PSNZ Submission - Towards NZ Medicines Strategy

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THE PAEDIATRIC SOCIETY
OF NEW ZEALAND
Project Manager:
Email:
Robyn Liddell
P O Box 22 234
Wellington
Tel:
(03) 548 4254
Mobile: 0274 455 796
robyn.psnz@xtra.co.nz
March 2007
Towards a NZ Medicines Strategy: Consultative Document
The framework of this document, as recommended by WHO, focuses on the following
objectives:
1. Access to medicines
2. Quality, safety and efficacy
3. Optimal use of medicines
Our response to this document from a paediatric pharmacy perspective is:
1.
Access to Medicines:
Community Funding of Children’s Medicines:
The current Pharmac tender process for obtaining funded medicines can sometimes
disadvantage children who may require “niche” products and often in small volumes. These
products are frequently not funded. This has, in part, been addressed by the Hospital
Exceptional Circumstances (HEC) approval, however this application process places an extra
burden on the time restraints of hospital medical and pharmacy personnel. Following HEC
approval the medicines can only be obtained from a DHB hospital, increasing the workload of
hospital pharmacies and decreasing access for the child and the family. The family may need
to return to the hospital pharmacy, on a weekly basis, to obtain a manufactured medicine. This
may be an impossibility for a child living in a rural environment and these children may
therefore be disadvantaged in obtaining an optimal medicine.
The Pharmacists Special Interest Group (SIG) of the Paediatric Society of New Zealand is
working with Pharmac in an endeavour to increase the number of government funded
medicines for children.
Proprietary Medicines for Children:
The pharmaceutical industry has been slow to provide appropriate proprietary formulations for
children. This may result in children being supplied with a medicine which is manufactured as
an extemporaneous preparation by a pharmacy. These preparations may have unknown
stability and therefore provide unknown efficacy. Their short shelf-life may mean the family
must return to the pharmacy (community or hospital) on a weekly basis to obtain further
supplies.
New Zealand Availability of Proprietary Medicines for Children:
Several proprietary formulations available for children in other countries are not available in
New Zealand, despite the drug being available as a formulation appropriate for an adult. An
example of this is trimethoprim oral liquid which is available in the U.K. for children but the only
drug preparation available and funded in New Zealand is trimethoprim tablets.
“Health of our children: Wealth of our nation”
1
Continuity of Supply of Medicines:
A continuity of supply of appropriate medicines is essential to provide optimal treatment for
children.
In summary:
 Children should not be disadvantaged in the government funding of medicines,
but should receive the same funding status as is provided for adults.
 Medicine availability from community pharmacies should be easy for the child’s
parent/ caregiver.
 The pharmaceutical industry must be encouraged to provide appropriate
proprietary products for children.
 Children in New Zealand should have access to the same proprietary products
as those available to children in other countries.
 There must be continuity of supply of medicines for children.
2. Quality, Safety, Efficacy:
Quality:
Global incentives to stimulate drug trials in children will result in an improved quality of
children’s medicine. A drug found to be safe and effective in children will be produced, by
the pharmaceutical industry, in an appropriate children’s formulation. These products will
have known stability, will be manufactured under regulatory quality assurance practices,
and be packaged in regulatory approved packaging. This will result in a reduction in the
current inconsistent quality of extemporaneous medicines produced by pharmacists. (#1
Access to Medicines/Proprietary Medicines for Children).
Safety and Efficacy:
Drug dose prescribing for children is often inconsistent due to minimal or no regulatory
approved data for many drugs. Drug dose regimens may be obtained from a variety of
sources: a paediatric pharmacopoeia, evidence-based literature, local prescribing
experience, or extrapolation of adult data. There are difficulties and inconsistencies within
all these sources leading to a potential for a drug dose regimen to be subtherapeutic, toxic
or produce an adverse drug reaction.
An increase in regulatory data coupled with the development of national guidelines for
children’s drug dosing will increase the safety and efficacy of drug treatment in this patient
group.
In summary:
 New Zealand must support the global incentives to stimulate drug research in
children. The flow on effect will be safer and more efficacious drug dosing
and the availability of appropriate drug formulations for children.
3. Optimal Use of Medicines
Pharmacists specialising in paediatrics have a role to play in the optimal use of medicines
for children: information resource, education, and communication.
Information Resource:
Paediatric pharmacists are a resource of information for hospital medical and nursing staff
regarding drug treatment for children. This is particularly necessary for those drugs with no
regulatory data to provide pharmaceutical, dosing and formulation advice ( #2 Quality,
Safety & Efficacy).
Education:
Paediatric pharmacists educate parents and families about their children’s medicines. This
is important at the time of discharge from hospital when medicine doses, drug indications,
storage, and collection of medicine repeats is discussed. Written information on some
drugs (Patient Information Leaflets), produced by the hospital pharmacy, are supplied to
parents also.
Communication:
Communication with pharmacists in the community is undertaken at the time of a child’s
discharge from hospital, in an endeavour to ensure a continuity of medicine supply. This
may involve discussions on the supply or manufacture of a medicine.
In summary:
 Paediatric pharmacists contribute significantly to the optimal use of
medicines for children. However there needs to be increased recognition of
this sub-speciality to ensure a better outcome for medicines for children.
Brenda Hughes
Chair of Pharmacy Special Interest Group
Paediatric Society of New Zealand.
William Wong
Chair Drugs and Therapeutic Special Interest Group
Paediatric Society of New Zealand.
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