Editor, – Your fascinating article outlines the decision by one pharmaceutical company to employ unethical strategies to promote off-label uses for gabapentin (Aust Prescr2003;26:18-9), a decision which could be described as corporate risk. However, the prescriber and the patient also share the risks associated with off-label prescribing. While the final paragraph highlights an 'imperative to carefully weigh the potential benefits and harms' of off-label prescribing, I believe the article stopped prematurely in developing this notion of who bears the risks.
Off-label prescribing includes using the drug for an unapproved indication, or at an unapproved dose or by an unapproved route, or disregarding the contraindications or precautions of the product information. In the gabapentin example, a belief by prescribers that off-label use was supported by clinical evidence was probably unfounded. The decision as to whether this use was appropriate will come down to standards of reasonable care. The pharmaceutical company will consider that its drug has been used in an unauthorised manner and so cannot officially sanction such prescribing.
It has been noted that 'prescribing outside the licence [approved product information] alters, and probably increases, the doctor's professional responsibility'.1 When considering prescribing a drug, it is important to be aware of what is on the label to minimise the chances of being left 'hung out to dry'.
Craig Patterson
Pharmacist
National Prescribing Service
Sydney
Editor, – Further to the articles in Australian Prescriber on prescribing of gabapentin (Aust Prescr 2003;26:18-9),in addition to the issues discussed, there are legal issues for the prescriber and the manufacturer/sponsor of the product to consider.
My first observation is that prescribers who use gabapentin for a condition which is outside the marketing approval in Australia could be subjected to a compensation claim should a patient suffer a serious adverse event due to the drug. If such an event occurred it could also involve the promoter of the drug if off-label promotion was involved.
The second observation concerns prescribing gabapentin as a pharmaceutical benefit. The National Health Act provides penalties for prescribing 'restricted' and 'authority required' drugs for other than the allowable conditions determined for that drug. In instances of off-label prescribing, the prescriber has breached the legislation. The articles allude to off-label promotion of gabapentin overseas. If this occurred in Australia it follows that the manufacturer promoting the drug for an off-label condition may also be party to an offence under the National Health Act.
Brian Foster
Pharmacist
Melbourne
(Until 1996 I was Manager of the Pharmaceutical Benefits Branch of the Health Insurance Commission in Victoria. I joined the Pharmaceutical Branch of the Commonwealth Department of Health in 1969 and retired from the Health Insurance Commission in 1996.)
