We ask specials suppliers what’s new at their companies and in the unlicensed medicines sector generally

Specials play a key role in healthcare, providing the right medicines to suit patients’ therapeutic needs when a licensed alternative isn’t available or viable. According to Sharon Griffiths, chair of the Association of Pharmaceutical Specials Manufacturers and managing director at the Specials Laboratory, the biggest issue in the sector remains the pressure on NHS budgets, which has put the cost of specials under increased scrutiny.

In December 2016, the latest data for the specials market in primary care showed that spend was just over £80.5m for the 12-month period October 2015 to September 2016. According to the APSM, although the market continues to decline year-on-year, it is now stabilising following a period of readjustment in the wake of the launch of the Specials Tariff in November 2011. During this time, the mean cost per item has reduced from £180 per item before November 2011, to an average £116 for the same 12-month period to September 2016.

Whilst this represents value for money to the NHS, at the same time the high standards of quality involved in specials manufacture have needed to be maintained. During 2017, the APSM will be raising awareness of the support role provided by specials manufacturers alongside prescribers and dispensers to ensure that patients receive the right medicine at the right time. “APSM members deal with up to 500 different formulation requests a day and are uniquely qualified to advise the prescribers and dispensers on many aspects of specials,” says Ms Griffiths. “Sometimes that means changing a formulation or even recommending that a special is not appropriate. The primary concern is the patient’s best interest.”

Pharmacists should ask specials 

suppliers about their quality process

Supporting pharmacies

As pharmacists are pushed into taking a more clinical role, adding to already stretched schedules, specials manufacturers are working hard to make pharmacy customers’ lives easier. According to Catherine Brown, commercial director of the Specials Division at Quantum Pharma, the series of efficiency measures that have arisen as a result of the £22bn NHS funding gap has hugely increased the pressure on pharmacies’ time and resource. “The funding cut reforms coupled with the shift to integrate pharmacy expertise into primary care, present both a challenge and a prime opportunity for all stakeholders within the supply chain to add value and to support pharmacies through these challenging times,” she says.

“We know that if a patient has to wait too long for a prescription, then next time they might go elsewhere and that means lost business for a pharmacist. Saving time and meeting patient needs quickly are therefore at the core of a successful pharmacy business.”

Karen Cole, group sales and marketing manager at Nova Laboratories, says specials prescriptions can prove an administrative burden on pharmacies and, with pharmacists getting busier, they need more support from manufacturers. “When we get a call from a pharmacist, the first thing we advise on is whether a prescription can be fulfilled.” Nova’s dedicated support pharmacist and customer service team resolves many formulation issues and technical problems for pharmacies, says Ms Cole.

“Nova Laboratories is, first and foremost, a traditional specials company. Where other companies have merged or switched their focus to products with high revenues, we continue to fill a vital niche in medicine by delivering tailored healthcare, treating our most vulnerable patients and improving their quality of life. 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.”

Quality and efficiency

According to Ms Griffiths, the Specials Laboratory firmly believes quality should remain prominent before price and any other buying decision. “The fundamental ‘unlicensed’ nature of specials means they are not subject to the same approval process as licensed products,” she says. “As a result, pharmacies need to take extra care when selecting their specials partner, ensuring that they manufacture the required medicines to the highest possible standards and pharmacists need to ensure that they have the right information.”

Pharmacists should ask specials suppliers about their quality process, which is information they should be willing to give, suggests Ms Griffiths. If a pharmacist’s specials partner is performing these types of checks, it also gives confidence that the product supplied to the patient is made in the right type of facility and by the people with the right experience and qualifications, she says. “This is a very important point, considering that every pharmacist, when making a supply of any medicinal product, assumes a duty of care to the patient. With this in mind, we expect to see an increasing shift towards increased awareness around shared liability when it comes to specials.”

The world of pharmacy has certainly changed, and there is now a need to free up more time to enable pharmacies to be at the front line, says Ms Brown. “This would provide enhanced services while also generating the revenue needed to overcome funding cuts.” This means that pharmacy operations must become more efficient in the back office, she says.

“If specials suppliers want to grow and remain relevant, it’s important that we focus firmly on delivering support that drives efficiencies and optimises patient outcomes. To ensure success, it’s important that we work closely with our pharmacy customers and the wider healthcare community to understand the impact of changes that are affecting them in what has become a hugely demanding environment.”

Managing CCG advice

The NPA has issued guidance for pharmacists on dealing with CCG recommendations about the use of off-label or unlicensed medicines.

Some CCGs issue guidance on medicines optimisation to reduce the total cost of their drugs budget. And this guidance may recommend the use of an off-label or unlicensed medicine in preference to a licensed option. The NPA advises that pharmacy contractors should consider the potential implications of this action before dispensing an off-label or unlicensed medicine.

A CCG recently suggested that doctors consider prescribing tablets to be dispersed in water (off-label) in preference to a licensed liquid formulation, as a way of saving money because of the significant price difference between licensed amlodipine oral solution and amlodipine tablets.

Recommending the off-label use of amlodipine contradicts the Medicines and Healthcare products Regulatory Agency (MHRA) guidance on ‘The supply of unlicensed medicinal products ‘specials’: MHRA guidance note 14’. This states that if a UK-licensed medicine is available to meet a patient’s clinical need, then an off-label or unlicensed medicine should not be used.

When supplying a medicine against a prescription where the prescriber has indicated an off-label use of a medicine, pharmacists should consider that its product licence may not cover the use of tablets
to be crushed and dispersed in water or capsules to be opened for administration. Alternative recommendations which could be suggested to a prescriber include prescribing a different licensed formulation, or switching to an alternative medicine.

Liability issues

Pharmacists should be aware that they will not be exempt from any liability should a complication arise from dispensing an off- label/unlicensed medicine on a CCG’s recommendation. It is therefore imperative that pharmacy contractors and individual pharmacists, including locum pharmacists, check with their indemnity insurance provider before dispensing such a prescription.

The NPA warns that its insurance will not routinely cover pharmacists who follow the advice or recommendations of their local CCG without question. NPA Insurance will, however, continue to indemnify, protect and support members and pharmacists who have acted in the patient’s best interests by dispensing an off-label or unlicensed product in an emergency or in exceptional circumstances.

It is therefore important to speak to prescribers on an individual patient basis to check that patients have been clinically assessed for the use of an off-label or unlicensed medicine before dispensing a prescription. Prescribers should be alerted to the availability of licensed medicines (where they are available) and advised of current MHRA guidance.

If the prescriber is not willing to prescribe an alternative licensed medicine, the pharmacist should make a professional decision as to whether to supply the requested off-label/unlicensed medicine. They should also keep a record of any discussions with the prescriber and their justification for supplying the medicine on the patient medication record.