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Transparency over unlicensed and special medicines, an emphasis on quality and standards, and increasing use of specials manufacturers all benefit patients, reports Charles Gladwin

As austerity continues, obtaining best value for money with medicines remains a healthcare priority. The Drug Tariff for England and Wales introduced a specials section in 2011 to specify maximum prices for a range of specials medicines that account for around 1 per cent of prescription costs. However, concerns about pricing linger on, and not just in England.

In November 2014, the Northern Ireland Audit Office raised the matter in its report on Primary Care Prescribing. In 2013, 250,000 prescription items costing £15 million were charged to the ‘unclassified’ code, it says. This is used “where a GP prescribes an unusual item or a liquid form of a routinely dispensed tablet.” The data “shows that the level of unclassified expenditure has more than doubled in the 10-year period to 2013”.

The NIAO examined the top 100 most expensive items prescribed and allocated to ‘unclassified’ in December 2013 and found that just over half of all items selected (costing £46,000) were liquid forms of routinely dispensed medicines. It also found a reimbursement request relating to a special costing just over £400 had been turned down by the Health & Social Care Board – it advised the pharmacist to dispense the treatment in tablet form, which cost £1.48.

“In our view, additional savings could be generated by strengthening controls,” said the NIAO report. “We recommend that the HSC Board continues to work closely with healthcare professionals to ensure that all possible alternatives are considered before a ‘special’ item is dispensed.”

Working within guidance

Meanwhile, in August 2014, Grampian Health Board wrote to pharmacy contractors about working within the NHS Grampian guidance for the authorisation of specials. While the majority of pharmacies were following the guidance, NHS Grampian had recently “claimed back excessive purchase costs from a number of pharmacies where this authorisation process has not been followed.”

We see a specials market that is under pressure as pharmacists and other healthcare providers are asked to cut or at least monitor the number they dispense

Addressing some of these concerns, the Association of Pharmaceutical Specials Manufacturers (APSM) published a paper in December on ‘How specials can deliver value to the NHS without compromising patient safety, striking the balance between cost and quality: a case study approach’.

“There is robust guidance and regulation in place to ensure that specials should only ever be prescribed when there is no alternative to meet patient need,” it says. However: “Specials must be produced to pharmaceutical standards, but there are concerns that increased pressure to reduce cost could be compromising quality through sourcing lower cost supply, or even reluctance to prescribe a special when required.”

APSM chair Sharon Griffiths says: “There is regulation and guidance to prevent unnecessary prescribing of a special and as an industry we have a duty to support this. However, when a special is indicated, we’re concerned that there is too much pressure on cost and not enough emphasis on patient safety.”

The paper takes a series of typical patient scenarios where a special is indicated and identifies the potential cost to the NHS of attempting to meet patient need with a lower cost, or higher risk alternative (see case study example p26). In all cases, the additional cost exceeds that of providing a special and sourcing it according to established guidance.

The total spend on specials was £99.7m in 2013. But the overall cost of specials has reduced by almost 30 per cent since being added to the Drug Tariff in 2011. “While the overall prescription spend has increased, the spend on specials has continued to fall and now accounts for 1.06 per cent of total spend on prescriptions, equivalent to £1.74 per person in 2013,” says the report.

Manufacturers respond

Specials manufacturers recognise the challenges. “At Nova, we see a specials market that is under pressure as pharmacists and other healthcare providers are asked to cut or at least monitor the number they dispense, particularly extemporaneously prepared specials, partly due to lingering concerns over pricing transparency,” says Karen Cole, business account manager at Nova Laboratories.

She anticipates and welcomes further pricing transparency as the specials tariff in England and Wales is expanded. Many pharmacists and commissioners worry that they do not know the true costs of their total specials use, she says. “They know that whilst the tariff caps the prices on a small number of specials, it leaves thousands of products outside of the tariff where prices can be escalated by suppliers anxious to profit where they can. So the challenge to pharmacists to offer value to our NHS paymasters remains an issue, in ensuring a fair charge for unlicensed medicines.”

Rosemont notes that since the 2011 Drug Tariff changes, more pharmacies are purchasing specials directly from manufacturers. “Pharmacists are becoming increasingly concerned about the quality of the special supplied, now that the price is guaranteed and are aware that there can be significant variances in the products supplied by different specials manufacturers,” it says.

In addition, around 60 per cent of people over the age of 60 have experienced difficulty in swallowing tablets or capsules at some time: “An increasing ageing population means that the need for oral liquid medicines is likely to increase, with more solid dosage forms becoming available as liquid specials.”

The specials market at a glance

• Total spend on specials in 2013 in England and Wales – £99.7m – or 1.06 per cent of the total £9.4bn spend on all drugs
• 500 product lines account for 96 per cent of all specials spend
• Mean cost of special item before introduction of specials tariff (Nov 2011) – £179.56
• Mean cost of special item after introduction of tariff – £128.17 – a 28.6 per cent drop
• Average spend per person in England and Wales in 2013 on all prescriptions – £165.00
• Average spend per person in England and Wales in 2013 on specials – £1.74

Guidance and good practice

The General Pharmaceutical Council entered the arena a year ago, setting out guidance on specials preparation. “[This] was a useful tool for pharmacists and a move towards better standards, and, given pharmacists share legal responsibility for patient safety whenever they prepare a special, we welcome that,” says Ms Cole. “Yet as the APSM said at the time, most pharmacies dispense fewer than 10 specials scripts per month. Indeed most pharmacists outsource the work to registered manufacturers to release their time to patient care.”

Rosemont adds that all its products are manufactured to the same standards of good manufacturing practice (GMP), whether a licensed or a special medicine, and have a certificate of analysis (CoA).

“The CoA is evidence that critical parameters have been confirmed by retrospective physical, chemical or microbiological assay of a sample of the final product. This differs considerably from a certificate of conformity which is a signed statement by the manufacturer that they believe the product complies with the purchaser's specification.”

To support pharmacists, “Nova’s focus is to expand our range of special medicines and consultancy services at a time when the tariff is being expanded and when the GPhC guidance has focused minds on quality,” says Ms Cole.

“With more specials being added to the tariff all the time, community pharmacists face a big administrative burden, especially with the less familiar prescriptions. Our development pharmacists help us update and develop new formulations and increase product shelf lives. We regularly alert pharmacists to our latest formulation news through monthly newsletters.”

Focus and quality

Rosemont’s recent activity includes changing the packaging of its specials liquid medicines into cartons with a patient information leaflet included in the pack. The cartons are also compatible with dispensing robots. And it has extended its ordering service, so that liquid medicines can be ordered up until 7pm from Monday to Friday on the telephone ordering line.

The free Rosemont app is also receiving favourable reviews, listing all Rosemont liquid medicines, both licensed and specials, together with a product profile. The app can be downloaded from iPlayer and Google Play and provides linked access to each licensed product’s summary of product characteristics, and specials’ most recent CoA.

It includes “a unique liquid medicine dosage calculator which is designed to help with accurate dose titration and takes into account a patient’s age and weight. The app also contains valuable information about the legal aspects of medication management and in particular medication manipulation.”

In addition, the manufacturing facilities at Rosemont Pharmaceuticals in Leeds have just received full Halal approval from the Halal Food Authority (HFA). “The liquid medicines receiving Halal approval do not contain alcohol or any ingredients derived from animals, making these products suitable for a wide range of patients across many different faiths.” The first 17 Rosemont liquid medicines have been awarded Halal certification, and Rosemont expects around 80 of its liquid medicines will eventually be approved.

Case Study

Patient with an allergy to an eye drop preservative

A special was required when a patient developed an allergy to benzalkonium chloride, which was used as a preservative in a licensed eye drop. The eye drops were used to treat bacterial infections of the eyelid and eyeball, bacterial keratitis, and without treatment the patient could suffer loss of sight or, in the worst case, blindness.

If rapid action had not been taken and a suitable unlicensed special dispensed, the patient may have lost their eyesight. It is difficult to cost blindness but there may also have been a need for an in-patient stay and ocular surgery at some stage. A non-surgical ophthalmology NHS tariff with a length of stay of two days or more is costed as £2,385. The full cost of lifetime blindness is difficult to quantify, but the cost of the first year of blindness is estimated to be about £6,455, falling to £6,295 in the second and subsequent years.

The quality of life is also likely to be significantly better with retained vision. The quality-adjusted life year (QALY) is likely to remain around 0.8 –1.0 rather than fall to 0.6 or below if the patient had lost their sight. DALYs (disability adjusted life years) are also significantly improved if blindness is prevented. Many patients with loss of eyesight/impaired insight also become depressed, which is associated with significant costs, as well as impairing quality of life. Indirect costs attributable to a poor outcome, without the use of the unlicensed special, could potentially include loss of productivity, lower employment, absenteeism, premature mortality and informal care costs.

 

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A Quantum of progress

 

Numark has confirmed Quantum Pharmaceutical as its preferred supplier of unlicensed medicines as members “can benefit from Quantum’s market leading late opening and cut-off times as well as a choice of over 22,000 specials and hard-to-source products.”

Sundeep Nagra, commercial manager at Numark, says: “We chose Quantum as our preferred supplier because they provide good quality and a comprehensive product range delivered within the timescales our members require. Some of our pharmacists operate 100-hour pharmacies, so a 9pm cut-off for delivery next morning is extremely useful and enables them to respond to their patients’ needs faster.”

Quantum started trading ordinary shares on AIM (Alternative Investment Market), a market operated by the London Stock Exchange, in December. The flotation is part of plans to expand its offering for pharmacy, primary and secondary care and pharmaceutical companies. Quantum is about to celebrate the dispatch of its two millionth specials order.

Chief executive Andrew Scaife says: “Having established our position as a market leader in the UKniche pharmaceutical market, becoming a PLC will afford us the opportunity to continue expanding to keep ahead of the rapidly changing needs of customers, their patients and service users and the health service.”