Pharmacy & Therapeutics - January 2009 - (Page 50) MEDICATION ERRORS continued from page 10 Pharmaceutical Approval Update continued from page 29 and a follow-up evaluation is needed to confirm them. Examples include: • drugs: diphenhydramine (Benadryl, McNeil), vitamin K, flumazenil (Romazicon, Roche), glucagon. • laboratory findings: elevated drug levels, aPTT, INR, serum creatinine. • other: rash, lethargy, falls, abrupt stopping of medications, or transfer of the patient to a more critical level of care. Balancing Measures Balancing measures can be used to ensure that a change in one part of the system is not causing problems in another part of the system. By using balancing measures, one hospital quickly learned that instituting a change in an antiemetic agent to decrease the time a patient needed to spend in the oncology clinic actually resulted in reduced patient satisfaction because the patients felt rushed and unable to talk to staff about their diagnosis and therapy. CONCLUSION Measuring medication safety is not easy, but it must be a core component of improvement efforts. If an effective measurement plan is not in place, an interdisciplinary team should consider the examples listed earlier and identify a place to start. Each measure, its goals, and the data-collection plan should be clearly described. Remember: traditional efforts to measure medication safety have not succeeded in bringing about improvement in reducing ADEs. Even if a measurement plan is already in place, it might be time to look at it again with fresh eyes and updated tools. The reports described in this column were received through the ISMP Medication Errors Reporting Program (MERP). Errors, close calls, or hazardous conditions may be reported on the ISMP Web site (www.ismp.org) or communicated directly to ISMP by calling 1-800-FAILSAFE or via e-mail at ismpinfo@ismp.org. I Liver enzymes (ALT, AST, and bilirubin) and CBCs, including platelet counts and peripheral blood smears, should be monitored before and throughout therapy. If bilirubin is elevated, fractionation should be performed. The CBC should be monitored for at least four weeks following discontinuation of eltrombopag. In clinical studies, platelet counts generally increased within one to two weeks after therapy begins and decreased within one to two weeks after eltrombopag is discontinued. Eltrombopag is taken on an empty stomach, one hour before or two hours after a meal. Patients should allow at least a fourhour inter val before they take other medications (e.g., antacids, calcium-rich foods) or supplements containing polyvalent cations such as iron, calcium, aluminum, magnesium, selenium, and zinc. Monitoring and dose adjustments. The dose should not exceed 75 mg daily. Hematology and liver tests should be monitored throughout therapy, and the dosage should be modified according to the platelet count. During therapy, the CBC is assessed weekly until a stable platelet count has been achieved; after that, the CBC is obtained monthly. Dosages of concomitant ITP medications, as medically appropriate, should be adjusted to avoid excessive increases in platelet counts during therapy. Patients should not take more than one dose within any 24-hour period. Discontinuation of therapy. Patients should stop taking this drug if the platelet count does not increase to a level sufficient to avoid bleeding after four weeks of therapy at the maximum daily dose of 75 mg. If platelet count responses or liver test abnormalities occur, eltrombopag should be discontinued. Commentar y: Eltrombopag is an oral platelet growth factor agent developed to treat chronic immune (idiopathic) thrombocytopenic purpura, or ITP, a rare disorder characterized by increased platelet destruction or inadequate platelet production. Patients with chronic ITP often bleed from small blood vessels, resulting in bruises, nosebleeds, or even fatal GI tract or intracerebral bleeding. Between 50,000 and 100,000 individuals in the U.S. have chronic ITP. The goal of therapy is to keep the platelet count at about 50 × 109/L in order to lower the risk of bleeding, but eltrombopag is not indicated for normalizing the platelet count. During therapy, the dose may need to be modified. Blood platelet counts are performed before, during, and after therapy. Eltrombopag is available only through a restricted program. Sources: www.promactacares.com; http://us.gsk.com I 50 P&T® • January 2009 • Vol. 34 No. 1 http://www.ismp.org http://www.promactacares.com http://us.gsk.com
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