Category: AHFS DI

COVID-19 Updates

17 March, 2020 no responses

ASHP is committed to bringing you the most relevant COVID-19 updates as we navigate these unprecedented times. 

  • Today, President Trump’s Coronavirus Task Force issued new recommendations to include limiting social gatherings to no more than 10 people over the next 15 days. 
  • The  first participant in a clinical trial for a vaccine to protect against COVID-19 received an experimental dose on Monday.
  • ASHP continues to monitor for impact to drug shortages. 
  • ASHP sent a letter to Vice President Mike Pence urging the Trump Administration to take immediate steps to maximize pharmacist engagement in COVID-19 preparedness and response efforts. We also asked that decisive action by the Centers for Medicare & Medicaid Services be taken to remove barriers to pharmacists’ patient care services. 
  • We are also closely monitoring the impact to personal protective equipment supply and will report results of our survey later this week.
  • We have made AHFS Drug Information available to the public through May 31. You may access this resource with the username “ahfs@ashp.org” and password “covid-19.” 

We encourage you to bookmark ASHP’s COVID-19 Resource Center, which serves as a clearinghouse for more information on COVID-19.

New:  COVID-19 Pandemic Assessment Tool
ASHP has released its COVID-19 Pandemic Assessment Tool for Health-System Pharmacy Departments, which is intended to assist in COVID-19 pandemic planning efforts in departments of pharmacy and to foster pharmacist involvement in preparedness at the institutional and community levels. 

AHFS Drug Information/Essentials Update – October 2017

19 October, 2017 no responses

The October update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New First-Release Monographs

  • Gemtuzumab Ozogamicin (Mylotarg®) – 10:00 (Antineoplastic Agents)
    • Gemtuzumab was removed from US market June 2010 and reapproved September 2017 with many changes
    • New indications: 
      • Treatment of newly diagnosed CD33-positive acute myeloid leukemia in adults.
      • Treatment of relapsed or refractory CD33-positive AML in adults and in pediatric patients 2 years and older.
  • Deutetrabenazine (Austedo®) – 28:92 (Central Nervous System Agents, Miscellaneous)
    • Treatment of chorea associated with Huntington’s disease.
    • Treatment of tardive dyskinesia in adults.
  • Daunorubicin And Cytarabine (Vyxeos®) – 10:00 (Antineoplastic Agents)
    • A liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
  • Selenious Acid – 40:12 (Replacement Preparations)
    • Trace element
  • Inotuzumab Ozogamicin (Besponsa®) – 10:00 (Antineoplastic Agents)
    • Treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA MedWatch Alerts

  • Increased risks associated with the use of pembrolizumab (Keytruda) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma.
    • Affected monographs:
      • 315018,”Pembrolizumab”,”10:00″
  • Obeticholic acid (Ocaliva) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death.
    • Affected monographs:
      • 316059,”Obeticholic Acid”,”56:92″
  • Avoid taking the potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) at the same time as other medicines taken by mouth.
    • Affected monographs:
      • 382108,”Sodium Polystyrene Sulfonate”,”40:18.18″
  • Opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system (CNS).
    • Affected monographs:
      • 382134,”Methadone”,”28:08.08″
      • 387004,”Buprenorphine”,”28:08.12″

AHFS Drug Information/Essentials Update – September 2017

20 September, 2017 no responses

The September update to the AHFS Drug Information/Essentials database has been published. Highlights from this month’s update include:

New Full-Length Monographs

  • Etelcalcetide Hydrochloride (Parsabiv®) – 68:24.04 (Antiparathyroid Agents)
    • A calcium-sensing receptor agonist indicated for secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on  hemodialysis.
  • Obeticholic Acid (Ocaliva®) – 56:92 (GI Drugs, Miscellaneous)
    • Treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA; [ursodiol per USAN]) in adults with an inadequate response to UDCA, or as monotherapy in adults unable to tolerate UDCA.
  • Lifitegrast (Xiidra®) – 52:08.92 (Anti-inflammatory Agents, Miscellaneous)
    • Treatment of the signs and symptoms of dry eye disease.

New First-Release Monographs

  • Sofosbuvir, Velpatasvir, And Voxilaprevir (Vosevi®) – 8:18.40.16 (HCV Polymerase Inhibitors)
    • Treat adults with chronic hepatitis C virus (HCV) genotypes 1-6 without cirrhosis (liver disease) or with mild cirrhosis.
  • Enasidenib Mesylate (Idhifa®) – 10:00 (Antineoplastic Agents)
    • Treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
  • Neratinib Maleate (Nerlynx®) – 10:00 (Antineoplastic Agents)
    • Extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy.
  • Glecaprevir And Pibrentasvir (Mavyret®) – 8:18.40.20 (HCV Protease Inhibitors)
    • Treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both.

FDA MedWatch Alerts

  • None
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