Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

March 2019

New or Updated Treatment Guidelines

• Updated guidelines for the screening, diagnosis, prevention, and treatment of cytomegalovirus in organ transplant recipients, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).
• Updated guidelines on potential drug-drug interactions between anti-infectives and immunosuppressants, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).
• Updated guidelines for the diagnosis, prevention, and management of tuberculosis in the pre- and post-transplant period, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).
• Updated guidelines for the diagnosis, prevention, and management of Nocardia infections after solid organ transplantation, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).
• Updated guidelines for the diagnosis, prevention, and management of RNA respiratory viral infections in the pre- and post-transplant period, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).
• Updated guidelines for the diagnosis, prevention, and management of viral hepatitis in the pre- and post-transplant period, from the Infectious Diseases Community of Practice of the American Society of Transplantation (Clin Transplant 2019 Feb 28 [Epub ahead of print]).

Drug Shortages (US)

• Antimicrobial drugs or vaccines in reduced supply or unavailable (as of March 2, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
  • [New on the list since February 17]: Erythromycin 0.5% ophthalmic ointment
  • [Shortage recently resolved]: Ciprofloxacin injection
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Amphotericin B injection (unavailable), Fluconazole injection, Nystatin oral suspension (unavailable)
    • Antiparasitic drugs: Pentamidine isethionate
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection (unavailable), Valganciclovir oral powder for solution
    • Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).

• Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
  • Recent discontinuations: 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

February 2019

Post-licensure Safety Surveillance of Shingrix

• Recombinant adjuvanted zoster vaccine (RZV, Shingrix) was approved in October 2017. It is indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older. The recommended administration schedule is two 0.5 mL intramuscular (IM) doses, given 2-6 months apart. RZV is supplied as two vials that must be combined before administration; one contains the lyophilized antigen and the other contains the liquid adjuvant suspension component. After licensure, CDC and FDA began safety monitoring of RZV in the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system for adverse events after administration of US-licensed vaccines.
• The initial safety data from VAERS for the first 8 months of vaccine use, when approximately 3.2 million doses were distributed, are consistent with the safety profile observed in prelicensure clinical trials. VAERS received 4,381 reports of adverse events, a reporting rate of 136 reports per 100,000 doses. Only four reports per 100,000 doses were classified as serious. Pyrexia was reported most frequently (23.6%), followed by injection site pain (22.5%), injection site erythema (20.1%), chills (19.3%), headache (16.7%), fatigue (16.0%), and myalgia (12.1%).  230 vaccination error reports were submitted during the analytic period. 143 (62.2%) of the reports were administration errors, most commonly incorrect route (subcutaneous rather than IM); other errors were administration of only the adjuvant and mixing the lyophilized antigen in the wrong diluent. In several reports, health care providers did not administer the second dose of RZV because of a local or systemic reaction, although such reactions are not unexpected; the effectiveness of a single dose of RZV is not known. Overall, these data concerning postlicensure safety data of RZV are reassuring. Adverse reactions are self-limited and generally should not affect completion of the 2-dose series (Morb Mortal Wkly Rep 68:91, 2019).

Antimicrobial Stewardship

• The routine use of antibiotics in asthma exacerbation is not recommended, but we know it happens frequently. The evidence addressing this issue is limited. In a retrospective cohort study of 19,811 patients hospitalized for an asthma exacerbation treated with corticosteroids in 542 acute care hospitals in the US over a two-year period, 8,788 (44.4%) received antibiotics initiated within the first two days of hospitalization (and prescribed for a minimum of two days). The most frequently prescribed antibiotics were macrolides, fluoroquinolones, and third-generation cephalosporins. Compared to patients who did not receive antibiotics, antibiotic-treated patients had a significantly longer hospital stay, higher risk of antibiotic-associated diarrhea, and higher cost of hospitalization. The risk of treatment failure (initiation of mechanical ventilation, transfer to the ICU after day 2, in-hospital mortality, or readmission for asthma) was similar in both groups. These findings support the recommendations of current clinical treatment guidelines and illustrate the need for further research to improve antimicrobial stewardship in asthma (JAMA Intern Med 2019 Jan 28 [Epub ahead of print]).

Drug Shortages (US)

• Antimicrobial drugs or vaccines in reduced supply or unavailable (as of February 2, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
  • [New on the list]: Amphotericin B injection, Pentamidine isethionate (Nebupent) for inhalation
  • [Shortage recently resolved]: Oxacillin injection, Penicillin G Procaine injection
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Piperacillin/tazobactam injection
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Fluconazole injection, Nystatin oral suspension (unavailable)
    • Antiparasitic drugs: None
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection, Valganciclovir oral powder for solution
    • Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).

• Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
  • Recent discontinuations: 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

 
Sperryville, VA – Sanford Guide, the leading reference for the treatment of infectious diseases, celebrates its fiftieth year in 2019 with a renewed focus on providing clinically actionable guidance through digital platforms. While the company continues to update its ubiquitous print guides annually, advances in technology have enabled the development of market-leading mobile apps, a content delivery API, customizable apps for antimicrobial stewardship guidelines, a responsive web platform, and other tools that provide continually updated information to clinicians at the point of care.
 
In an effort to facilitate the adoption and use of local guidelines and antibiograms, Sanford Guide recently developed Stewardship Assist™, an innovative tool that enables antimicrobial stewardship programs to disseminate guidelines via web and app in real time. Paired with Sanford Guide’s comprehensive information, these local guidelines improve patient care and facilitate the appropriate use of antibiotics.
 
With the launch of the Sanford Guide API in 2017, guidelines became available through electronic health records, clinical surveillance platforms, diagnostic lab reports, and other healthcare IT packages. Serving Sanford Guide content in real time, Sanford Guide API provides guidelines seamlessly integrated within the clinical workflow.
 
At its inception in 1969, Sanford Guide creator Jay P. Sanford, M.D. had little idea of the impact his seminal reference guide would have for generations of health care providers. What began as a series of tables that would describe and compare the newer antibiotics available in the late 1960s evolved over time into the expansive resource relied upon by over a million practitioners worldwide.
 
Sanford Guide remains a family-owned enterprise and collaborative effort, integrating the expertise of its nine-member editorial board and the many practitioners around the world who contact us each year with questions and comments. David N. Gilbert, M.D., the longest-serving member of the Sanford Guide editorial board, expressed the sentiment best when he described his service on the editorial board as “a rare and humbling privilege for which I am eternally grateful.” “Our mission in 2019 remains true to the original purpose in 1969: to provide health care professionals with concise, accessible guidance for making appropriate treatment decisions in an increasingly complex world” said Jeb C. Sanford, Managing Editor. The Sanford Guide team takes great pride in the company’s work over the past fifty years, and looks forward to continued success in the next fifty.
 
Press Contact: Scott Kelly, Vice President, 540-987-9480

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

January 2019

Drug Safety Communications

• Following a review of reported cases and four published observational studies, the US FDA has issued a warning that fluoroquinolone antibiotics* can increase the occurrence of aortic aneurysm or dissection. This is the latest in a series of Drug Safety Communications regarding fluoroquinolones dating back to 2008. The drugs should not be prescribed to patients who have an aortic aneurysm or are at risk for one unless no other options are available. The underlying mechanism for the increased risk of an aortic aneurysm event cannot be determined from these studies, and the background risk varies among populations; nevertheless, the data suggest about a two-fold increase in risk in patients taking a fluoroquinolone antibiotic. A warning about this risk will be added to the prescribing information and patient medication guide for all fluoroquinolones. The full communications can be found here.

New Vaccine Approval

• Vaxelis, a vaccine indicated for active immunization to prevent diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to H. influenzae type b. It is approved as a 3-dose series in children 6 weeks through 4 years of age (0.5 mL IM at 2, 4, and 6 months of age). The 3-dose series constitutes a primary immunization course against diphtheria, tetanus, polio, and invasive Hib. This combination vaccine may be used to complete the hepatitis B immunization series, and an additional dose of pertussis-containing vaccine is required to complete the primary immunization series against pertussis. Vaxelis is not expected to be commercially available in the US prior to 2020.

New or Updated Treatment Guidelines

• Updated clinical practice guidelines for the diagnosis, treatment, chemoprophylaxis, and institutional outbreak management of seasonal influenza* from the Infectious Diseases Society of America (Clin Infect Dis 2018 Dec 19 [Epub ahead of print]). These guidelines update the 2009 version (published prior to the 2009 H1N1 pandemic) and are available on the IDSA website.

• Practice guidelines for the individualized use of voriconazole* from the Division of Therapeutic Drug Monitoring, Chinese Pharmacological Society (Ther Drug Monitor 40:663, 2018). The guidelines are available on the journal website.

• The latest revisions to the Italian guidelines for the use of antiretroviral agents in HIV-infected patients from the Italian Society for Infectious and Tropical Diseases (New Microbiol 41:247, 2018). This publication updates the 2017 guidelines and are available on the journal website.

Drug Shortages (US)

• Antimicrobial drugs or vaccines in reduced supply or unavailable (as of January 7, 2019) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
  • [New on the list]: Valganciclovir oral powder for solution
  • [Shortage recently resolved]: Dalbavancin injection
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection, Piperacillin/tazobactam injection
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Fluconazole injection, Nystatin oral suspension (unavailable)
    • Antiparasitic drugs: None
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
    • Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).

• Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
  • Recent discontinuations: 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. If you received this message from a colleague, subscribe now.
 

December 2018

New Drug Approvals

• Aemcolo (rifamycin SV*), approved for the treatment of travelers' diarrhea caused by non-invasive strains of E. coli in adults. Rifamycin SV is a poorly absorbed member of the rifamycin (technically ansamycin) class of antibiotics that was actually the first to be used in clinical practice (1963). In theory the product's MMX (multimatrix) technology allows for release of active antibiotic only after it reaches intestinal pH levels of ≥7 in the distal small bowel and colon, with an additional 1 hour delay upon reaching this pH. The recommended dosage is 388 mg po bid x3 days, with or without food (but not with alcohol). Tablets should be swallowed whole (not crushed, chewed, or broken) with 6-8 ounces of fluid. Rifamycin SV interacts with many CYP450 and transporter proteins, but because of negligible systemic rifamycin concentrations no clinically relevant drug interactions are expected. Product availability: 194 mg tablets.

• Temixys* (lamivudine 300 mg + tenofovir disoproxil fumarate 300 mg), approved (in combination with other antiretroviral agents) for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg. This product is a generic formulation that has essentially the same activity and safety profile as Truvada (emtricitabine + tenofovir disoproxil fumarate). The recommended dosage is one tablet once daily, with or without food.

New or Updated Treatment Guidelines

• Updated clinical practice guidelines for the management of outpatient parenteral antimicrobial therapy from the Infectious Diseases Society of America (Clin Infect Dis 2018 Nov 13 [Epub ahead of print]). These guidelines update the 2004 version and are available on the IDSA website.

Drug Shortages (US)

• Antimicrobial drugs or vaccines in reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
  • [New on the list]: Nystatin oral suspension
  • [Shortage recently resolved]: Cefpodoxime oral suspension, Mafenide powder for solution
  • [Continue to be in reduced supply]:
    • Aminoglycosides: Amikacin injection, Gentamicin ophthalmic ointment (unavailable), Tobramycin injection
    • Carbapenems: Meropenem injection
    • Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (unavailable), Cefoxitin injection, Ceftazidime injection, Ceftriaxone injection, Cefuroxime injection
    • Fluoroquinolones: Ciprofloxacin injection, Ciprofloxacin 0.3% ophthalmic solution, Ciprofloxacin oral suspension, Gemifloxacin tablets
    • Glyco-, glycolipo-, lipopeptides: Dalbavancin injection, Daptomycin injection, Vancomycin injection
    • Macrolides: Azithromycin injection, Azithromycin ophthalmic solution 1% (unavailable), Erythromycin lactobionate injection (unavailable)
    • Penicillins: Ampicillin/sulbactam injection, Oxacillin injection, Penicillin G procaine injection (unavailable), Piperacillin/tazobactam
    • Other antibacterials: Clindamycin injection, Metronidazole injection, Mupirocin calcium 2% cream, Mupirocin calcium 2% nasal ointment (unavailable), Nitrofurantoin oral suspension
    • Antifungal drugs: Fluconazole injection
    • Antiparasitic drugs: None
    • Antiviral drugs: Cidofovir injection (unavailable), Letermovir injection
    • Vaccines: Hepatitis A virus vaccine inactivated, Hepatitis B vaccine recombinant, Zoster vaccine recombinant (Shingrix), Yellow Fever vaccine (YF-VAX is unavailable, but Stamaril can be obtained through a limited number of clinics in the US. Click here).

• Antimicrobial drugs newly discontinued: Quinidine gluconate IV (in December 2017). Product distribution will continue until expiration of current stock (March 2019).
  • Recent discontinuations: 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)

• For detailed information including estimated resupply dates, see http://www.ashp.org/menu/DrugShortages