The Pharmaceutical Journal Vol 265 No 7114 p396
September 16, 2000 Letters

Paediatrics

Disagreement

From Mr N. E. Ballantine, MRPharmS

SIR,-It is clear from his reply to my letter (PJ, July 29, p162), and previous correspondence, that Dr Jackson and I are never going to agree. However, I would be grateful if you will permit me to make a couple of points in response to his reply to my letter.
My concern, and that of my colleagues working at other paediatric centres, is primarily with regard to two issues. First, that recent and continuing pressure to license medicines in children may, on the basis of the actions of Glaxo Wellcome UK, have unforeseen consequences which will actually make the situation worse rather than better. That is a general point, and it remains to be seen whether this concern is well-founded, or not.
The second issue relates to the actions of Glaxo Wellcome specifically. Glaxo Wellcome took the decision to discontinue these unlicensed medicines without any consultation with the professions. Dr Jackson does not dispute this. Indeed, a couple of years ago, in response to rumours that these products might be withdrawn, I telephoned the medical department at Glaxo Wellcome. At that time I made clear the concerns of the paediatric oncology pharmacist community regarding the possible withdrawal of these products but, understandably in the light of recent events, was given no assurance that such action would not be taken.
Dr Jackson justifies Glaxo Wellcome's position by making a number of points about alternative sources of supply. If I may respond to these in turn:

• The fact that licensed forms of Lanvis and Puri-Nethol continue to be available is irrelevant to paediatric practice. The withdrawn tablets enabled dosage to be adjusted in 5mg increments which is clearly impossible with a 40mg or 50mg tablet
• The companies we were informed could offer these drugs in capsule form, when approached, informed us that they had no previous experience of preparing these drugs in capsules but would possibly be able to do so at some future time. This they have indeed done
• Young children find capsules difficult to swallow; opening them to give their contents in a drink or with food has the potential to expose their families to a cytotoxic drug, and the capsules cannot be split to provide a 5mg dose increment as the tablet could
• The IV formulation of Myleran is unlicensed in the UK, is considerably more expensive than the previously available high-strength tablets, and if used within the same dosing schedule as the tablets would result in significant and costly wastage
• I am unaware of any such discussions with institutions regarding alternative dosing strategies for Myleran - certainly there has been none with the major centre for paediatric bone marrow transplantation at which I work

Dr Jackson points out the number of studies which are ongoing or planned to which paediatric patients will be recruited. This is to be welcomed, but the discontinuation of the unlicensed cytotoxic drugs shows that Glaxo Wellcome is only willing to support paediatric medicine when it suits the company, rather than by responding to the needs of patients. The support those of us working with sick children are looking for is the continued availability of dose forms which we, and they, have come to rely on over many years. The numbers are not small - 400 children are diagnosed with acute lymphoblastic leukaemia each year in the UK and the treatment for boys now extends over three years.
For a business the size of Glaxo Wellcome the costs of maintaining these supplies would be tiny, yet the costs to our patients of withdrawing them are, and will be, significant.

Nigel Ballantine
Specialist Clinical Pharmacist (Haematology Oncology), Birmingham Children's Hospital NHS Trust