To help address the challenges faced by pharmacists with regards to specials, the Royal Pharmaceutical Society published professional guidance in 2015 “to ensure the safe and appropriate procurement and supply of specials”. RPS president Ash Soni says that from the Society’s perspective, pharmacists “where possible” should try to avoid specials and use licensed products.
The RPS continues to recognise that the use of specials should be exactly that – special – and not routinely prescribed, he says. “There are occasions where it is not possible to do that but, at any time, the prescriber should be looking at the evidence available to justify the use of that product.” The RPS has also produced information on pharmaceutical issues when crushing, opening or splitting oral dosage forms but, increasingly, community pharmacists now buy specials rather than prepare medicines extemporaneously in the pharmacy.
“It is a practice pharmacists don’t really get involved with any more. Gone are the days of crushing tablets and making extemporaneous medications because of the readily available preparations in the market,” says Lila Thakerar, pharmacist at Shaftesbury Pharmacy, Harrow. Neither do pharmacists have the facilities to do it any more, she adds.
A special is an unlicensed medicine prescribed to meet the individual clinical need of a patient when a suitable licensed medicine is not available. Specials account for approximately 1 per cent of all prescriptions in the UK, with more than 75,000 different formulations prescribed each year.
There are many different reasons why a licensed medicine might not be available, the Association of Pharmaceutical Specials Manufacturers says. “Often the formulation that would best meet the patient’s needs has not been commercially manufactured by any drug company in a licensed version. Sometimes the licensed product that may suit the patient’s needs has been discontinued temporarily. In these circumstances a special will be prescribed.”
Very few specials formulations are exactly the same or required at the same time so, although some can be made up in small batches, a large number are made up individually to meet the particular needs of the patient.
One of the biggest challenges for pharmacists continues to be the cost and the time it takes to be reimbursed for dispensing specials, which has an inevitable impact on cash flow. Mike Hewitson, pharmacy owner at Beaminster Pharmacy in Dorset finds the whole area of specials a “thankless task”.
“Some specials can be enormously expensive,” he says, citing the case of one pharmacy he knows that has to pay £19,000 every six months and then wait to be reimbursed by the NHS.
Earlier this year the cost of specials was highlighted in a series of articles in The Times, which claimed the NHS was spending as much as £30m a year on unlicensed medicines that were available more cheaply elsewhere.
Managing the price of specials is an ongoing issue for the Government. To help control the cost, the Department of Health and Social Care (DHSC) developed Drug Tariff Part V111b in 2011. PSNC points out that when the ‘specials tariff’ was launched it had 58 lines. As of November this year, that number had grown to 544. PSNC says it “supports in principle an extension of the tariff ”.
The Association of Pharmaceutical Specials Manufacturers (APSM), which represents the interests of its members who supply specials and unlicensed medicines in the UK, says that since the tariff was introduced, almost all of the higher volume specials have been incorporated into it and their average cost has reduced by 35 per cent. At the same time, it says, the number of specials prescribed in primary care has fallen steadily, so that the spend on specials overall has decreased by some 45 per cent.
The APSM says it has “always supported” the specials tariff and has worked closely with the DHSC to implement it and provide data that can help to inform the prices, although the exact mechanism of pricing is determined by the DHSC.
Some specials are not included in the specials tariff, usually because there is such a small number prepared each month that it is not possible to set a price. However, the DHSC is keen to extend the system for ensuring transparent pricing across all specials and “we are supporting them to achieve this,” the APSM says.
According to the association, specials represented “a fraction” of the £20.2bn annual medicines spend (£9bn in primary care) in England in 2017/18. In 2017, £77.5m was reimbursed through community pharmacy. The average cost of a special in primary care in 2017 was £118, according to the APSM.
Specials were in the spotlight this year when, on July 1, the Department of Health and Social Care (DHSC) introduced greater powers to request information about the prices and costs associated with products purchased for the NHS.
The Health Service Products (Provision and Disclosure of Information) Regulations 2018 were introduced largely to help the DHSC control the price of medicines and its primary aim is to require manufacturers and wholesalers to provide information on costs. “Any failure to provide the information requested could lead to a financial penalty,” the PSNC says.
“It is expected that the regulations will help improve the information available to DHSC when reviewing shortages and setting price concessions,” PSNC adds. The regulations apply to community pharmacy contractors in two main ways:
Keep, record and provide information on price and volume
Contractors are required to record and keep relevant information on the price and volume of medicines, appliances and borderline substances dispensed for the NHS and to provide this to the DHSC in response to a written request.
Contractors will be used to keeping records for products they dispense and many will have previously submitted this type of information as part of the regular margin surveys. The DHSC has indicated that its intention is to continue with this system. Smaller contractors will only be required to provide invoices and existing documents.
Provide information on costs
Contractors are required to provide any relevant information on the costs of distributing or supplying a medicine or appliance associated with NHS dispensing, in response to an information notice from the DHSC.
PSNC has published PSNC Briefing 034/18: Information and Disclosure Regulations, which explains these requirements, provides clarification on the information that may be requested and outlines the responsibilities for different types of contractor.
As for the number of specials requested, Ash Soni says that from a community pharmacy perspective, they “appear to have declined”. Prescribers using evidence-based medicine decisions, financial pressures to reduce the use of specials from clinical commissioning groups because of high costs, and the general pressure on NHS funding have all had a knock-on effect on this category’s decline, Soni suggests.
Lila Thakerar says she has witnessed “a drastic reduction in specials” during the last five years. “The number of specials has gone from around 50 a month to one a month.” One of the reasons for the decline, she says, is pharmacists’ responsibility “to go back to the prescriber if prices are exorbitant”.
While the number of prescribed specials may have gone down, this could actually have led to a rise in their cost. The APSM says it is aware that “from time to time a special is sold at an inflated cost”.
This may be because it has passed through a wholesaler supply chain rather than being supplied directly from a manufacturer. Again, the APSM says it supports the DHSC in initiatives to control the cost of all specials without limiting the supply and availability of these essential medicines.
Ash Soni believes that the decrease in the number of specials being prescribed means there has been an inverse effect on pricing. “What we’re finding is that getting hold of some of these specials is becoming more expensive,” he says. However, now that about 95 per cent of all specials are covered by drug tariff pricing, “this helps from a pharmacy perspective because we have an understanding of the costs we should be seeing”.
Variation in price needs to be addressed, the NPA says. “Specials represent a small proportion of all the NHS medicines dispensed but the variability of specials pricing certainly requires attention.”
In July, the Government introduced the Health Service Products (Provision and Disclosure of Information) Regulations 2018, which was largely to help the DHSC control the price of medicines such as specials and generics. This requires manufacturers and wholesalers to provide information on costs (see above).
Despite these latest regulations, community pharmacists continue to face difficulties. For Lila Thakerar “a duty of care to patients” is the most important priority – but specials still present challenges.
“I have to provide the medication to the patient as promptly as I can. If a supplier isn’t able to give me the product within a day or so, then that is no good to me. I will go for a supplier who is able to provide the medication to me as soon as possible,” she says. But community pharmacists also have to find the most costeffective supplier, with prices for a pharmacy special sometimes ranging from £50 up to £250, £300 or even more.
Sourcing cost-effective and therapeutically effective medicines for patients can involve numerous phone calls. “You are looking at staff dedicating up to an hour to get one unlicensed product,” says Thakerar. The cost of a special reflects the pharmaceutical-standard quality and bespoke manufacturing processes, plus the cost of the pharmaceutical ingredients, but she says her experience has been that these costs can often be “exorbitant” and that prices can fluctuate, sometimes by thousands of pounds.
In these cases “it is my responsibility to inform the prescriber who may not be aware of just how much these specials are costing. They can then decide whether they want to go ahead with prescribing a special or not.”
Prescribers and patients may appreciate the time and effort pharmacists put in to sourcing specials but some pharmacists feel that from a monetary point of view it is simply no longer worth it.
“A long time ago there was a margin to be made out of specials but now, with the way the rules have evolved over the years, this is no longer the case. I don’t know why we deal with them these days; they are just hassle,” says Mike Hewitson.
While there are perfectly valid clinical reasons for prescribing specials, he questions why pharmacists are taking the reputational hit with them. “No matter what you do you always get criticised by someone, whether it is the Government moaning about the cost of specials or patients complaining about service levels. I’m sure the NHS thinks pharmacy is ripping the service off. This reputational damage outweighs any positive impact,” he says.
“The system isn’t working and there isn’t any driver for us to be involved with specials any more. I don’t want the huge financial burden of financing them and I don’t want them to disrupt my work.” It seems many pharmacists feel the same.