Criteria for supply of second-line
tuberculosis drugs
The Department of Health funds the Victorian Tuberculosis (TB) Program at Melbourne Health to purchase TB drugs for use in
Victoria. In certain clinical situations, specified second-line anti-TB drugs are required. These drugs include amikacin, moxifloxacin,
prothionamide, clarithromycin, and cycloserine. In addition, there is provision for the purchase of less frequently used drugs such as
PAS and linezolid, if required. Management of drug resistant TB is generally complex and should only be undertaken by, or in
consultation with, an experienced TB physician.
Because treatment of drug resistant TB and use of second-line therapy is highly specialised, the Victorian Tuberculosis Advisory
Committee has recommended that specific clinical criteria must be met in order for patients to be eligible for funded second-line
drugs.
Please complete the information below (including clinical indication for second-line therapy) and forward to your hospital pharmacy.
This information must be supplied by the pharmacy when ordering second-line medications from the Victorian TB Program at
Melbourne Health.
Pharmacists: Please fax this form with your TB drug order to the Victorian TB Program at Melbourne Health, 03 8344 0781.
Please outline proposed drug regimen:
Affix patient label
Proven or suspected multi-drug resistant (MDR) TB. For suspected MDRTB, the patient should have a documented history of past TB
treatment and now presents with a relapse of disease and high risk of MDRTB. It is also recommended that molecular testing for rifampicin
resistance is arranged pending full drug sensitivity testing (DST) in order to meet these criteria. Please provide details:
Ethambutol (EMB) therapy is required for initial therapy but is contraindicated due to:
 Renal failure
 Ocular disease (pre-existing)
 Ocular toxicity due to ethambutol
 Inability to monitor for ocular toxicity
Other significant EMB side effect (please specify):
NOTE: EMB is not required for initial therapy if the isolate is already known to be pan-sensitive or if the likelihood of isoniazid (INH)
resistance is less than 5%
Non hepatotoxic regimen is required (e.g. pre-existing cirrhosis of the liver)
Proven INH or RIFAMPICIN monoresistance, PLUS:
 severe (eg. cavitating smear positive pulmonary) or disseminated disease (where moxifloxacin is added to increase the bactericidal
activity of the regimen). NOTE: Moxifloxacin should be ceased during the continuation phase of treatment
 where EMB is contraindicated
As part of a combination regimen for treatment of latent TB infection (LTBI), where the index case is known MDRTB. (NOTE: All patients
who are treated for LTBI with any drug other than INH must be notified to the Department of Health.)
Has a Notifiable Conditions form been completed and sent to the Department of Health? Yes No
Prescribing physician (print name):
Consultant physician (if appropriate):
Date:
Department of Health
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Department of Health