Unlicensed medicine supply liability

In Guidance Note 14, the Medicines and Healthcare Products Regulatory Agency states that hospital trusts, health authorities and independent hospitals should have clear policies on the use of unlicensed medicines, explaining liability considerations and requiring all those involved in the supply chain to ensure that the unlicensed status of a product is commimicated and fully understood. 

Where a company suspects that the product is to be used in a way that is not safe for patients, its duty to those patients may involve warning the doctor that it considers the proposed use to be hazardous and, if necessary, refusing or terminating supply. While there is no general obligation to provide product information with unlicensed medicines (and, as noted above, the use of promotional material is prohibited), from a product liability standpoint, the provision of basic safety information about the product is a sensible precaution. 

Although hydroxycarbamide is a licensed medication, it is not licensed for the management of sickle cell anaemia use in this case is unlicensed or off-licence. As every pharmacist assumes a duty of care to a patient when supplying a medicine, this means that if an adverse reaction is suffered, the supplying pharmacist may assume some liability along with the doctor who prescribed it. 

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