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GPhC calls for higher standards for specials preparation

Clinical 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of making a mistake in specials preparation warranted an initial risk assessment and regular reviews, the GPhC said in draft guidance released yesterday

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of making a mistake in specials preparation warranted an initial risk assessment and regular reviews, the GPhC said in draft guidance released on Tuesday (January 28).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

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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.

Do guidelines for preparing specials need to be more stringent?

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Yo Palumeri, Community pharmacist

Just remeber litigation and are your pharmacy standards really up to the current guidlines for pharmaceutical manufacture. Use a specials manufacture of repute and go and vist themn and see their standards. You will never manufacture in the pharmacy again

Calum Nelson, Locum pharmacist

When I was at Uni I narrowly failed the class that taught us how to make extemps (way back in a year called 2008). When the resit came we only had to resit the written part and there was no practical resit (and no individual feedback on our exams, as was the case with all our classes). That means to this day I have no idea what I did right and what I did wrong, despite being qualified now for 2 years. How's that for specials standards? Thankfully I never have to do anything more complicated than mixing two creams together but I would never feel confident doing anything more complex.

Really? Wow, Superintendent Pharmacist

Calum, what you are saying is that this is an issue for the Education committee as they are obvious failing if you have not got the skills, or the skills required to do basic Extemp Prep?

This is maybe harking back to the explosion in Pharmacy schools in the past 10 years....are they all hitting the standards required?

....Maybe not!!

Clive Hodgson, Community pharmacist

The requirements proposed seem so onerous that it would be difficult to understand why any Pharmacy would now want to undertake the preparation of any “special”.

The result will be that even the simplest of “special” will be referred to one of the Special Manufacturers at increased cost to the NHS.

Additionally, is there any evidence that there exists a current problem with such procedures in a Pharmacy?

Geoffrey Lay, Locum pharmacist

Agreed. I will make up simple cream formulations about once a month. It's my last link to the 'ceutics' practicals of thirty years ago.

I really don't think that involving a specials lab will provide a better service or product and will only increase the expense to the NHS.

Will there be any comparison to the Scottish experience where pharmacies are required to perform simple extraneous preparations?

Ian Kemp, Community pharmacist

Obviously of similar vintage Geoffrey and I agree making simple cream formulations can be great fun BUT are you honestly suggesting that NO clinically equivalent licensed product is available for the items you extemp prep?! Move on professionally and use you hard won skills for fun in the kitchen instead.

Stephen Eggleston, Community pharmacist

Sadly, Ian, I must agree with you. Us (slightly) older pharmacists must reserve our skills for less potentially litigious use, although I do miss making something from scratch, based on your knowledge & experience of both chemistry & pharmaceutics.
Thems were the days

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