Tuesday, 9 December 2014

Specials White Paper - Value and quality for the NHS

NEW White Paper – How Specials can deliver value to the NHS without compromising patient safety.

The APSM, Association of Pharmaceutical Specials Manufacturers, has launched a White Paper which for the first time attempts to attribute an economic value to the provision of unlicensed medicines within the NHS.  The paper takes a series of typical patient scenarios where a Special is indicated and then identifies the potential cost to the NHS of attempting to meet patient need with a lower cost, or higher risk alternative.  In all of these cases this additional cost has exceeded that of providing a special and sourcing it according to established guidance.
The White Paper was commissioned in the light of growing concern about cost pressures leading to higher risk practice in the supply chain.

Striking the balance between cost and quality
Specials account for approximately 1% of prescription costs and in recent years, as part of overall pressure on NHS budgets, the cost of Specials has come under scrutiny.  Costs are regulated by Tariff and in the last 3 years the overall cost of specials has reduced by almost 30%.
Specials must be produced to pharmaceutical standards, but there are concerns that increased pressure to reduce cost could be compromising quality through sourcing lower cost supply, or even reluctance to prescribe a Special when required.
In a recent survey amongst GPs, 54% said they had been asked by their CCG to reduce prescribing of Specials1.  In the same survey, 45% of GPs stated that they were happy to prescribe a licensed medicine with instructions to the patient to split or crush capsules or tablets – compared with just 29% in 2012.   The risks of tablet crushing are well documented and, the APSM believes, is just one example of how continued pressure to reduce cost could be forcing prescribers and dispensers to opt for higher risk options for meeting patient need.  
In this respect the APSM strongly supports the cautionary comments of the British Medical Association recently in relation to the doctor’s role in optimising the limited resources of the NHS.     "While staff and management should work closely to maximize the use of the NHS's very limited resources, a doctor's primary duty is to their patient, and it is vitally important that decisions around patient care are around clinical value."2
This White Paper sets out to explore the true cost of selecting a higher risk alternative and how a well regulated and high quality Specials sector can provide value to the NHS.  Through a series of case study scenarios, it looks at what happens when patient need and safety is compromised to the extent that there is additional cost incurred to the NHS.  In all of these cases this additional cost has exceeded the initial cost of providing a Special in line with the established guidance.
There is robust guidance and regulation in place to ensure that Specials should only ever be prescribed when there is no alternative to meet patient need. However, when a Special is indicated, it is clear that attempts to cut cost in the supply chain are likely to result in increased demands on the NHS budget.

Says, APSM Chair, Sharon Griffiths.  ‘There is regulation and guidance to prevent unnecessary prescribing of a Special and as an industry we have a duty to support this.  However, when a special is indicated, we’re concerned that there is too much pressure on cost and not enough emphasis on patient safety.’
Cost is an inevitable fact of life and although it’s difficult to quantify the benefit to every patient of every individual special that is provided, as an industry, we felt we needed to find a way to demonstrate the value of specials and define what a high quality supply chain means to the NHS and to the patient.  We believe this White Paper provides a very clear justification of that value.’

Copies of the White Paper, are available on www.apsm-uk.com and can also be requested from info@apsm-uk.com


1.      1.  Survey conducted on behalf of APSM by Opinion Health

Thursday, 13 March 2014

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.