It is important that the patient is prescribed the most appropriate presentation of their medication, bespoke if necessary, in order to optimise adherence

NHS spending pressures mean specials medicines continue to face challenging times, particularly from service commissioners, as Charles Gladwin reports

At the end of 2014, specials manufacturers warned about the problems the sector was facing. The trade body, the Association of Pharmaceutical Specials Manufacturers, issued a discussion document stating: “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.”

Half a year later, those concerns persist. “With an estimated £30bn NHS funding gap to plug over the next five years, there is no doubt that the future will bring challenges for everyone involved in healthcare,” says Brian Fisher, group commercial director at Quantum Pharmaceutical. “We’re in an environment now where clinical commissioning groups continue to challenge prescribers to think differently about specials.”

One of Mr Fisher’s concerns is the lack of consistency in specials prescribing. Data collected by the NHS Business Services Authority shows prescribing levels of specials differ greatly by region. “These patterns are heavily influenced by CCGs’ differing attitudes to the value and perceived affordability of unlicensed medicines, and by the guidance they give to local prescribers,” he says.

“In the past, the decision would and should have been purely focused on patient outcomes, with GPs weighing up variables such as whether the patient would or could take medication in the standard format, or crush/split tablets as instructed. In the current climate, health economics is a major factor in the thought process around all healthcare decisions.”

While Mr Fisher says there will always be circumstances where crushing tablets is an appropriate option, he is concerned that pressure from CCGs – led by a desire to drive down costs – could lead to changes in prescribing habits which ultimately could compromise patient health. “It is important that the patient is prescribed the most appropriate presentation of their medication, bespoke if necessary, in order to optimise adherence,” he says.

Kasia Jawor, marketing manager at IPS Specials, agrees. “As highlighted by the APSM, there is a high risk that if the pressure to cut costs on specials by CCGs continues, despite the introduction of the Drug Tariff and noticeable cost reductions on specials, patients’ positive outcomes will eventually be compromised. Education about unlicensed products is still a vital part of changing the attitude towards specials and seeing specially formulated medicines as an important part of the pharmaceutical industry.”

The impact of the Drug Tariff

Since their introduction into Part VIIIB of the Drug Tariff in November 2011, the overall spend on specials gradually declined by more than 30 per cent to £89.5m in 2014, although the number of specials prescribed is relatively steady, says the APSM. Mr Fisher finds it reassuring that, although the NHS is spending less now the tariff has been introduced, the volume of specials being prescribed has remained stable. “Yet, if the focus continues to be on driving down short-term costs, quality could be compromised, patients put at risk and the result may be more mismanaged conditions and emergency admissions which we know will put the NHS budget under strain.”

He notes that the specials tariff was introduced to reduce the cost of the highest volume specials to the NHS and it appears that the introduction of the tariff has resulted in efficiency savings. However, he warns: “We should beware that the specials industry, like any other sector, is subject to market forces and commercial considerations. If the current trend continues, costs could be squeezed to such an extent that it would no longer be viable for manufacturers to provide the level of service that they do today.”

Chris Palmer, product manager at Rosemont Pharmaceuticals, agrees that the cost of delivering care will continue to be an issue for the NHS and prescribing costs are likely to continue under the spotlight as an area for potential savings. “However, the overall cost of specials to the NHS is now only 1 per cent of the annual NHS spend on prescriptions, so whilst costs need to be contained, potential savings are comparatively small, particularly when compared to patient safety issues,” he says.

The Drug Tariff continues to be updated to reflect the specials sector. In June, 27 items were removed from the Part VIIIB list, representing about 5 per cent of DT specials. Ms Jawor says the reduction “might indicate an attempt by the Department of Health to balance the number of products which are available both as a licensed product and as an unlicensed formulation through the Drug Tariff in order to further manage costs on specials.”

The APSM expands on this: “The Tariff was always intended to have the flexibility to add and remove products. Since 2011 the number has increased steadily, but there may not be too many additions now and so the total number will fluctuate, for example, if a licensed product becomes available or if the volumes for that particular product become too small.”

Pharmacists’ attitudes

On a positive note, there are signs that initiatives such as the tariff, Royal Pharmaceutical Society guidelines on specials, improved information systems and quality infrastructure have resonated with pharmacists. “Our research continues to underline that the specials tariff has restored confidence in the supply chain,” says the APSM.

Since 2012, the APSM has conducted an annual audit of attitudes to prescribing and dispensing specials in Primary Care. The latest results show evidence of continued pressure on pharmacists to reduce specials spend, with almost two thirds stating that they are monitoring spend on specials, or that they are being asked by their CCGs to reduce or monitor specials dispensing.

Although there is still concern that specials may sometimes be prescribed unnecessarily, this is reducing – the latest survey found 35 per cent of pharmacists strongly agreeing, compared with 54.6 per cent in 2013. “We can see this reflected in the fact that 43 per cent of respondents said that they had declined to dispense a special in the past on the grounds of necessity or cost,” says the APSM. “This is potentially a good sign that pharmacists are following guidelines and if necessary questioning the need or formulation with the GP first. We know from a parallel survey of GPs that they are in general much less knowledgeable about specials (54 per cent feel they don’t have enough knowledge or experience) and the mechanisms are in place between dispenser and specials manufacturer to avoid unnecessary prescribing.”

However, the APSM is aware of anecdotal reports about patients sometimes being refused a special on the grounds of cost rather than necessity. “This is a matter of concern and our GP research shows that GPs are certainly less confident and comfortable about specials than pharmacists. GPs are in the frontline and facing difficult decisions about balancing cost and quality.”

What lies in store?

So how will the role of specials develop? Mr Palmer says education will continue to be needed to clarify what specials are and what their role is in prescribing and dispensing. “Many prescribers seem to believe that all liquid medicines are specials and vice versa. Clarity is needed to help optimise prescribing practices,” he says. However, demand for paediatric formulations is likely to increase, in part due to the increasing birth rate.

Quantum’s view is that in a competitive market, customer service will be what differentiates the competition. “We constantly challenge ourselves on service to ensure we are pharmacists’ first choice,” says Mr Fisher. “We’ve reduced our lead times and extended our opening hours over time to reflect the changing role of pharmacies. We work hard to respond to the challenges facing the healthcare sector with agility and pragmatism, be that by delivering faster, staying open longer, or engineering ways to make a significant difference. It is no longer enough to provide good quality medicines; we give clinicians the tools to make sure patients take medicines as they should and intervene if they don’t.”

Quantum Specials, which has now manufactured and despatched its two millionth specials order, is part of the larger Quantum Pharmaceutical Group. The group is exploring opportunities to combine synergistic services from all its subsidiary companies, says Mr Fisher. “For instance, providing the opportunity to optimise adherence to all medicines, licensed and unlicensed, through the Biodose Connect medicines management system is due for launch in 2016.”

Another development will be more timely information. Oxford Pharmacy Stores recently announced a new section to its website containing information and estimated arrival dates for any of its products which are out of stock. The information is available to download as a spreadsheet, which is updated whenever OPS receives updates from its suppliers. “The aim is to make our service more efficient for customers by having this information easily accessible. For products that are subject to extended periods of being out of stock we look to source and supply alternatives wherever possible.”

The RPS has been updating its procurement guidance for specials and invited comments on the new draft in May. Later this year it will also be working with other healthcare professional bodies to update the guidance for the prescribers of specials. This was first published by the National Prescribing Centre (now part of NICE) in 2011.

At the same time, the Royal Pharmaceutical Society announced that it is supporting the work of the NHS Pharmaceutical Quality Assurance (NHS PQA) Committee to develop a detailed handbook collating all available guidance regarding the purchasing, preparation and supply of unlicensed medicines. “The handbook will be a resource for hospital and community pharmacists and their colleagues to use to help ensure that patient outcomes are optimised when unlicensed medicines are prescribed,” says the RPS, adding that the handbook will be hosted on its website.

Additional resources

RPS guidance on specials 

APSM White Paper 

NHS Business Services Authority ‘Volume and Cost of Special Order Products’