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.