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The alteration of medication formulations (e.g. crushing tablets, opening capsules) to aid administration to patients with swallowing difficulties is also usually an unlicensed activity, with the same legal implications as "off-label" medication administration via enteral feeding tubes.
When drug administration via enteral feeding tubes is necessary, the prescriber takes responsibility for the off-licence use of the drug concerned. However the person administering the medication may still share some responsibility, even if they have written authority from the prescriber. Giving medicines via alternate routes (e.g. via enteral feeding tubes) or by alternate methods (e.g. crushing tablets) contrary to the directions of a prescriber could result in a finding of professional misconduct.
Patient response to drugs administered via unlicensed routes can be unpredictable. Drugs may have a greater or lesser therapeutic effect than when given by the oral route. The onset and duration of effect may be affected. Side effects, particularly those involving the gastrointestinal system, are likely to be exacerbated. The side effects of drugs which have been given by an unlicensed route are also the responsibility of the prescriber.
If putting medication down an enteral feeding tube is unavoidable then it is sensible to keep drug therapy to a minimum. If problems do arise, please contact your Pharmacist who is in an ideal position to advise on the formulation, timing, and route of administration of drugs.
These guidelines are intended only as a guide to administration, and are not an authority for unlicensed administration of medication. The information contained in this guide is mostly anecdotal, as there is little information on drug administration outside marketing authorisation.
There is no formal assessment of product safety or efficacy for these medicines. All "specials" are therefore unlicensed563,1169.
4. Use their skills and knowledge, including up-to-date evidence, to deliver care and improve the quality of care they provide.
5. Make the care of the person their first concern, and act in their best interests.
Use their judgement to make clinical and professional decisions with the person or others.
Have the information they need to provide appropriate care.
The GPhC standards for registered pharmacies require that medicines and medical devices are983:-
4. Obtained from a reputable source.
Safe and fit for purpose.
Guidance from the Royal Pharmaceutical Society indicates that supply of a special is justified only when there is no available licensed medicine which fully meets the patient’s clinical needs.1169
To meet these standards, pharmacists have a responsibility to ensure that1169:-
. Patients receive medication that is safe, appropriate for their condition and circumstances, and of acceptable quality in a timely fashion
. A special is only supplied when there is no available licensed medicine which fully meets the patient's clinical needs
. Any special supplied is of appropriate quality and clinically appropriate for the patient
When no appropriate licensed medicine is available, options to consider include563:-
. Importation of a product licensed in Europe, USA, Canada, Australia, or in another MHRA recognised authority
. Purchase of a special from an external manufacturer with a Manufacturer's specials Licence
. Prescription and supply of an alternative licensed presentation
. Extemporaneously dispensing - this would include crushing tablets
When making the choice, the pharmacist should consider the patient's clinical need, which option minimises the risk to the patient and the urgency with which the supply must be made.