Polidoconol
The Board of the BAS were concerned that some members were experiencing difficulties prescribing Polidoconal for the treatment of leg veins.
MHRA had indicated that polidocanol can only be imported for the treatment of a medical condition and, although didn't say this, implied that varicose veins are not a medical condition but a cosmetic problem. It was the opinion of the board that this was at variance with published medical literature. The MHRA wrote this,
"There is no provision in UK law for importation of unlicensed products classified as medicines that are intended for administration to humans for other than medical purposes. It is therefore not possible to notify the MHRA for importation of medicines where the need is essentially cosmetic. Consequently, the MHRA must object to notifications of this nature. Notifications for importation of unlicensed medicines required for genuine clinical (medical) needs will be assessed in the normal manner."
Mr. Coleridge Smith wrote on behalf of the BAS and attached a copy of a recently published document in which a group of distinguished international experts have reached a consensus on the classification of venous problems affecting the lower limb, referring to the CEAP Classification system. In fact, this was a revised version of a document first published 10 years ago. It is a widely used and respected document amongst physicians who treat vein problems. All clinical presentations of venous disease are recognised as diseases – there is no mention in any part of this document that some parts of the clinical classification should be regarded as cosmetic problems. The classification does include a 'C0' (clinical class 0) group in which there is no clinical evidence of venous disease. Perhaps it is in this group that MHRA would consider any treatment to be for a cosmetic condition?
The remainder of the classification varies from C1 which includes telangiectases and reticular varices, C2 – uncomplicated varicose veins, C3 – limbs with oedema, C4 – 6 – skin changes ranging from eczema to leg ulcers. All of these stages can produce troublesome symptoms ranging from aching, itching and discomfort on standing in C1 and C2 classes to severe pain in classes C4 – C6.
National guidelines limit treatment in the NHS to patients with haemorrhage, thrombophlebitis and skin changes including leg ulcers. Haemorrhage most commonly occurs in patients of the C1 group, thrombophlebitis in those of C2 and skin changes and leg ulcers in patients of C4 – C6. Therefore patients in all of the clinical classes C1 – C6 may be eligible for NHS treatment under some circumstances. Patients not fulfilling national guidelines for NHS treatment may still seek private treatment for venous disease in order to moderate lesser symptoms. These clinical stages still constitute a medical condition, not a cosmetic condition, according to international consensus.
MHRA responded
'There is no intention to prevent usage of these products for medical conditions falling, for example, under national NHS guidelines, and it is accepted that varicose veins and related conditions are medical conditions. There is, however, objection to importation for purely cosmetic purposes. The number of notifications for these products has risen markedly over the last year and concern has been expressed over their increasing use in some cosmetic clinics. It is for this reason that the MHRA has asked importers to ensure that there are proper clinical needs in line with the legislation. Even relatively minor medical conditions constitute valid clinical needs if the prescriber considers that this type of treatment is appropriate for their individual patients. We do, however, wish to continue to monitor the situation given the rapid rise in notifications.'
The 'notifications' refers to the number of importations of polidocanol notified to the MHRA. From 1st November 20005 a change in the rules made such notifications mandatory and this appears to have resulted in a substantial increase. The Board of the BAS are not aware of any information suggesting that the use of polidocanol for sclerotherapy has increased greatly in the last 12 months. We consider that all types of venous disease referred to in the CEAP classification constitute 'disease' and not a cosmetic problem for the reasons argued in the correspondence above. Therefore there is a medical indication for treatment and polidocanol CAN be imported legally for this purpose. It is perfectly legitimate for a doctor to prescribe an unlicensed drug in this way if there is no suitable alternative. However, he does take on all responsibility for the consequences of its use.
|
