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Specials Manufacturers

'Specials' manufacturers are not allowed to advertise or promote individual 'Special' products, because under the Medicines Act it is only possible to advertise licensed medicines. This means that it can be difficult to find information about 'Specials'. It is therefore worth keeping a record of 'Specials' manufacturers and the products they can supply.

When selecting a 'Specials' manufacturer, consider asking some of the following questions to ensure the reliability of the supplier:

  • Do you hold an appropriate Manufacturer's 'Specials' licence?
  • What is the turn-around time from an order being received to delivery?
  • Does the company offer a 24 hour service if needed?
  • Does the company specialise in any particular types of products?
  • Does the company provide certificates of analysis or only a certificate of conformity?
  • Does the company guarantee quality?
  • Is professional advice available 24 hours a day, seven days a week?
  • Does the product have a reasonable shelf life that will allow you to get it to the customer before it expires?
  • Does the company have a transparent pricing policy and provide a published list of 'Specials' prices?

The answers to these questions will help to ensure the quality of the medicine supplied. 'Specials' can only be manufactured if a company has a Manufacturer's 'Specials' Licence; this means that a Medicines Inspector from the regulatory authority can inspect the premises at any time.

Not all 'Specials' are the same

It cannot be assumed that all 'Specials' manufacturers will produce exactly the same 'Special' medicine and switching between suppliers can lead to adverse changes in disease control and side effects.

Case study 1: Potential problems with extemporaneous suspensions11

A child with epilepsy was prescribed clobazam tablets, which are licensed for epilepsy for children aged 3 years and older. The mother reported that the child was struggling to swallow the tablets and the GP decided that it was necessary to prescribe a liquid preparation. The BNF for Children confirmed that no licensed liquid was available, so the GP typed out a prescription for the appropriate dose and strength of liquid clobazam. The community pharmacist subsequently dispensed this unlicensed medicine as an extemporaneous product. The mother returned a week later reporting that the child had increased fitting.

Although the GP prescribed clobazam liquid at the appropriate dose and strength and the pharmacist dispensed the correct medicine, clobazam is very hard to suspend. This means that unless the unlicensed liquid dispensed has an appropriate formula and production method and the bottle is shaken well before dosing, the amount of active ingredient that that child will receive in each dose will vary enormously. Indeed, in some bottles, clobazam is so caked on the bottom of the bottle that the strength of the suspension is only 20% of that expected even after vigorous shaking.

While it is hard for the GP to avoid such a problem advice should be sought from the original prescriber or pharmacist to ensure that the child receives the most appropriate unlicensed medicine. They should also be prepared to closely monitor the patient and warn parents/carers that symptom control may vary when swapping between products that are not licensed.

Changing preparations may impact on symptom control and result in adverse events