It's essential for specials manufacturers to procure, manufacture, and supply in a cost-effective, ethical, and quality-driven manner

In November, the Association of Pharmaceutical Specials Manufacturers blogged about the 24-hour turnaround for bespoke specials prescriptions. The APSM points out that all its members "sign up to a commitment of timely delivery to patients and for all members that now means next day delivery as standard." Between 95 and 99 percent of orders are despatched the same day for delivery the following day.

Sharon Griffiths, APSM Chair, comments: "What may have started as an effort to offer a competitive advantage, we're happy to say is now the norm amongst APSM members, which is good news for patients. Patients who are prescribed specials often have a specific and urgent clinical need - they should not have to wait for this medicine just because it isn't a licensed or off-the-shelf preparation.

It's no mean feat: with more than 20,000 potential preparations on the books, manufacturers may have to deal with 500 different orders a day. Once ordered, a product is dispensed, goes through quality assurance, and is dispatched within 24 hours.

Ms. Griffiths is also managing director at The Specials Laboratory. She says the company believes most community pharmacists are aware of the level of service and speed of delivery market-leading manufacturers of specials consistently offer. "However, we work closely with our pharmacy customers to ensure the wider team in the dispensary understands how we work and what to expect. For instance, recently qualified pharmacists and pharmacy technicians may be responsible for ordering specials so it's essential we educate and work in collaboration with such customers to ensure they get the absolute best from our service."

The Specials Laboratory also stakes a claim to being the first to market with the 24-hour delivery concept and it took the competition a while to catch up. As a result, independent community pharmacy teams may have experienced inconsistent levels of service, suggests Ms. Griffiths. "With this in mind, we believe the recent APSM piece on the importance of 24-hour turnaround for bespoke specials prescriptions was a useful and timely reminder for everyone involved in ordering unlicensed medicines. Indeed, in some cases delivery can even be the same day where an urgent case is presented or we are able to deliver locally within the same day."

Another challenge that pharmacists face is licensed product shortages. The APSM reassures pharmacists that specials manufacturers are continuing to meet the patient need on a daily basis, 365 days a year. Continuity of supply is being maintained in spite of the fact that specials are unusual. "In addition to quality processes and next-day delivery service, our customer advice lines are an extremely important feature of our service. These are able to provide detailed technical support - often from a pharmacist member of the specials manufacturer team - about product formulation and the availability of licensed alternatives."

The economics of specials

The main purpose of specials is to meet a patient clinical need while ensuring patient safety. The MHRA requires commercial manufacturers to carry sufficient capacity to meet demands on a daily basis. Taking all this into account means costs associated with this intensity of commercial manufacture are reflected in the price.

National figures suggest that a typical pharmacy will deal with one special item a week. "Due to this infrequency, the awareness around service delivery from each provider may not be front of mind when ordering, however, it can quickly become a burden when the item does not arrive promptly," says Catherine Brown, head of the commercial at Quantum Pharmaceutical. "We work hard to make the process of sourcing high-quality, bespoke, or hard-to-find products (no matter how infrequent) simple and painless."

Quantum's dedication is reflected in its 8 am-10 pm opening times, "market-leading" cut-off times, and stringent quality standards, says Ms. Brown. This ensures that quality remains paramount in an environment where turnaround times are tight, she says. "We offer all this so that when a pharmacy is faced with a script they can't fulfill via their wholesaler's core range, be it a special or any other hard-to-source product, they can count on us to get the job done."

Ms. Brown says Quantum's efficient processes underpin a fast turnaround. "Despite never knowing which of the thousands of items on our system will be requested at a given time, we are able to order, manufacture and deliver orders following vigorous quality control checks in as little as 15 hours. This is the result of having steadily refined and improved our quality processes over a decade, enabling us to work to late cut-off times and guarantee next morning delivery."

From start to finish

The Specials Laboratory similarly deals with thousands of orders each week, says Ms. Griffiths. "From the start to the end of an order, our team is always available to help pharmacies, especially when it comes to technical support on questions relating to product formulations. Whatever the size of the pharmacy, our commitment is to provide a wide range of bespoke and batch-manufactured products within our 24-hour promise."

Ms. Griffiths notes the importance of manufacturers adding value to their service: "In recent years, the specials drug tariff has had a significant impact on the market and will continue to do so as it evolves in the future. With increased scrutiny on costs around specials and how they are reimbursed, our job has been to add value by helping protect customers as much as possible. So for us, this means assistance and education in terms of ensuring pharmacies gain the correct reimbursement and making the administration around reimbursement and CCG reporting as simple as possible."

Specials manufacturers will continue to be under pressure with respect to innovation as there will be a need to adapt to the evolving needs of community pharmacy, says Ms. Griffiths. "For us, this will mean a constant focus on new products and services to ensure we are meeting the needs of pharmacists, doctors, and, of course, patients. At present, this involves us investing in new facilities, product development, staff training, and recruiting the best possible staff to deliver this service. It's essential for specials manufacturers to procure, manufacture and supply in a cost-effective, ethical, and quality-driven manner," she says.

The need to know

While pharmacy teams are comfortable handling special requests, Ms. Griffiths notes (with her APSM hat on): "GPs only initiate 10 percent of specials prescriptions in primary care, so much of the knowledge exists in secondary care. We recognize there is a need to further educate and support prescribers about specials and, in particular, the role that the manufacturer and the pharmacist play in terms of risks and patient safety."

Ms. Brown adds: "There has been an increase in the number of GPs willing to prescribe tablets with instructions to split or crush (despite documented risks). It is clear that GPs in the frontline face difficult decisions about balancing cost and quality that could impact patient health and adherence."

An APSM survey last year found that pharmacists have a positive view of the role of specials, with 80 percent agreeing that they are essential to meet the special clinical needs of some patients. However, a parallel survey of GPs showed they are less confident and comfortable about specials than pharmacists. Guidance to prescribers about specials was first issued by the National Prescribing Centre and NICE in 2009, but as the NPC has since been subsumed into NICE, the Royal Pharmaceutical Society was asked in the autumn of 2015 to review the guidance, with the consultation on the draft updated version closing shortly before Christmas.

The APSM has "been involved from day one and our comments have been incorporated along the way," says Ms. Griffiths. "We welcomed the addition of specific scenarios around vitamins and food supplements and medical devices. We were keen that it was balanced and truly reflected patient risk and professional responsibilities. Overall we welcome the guidelines and the input from the multidisciplinary experts involved."

The updated guidance remains based on five principles that can be used to guide prescribing decisions. However, as well as reflecting evolving regulatory, clinical practice, and NHS environments, a significant change has been the introduction of "case studies that illustrate the challenges that we have to meet to ensure that patients receive optimal treatment."

Note that the draft guidance points out: "Communication between prescribers and pharmacy colleagues also receives more emphasis, encouraging pharmacists and prescribers to work together to ensure that patients are prescribed specials appropriately and supported adhere to their treatment."

Ms. Griffiths comments: "Given the nature of specials, pharmacists and doctors need to be able to trust their specials supplier. We take this role very seriously and are committed to protecting patients as well as our independent pharmacy customers. With this in mind, it's essential that we, as a specials manufacturer, operate in an ethical manner at all times and take no chances when it comes to product quality."

Guidance update

Another document to look out for is the updated RPS guidance for pharmacists on the procurement and supply of specials, again based on the same five principles as guidance for prescribers, published in December 2015.

"Increasingly, community and hospital pharmacists now buy specials rather than preparing medicines extemporaneously within the pharmacy," says Ash Soni, RPS president, in his introduction to the revised guidelines. "There has also been steady growth in the use of homecare services to dispense and supply ready-to-administer medicines, many of which are specials, to patients at home. This update therefore also reflects an increased focus on governance to ensure that specials are always procured and supplied safely and appropriately.

"Decisions about the prescribing, supply and procurement of specials rely heavily on professional judgment based on understanding individual patient needs. To reflect that we have redesigned the guidance to provide five principles that support professional practice, along with case studies that illustrate the challenges we have to meet to ensure that patients receive optimal treatment."

The figures

The NHS Business Services Authority updates data every month showing national trends in special prescribing and spending in the previous 25 months. The number of special items dispensed in England each month ranges typically between 50,000 and 60,000. Around 30,000 of these are classed as Special Order items and the remainder are Drug Tariff Special Order.

The total monthly average dropped by about 10,000 in May, and 27 special items were removed from the June 2015 Drug Tariff Part VIIIB. Prior to this, total orders had been over 70,000 items a month. Despite the volume change, the overall net ingredient cost (NIC) has only decreased slightly and still fluctuates around the £7 million per month mark.

Last summer, special manufacturers started supplying pharmacists with pre-printed labels to make it easier to endorse prescriptions with all the correct information. However, in November, the National Pharmacy Association advised members that the NHSBSA had asked pharmacy contractors not to use these labels for endorsing purposes.

Quantum Pharmaceutical, which had been issuing the labels, says: "Our understanding of the advice that has been issued to NPA members is that pharmacies should not stick the labels over the product information, as when the sticker is peeled off to reveal the product details it can leave a sticky residue which causes issues. We understand that very few special scripts are scanned by NHSBSA, therefore reducing the impact that this will have."

"We believe that if the sticker is applied correctly to the left-hand column of the script, it is slim enough not to cover the product information. Feedback from our customers about our stickers has been very positive as endorsing correctly can be a time-consuming task. If a pharmacy chooses not to use the stickers we also provide all the information on the paperwork so that the endorsement can be handwritten on the script."

Cost controversy

In December, the British Association of Dermatologists issued a statement criticizing the way special medicines are reimbursed in community pharmacies. It called on the government "to revisit a policy that allows certain medicines prescribed by GPs to cost up to 17 times more than the same drugs prescribed in hospitals, needlessly wasting the NHS millions of pounds each year."

"This huge cost to the NHS is resulting in patients being denied access to treatment, as GPs and the clinical commissioning groups who oversee them are unable to justify such high costs. And the problem is not limited to dermatological specials, with medicines for other disease areas also being prescribed at greatly inflated prices."

The Daily Mail picked up on the BAD statement, describing specials as a "sickening rip-off" which sees the NHS "paying many times over the odds for products." However, the APSM has refuted market statistics used by the newspaper and corrected "a significant number of inaccuracies about the specials market and APSM activities."

Points made by the Daily Mail, and the APSM response, include:
Daily Mail quote: "The NHS is charged more than £300 a pot for products that could cost just £12."

APSM Response: "If an NHS manufacturing unit charges £12 then this reflects the price they charge, not necessarily the cost of the product - this would not be sustainable in a normal commercial environment. The full costs of manufacture may have been allocated elsewhere within the NHS budget (staffing, capital investment, etc). Also, for some medicines they may have been able to manufacture a batch in advance or at a later date and can achieve cost efficiencies this way, ie, they are not always operating a same-day service."

"In England and Scotland a number of hospital pharmacy units are supplying specials alongside commercial manufacturers and together we are providing essential services to patients. However, most in-house hospital units are not geared up to large volume production across such a wide range of possible products so could not meet the demand for specials - particularly in England. Therefore the majority of capacity and volume in the market comes from the commercial pharmaceutical manufacturing sector and so the cost structure of the market has to be based on a commercial rather than an NHS-funded model."

Daily Mail quote: "Because of a commitment to open the NHS to market forces and competition, the government has now prevented NHS pharmacies that manufacture these creams for hospital use from also offering them through community pharmacies."

APSM Response: "Our understanding is that any hospital pharmacy with an MHRA specials license can - and does - supply to community pharmacy."

Daily Mail quote: "The practice has been exposed by the BAD, which says up to £400m a year of taxpayers' money is being wasted on paying too much for these treatments. Even 2 percent salicylic acid cream which can be effective for these conditions costs the NHS £75m per year."

APSM response: "Dermatology specials are a small proportion of specials spend in primary care - less than £1m per year. The total spend on specials in 2014 was £89.5m in primary care. A very small percentage of this is for dermatology specials through community pharmacy."