Reacting to the ‘other things’ in prescribed medication is yet another hazard that confronts those suffering from allergies and intolerances. For some a reaction will come as an upset stomach, a wheezing attack or an eruption of eczema or urticaria. For hyperactive children it may result in serious deterioration in behaviour. But for some, like FM readers Jacquie Broadway and Catherine Hislop (see FM April & May 05), being treated with standard medication could be fatal.

The problem lies in the non-active materials, known as excipients. These carry or contain the active drugs, give the drugs shelf life (often several years of shelf life) and colour them to make them look appealing and to distinguish them from each other.

Drug Formulation & Manufacture
In olden days, when chemists in white coats weighed and pounded their powders and potions at the back of their pharmacies, they could, and did, make up medicines to suit the individual needs of their customers. However, times have changed and the risks of inaccurate dosages and contamination inherent in making up medicines in small individual pharmacies are too great. As a result medicines must now be licensed before they can be sold to the public - and this means that they can only be manufactured by those who hold a license to do so. Manufacturing requirements are, rightly, stringent and licenses to manufacture drugs are only held by pharmaceutical manufacturing companies and some of the larger hospitals where their drug requirements justify the expense of a full pharmaceutical manufacturing department.

Because the development of drugs is an extremely costly, if also profitable, business drug companies develop specific formulations, which include both active and non-active ingredients. These are then granted a license to be prescribed and sold.

However, the license is specific to that formulation. Changing anything in the formulation, even if it is only a colouring agent, means that its license is no longer valid and that a new license would need to be obtained for the new formulation.
Nonetheless, most drugs, especially the common ones, are available in a number of licensed formulations, often both in tablet/capsule and in liquid form. A little research on the part of the doctor or pharmacist may unearth a licensed formulation which does not contain the ingredient to which you react.

‘Specials’
However this is not always the case. When no appropriate formulation is available medicines legislation (Medicines for Human Use Regulations 1994/SI 3144) allows the ‘manufacture and supply of unlicensed medical products (known as ‘specials’) provided that:
• there is a bona fide unsolicited order
• the product is formulated in accordance with the requirement of a doctor or dentist registered in the UK
• the product is for use by their individual patients on their direct personal responsibility
• if the 'special' is manufactured in the UK the manufacturer holds a “specials” license issued by the MCA
• an equivalent licensed product is not available
• essential records are kept and serious adverse drug reactions are report to the MCS.’

Specials manufacturers tell us that, provided they have access to the active ingredients (occasionally the manufacturer is not prepared to release these) they can make up drugs to suit virtually any restricted diet, no matter how bizarre the restriction may be.

However... There are two stumbling blocks for those who might want to make use of this provision. One is that very few GPs appear to be aware that, if they provide the appropriate prescription, it is possible to get ‘special’ drugs made up.

The second is that, even if they do know about ‘specials’, they are often reluctant to prescribe them as the cost of manufacturing (often very high as each drug has to be individually made up under full clinical conditions) has to come out of their budget.

Problem ingredients
The five non-active ingredients in most drug formulations that are likely to cause problems are:
• Colourings
•Preservatives
• Lactose
•Starch
• Glucose

Finding out about Excipients
Drug companies are required by law to list all the ingredients, both active and non-active, on the sheet of information that comes with the drug. You should be able to discover from your local pharmacy what the ingredients of any specific drug your doctor wishes to prescribe may be. If not, some searching on the web should unearth them.

Some ingredients may be classified by their E numbers. A copy of Maurice Hanssen’s E for Additives (Thorsons £7.99) or a web search should identify the E numbers that you need to avoid.

Foods Matter will also be publishing an E Number Supplement next yearas we have had a number of requests for a ‘potted guide’ to E numbers, not only for identifying undesirable ingredients in drugs but in normal foodstuffs.

Colourings
Colourings are used to differentiate one drug from another and to make the tablets, capsules or liquid medicines look more ‘appealing’. Because they produce brighter colours, azo or coal tar dyes are often used even though azo dyes are known to affect hyperactive children. To avoid possible allergic reactions, antihistamine type medications normally use natural colours. Colours are not integral to the formulation and can just be left out.

Preservatives
Preservatives are found mainly in creams, ointments and liquids. Because licensed drugs are required to have long, often very long, shelf lives preservatives are needed to inhibit microbial growth and prevent the drugs themselves becoming toxic.

Although a number of different preservatives are used the most common are benzoates, known to cause a number of allergic reactions.
If a patient has a problem with the available preservatives, a specials manufacturer will simply leave them out, making up only a small amount of the drug - enough for a maximum of 28 days - so that preservation is no longer an issue.

Lactose
One of the problems that drug manufacturers and pharmacists face is that the active ingredient in a drug is often tiny in volume so they need to ‘bulk it out’ into a pill or capsule that the patient can handle safely and easily.

Lactose is very widely used in the drug industry for ‘bulking out’ both tablets and capsules because it is inert, stable and manageable. It can also be relied on to maintain its consistency until it gets to the part of the digestion where it is required to disintegrate. Where licensed lactose free formulations are not readily available, a specials manufacturer can, provided they can obtain the active ingredient, formulate the medication without lactose, often as a liquid.

Starch
Starch (wheat or corn based) can also be used as a bulking agent although it is more often used as a disintegrant - to ensure that the tablet disintegrates in the stomach releasing the active ingredient. The level of protein which remains in the starch is extremely low; so low that it is questionable whether it would retain any allergenicity. However, those who are particularly sensitive should still beware.

A specials manufacturer would probably formulate the drug as a liquid preparation.

Sugar/Glucose/Sweeteners
Sugar and sweeteners are used mainly in liquid formulations (especially for children) to make them more palatable - even though a substantial number of children may react to both sweeteners and sugar.
Sugar-free formulations of a number of licensed drugs do exist but if your doctor or pharmacist cannot locate any, a specials manufacturer will make up your drug in a sugar-free liquid formulation.

Persuading your Doctor
• Persuading your doctor that you really are allergic/intolerant to the relevant ingredient may be the hardest part of the job.

• If they do not know about ‘specials’ refer them to the Medicines Control Agency for verification that ‘specials’ exist and are legal. They can call 020 7084 2573, look on the MCA website (www.mhra.gov.uk - A-Z index - under G - Guidance notes (2) - Note 14 under results 11-20) or follow the direct link from www.foodsmatter.com/specials

For further information they can check in with the Association of Specials Manufacturers - 01279 504 254 www.acsm.uk.com.

• Ask your pharmacist what they know about ‘specials’. Most major groups will have their own manufacturers. Boots for example own a
company called BCM Specials (0800 952 1010
www.bcm-specials.co.uk ) who will advise any Boots pharmacist on how to proceed.

• Be persistent - advice that is scarcely needed by most allergicor intolerant people for whom ‘ Persistence’ has become their middle name!

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