Update: Special guidance

Medicines without a product licence must be treated differently at all stages of the supply chain. Recent RPS guidance puts the prescribing of specials back under the microscope.


Unlicensed medicines have an important niche in healthcare and have different manufacturing, prescribing and dispensing requirements to those products with a licence. Guidance and regulations from professional and regulatory bodies reflect these requirements.

The latest guidance for prescribers of specials was published by the Royal Pharmaceutical Society in April. This updated the resource first published in 2011 by the National Prescribing Centre and is intended to be used alongside the RPS ‘Professional guidance for pharmacists on the procurement and supply of specials’, which was published last year.

The updated guidance continues to be based around five principles that should be used to guide prescribing decisions (see panel) but now contains case studies that illustrate the challenges to be met in ensuring that patients receive optimal treatment.

The importance of ensuring that patients and prescribers are aware of the complexities and risks associated with transferring the prescribing and supply of specials across settings is given more emphasis in this latest guidance. Communication between prescribers and pharmacy colleagues is also emphasised.

Additional precautions for specials prescribing are highlighted in the case studies, and include: 

  • Prescribers must be satisfied that there is sufficient evidence or experience of using the unlicensed medicine to demonstrate its safety and efficacy
  • Specials have not been assessed by the regulatory authorities for safety, quality and efficacy in the same way as licensed medicines and they have no summary of product characteristics (SPC) outlining the dose, contraindications, storage conditions and side-effect profile
  • Patient information leaflets are not routinely available for specials
  • Specials can be obtained from a range of sources and are not all manufactured in the same way, so their quality, bioavailability and consistency can vary even where the same product is prescribed
  • It can be difficult to identify a special at the point of prescribing
  • When responsibility transfers from one prescriber to another, ensuring a safe and timely supply can present additional challenges for the prescriber and the supplying pharmacist. In cases where patient care is transferred between different settings and prescribing responsibility changes, potential risks increase, so there must be a planned transfer of information that ensures a safe, consistent and timely supply is maintained.


Key facts

  • Specials have different manufacturing, prescribing and dispensing requirements
  • New RPS guidance on specials supply recommends that the agreed formulation should be confirmed to the manufacturer in writing
  • The overall cost of specials to the NHS is now only 1 per cent of the annual spend on prescriptions


Although the new guidance is more comprehensive than the previous version, it should not be used in isolation, says the Association of Pharmaceutical Specials Manufacturers. While the advice references the MHRA’s Guidance Note 14 (a major regulatory standard for specials), it omits some of the detail.

For example, GN14’s hierarchy of risk sets out a preferential order for product choice, moving from UK licensed, to UK licensed off-label, to non-UK licensed, then UK-manufactured special (or other, but not stating what this is). The APSM would like to see this risk hierarchy re-introduced to the guidelines.

GN14 does not make provision or recommendations around dosage manipulation, or crushing tablets. The risks of crushing tablets are widely accepted within the sector and by regulators, although it is still sometimes recommended. The APSM does not believe that dosage manipulation should be encouraged.

Shared roles and responsibilities

All APSM member companies have customer services helpline teams and pharmaceutically trained specialists. Their role is to provide advice and support to pharmacists on all aspects of supply and manufacture. For example, a specials supplier may recommend an alternative formulation, or advise if a licensed product is available.

Although most pharmacists are confident in the support offered by manufacturers, many prescribing doctors are unaware of manufacturers’ role in helping to ensure the appropriate formulation is provided, says APSM chair Sharon Griffiths.


The RPS’s five principles of specials prescribing

Principle 1. Establish the optimal treatment for the patient. All treatment options are evaluated. Specials should only be prescribed when the patient has a special clinical need that cannot be met by a licensed medicine of established safety, efficacy, and quality. This does not include reasons of cost, convenience or operational need.

Principle 2. Understand the patient’s experience and make a shared decision. Prescribers discuss the patient’s needs, values and preferences to ensure that the implications and practicalities of treatment options are understood. When a special is prescribed this is a shared decision and patients are supported to adhere to their medicines.

Principle 3. Identify medicines and preparations. The risks and benefits of using a special will differ for different patient groups, different medicines and in individual clinical circumstances. Prescribers need to take into account the safety, efficacy, quality and cost of the different specials available to patients.

Principle 4. Monitor and review. The appropriateness of continued prescribing of a special is reviewed to ensure that it remains the best option and ongoing supply is justified by the patient’s continued special clinical need.

Principle 5. Ensure effective prescribing governance. Prescribers understand the rationale for using a special and the practical implications of prescribing before initiating, transferring or taking over responsibility for prescribing.


“Our members deal with up to 500 different formulation requests a day and we are uniquely qualified to advise prescribers and dispensers on many aspects of specials – sometimes that means changing a formulation or even recommending that a special is not appropriate. Our primary concern is the patient’s best interest.”

The APSM announced in September that it was broadening its membership criteria to include importers as well as virtual specials manufacturing organisations that own the rights to, and act as the first supplier of, a specials medicine in the UK. Its decision reflected the changing shape of the specials market, particularly over the past five years following the introduction of the Specials Tariff and a developing regulatory framework and professional guidance around specials.

“The decisions and actions we take now have implications for the entire supply chain and we need to give other organisations who have an interest in this market an opportunity to contribute to those decisions,” says Griffiths. “Our ultimate goal is to maintain a sustainable specials sector that provides high quality, safe medicines to patients. We are looking forward to working with more organisations who share this vision.”

The specials market in numbers

  • Total spend on specials in primary care in 2015 was £81.4m
  • Specials accounted for 0.83 per cent of the total spend on all drugs in England and Wales in 2015
  • 500 product lines account for 93 per cent of the spend on specials
  • The mean cost per specials item fell by 33 per cent, to £120.73, after the introduction of the Specials Tariff in 2011


Talking on the telephone

The General Pharmaceutical Council announced earlier this year that it had been contacted by the MHRA regarding the ordering of specials from manufacturers. The agency had received reports from firms that some pharmacists were not confirming telephone orders in writing which, it believes, increased the risk of atranscription error and therefore the wrong product being supplied to the pharmacy.

To avoid such errors, the MHRA requires specials manufacturers to get confirmation of orders in writing, for example by email, fax, or via an online ordering system provided by the manufacturer. RPS guidance on specials supply also recommends that, where necessary, the agreed formulation should be confirmed to the manufacturer in writing.

The APSM says most orders are not received in written form because pharmacists don’t work in this way, preferring to talk to a customer services representative/formulation expert for formulation guidance and immediate confirmation of acceptance of the order.

As soon as the order is confirmed, the manufacturer has to begin preparation in order to deliver within the expected timeframe, which is usually 24 hours. Mandatory written confirmation could lead to delays.

Most requests are for easily identifiable items that are unlikely to be mistaken for anything else, according to the APSM, and its members train their customer services teams to ensure that special clinical needs are understood and correctly identified.

“The effectiveness of this part of the quality system of each member company can be, and often is, verified during regulatory inspection,” says Griffiths. “Therefore, in most cases, a written request is not essential. While APSM members are happy to receive orders in written form, the expectation from our customers is that telephone orders are the preferred method because this has proved to be the most efficient and satisfactory service.”

Company round-up

While some suppliers have merged or switched their focus to products with high revenues, Nova Laboratories remains “a traditional specials company”, says Karen Cole, group sales and marketing manager. “We continue to fill a vital niche in medicine by delivering tailored healthcare, treating our most vulnerable patients and improving their quality of life,” she says.

Future innovations from specials companies will come in the form of expanding formulation choice and improved product safety and quality, as demand for tailored healthcare grows. “Our formulation pharmacists help us update and develop new formulations and increase product shelf lives. We regularly alert pharmacists to the latest formulation news and respond quickly to changing customer needs.”

Nova Laboratories is receiving more requests from pharmacists for conversion into batch products, says Cole. “That is what they want and they know we will always act on feedback received and deliver for them where possible.”

More education required

Ongoing education about the role of specials is required, says Chris Palmer, senior brand manager at Rosemont Pharmaceuticals. “There still appears to be some confusion about specials, off-licence and unlicensed medicines. Many prescribers seem to believe that all liquid medicines are specials and vice versa.” Clarity is also needed to help optimise prescribing practices, says Palmer.

For example, medicines only licensed for use in adults may be prescribed to children if a licensed paediatric formulation is not available.

More than half of medicines used in children in the EU have never actually been studied in this age group, while in the UK unlicensed or off-label products account for:

  • 11 per cent of medicines used for children in general practice
  • 25 per cent of medicines in general hospital wards
  • 40 per cent in paediatric intensive care units
  • 80 per cent in neonatal intensive care units.

Prescribing costs are likely to remain under the spotlight as an area for potential NHS savings. However, the overall cost of specials to the NHS is now only 1 per cent of the annual spend on prescriptions – so while costs need to be contained, potential savings are comparatively small, particularly when considering patient safety issues.

Meeting patient needs

Saving time and meeting patient needs quickly are at the core of a successful pharmacy business, says Catherine Brown, commercial director of the specials division at Quantum Pharma. “We have evolved our service with this in mind.”

Quantum’s opening times are 8am until 10pm most days. “We are ready to manufacture and deliver a range of products within 15 hours of an order being placed to hit our next morning delivery promise. If it is something we stock, orders can be placed as late as 9pm for delivery before noon next day. If it is a product we make, pharmacies can order by 6pm and items will still arrive before noon the next day.”

Quantum works hard to make pharmacists’ lives easier, says Brown. “Our automated prompts and expert team of in-house pharmacists are on hand to provide safeguarding checks and formulation advice at the point of ordering.” Our systems and experts work together to flag up licensed alternatives and also when supply of a brand-specific drug is required to optimise patient outcomes, she says. With increasing scrutiny from regulators, such as the GPhC, quality is also key to optimising patient outcomes.

“We operate a rigorous internal and external quality assurance process, which includes up to 150 checks in the production of each special, GMP and GDP compliance, alongside an agile and fully audited supply chain to ensure patient safety.”


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