ID Update

by admin last updated 2022-11-08T08:17:41-05:00 © Antimicrobial Therapy, Inc.

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NOVEMBER 2022

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

Visceral Leishmaniasis in Persons Living with HIV

  • Updated WHO guidelines (click here to download PDF) describe the management of visceral leishmaniasis (VL) caused by Leishmania donovani in HIV co-infected patients in East Africa and South-East Asia. The recommendations are also applicable to other areas endemic for L. donovani.
  • Until now, the generic recommendation for treatment of a VL episode in an HIV co-infected patient was monotherapy with liposomal amphotericin B 3-5 mg/kg IV daily or in 10 intermittent doses (on days 1–5, 10, 17, 24, 31 and 38) to a total dose of 40 mg/kg.
  • New recommendations: Liposomal amphotericin B (up to a cumulative treatment dose of 30 mg/kg, given as 5 mg/kg IV on each treatment day 1, 3, 5, 7, 9, 11) + miltefosine (100 mg/day po for 14 days if acquired in South-East Asia, 28 days if acquired in East Africa).
  • Secondary prophylaxis (vary low certainty of evidence):
    • East Africa: Pentamidine 4 mg/kg [300 mg for an adult] IV q3-4 weeks.
    • South-East Asia: Amphotericin B deoxycholate 1 mg/kg IV q3-4 weeks or liposomal amphotericin B 3-5 mg/kg IV q3-4 weeks. Prophylaxis can be stopped if the CD4 cell count is maintained at >350, or the HIV viral load is undetectable for at least 6 months and there is no evidence of VL relapse.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 6, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since October 9, 2022:
      • Amoxicillin (all oral formulations)
      • Dalbavancin injection
      • Oseltamivir capsules, powder for oral suspension
      • Penicillin G sodium injection
      • Primaquine tablets
    • Shortage recently resolved:
      • Cefepime injection
      • Daptomycin injection
      • Neomycin and Polymyxin B sulfates GU irrigant
      • Rifapentine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Rifaximin 200 mg tablets
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment (unavailable)
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B Lipid Complex (ABLC)
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Isoniazid 300 mg tablets
      • Rifampin capsules
      • Rifampin injection
    • Antiviral drugs in continued reduced supply
      • None
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

OCTOBER 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

From ACIP

  • This report summarizes all recommendations from CDC’s Advisory Committee on Immunization Practices (ACIP) for the use of lyophilized CVD 103-HgR vaccine (Vaxchora) in the US. CVD 103-HgR, a single-dose, live attenuated oral cholera vaccine derived from V. cholerae O1, is the only cholera vaccine licensed for use in the US (MMWR Recomm Rep 2022;71:1-8). PDF available here.
  • Updated recommendations for the use of 15-valent pneumococcal conjugate vaccine (PCV15, Vaxneuvance) in US children (MMWR Morb Mortal Wkly Rep 2022;71:1174). PDF available here.

Pentavalent Antimonials for Leishmaniasis

  • Stibogluconate sodium (Pentostam) has been discontinued by GSK worldwide and is no longer available from CDC.
  • Meglumine antimoniate (Glucantime) is available from Sanofi after obtaining an IND from FDA. Click here for instructions.

CDC Discontinues Distribution of Artesunate

  • CDC has discontinued distribution of intravenous artesunate for treatment of severe malaria in the US. Commercial IV artesunate is available in adequate supply from major drug distributors. Click here for more details.

ZeNix Trial for Highly Drug-Resistant Tuberculosis

  • The six-month oral regimen of bedaquiline-pretomanid-linezolid has 90% efficacy against highly drug-resistant tuberculosis. Unfortunately, peripheral neuropathy and myelosuppression associated wtih linezolid (1200 mg po once daily) in this regimen are problematic. In the ZeNix trial, different doses and durations of linezolid were investigated for efficacy and safety. The regimen employing linezolid 600 mg once daily for 26 weeks appeared to have the most favorable risk-benefit profile (N Engl J Med 2022;387:810).

ART in Pregnancy

  • A dolutegravir (DTG)-based regimen is preferred as first-line antiretroviral therapy (ART) in pregnant persons infected with HIV. However, safety and efficacy data for other INSTI-based, PI-based, and NNRTI-based regimens compared to DTG-based ART are lacking. In this US multisite cohort study, DTG-based ART was superior to regimens based on atazanavir/r, raltegravir, and elvitegravir/cobicistat, and similar to regimens based on darunavir/r and rilpivirine, in achieving viral suppression at delivery. No clear differences in risk of adverse birth outcomes with DTG-based ART compared to other ART regimens were observed (N Engl J Med 2022;387:799).

Ceftaroline and CNS Infection

  • Ceftaroline is a possible option for CNS infection due to MRSA, but supportive data are scant. In a population pharmacokinetic model, an inverse relationship was found between CSF glucose concentration and intercompartmental clearance into the CSF. Model simulations showed a median ceftaroline penetration into the CSF of 4% in the group with uninflamed meninges, 19% in the group with mildly inflamed meninges, and 62% in the group with inflamed meninges. These differences in CSF exposure result in marked differences in probability of target attainment for specific microbes. The authors suggest that a dose of 600 mg IV q8h should be further evaluated for treatment of CNS infection (Antimicrob Agents Chemother 2022;66: e0074122).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 9, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since September 11, 2022:
      • None
    • Shortage recently resolved:
      • Cefepime injection
      • Daptomycin injection
      • Neomycin and Polymyxin B sulfates GU irrigant
      • Rifapentine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Rifaximin 200 mg tablets
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment (unavailable)
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B Lipid Complex (ABLC)
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Isoniazid 300 mg tablets
      • Rifampin capsules
      • Rifampin injection
    • Antiviral drugs in continued reduced supply
      • None
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

SEPTEMBER 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • September 11: We have completely reworked our COVID-19 vaccines page for the new bivalent vaccines. Check it out!
  • August 31: The US FDA amends the EUAs of the Moderna and Pfizer-BioNTech vaccines to authorize bivalent formulations for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines contain two mRNA components of SARS-CoV-2 virus: one of the original strain of SARS-CoV-2, and the other one in common between the BA.4 and BA.5 lineages of the omicron variant.

    The Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals ≥18 years of age. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals ≥12 years of age.

  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

2022-2023 Influenza Vaccination

  • Prevention and control of seasonal influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2022–23 influenza season (MMWR Recomm Rep 2022;71(No. RR-1):1–28). PDF available here.

Polio Vaccination

  • In June 2022, poliovirus was confirmed in an unvaccinated immunocompetent adult resident of Rockland County, New York. Vaccine-derived poliovirus type 2 was isolated from the patient and also identified from wastewater samples in two neighboring New York counties. Here are the current recommendations for children who were not vaccinated per the routine schedule, and adults who have had less than 3 doses.
    • Primary schedule, routine, age 6 weeks through 17 years: IPV at ages 2, 4, and 6-18 months.
    • Catch-up schedule if not initiated at normal age: 0, 1, and 2 months if age <4 years; 0, 1, and 6 months if age ≥4 years.
    • Adults who have had 1 or 2 prior polio vaccine doses should get the final 1 or 2 doses per the standard interval.
  • No additional doses are recommended for those previously fully vaccinated.
  • See Polio, Vaccine and Poliovirus, Poliomyelitis.

AHA Scientific Statement on Endocarditis in PWID

New Practice Guidelines

  • Management of Helicobacter pylori infection, from the Italian Society of Gastroenterology and the Italian Society of Digestive Endoscopy (Dig Liver Dis 2022;54:1153). PDF available here.

Fluoroquinolones and Acute Liver Injury

  • In a nationwide register-based cohort study conducted in Sweden, oral fluoroquinolone use was associated with a 2-fold increased risk of acute liver injury (compared to amoxicillin) within a 60-day period after the start of treatment. The absolute risk was low (estimated to be five additional events per one million courses of treatment). The majority of treatment courses consisted of ciprofloxacin (79.3%), followed by norfloxacin (17.4%), moxifloxacin (1.78%), levofloxacin (1.11%), and ofloxacin (0.47%) (Clin Infect Dis 2022;74:2152). PDF available at PMC.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of September 11, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since August 7, 2022:
      • Isoniazid 300 mg tablets
      • Rifaximin 200 mg tablets
    • Shortage recently resolved:
      • Cefepime injection
      • Daptomycin injection
      • Neomycin and Polymyxin B sulfates GU irrigant
      • Rifapentine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G sodium 5 million units/vial (10 count)
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment (unavailable)
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B Lipid Complex (not liposomal)
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Rifampin capsules
      • Rifampin injection
    • Antiviral drugs in continued reduced supply
      • None
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

AUGUST 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

EC Approval of Lenacapavir

  • The European Commission (EC) has granted marketing authorization for lenacapavir (brand name: Sunlenca) injection and tablets for the treatment of HIV infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. Lenacapavir is a first-in-class capsid inhibitor that directly binds to the interface between capsid protein subunits and inhibits HIV-1 replication by interfering with multiple, essential steps of the viral lifecycle. It is administered subcutaneously twice-yearly.

From CDC

  • Interim guidance for prevention and treatment of monkeypox in persons with HIV infection (MMWR Morb Mortal Wkly Rep 2022 Aug 5 [Epub ahead of print]). PDF available here.
  • Interim recommendation from ACIP for use of the Novavax vaccine in persons aged ≥18 years as a primary 2-dose series vaccination for the prevention of COVID-19 (MMWR Morb Mortal Wkly Rep 2022;71:988–992). PDF available here.

Reduced Susceptibility of C. difficile to Vancomycin

  • Clostridioides difficile isolates exhibiting reduced susceptibility to vancomycin are described in two distinct geographic locations on different continents (Houston, Texas and Nairobi, Kenya). To identify stool samples containing nonsusceptible C. difficile isolates, samples were plated on C. difficile culture medium (CDPA) only and CDPA containing either vancomycin 4 μg/mL or metronidazole 8 μg/mL (based on CLSI breakpoint concentrations). Of the Houston stool samples (obtained from patients with CDI), 114/438 (26%) contained vancomycin nonsusceptible C. difficile isolates. 66/98 (67%) of the stool samples from Nairobi patients harbored vancomycin nonsusceptible isolates. 29% and 85% of the isolates from Houston and Nairobi were metronidazole nonsusceptible, respectively. In a CDI mouse model infected with a vancomycin nonsusceptible isolate, vancomycin failed to eradicate the infection. Whole-genome sequencing analyses did not identify vanA genes, suggesting an alternate mechanism of resistance. The potential spread of vancomycin nonsusceptible C. difficile has serious public health implications (Clin Infect Dis 2022;74:120).

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 7, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since July 11, 2022:
      • Amphotericin B Lipid Complex (not liposomal), Penicillin G sodium 5 million units/vial (10 count)
    • Shortage recently resolved:
      • Amphotericin B injection, Tocilizumab injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Rifampin capsules
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • None
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

JULY 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • July 13: The US FDA issues an EUA for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 in individuals ≥18 years of age. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant. It is administered as a two-dose primary series, three weeks apart. Fact sheet here.
  • July 6: The US FDA revises the nirmatrelvir + ritonavir (Paxlovid) EUA to authorize state-licensed pharmacists to prescribe to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing (press release here). Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs, if any of the following apply:
    • Sufficient information is not available to assess renal and hepatic function.
    • Sufficient information is not available to assess for a potential drug interaction.
    • Modification of other medications is needed due to a potential drug interaction.
    • Nirmatrelvir + ritonavir is not an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

New IDSA Guidance on Treatment of Resistant Infections

  • Guidance document for treating AmpC β-lactamase-producing Enterobacterales (AmpC-E), carbapenem-resistant Acinetobacter baumannii (CRAB), and Stenotrophomonas maltophilia infections (Clin Infect Dis 2022;74:2089-2114). PDF available here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of July 11, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since June 13, 2022:
      • Erythromycin 0.5% ophthalmic ointment
    • Shortage recently resolved:
      • Acyclovir injection, Amphotericin B injection, Ethambutol tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Rifampin capsules
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

JUNE 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

New co-packaged treatments for H. pylori

  • Vonoprazan/amoxicillin/clarithromycin (brand name Voquezna "Triple Pak") and vonoprazan/amoxicillin (brand name Voquezna "Dual Pak") for the treatment of H. pylori infection in adults. Vonoprazan is an oral potassium-competitive acid blocker, co-packaged with amoxicillin ± clarithromycin. The recommended oral dosage of the Triple Pak is vonoprazan 20 mg bid + amoxicillin 1000 mg bid + clarithromycin 500 bid, with or without food, for 14 days. The recommended oral dosage of the Dual Pak is vonoprazan 20 mg bid + amoxicillin 1000 mg tid, with or without food, for 14 days. Product launch is expected in the third quarter of 2022.

New Dosage Form of Tecovirimat

  • Tecovirimat 200 mg injection (brand name Tpoxx) for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg. Recommended dosage (for up to 14 days): weight 3 to <35 kg, give 6 mg/kg IV q12h; weight 35 to <120 kg, give 200 mg IV q12h; weight ≥120 kg, give 300 mg IV q12h. Doses should be infused over 6 hours.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of June 13, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since May 7, 2022:
      • None
    • Shortage recently resolved:
      • Acyclovir injection, Amphotericin B injection, Ethambutol tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Cefuroxime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Rifampin capsules
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

MAY 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 7, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since April 23, 2022:
      • Cefuroxime injection
    • Shortage recently resolved:
      • Acyclovir injection, Methenamine hippurate tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Quinupristin-Dalfopristin injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B injection
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Ethambutol tablets
      • Rifampin capsules
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

APRIL 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • April 25: The US FDA expands the approval of remdesivir to include pediatric patients ≥28 days of age weighing ≥3 kg with positive results of direct SARS-CoV-2 viral testing, who are hospitalized OR not hospitalized and have mild-to-moderate COVID-19 and are at high risk for progression to severe COVID-19, including hospitalization or death.
  • April 5: Sotrovimab is no longer authorized to treat COVID-19 in any US region due to increases in the proportion of cases caused by the BA.2 sub-variant.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

Approval of Oteseconazole

  • The US FDA has approved Vivjoa (oteseconazole*) to reduce the incidence of recurrent vulvovaginal candidiasis* (RVVC) in females with a history of RVVC who are not of reproductive potential. Oteseconazole is a tetrazole antifungal with less affinity for human CYP enzymes. There are two recommended dosage regimens, one with fluconazole (not supplied in the carton) and one without (see drug page for details).

Updated Practice Guidelines

  • Updated clinical practice guidelines for the management of chronic hepatitis B, from the Korean Association for the Study of the Liver (Clin Mol Hepatol 2022;28:276-331). These guidelines update the 2018 release. PDF available here.

New Dosage Form of Triumeq

  • Triumeq PD (abacavir 60 mg, dolutegravir 5 mg, lamivudine 30 mg) tablets for oral suspension, for treatment of HIV-1 infection in pediatric patients weighing 10 to <25 kg. Not recommended in patients weighing ≥25 kg. The two dosage forms of Triumeq (tablets, PD tablets for oral suspension) must not be interchanged on a mg-for-mg basis due to differing pharmacokinetic profiles of the dolutegravir component.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of April 23, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since March 7, 2022:
      • Quinupristin-Dalfopristin injection
      • Rifampin capsules
    • Shortage recently resolved:
      • Hepatitis B vaccine recombinant
      • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
      • Posaconazole injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methenamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B injection
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Ethambutol tablets
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Acyclovir injection
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

 

MARCH 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • March 30: The US FDA authorizes a second booster dose of either the Pfizer-BioNTech or Moderna vaccine for older people and certain immunocompromised individuals, as follows:
    • A second dose of either vaccine to Individuals ≥50 years of age, ≥4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine.
    • A second booster dose of the Pfizer-BioNTech vaccine may be administered to individuals ≥12 years of age with certain kinds of immunocompromise, ≥4 months after receipt of a first booster dose of any authorized or approved COVID-19 vaccine. These are people who have undergone solid organ transplantation, or who are living with conditions that are considered to have an equivalent level of immunocompromise.
    • A second booster dose of the Moderna vaccine may be administered ≥4 months after the first booster dose of any authorized or approved COVID-19 vaccine to individuals ≥18 years of age with the same certain kinds of immunocompromise.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

Interim CDC Guidance for a Novel TB Regimen

  • CDC recommends the 4-month RPT-MOX regimen as an option for treating patients aged ≥12 years and body weight ≥40 kg with pulmonary TB caused by organisms that are not known or suspected to be drug-resistant and who have no contraindications to this regimen. The 4-month daily treatment regimen consists of an intensive phase composed of 8 weeks of daily treatment with rifapentine, moxifloxacin, INH, and PZA, followed by a continuation phase of 9 weeks of daily treatment with rifapentine, moxifloxacin, and INH. The drugs are administered once daily with food, 7 days per week, for a total of 119 treatment doses. Similar to the standard 6-month regimen, at least 5 of 7 weekly doses should be administered under DOT. Ref: MMWR Morb Mortal Wkly Rep 2022;71:285. PDF of guidance here.

New or Updated Practice Guidelines

  • Updated Japanese clinical practice guidelines for the management of children with mother-to-child transmitted HCV infection, from the Japan Society for Pediatric Gastroenterology, Nutrition, and Hepatology (Pediatr Int 2022 Jan;64(1):e14962). Available to read here.
  • Updated clinical practice guidelines for the use of tympanostomy tubes in children, from the American Academy of Otolaryngology–Head and Neck Surgery Foundation (Otolaryngol Head Neck Surg 2022;166(1 suppl):S1-S55). These guidelines update the 2013 release. Available as PDF here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of March 29, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since March 7, 2022:
      • Rifampin capsules
    • Shortage recently resolved:
      • Ceftolozane-tazobactam injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B injection
      • Clotrimazole 10 mg oral troches
      • Posaconazole injection
    • Antimycobacterial drugs in continued reduced supply
      • Ethambutol tablets
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Acyclovir injection
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

 

FEBRUARY 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • February 11: EUA issued by US FDA for bebtelovimab, a new monoclonal antibody that retains activity against omicron. The EUA is for the treatment of mild to moderate COVID-19 in adults and pediatric patients (≥12 years of age, weight ≥40 kg) with a positive COVID-19 test, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options approved or authorized by the FDA are not accessible or clinically appropriate.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

Updated ACIP Recommendations

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of February 8, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since January 21, 2022:
      • None
    • Shortage recently resolved:
      • Ceftolozane-tazobactam injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefixime capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B injection
      • Clotrimazole 10 mg oral troches
      • Posaconazole injection
    • Antimycobacterial drugs in continued reduced supply
      • Ethambutol tablets
      • Rifampin injection
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Acyclovir injection
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

 

JANUARY 2022

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • January 21: The US FDA expands the use of remdesvir to certain non-hospitalized adults and pediatric patients for the treatment of mild-to-moderate COVID-19 disease:
    • The approved indication now includes adults and pediatric patients (≥12 years, weight ≥40 kg) with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization or death. Revised PI here.
    • The EUA now authorizes use in pediatric patients weighing 3.5 kg to <40 kg or <12 years of age weighing >3.5 kg, with positive results of direct SARS-CoV-2 viral testing, who are not hospitalized and have mild-to-moderate COVID-19, and are at high risk for progression to severe COVID-19, including hospitalization of death. Fact sheet for healthcare providers here.
  • January 3: The US FDA amends the EUA for the Pfizer-BioNTech COVID-19 vaccine to:
    • Expand the use of a single booster dose to include use in individuals 12 through 15 years of age.
    • Shorten the time between the completion of primary vaccination with the Pfizer-BioNTech vaccine and a booster dose to at least five months.
    • Allow for a third primary series dose for certain immunocompromised children 5 through 11 years of age.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

Clindamycin Vaginal Gel for BV

  • The US FDA has approved clindamycin phosphate vaginal gel, 2% (Xaciato) for the treatment of bacterial vaginosis in females 12 years of age and older. Recommended dosage: one applicatorful (5 gm of vaginal gel containing 100 mg of clindamycin) administered once intravaginally as a single dose at any time of the day.

Updated ACIP Recommendations

  • On October 20, 2021, the Advisory Committee on Immunization Practices (ACIP) recommended 15-valent PCV (PCV15) or 20-valent PCV (PCV20) for PCV–naïve adults who are either age ≥65 years or age 19–64 years with certain underlying conditions. When PCV15 is used, it should be followed by a dose of PPSV23, typically ≥1 year later (MMWR 2022;71:109-117). PDF here.
  • On October 20, 2021, the ACIP recommended 2 doses of recombinant zoster vaccine (RZV) for the prevention of herpes zoster and related complications in adults aged ≥19 years who are or will be immunodeficient or immunosuppressed because of disease or therapy. RZV is the first herpes zoster vaccine approved for use in immunocompromised persons (MMWR 2022;71:80-84). PDF here.

New or Updated Practice Guidelines

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 21, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since December 13, 2021:
      • Acyclovir injection, Cefixime capsules, Posaconazole injection, Rifampin injection
    • Shortage recently resolved:
      • Ceftolozane-tazobactam injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs in continued reduced supply
      • Amphotericin B injection
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs in continued reduced supply
      • Ethambutol tablets
      • Rifapentine tablets
    • Antiviral drugs in continued reduced supply
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

 

DECEMBER 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • December 23: The US FDA issues an EUA for molnupiravir for the treatment of mild-to-moderate COVID-19 disease in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Rcommended dosage: 800 mg (four 200 mg capsules) po q12h for five days.
  • December 22: The US FDA issues an EUA for nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use (Paxlovid) for the treatment of mild-to-moderate COVID-19 disease in adults and pediatric patients (≥12 years, weight ≥40 kg) with positive results of direct SARS-CoV-2 testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Nirmatrelvir + ritonavir should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset. Recommended dosage: nirmatrelvir 300 mg twice daily + ritonavir 100 mg twice daily (taken together) for five days.
  • December 9: The US FDA amends the Pfizer-BioNTech COVID-19 vaccine EUA to authorize the use of a single booster dose to individuals 16 and 17 years of age at least six months after completion of primary vaccination with the Pfizer-BioNTech vaccine.
  • December 8: The US FDA issues an EUA for tixagevimab co-packaged with cilgavimab and administered together for the pre-exposure prophylaxis of COVID-19 in certain adults and pediatric individuals (≥12 years of age weighing ≥40 kg). Authorization is only for individuals who are not currently infected with SARS-CoV-2 and who have not recently been exposed to an infected individual. The EUA also requires that individuals either have a moderate to severely compromised immune system or a history of severe adverse reaction to vaccination.
  • December 3: The US FDA amends the EUA of bamlanivimab and etesevimab (previously authorized for pediatric patients ≥12 years of age weighing ≥40 kg), authorizing the combination for the treatment of mild to moderate COVID-19 in all younger pediatric patients, including newborns, who have a positive COVID-19 test and are at high risk for progression to severe COVID-19, including hospitalization or death. This revision also authorizes the combination for post-exposure prophylaxis for prevention of COVID-19 in all pediatric patients, including newborns, at high risk of progression to severe COVID-19, including hospitalization or death. Fact sheet here.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2021 Nov 22 [online ahead of print]). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.
  • Saudi Critical Care Society practice guidelines on the management of COVID-19 in the ICU: therapy section (J Infect Public Health 2021 Oct 20 [online ahead of print]). Last updated in 2020. Available at PMC.

New or Updated Practice Guidelines

  • Executive summary. Guidelines for chlamydial urethritis, from the Asian Association of Urinary Tract Infection and Sexually Transmitted Infection (J Infect Chemother 2021 Dec 6 [online ahead of print]).
  • Joint Healthcare Infection Society (JIS) and Infection Prevention Society (IPS) guidelines for the prevention and control of methicillin-resistant Staphylococcus aureus (MRSA) in healthcare facilities (J Hosp Infect 2021;118S:S1).
  • Prevention, diagnosis, and management of post-surgical mediastinitis in adults: consensus guidelines of the Spanish Society of Cardiovascular Infections, the Spanish Society of Thoracic and Cardiovascular Surgery, and the Biomedical Research Centre Network for Respiratory Diseases (J Clin Med 2021;10(23):5566). Available at PMC.

Injectable Cabotegravir for PrEP

  • The US FDA has approved Apretude (cabotegravir extended-release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents weighing ≥35 kg. Recommended dosage: Initiation with a 600 mg/3 mL IM injection administered one month apart for two consecutive months, then continuation with a single 600 mg/3 mL IM injection administered every two months. Lead-in with oral cabotegravir (30 mg po once daily x28 days) may be administered before initiating the first injection to assess tolerability.

Dengue Vaccine Recommendations

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 13, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since November 8, 2021:
      • Amphotericin B injection
      • Doxycycline oral suspension
      • Rifapentine tablets
    • Shortage recently resolved:
      • Cefotetan injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Gentamicin sulfate 3% ophthalmic ointment
        • Neomycin tablets
        • Tobramycin injection
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefepime injection
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
        • Ceftazidime injection
        • Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones:
        • Ciprofloxacin 0.3% ophthalmic solution
        • Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Ampicillin-sulbactam injection
        • Dicloxacillin capsules
        • Piperacillin-tazobactam injection
      • Topical (miscellaneous) antibacterials:
        • Bacitracin ophthalmic ointment
        • Neomycin and Polymyxin B sulfates GU irrigant
        • Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment
        • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
        • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)

 

NOVEMBER 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • November 23: The US FDA amends the EUA for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine. 
  • November 4: The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK authorizes the use of the orally administered drug molnupiravir (Lagevrio) for use in people who have mild to moderate COVID-19 and at least one risk factor for developing severe illness. Such risk factors include obesity, older age (>60 years), diabetes mellitus, or heart disease. The authorized dose is 800 mg (four 200 mg capsules) every 12 hours for 5 days.
  • October 29: The US FDA authorizes the emergency use of the Pfizer-BioNTech vaccine for the prevention of COVID-19 to include children 5 through 11 years of age. It is administered as a two-dose primary series, 3 weeks apart, but at a lower dose (10 µg/0.2 mL IM) than that used for individuals ≥12 years of age (30 µg/0.3 mL IM).
  • October 20: The US FDA revises the EUAs for COVID-19 vaccines to allow for the use of a single booster dose as follows:
    • The use of a single booster dose of the Moderna vaccine (50 µg/0.25 mL IM, which is half of the dose given for a primary series dose) administered at least 6 months after completion of the primary series to individuals:
      • ≥65 years of age.
      • 18 through 64 years of age at high risk of severe COVID-19.
      • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
    • The use of a single booster dose of the Janssen (Johnson and Johnson) vaccine (0.5 mL IM, which is the same dose as the first dose) may be administered at least 2 months after completion of the single-dose primary regimen to individuals 18 years of age and older.
    • The use of each of the available vaccines as a heterologous (“mix and match”) booster dose in eligible individuals following completion of primary vaccination with a different vaccine.
  • September 22: The US FDA revises the EUA for the Pfizer-BioNTech vaccine to allow for use of a single booster dose (30 µg/0.3 mL IM, which is the same dose as a primary series dose) to be administered at least six months after completion of the primary series to individuals:
    • ≥65 years of age.
    • 18 through 64 years of age at high risk of severe COVID-19.
    • 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;374:n1703).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.
  • Saudi Critical Care Society practice guidelines on the managment of COVID-19 in the ICU: therapy section (J Infect Public Health 2021 Oct 20 [online ahead of print]). Last updated in 2020. Available at PMC.

US FDA New Product Approval

  • Maribavir for the treatment of adults and pediatric patients (≥12 years of age, weight ≥35 kg) with post-transplant cytomegalovirus (CMV) infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir or foscarnet. Maribavir inhibits human CMV-encoded kinase pUL97, an important enzyme in viral replication. HCMV pUL97 is also responsible for the activation of ganciclovir. Recommended dosage: 400 mg (two 200 mg tablets) po twice daily, with or without food.

New or Updated Practice Guidelines

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 8, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since October 12, 2021: Metronidazole injection
    • Shortage recently resolved: Artesunate injection
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Gentamicin sulfate 3% ophthalmic ointment, Neomycin tablets, Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin-sulbactam injection, Dicloxacillin capsules, Piperacillin-tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment, Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).

 

OCTOBER 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • September 16: The US FDA revises the EUA for Bamlanivimab + Etesevimab authorizing the combination for emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. It remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Fact sheet here.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;374:n1703).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

New or Updated Practice Guidelines

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 12, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since September 7, 2021: Gentamicin sulfate 3% ophthalmic ointment
    • Shortage recently resolved: Ceftazidime-avibactam injection, Cidofovir injection, Chloroquine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Neomycin tablets, Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin-sulbactam injection, Dicloxacillin capsules, Piperacillin-tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment, Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
      • Tocilizumab injection
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).

 

SEPTEMBER 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;374:n1703).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

New Sanford Guide Resources

  • The Tables & Tools menu contains a wealth of information. For a quick view of what is included, see What's in Tables & Tools.
  • New table: Pharmacodynamics of Antimicrobial Agents

Preventing Influenza in Children

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of September 7, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since August 10, 2021: Dicloxacillin capsules, Tocilizumab injection
    • Shortage recently resolved: Ceftazidime-avibactam injection, Cidofovir injection, Chloroquine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Neomycin tablets, Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin-sulbactam injection, Piperacillin-tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment, Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).

 

AUGUST 2021

SARS-CoV-2 / COVID-19

Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.

  • Important Note August 2021 re Delta Variant:
    • Other than hypertransmissibility and high peak viral loads, current understanding of SARS-CoV-2 infection with the currently predominant Delta variant, is very limited although improving daily. Delta has many unique properties. Most knowledge of clinical, epidemiologic, therapeutic, and diagnostic aspects of infection and COVID-19 are based on studies done in the pre-Delta era and recommendations based on references that pre-date Delta should be interpreted in that context. Of course, we will continue to update COVID-19 information and recommendations based on new developments.
  • July 28: The US FDA revises the EUA to authorize baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Under the revised EUA, baricitinib is no longer required to be administered with remdesivir. Fact sheet here.
  • July 28: The US FDA revises the EUA for Casirivimab + Imdevimab authorizing it for emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. It remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Fact sheet here.
  • CDC: Interim public health recommendations for fully vaccinated people here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;374:n1703).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

First COVID-19 Vaccine Approval

  • The Pfizer-BioNTech COVID-19 mRNA vaccine (Comirnaty (koe-mir’-na-tee)), for the prevention of COVID-19 disease in persons 16 years of age and older. The vaccine also continues to be available under EUA for individuals 12-15 years of age and for the administration of a third dose in certain immunocompromised persons. Vaccination schedule: 2 doses (0.3 mL each) administered intramuscularly, 3 weeks apart.

From CDC

  • 2021-22 recommendations of the Advisory Committee on Immunization Practices (ACIP) regarding the use of seasonal influenza vaccines in the United States (MMWR Recomm Rep 2021;70;1-28). Available here.

New or Updated Clinical Practice Guidelines

  • Diagnosis and management of acute hematogenous osteomyelitis in pediatrics, from the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America (J Pediatric Infect Dis Soc 2021 Aug 5 [online ahead of print]). The guidelines are available here.
  • Immunizations in patients with inflammatory bowel disease (part 1: live vaccines), from the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association (Gastroenterology 2021;161:669). The guidelines are available here.
  • Immunizations in patients with inflammatory bowel disease (part 2: inactivated vaccines), from the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association (Gastroenterology 2021;161:669). The guidelines are available here.
  • European Crohn’s and Colitis Organization (ECCO) guidelines on the prevention, diagnosis, and management of infections in inflammatory bowel disease (J Crohns Colitis 2021;15:879). The last update was in 2014. Available here.
  • Japanese clinical practice guidelines for management of sepsis and septic shock 2020 (J-SSCG 2020) (J Intensive Care 2021;9:53). These guidelines, revised from J-SSCG 2016 jointly by the Japanese Society of Intensive Care Medicine and the Japanese Association for Acute Medicine, were first released in September 2020 and published in February 2021. An English-language version of these guidelines was created based on the contents of the original Japanese-language version. Available here.

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 10, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
    • New on the list since July 13, 2021: None
    • Shortage recently resolved: Ceftazidime-avibactam injection, Cidofovir injection, Chloroquine tablets
    • Antibacterial and antimycobacterial drugs in continued reduced supply:
      • Aminoglycosides: Amikacin injection, Gentamicin injection, Neomycin tablets, Tobramycin injection
      • Carbapenems: Meropenem injection
      • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftolozane-tazobactam injection
      • Clindamycin injection
      • Ethambutol tablets
      • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
      • Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
      • Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
      • Methanamine hippurate tablets
      • Nitrofurantoin oral suspension
      • Penicillins: Ampicillin-sulbactam injection, Piperacillin-tazobactam injection
      • Tetracyclines: None
      • Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment, Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal, antiparasitic, and antiviral drugs in continued reduced supply
      • Clotrimazole 10 mg oral troches
      • Hydroxychloroquine tablets
    • Vaccines in continued reduced supply:
      • Hepatitis B vaccine recombinant
  • Antimicrobial drugs recently discontinued: 
    • Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).