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Dispensing regulations - The importance of clear labelling

Good practice and common sense play a large part in the labelling process, writes Annette Arthur.

Most of us have met patients who are convinced that all dispensers have to do is take a box off the shelf and stick a label on it. The reality is that, before the drug can be given to the patient, the dispenser has to go through several steps to ensure the labelling process meets regulations.

Legal requirements
The legal requirements are enshrined in the Medicines (Labelling) Amendment Regulations 1976; 1977; 1978; and 1992. There are five items which must appear on each and every drug provided to a patient: the name of the patient; the name and address of the dispensing doctor/pharmacist; the date of dispensing; the words 'keep medicines out of reach of children'; and the quantity dispensed in that box.

Other details should be included for the convenience and safety of the patient, if there is space on the label, though these are not enforceable. They are: the name of the drug; directions for use of the drug; precautions during use; storage conditions; and expiry date (unless this already appears on the container).

Emergency prescriptions
These rules apply whether the drug comes from a dispensary or an emergency bag. It also means that two boxes of the same drug should not be stuck together with only one label on the package, and that all items in a GP's bag should have a blank label on them for the GP to fill in should a drug be left with a patient.

Since some clinical systems print a quantity that refers to the whole prescription, rather than the amount in each individual pack, the dispenser must make sure that the label is altered to reflect what is in the box.

Warnings of interactions; drowsiness; effects of sunlight; and so on should be included as good practice and most computers are already programmed to do this. However, when handwriting labels, the dispenser must take care to include any cautions necessary. All the cautionary labels that may be required are listed in Appendix 9 of the BNF.

Handwritten labels should be printed for safety, preferably in black ink, and must be legible. If dealing with a visually impaired patient, it should be possible to print the label in large type, even if it means using two labels.

Once the task of including everything required on a label has been achieved, the dispenser is faced with a more difficult problem: where to place this on an item sometimes no bigger than a matchbox. There are regulations that must not be breached in this process.

The label should not obscure manufacturer's precautions; the name of the drug or the strength; expiry date; or batch number. Frequently, the dispenser has to be quite inventive to comply with this.

If a patient suffers an adverse reaction because the label has covered a manufacturer's warning, the dispenser and the dispensing doctor become liable.

External preparations, such as eye drops and ointments, should have the label placed on the bottle or tube and the patient should be instructed to keep the medication in its box between uses.

However, in the case of the very small bottles in which a number of eye and ear drops now come, it is impossible to label these without fouling the dosage mechanism, so the label should be placed on the outer container and the patient informed of this.

Responsibility
We cannot legislate for what the patient may do with their drugs once they get home, but the dispenser will have discharged their responsibility by telling the patient what has been done. Some practices may produce a slip of paper that goes out with the drug, so there is physical evidence of the instruction.

Labels can be stacked on top of one another or 'flagged' - attaching just one edge to the box and folding the label in on itself; however, they must be securely stuck down. Good practice and common sense are important in labelling. Safety for both the patient and dispenser must be paramount.

  • Annette Arthur is a consultant for dispensing practices
Labelling
  • Make sure each label includes the legal requirements.
  • Each box of medication must have its own label.
  • Each label must reflect the number of tablets in that box.
  • Check all the cautionary labels that might be required.
  • Apply the label to the box in the safest way to comply with regulations.

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