Drug Topics - March 2009 - (Page 50) Clinical LAMICTAL STARTER KITS FDA SAFETY PAGE Carol Holquist, RPh, Todd Bridges RPh, and Zachary Oleszczuk, RPh, PharmD Lamictal starter kits: What you need to know to avoid medication errors he Food and Drug Administration (FDA) has received six unique reports of medication errors involving Lamictal starter kits. Three of the six reports indicate that the wrong kit was dispensed to the patient; the other three reports say the patient incorrectly administered the product. The adverse events reported ranged from sensations of fuzziness and buzzing in the head to Stevens-Johnson Syndrome. Factors contributing to these errors are users’ lack of awareness these kits are available, and their incomplete understanding of the differences between the three available kits. Lamictal starter kits were designed by the manufacturer, GlaxoSmithKline, to provide the recommended initial dose and dose escalation regimen for the first five weeks of treatment with lamotrigine for patients older than 12. It is important to note that the sponsor currently markets three different starter kits with titration schedules that vary depending on what other medications a patient is taking (see below). Lamictal starter kits: The orange Lamictal starter kit is for patients who are not taking the following medications: Carbamazepine, phenytoin, phenobarbital, primidone, rifampin, or valproate (valproate includes valproic acid and divalproex sodium). The blue Lamictal starter kit is for patients taking valproate. The green Lamictal starter kit is for patients taking carbamazepine, phenytoin, phenobarbital, primidone, or rifampin and not taking valproate. T To help ensure that the appropriate Lamictal starter kit is prescribed and given to patients, pharmacists should: Ask what medications the patient is currently taking. This will be key information in helping determine whether the correct starter kit has been prescribed. If the patient is unsure, call the provider or other pharmacies that have lled previous prescriptions for the patient. If you receive a prescription that indicates the starter kit simply by color (e.g., blue Lamictal starter kit), contact the physician or healthcare provider to verify that the correct starter kit has been ordered. Make sure that the patient knows how to take the tablets in the starter kit correctly. Although the starter kits are supplied in a self-contained package with dosing instructions, it might not be immediately clear how the tablets should be taken. Advise the patient that the dose will increase from week to week and explain that this is necessary to get the body accustomed to taking Lamictal. Warn the patient to contact the prescriber immediately if a rash appears, as this may be a sign of a serious reaction. Offer the patient a copy of the current medication pro le to carry and share during doctor visits or visits to other pharmacies. Suggest that patients make a list of all medications they are currently taking, including brand names, generic names, strengths, doses, and frequencies. Their lists should include any over-the-counter products they may be taking. Suggest they keep their lists in their wallets or purses. Encourage patients to carry the names and phone numbers of the pharmacies where they have prescriptions lled. It is important that patients receive the correct starter kit to avoid adverse events resulting from over- or underdosing. Overdosing a patient could result in ataxia, nystagmus, increased seizures, decreased level of consciousness, coma, and intraventricular conduction delay. Patients receiving less than the recommended dose could experience sub-therapeutic blood levels of Lamictal and may only get limited relief from epilepsy or bipolar disorder. If you become aware of medication errors involving Lamictal starter packs or other products, report them to the FDA MedWatch program online at www.fda. gov/medwatch. Carol Holquist, RPh, is Director, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA; Todd Bridges, RPh, is a Safety Evaluator Team Leader, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA; Zachary Oleszczuk, RPh, PharmD, is a Safety Evaluator, Division of Medication Error Prevention and Analysis, Office of Surveillance and Epidemiology, FDA. W W W.D R U GTO P I C S .C O M 50 DRUG TOPICS March 2009 COURTESY FDA http://www.fda.gov/medwatch http://www.fda.gov/medwatch http://WWW.DRUGTOPICS.COM
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