Outcome Statement of the Paediatric Medicines Advisory Group (PMAG) meeting 19 June 2012

Outcome Statement of the National Medicines Policy Committee - June 2012

Page last updated: 24 July 2012

PDF printable version of the Outcome Statement of the Paediatric Medicines Advisory Group (PMAG) meeting 19 June 2012 (PDF 221 KB)

Medicine needs in the paediatric health setting

PMAG 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, as a result of PMAG’s efforts, tocilizumab concentrate for injection is now listed on the Pharmaceutical Benefits Scheme, and the listing for cefuroxime oral suspension will be effective on 1 August 2012. In addition, the Pharmaceutical Benefits Advisory Committee (PBAC) has recently recommended an extension of the current Authority Required listing for etanercept.

The achievements of PMAG to date are outlined at Attachment B.

Liaison with stakeholders

Members noted that the PMAG Chair had liaised with a number of pharmaceutical companies and expert paediatric groups since the last meeting to further discuss a number of medicines on PMAG’s priority list, and to seek advice on specific issues in paediatric medicine.

In particular, members noted the advice received from the Queensland Paediatric Cardiac Service regarding the clinical need for atenolol solution for the treatment of hypertension in children, and the advice from the Australian Paediatric Rheumatology Group in relation to the number of potential patients who would require treatment for triamcinolone hexacetonide for the treatment of juvenile idiopathic arthritis. To inform discussions at the next Advisory Group meeting, liaison between the Chair and various stakeholders will continue over the coming months.

Liaison with other agencies

PMAG is continuing to liaise with the Australian Prescriber Editorial Committee in relation to a potential article on the work that is being done by the Advisory Group to improve the availability of medicines for paediatric use in Australia.

PMAG will also remain involved in current antibiotic resistance surveillance activity, which is being led by the Australian Commission on Safety and Quality in Healthcare.

National and International developments

Members noted the ongoing national and international developments to improve access to medicines suitable for paediatric use. In particular, members are pleased to announce that PMAG has been given responsibility for overseeing the development of a national paediatric medicines dosing resource. The project, an initiative of the Australian Health Ministers’ Advisory Council, involves the development of a dosing resource containing the most commonly used medicines in Australia for children and young people from birth to 18 years of age.

The Department of Health and Ageing has engaged Adelaide-based Australian Medicines Handbook Pty Ltd to develop and maintain the paediatric dosing resource, which will be available for sale from mid-2013. The resource will be for use by all Australian health professionals prescribing, dispensing, and administering medicines to children.

Next meeting

The next meeting of the Advisory Group is scheduled for late October in Canberra.

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 visit the Paediatric Medicines Advisory Group website.
or contact the Advisory Group Secretariat:

Phone: (02) 6289 8023
Email: pmag@health.gov.au

Attachment A

Medicines currently under Advisory Group consideration - as at 19 June 2012

Clinical need as agreed by the Advisory Group
Clindamycin suspensionCommunity acquired MRSA (in skin and soft tissue infection) and osteomyelitis
Calciferol/cholecalciferolVitamin D deficiency
Clobazam tabletsResistant epilepsy
Triamcinolone hexacetonideSteroid joint injections for juvenile idiopathic arthritis
Mycophenolate sodiumNephrotic syndrome
Diazepam mixtureChronic spasticity
AtenololBeta-blocker used to treat hypertension
LeuprorelinPrecocious puberty
AdalimumabUveitis related to juvenile idiopathic arthritis, enthesitis and crohn disease
AnakinraSystemic juvenile idiopathic arthritis
LeflunomideJuvenile idiopathic arthritis
InfliximabAnkylosing spondylitis
AbataceptPolyarticular juvenile idiopathic arthritis
BosentanPulmonary hypertension
Glycopyrrolate oral solutionDrooling
MelatoninSleep disorders (particularly those with neurological impairment/cortical blindness)
EtanerceptTo treat severe psoriasis in paediatric patients who have not responded to or are unable to receive other therapies.
NatalizumabRefractory multiple sclerosis
Midazolam buccal preparationStatus epilepticus
KindergenMedicinal food for older children
6-Mercaptopurine and Thioguanine suspensionAcute leukaemia
Tacrolimus suspensionOrgan transplant

Attachment B

Paediatric Medicines Advisory Group Achievements

To date, as a result of the Advisory Group’s work, the following eight new medicines have been listed on the Pharmaceutical Benefits Schedule (PBS).

*Clarithromycin powder for oral liquidAbbott Australasia
Levetiracetam oral solutionUCB Pharma
Voriconazole powder for oral suspensionPfizer
Ondansetron syrupGlaxoSmithKline
Lansoprazole tablet (orally disintegrating)Wyeth Australia (Pfizer)
Artemether with Lumefantrine dispersible tabletNovartis Pharmaceuticals
Fluconazole powder for oral suspensionPfizer
Cefuroxime oral suspensionGlaxoSmithKline
* Please note that the recent community epidemic of pertussis in Australia has been sustained over the last 3 years. This has resulted in huge increases in children requiring effective therapy to eradicate Bordetella pertussis, either as patients with whooping cough (pertussis) or as contacts of cases. Traditional therapy with erythromycin requires 14 days of therapy of 4 doses per day. Newer therapies, clarithromycin and azithromycin, not only are effective, but are also easier to complete (meaning more children finish their therapy) and have fewer side effects. Having a preparation of clarithromycin means that not only can doctors use therapy with the best evidence against pertussis, but which is also the safest.

There have also been twelve amended listings on the PBS for the following products:

Risperidone oral solutionJanssen-Cilag
Methylphenidate HydrochlorideJanssen-Cilag (tablets) and Novartis Pharmaceuticals (capsules)
Ciprofloxacin ear dropsAlcon Laboratories
Dornase alfa solution for inhalationRoche Products
Albendazole chewable tabletGlaxoSmithKline
Nevirapine oral suspensionBoehringer Ingelheim
TerbinafineNovartis Consumer Health Australasia (cream) and numerous companies for the tablet formulation.
Deferasirox dispersible tabletNovartis Pharmaceuticals
Ribavirin with pegylated interferonMerck Sharp and Dohme
Tocilizumab concentrate for injectionRoche
Further information on the medicines listed above, including the indication, is available at the PBS website.

The work of the Advisory Group has also improved access to diazoxide oral suspension (Aspen Pharmacare) via the Special Access Scheme.

The Advisory Group relies on the willingness of companies and thanks those listed above for their assistance in making these medicines available for paediatric use in Australia.Top of page