Pharmacies preparing specials should regularly audit their records, staff training, quality controls and equipment, the General Pharmaceutical Council (GPhC) has said.

The "potentially serious consequences" of making a mistake in specials preparation warranted an initial risk assessment and regular reviews, the GPhC said in draft guidance released on Tuesday (January 28).

The publication comes in response to the GPhC's consultation on premises standards in 2012, which identified specials preparation as an area in which pharmacies would like more guidance. Pharmacists will now have six weeks to provide feedback on the plans, which are aimed at ensuring all specials are of the same quality as licensed medicines.

The GPhC advised pharmacy owners and superintendents to carry out a "careful and thorough" risk assessment before preparing unlicensed medicines	More on specials Specials treatment Specials manufacturers raise concerns about cost cutting Widen specials fraud inquiry to examine pressure on pharmacists, LPCs urge
	The GPhC advised pharmacy owners and superintendents to carry out a "careful and thorough" risk assessment before preparing unlicensed medicines, which should take into account whether there is a licensed product available.

The assessment should look at the suitability of premises and specialist equipment, as well as ensuring there is a robust formula and adequate hygiene measures, the regulator said.

The GPhC named staff training as another key area for pharmacy owners and superintendents to assess. Staff must be "closely supervised" until they complete full training in the area, the regulator stressed, and there must be "clear lines of accountability".

It highlighted the need for detailed record-keeping to ensure patients could be contacted if there was a recall or safety issue. Patients should also be informed of the process, and it should be made clear that the pharmacist would be preparing the medicine, the GPhC said.

There was no legal requirement for unlicensed medicines to have a package leaflet, so it was up to the pharmacist to provide information to the patient to ensure they used it safely, it added.

The regulator recommended regular audits of records, staff, equipment, quality controls, hygiene issues and premises, with additional reviews if there were any changes to those areas or concerns raised.

GPhC chief executive Duncan Rudkin said patients had the right to expect unlicensed medicines to be of the same quality as their licensed equivalents. "This new guidance will help pharmacies make sure they are achieving the necessary standards and that every unlicensed medicine they prepare is safe and appropriate for their patient," he stressed.

The GPhC will accept feedback on the guidance until March 14. Pharmacists can give their views by completing an online survey, emailing [email protected] or addressing a letter to the standards advisory team at 129 Lambeth Road, London SE1 7BT.

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