APSM WELCOMES GPhC SPECIALS GUIDANCE – but says more education and support is needed for pharmacists

The Association of Pharmaceuticals Specials Manufacturers (APSM) has welcomed the recent initiative by the General Pharmaceutical Council (GPhC) to introduce guidance for pharmacists preparing unlicensed medicines.  Although extemporaneous preparation (Section 10 exemption) is only intended for use in emergencies, it is nonetheless an essential part of the overall specials supply chain.

Patient safety is a priority for all parties concerned and in the past decade we have seen huge investment in process and systems by the Department of Health and Specials Manufacturers alike. This investment, combined with the stringent quality requirements of the MHRA for MS licensed Specials manufacturers, means that the UK specials sector is one of the safest in the world.

As GPhC Chief Executive Duncan Rudkin stated, ‘patients have the right to expect unlicensed medicines to be of the same quality as their licensed equivalents’.    Through legislation and best practice guidance, the UK is on-track to achieving this goal and in a recent survey by the APSM, 72% of pharmacists felt that the quality of Specials compared with licensed medicines (an improvement from 58% in 2012).
Of course, extemporaneous preparation can never be subject to the rigorous quality measures required of any Special manufactured under an MS licence.  However, given that pharmacists share legal responsibility for patient safety when they prepare a Special, it is only right that they are given as much guidance as possible to help minimise risk to themselves and to their patient.

The APSM recognise that a large number of pharmacists lack sufficient knowledge and experience of Specials.  In the same poll last year, 42.9% agreed or strongly agreed with the statement ‘I don’t feel I have enough experience about unlicensed medicines’.  This is possibly not surprising when most pharmacies dispense less than 10 Specials scripts per month and due to complexity, economics or time pressures, many of these would need to be prepared by a specialist manufacturer.


For these quality measures to succeed, pharmacists will need to be supported – which is where the APSM has a role to play.  Providing advice and support to pharmacists is a key undertaking of any member company of the APSM and we encourage pharmacists to contact us with any questions relating to Specials.  All members have a customer service team with access to qualified (pharmacy) staff and their remit goes beyond order fulfilment.  We estimate that up to 10% of our customer contacts do not result in us supplying the special, often we just give advice or even steer them in the direction of a licensed alternative – or a different formulation.   

APSM Specials Survey

How Specials are Regulated

Fact Sheet

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