Meeting Outcomes Statement
Outcome Statement of the Paediatric Medicines Advisory Group meeting 12 June 2008
Outcome Statement of the Paediatric Medicines Advisory Group meeting 12 June 2008Medicine needs in the paediatric health setting
The Advisory Group has identified a priority list of medicines requiring access for paediatric use in Australia, with some alterations made at this meeting. The medicines currently under consideration by the Advisory Group are at Attachment A.
Members noted that the 21st edition of the Australian Pharmaceutical Formulary and Handbook is currently being developed and is due for release later this year. In this context, members discussed the importance of extemporaneous compounding in maintaining and improving access to medicines suitable for paediatric use.
Promotion and evaluation of Advisory Group activities
Members considered a number of strategies to promote and evaluate Advisory Group activities, which will be further developed for consideration at the next Advisory Group meeting.
National and International developments
Members noted the ongoing national and international developments to improve access to medicines suitable for paediatric use.
In particular, members noted that the Department of Health and Ageing had recently released a tender seeking to engage a consultant to conduct a scoping study to explore any barriers to registration and PBS listing of paediatric medicines in Australia as experienced by the pharmaceutical industry.
Members also noted the continuing work being undertaken internationally, particularly the current activities of the European Medicines Agency Paediatric Committee.
The next meeting of the Advisory Group will be held on 11 September 2008 in Melbourne.
Outcome statements are provided after each meeting, so that members can distribute them widely to their networks. For further information on the Advisory Group, please contact:
The Advisory Group Secretariat
Phone: (02) 6289 8023
Attachment A: Medicines currently under Advisory Group consideration - as at 12 June 2008
Clinical need as agreed by the Advisory Group
|Clindamycin suspension||Community acquired MRSA and osteomyelitis.|
|Spironolactone suspension||Congenital heart disease in neonates and chronic lung disease.|
|Ciprofloxacin suspension||Cystic Fibrosis, atypical mycobacterial infections and urinary tract infections.|
|Clarithromycin (Klacid) powder||Pertussis and atypical mycobacterial infections (particularly in immunosuppressed patients).|
|Fusidic acid suspension||Anti-infective used to treat MRSA.|
|Nitrofurantoin suspension||Antibiotic for prophylaxis and treatment of complicated urinary tract infections.|
|Trimethoprim suspension||Antibiotic for prophylaxis and treatment of complicated urinary tract infections.|
|Atenolol solution||Beta-blocker - used to treat hypertension.|
|Gabapentin suspension||Used for neuropathic pain and as anti-convulsant.|
|Aciclovir suspension||To treat herpes simplex infections/ prevent recurrent herpes simplex infections.|
|Midazolam oral solution||Sedative.|
|Calciferol/cholecalciferol||Vitamin D deficiency.|
|Cefuroxime oral suspension||Antibacterial used to treat a range of mild to moderately severe infections.|
|Infliximab||Juvenile chronic arthritis.|
|Ciproflaxacin/ hydrocortisone ear drops||Otitis externa with perforation of the tympanic membrane or a grommet in situ.|
|Ciproflaxacin ear drops||Chronic suppurative otitis media with perforation of the tympanic membrane or a grommet in situ.|
|Clobazam tablets||Resistant epilepsy.|
|Mupirocin topical ointment||Short term use in mild impetigo.|
|Diazoxide suspension||Endocrine conditions with hypoglycaemia/hyperinsulinaemia.|
|Fluconazole suspension||Same indication as current PBS listing for capsule and solution for IV infusion.|
|Itraconazole suspension||Same indication as current PBS listing for capsule plus treatment and prevention of invasive fungal infections in patients with significant neutropenia or neutrophil function defect.|
|Intranasal steroid preparations||Allergic rhinitis.|
|Levetiracetam||Same indication as current PBS listing for tablet|
|Sildenafil suspension||Pulmonary hypertension.|
|Tacrolimus suspension||Organ transplants.|
|Triamcinolone hexacetonide||Steroid joint injections for juvenile idiopathic arthritis.|
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