Untitled Document

August 2014

From the Desk of the Managing Editor

Off label use of medicines

“Off label” prescribing is the term used; when a medicine is used in ways other than those specified in the TGA approved Product information. This differs from an unlicensed or unregistered medicine which is a medicine or dosage form of a medicine that has not been evaluated nor approved for use in Australia and hence not entered on the Australian Register of Therapeutic Goods.

Off label prescribing can encompass a number of scenarios including when a medication is prescribed or administered for an indication, at a dose, by a route of administration or for a patient group that is not included in the approved PI. There are often groups of patients who are excluded from the clinical trials undertaken for a products registration. These groups often include paediatrics, the elderly or pregnant or lactating women. Prescribing the medication for patients in these categories would be ‘off label” if they are not listed in the PI. (Seale 2014)

Similarly, based on a medications mechanism of action, it may be hypothesised that the drug may be efficacious in treating an indication not listed on the approved PI. It is considered acceptable to prescribe a medication for an off label indication in patients provided there is sufficient evidence of efficacy and safety. This is particularly true when a drug’s patent has expired – it is unlikely that the pharmaceutical company will engage in the process of submitting data to the TGA to have the PI revised.

Patients should be advised by their doctor if a medication is being used for an off label indication as they may become concerned if their condition is not listed on the CMI.

A lot has been published about the extent of and problems associated with the off label use of medicines, and the extent of off label prescribing is reported to be between 7.5% and 40% and may be up to 90% in some hospitalised paediatric patients. (Gazarian 2006)

A recent survey of 150 million off label prescription in the US found that 73% had little or no scientific support. (Gazarian 2006)

Late last year the Council of Australian Therapeutic Advisory Groups published a document entitled
“Guiding Principles for the quality use of off- label medicines”

This document was produced to provide a framework to support the quality use of off label medicines in Australian public hospitals and to assist the decision-making by health professionals, consumers and Drug and Therapeutics Committees in the evaluation, approval and use of these medicines.

Consider the off label use of a medicine only when all other options, including medicines approved by the TGA, are unavailable, exhausted, not tolerated or unsuitable
Use high quality evidence to determine appropriateness of off label medicine use.
Involve the patient/carer in shared decision-making when recommending an off label medicine
Consult the Drug and Therapeutics Committee when prescribing an off label medicine, except when the use of a medicine off label is considered routine
Ensure appropriate information is available at all steps of the medicines management pathway
Monitor outcomes, effectiveness and adverse events
Consider liability and accountability when using medicines off label

For further information on these principles see “Rethinking medicines decision-making in Australian Hospitals: Guiding Principles for the quality of off-label medicines” http://www.catag.org.au/resources/

References
Gazarian M, et al. Off-label use of medicines: consensus recommendations for evaluating appropriateness. Med J Aust 2006; 185 (10): 544-548.

Seale JP. Off label prescribing. Med J Aust 2014; 200 (2): 65.