February 2012 Drug Update Information - Pharmacy Benefits ...

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4 mL Novaplus vial (NDC 00409-1412-49) 10 mL vial (NDC 00409-1412-10) 10 mL Novaplus vial (NDC 00409-1412-50) Reason for the Shortage Ben Venue voluntarily suspendedd all manufacturing and distribution in mid-November, 2011. Product will become available in stages as production resumes. Bedford Laboratories has multiple products affected by this suspension of manufacturing. Availability of all products, including those not manufactured at Ben Venue, is updated as information changes on the Bedford Laboratories website. Baxter discontinued bumetanide 0.25 mg/mL 2 mL vial in early-2011. West-Ward acquired several Baxter products including bumetanide in mid-2011. Hospira has bumetanide on shortage due to manufacturin ng delays. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=674 Source: http://www.a ashp.org Morphine Injections February 7, 2012 Products Affected - Description Astramorph (preservative-free) injection, APP 0.5 mg/mL 2 mL ampule, 10 count (NDC 63323-0291-80) 0.5 mg/mL 10 mL vial, 5 count (NDC 63323-0291-10) 1 mg/mL 2 mL ampule, 10 count (NDC 63323-0292-80) ) 1 mg/mL, 10 mL vial (NDC 63323-0292-10) Morphine injection, West-Ward 5 mg/mL, 1 mL vial (NDC 10019-0176-44) 10 mg/mL, 1 mL vial (NDC 10019-0178-44) 8 mg/mL, 1 mL vial (NDC 10019-0177-44) 10 mg/mL, 10 mL vial (NDC 10019-0178-62) 15 mg/mL, 1 mL vial (NDC 10019-0179-44) 15 mg/mL, 20 mL vial (NDC 10019-0179-63) 8 mg/mL, 1 mL ampule (NDC 10019-0177-68) - discontinued 10 mg/mL, 1 mL ampule (NDC 10019-0178-68) - discontinued Duramorph (preservative-free), West-Ward 0.5 mg/mL, 10 mL ampules (NDC 60977-0016-02) 1 mg/mL, 10 mL ampules (NDC 60977-0017-01) Morphine injection, Hospira 1 mg/mL 10 mL amp, package of 5 (NDC 00409-4058-21) - discontinued 0.5 mg/mL 10 mL, preservative-free vial (NDC 00409-3815-12) 1 mg/mL, 30 mL PCA vial (NDC 00409-2029-02) 2 mg/mL, 1 mL Carpuject syringe (NDC 00409-1762-30) 4 mg/mL, 1 mL Carpuject syringe (NDC 00409-1258-30) 5 mg/mL, 30 mL PCA vial (NDC 00409-6028-04) 8 mg/mL, 1 mL Carpuject syringes (NDC 00409-1260-69) 10 mg/mL, 1 mL Carpuject syringes (NDC 00409-1261- -30) vial (NDC 00409-3814-12) 1 mg/mL 10 mL preservative-free 25 mg/mL, 1 mL preservative-free vial (NDC 00409-1135-02) 25 mg/mL 4 mL Add-Vantage vial (NDC 00409-6177-14) Reason for the Shortage APP states the shortage is due to a change in manufacturing sites. Hospira states the shortage is due to manufacturing delays. 54
West-Ward states the shortage is due to increased demand for product. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=664 Source: http://www.a ashp.org Dexamethasone Sodium Phosphate February 7, 2012 Products Affected - Description Dexamethasone Sodium Phosphate Injection, 4 mg/mL, American Regent 1 mL single dose vial (NDC 00517-4901-25) 5 mL multiple dose vial (NDC 00517-4905-25) 30 mL multiple dose vial (NDC 00517-4930 -25) Dexamethasone Sodium Phosphate Injection, 10 mg/mL, West-Ward (formerly Baxter products) 1 mL vial (NDC 00641-0367-25) Reason for the Shortage American Regent voluntarily recalled all dexamethasonee sodium phosphate due to the presence of particulate matter in the solution and discontinued manufacture off all dexamethasone 4 mg/mL presentations s in March, 2011. American Regent had temporarily suspendedd distributionn of most drug products including dexamethasone in April, 2011. American Regent resumed manufacturing in Shirley, New York in early-May, 2011. APP states the dexamethasone sodium phosphate shortage was due to supply and demand issues. Baxter could not provide a reason for the shortage. Baxter sold several products to West-Ward in mid-2011. Pfizer launched dexamethasone sodium phosphate injection in January, 2012. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=751 Source: http://www.a ashp.org Epinephrine Metered Dose Inhaler February 7, 2012 Products Affected - Description Primatene Mist Inhaler (CFC), Armstrong Pharmaceuticals 0.22 mg/ /actuation, Over-the-Cou unter Reason for the Shortage To decrease depletion of the ozone layer, the Food and Drug Administration (FDA) announced that epinephrine metered dose inhalers (MDIs) containing chlorofluorocarbon (CFC) propellant must be withdrawn from the market by December 31, 2011. Other prescription metered dose inhalers such as albuterol were previously transitioned from a CFC propellant to a hydrofluoroa alkane (HFA) propellantt in 2008. Armstrong Pharmaceuticals is the only manufacturer of over-the-counter epinephrine inhalers. Patients will now need a prescription for any type of metered-dose inhaler. Additional information for patients is available online. Armstrong discontinued Primatene Mist with CFC propellant at the end of 2011. The company is hoping to release a more environmentally friendly Primatene Mist in the near future. Article link: http://www.ashp.org/DrugShortages/Current/Bulletin.aspx?id=848 Source: http://www.a ashp.org Trazodone Tablets February 8, 2012 Products Affected - Description 55
Page 1 and 2:
February 2012 Drug Information Upda
Page 3 and 4: GENERIC DRUG NAME GENERIC APPROVAL
Page 5 and 6: CICLOPIROX/ TOPICAL PEDIPIROX-4 New
Page 7 and 8: [Posted 01/09/2012] ISSUE: Novartis
Page 9 and 10: Studies Article Link: http://www.fd
Page 11 and 12: the use of XARELTO® (rivaroxaban),
Page 13 and 14: acteria. The Food and Drug Administ
Page 15 and 16: Statins raise risk of Type 2 diabet
Page 17 and 18: The Million Women Study, a U.K. pro
Page 19 and 20: Azithromycin 250 mg tablets, 1 card
Page 21 and 22: RECALLING FIRM/MANUFACTURE Recallin
Page 23 and 24: Recalling Firm: Pfizer Us Pharmaceu
Page 25 and 26: 250 mg, 100 count (NDC 00591-3969-0
Page 27 and 28: Sandoz states the shortage is due t
Page 29 and 30: 5 mL ampule (NDC 10019-0033-72) 20
Page 31 and 32: Article Link: http://www.ashp.org/D
Page 33 and 34: Lidocaine 2% (with epinephrine 1:10
Page 35 and 36: Source: http://www.a ashp.org Halop
Page 37 and 38: ecome unavailable for an extended t
Page 39 and 40: American Regent resumed manufacturi
Page 41 and 42: Trandate tablets, Prometheus 100 mg
Page 43 and 44: Article link: http://www.ashp.org/D
Page 45 and 46: Bedford Laboratories has multiple p
Page 47 and 48: Thiothixene capsules, Mylan 2 mg ca
Page 49 and 50: 20 mL vials (NDC 10019-0905-03) - d
Page 51 and 52: 500 mg extended release, 500 count
Page 53: 1 mg/mL, 4 mL vial (NDC 25021-0781-
Page 57 and 58: 150 mL bottle (NDC 63304-0954-02) C
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February 2012 Drug Update Information - Pharmacy Benefits ...

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