VA Center for Medication Safety - A Patient Safety Center for Inquiry

• Look-Alike Sound-Alike Efforts

• Pharmacovigilance and Drug Safety Projects

• Policies

• Drug Market Withdrawals

1. LOOK-ALIKE/SOUND-ALIKE EFFORTS
   1. Alerts
      
      PBM WARNING LETTER: Sulfasalazine and Sulfadiazine LA/SA Errors
      Warning Letter - Sulfasalazine-Sulfadiazine LA-SA Errors
      
      Look-Alike Sound-Alike Confusion Potential with Humapen Memoir® and Humira® Pen – January 2007
      Two Pens Different Uses; PBM Ez-Minutes January – March 2007
      
      HUMIRA Pen and HumaPen; ISMP Newsletter April 2007
      
      Look-Alike Sound-Alike Vaccine Mix-ups: Adacel (Tdap) and Daptacel (DTaP) – August 24, 2006
      ISMP Newsletter
      
      Fluarix® and Twinrix® Look-Alike Confusion Potential
      National PBM Bulletin - Look-Alike Safety Alert Regarding Fluarix® and Twinrix®
      
      LOOK-ALIKE SAFETY ALERT FOR HALOPERIDOL AND CYANOCOBALAMIN 1ML VIALS
      National PBM Bulletin
      
      
   2. Pilot Project for Determining Look-alike Sound-alike Drug Names for New Molecular Entities (NMEs)
      
      1. LASA Draft Paper
      2. Appendix I
      3. Appendix 2
      4. Appendix 3
         
         
   3. VA-Specific LASA pairs
      
      1. Cumulative VA LASA list
      2. VA LASA list 2011
         
         
   4. Institute for Safe Medication Practice
      1. ISMP Confused Drug Name
      2. Reported LASA in ISMP Newsletters 2011
         
         
   5. FDA LASA Alerts for 2011
      
      

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2. PHARMACOVIGILANCE AND DRUG SAFETY PROJECTS
   
   
   1. GENERAL SAFETY PROJECTS/PILOT PROJECTS
      1. Adverse Drug Event (ADE) Reporting
      2. Look-Alike Sound-Alike (LA/SA) Drug Names for New Molecular Entities (NMEs)
      3. Active Surveillance – Signal Detection
      
      
      
   2. SITE-BASED MEDICATION SAFETY EVALUATIONS
      1. Conversion to and Initiation with Travoprost in Glaucoma Management
      2. Erythropoeitin Stimulating Agents (ESA) Database Medication Use Evaluation (MUE) Tracker
      3. Evaluation of Amiodarone Monitoring
      
      
      
   3. RISK REDUCTION PROJECTS
      1. Glyburide Use in Patients with Renal Insufficiency
      2. High Dose Zolpidem
      3. High Dose Atypical Antipsychotic
      
      
      
   4. DRUG SURVEILLANCE/PHARMACOVIGILANCE PROJECTS (Ongoing)
      1. Polypharmacy in Post Traumatic Stress Disorder (PTSD)
      2. Atypical Antipsychotic/SSRI/Benzodiazepine Rapid Cycle Analysis
      3. Varenicline Rapid Cycle Analysis
      4. PPIs Rapid Cycle Analysis
      5. Rapid Cycle Evaluation of Thiazolidinediones
      6. Long-Acting Opioids
      7. Bisphosphonates Pharmacovigilance-Rapid Analysis
      8. Rapid Cycle Analysis: Bevicizumab and Ranibizumab
      9. Rapid Cycle Signal Strengthening Evaluation: PPIs, H2Bs, and ACEs
      10. Rapid Cycle Analysis - Antiviral Drugs: Amantadine, Oseltamivir, Rimantadine, and Zanamivir
      11. Osteoporosis
      12. Vaccine Safety
      13. Influenza Project
      14. Risperidone
      15. Varenicline
      16. Beta-Blockers
      17. Glyburide
      18. Warfarin
      19. Fluoroquinolones
      
      
      

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3. POLICIES
   1. Pharmaceutical Use Outside of Approved Indications Guidance on Off-Label Prescribing

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4. DRUG MARKET WITHDRAWALS
   
   
   1. Rofecoxib (Vioxx®)
      1. PBM Bulletin/News Alert
      2. Physician Notification Letter
      3. Pharmacist Notification Letter
      4. Dear Healthcare Provider Letter
      5. FAQ’s
      6. Patient Letter
   2. Valdecoxib (Bextra®)
      1. Guidance
      2. Patient Letter
   3. Natalizumab (Tysabri®) – February 2005 - June 2006
      1. FDA Public Health Advisory
      2. FDA Alert – Information for Healthcare Professionals
      3. Dear Healthcare Professional Letter – March 2005
      4. Dear Healthcare Professional Letter – April 2005
      5. FAQ’s on the Clinical Hold
      6. FAQ’s on Natalizumab
      7. Prescribing Information
      8. PBM Removal Communication and Actions
      9. Important Drug Warning Letter from Biogen/Idec, Elan
      10. FDA Information on resumed market
   4. Gatifloxacin (Tequin®)
      1. Letter of Discontinuation from Bristol Myers Squibb – May 2006
      2. FDA Alert – Information for Healthcare Professionals – March 2006
      3. FDA Alert – Patient Information – March 2006
      4. Prescribing Information
   5. Mivacurium (Mivacron®)
      1. FDA Drug Shortages
   6. Tegaserod (Zelnorm®) and Discontinued Marketing – March 30, 2007
      1. FDA News
      2. Questions and Answers on Zelnorm
      3. FDA Public Health Advisory
      4. National PBM Bulletin
      5. Tegaserod Provider Letter
      6. Tegaserod Patient Letter
      7. Restricted Use of Zelnorm – July 2007
   7. FDA Recalls, Market Withdrawals, Safety Alerts

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