Obtaining 'free from' prescription drugs
'If the disease doesn’t kill me the drugs probably will...’ For those who are allergic to penicillin and other active drugs this is a well recognised and justifiable fear. But what of those who are allergic or intolerant to the other, non-active ingredients in standard medications ? the lactose, the glucose, the preservatives or the colourings? Michelle Berriedale-Johnson describes what should happen; John Scott, Jacquie Broadway and Julie Cox give their experiences.
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 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 and manufacture
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 Changing anything in the formulation, even if it is only a colouring agent, means that its license is no longer valid and that a new license would need to be obtained for the new formulation.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 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.
Finding out about excipients
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 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.
A specials manufacturer would probably formulate the drug as a liquid preparation.
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
• If they do not know about ‘specials’ refer them to the Medicines Control Agency for verification that ‘specials’ exist and are legal. They can look on the MCA website www.mhra.gov.uk for general information and specficic guidance notes. (Just put 'specials' into the search box if the link does not take you straight there.) They can also call on 020 3080 6844. They could also check in with the Association of Specials Manufacturers – www.acsm.uk.com.
• Ask your pharmacist what they know about ‘specials’. They should know all about them but (see John's Scott's comments below) do not always appear to do so.
• Talk to the 'specials' manufacturers yourself. You will need to make it very clear that you are only looking for information to relay back to your doctor/pharmacist and that you know that they cannot supply you direct. You also need to be sure that you understand all the shades of your intolerance (see Jacquie Broadway's experience below) as they may well suggest alternative excipients that they think would be problem free but which you know will not be!
The following companies all manufacture 'specials' medicines and, according to Jacquie Broadway, were very helpful.
• Be persistent - advice that is scarcely needed by most allergic or intolerant people for whom ‘ Persistence’ has become their middle name!
Shortly after this article was first published in 2005, John Scott tried to put Michelle's advice into practice – but with only limited success.
I heard recently, for the first time, of the existence of 'specials' - medicines manufactured on an individual basis to specific requirements, such as the omission of specified allergens.
In early 2012 Jacquie Broadway who is extremely sensitive to sugar and grain starch (especially corn starch) and to moulds, and has severe malabsorption and digestive problems, had a hip replacement. She has had an on-going battle to get a supply of antibiotics that she could tolerate but now she was faced with trying to get some pain killers that would not contain either starch or sugar.
Jacquie's GP has known her for many years so is aware of her allergies and digestive problems, but had managed, mainly by being unavailable, to avoid addressing the problem of getting her some pain killers that she could tolerate.
Her local Boots pharmacist was helpful and did know about 'specials'. However, she did not know about severe allergy or digestive problems, so she offered alternative versions of standard painkillers including, for example, one based on lactitol. But lactitol is a sugar alcohol which is well known to cause diarrhoea – totally inappropriate for someone with Jacquie's history. (This is why, if you are to go down this route, you need to know exactly what you can and cannot tolerate.)
Finally, she called up the 'specials' manufacturers listed above who, she said, were very helpful, especially The Specials Laboratory. But even with the manufacturers, it took her some time to persuade them that such was her sensitivity to corn that, even if it had been hydrolysed (the protein broken down into tiny molecules) she would still react to it.
However, they did come up with two formulations for paracetamol, one as a liquid (with only a few weeks shelf life) and one as crystals, which would last rather longer but would be quite unpleasant to take.
Armed with this information, Jacquie got back onto her GP. After further delay, the practice secretary came back to her to say that the drugs would cost around £300 and 'couldn't she make do with something else' ... at which point, her husband lost his cool, marched into the surgery and demanded that they get her some drugs that she could use without them making her seriously ill and risking killing her. She now has her paracetamol crystals ...
Although Jacquie got a single prescription of 'special' Paracetamol out of her doctor after her husband blew his fuse, she has now been told that she cannot have an ongoing prescription for the drug.
'The view expressed (by the medicine's management team) is that if you had a more ongoing painful problem that required regular pain relief at intervals during the day then further one off prescriptions of the Paracetamol could be provided, but that in the interim we should provide you Mefenamic acid for pain or fever relief (a non-steroidal anti-inflammatory drug, known as Ponstan, used to treat period pain and pre-menstrual migraine – not pain resulting from orthopaedic surgery in an 70-year-old), assuming that your orthopaedic surgeon has not identified any long-term contra indication to infrequent use of this drug.'
May 2012 – USA – Labelling for gluten
The American Celiac Disease Alliance has been lobbying to bring in mandatory labelling for gluten in prescription drugs. For more information check in here.
I have been having medicines made by 'BCM Specials' free from lactose, wheat starch, azo dyes, colours, flavours and preservatives.
This has worked very well after a lot of initial effort getting it set up by me but all of a sudden my helpful lady doctor is off for months and will may be not be returning and unhelpful doctor has been appointed prescribing lead and has refused me any more prescriptions of the free from medicines.
I have had allergies since birth and was covered in inflamed eczema as soon as cows milk and wheat were introduced. I come from an atopic family with food allergy (type 1), hay fever, eczema, migraine, photosensitive skin, and asthma, affecting many family members through the generations. All generic medicines contain different colours, azo dyes, artificial flavourings, preservatives, and fillers like lactose and modified starches which can be wheat based, all of which have the potential to cause me severe reactions.
Ed: We blogged Julie Cox's comments and received the following advice for her from John Scott:
The action of your new doctor in refusing to continue the care delivered by your previous doctor is preposterous and needs to be challenged. (I'm jumping up and down here in indignation, just thinking about the way you've been treated!) Here are some options.
1. Challenge the new doctor face-to-face and make him aware that you will do whatever is necessary to have your special medication needs met, and existing, longstanding prescribing practice continued.
2. If you don't feel you want the stress of a direct confrontation, just locate a new practice using this "Find a GP" tool and ask them if they will accept you. You won't need to see anyone at your old practice again.
3. If you want to stay with your existing practice, you could make a formal complaint to the NHS using their complaints procedure here.
4. Involve the media. If you're up for this, it would help others who will inevitably, given the current climate, face a similar situation. I'm sure your local BBC TV service would take up a story like this, and your new, cost-conscious GP would be invited to justify his actions on camera… I'm also certain that the Daily Mail would run this story. It's the kind of thing they love! And perhaps also the Guardian.
On a much more positive note, are you aware of Helminthic Therapy? If not, you may like to know that there is a very good chance that HT would remove your need for special medications - and put many of your health problems into remission. To get an idea of what HT can do, you could read my own story here.
And to learn all about Helminthic Therapy, see this list of links to all the most important information.
The main part of this article was first published in 2005; it was revised in 2012.