THE PAEDIATRIC SOCIETY
OF NEW ZEALAND
Secretariat:
Email:
Website:
Weee
Denise Tringham
P O Box 22 234
Wellington 6441
Tel:
(04) 938 4827
Fax: (04) 976 4827
psnz@paradise.net.nz
www.paediatrics.org.nz
18 November 2010
Christine Chapman
Therapeutic Group Manager
PHARMAC
PO Box 10 254
Wellington 6143
Christine.chapman@pharmac.govt.nz
Dear Christine
RE: Proposal to list various pharmaceuticals on the Pharmaceutical Schedule
The Pharmacist and Therapeutics Special Interest Group (P&T SIG) of The Paediatric Society
have reviewed this proposal and would like to comment on the inclusion of the sodium chloride
7% solution and the caffeine citrate oral solution.
Proposal to fund Biomed sodium chloride 7% solution (90 mL) under Section B and Part II of
Section H of the Pharmaceutical Schedule..
The P&T SIG endorses this proposal and notes that the issues identified in our previous
correspondence to PHARMAC 1,2 have been addressed with the pending community
availability of this funded product.
Proposal to fund Biomed caffeine citrate oral liquid under Section B of the Pharmaceutical
Schedule
The P&T SIG endorses the availability of this product for short-term treatment of neonatal
apnoea. However we consider the proposed product has some quality and safety issues for
the intended patient group:
1. Data entry in the Pharmaceutical Schedule
The PHARMAC consultation document, dated 29 October 2010, states a product caffeine
citrate 10mg per ml. However, as we understand, this strength is not correct and the
product manufactured by Biomed is caffeine citrate 20 mg per ml, containing caffeine base
10 mg per ml. The content strength is a crucial point with this particular product and it must
be entered correctly in the Pharmaceutical Schedule.
2. Product label and potential for dosing errors
The Biomed product label states the strengths as “caffeine citrate 20mg per ml” and
“caffeine base 10 mg per ml”. Throughout New Zealand there are various protocols and
reference texts used for the prescribing of caffeine citrate/caffeine base. Some of these
reference texts refer to caffeine base eg. BNFc and others refer to caffeine citrate eg.
Royal Children’s Hospital Melbourne Paediatric Pharmacopoeia. At a recent P&T SIG
Teleconference session it was established that four hospitals use caffeine citrate in their
prescribing protocol and seven hospitals use caffeine base. From experience we are aware
of dosing errors when a prescriber uses the caffeine citrate protocol but prescribes as just
“caffeine”. If the prescription for “caffeine” is not clarified the dose calculated and
administered could be as the caffeine base content which therefore results in a double
dosing error. When this inadvertent double dosing error occurs adverse drug reactions
have resulted eg. tachycardia. We propose that an interdisciplinary education campaign
accompanies the community availability of this product to ensure all health professionals
dispensing and administering this product are aware of this issue and the importance of
clarifying if “caffeine base” or “caffeine citrate” is intended on the prescription. The Safe &
Quality Use of Medicines Group, DHBNZ, may be able to help; in addition dissemination of
“Health of our children: Wealth of our nation”
the information may need to be channelled through the Pharmaceutical Society, the
Paediatric Society and by PHARMAC.
3. Storage of the product
Caffeine citrate oral liquid will precipitate if stored in a refrigerator, therefore PHARMAC
need to be satisfied that community pharmacists are aware of this storage requirement i.e.
it is a product that must be stored at room temperature.
4. Expiry date of the product once opened
Because the product is not stored under refrigerated conditions and also contains no
preservative the labelling should convey a statement “to be used within ? days of opening”.
This expiry date, associated with the time the bottle is opened, should be established by
Biomed; we would consider an “expiry-after-opening” to be no greater than seven days.
This expiry date, once established, will impact on the re-imbursement entitlement to the
community pharmacists.
This letter is supported by members of the Pharmacist & Therapeutics Special Interest
Group of the Paediatric Society:
Brenda Hughes, Senior Paediatric Pharmacist, Auckland City Hospital, & SIG Convenor.
Dr Desiree Kunac, Senior Research Fellow, NZ Pharmacovigilance Centre, University of
Otago.
Dr Philip Moore, Paediatrician, Hawkes Bay Hospital.
Dr Simon Rowley, Neonatologist, Auckland City Hospital.
Libby Martindale, Paediatric Pharmacist, Hawkes Bay Hospital.
Barbara Robertshawe, Paediatric Pharmacist, Christchurch Hospital.
Dianne Wright, Clinical Advisory and Paediatric Pharmacist, Taranaki Base Hospital.
Bevan Clayton-Smith, Paediatric Pharmacist, Palmerston North Hospital.
Caroline De Luca, Senior Paediatric & Formulary Pharmacist, Auckland City Hospital.
Andrew Sutton, Team Leader, Women & Children’s Health, Auckland City Hospital.
Kirsten Simonsen, Paediatric Pharmacist, Dunedin Hospital.
Letter also supported by:
Johana Marcroft, Lead Pharmacist - Medication Safety, Auckland City Hospital
References:
1. www.paediatrics.org.nz PSNZ Submissions/2009/Feedback to Pharmac re Proposal to Fund
Sodium Chloride 7% x 500ml bag (June).
2. www.paediatrics.org.nz PSNZ Submissions/2003-2008/Comments to Pharmac re Proposal to
Fund Hypertonic Saline for use by Cystic Fibrosis Patients in their Nebulisers (October 2007).