ࡱ> [^Z bjbjUU i2??3* * mm111$UUUP4UHt)#)#)#HHHHHHH$KMT@H1)""|))@HmmUH---)m8RH-)H--C"GU+pFlHkH0HFN+NGN1GX)#$&-%&)#)#)#@H@H,)#)#)#H))))N)#)#)#)#)#)#)#)#)#* 3:  22 March 2010 Greg Williams Therapeutic Group Manager PHARMAC PO Box 10-254 Wellington 6143 Email: greg.williams@Pharmac.govt.nz Re: Request for funding of Diflucan (Fluconazole) 50 mg/5 mL Powder for Oral Suspension via Discretionary Community Supply Dear Greg, The Paediatric Society would like to propose the funding of Fluconazole suspension (Diflucan) via Discretionary Community Supply (DCS) for prophylaxis and treatment of systemic candidiasis in immunocompromised children. Fluconazole is an antifungal agent used in the adult and paediatric population for the treatment and prophylaxis of specific fungal infections. Capsules are funded in the community in several strengths. The doses required in paediatric patients are often small and can only be measured accurately using a liquid preparation. There is a commercial preparation of fluconazole suspension (Diflucan) registered and available in New Zealand. This is the preferred paediatric formulation; however, this is currently not funded. Families are currently faced with the costs of a relatively expensive medicine on discharge from hospital. No formulation data is available to compound fluconazole extemporaneously into a liquid preparation. We are aware of inappropriate practices in the community, including estimation of doses from the powder content of the capsules or dispersing the contents of the capsules in water and administering the required dose. The contents of the capsule do not disperse evenly in water and accurate dosing cannot be guaranteed. These are unlicensed methods of administration and there is no stability data to support this practice. Fluconazole suspension (Diflucan) is a registered product in New Zealand. The Medsafe datasheet for Diflucan includes the following relevant indications: Systemic candidiasis including candidaemia, disseminated candidiasis and other forms of invasive candidal infection including infections of the peritoneum, endocardium and pulmonary and urinary tracts. Patients with malignancy, in intensive care units, receiving cytotoxic or immunosuppressive therapy, or with other factors predisposing to candidal infection may be treated. Prevention of fungal infection in immunocompromised patients considered at risk as a consequence of HIV infections or neutropenia following cytotoxic chemotherapy, radiotherapy or bone marrow transplant We envisage using Diflucan suspensionfor prophylaxis and treatment of systemic candidiasis in immunocompromised children. This will include children receiving chemotherapy, transplant recipients (solid organ and bone marrow transplant), and children with HIV or other long term conditions reducing their immune system function . PSNZ Feedback Re Request for funding of Diflucan (Fluconazole) 50 mg/5 mL Powder for Oral Suspension via Discretionary Community Supply Fluconazole is considered the treatment of choice compared to other antifungals: Fluconazole has licensed dosing recommendations for all children, including neonates. It is generally well tolerated and requires once daily dosing. Nystatin is used for oral thrush and as it is not absorbable it is not beneficial in preventing systemic candidiasis. It should be used four times a day to prevent oral candidiasis. Itraconazole has undesirable adverse effects, drug interactions and requires therapeutic monitoring. There is also limited data available for dosing in infants. The oral liquid preparation of itraconazole is only funded via DCS for liver transplant patients. The incidence of adverse effects with itraconazole such as diarrhoea, abdominal pain, vomiting, fever, rash and mucositis is higher in the paediatric population. Voriconazole is used specifically to treat invasive aspergillosis infections. It is not appropriate to use this first line to prevent or treat candidiasis. There is currently no antifungal funded by Pharmac in an appropriate paediatric formulation. Hospital exceptional circumstances is required to fund these medicines. If Diflucan suspension gains funding approval via DCS, we believe there will be direct cost savings to the DHB. A 35ml bottle costs $34.56, compared to a day in hospital at approximately $1000. Restricting the DCS criteria to immunocompromised children will prevent inappropriate use of Diflucan suspension and allow usage to be monitored by the appropriate clinical teams. We estimate that usage in the paediatric population will involve 50 patients or less per year. We strongly urge you to look favourably on our request to fund Diflucan suspension for the treatment and prophylaxis of systemic candidiasis in immunocompromised children with review at 6 weeks. Yours sincerely,  Dhrita Khatri On behalf of the Pharmacist & Therapeutics SIG, Paediatric Society of New Zealand This letter is endorsed by: Dr Sarah Strandjord, Paediatric Oncologist, Wellington Hospital, CCDHB Vids Sritharan, Neonatal and Medicines Information Pharmacist, Wellington Hospital, CCDHB Dianne Wright, Clinical Advisory and Paediatric Pharmacist, Taranaki Base Hospital Brenda Hughes, Convenor Pharmacist & Therapeutics Special Interest Group Andrew Sutton, Pharmacy Team Leader, Women & Children's Health, ADHB Caroline De Luca, Senior Paediatric Pharmacist, Starship Childrens Health, ADHB Dr Helen Evans, Paediatric Gastroenterologist/Hepatologist, Starship Childrens Health, ADHB Dr William Wong, Paediatric Nephrologist, Starship Childrens Health, ADHB Dr Elizabeth Wilson, Paediatric Infectious Disease consultant, Starship Childrens Health, ADHB Dr Nyree Cole, Paediatric Haematologist, Starship Childrens Health, ADHB     THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Health of our children: Wealth of our nation   n o u 5 6 s { | ~    \wx弬弬h~h~CJ^JaJh~CJ^Jh4lhrNh6CJ^Jh4lhrNhCJH*^Jh4lhrNhCJH*^JmH sH h4lhrNhCJ^JmH sH h4lhrNh5CJH*^Jh4lhrNh5CJ^Jh4lhrNhCJ^JhrNhCJ^JhrNhh$G-!;CQa     yzgdrNh\]2345{]^_p & F$ d*$gdrNhgd~gdrNh & F% d*$gdrNh245|7oqr18./06?mnϻϻïϻϻϑsϻhhhrNhCJ^J"h4lhrNhhBPCJ^JmH sH hrNhCJ^JmH sH h4lhrNhCJ^JmH sH jhqhrNhCJU^Jh4lhrNhCJH*^JhrNhCJ^Jh4lhrNhCJH*^Jh4lhrNhCJ^Jh~CJ^JaJh~h~CJ^JaJh~h~CJH*^JaJ"pqs90u#n "d 0gdgC]gdrNhgdrNh !#$&')*+PQRijĻ}}ykyyjh$GUmHnHuh$Gh$G5B*CJOJQJphh$GB*CJOJQJphh$G5B*CJ(OJQJphh$G5B*CJ$OJQJphh$G5OJQJ%jh$G5OJQJUmHnHuh7Gjh7GU hgCCJh{/hrNhhwzhrNh^JaJmH sH "#%&()+QR_`abcjz  $If  $If  !Sn#$If !Sn#$If$ x$Ifa$  $Ifd{{{r{ $ !a$gd~gdgC $ !n#a$ !ekde $$If\u+#a  0gdgCgd~,&P . 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The Paediatric Society believes all children and youth should, by right, attain optimal physical, mental and social health and wellbeing.  By working as a coordinated national network of health professionals the Society dedicates its efforts and resources to making official submissions to both Government and Non-Government organisations on issues that will impact on the health and wellbeing of children and young people.

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