The Weekly Mortar & Pestle

Transcription

1 The Weekly Mortar & Pestle A Publication of Walgreens Health Initiatives January 24, 2008 A publication created especially for our clients and associates, delivering up-to-date information about brand-name and generic medication, medical products, and other pharmaceutical-related information collected from key government and industry sources. Formulary and P&T Committee News Summary P&T Meeting December 10, 2007 Agenda Items Committee Decisions MUE Januvia /Janumet expedited MUE update Approved with noted changes. Medication Management November subcommittee meeting minutes Approved with no changes. MedMonitor October and November subcommittee meeting minutes Approved with no changes. Specialty Development 1. Rheumatoid arthritis patient education booklets 2. Bleeding disorders welcome packets a. Hemophilia b. Von Willebrand disease 3. November subcommittee meeting minutes 1. Approved with suggested changes 2. Approved with no changes. 3. Approved with no changes. The accuracy and completeness of the content herein are not guaranteed by Walgreen Co. or its affiliates and subsidiaries. Content not to be construed as a solicitation or recommendation. Brand names are the property of their respective owners Walgreens Health Initiatives. All rights reserved. 1

2 Recent Food and Drug Administration (FDA) warnings and health news for patients and healthcare professionals (Updates to previously printed news are noted in blue.) Drug/Issue Date News Event(s) Member/ Antidepressant s/multiple products and manufacturers Issue: Study results 01/17/08 A study published in the January 17, 2008 issue of the New England Journal of Medicine examined how accurately published literature conveys efficacy of drugs to the medical community. Study investigators compared drug efficacy inferred from published literature with drug efficacy according to FDA reviews. Among 74 studies reviewed by the FDA, 38 were deemed to have positive results, of which 37 were published in agreement with FDA judgment. Thirty-six studies deemed to have questionable or negative results by the FDA were either not published or were published with positive results, conflicting with FDA conclusions. The study found a bias toward the publication of positive results. Moreover, results that were not positive were often published in a way that conveyed a positive outcome. As a result, nearly all published trials of antidepressants were positive, even though FDA analysis of the trial data showed that only about half of the trials had positive results. Overall, studies the FDA judged as positive were approximately 12 times more likely to be published in agreement with FDA analysis than those with questionable or negative results. High utilization of this medication class. The medications in this class have been evaluated by the FDA and meet safety and efficacy requirements for marketing. Patients should continue their antidepressant therapies as prescribed and discuss any questions they have with their doctors. 2

3 Drug/Issue Date News Event(s) Member/ Although there are several reasons study results are not published, selective reporting of clinical trial results may lead to inappropriate prescribing decisions, and hinder the advancement of medical knowledge. Cytoxan tablets and cyclophosphamide tablets/bristol- Myers Squibb and Boehringer Ingelheim/Roxane 01/14/08 Cytoxan tablets are discontinued due to low use. Cyclophosphamide 25 mg and 50 mg tablets are on back order, and a release date is not available. Orders will be filled as product becomes available. Limited emergency supplies are available through the manufacturer. Clinical benefits of antidepressant s should be evaluated on a case-by-case basis. utilization. Generics are available, and supply is expected to meet demand. shortage update Epidrin and Midrin (acetaminophen, dichloralphenazone, and isometheptene)/ Excellium and Caraco shortage update Tikosyn (dofetilide) 0.25 mg and 0.5 mg capsules/ Pfizer 01/16/08 Midrin from Caraco is on back order and is being shipped to wholesalers as it becomes available. Epidrin in 100-count bottles is on back order with an estimated release date in late January. Epidrin in 250-count bottles has been temporarily discontinued. Most acetaminophen/dichloralphenazone/isometheptene products have been discontinued, as these products are not FDAapproved and therefore cannot be AB rated. 01/15/08 Pfizer is experiencing manufacturing delays with Tikosyn capsules. Pfizer estimates a release date of Tikosyn 0.25 mg and 0.5 mg capsules by the end of January. utilization. Affected members should discuss alternatives with their doctors. Supply is expected to meet demand. 3

4 Drug/Issue Date News Event(s) Member/ shortage Tikosyn 0.25 mg and 0.5 mg capsules are available from wholesalers for emergency use only. Tikosyn mg capsules are currently available, although Pfizer expects this strength will also be placed on backorder. New Products* Drug/ Manufacturer Alvesco (ciclesonide) inhalation aerosol/ Aventis Tysabri (natalizumab) injection/ Biogen Idec and Elan Therapeutic Class Antiasthmatic Cancer therapy Indication(s) Date Projected Launch Comments New FDA-Approved Agents Maintenance 01/10/08 Later in Alvesco is an inhaled corticosteroid and treatment of 2008 is administered once-daily. asthma moderate to severe Crohn s disease New Dosage Forms & Combinations None to report New FDA-Approved Indications 01/14/08 End of February New First-Time Generic Drug Approvals None to report * Note: If FDA-approved, s are under P&T review and reside on the 3 rd tier. Patients using the drug for this latest indication must be enrolled in the Crohn s Disease Tysabri Outreach Unified Commitment to Health Prescribing Program, a special, restricted distribution program. Tysabri is also approved for the treatment of relapsing forms of multiple sclerosis. Programs Planned P&T review planned. MedMonitor will review for conflict edits when available. P&T review planned. 4

5 Pipeline Analysis Drug/Manufacturer BEMA Fentanyl (fentanyl)/biodeliver y Sciences International Fablyn (lasofoxifene) tablets, formerly Oporia/ Pfizer Alendronate tablets/ multiple manufacturers Donepezil tablets/teva Therapeutic Class Narcotic analgesic Osteoporosis Osteoporosis Alzheimer s Indication(s) Status Comments breakthrough cancer pain in opioid tolerant patients osteoporosis osteoporosis New drug application (NDA) submitted. NDA submitted. First-Time Generic Drugs in the Pipeline Tentative approval received. dementia of the Alzheimer type Tentative approval received. BEMA Fentanyl consists of a small, dissolvable, polymer disc, formulated with fentanyl for application inside the cheek. Fablyn is a selective estrogen receptor modulator for the treatment of osteoporosis in postmenopausal women. Alendronate is the generic equivalent of Fosamax tablets. Patent will expire on February 6, and Merck will launch an authorized generic. Donepezil is the generic equivalent of Aricept tablets, for which the patent expires in November Teva is currently in patent litigation with Eisai. Information for Mortar & Pestle is obtained from the following sources (with secondary-source links provided): Food and Drug Administration ( American Society of Health-Systems Pharmacists ( P&T Community ( Pharmaceutical News Harvest ( Drugs.com ( Pharmacy OneSource ( 5