ID Update

last updated Feb 23, 2024 09:43 AM © Antimicrobial Therapy, Inc.

ID Update™ is the Sanford Guide infectious diseases news page. Interested in receiving the Sanford Guide ID Update in your e-mail inbox, or in sharing it with a colleague? Sign up here! Interested in a Sanford Guide subscription? Click here to learn about individual and hospital-wide licenses.

Click here to manage your personal Sanford Guide account or reset your password, or here to access your hospital's subscription.

FEBRUARY 2024

SARS-CoV-2 / COVID-19

Cefepime-Enmetazobactam Approved

  • Cefepime-enmetazobactam (Exblifep) has been approved by the US FDA for complicated UTI in adults. Enmetazobactam is a beta-lactamase inhibitor similar to tazobactam. A key structural difference improves penetration into the bacterial cell. Enmetazobactam enhances the activity of cefepime vs Ambler Class A enzymes, such as ESBLs. The recommended doage is 2.5 gm (cefepime 2 gm + enmetazobactam 0.5 gm) IV q8h x7-14 days. Each dose is infused over 2 hours. In a recently published phase 3 RCT in patients with complicated UTI or acute pyelonephritis caused by gram-negative bacilli, cefepime-enmetazobactam (compared with piperacillin-tazobactam) met criteria for noninferiority as well as superiority with respect to the primary outcome of clinical cure and microbiologic eradication (JAMA 2022;328:1304).

CDC Syphilis Testing Recommendations

  • Approximately six million new cases of syphilis occur globally each year. A syphilis epidemic is occurring in the US, with sustained increases in primary and secondary syphilis from 5,979 cases reported in 2000 to 133,945 cases reported in 2020. This epidemic is characterized by health disparities, particularly among sexual and gender minority populations, intersections with the HIV and substance use epidemics, and increased morbidity and mortality due to congenital infection. The US CDC has published new recommendations for syphilis testing, including laboratory-based tests, point-of-care tests, processing of samples, and reporting of test results (MMWR Recomm Rep 2024;73(1):1-35). PDF available here.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • New shortages:
    • Isoniazid injection 100 mg/mL (24 Jan 2024)
  • Shortages recently resolved:
    • Cefixime capsules 400 mg (9 Jan 2024)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable (as of 12 Feb 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (22 Feb 2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir, all oral formulations (29 Jun 2023)
        • Cefixime 400 mg capsules (21 Jan 2022)
        • 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).
      • Chloramphenicol injection (9 Oct 2023)
      • Clindamycin phosphate injection (25 Jun 2015)
      • Doxycycline oral suspension (16 Nov 2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (13 Jan 2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1%
        • Erythromycin 0.5% ophthalmic ointment (8 Jul 2022)
      • Metronidazole injection (20 Oct 2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin. all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Ampicillin injection (19 Oct 2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (1 Feb 2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (31 Mar 2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (17 May 2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (31 Mar 2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (21 Sep 2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs
      • Amphotericin B injection (10 Nov 2022)
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Nystatin topical powder (18 Aug 2023)
    • Antimycobacterial drugs
      • Isoniazid 100 mg, 300 mg tablets (1 Sep 2022)
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (24 Oct 2023)
      • Oseltamivir capsules, powder for oral suspension (1 Nov 2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution (23 May 2023)
      • Valganciclovir tablets, powder for oral solution (7 Feb 2023)
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (Dec 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (Jun 2023)
    • Ritonavir oral solution 80 mg/mL (Jan 2023)

JANUARY 2024

SARS-CoV-2 / COVID-19

Something New: Doxy-PEP

  • Doxycycline post-exposure prophylaxis (doxy-PEP) has been shown to reduce the incidence of gonorrhea, syphilis, and Chlamydia among cisgender MSM and transgender women who have had at least one of these STIs in the past 12 months (N Engl J Med 2023;388:1296-1306). It can be considered for such persons who have not had a recent STI but are at risk because of multiple partners. Doxy-PEP was not effective in a study conducted in cisgender women (N Engl J Med 2023;389:2331-2340), so more studies regarding its use after vaginal sex are needed. There are no data available for heterosexual, cisgender men who are at risk of STIs, nor for transgender men. Possible long-term effects of doxy-PEP include its potential impact on antibiotic resistance and alterations in the microbiome. The recommended dose of doxycycline (hyclate or monohydrate) is 200 mg orally administered within 24-72 hours of condomless sex.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 8, 2024) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since December 8, 2023:
      • None
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (02/22/2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (6/4/2018)
        • Cefdinir, all oral formulations (6/29/2023)
        • Cefixime 400 mg capsules (1/21/2022)
        • 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).
      • Chloramphenicol injection (10/9/2023)
      • Clindamycin phosphate injection (6/25/2015)
      • Doxycycline oral suspension (11/16/2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (1/13/2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/2023)
        • Moxifloxacin 400 mg tablets (12/6/2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (6/1/2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment (7/8/2022)
      • Metronidazole injection (10/20/2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin. all oral formulations (10/18/2022)
        • Amoxicillin-clavulanate, all oral formulations
        • Ampicillin injection (10/19/2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (2/1/2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (3/31/2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (5/17/2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (03/31/2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs
      • Amphotericin B injection (10/10/2022)
      • Amphotericin B Lipid Complex
      • Nystatin topical powder (08/18/2023)
    • Antimycobacterial drugs
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (10/24/2023)
      • Oseltamivir capsules, powder for oral suspension (11/01/2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Posaconazole oral susp 40 mg/mL (December 2023, by Merck)
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)

DECEMBER 2023

SARS-CoV-2 / COVID-19

Expanded Clofazimine Access

  • Clofazimine (Lamprene) has been unavailable in US pharmacies since 2004. Currently, individuals with leprosy may obtain access to clofazimine from the National Hansen's Disease Program. Under certain circumstances, patients may be able to obtain access to clofazimine for the treatment of non-tuberculous mycobacterial (NTM) infections or other infections (uses for which clofazimine does not have FDA approval) from Novartis. Click here for more information.

CDC Immunization Schedules

  • The 2024 US CDC recommended immunization schedules and associated footnotes are updated annually by the US Centers for Disease Control and Prevention (CDC). Beginning with the 2024 schedule, the final version for the upcoming year will be published online in November of the previous year. This is about three months earlier than previously to allow for supply chain and payor coordination for any changes.  

Updated Anthrax Guidelines

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since November 12, 2023:
      • Moxifloxacin 400 mg tablets (12/6/2023)
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection (02/22/2021)
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection (6/4/2018)
        • Cefdinir, all oral formulations (6/29/2023)
        • Cefixime 400 mg capsules (1/21/2022)
        • 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).
      • Chloramphenicol injection (10/9/2023)
      • Clindamycin phosphate injection (6/25/2015)
      • Doxycycline oral suspension (11/16/2021)
      • Fluoroquinolones:
        • Ciprofloxacin injection (1/13/2023)
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/2023)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (6/1/2015)
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment (7/8/2022)
      • Metronidazole injection (10/20/2021)
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Ampicillin injection (10/19/2023)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA) (2/1/2023)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR) (3/31/2023)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL) (5/17/2023)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution (03/31/2023)
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/2023)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs
      • Amphotericin B injection (10/10/2022)
      • Amphotericin B Lipid Complex (ABLC)
      • Nystatin topical powder
    • Antimycobacterial drugs
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Nirsevimab-alip injection (10/24/2023)
      • Oseltamivir capsules, powder for oral suspension (11/01/2022)
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • 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)

NOVEMBER 2023

SARS-CoV-2 / COVID-19

Vaccine for Chikungunya Virus

  • Single dose, live attenuated virus vaccine (Ixchiq, Valneva) for age >18 years now FDA approved.
    • Vaccine efficacy trial to be done in Phase 4 with readouts by 2027.
    • Recommended for: Adults with travel to areas with current CDC declared outbreaks.
    • Consider for: Certain persons traveling to transmission areas (within past 5 years as determined by CDC).
      • Long-stay travel (>6 months).
      • All persons age >65 years especially with co-morbidities.
    • FDA specified sero-response rate met in 98.9% of non-endemic subjects with 12-month persistence in pivotal Phase 3 trial (Lancet 2023; 401:P2138).
    • Adverse effects: Headache (31.6%), fatigue (28.5%), myalgia (23.9%), arthralgia (17.2%), fever (13.5%), nausea (11.2%).
    • Severe adverse effects: Chikungunya-like illness in 1.6%. 
    • US CDC ACIP draft proposal (vote in February 2024).

New Meningococcal Vaccine

  • A new combination meningococcal vaccine MenABCWY (Penbraya, Pfizer) has been approved by the US FDA and ACIP recommendations made. Penbraya may be used when both MenACWY and MenB are indicated at the same visit and desired by the patient. Common situations will include:
    • Healthy persons age 16-23 years (routine schedule) when shared clinical decision-making favors administration of MenB vaccine and the person is already due for the age 16 dose of MenACWY.
    • Persons age >10 years at increased risk of meningococcal disease (e.g., due to persistent complement deficiencies, complement inhibitor use, or functional or anatomic asplenia) due for both vaccines at the same visit.
  • In most situations the second dose of MenB-containing vaccine will need to be with Trumenba (MenB monovalent vaccine). This combination vaccine introduces many complexities into the quite different MenACWY and MenB schedules.

Composition of Future Influenza Vaccine

  • Quadrivalent influenza vaccines protect against four different viruses: one H1N1 virus, one H3N2 virus, one B/Victoria virus and one B/Yamagata virus. All current influenza vaccines in the US are quadrivalent. US CDC and global surveillance data show that B/Yamagata lineage viruses have not been detected since March 2020, perhaps a result of the widespread public health countermeasures imposed during the COVID-19 pandemic. After review of these data, the WHO Influenza Vaccine Composition Advisory Committee and US FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) have recommended that B/Yamagata lineage antigens be removed from influenza vaccines used in the US and internationally as soon as reasonably possible. For further information from CDC regarding the 2023-24 influenza season, click here.

Fexinidazole Availability

  • Fully FDA-approved fexinidazole tablets (Sanofi), the treatment of choice for West African trypanosomiasis due to both Stage 1 and 2 T. brucei gambiense infection, are now available in the US. The fully oral regimen replaces the need for the previous regimen that includes a week of IV Eflornithine (stocked only by CDC). However, with Stage 2 disease with WBC >100/µL in CSF, the older regimen must still be used. Contact Sanofi directly (no commercial distribution) for free drug: Sanofi Medical Affairs at 1-800-372-6634 or customersupport@sanofi.com.

Mpox Update

  • For Mpox prevention, CDC has moved from earlier outbreak-based recommendations to standing recommendations.
  • Persons >18 years of age with risk factors should receive two doses of Jynneos 28 days apart. Jynneos will move to commercial distribution in the next few months.
  • Persons at risk:
    • Gay, bisexual, and other men who have sex with men, transgender or nonbinary people who in the past six months have had one of the following:
      • At least one sexually transmitted disease
      • More than one sex partner
      • Sex at a commercial sex venue
      • Sex in association with a large public event in a geographic area where mpox transmissions is occurring
    • Sexual partners of persons with the risks described above
    • Persons who anticipate experiencing any of the above
    • Persons deemed at risk by health authorities in outbreak situations
  • Pregnancy: No recommendation at present, but pregnant persons with risk factors as above MAY receive Jynneos.
  • Healthcare workers: Should not receive Jynneos unless they have a sexual risk factor as above.

Drug Shortages (US)

  • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of November 12, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since October 8, 2023:
      • Ampicillin injection (10/19/2023)
      • Chloramphenicol injection (10/9/2023)
      • Nirsevimab-alip injection (10/24/2023)
    • Shortage recently resolved:
      • Isoniazid injection, 100 mg/mL (9/23/2023)
      • Neomycin 500 mg tablets (9/7/2023)
      • Tedizolid injection (10/2/2023)
      • Tedizolid phosphate 200 mg tablets (10/2/2023)
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefdinir (all oral formulations)
        • 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),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Levofloxacin oral solution, 25 mg/mL (9/15/23)
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Neomycin and Polymyxin B Sulfates GU Irrigant
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection (Bicillin-LA)
        • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
        • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
        • Piperacillin-tazobactam injection
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
      • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/23)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
      • Nystatin topical powder
    • Antimycobacterial drugs
      • Isoniazid 100 mg, 300 mg tablets
      • Rifampin capsules
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules, powder for oral suspension
      • Podofilox 0.5% topical gel
      • Ribavirin for inhalation solution
      • Valganciclovir tablets, powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
    • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • 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 2023

CDC Health Alert Network

  • October 23: Health Advisory issued to provide options for clinicians to protect infants from RSV in the context of a limited supply of nirsevimab-alip. Click here for complete advisory, here for Sanofi press release.

SARS-CoV-2 / COVID-19

COVID-19 Vaccination Summary

  • US guidelines have shifted to annual universal vaccination as of September 2023 because:
    1. Persons of any age and health status have at least some measurable risk of severe illness.
    2. Co-morbid conditions that increase the risk of severe illness are widespread.
  • CDC guidelines refer to "2023-24 COVID vaccine" with no preferred product (Modern, Pfizer, Novavax) regardless of past vaccine history. One dose of 2023-4 vaccine is indicated for all persons ≥6 months of age as soon as vaccine is available.
  • A full primary series is no longer indicated for healthy persons >5 years of age as almost the entire US population has antibody against SARS-CoV-2 from previous infection or vaccination.
  • All US persons age >6 months should be up-to-date on vaccination regardless of:
    • A history of symptomatic or asymptomatic SARS-CoV-2 infection;
    • Presence of long COVID;
    • History of SARS-CoV-2 breakthrough infection.
  • In short, a normal host age ≥5 years is up-to-date after receipt of one updated COVID-19 vaccine, regardless of the number of previous doses of mRNA or Janssen/J&J vaccine. Healthy children age 6 months to 4 years are up-to-date after receipt of all recommended primary mRNA doses (two Moderna or three Pfizer) including at least one dose of updated COVID-19 vaccine.
  • Defer vaccination until recovery from an acute episode and discontinuation of isolation. After SARS-CoV-2 infection, consider delaying next dose by three months from symptom onset or positive test.
  • There are no human efficacy data for the 2023-4 vaccine, but there is a documented boost in neutralizing antibody titers (only against current strains).
  • Observational data from recent bivalent vaccine indicates approximate effectiveness against hospitalization of about 50% in close proximity to the date of vaccine receipt.
  • WHO COVID-19 vaccination recommendations:
    • WHO recommends a simplified single-dose regimen for primary immunization, with eligibility determined by national priorities for most COVID-19 vaccines.
    • When monovalent XBB vaccines are not available, any available WHO- approved vaccine, bivalent variant-containing or monovalent index virus vaccines, may be used since they continue to provide benefits against severe disease in high-risk groups.

    ACIP Maternal RSV Recommendations

    • Of the two available RSV vaccines, only Abrysvo (Pfizer) is FDA approved for maternal prenatal vaccination at 32-36 weeks gestation to protect infants with passive antibody.
      • ACIP recommends seasonal administration of a single dose of Abrysvo for pregnant persons who are between 32-36 weeks gestation during the period of September to January to passively protect babies born between October and March as an equal option to nirsevimab-alip (Beyfortus) given to infants for their first RSV season.
        • In Alaska, parts of Florida, Hawaii, Puerto Rico, the U.S. Virgin Islands, and Guam, RSV can circulate year round. The seasonal rule for use of the vaccine would not apply in these areas.
    • When applicable, ACIP recommends seasonal administration of Abrysvo as an equal option to postnatal nirsevimab-alip. At other times of year, outside the maternal indications for Abyrsvo, nirsevimab-alip given to infants would be the only option.
    • Administration of both nirsevimab-alip to an infant and Abrysvo to the mother provides no benefit over administration of one or the other, but may be considered if the mother is immunocompromised or the infant has especially high RSV risk.  
    • Infants born <34 weeks gestation, or if the mother was vaccinated but the infant was born <14 days after vaccination, are recommended to receive nirsevimab-alip.
    • Abrysvo is about half the cost of nirsevimab-alip, but the effect does not appear to last as long (three months for Abrsyvo).
    • The complexities in choice of approach are likely to cause confusion among both patients and providers.

    Other Vaccine Recommendations from CDC

    Approved: Metronidazole Oral Suspension

    • The US FDA has approved metronidazole oral suspension (Likmez) for the treatment of trichomoniasis in adults, amebiasis in adult and pediatric patients, and anaerobic bacterial infections in adults. Product availability: 200 mL bottle, 500 mg/5 mL, strawberry-peppermint flavor. Refrigeration is not required.

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of October 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since September 14, 2023:
            • Levofloxacin oral solution, 25 mg/mL (9/15/23)
            • Sulfacetamide 10%/Prednisolone sodium phos 0.23% oph soln (9/21/23)
          • Shortage recently resolved:
            • Isoniazid injection, 100 mg/mL (9/23/2023)
            • Neomycin 500 mg tablets (9/7/2023)
            • Tedizolid injection (10/2/2023)
            • Tedizolid phosphate 200 mg tablets (10/2/2023)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Nystatin topical powder
          • Antimycobacterial drugs
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Sulfacetamide 10%/Prednisolone acetate 0.2% oph ointment (Aug 2023 by Allergan, sole supplier)
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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 2023

        SARS-CoV-2 / COVID-19

        From CDC

        • 2023-2024 ACIP seasonal influenza vaccine recommendations (MMWR Recomm Rep 2023;72:1-28). PDF here.
        • 2023 ACIP recommendations for the use of pneumococcal vaccines in adults age ≥19 years (MMWR Recomm Rep 2023;72:1-39). PDF here.

        Second Indication for Abrysvo

        • The unadjuvanted, bivalent RSV vaccine Abrysvo was approved in August 2023 for active immunization of pregnant individuals at 32 through 36 weeks gestational age for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by RSV in infants from birth through 6 months of age.
          • ACIP guidelines are pending regarding preference vs. postnatal nirsevimab-alip for infants.
          • Concern exists regarding excess premature births in trials.
        • FDA news release here.

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of September 14, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since August 6, 2023:
            • Nystatin topical powder
          • Shortage recently resolved:
            • Neomycin 500 mg tablets (9/7/2023)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
            • Tedizolid phosphate injection
            • Tedizolid phosphate 200 mg tablets
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        AUGUST 2023

        SARS-CoV-2 / COVID-19

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 6, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since July 10, 2023:
            • Tedizolid injection
          • Shortage recently resolved:
            • Azithromycin injection
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • Carbapenems:
              • Meropenem injection
            • Cephalosporins:
              • Cefazolin injection
              • Cefdinir (all oral formulations)
              • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
            • Tedizolid 200 mg tablets
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Podofilox 0.5% topical gel
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        JULY 2023

        SARS-CoV-2 / COVID-19

        US Approval of Nirsevimab-alip

        • The US FDA has approved nirsevimab-alip (brand name Beyfortus), a monoclonal antibody that provides passive immunization against respiratory syncytial virus (RSV) by targeting the prefusion conformation of the fusion (F) glycoprotein. It is indicated for the prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Safety and efficacy are supported by three clinical trials. Nirsevimab has been available in the European Union since October 31, 2022. It will be available in the US ahead of the upcoming 2023-2024 RSV season.
        • Dosage for neonates and infants born during or entering their first RSV season:
          • Body weight at time of dosing <5 kg: 50 mg IM x1
          • Body weight at time of dosing ≥5 kg: 100 mg IM x1
        • Dosage for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season:
          • 200 mg IM x1, administered as two 100 mg injections
        • Product availability: Prefilled syringes, 50 mg/0.5 mL and 100 mg/mL
        • See FDA news release here.

        New Product for Molluscum Contagiosum

        • The US FDA has approved cantharidin 0.7% topical solution (brand name Ycanth) for the treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older. It is the first FDA-approved treatment for molluscum. Health care providers are to apply a single application to each lesion every three weeks as needed. See FDA news release here.

        US Approval of Anthrax Vaccine Adsorbed, Adjuvanted

        • Cyfendus, an adjuvanted formulation of Biothrax, has been FDA approved for PEP only (not PrEP).
        • Cyfendus eliminates the need for a third dose at 4 weeks for PEP.  Concomitant antibiotics are still necessary.
        • This vaccine simplifies the response to a large-scale public health emergency involving anthrax.
        • 3 million doses of Cyfendus (labelled AV7909) are already in US government stockpiles.
        • Detailed guidelines for use are pending ACIP recommendations, but dose and timing will be per FDA labeling.
        • See Anthrax, Vaccine page for more information.

        Locally Acquired Malaria in the US

        • CDC issued a Health Advisory (CDCHAN-00494) to share information regarding five US residents (four in Florida, one in Texas) diagnosed with locally-acquired, mosquito-transmitted Plasmodium vivax. In the US, most cases of malaria are diagnosed in people who have traveled to an endemic region. Locally acquired mosquito-borne malaria has not occurred in the US since 2003. Despite these cases, the risk of locally acquired malaria remains extremely low.

        RSV Vaccine: Key Points

        • The CDC Advisory Committee on Immunization Practices (ACIP) now advises that adults aged ≥60 years MAY receive a single IM dose of a respiratory syncytial virus (RSV) vaccine with either Abrysvo (Pfizer; unadjuvanted) or Arexvy (GSK; uses same adjuvant as Shingrix), using shared clinical decision-making. Immunocompromised persons SHOULD be vaccinated even if such individuals were not included in the clinical trials.
        • Both vaccines demonstrated significant vaccine effectiveness against RSV induced lower respiratory tract infection among older adults that lasted over at least 2 consecutive seasons; a second dose after 1 year conferred no additional protection. Data were insufficient (few cases in placebo group) to determine statistically significant vaccine effectiveness in persons aged ≥75 years or against hospitalization. Co-administration with all types of influenza vaccine appears safe without statistically significant effect on vaccine effectiveness for either vaccine, although titers for each vaccine were somewhat lower. Availability of both vaccines is anticipated for the 2023-24 winter RSV season (mid-September through mid-May; peaks late December to mid-February). Vaccination is recommended as soon as vaccine becomes available. Cost is expected to be USD 180-270 for Abrysvo and USD 200-295 for Arexvy.
        • A review of the prevalence, clinical characteristics, and outcomes of RSV infections vs. influenza in adults hospitalized with acute respiratory illness over a three-year period suggests that outcomes are worse in persons with RSV, and they frequently have underlying cardiopulmonary conditions (Clin Infect Dis 2023;76:1980).

        New Clinical Practice Guidelines

        Drug Shortages (US)

        • Bicillin-LA and Bicillin-CR availability: See Dear Healthcare Professional letter here.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of July 10, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since June 12, 2023:
            • Cefdinir (all oral formulations)
            • Neomycin and Polymyxin B Sulfates GU Irrigant
            • Podofilox 0.5% topical gel
            • Tedizolid 200 mg tablets
          • Shortage recently resolved:
            • Azithromycin injection
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 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:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection (Bicillin-LA)
              • Penicillin G benzathine/Penicillin G procaine (Bicillin-CR)
              • Penicillin VK tablets (250 mg, 500 mg), oral solution (250 mg/5 mL)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs
            • Isoniazid injection (100 mg/mL)
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Ribavirin for inhalation solution
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Penicillin G procaine 600,000 units/mL IM injection (June 2023)
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        JUNE 2023

        SARS-CoV-2 / COVID-19

        Second RSV vaccine approved

        • The US FDA has approved a second respiratory syncytial virus (RSV) vaccine (Abrysvo) for use in individuals 60 years of age and older. This unadjuvanted, bivalent vaccine is composed of equal amounts of recombinant RSV prefusion F protein from RSV subgroups A and B. Dosage is a single 0.5 mL injection. The vaccine will not be released until fall.

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of June 12, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since May 5, 2023:
            • Isoniazid injection (100 mg/mL)
            • Penicillin VK tablets (250 mg, 500 mg; 250 mg/5 mL oral solution
            • Ribavirin inhalation powder for solution
          • Shortage recently resolved:
            • Clotrimazole 10 mg oral troches
            • Rifampin injection
            • Rifapentine 150 mg tablets
            • Rifaximin tablets (200 mg, 550 mg)
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Penicillin G benzathine/Penicillin G procaine (Bicillin)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
          • Antimycobacterial drugs
            • Isoniazid 100 mg, 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        MAY 2023

        SARS-CoV-2 / COVID-19

        US FDA Drug Approvals

        • A co-packaged product containing nirmatrelvir and ritonavir tablets (Paxlovid) for the treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe disease, including hospitalization or death. Drug manufactured and packaged under the EUA and distributed by DHHS will continue to be available to ensure continued access for adults, as well as treatment of eligible children ages 12-18 who are not covered by the approval. Paxlovid is not approved or authorized for use as a pre-exposure or post-exposure prophylaxis for prevention of COVID-19. See FDA news release here.
        • A co-packaged product containing injectable sulbactam and durlobactam (Xacduro), for the treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Acinetobacter baumannii-calcoaceticus complex in patients ≥18 years of age. Sulbactam is a beta-lactamase inhibitor with intrinisic activity against Acinetobacter baumannii; durlobactam is a beta-lactamase inhibitor which helps to prevent degradation of sulbactam by enzymes produced by A. baumannii. Recommended dosage in normal renal function is 1 gm of sulbactam and 1 gm of durlobactam IV q6h (infused over three hours). The co-packaged product was granted Priority Review and designated as a Qualified Infectious Disease Product (QIDP). Availability is expected later this year. See FDA news release here.

        COVID Vaccine Summary

        • Latest recommendations from CDC (April 19, 2023 - normal host)(May 1, 2023 - immunocompromised) are that monovalent (original) mRNA vaccines are no longer recommended in the US.
        • Almost the entire US population has antibody against SARS-CoV-2 (via previous infection or vaccination).
        • All persons >6 years of age who are unvaccinated or previously completed a monovalent primary series should receive a bivalent mRNA vaccine. No further doses are needed except persons who are >65 years of age or immunocompromised.
        • A single additional bivalent vaccine dose for adults 65 years, and one or more additional doses for people who are immunocompromised, are recommended.
        • Immunocompromised persons age >12 years have the option to receive one additional dose of the Moderna (0.5 mL/50 µg) or Pfizer (0.3 mL/30 µg) vaccine ≥2 months following the last recommended bivalent dose. Further additional dose(s) may be administered, informed by clinical judgment and personal preference and circumstances ≥2 months after the last vaccine dose.
        • For young children, multiple doses continue to be recommended and vary by age, vaccine, and which vaccines were previously received. See Pfizer-BioNTech COVID-19 Vaccine and Moderna COVID-19 Vaccine.

        RSV Vaccine Approved

        • The US FDA has approved a respiratory syncytial virus (RSV) adjuvanted vaccine (Arexvy) for use in individuals 60 years of age and older. Dosage is a single 0.5 mL IM injection. The vaccine will not be released until fall. See FDA news release here.

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of May 5, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since April 8, 2023:
            • None
          • Shortage recently resolved:
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Penicillin G benzathine/Penicillin G procaine (Bicillin)
              • Piperacillin-tazobactam injection
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
            • Valganciclovir tablets, powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        APRIL 2023

        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 4: The US FDA issues an emergency use authorization (EUA) for the use of vilobelimab injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO. Vilobelimab is an anti-C5a monoclonal antibody. Recommended dosage: 800 mg IV within 48 hours of intubation (day 1) followed by administration on days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). Press release here. Fact sheet for healthcare providers here.
        • COVID-19 vaccination in cancer patients: 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.

        OTC Naloxone Nasal Spray Approved

        • On March 29, the US FDA approved naloxone HCl 4 mg nasal spray (Narcan) for over-the-counter (OTC) use. The timeline for availability and price will be determined by the manufacturer. The FDA will work with stakeholders to help facilitate the continued availability of naloxone nasal spray products during implementation of the switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. Click here for full news release.

        Vaccine Updates

        • Cholera Vaccine, Live, Oral (Vaxchora) has been unavailable in the US since December 2020. According to the manufacturer, resupply is scheduled for early May 2023.
        • The US FDA has approved the IM route of administration for M-M-R II (measles, mumps, and rubella virus vaccine), Varivax (varicella virus vaccine, live attenuated), and ProQuad (measles, mumps, rubella, and varicella virus vaccine) in addition to the previous subcutaneous-only route of administration. This allows all routine childhood vaccines to be administered by the same IM route, reducing complexity. Press release here.

        Malaria Detection by RDT

        • Rapid diagnostic tests (RDT) play an important role in malaria case management. The BinaxNOW Malaria test uses monoclonal antibodies to target the histidine-rich protein-2 (HRP2) antigen specific to Plasmodium falciparum and a pan-malarial antigen common to all four species of Plasmodium capable of infecting humans. A negative RDT no longer reliably rules out P. falciparum due to the increasing global prevalence of HRP2/3 deletion mutants. A negative RDT should be quickly followed by a malaria blood film (Malaria J 2022;21:26).

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of April 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since March 10, 2023:
            • Penicillin G benzathine/Penicillin G procaine (Bicillin)
            • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
          • Shortage recently resolved:
            • Ampicillin-sulbactam injection
            • Ciprofloxacin 0.3% ophthalmic solution
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Piperacillin-tazobactam injection
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules
            • Oseltamivir powder for oral suspension
            • Valganciclovir tablets
            • Valganciclovir powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        MARCH 2023

        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 2: A combined COVID/influenza vaccine for the upcoming 2023-2024 season respiratory illness season will likely not be available, but hopefully will be available the following season. according to Peter Marks, MD, PhD. Dr. Marks is Director of the Center for Biologics Evaluation and Research (CBER) at FDA. He made his comments during a recent National Foundation for Infectious Diseases webinar on COVID-19 vaccines. Click here for the webinar.
        • COVID-19 vaccination in cancer patients: 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.

        Rezafungin Approved

        • Rezafungin (tradename Rezzayo) has been approved for use in patients ≥18 years of age who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval is based on limited clinical safety and efficacy data. The recommended dosage is an initial 400 mg IV loading dose, followed by 200 mg IV once weekly. Safety has not been established beyond four weekly doses.

        CDC Health Alert Network

        • March 2: Health Advisory issued to notify clinicians and public health authorities of an increase in the number of cases of chikungunya reported in Paraguay. Click here for complete advisory.

        HBV Screening and Testing

        • Newly released CDC recommendations regarding screening and testing for hepatitis B virus infection (MMWR Recomm Rep 2023;72:1-25). This report updates and expands previously published (2008) recommendations regarding screening for HBV infection in the US. PDF available here.

        DT Discontinued

        • Sanofi Pasteur has discontinued production and distribution of Diphtheria and Tetanus Toxoids Adsorbed (DT) and is withdrawing its licenses in all countries. DT was indicated for active immunization against diphtheria and tetanus in children 6 weeks through 6 years of age (prior to 7th birthday). See Sanofi Pasteur's letter to providers here.

        New or Update Practice Guidelines

        • Executive summary from the Spanish Society of Infectious Diseases and Clinical Microbiology (and collaborators): Management of patients with suspected or confirmed antibiotic allergy (Enferm Infecc Microbiol Clin (Engl Ed) 2023;41:181-6).
        • From The Society of Bacterial Infection and Resistance of Chinese Medical Association, the Expert Committee on Clinical Use of Antimicrobial Agents and Evaluation of Antimicrobial Resistance of the National Health Commission, the Infectious Diseases Society of Chinese Medical Education Association, and the China Clinical Practice Guideline Alliance: Guidelines for the diagnosis, treatment, prevention, and control of infections caused by carbapenem-resistant gram negative bacilli (J Microbiol Immunol Infect 2023 Feb 18 [online ahead of print]). PDF available here.

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of March 10, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since February 10, 2023:
            • None
          • Shortage recently resolved:
            • Ceftazidime injection
            • Cefuroxime injection
            • Dalbavancin injection
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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),
            • Clindamycin injection
            • Doxycycline oral suspension
            • Fluoroquinolones:
              • Ciprofloxacin injection
              • Ciprofloxacin 0.3% ophthalmic solution
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all oral formulations)
              • Ampicillin-sulbactam injection
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Penicillin G benzathine injection
              • Piperacillin-tazobactam injection
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules
            • Oseltamivir powder for oral suspension
            • Valganciclovir tablets
            • Valganciclovir powder for oral solution
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Ritonavir oral solution 80 mg/mL (January 2023)
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        FEBRUARY 2023

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

        • January 26: The US FDA revises the EUA for Tixagevimab + Cilgavimab (Evusheld) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is ≤90%. Based on this revision, Evusheld is not currently authorized for use in the US until further notice. Click here for more information.
        • COVID-19 vaccination in cancer patients: 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.

        CDC Health Advisory: Increase in XDR Shigella

        • CDC has been monitoring an increase in extensively drug-resistant (XDR) Shigella infections (shigellosis) reported through national surveillance systems. CDC defines XDR Shigella as strains resistant to all commonly recommended empiric and alternative antibiotics: azithromycin, ciprofloxacin, ceftriaxone, TMP-SMX, and ampicillin. To date, there are no CDC recommendations for treating XDR shigellosis in the US. Click here for the complete advisory.

        US ACIP Recommended Immunization Schedules, 2023

        Updated HHS HIV/AIDS Practice Guidelines

        Other New or Updated Practice Guidelines

        Drug Shortages (US)

        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of February 10, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since January 8, 2023:
            • Benzathine penicillin G injection
            • Ciprofloxacin injection
            • Valganciclovir tablets, oral powder for solution
          • Shortage recently resolved:
            • Dalbavancin injection
            • Penicillin G sodium injection
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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
              • Ofloxacin 0.3% ophthalmic solution
            • Glycopeptides, glycolipopeptides, lipopeptides:
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all formulations)
              • Ampicillin-sulbactam injection
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Piperacillin-tazobactam injection
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
          • Vaccines:
            • None
        • Antimicrobial drugs recently discontinued: 
          • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
          • 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)

        JANUARY 2023

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

        • January 26: The US FDA revises the EUA for Tixagevimab + Cilgavimab (Evusheld) to limit its use to when the combined frequency of non-susceptible SARS-CoV-2 variants nationally is ≤90%. Based on this revision, Evusheld is not currently authorized for use in the US until further notice. Click here for more information.
        • COVID-19 vaccination in cancer patients: 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.

        Updated Practice Guidelines

        Deuterated Drugs

        • A deuterated drug is a drug in which deuterium replaces one or more hydrogen atoms in the drug. The C-D bond is known to be stronger than the C-H bond. Because the breaking of C-H bonds is so common during oxidative (phase I) drug metabolism, deuteration alters drug pharmacokinetics and metabolism. Selective replacement with deuterium may result in beneficial changes in the biological effects of a drug, such as less frequent dosing (owing to decreased rate of metabolism) or reduced formation of a toxic metabolite (Expert Opin Ther Pat 2014;24:1067).

          VV116 is a deuterated, tri-isobutyrate ester prodrug of the remdesivir parent nucleoside. Following oral administration, it is rapidly metabolized to the parent nucleoside, which is then converted to the active triphosphorylated metabolite by intracellular kinases (Acta Pharmacologica Sinica 2022;43:3130). This metabolite acts as an analog of adenosine triphosphate and competes for incorporation into nascent RNA chains by SARS-CoV-2 RNA-dependent RNA polymerase.

          In a recently published trial, 822 symptomatic adults with mild-to-moderate COVID-19 at high risk of progression were randomized to a five-day course of oral VV116 or nirmatrelvir-ritonavir (Paxlovid). VV116 was noninferior to nirmatrelvir-ritonavir in shortening the time to sustained clinical recovery. The incidence of adverse events was lower in the VV116 group (N Engl J Med 2022 Dec 28 [online ahead of print]).

        Drug Shortages (US)

        • CDC HAN (12/14/2022): Guidance in light of reduced availability of oseltamivir (Tamiflu and generic) during high seasonal influenza activity.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since December 11, 2022:
            • Ofloxacin 0.3% ophthalmic solution
          • Shortage recently resolved:
            • Dalbavancin injection
            • Penicillin G sodium injection
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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 injection
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Amoxicillin-clavulanate (all formulations)
              • Ampicillin-sulbactam injection
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Piperacillin-tazobactam injection
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B injection
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
            • Rifampin injection
            • Rifapentine 150 mg tablets
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
          • Vaccines:
            • 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)

        DECEMBER 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.

        Lenacapavir Approved

        • The US FDA has approved Sunlenca (lenacapavir) for the treatment of HIV-1 infection (in combination with other ARVs) in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current ARV regimen due to resistance, intolerance, or safety considerations. Lenacapavir is a first-in-class HIV-1 capsid inhibitor. Initiation dosage is administered as oral tablets and subcutaneous injections, followed by maintenance sc injections every six months.

        Second Indication for Ibrexafungerp

        • The US FDA has approved ibrexafungerp for the reduction in the incidence of recurrent vulvovaginal candidiasis in adult and post-menarchal pediatric females. The recommended dosage to prevent recurrences is 300 mg po q12h x2 doses, administered monthly for six months, with or without food.

        Updated ARV Guidelines

        • Antiretroviral drugs for treatment and prevention of HIV infection in adults: 2022 recommendations of the IAS-USA panel (JAMA 2022 Dec 1 [online ahead of print]). These guidelines update the 2020 consensus recommendations.

        Priorix: ACIP Recommendations

        • Since 1978, only one MMR vaccine, M-M-R II (Merck), has been available in the US. Last June US FDA approved a second MMR vaccine, Priorix (GlaxoSmithKline Biologicals), for the prevention of measles, mumps, and rubella in persons aged ≥12 months. The three live attenuated viruses contained in the new vaccine are genetically similar or identical to the corresponding viruses in M-M-R II. The Advisory Committee on Immunization Practices (ACIP) has unanimously recommended Priorix as an option to prevent measles, mumps, and rubella according to the existing recommended schedules and for off-label uses. Priorix and M-M-R II are fully interchangeable for all indications for which MMR vaccination is recommended. This report contains ACIP recommendations specific to Priorix and supplements the existing ACIP recommendations for MMR use (MMWR 2022;71:1465-70). PDF available here.

        Update on Meningococcal Vaccines

        • MenQuadfi, Meningococcal (Groups A, C, Y, W) Conjugate Vaccine, has fully replaced the discontinued Menactra as the sole quadrivalent vaccine available from Sanofi. MenQuadfi is approved for use in persons 2 years of age and older. Menveo (GSK) is approved for use in persons 2 months through 55 years of age, but may be used off-label in older adults.

        Drug Shortages (US)

        • CDC HAN (12/14/2022): Guidance in light of reduced availability of oseltamivir (Tamiflu and generic) during high seasonal influenza activity.
        • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of December 11, 2022) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
          • New shortages since November 6, 2022:
            • Amphotericin B injection
            • Azithromycin injection
            • Amoxicillin-clavulanate (all formulations)
            • Rifapentine 150 mg tablets
          • Shortage recently resolved:
            • Penicillin G sodium injection
          • Antibacterial drugs:
            • Aminoglycosides:
              • Amikacin injection
              • Gentamicin injection
              • Neomycin tablets
              • Tobramycin injection
            • Bacitracin ophthalmic ointment (unavailable)
            • 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:
              • Dalbavancin injection
              • Vancomycin injection
            • Macrolides/azalides:
              • Azithromycin ophthalmic solution 1% (unavailable)
              • Erythromycin 0.5% ophthalmic ointment
            • Metronidazole injection
            • Nitrofurantoin oral suspension
            • Penicillins:
              • Amoxicillin (all oral formulations)
              • Ampicillin-sulbactam injection
              • Dicloxacillin capsules (250 mg, 500 mg)
              • Piperacillin-tazobactam injection
            • Quinupristin-Dalfopristin injection
            • Rifaximin 200 mg tablets
            • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
            • Sulfanilamide 15% vaginal cream (unavailable)
          • Antifungal drugs
            • Amphotericin B Lipid Complex (ABLC)
            • Clotrimazole 10 mg oral troches
          • Antimycobacterial drugs
            • Isoniazid 300 mg tablets
            • Rifampin capsules
            • Rifampin injection
          • Antiparasitic drugs:
            • Primaquine
          • Antiviral drugs: 
            • Oseltamivir capsules, powder for oral suspension
          • Vaccines:
            • 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)

        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).