The Council of the Royal Pharmaceutical Society has published a document laying down standards of good professional practice for the dispensing of extemporaneous preparations.
The new standard is set out below. It will be incorporated into the next edition of ‘Medicines, ethics and practice: a guide for pharmacists', which is due to be published in January, 2001. It will be added to the Appendix to the Code of Ethics, where it will join the 19 existing standards covering various aspects of professional practice. As with all amendments to the code, the new standards will be submitted to the next annual general meeting of the Society for the membership's approval.
This standard is not intended to cover the reconstitution of dry powders with water or other diluents.
The public is entitled to expect that products extemporaneously prepared in a pharmacy will be prepared accurately, will be suitable for use and will meet the accepted standards for quality assurance.
Pharmacists wishing to be involved in extemporaneous preparation must ensure that they, and any other staff involved, are competent to undertake the tasks to be performed and that the requisite facilities and equipment are available.
20.1 A product should only be extemporaneously prepared when there is no product with a marketing authorisation available.
20.2 Equipment must be maintained in good order to ensure that performance is unimpaired.
20.3 Pharmacists must be satisfied as to the safety and appropriateness of the formula for the product.
20.4 Ingredients must be of acceptable pharmaceutical quality. All calculations and, where possible, measurements should be checked. Pharmacists must pay particular attention to substances which may be hazardous and require special handling techniques.
20.5 The product must be labelled with the necessary particulars, including any special requirements for the safe handling or storage of the product, and an expiry date.
20.6 Records must be kept for two years (but ideally for five years). The records must include the formula, the ingredients and the quantities used, their source, batch number and expiry date. Where the preparation is dispensed in response to a prescription the records must also include the patient's and prescription details, the date of dispensing and a copy of the label. A record must be kept of personnel involved including the identity of the pharmacist taking overall responsibility.