USE OF G-CSF TO MOBILIZE PBSC IN NORMAL HEALTHY DONORS - AN INTERNATIONAL SURVEY

A questionnaire was mailed to a senior haematologist in each of 31 cou ntries to investigate the current use of G-CSF for PBSC mobilisation i n normal healthy donors. The questions related to the regulatory statu s of G-CSF, its use in the related and unrelated donor settings, wheth er a national standardised protocol had been developed, which routes o f vascular access were permitted, whether self-administration of G-CSF was allowed, strategies for monitoring long-term aftereffects of the use of G-CSF and the approximate numbers of donors who had received G- CSF in each country during 1996. Responses were received from 28 count ries. Clinicians in all 28 countries are administering G-CSF to relate d donors, and in nine countries also to unrelated donors; the situatio n vis-a-vis unrelated donors is under review in another 11 countries. Responses indicate that approval for the use of G-CSF has come mainly through local research ethics committees. Of those countries permittin g the use of G-CSF in the unrelated donor setting, six permit it for s econd donations, two for both first and second donations, and one in a limited trial situation only. In just one of these nine countries has a national standardised protocol been developed. Self-administration of G-CSF by donors is allowed in 18/27 countries. Venous access is res tricted to peripheral veins in 10/28 countries, the remaining 18 permi t central venous access if peripheral access fails. Regarding the numb er of normal donors receiving G-CSF during 1996, Germany, Israel, Ital y and Spain report more than 100 each, Canada, The Netherlands, South Africa, and the UK report in the range 31-100, and the remaining respo nding countries each report under 30 donors. Methods for long-term fol low-up vary considerably from country to country and involve questionn aires and/or medical examinations, with less than half the responders specifying the need for laboratory investigations.