Specials - a 10-point essential guide
By Alan Krol, Managing Director, Moorfields Pharmaceuticals
Why are specials prescribed?
A special is a specially prepared formulation prescribed to meet the special clinical need of a patient, where there is currently no licensed version. For example, a particular strength, a preservative-free formulation, or a particular product presentation or form.
A special will only be prescribed if there is no licensed alternative which is equivalent and if there is a licensed alternative – there can be no special. i.e. as soon as a special is licensed it cannot be prepared as a special.
Specials represent only a small percentage of all prescriptions.
How are specials prescribed?
A special is prescribed using a standard prescription format, but it is apparent to the pharmacist on presentation that this is an unusual formulation – i.e. a special. In these circumstances the pharmacist will generally contact a specials manufacturer to discuss the formulation and its availability. The pharmacist may well discuss with the prescribing clinician to confirm dosage, or in some instances a slight change to the prescription based on advice from the specials supplier about formulation and availability. The pharmacist will also check the dosage and confirm that no licensed alternative is available.
Specials are generally made to order in small quantities and can be despatched the same day or the following day.
Are they safe?
In the vast majority of cases, specials are based on generic drugs which have established safety and efficacy. However, it is the responsibility of the prescribing clinician to ensure that the ‘special’ is appropriate for their patient. If the special is particularly unusual and there is little data available about it then it will also be given a very short shelf life.
The specials manufacturer has a responsibility for quality and this is governed by the MHRA. Specials are manufactured to a quality standard in a facility that is approved by the MHRA. Some specials manufacturers, such as Moorfields Pharmaceuticals, have a long history and experience and adhere to very robust standards for the manufacture of specials. In overall terms manufacturers are compliant with MHRA guideline no. 14. In the case of Moorfields Pharmaceuticals, the facility is licensed by product type e.g. ‘sterile facility’ and in this case necessitates an even higher level of inspection and control.
What forms do they come in?
Specials come in all shapes and sizes? Because they are based on individual patient need it is often possible to prepare them to meet the exact requirements of the patient. For example, preservative-free formulations are increasingly provided in single dose units.
Moorfields Pharmaceuticals, for example, produces more than 100 specials for use in ophthalmics – these range from single dose units to bottles, vials and pre-filled syringes.
Moorfields Pharmaceuticals recently introduced a colour-coding system to help patients who are prescribed two or more products from different groups, for example corticosteroids and myotics, to assist in understanding their dosage instructions. However, this is not a replacement for reading the name on the bottle and the onus remains on the pharmacist to ensure that the products are also clearly labelled when dispensed.
How much does a special cost?
Specials are produced individually in very small quantities, at very short notice and despatched same day in most instances. This is reflected in a premium pricing, however, this is fully reimbursed under the prescription pricing authority scheme including associated delivery charges.
Who can I call for help with a script for a special?
In most instances the specials manufacturer will provide detailed advice and guidance. Moorfields Pharmaceuticals has a specialist help desk, in particular for ophthalmic queries. Their long history associated with pharmacy for the Moorfields Eye Hospital means that they are highly qualified and experienced to provide advice.
The Association of Commercial Specials Manufacturers can also provide advice and direction.
Legislation prohibits specials to be advertised – even to prescribing clinicians. Organisations manufacturing specials such as Moorfields Pharmaceuticals can only promote the service they provide.
In this respect, Moorfields Pharmaceuticals has produced a range of information tools for pharmacists, including a unique tool for identification of the colour groups used for their range of Specials. Presented as a wheel design, this simple mechanic enables a pharmacist to quickly and easily identify which colour represents which group of Specials, thus making dispensing and education to their patient much easier.
Who is responsible for specials?
Ultimately responsibility lies with the prescribing clinician and they prescribe in the full knowledge that this will be a special. Manufacturers are also strictly governed by the MHRA section 14 regarding the supply and cGMP which ensures that the quality of manufacture and aspects such as the correct labelling are adhered to. The dispensing pharmacist also has a role – as with any prescription – for querying any incomplete or inconsistent information.
It is possible that in the future there will be more regulation around specials. This is not because of UK based specials manufacture which is a very small and highly regulated sector of the market, but more to do with the increase in imported products which although licensed in their country of origin, are unlicensed here – and therefore fall into the specials category. On this basis, the MHRA has recently started an informal review of specials.
Are specials becoming more popular?
Only in as much as clinicians are better at identifying individual clinical needs in patients. Certain environmental and demographic factors are driving this, such as the ageing population which increases diseases such as wet AMD (age-related macular degeneration), dry eyes and diabetes; other factors such as dry eyes associated with air-conditioning and from increased use of computers; Sjrogens syndrome, and general increase in allergies and hayfever also affecting the younger population.
However, overall specials are and will remain a niche market, and will continue to meet the special clinical needs of the patient.
How do I store a special?
Specials are no different from licensed medicines, although they may have a shorter shelf-life. The storage instructions will be clearly printed on the labels.
