The UK’s increasingly ageing population means that the Specials’ market is going to mushroom over the next few decades. Let’s take a look at some of the current statistics and speak to some of the major movers and shakers.
There are positive signs that the balance between cost and quality is being restored in the Specials market – certainly according to the latest annual Specials Survey, conducted by the Association of Pharmaceutical Specials Manufacturers (APSM).
For the first time since the survey began in 2012, fewer pharmacists are referring to CCGs as the first source of advice about dispensing Specials (34 per cent compared with 52.5 per cent in 2013), turning instead to Royal Pharmaceutical Society (RPS) Guidelines (47.5 per cent) or the GP (47 per cent).
There is still evidence of pressure to reduce Specials’ spend – with almost two thirds of pharmacists stating that they are monitoring spend on Specials – or that they are being asked by their CCGs to reduce or monitor Specials dispensing.
The survey also points to the fact that pharmacists have a good understanding of Specials (over 75 per cent feel they have enough information or experience compared with 57 per cent in 2013) and have a positive view of the role of Specials, with 80 per cent agreeing that they are essential to meet the special clinical needs of some patients.
There is also encouraging evidence that the practice of splitting or crushing tablets – perhaps as an option to reduce cost – is losing support. 41.5 per cent are comfortable to dispense tablets with instructions to split or crush, compared with 52.7 per cent in 2013. This is echoed in a parallel GP survey, which showed that the number who were comfortable to prescribe a licensed medicine in this way has decreased slightly from 64.2 per cent in 2013 to 53.5 per cent today – although many would argue that is still too high for such a potentially risky practice which effectively renders the drug unlicensed.
Although there is still concern that Specials may sometimes be prescribed unnecessarily, this is reducing, with 35 per cent of pharmacists respondents 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,’ an APSM spokesman said. ‘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, there are 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.
‘The APSM research still reflects an undercurrent of concern about cost, but this is not exclusive to Specials. Everyone is trying to find efficiencies across the NHS and we are all mindful of this. APSM members are operating in an increasingly competitive environment – the demands of the MHRA are greater than ever in terms of quality and this doesn’t come without a cost. The APSM is committed to continuing to meet these standards required of us. There are no shortcuts to quality.
‘These are good signs that initiatives such as the tariff, RPS guidelines, 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 (67.5 per cent agree). As an industry we need to continue to work with community pharmacists to ensure that they are well supported and continue to get value from the Specials supply chain.’
Introduction of the Drug Tariff
The introduction of the Specials Tariff in 2011 has fulfilled its purpose by providing regulation and transparency in pricing. As a result, the increasing value of specials to the NHS is constantly reviewed and managed and has led to a stabilisation of the specials market. As noted by the APSM White Paper, in the three years since the Specials Tariff was introduced, the mean cost per item has reduced by more than 28% – this reflects the effects of the regulations and standardisation of prices brought by the Drug Tariff.
Cutting Costs and Risks
The APSM urges that 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, the patients’ positive outcomes will eventually be compromised. If the current trend of falling prices continues, there is a danger that in future, it will no longer be viable for Specials suppliers to manufacture certain products and maintain the high levels ofservice which they are able to provide in the current market. Therefore, the 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.
Why Specials are Expensive
Although Specials might appear to have an elevated price in comparison to their licensed equivalents, there is an array of factors which explains why this is the case. Specials manufacturers cannot attain the same cost-effectiveness as the big pharma companies which produce their products on a large scale. The bespoke nature of Specials, high quality manufacturing processes, quality assurance, batch testing, product labelling and the provision of customer support all contribute to the cost of Specials. Additionally, next day delivery provided as a standard adds to the pressure of delivering high quality, bespoke products, fast.
How Specials are Manufactured
In cases where a formulation is unknown and needs to be developed, research is conducted to identify the base for the formulation. Then, raw materials are sourced, only from approved and certified pharmaceutical active ingredient suppliers. New formulations go through a rigorous process of research, calculations, trials, checks and validation before the actual product is manufactured. Having that in mind, it is worth noting that on average, provided the formulation and the raw materials are available, the manufactured product is packed and ready for dispatch, normally from within 1h – 1,5h from the order being placed by a pharmacy with the customer service team at IPS Specials.
Risks of Crushing Tablets and Splitting Capsules
GPs are encouraged to prescribe a licensed medicine with instruction for a patient to crush or split tablets and capsules in order to cut costs on Specials spend. There are times when splitting, opening or crushing tablets and capsules are a viable option, for instance, when the whole dose of a medicine (which is non-potent, immediate release, uncoated etc.) needs to be taken. However, the dangers are still present and are particularly important when dealing with potent, low dose, time-released or coated tablets:
- Healthcare professionals or carers could be exposed to health risks through powder aerosolisation
- Irritation if the drug was inhaled or came into contact with eyes, skin or other mucous membranes and, in some cases, causing skin toxicity
- Negative impact on the stability of the drug substance
- Less drug available to produce the desired clinical effect (e.g. through powder loss or uneven split)
- Loss of protection of the drug from the effects of light
- Changes in the drug pharmacokinetics & bioavailability resulting in underdosing/overdosing or adverse effects
- May cause oesophageal or stomach irritation or ulceration if tablets are crushed or capsules opened
- Refusal of taking the medication due to unpleasant taste
- Possible anaesthetic effect on the tongue, particularly if sertraline is given in a powdered form
- Potential of an unintended large bolus dose being delivered rather than controlled release over the intended timescale resulting in a potentially toxic dose with an increased risk of adverse effects
- Crushing enteric coated tablets may result in the drug being released too early, destroyed by stomach acid, or irritating the stomach lining
Summary
Considering strict cGMP standards and the MHRA regulations followed at the state of the art manufacturing facilities available to Specials manufacturers, like IPS Specials, it is probably easier to appreciate the significant role they play in the healthcare system.
Contributing to only 1.06% of total spend on all drugs in England and Wales in 2013, Specials account for a relatively small fraction of the total NHS spend. There is still a lack of understanding about Specials and confusion around Specials, off-license and unlicensed medicines. Therefore, education is needed to:
- Help improve the understanding between Specials, off license, unlicensed products.
- Avoid reluctance to prescribe specials due to cost by GPs
- Change the attitude to prescribing specials and the perception of it being a luxury product
- Consider all processes and quality assurance controls involved in manufacturing a Special, when evaluating the price
- Realise the long-term savings to the NHS by providing an acute medical intervention and preventing potential complications resulting from crushing tablets
- Increase the focus on patients positive outcomes, instead of short-term savings on medicines
Further education is needed to ensure prescribers make well-informed decisions about prescribing Specials to their patients and avoid risky decisions of prescribing a licensed medicine in its modified form (spilt capsule, crushed tablet etc.) and potentially compromise patient’s positive outcome.
