By Brian Fisher
The are many factors which have shaped the Specials sector in recent years. Emphasis on quality and Good Manufacturing Practice (GMP) has meant additional responsibilities for manufacturers.
This, combined with the reduction in market size and pressure to find cost savings across the NHS, has resulted in consolidation within the sector and a smaller number of highly specialised manufacturers.
The majority of these manufacturers are members of the Association of Pharmaceutical Specials Manufacturers (APSM), an organisation dedicated to maintaining a high quality and sustainable supply of Specials in the UK.
APSM members work closely with pharmacists and play a key support role, not only in supplying a product, but also in providing advice and expert guidance about many aspects of specials.
The only criterion for prescribing Specials is when the patient has a clinical need that can’t be met with a licensed medicine.
Pharmacists typically receive less than five Specials prescriptions a month, but they need to be able to recognise that there is no equivalent licensed preparation available (in which case it can’t be prescribed) and fulfil that prescription without any delay to the patient.
The role of the pharmacist in specials supply is clearly defined in RPS guidelines. APSM member companies provide dedicated pharmacy support services and our experience is that although pharmacists are proactive and knowledgeable in their approach to understanding patient need, they need to work closely with the prescriber and manufacturer.
Pharmacists may not be aware of recent licence changes or product availability and sometimes it’s down to the Specials manufacturer to suggest an imported equivalent, or to provide the pharmacist with details of an existing licensed preparation.
Likewise, a manufacturer should be able to offer advice about formulation, if necessary, recommending a flavouring or presentation that might be more acceptable to patients.
New products are licensed each month, but the number of specials prescriptions remains stable, or is even increasing.
It is clear that specials continue to be essential to a small, but significant cohort of patients and this underlines the vital role of the sector.
Since 2011, when the Drug Tariff Part VIIIB was introduced to control the cost of Specials (and more recently Part VIIS in Scotland) many higher volume Specials have been incorporated into the Tariffs and their average cost has reduced by more than a third.
At the same time, reimbursement value in primary care has reduced by more than 50 per cent. In 2019, £62.2 million was spent on specials in primary care in England. This is less than 0.5 per cent of all prescriptions.
The Tariffs are continuously evolving and rely on APSM engagement and industry data to ensure that the NHS is achieving best value for money.
The processes are rigorous and regularly reviewed and the consensus is that they are robust and effective. The APSM has always supported the Specials Tariffs and has frequent meetings and regular dialogue with the Department of Health and Social Care to implement the Tariff (England and Wales) and provide the data that helps to inform prices.
The DHSC is currently looking at ways to extend the system to ensure transparent pricing across all Specials in England and Wales. The APSM is supporting them to achieve this.
The industry continues to work hard to provide value for money to the NHS, whilst still maintaining the highest levels of patient safety and in spite of the market pressures, we still maintain one of the most well-regulated and high-quality specials industries in the world.
In the UK, the majority of Specials are manufactured and prepared by Specials manufacturers who are licensed, regulated and inspected by the MHRA and must comply with the principles of Good Manufacturing Practice adopted by the European Union.
These licensed manufacturers provide additional assurances of quality. A certificate of analysis is provided for batch manufactured Specials as evidence that critical parameters have been met through physical, chemical or microbiological analysis of the final product.
Where individual or bespoke Specials are prepared, the manufacturer will provide a certificate of conformity to show that the product meets the specification.
In addition, APSM members voluntarily undertake to apply the Yellow Card reporting scheme for their specials (unlicensed medicines). This is the same pharmacovigilance process adopted by manufacturers of licensed pharmaceuticals.
APSM members have invested more than £150 million in quality and infrastructure in the last five years. Many of these pharmaceutical companies have diversified, applying their specialist knowledge to the manufacturer of niche products for hospitals as well as unmet patient clinical needs.
Some of these innovations inevitably benefit their Specials service, such as new flavourings, packaging and labelling and improved stability – all of which can improve the patient experience.
Much of our work is to promote technical, quality and regulatory excellence and we have committees that regularly share and advance best practice. We also collaborate with regulators, such as the Medicines and Healthcare products Regulatory Agency and DHSC to help maintain and raise standards across the sector.
As an industry association, our remit is to ensure a sustainable and high-quality Specials sector that meets the specialist needs of a vulnerable patient group.
Brian Fisher is chair of the Association of Pharmaceutical Specials Manufacturers
This article also appears in the December/January issue of Pharmacy Business.