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There have been significant changes in the specials market in the past few years €“ so it is important to keep up to speed with developments.

Since specials were added to the English Drug Tariff in November 2011, the quantity prescribed has remained relatively steady but the amount spent on them has declined by more than 30 per cent, according to the Association of Pharmaceutical Specials Manufacturers (APSM). In 2014, the amount spent on specials was £89.5m. The mean cost per item before they were added to the Drug Tariff was £179.95; now it is £122.22 €“ and this downward trend is continuing.

NHS Business Services Authority figures for July 2014 to June 2015 indicate that £77.9m was spent on specials in England. Put another way, that is over 728,000 items at an average cost of around £112 each. Over the same 12-month period the average net ingredient costs per item in CCGs ranged from £71.84 in Surrey Downs to £205 in Greater Huddersfield.

Specials now account for 0.95 per cent of the total NHS drugs spend of £9.4bn, with just over 500 product lines accounting for 95 per cent of specials' spend.

€We all have an interest in keeping NHS costs down, but this cannot be at the expense of positive patient outcomes,€ says Brian Fisher, managing director, specials division at Quantum Pharma. €We must not forget, for example, that crushing tablets can affect drugs' pharmacological effects and the likelihood of adherence.

€With further additions to the tariff, the administration of specials is becoming simpler for community pharmacies. Any initiative that enables prescribers to continue providing bespoke specials safely and within budget is to be welcomed. However, it needs to be as accessible and manageable as possible for pharmacists. NHS Scotland has recently made some changes to processes in order to establish a smoother process as the system had become time-consuming.€

Dispensing and reimbursement

In February 2013, Part 7S was introduced into the Scottish Drug Tariff, following the introduction of Part VIIIB in November 2011 in England. These sections contain a list of commonly prescribed specials for which prices are set and reviewed regularly. In Scotland, health board authorisation is required for a special unless the product is listed in Part 7S. For those products not in 7S, authorisation is not required if:

• Authorisation was obtained within the past 12 months and the price has not changed by more than 20 per cent
• The preparation is available from a NHS manufacturing unit in Scotland/England/Wales.

Prescriptions should be endorsed with the fixed (£30) non-part 7S handling charge (hc) and any out-of-pocket expenses, including wholesaler handling charges. The prescription should also be endorsed with postage and packaging (pp).

In England, there is no requirement for specials authorisation to ensure reimbursement. There is a fixed fee (£20) to cover all costs incurred when sourcing the product. Prescriptions must be endorsed with 'SP' to claim the payment.

Where the item is not listed in Part VIIIB of the Drug Tariff, the pharmacy is required to endorse the invoice price of the product. Prescriptions for specials should be separated from the rest of the bundle and placed in the red separator for submission.

For specials not listed in Part VIIIB, the pharmacy must stamp, date, initial and endorse the certificate of analysis (CoA)/certificate of conformity (CoC) with the invoice price and prescriber's details.

If a CoA/CoC is not available, the contractor must stamp, date, initial and endorse the invoice with the invoice price less discount (where not clearly detailed by the supplier) and the prescriber's details. At the end of each month, these are sent to the prescriber's local NHS England team.

When a special is supplied, the MHRA requires the pharmacy to keep a record of the following for five years:

• The source of the product
• The person to whom and the date on which the product was sold or supplied
• The prescriber's details
• The quantity of each sale or supply
• The batch number of the product. These records must be available for inspection by the licensing authority.

Pharmacists should supply medicines based on the risk hierarchy criteria outlined by the MHRA:

• Where a UK licensed product exists, this must be supplied
• Use of a UK licensed product off-label (for example, for an unlicensed dose or indication) is preferable to prescribing an unlicensed special
• If a UK licensed product is not available, then a licensed foreign medicinal product should be sourced
• If none of the above are available, then an unlicensed product may need to be manufactured by a UK specials manufacturing company.

Special delivery

The APSM is the trade body for specials manufacturers. Members sign up to a commitment of timely delivery to patients, which means that next day delivery is now standard. Between 95-99 per cent of orders are despatched the same day.

€Patients who are prescribed specials often have a specific and urgent clinical need €“ they should not have to wait for a medicine just because it is not licensed or an off-the-shelf preparation,€ says APSM chair, Sharon Griffiths.

Specials manufacturers have more than 20,000 potential preparations on their systems. For a typical specials manufacturer, there can be 500 different orders a day.

€We are committed to maintaining a sustainable manufacturing base for specials in the UK and, in spite of increased commercial pressures, our members have continued to invest in high quality infrastructure and processes. In the past five years APSM members have collectively invested over £100m in service improvements €“ which is more than the value of the specials market,€ explains Griffiths.

Perceived expense

There is no doubt that specials are expensive, but is the cost justified? €Achieving the right balance of cost, safety and speed against a backdrop of NHS cost saving, is an ongoing consideration for prescribers and we're in danger that the perceived expense of specials could falsely eclipse the possible impact of the alternatives €“ such as the prescribing of sub-optimal treatments or encouraging patients to crush or split tablets themselves €“ on patient safety and adherence,€ says Brian Fisher.

€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.

€We should be aware 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,€ he warns.

Professional responsibility

Everyone involved in the supply of a special €“ including the patient €“ should be aware of the unlicensed nature of the medicine. This means that patients discharged from hospital with a special are made aware that it may take longer for pharmacies to source the product, so they shouldn't leave it until the last minute to re-order. RPS guidance says pharmacists should ensure the prescriber is also aware of the unlicensed status of a prescription for a special.

Robin Conibere, practice clinical pharmacist at Beacon Medical Group in Devon and Cornwall, endorses this policy, explaining that despite knowing that it is a special, GPs may be completely unaware of the costs. €Their clinical systems may not indicate this, so it is worth having a conversation with the prescriber to ensure they know about the product's status and cost, as well as the expiry date if short.€

It is also possible, he says, that an item may have been prescribed in secondary care when a patient was acutely unwell and continued after discharge without considering the patient's current clinical picture. For example, the patient might have had swallowing difficulties, which have now improved.

Community pharmacy is probably better placed to reassess this with patients, he says, whether through a MUR ('I notice that you have this medicine as a liquid, but all your other drugs are tablets. Is there a reason for that?') or informally.

Other considerations concern crushing tablets or opening capsules. €A good resource I use is The NEWT guidelines, which provides information around swallowing difficulties and patients with PEGs [percutaneous endoscopic gastrostomies],€ says Conibere. It is also important to be aware that some hospitalonly dermatological preparations may be manufactured relatively cheaply in hospital but can be far more expensive if prescribed in primary care, he says.

Prescribers may also not be aware of, or consider, all of the options, such as a change to an alternative medicine in the same class, he says, citing the examples of lansoprazole orodispersible as opposed to special omeprazole liquid, and atenolol liquid instead of other special beta-blocker liquids.

€GPs sometimes dread these calls from community pharmacy, so try to be non-confrontational. Instead of presenting the GP with a problem to solve, it is better to provide him or her with a possible solution, he advises.

€Suggest an alternative that you have in stock and is equivalent, along the lines of: 'Unfortunately drug x is an unlicensed expensive special which will take us three to five days to get in, but we have drug y, which is in the same class. I've discussed the tablets with the patient and, because they are smaller than drug x, she feels she can swallow them. Would you consider prescribing these instead?'€

Pharmacy research

Since 2012, the APSM has conducted an annual audit of attitudes to the prescribing and dispensing of specials in primary care. The latest results regarding pharmacists show continuing evidence of pressure to reduce specials spend, with almost two-thirds saying they are monitoring their 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 concern is reducing. Only 35 per cent of pharmacist respondents strongly agreed that this was the case, compared with 55 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. This is potentially a good sign that pharmacists are following guidelines and, if necessary, questioning the need or formulation with the GP first.€

However, the APSM has concerns that a focus on reducing the costs of specials may be having unintended consequences. €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 doctors are certainly less confident and comfortable about specials than pharmacists. GPs are in the frontline and facing difficult decisions about balancing cost and quality.€

Appropriate supply

The introduction of the specials sections of the Drug Tariff is having the desired effect on reducing the cost of specials, but there is still an important role for pharmacists to play in ensuring that the special is appropriate and that those patients who have a need for a special receive it when required.

Specials manufacturers have more than 20,000 potential preparations on their systems