day continuous infusion 40 mg /day continuous infusion The Pharmacy Advisor 1 Pharmacy’s Top 10 Helpful Hints for Effective Use of Provider Order Entry (POE) for: Medications, IV Therapy and Parenteral Nutrition Orders Provider Order Entry (POE), our computerized order entry system, is now live on the West Campus in all in-patient nursing units and critical care areas. POE brings technological advances to the methods we use to write patient-care orders and the POE menu is comprised of 14 different types of order entry options. With relation to the medication ordering component of POE, order-entry options include “medications,” “IV Therapy” and “TPN” orders. In addition to facilitating medication selection, POE provides additional information during the medication order-entry process regarding: dosing, allergies, connections to relevant laboratory information and drug interactions. In recognition of the complex nature of the medication order-entry process, some of the highlights of POE order entry are described here. To initiate the order writing process in POE, an entry for one of the 14 menu options is selected in the web-based system. Prescribers are guided through nursing-unit census and patient selection screens to the specific order options. Within the medication order options, “quick-pick” medication lists are available to facilitate medication selection. Prescribers may select medications from this list or should the desired medication not be found here, medication selection can be performed by entering the generic name of the drug in the space provided. The medication order screens have been designed to provide default dosing and schedules within usual dose ranges. Patientspecific dosing outside of these ranges must be manually entered. Throughout the medication order-entry process, various alerts and rules have been programmed into the POE system to make the order-entry process safe, accurate and user-friendly. Upon completion of a medication, IV or parenteral nutrition order, prescribers electronically sign the order and the information is transmitted to pharmacy for review. Subsequent to this review and if no interventions are required, the pharmacist acknowledges the order. The order is then available to nursing for review and acknowledgement and it is this process that generates a medication administration label that includes instructions for administration to the patient. Members of the pharmacy department have identified the following helpful hints for effective use of POE, regarding the entry of Medications, IV Therapy and TPN orders. 1. Avoid the unnecessary use of abbreviations to enter a medication order. Popular abbreviations or slang terms are not linked to the available medication options. 2. Use generic names to search for medications. Many medications have multiple brand names that are not programmed into the POE system. Medications are programmed using the generic name. 3. Search for medications using the first 3 or 4 letters of the generic name only. Spelling errors often result in a failure to find the desired formulary medication. A misspelled medication is unrecognized by POE and generates a non-formulary medication request form. Entering the first 3 or 4 letters of the generic name will provide a list of all formulary matches and will facilitate medication selection. 4. Radiological agents are not ordered using the “medication” option in order entry. Radiological agents are ordered using the “general care” option. 5. “Free water boluses,” orders for “water” or “water sips” are not ordered using the “medication” option. These items are ordered using the “general care” option. 6. Do not enter drug doses or schedule information in the “comments” section of the Medication or IV Therapy order. Dosing and schedule information should be included in the programmed fields of the medication order. Including this information in the “comments” section may lead to “errors of omission” as the pharmacist or nurse may not readily detect this information upon review. 7. Use the “Medication” option to enter orders for replacement electrolytes that will be given as intermittent or small volume boluses. Orders for potassium, calcium, magnesium and phosphate replacement are available in the “medication” option of order entry. This option is particularly useful for sliding scale therapy. Continuous infusions of maintenance electrolytes are ordered using the IV Therapy order option. 8. When changing formulations (e.g. IV to PO) the provider must discontinue the current order and enter a new order for the new formulation. Medications have been programmed based on specific dosing and schedule information. Avoid using the “change” order for this function, because medication specific alerts may not be linked to the original compound. 9. ID approval must be obtained prior to specified antibiotics being dispensed by pharmacy. It is the responsibility of the prescribing physician to contact the ID fellow on call for approval for targeted antibiotics. When ordering antibiotics requiring ID approval, POE provides a direct link to the page system, to facilitate this call. To avoid treatment delays, it is advisable to contact the ID fellow on call as soon as possible when ordering an ID restricted antibiotic. 10. Parenteral Nutrition order deadline is 1:00 PM. All orders for parenteral nutrition must be entered into POE and signed by the provider before 1:00 PM. POE will not accept orders for TPN after 1:00 PM. When the deadline is missed the provider may order a “Quick Mix” peripheral nutrition formula to hold the patient over until the next day when therapy may be reassessed. In addition to the POE features mentioned above, POE has a “feedback” link (located in the heading of the “census” page) that is accessible to all POE users. The purpose of this feature is to provide a mechanism to convey issues and comments regarding the POE process. This information is reviewed by the Department of Information Services and is invaluable with regard to process improvement. The Pharmacy Advisor 2 Medication Reliability Safety concerns with transcription and the use of abbreviations Identification and avoidance of medication errors is a priority at BIDMC. Inaccuracies in transcription as well as in the manual transferring of pertinent information from one record to another has long been implicated as a potential source for medication errors. Illegible handwriting, similar drug names and abbreviations have all contributed to this problem. Electronic medical records and computerized provider order entry (POE) have automated many of the manual steps involved in writing in the medical record; however the accuracy of this information remains dependent on the accuracy of the information source and the accurate transfer of this information into the electronic system. Computerized medication order selection, default dosing to common drug regimens and the use of standardized concentrations for infusions (in particular heparin, insulin and narcotics) are functions within POE, which can minimize medication errors. When these options are by-passed and freetext order writing is utilized, the potential for a patient to receive the wrong drug or wrong dose is escalated. The continued use of abbreviations and shortcuts for drug ordering and dosing, even within POE, have demonstrated the ability to lead to medication errors. Transcription and abbreviation errors are exemplified by the following case. A patient recently admitted to the medical center had been receiving epoetin alfa, 20,000 units weekly as an outpatient. This regimen was written throughout the patient’s medical record and had been documented as both 20,000 U and also as 20 MU. On admission, the epoetin dose was obtained from the record and although 20,000 units was available as a default dose selection for epoetin in POE, it was not selected. The dose was manually entered as 20 MU and misinterpreted to mean 20 million units. This dosing error managed to be processed through the system without initial detection and was identified as a “near miss” when it was finally recognized as inappropriate and corrected. FDA Approved The learning point from this case is that the unnecessary use of abbreviations should be avoided. Mistakes can occur when abbreviations such as (MU) are used and to mean million units when written as penicillin 2MU and thousand units when written epoetin 20 MU. It is important to remember that such errors in transcription can occur even with electronic systems that have steps built in to prevent errors in prescribing. When warnings or alerts are overridden in POE, care must be taken to ensure the appropriateness of the medication order. Ultimately, the health care provider must evaluate each computerized drug order as is the process with written orders to ensure that the order makes practical sense. In both of the mentioned examples, the full dose should be written and the word “units” used in place of the abbreviated “U.” The Institute for Safe Medication Practices recommends that the same safety measures, with regard to eliminating the unnecessary use of abbreviations, be instituted for electronic order writing. They further recommend that this safety measure be applied to other documents (e.g., order forms, protocols, care maps, computer-generated medication administration records, prescription labels, and in-house newsletters). Let’s follow this recommendation. Formulary Update: The following medications have recently been approved for addition to the BIDMC formulary Cefepime (Maxipime™): Cefepime hydrochloride is a semi-synthetic, broad-spectrum cephalosporin antibiotic for parenteral administration. FDA Approved Indications: Cefepime is indicated in the treatment of moderate-to-severe pneumonia, uncomplicated skin and skin structure infections, complicated and uncomplicated urinary tract infections (UTIs) including pyelonephritis, complicated intra-abdominal infections in adults (w/metronidazole). Cefepime is also indicated for empiric therapy in febrile neutropenia. Dosing: Administer IV infusion over 30 minutes. Empiric therapy for febrile neutropenic patients: 2 g IV Q8H. Non-neutropenia indications: 1-2 g IV q12H. Dosage adjustment required in patients with renal insufficiency. Refer to BIDMC Pharmacy Renal Dosage Guidelines. BIDMC Restrictions: Cefepime has been approved for formulary use without restriction in the treatment of febrile neutropenia. ID Approval will be required for all other indications. ______________________________________________________________________ Zoledronic Acid (Zometa™): Zoledronic acid is a newly approved parenteral bisphosphonic acid. FDA Approved Indications: Zoledronic acid is indicated in the treatment of hypercalcemia of malignancy and as adjunct therapy in multiple myeloma and bone metastases of solid tumors. Dosing: Administer by IV infusion over at least 15 minutes. Hypercalcemia of malignancy (albumin-corrected serum calcium > 12 mg/dL): max 4 mg IV as a single-dose infusion; allow at least 7 days before retreating. Multiple myeloma or bone metastases: 4 mg every 3-4 weeks. ______________________________________________________________________ Darbepoetin (Aranesp™):Darbepoetin is a long-acting epoetin analog. FDA Approved Indication: Darbepoetin is indicated for the treatment of anemia associated with chronic renal failure, including patients on dialysis and not on dialysis. Darbepoetin has recently received approval for the treatment of anemia associated with cancer chemotherapy. Dosing: Administer by IV or SC injection once every 1-2 weeks. Do not increase more frequently than once per month. For patients not currently on epoetin alfa: Initially 0.45 mcg/kg once weekly. Adjust based on hemoglobin levels (target not to exceed 12 g/dL); reduce dose if hemoglobin increases more than 1 g/dL in any 2-week period. To convert patients currently receiving epoetin alfa to darbepoetin and for dose titration, refer to Aranesp package insert. BIDMC Restrictions: Outpatient treatment of anemia associated with chronic renal failure. New oncology indications to be reviewed at P&T. ______________________________________________________________________ Tenofovir (Viread™): Tenofovir disoproxil fumarate is the oral salt form of tenofovir, a nucleotide reverse transcriptase inhibitor. FDA Approved Indication: Tenofovir is indicated for use in the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents. Dosing: The recommended dose is 300 mg po qd, with food, to increase the extent of absorption ______________________________________________________________________ Valganciclovir (Valcyte™): Valganciclovir, an antiviral agent, is the valyl ester prodrug of ganciclovir. FDA Approved Indication: Valganciclovir is indicated for the treatment of AIDS-related cytomegalovirus (CMV) retinitis. Dosing: Take with food. Induction: 900mg twice daily for 21 days. Maintenance: 900mg once daily. Renal impairment: (CrCl <60 mL/min): reduce dose. Refer to BIDMC Pharmacy Renal Dosage Guidelines. The Pharmacy Advisor 3 DRUG SHORTAGES A National Problem with Patient-Care Implications National Drug Shortages continue to have a significant impact on the provision of pharmaceutical care to our patients. Although some short-term shortages are able to be handled seamlessly by pharmacy, other long-term shortages require more significant multi-disciplinary management and have the potential to have greater impact on the healthcare system and patient care. To address the resultant problems attributable to drug shortages, it is important to understand that the reasons for shortages are multifactorial and involve all segments of the supply chain. Reasons for drug shortages include lack of raw materials, manufacturing difficulties with product production or secondary to FDA enforcement of good manufacturing practices, manufacturer business decisions leading to the discontinuation of products or a delay in production and increased product utilization in the face of lower manufacturer and wholesaler inventories and safety stock. Frequently, pharmaceuticals are only available from a single or small number of manufacturers and if issues arise with one of the manufacturers, the remaining suppliers may have difficulty meeting the increased demands. The lack of suitable alternative agents, the use of unfamiliar substitutes, patient safety concerns, and a lack of advanced warning of impending shortages have all been noted as major concerns. Among the negative impacts of drug shortages are the costs of reallocating resources to manage the shortage, the risks associated with an increased potential for adverse drug reactions and medication errors, increased drug expenditures, and patient and prescriber inconvenience. At BIDMC, the pharmacy department regularly reviews drug shortages and determines if needed product can be obtained from alternate sources. If product is not available, potential alternate therapies are reviewed and contingency plans formulated. For immediate patient care needs relating to products that are unavailable, a pharmacist will contact prescribers directly to discuss therapy and make recommendations for treatment. Updates regarding current drug shortages will be featured regularly in The Pharmacy Advisor to alert health care providers to both short and long-term drug shortages. Both the FDA and The American Society of Health-System Pharmacists (ASHP) maintain websites that specifically address drug shortages. The FDA Website (www.fda.gov) lists the drugs in short supply along with the reason for the shortage. The ASHP website ( http://www.ashp.org/shortage/) lists the drugs in short supply, and provides suggestions for alternative therapy and guidelines on managing Drug Product Shortages. The following list contains several of the products currently affected by ongoing shortage and the impact to inpatients at BIDMC. For additional information regarding these and other national drug shortages, please refer to the link on the Pharmacy page of the BIDMC intranet. This link connects to the ASHP website, which provides detailed information regarding medications affected by shortages. Antiemetics: Prochlorperazine injection, Compazine Spansules, and Compazine syrup: nationwide back order due to increased demand for product and a delay in obtaining raw material. Prochlorperazine rectal suppositories and oral tablets are not affected by this shortage and can be prescribed as appropriate. Consider metoclopamide and promethazine for patients requiring parenteral antiemetic therapy. Diuretics: Chlorothiazide (Diuril™) injection: Merck would not provide a reason for the shortages of Diuril injection and oral suspension. Currently, no product is available from the manufacturer. Furosemide: Furosemide is on nation-wide back order because Aventis, Wyeth, and Watson stopped making the product and the remaining manufacturers have not yet been able to meet the increased demand for their furosemide products. BIDMC has been receiving intermittent shipment and currently has furosemide injection in stock. Parenteral Steroids: Betamethasone (Celestone™ Soluspan): nationwide back order since late 2000 because of increased demand for the product. Schering-Plough has limited supplies of betamethasone acetate and betamethasone sodium phosphate injection available for use only in labor and delivery settings. The company has increased production of this product but would not estimate when the shortage will resolve. Schering-Plough has discontinued production of betamethasone sodium phosphate injection (Celestone ™ Phosphate). BIDMC will comply with regulations to provide allocated betamethasone injection (Celestone™ Soluspan) for use only in the labor and delivery settings. Methylprednisolone acetate suspension injection (Depo-Medrol™) is on nationwide back order due to manufacturing problems. Manufacturers are allocating limited shipments on a monthly basis. BIDMC is allocating this limited supply upon receipt. Methylprednisolone sodium succinate (Solu-Medrol™) is on nationwide back order due to manufacturing problems. BIDMC has been receiving intermittent shipments and currently has methylprednisolone sodium succinate (Solu-Medrol™) injection in stock. Triamcinolone diacetate injection (Aristocort™) and triamcinolone hexacetonide injection (Aristospan ™): manufacturing difficulties and a raw material shortage. BIDMC does not have either Atristocort™ or Aristospan™ injection in stock. Triamcinolone acetonide injection (Kenalog™-10, Kenalog™-40): nationwide back order due to increased demand. BIDMC has been receiving intermittent shipments and currently has a limited supply of Kenalog injection in stock. Narcotics: Meperidine hydrochloride for injection: short supply due to a product recall and increased market demand. BIDMC has been receiving intermittent shipments is allocating this limited supply upon receipt. The Pharmacy Advisor 4