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Unlicensed drug use on ICU


The use of medicines outside the terms of the product licence is a common occurrence on the ICU. While the extent of unlicensed prescribing has been quantified in paediatric practice [1], no studies have so far addressed this in the adult ICU setting. There are various types of unlicensed drug use including an unlicensed drug or a licensed drug used in an unlicensed manner. Identifying unlicensed drug use is important because the prescriber is responsible for any adverse effects suffered by the patient.


To assess unlicensed drug use in the Intensive Care Unit of the Middlesex Hospital.


Specific drug charts were selected at random over a 14 day period. Details of each administered drug was compared with the product licence of the drug. Aspects of use examined included indications, route, dose, dilution, diluent and compatibility. For generic drugs, the parent branded drug's product licence was used, where applicable, to define the licensed use.


Eighteen out of the 20 patients (90%) received at least one unlicensed drug administration. Of the 176 drugs prescribed, 41% were 'unlicensed' due to: unlicensed indication 13%, unlicensed route 51%, unlicensed dose 11%, unlicensed dilution/ diluent 21%, unlicensed drug 4%.


In this sample 41% of drug use was 'unlicensed' and 90% of patients received medication administered in an 'unlicensed' manner. All nasogastrically administered drugs, adrenaline and morphine infusions were considered 'unlicensed'. Although licensed drugs for licensed uses should be used where possible, ICU doctors are generally unaware of licence specifics despite being potentially legally responsible for any adverse effects that arise from this use.


  1. Turner S, et al.: Use of 'off-label' and unlicensed drugs in paedi-atric ICU. Lancet 1996, 347: 549-550. 10.1016/S0140-6736(96)91182-4

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Goldsmith, C., Shulman, R. Unlicensed drug use on ICU. Crit Care 6 (Suppl 1), P226 (2002).

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