Manufacturers of unlicensed medicines constantly strive for the highest possible standards. And pharmacists that prepare their own specials have just had new high standards set for them as well, as Steve Bremer explains

New GPhC guidance on the preparation of unlicensed medicines on the premises focuses on the need for pharmacy staff to communicate appropriately with patients to ensure that they have the relevant information they require about an unlicensed medicine. It sets out the key areas that the pharmacy owner and superintendent pharmacists need to consider when unlicensed medicines are prepared by a pharmacist or under the supervision of a pharmacist in a registered pharmacy.

The guidance, which was published in May, covers all unlicensed medicines prepared in a pharmacy (see panel overleaf). Responsibility for following the guidance lies with the business owner, or if the pharmacy is owned by a body corporate the superintendent pharmacist also has responsibility. It advises business owners and superintendents how to demonstrate that they are achieving the relevant standards and that they are safeguarding patients and the public when unlicensed medicines are prepared. This is the first guidance document to be published as part of the GPhC’s standards for registered pharmacies.

Chief executive and registrar Duncan Rudkin says: “We recognise that preparing an unlicensed medicine in a pharmacy is an activity that can pose a risk to patients, and may potentially have serious consequences if processes are not managed properly. I hope that our new guidance will assist pharmacy owners and superintendents in ensuring that patients are kept safe and that our standards for registered pharmacies are met.”

The Association of Pharmaceutical Specials Manufacturers has welcomed the guidance. It makes clear that, although extemporaneous preparation (section 10 exemption) is only intended for use in emergencies, it is nonetheless an essential part of the overall specials supply chain.

“Patients have the right to expect unlicensed medicines to be of the same quality as their licensed equivalents,” says Mr Rudkin, and the APSM believes that the UK is on-track to achieving this goal. A recent APSM survey found that 72 per cent of pharmacists felt that the quality of specials compared with licensed medicines, up from 58 per cent in 2012.

Extemporaneous preparation can never be subject to the rigorous quality measures required of any special manufactured under a manufacturing specials licence. But, given that pharmacists share legal responsibility for patient safety when they prepare a special, it is only right that they are given as much guidance as possible to help minimise risk to themselves and to their patient, says the APSM.

A cautionary note

The guidance strikes a “cautionary note” for pharmacists considering preparing unlicensed medicines in their pharmacy, says Brian Fisher, group commercial director for the Quantum Pharmaceutical Group. It runs alongside National Prescribing Centre advice that, in the absence of a manufacturer’s licence, there is unlikely to be any documented evidence of quality.

Under the guidance, pharmacists are expected to carry out regular audits of processes and provide patients with as much written information as possible, as well as having an established process for recalling drugs if a problem arises. “Whether the new procedures prove too onerous for independents remains to be seen. However, the time involved and potential risks will inform pharmacists’ judgement as to whether they prepare medicines extemporaneously,” says Mr Fisher.

Patients have the right to expect unlicensed medicines to be of the same quality as their licensed equivalents

It may be that, in order to achieve a balance between cost, speed and safety, and for the reassurance of a full audit trail including certificates of analysis and conformity, most independents choose to source from a specialist manufacturer, suggests Mr Fisher. “We can’t expect community pharmacies to replicate the safety, speed and quality of a specialist. Where we can bridge the knowledge gap is by making sure pharmacies are confident commissioning this service from the right provider and supporting adherence through expert engagement with the patient.”

Tariff improves transparency

The total spend on specials in 2012 was £112.7m, or 1.2 per cent of the total spend on all drugs in England and Wales. Although over 75,000 different formulations of specials are prescribed every year, only 500 product lines account for 96 per cent of the total spend.

Since the introduction of the specials tariff in England and Wales at the end of 2011, the mean cost per item of specials fell by over a quarter, to £131.57 by last September. The tariff provided a “much-needed first step in delivering transparency to the pricing of specials as well as providing stability to the market,” says Jan Flynn, marketing manager at Rosemont Pharmaceuticals. “A tariff is important to help guard against the uncontrolled price escalation of specials.”

Patients and the NHS both benefit from the tariff, because prescribers now have the confidence to prescribe a special in the knowledge that they can check the cost in advance, says Ms Flynn. Pharmacists are becoming increasingly aware that not all specials are the same and their focus has moved towards concern about the quality of the product now that the price is guaranteed.

More pharmacies appear to be purchasing specials directly from manufacturers than before the tariff was introduced, says Ms Flynn. “This has enabled pharmacists to obtain the most cost-effective, high quality specials for their patients. In the future we expect to see more specials added to the tariff in England and Wales.”

But NHS budgetary pressures mean that prescribers are under increased pressure to justify their spending. Specials prescribing and dispensing varies widely across the country, due to differing guidance to prescribers from CCGs, according to Quantum Pharmaceutical. Pharmacists are also reporting pressure to reduce both their specials dispensing and spend.

A specials app

Rosemont’s new app for healthcare professionals is a useful medicines management tool for liquid medicines. It lists all Rosemont liquid medicines, both licensed and specials, with a product profile, and provides linked access to each licensed product’s summary of product characteristics (SPC) and specials’ most recent certificates of analysis. A key word search means that information can be obtained quickly and easily. And information can be accessed by typing in a product name or category, a disease or a medical indication.

The app includes a “unique” liquid medicine dosage calculator that takes into account a patient’s age and weight and works in both milligrams and micrograms. The app also contains information about the legal aspects of medication management and, in particular, medication manipulation.

Feedback from pharmacists in the first three weeks following the launch had been “highly positive”, says Ms Flynn. The app can be downloaded free of charge at the App Store for Apple devices, and on Google Play for Android devices. Initial reviews give it either a four or five star rating.

Rosemont began changing the packaging of its special liquid medicines into cartons (wherever feasible) last year, with a patient information leaflet (PIL) included in the pack, bringing its specials in line with its licensed range. This is a rolling programme with the repackaged specials being introduced once previous batches have been used.

Services for independents

Nova Laboratories offers a range of services aimed specifically at independent pharmacists, to reflect the fact they are busy professionals whose time is spread across a number of daily tasks, says Karen Cole, the company’s business account manager for specials.

Nova offers a next-day delivery service to mainland UK on all orders received before 12pm, but it can deliver products on the same day if requested. “We also provide a dedicated support pharmacist and highly experienced customer service team who can advise customers on any formulation issues and help to resolve any technical problems.”

Nova regularly reviews its product range to ensure it offers as many items from the drug tariff as competitively as possible, says Ms Cole. “With our development pharmacists we are always willing to develop new products requested by our customers, and we are working across the product range to increase the shelf lives of our products wherever possible. Our primary focus is to provide a wide range of value for money specials but also to support pharmacists, and help improve their knowledge of unlicensed medicines.”

Pride in customer relationships

IPS Specials recruited David Francis as sales and marketing director in May to help strengthen its relationships and offering to customers. Managing director Mark Stephenson says: “Our customer base has expanded significantly over the last 12 months and David will add value to the senior management team and allow us to ensure we maintain and build upon the quality and frequency of our customer relationships that IPS has always prided itself on.”

IPS Specials is a “company like no other”, says Mr Francis. “They have managed to build effective relationships with a varied customer base from independent pharmacists to large chains to wholesalers and hospitals, whilst maintaining world-class service and outstanding quality.”

Quality first

Quality must be at the forefront of prescriber, pharmacist and patient thinking, as there have been several instances of medication failing due to crushed tablets being used instead of a special prepared by a licensed manufacturer, says David Clough, commercial director at Eaststone Specials. Dose variability, as a result of patients or inexperienced staff crushing tablets or opening capsules, can be high, and there have been instances of substantial under- and over-dosing due mainly to issues around suspension and formulation.

“Specials meet the individual requirements of patients and there is no reason why an unlicenced medicine should not be manufactured to the same high standards as an equivalent licenced medicine – it just needs the 'supply triangle' of prescriber, pharmacist and of course patient to fully understand that not all unlicenced medicines are manufactured to the same rigorous standards,” says Mr Clough.

Birthday bash

The Specials Laboratory has been celebrating 15 years in business. Its head of marketing Jan Armstrong says: “Our birthday celebrations are all about saying thanks to each and every one of our staff and pharmacy customers who have helped us serve patients across the UK over the last 15 years. With our new US owners on board, the future is very bright at The Specials Laboratory and we look forward to raising industry standards for many years to come.”