Recommended Management of Gonococcal Infections during Cefixime Shortage

Starting date:

September 26, 2014

Posting date:

March 31, 2015

Type of communication:

Advisory

Subcategory:

Drugs

Source of recall:

Health Canada

Issue:

Supply

Audience:

Healthcare Professionals

Identification number:

RA-41601

Revised: April, 2015

Issue

The Public Health Agency of Canada (the Agency) has been made aware of a national cefixime shortage which is expected to last until September 2015. There is only one Canadian supplier of cefixime at present; however, the shortage is a result of a problem with a third party manufacturer.

Gonococcal infections have shown progressive resistance to penicillin, tetracycline, and quinolones; third generation oral and injectable cephalosporins are the last remaining first-line treatments. As one of the recommended treatments for gonococcal infections, the shortage of cefixime hinders our efforts to control this infection.

The Agency is working closely with Health Canada regulators to develop options to mitigate the shortage in the longer term. As a short-term mitigation strategy, please consider conserving available stock of cefixime for patients with gonococcal infection in whom ceftriaxone is contraindicated (or in settings where its use is not possible), and using alternative treatments instead of cefixime for non-gonococcal infections.

In consultation with the Expert Working Group for the Canadian STI Guidelines, the Agency is providing health care professionals with the following interim recommendations for the treatment and follow-up of gonococcal infections until the shortage is resolved.

Diagnosis

Samples should ideally be taken from all sites of exposure; consider using both culture (where available) and Nucleic Acid Amplification Tests (NAAT) particularly in symptomatic patients and identified contacts of cases. Culture will allow for antimicrobial susceptibility testing. For more information on laboratory testing and site specific information please refer to the Laboratory Testing /Diagnosis and Specimen Collection/Transport section of the Gonococcal Infections chapter.

Treatment/Administration

• Combination therapy with ceftriaxone 250 mg IM and azithromycin 1 g PO is the recommended first line treatment for uncomplicated anogenital and pharyngeal infection in adults during the cefixime shortage. For complicated gonococcal infections, please refer to the Treatment section of the Gonococcal Infections chapter.
  • Ceftriaxone 250mg should be administered deep IM in the ventro- or dorsogluteal muscle. Pain can be lessened when reconstituted with 0.9ml 1% lidocaine without epinephrine (note: alternate diluent is sterile water). Refer to the product monograph for additional information.
• Monotherapy with Azithromycin 2 gm orally as a single dose should only be used in severe cephalosporin allergy and/or with documented gonococcal susceptibility to azithromycin.

Reporting and Partner Notification

Gonorrhea is a reportable infection and public health authorities should be promptly notified.

Local public health authorities may assist with partner notification and with appropriate referral for clinical evaluation, testing, treatment and health education.

All partners who have had sexual contact with the index case within 60 days prior to symptom onset or date of specimen collection (if the index case is asymptomatic) should be notified, tested and empirically treated. Treatment as outlined above should be offered regardless of clinical findings and without waiting for test results.

The same precautions related to the use of Azithromycin monotherapy apply to the treatment of contacts.

Follow up

Test of cure (TOC) should be performed on all patients who test positive. In order to test for antimicrobial resistance, culture is recommended and should be performed 3-7 days following completion of treatment. Culture is particularly important for TOC if the case was treated with azithromycin monotherapy. If culture is not available, then NAAT should be performed 2-3 weeks following the completion of treatment.

For more detailed information on follow-up and test of cure recommendations, please refer to the Gonococcal Infections chapter of the Canadian Guidelines on Sexually Transmitted Infections.