How Specials Can Deliver Value to the NHS | Page 2

FOREWORD
It is a costly process taking a medicine to licence and pharmaceutical manufacturers have little incentive to
create certain drugs and all formulations where their potential volumes are small, even if there is a patient
need. In these instances, where there is no licensed medicine to meet this patient need, a specially formulated
unlicensed medicine (or Special) must be prepared. For this reason, Specials fulfil an extremely important role
in the patient pathway.
Many patients who need Specials have complex medical needs, with overlapping conditions. Failure to receive
appropriate medication may result in exacerbation of symptoms, unnecessary suffering and increased cost to
the NHS.
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 three
years the overall cost of Specials has reduced by almost 30%1.
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 Clinical Commissioning Group (CCG),
to reduce prescribing of Specials2. 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 costs could be forcing prescribers and dispensers to
opt for higher risk options for meeting patient need.
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.

Context and Best Practice for Specials. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Assessing clinical need.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Case Study 1 Patient with an allergy to an eye drop preservative.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Case Study 2 Child with epilepsy where an extemporaneous product resulted in increased fits.. . . . . . 10
Case Study 3 A child where the adult dose was not appropriate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Case Study 4 Dose consistency for an anti-rejection drug. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Case Study 5 Quality of life in ADHD. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Case Study 6 Child where licensed product was not suitable.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Case Study 7 Non-availability of licensed/fragile supply chain in high-risk disease areas. . . . . . . . . . . . . . . 20
Case Study 8 An elderly patient with arrhythmia, unable to swallow capsules. . . . . . . . . . . . . . . . . . . . . . . . . . 22
Case Study 9 Management of blood pressure in a patient in a care home. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
2

1. Prescription Cost Analysis in England 2013 http://hscic.gov.uk, [date accessed Aug 2014]
2. Survey conducted on behalf of APSM by Opinion Health June 2013