The year ahead for the Specials industry

The Specials market has become a key ally of community pharmacies in delivering medicine to patients. Sarwar Alam speaks to key members of the industry to find out how the Specials market is developing and how it has been effected by the recession.

Specials are always manufactured to meet the individual clinical need of a patient and in the same way that every individual is unique, the same could be said of Specials. For that reason, Development is a continuous process as we and the clinicians who prescribe Specials are always working to prepare an exact formulation that can better meet the patient need.

Alan Krol, managing director of Moorfields
Pharmaceuticals

For example, we have recently added new anti-fungals and anaesthetic eye drops to our portfolio. From a manufacturing perspective we have focused on new and improved presentations such as single-unit dose technology, which will further enable us to provide preservative-free formulations for the many patients. We have also developed pre-filled syringes for theatre use to improve clinical practice, speed and compliance. This is definitely an area where we will see more innovation
in the future.

The recession has not impacted our business, which may also be seen with other suppliers to the industry. Our market model is based on responding to essential patient need, so the purchase of a Special isn’t an optional spend and our business has continued as normal. In fact, if anything, our Specials business has grown in the last two years as the patient population has
risen.

The Specials industry will see a continued increase in demand as more prescribing clinicians want to ensure the appropriate patient treatment. Alongside this growth we all anticipate an inevitable tightening of regulation following the MHRA review of unlicensed medicines, for example, the possible provision of patient information leaflets, PILS.

Customer service is a cornerstone of our business at Moorfields Pharmaceuticals and we have invested in all areas of our service to pharmacists.

We have a dedicated specialist help desk, in particular for ophthalmic queries where we can provide advice based on our long history associated with pharmacy at Moorfields Eye Hospital. In October we launched an online resource for ophthalmic professionals, including pharmacists, giving very specialist information about diagnosis and treatment of dry eye conditions; www.dryeyesmedical.com.

Recently, we have supplemented this with a team of customer representatives who go out and visit pharmacists and clinicians to help educate about our Specials services. We have also taken measures to ensure speed and continuity of supply.

Robert Sludden,
quality and technical services manager at the Specials Laboratory

As always, there is a need to develop and deliver specials medicines as quickly as possible to ensure patient needs are met.
With this in mind, new developments at the Specials Laboratory have related to expanding our technical team to enable a rapid response to ongoing requests for new specials medicines, when the licensed product is not suitable for an individual patient.

In general the pharmaceuticalindustry tends to be less influenced by general market conditions than other industries, so the pharmaceutical industry tends to remain relatively stable during times of recession.

The Specials Laboratory is in the process of building a new on site Quality Control (QC) laboratory with the aim of bringing QC testing of raw materials and products in house during 2010. The Specials Laboratory aims to increase its product development activities and also generate more data on existing products through the new QC laboratory.

Moving into 2010 there is likely to be a continued need for specials medicines for individual patients with special clinical needs
who can’t for example, take the standard tablet version or standard strength available as a licensed product.

While the majority of specials medicines are manufactured at very small volumes and very infrequently, some specials medicines do become regular supply items and move towards a scale where, if combined with a suitable shelf life, larger scale batch manufacture becomes a reality. This in turn can then progress towards the possibility of there being sufficient demand for the medicine to make development of the product through product licensing a real option for several of the medicines currently being supplied as unlicensed specials.

We are constantly looking at ways in which we can improve the quality and efficiency of our service to ensure each product is delivered to the pharmacist and patient as rapidly as possible. We pride ourselves on providing a customer service and customer relations team that is passionate about helping pharmacists and making their job easier.

Additionally our product development team works closely with customers and is always looking at new formulations, increasing product shelf life and sourcing new products to help meet individual patient needs more effectively.

We are currently delivering well over 90 per cent of orders to our customers within 24 hours. Moving forward the plan is very much to continue what we’re doing and keep improving – invest in our people, ensure product quality and drive lead-time.

Brian Dougherty,
chairman of the Association of Commercial Specials Manufacturers (ACSM)

Recession hasn’t really affected the industry and I think that the Specials market will be one of the last things to be hit during the recession. There is still a steady growth in the market. There hasn’t been any sudden dip or tailing off since the recession hit. Our sales haven’t been effected and I don’t think they will be effected in the near future.

The Specials market is so essential because its for people with real needs its not like we’re doing stuff like cough medicine. People will always pay for medicines for children, cancer patients and that’s the majority of what we do.

We’re right in there with essential services. We are one of the few players in town who can deliver medicine within 24/48 hours. We do fast turnaround and we deal directly with patients. Certain pharmaceutical companies will be hit by recession
because they might lose on funding for projects, their contractors might not buy as much, but with us everything is used straight away by the patients.

As for the future, I think you’ll see an increase in quality in the Specials market as the MHRA get more and more involved in the work we are doing.

As for us, we always looking at new products and better ways to deliver drugs. The association itself delivers 85 per cent of commercial specials. We have invested about £17 million in new products. We always looking for better ways to deliver drugs to patients and better ways to make sure that patients always get the same thing everytime its made, which is quite difficult when you are doing one or two and not full batches of some medicine.

We’re always involved in quality assessment schemes to improve our business. Human error reduction programme is something we are a part of. We’re always improving on our facilities and recently invested £30m on new facilities. That is a total of £50 million a year on facilities and new products and development of new formulations, which is quite a lot for an industry which doesn’t really own any of those formulations. And if you compare that to to what the NHS invested
over three years – which was £42 million - then we are miles ahead.

Vyan Fenwick,
senior production pharmacist at BCM Specials

One of the major developments within the specials industry was the MHRA Interim Report, published in May 2009, outlining the ideas for reform as part of the Review of Unlicensed Medicines. The final reform will determine the direction the industry is heading in the coming year.

It is widely accepted that there is a need for standardisation within the market and we fully support the objectives of reform outlined in this Interim Report. However, as an industry, we must ensure that the major changes or developments proposed
do not compromise the ability to respond to a patient’s urgent clinical need and reduce clinical freedom, delay treatment
or create risks to patient safety.

There is likely to be increased regulation of formulations within the industry as more pharmacoepial monographs for Specials are developed.

At BCM Specials we adopt the attitude that standards should be consistently high, regardless of whether a medicine is licensed or not. BCM Specials makes no differentiation between the rigorous standards of a licensed medicine, which may be made in the hundreds of thousands, and a one off “hand made” special. In addition, BCM Specials is situated in a facility in which licensed medicines are made. This enables us draw on the expertise and learnings from this facility, and have the same exacting standards.

While the specials industry has not been directly affected by the recession, our customers are increasingly understanding
the cost of producing a special compared to licensed products, as well as recognising the safety, liability and patient benefits
associated with ordering a special from a commercial Specials manufacturer, rather than manufacturing under Exemption 10.

BCM Specials has a seventyyear history as a supplier of high quality Specials that people can trust. Our service has benefits for
our customer, as well as their patient, because it frees up time for the pharmacy team, enabling them to concentrate on providing patient services such as advising/counselling, smoking cessation clinics and undertaking Medicines Use Reviews. The breadth of our offer, which includes sterile and non-sterile products, means that we provide a single service that is simple, reliable and convenient to use.

As part of our ongoing commitment to professional good practice, we have recently relaunched our website www.bcmspecials.
co.uk, including a generic patient information leaflet, available for our customers to download. This leaflet is a first for BCM Specials and demonstrates a proactive stance and a commitment to promoting greater patient understanding of the nature of a special.

Jan Flynn,
marketing manager at Rosemont Pharmaceuticals

Rosemont’s expertise lies in oral liquid medicines, which are of particular benefit to patients who have difficulty swallowing solid medications, often older people. With an increasingly ageing population, the need for liquid medicines is continuing to grow.

Two key issues for the Specials industry are the price of Specials and the need for education about the vital role of Special medicines.

Cost is a key issue for the Specials industry and the focus of PCTs and commissioners is increasingly on medicines
expenditure. Transparency of pricing is the way forward and all Specials manufacturers should provide regularly updated
price lists, which are available on request to healthcare professionals. This will facilitate realistic cost comparisons so that informed purchasing / supply decisions can be made. This move is essential to protect the future integrity of the
Specials industry.

There needs to be more education about the vital role that Specials play in managing the conditions of some of the most vulnerable patient groups like older people and children. Specials are an essential aspect of healthcare for many patients who have medical needs which are not met by licensed medicines. This message needs to be widely communicated. Patient concerns about being prescribed an unlicensed medicine need to be addressed and appropriate reassurance given.

Rosemont is continually expanding the range of Specials offered as liquids and actively invite pharmacists to tell us which products they require in this format. We introduced 16 new liquid Specials in 2009 and will continue to introduce more in 2010.
Rosemont’s Specials are manufactured to the same exacting Good Manufacturing Practice standards as our licensed medicines. We do not crush, dissolve or suspend tablets to produce Specials and all products have full batch records and stability testing as well as fully supported shelf lives, most of which are more than nine months.

In addition to our liquid medicines, we are also committed to supporting pharmacists through educational resources. We have just introduced a new paediatric medicines leaflet to complement the recently introduced paediatric guidelines on unlicensed medicines. A new patient leaflet about swallowing difficulties and medicines management is now available. The Rosemont
website is being updated to provide easily accessible information and training for pharmacists including Case Interact - a new pharmacist interactive training programme where participants respond to sets of symptoms and play out real life case scenarios. All results are recorded and a certificate can be printed as evidence for the CPD folder.

Steve Harvey,
sales and marketing director at Martindale Pharma®

As the UK’s leading Specials supplier, Martindale Pharma® fully understand the importance of our Specials service to our customers. We continue to focus on delivering a premium service and are committed to supporting pharmacies, especially in the current economic climate.

Pharmacists and their staff can enhance the service to their community by spending time with customers to offer advice, conduct MURs and deliver other key services. Time is a valuable resource. That is why we make ordering as simple as possible, whether by phone fax or e-mail. In addition we can set up standing orders for repeat prescriptions so that our customers can be confident that their orders will be delivered when they are needed, without having to spend time reordering.

The supply of Specials is extremely competitive, as would be expected in a growth market place. We understand the many
factors driving this growth. For example an increasing elderly population, an increased need for specialist treatments for children and adherence to guidelines that seek to reduce extemporisation.

Martindale Pharma ® leads the market in responding to and driving the expectations of our customers.

We use PolarSpeed as our logistics partner to ensure that our product is delivered in a timely fashion. The majority
of our products are now delivered to our customers within 24 hours of ordering. One of the key reasons we use PolarSpeed, in addition to their reliability, is their expertise in transporting all our products at the correct temperature, whether ambient
or chilled. This means that the care and expertise we devote to manufacturing our Specials continues right to the point of delivery.

Inevitably, growth has attracted external scrutiny of the Specials market, which Martindale Pharma® welcomes. We are confident that the service we deliver is commercially competitive, ethical and constantly evolving in line with
pharmacists’ and Governmental demands.

Underlying all of the decisions we make and actions we have taken to improve our service the key driver is always to make our customers’ lives better. Moreover we are dedicated to supplying a Specials service that can help improve the life of our ultimate customer, the patient – whatever their need might be.