ࡱ> ikh 6bjbj T-3* * mm1114eeeh< <eBE(mmmm###aBcBcBcBcBcBcB$DDGJB1y+!#%#|y+y+BmmmmB...y+m8mRmaB.y+aB..m>"AmP(#BeU,AfMBB0BAnG=-jGAAG1BL#R%.'T(###BB-j###By+y+y+y+G#########* 3:  30 September, 2009. Dr Paul McCormack, Chairman, Review Panel, High Cost Highly Specialised Medicines Committee c/- Megan Simmons, Ministry of Health, PO Box 5013 Wellington 6145 Dear Dr McCormack Re: High Cost Highly Specialised Medicines: Potential and Affordable Means to improve access to these Medicines Thank you for the opportunity to feedback to the Panel on this topic. The following is a collation of ideas from paediatricians and paediatric pharmacists who have long standing involvement with paediatrics in New Zealand and in some cases the U.K. They are all actively involved in the Pharmacists Special Interest Group of The Paediatric Society through regular meetings via the Telepaediatric network. Children aged 0 to 18 years of age comprise up to 25% of the New Zealand population1. A small proportion of them will require specialised medical treatment and these children should have the same access to medicines as an adult patient. In 2007/8, Starship Childrens Health treated approximately 98,776 patients2, many of whom were prescribed one or morehighly specialised medicine or formulation. Many of these medicines were not high cost. The main issues of concern surrounding the supply of medicines for children are outlined below and are further demonstrated in the following case studies. a) Appropriate dosage form of medicines This forms the basis of Highly Specialised medicines for children. Worldwide the number of medicines registered in child-friendly form (i.e. oral liquids) is small. This is due to the small number of drug trials that have been performed in the paediatric population. Small children are unable to swallow tablets and capsules or may require only a portion of the available dosage form. Therefore a medicine must be supplied to them in an appropriate dosage form that will give an accurate dose. b) Registered medicines in New Zealand To register a drug in New Zealand a drug company must submit pharmacokinetic and pharmacodynamic information to Medsafe. This registration is termed an Approval for Distribution, but may be called a licence or registration in other countries. The data sheet supporting an approved drug will specify the registered/approved patient age groups and the formulation. Through the tender process Pharmac will only consider registered medicines and this process covers most medicines for adults but not many medicines for children. Childrens medicines that are licensed, funded and available in other parts of the world are often not available in New Zealand. This may be due to small volume sales returns and high Medsafe registration fees. Such medicines are only available via Section 29 of the Medicines Act and require funding by the DHB hospital using the Exceptional Circumstances scheme. c) Pharmacist requires stable formulation & funded ingredients. Many medicines are prepared into a liquid formulation by community pharmacies with little or no stability data supporting their use. Different pharmacies produce different end products, using variable formulas3,4, resulting in inconsistent strengths, taste, storage conditions, shelf life, and potentially different absorption characteristics leading to unpredictable and variable clinical efficacy. Prepared liquid medicines are often assigned a short expiry of seven days, requiring parents to return to their pharmacies every week to collect a new supply. Some hospital pharmacies have the facilities and expertise to research stability data information and collate appropriate formulations. There are concerns that community pharmacies may not have access to this information. d) Brand Changes and Discontinuations Disruptions in medicine supply and product withdrawal pose another problem for paediatric patients. Often in these cases there is not a suitable paediatric alternative medicine or manufacturing formulation readily available. This can lead to delays or interruptions in therapy whilst an alternative preparation is sourced from overseas or stability data to support a pharmacist-manufactured formulation is investigated. Case 1 Child (18 mths old) discharged with script for Azathioprine 10mg once daily Child needs: oral liquid Community pharmacy: unable to supply as vehicle for formulation (Ora Plus/Ora Sweet) is not funded. Also requires cytotoxic precautions for manufacture. Medsafe status: not registered in NZ U.K. Status: Special Licence. NZ Pharmaceutical Schedule: 50 mg tablets funded HEC Application: required Hospital Pharmacy: supplied from hospital pharmacy and charged back to hospital budget Case 2 Infant (2 yrs old) discharged from Starship with script for Flecainide oral liquid 25 mg every 12 hours Infant needs: oral liquid Community pharmacy: can supply but not funded Medsafe status: not registered in NZ (Penn brand) UK status: Special Licence. NZ Pharmaceutical Schedule: Section 29 medicine: Not funded in the community. HEC Application: required Hospital Pharmacy: supplied from hospital pharmacy and charged back to hospital budget Case 3 Infant (3 yr old) prescribed Amiodarone 60 mg orally daily Infant needs: oral liquid Community pharmacy: must manufacture but requires stable formulation & funded ingredients. Stability of formulation has an expiry of seven days therefore requiring the caregiver to return to the community pharmacy every seven days to obtain a new supply. The pharmacy may not carry or be reluctant to buy ingredients because expiry dates may be reached before the stock is used up. Medsafe status: Tablets for manufacturing oral liquid are funded. NZ Pharmaceutical Schedule: Ingredients for manufacture are funded. Case 4 Child age 7yrs currently stabilised on funded brand of topiramate. Pharmac contracts to purchase another brand of topiramate. Childs therapy is changed to newly funded brand with loss of seizure control. We submit the following recommendations to help improve childrens access to highly specialised medicines in New Zealand. 1.Hospital Exceptional Circumstances (HEC): The current process to apply for exceptional circumstances funding is time consuming and can be lengthy. In 2009, 30% of HEC applications from ADHB were for paediatric patients. This clearly demonstrates the disparities between access to medicines for adults and children. The existing criterion for community exceptional circumstances needs to be reviewed. Currently the restriction of a rare condition or circumstances means most patients can only obtain hospital exceptional circumstances, thus substantially inhibiting the ability to provide appropriate treatment to patients from a community access point. This also means the cost is transferred to the DHB. The impact of this on smaller DHBs is significant and Starship cannot end up funding medicines for children around New Zealand. Starship doctors apply for many HECs on behalf of other DHBs, as it is the specialist centre where treatment is initiated. Exceptional Circumstance applications are commonly made for paediatric patients to use a medicine that would be available to an adult patient in an appropriate dosage form. A considerable amount of time involving medical and pharmacy staff is spent collating information and evidence to support an application. Often there is limited evidence available for paediatric sub-specialty medicines as compared to adult medicine. Randomised controlled trials and other clinical studies are often not possible in the paediatric population resulting in many clinical decisions being based on clinical experience and case reports. Therefore, the clinical opinion of the paediatric sub-specialist is the most relevant form of evidence. The EC scheme needs to be adapted to allow for this disparity and improve efficacy with the application process. 2. Section 29 Medicines and the Pharmac tender process: As part of the tender process Pharmac should be seeking paediatric options where appropriate. Many of these medicines may be imported to New Zealand as unregistered medicines and the process needs to make an allowance for the funding of these medicines. This may need to be controlled via the Special Authority scheme, but would allow children access to stable formulations produced by licensed pharmaceutical manufacturing companies eg. Penn flecainide oral liquid 25 mg/5ml. 3. Ora Plus/Ora Sweet as a medicine vehicle/ suspending agent Funding of an evidence-based suspending agent such as Ora-Plus/Ora-Sweet is required to improve access to appropriate medicines for children. This product can be used for over 25 different medicines and produces a higher quality suspension with an expiry of at least 30 days. It is promising to note that Pharmac are reviewing the possibility of including this product in the Pharmaceutical Schedule and we look forward to discussing this further with them. 4. Hospital Pharmacy Manufacturing: There may be a need to increase the use of specialist hospital pharmacies or special manufacturing units to supply medicines in an appropriate paediatric form. This may provide better access to appropriately researched formulations, appropriate ingredients, manufacturing facilities and expertise. These pharmacies may require increased funding to do this eg. funding for courier fees to transport these medicines to a patients local pharmacy. 5. Pharmaceutical Schedule: Community pharmacists need to be provided with access to an agreed database of approved formulations. These formulations could be published within a paediatric section of the NZ Pharmaceutical Schedule. Community pharmacists would be paid to prepare these approved formulations, including excipients. 6.Product Discontinuation and Brand Changes There needs to be an introduction of Best Practice Guidelines to ensure adequate notification of product discontinuation and brand changes. Similar guidelines exist in Australia and the U.K. 7. Paediatric Advisory Group: In 2007 the World Health Organisation spearheaded a global campaign 'make medicines child size' to raise awareness and accelerate action to address the need for improved availability and access to safe child-specific medicines for all children under 15. The US, Europe and Australia all have advisory groups and initiatives in place to address paediatric specific issues regarding access to medicines. There is a need for New Zealand to develop a Paediatric Advisory Group to review medicines being funded by Pharmac with paediatric issues in mind which would include specialist medical and pharmacy representation. PTAC (Pharmacology & Therapeutics Advisory Committee) Appropriate paediatric specialist representation is also required on PTAC when medicines being submitted have paediatric applications. PTAC should be encouraged to seek advice from paediatric subspecialists in their disciplines, acknowledging that they can play an important role in providing information on medications which have paediatric usage. The letter was prepared from the suggestions of members of the Pharmacists and Therapeutics Special Interest Group of the Paediatric Society. Dr Rosemary Marks Brenda Hughes President Convenor, Pharmacist and Therapeutics SIG References: Statistics New Zealand  HYPERLINK "http://www.stats.govt.nz" www.stats.govt.nz Starship website:  HYPERLINK "http://www.starship.org.nz" www.starship.org.nz Kairuz T, Chhim S, Hasan F et al. Extemporaneous compounding in a sample of New Zealand hospitals: a retrospective survey. New Zealand Medical Journal 2007; 120: 1-9 Lowey A, Jackson M. A Survey of extemporaneous preparation in NHS trusts in Yorkshire, the North-East and London. 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The Paediatric Society believes all children and youth should, by right, attain optimal physical, mental and social health and wellbeing.  By working as a coordinated national network of health professionals the Society dedicates its efforts and resources to making official submissions to both Government and Non-Government organisations on issues that will impact on the health and wellbeing of children and young people.

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