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Meeting Outcomes Statement

Outcome Statement of the Paediatric Medicines Advisory Group meeting 12 June 2008

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Outcome Statement of the Paediatric Medicines Advisory Group meeting 12 June 2008

Medicine 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.

Extemporaneous Compounding

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.

Next meeting

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
Email: pmag@health.gov.au

Attachment A: Medicines currently under Advisory Group consideration - as at 12 June 2008

Medicine	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.
Esomeprazole suspension	Reflux.
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.
Voriconazole suspension	Antifungal.
Intranasal steroid preparations	Allergic rhinitis.
Levetiracetam	Same indication as current PBS listing for tablet
Propofol	Anaesthetic agent.
Sildenafil suspension	Pulmonary hypertension.
Sotalol	Cardiology.
Tacrolimus suspension	Organ transplants.
Triamcinolone hexacetonide	Steroid joint injections for juvenile idiopathic arthritis.