A special case

Specials are seen as a grey area by many in the pharma industry, but The Specials Lab wants change and greater recognition for this growing sector, reports Susan Birks.

In terms of global sales, the drug formulations sold under the banner of 'specials' hardly register on the charts, but those in this very niche sector will tell you that it is a market growing both in volume and in the range of services it provides.One company aiming to capitalise on this growth is The Specials Laboratory in the UK. It recently invested £1m in a new facility and has also bought the building adjacent to its existing two sites at Prudhoe, Northumberland, increasing its manufacturing base from just 6,000sq ft to 35,000sq ft. The company's turnover has increased by 50% and is expected to reach £6m this financial year with staff numbers likely to rise to 100.

niche sector

Now considered one of the big three UK players in this niche market, The Specials Laboratory was set up in 1999 by managing director Fiona Cruickshank, a registered pharmacist who spent 15 years in pharmaceutical manufacturing, and technical director, Brian Dougherty, also a registered pharmacist with QP status and 24 years' experience in manufacturing. Having worked on both sides of the fence, the two have considerable insight into the sector, plenty of ambition and they are not reticent in pushing for industry change where they feel it is needed.

The specials sector caters for a growing number of patient needs ranging from sterile products, such as infusion bags, ampoules, vials and eye drops, to non-sterile products which are manufactured in small batches to meet the special requirements of a small group of patients. Products may be reformulated to provide liquid doses, for patients such as children and babies who are unable to take solids, or into unusual dosage forms, such as pain relief lollipops, for patients with cancer of the buccal cavity or to provide products free of allergens such as lactose.

The specials category also covers many unlicensed medicines that have been around for years, such as Coal Tar preparations or herbal remedies, that have been used over generations but have never been licensed because of the complex nature of their constituents, which makes it impossible to work out which are the actives.

Many factors are at work that could see the specials market increase: the rising incidence and better diagnosing of allergies; the call for medicines formulated specifically for children; the growing demand for alternative herbal remedies and for more tailored products, particularly now that we have a greater understanding of our genetic make-up which in turn is driving research into genomics.

'The specials market is one that I believe will grow further as patient needs become more demanding,' says Cruickshank. 'There is a lot more development of drugs for specific gene types for example. Herbals coming under regulation could also mean more business in converting them to licensed drugs.'

It is a market sector with its own regulations. To produce specials in the UK you need a Manufacturer's (Specials) License from the Medicines and Healthcare products Regulatory Agency (MHRA), in the same way as a normal Manufacturing License. However, a major stipulation is that all sales must be unsolicited.

daily reformulation

The Specials Laboratory currently produces a wide range of non-sterile products and has access to unique dosage delivery systems. New products are researched and developed in conjunction with pharmacists on a daily basis, and the company has literally thousands of formulations on file. It can, for example, make medicines that are lactose-, colour- or preservative-free, or it can make medicines taste more palatable for children.

Dougherty says the sector is seen as a 'grey area' by many mainstream pharmaceutical companies. And, by its very nature, the business of prescribing specials is a potentially high-risk option. Unlike licensed medicines that have full pharmaco-kinetic, toxicity and stability data profiles supported by rigorous trial data, a special may have some or none of these. But for the many health professionals that call on the company, it is often the only option for providing a treatment.

The lack of medicines available for the treatment of children results in healthcare professionals cutting up suppositories, dissolving or crushing tablets to take a fraction of the original form, drawing up small volumes or diluting injections, all of which often involve complicated calculations and an associated increased risk of medication errors. The use of specials is often preferable to making extemporaneous preparations on the pharmacy bench or importing medicines.

child medicines

On the other hand, it is easy to see why the major pharmaceutical companies don't want to produce children's medicine. Making a new formula for children would require a huge investment; then there are issues of recruiting enough numbers to make clinical trials statistically significant; and questions of ethics would a six year-old understand the risks involved?

Governments are putting pressure on the pharmaceutical industry to produce licensed medicines for children, but it is a very big ask. 'It takes too long for a pharma company to get a formulation registered, it takes six months to even change a leaflet, it is just not going to happen,' says Dougherty. Should it happen, The Specials Laboratory has a wealth of experience in child dosages that would prove useful. In the meantime, the options are for nurses to crush tablets between spoons or pharmacists to go to specials manufacturers, says Dougherty.

Some manufacturers in the sector are working together to remove the 'grey area' image and to win greater recognition for the professional service they provide. Back in 2004, the Association of Commercial Specials Manufacturers (ACSM) was set up in the UK and within it some members are pushing for a badge of quality for those meeting set standards and criteria. Dougherty maintains that standards vary from company to company and that some members want to look beyond the MHRA licence.

'The specials industry has grown up through dispensaries rather than pharmaceutical producers,' explains Dougherty, 'so when it comes to regulation the MHRA doesn't quite know how to handle it.'

Ensuring that work standards are high is important in a sector where insurance is hard to come by. Specials manufacturers have liability for ensuring a formulation is made in accordance with the formula of the prescriber. The situation becomes a little blurred, however, if the manufacturer gives advice on the formulation shelf life (which is often the case). A prescribing physician who legally owns the formulation of a special carries the main liability for the drug. Next in line is the dispensing pharmacist, who shares responsibility with the prescribing physician.

But in practice, to get liability insurance as a specials manufacturer is very difficult. Cruikshank says: 'None of the insurance companies you would normally associate with pharmaceuticals are willing to cover this type of manufacture - a fact that is reflected in the premiums.'

call for change

To cut out unecessary risk the company would like to see changes come from within mainstream pharmaceutical companies, especially in terms of co-operation in getting hold of raw materials. 'It would be easier and safer to make specials from the patented materials,' Cruikshank says, 'yet you often can't get hold of them.'

They also feel a greater awareness by the healthcare sector of some of the liability issues would be desirable. For example, specials are frequently ordered verbally by community pharmacies, and to a lesser extent hospitals. To have legislation that specifies that orders must be written down is also on the company's wish list.

Despite the difficulties, the variety and speed of specials manuacture make this a very exciting industry to be in, says Cruikshank. With rising patient power and increasing efforts to cater for the welfare rights of individuals, and not just the masses, the sector looks set to grow and The Specials Laboratory aims to be among those improving the offering and setting the standards.