All licensed medicines have been tested for effectiveness & safety before being released onto the market. The data sheet provided by the pharmaceutical company with any licensed medication (which is summarised in the BNF) states the licensed indications, cautions and contra-indications together with recommended dosages and routes of administration. This means that the drug has been proven to be safe in the patient group if given at the recommended dose and via the recommended route in the form in which it was tested in. If a medicine is prescribed within the bounds of the license and subsequently causes patient harm, ultimate liability rests with the pharmaceutical manufacturer. The Thalidomide, Opren & more recently Vioxx cases all demonstrate this in action.
Under the Medicines Act, which governs all medicine usage in the UK, all prescribers (doctors, dentists, independent and supplementary) are allowed to prescribe medicines outside of their license either for unlicensed patient groups (off-label) or medicines with no license e.g. medicines with a non-EU license (unlicensed). By prescribing either an off-label or unlicensed medicine the liability rests with the prescriber. It may also rest with the administrator and supplier if they are aware of the unlicensed or off-label use and were in a position to intervene.
Tampering with a medicine before administration e.g. crushing or dispersing will render it unlicensed if this is not recommended by the manufacturer in the data sheet. In such circumstances, the responsibility for any adverse effects the patient may suffer rest with the prescriber. It is important that any decision to recommend unlicensed medicine usage is documented appropriately and the patient is informed. Appropriate questions regarding the suitability of the action should be asked and responses documented. If any action is then subsequently taken a paper trail demonstrating the competence of the practitioner is in place.
Other healthcare professionals without prescribing rights are not legally permitted to recommend medicines for off-label unlicensed use. If a non-prescribing healthcare professional recommends medicines tampering or chooses to tamper with the medicine without authorisation and a patient is harmed they will face the additional charge of contravening the Medicines Act.
Administering medicines via an enteral tube is almost always an unlicensed action and consequently it is always necessary to ensure that the appropriateness of the medicines prescribed for administration via this route is checked and the decision is recorded appropriately.