ࡱ> vv\wbwdwpwrwtwvwxwwwwxJxLxNx|x~xTyVyXy\ybyfy8z>z@zLzNzPzRzTzz{{jlؖږܖ"$&*8ln*չCJH*5CJ0JCJjCJU jCJUCJ5 jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH 0JCJmH0JCJj0JCJUCJ4z@{B{D{F{{{{{{{ؕ 8XZ&(* !$ ! 10 September, 2008 Geraldine MacGibbon Therapeutic Group Manager PHARMAC PO Box 10 254 Wellington 6143 E-Mail  HYPERLINK mailto:geraldine.macgibbon@pharmac.govt.nz geraldine.macgibbon@pharmac.govt.nz Thank you for the opportunity to comment on the following proposal: Proposal for Strattera (atomoxetine), Humalog (insulin lispro with insulin lispro protamine suspension), Zyprexa and Zyprexa Zydis (olanzapine) and Actos (pioglitazone) Atomoxetine (Strattera) Paediatric Society members welcome the proposal to fund atomoxetine, and thank PHARMAC staff for their efforts in achieving this. We make the following points: The proposal states that the Special Authority application may be from any relevant practitioner. We seek clarification as to which practitioners are considered relevant. We note that stimulant medications require application by a paediatrician or psychiatrist. Applications by General Practitioners for children over the age of 6 years are permitted, providing the application is on the recommendation of a paediatrician or Child Psychiatrist. Given atomoxetine is intended to be used as a second line treatment, we are of the opinion that consultation with a paediatrician or Child Psychiatrist should be a requirement. We note that the approval for atomoxetine is to be given for six months only. This seems appropriate for initial approval as six months is adequate for assessing clinical effect. However we submit that renewals should be for at least 12 months. Children who require pharmacological treatment for ADHD generally require treatment for several months and often long-term treatment for a period of years. A balance between ensuring treatment decisions are regularly reviewed, and avoiding requiring clinicians to carry out administrative tasks that do not contribute to improved clinical care needs to be maintained. We note the requirement for the applying practitioner to state that the child will not be receiving atomoxetine in combination with a stimulant. Clinical experience with the use of atomoxetine in New Zealand is limited. However, there appears to be a small group of children who benefit from a combination of atomoxetine and a small dose of stimulant. Support for this approach is now emerging in the literature1. We note that randomised controlled trials will be required to establish a sound evidence base for combination therapy. As atomoxetine and methylphenidate have different mechanisms of action, there is theoretical support for synergistic effects. As the elimination pathways are different one would not expect interactions between these two pharmaceutical agents, although appropriate clinical monitoring should always be provided. We therefore submit that this requirement should be removed. Humalog The Paediatric Society supports the proposed changes. Olanzapine and Pioglitazone The Paediatric Society has no comments specific to this part of the proposal General comments on medications for use in paediatric settings The importance of having formulations appropriate for use in paediatric settings available, cannot be overemphasised. Children, especially infants, children aged less than 6 years and children with disability and swallowing dysfunction, are often unable to take tablets or capsules. Palatable liquid formulations are essential for this group. The number of children requiring liquid formulations of medications more commonly used in adult settings is small; for example very few children are on antihypertensives, diuretics or thyroxine. However those that do need these medications should have access to appropriate paediatric formulations. While retail pharmacies will make up solutions for parents, there are a number of potential problems with this practice: Risk of measurement errors leading to dosage errors Risk that parents/caregivers will not ensure suspensions are adequately shaken prior to administration leading to dosage errors Short shelf life of extemporaneously compounded formulations, so that parents have to collect new supplies on a very frequent basis. This is particularly difficult for families with limited resources, a heavy burden of care or poor organisational skills, and those living in rural or remote areas. Paediatric Society members have particular concerns at present, with formulations of thyroxine (for infants with congenital hypothyroidism) and hydrocortisone (for infants with congenital adrenal hyperplasia). Our Diabetes and Endocrinology Special Interest Group is developing a position paper on this to assist with future decision-making. Pliszka SR, Crismon ML, et al. The Texas Children's Medication Algorithm Project: Revision of the Algorithm for Pharmacotherapy of Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry 2006; 45(6): 642-657.  Rosemary Marks President THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Proposal for Strattera (atomoxetine), Humalog (insulin lispro with insulin lispro protamine suspension),  PAGE 2 Zyprexa and Zyprexa Zydis (olanzapine) and Actos (pioglitazone) Health of our children: Wealth of our nation tu !=  /01HI&)*01ɼ0JCJj0JCJUCJ5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH5 jUmHCJmH B*CJmH nH CJH*5CJ0JCJjCJU jCJUCJ/+EM[kl|V n  & F# & F#+EM[kl|V n  !=} 01>?@ABIYhxſ    $  "   "  " #   #   #   ^ #  #   #  # E !=} 01 $x$ $  & F$d & F"1>?@ABIYhx4tuv $ !n# ! $$ u+#$ $  $ !Sn# $ !Sn#4tuvxyz{   ((((((((Jb:BHr(+D3&} [QEQEQEQEQEQEQEQEQY1topqk+fS ?3}3EVNy-m]"3}:9z}Z}P '>S֭EQEQEQEQEQEQEQEQEE412,!A,oX 4Mqypdx\egc N }!1AQa"q2#BR$3br %&'()*456789:CDEFGHIJSTUVWXYZcdefghijstuvwxyz? (((((((((((((((((((((((((((((((((((((((((((((((((((((]^ElQi%!#AoJ&%ot˫{u+֢R GB)QEQEQEQEQEQEQEQEQES8TO =Űn Ԛ 0* AY_/IXwX%'#*VQEQEQEQEQEQEQEQEQEYL>q!>ִ" ɥE&b( 3Fb46 M5ܒK1$ԒjQEQEQEQEW?oEAX\<(((si]D H!wX29봜n:AEQX.KỨl>E[dq/"{PYNP*$b8 _Aǻw8Z(DVTfҤ'^ kd)Y>+JEQEQEQ\i8-5f8WI^frcEQEQEOSK.N$D'ԩv)F&O.pC ߥ+ 7 m٤@A$EC0N1ߥ[Ҵb$ͼst*oaֵrWu&X࠰ <~7k94p 2IU$ھy0mje ai7rs= OH<˞34d=>gA!mZhﱳ2vb2A琠=OZ"+ $S UQwUIi v# ;[Yn%8HMgF y)U 0PFvnIEI߽]$Ȥ+=FIkR(3*)f!T xSb&de =EKE*4=PgT|j:t.$39KdzH((4JB 1\N@ sG~rw4(t(mmlq.ўԟE֊!/%w01Ȑ[@29:?&͗c1!JRMKJfylk#S2 %uؙ$wo6P"e &\Z7V֒vH<5kH.(!0cOrI?Ai:0MFӒp*#!`@8_Ċ."mWPEÃ2)P2܎0$ԓYUc\0!,u#c[\VHmޞ_SF1x--ykX5U.M.>ebq^j~ ]rڄ0$n[KeZAm(BFTwP -JX3vТ}Zy6yF3=QLeVRR0AEgaI'dhA ƚm(6r4q??/KZ))ׇ4^>?Ξc֙5Cѧjn5@?o F?.<-t㡺v@āV Eu(2AdRQETK8Dnm(u^  XG59].qg12aY 4IٰF꾛\u\ʑi0Яfc9ZZ} WH 0ij}ɫp[Al 85 ?Ju ʄP{qTƓw o^"p$X }YsO:,S\_`f?P HR% KEQP;hљzRk';z\aS J쵯EQEQEQEQEQETv^@\IJDUAJ̕ԑʗq z0e'֜\r{"S''ܞ;b=Ks%-:l,>Z((( ?JHumalog (insulin lispro with insulin lispro protamine suspension), Zyprexa and Zyprexa Zydis (olanzapine) and Actos (pioglitazone) Atomoxetine (Strattera) Paediatric Society members welcome the proposal to fund atomoxetine, and thank PHARMAC staff for their efforts in achieving this. We make the following points: The proposal states that the Special Authority application may be from  any relevant practitioner . We seek clarification as to which practitioners are considered relevant. We note that stimulant medications require application by a paediatrician or psychiatrist. Applications by General Practitioners for children over the age of 6 years are permitted, providing the application is on the recommendation of a paediatrician or Child Psychiatrist. G [H@HNormal$*$d @OJQJmH 00 Heading 1$@&500 Heading 2$@&>* Heading 3m$$*$@& \R" b2> Y!r"B%(*-0R3"68;>bA2DGI56@CJ00 Heading 4$@&CJ44 Heading 5$@&5CJ44 Heading 6$@&5CJ88 Heading 7 $$@&5CJ44 Heading 8 $$@&5<A@<Default Paragraph Font<<Address$5OJQJhmH nH 0@0Header  !CJ0 0Footer  !CJ(U@!( Hyperlink>*B*8V18FollowedHyperlink>*B* LBBL Body Text$*$1$ p@ @hnH F>RFTitle$*$1$ p@ 5CJ0hnH .Pb. Body Text 2CJXCrXBody Text Indent$*$ 0@CJ2Q2 Body Text 3$CJ W Strong544 No Spacing CJmH nH &)@& Page Number225 >*>nnnnnnnnq11vtX!(*q!t  ,R$@yV7e\]{W- W>@&  ( =z43 N CE%"  8   BCqDELFVSS?-;lbn2qk\D@ORQ8Q* gw  W <b14\5q<O>B 1 8w1N/ : f 1  y?  u M  4  `6U:LsNA_cknkAehS)8Z' sZ' *b?@`CE%"   TB CnDExFf%Ip,0A  K *   8 h  L  D kk nPn&k X>>@@`4B "H2   #  #$H2   # | N  3  N  3  TB  c $DjJ |( ?   C AC:\Documents and Settings\Denise\WORK\PSNZ Docs\Letterheads and Logos\RM.JPGB S  ?6 a4q=^tuD$t#u!*lr^`vwy^{(*  vwyDenisepC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ pharmac 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.docDeniseC:\Documents and Settings\Denise\WORK\PSNZ Docs\Submissions and Position Statements\2008\PSNZ Response to Pharmac Re Proposal for Strattera, Humalog, Zyprexa 10 sep.doc$|} D~NsrtZ*PpTVxGzfm "W 1 JRg :pKx=FP v  {n -  :. CB|0 1jB1 J3ѪnV 3 `l9 -J &X T] qc  r\4 t :u [ yW.... OJQJo( OJQJo( OJQJo( OJQJo(hh. hhOJQJo(^`.^`OJQJ- hh^h`OJQJo(0^`0o(. hhOJQJo(h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hH^`o(. ^`hH. pLp^p`LhH. @ @ ^@ `hH. ^`hH. L^`LhH. ^`hH. ^`hH. PLP^P`LhH.hho(. hhOJQJo( hhOJQJo( hh^h`OJQJo(hh.h ^`hH.h ^`hH.h pLp^p`LhH.h @ @ ^@ `hH.h ^`hH.h L^`LhH.h ^`hH.h ^`hH.h PLP^P`LhH.hh.0^`0o(.?o(.hh>*o(.?o(. hhOJQJo( hhOJQJo( hhOJQJo(?o(.hho(. hhOJQJo( hhOJQJo(h^`OJQJo(hHh^`OJQJ^Jo(hHohpp^p`OJQJo(hHh@ @ ^@ `OJQJo(hHh^`OJQJ^Jo(hHoh^`OJQJo(hHh^`OJQJo(hHh^`OJQJ^Jo(hHohPP^P`OJQJo(hH$&XP rV 3B1CB|0~}| :.mJ3"[T]qc-J 1{n -v :uKx= tl9JRg yW1$WW8Num1WW8Num2@^^LU^]@@GzTimes New Roman5Symbol3& zArial?Bodoni BookEAGaramond BoldA& Arial Narrow?5 zCourier New;Wingdings"qhsZɆZɆC† !#20E] TAX INVOICEracpDeniseiven atomoxetine is intended to be used as a second line treatment, we are of the opinion that consultation with a paediatrician or Child Psychiatrist should be a requirement. We note that the approval for atomoxetine is to be given for six months only. This seems appropriate for initial approval as six months is adequate for assessing clinical effect. However we submit that renewals should be for at least 12 months. Children who require pharmacological treatment for ADHD generally require treatment for several months and often long-term treatment for a period of years. A balance between ensuring treatment decisions are regularly reviewed, and avoiding requiring clinicians to carry out administrative tasks that do not contribute to improved clinical care needs to be maintained. We note the requirement for the applying practitioner to state that the child will not be receiving atomoxetine in combination with a stimulant. Clinical experience with the use of atomoxetine in New Zealand is limited. However, there appears to be a small group of children who benefit from a combination of atomoxetine and a small dose of stimulant. Support for this approach is now emerging in the literature1. We note that randomised controlled trials will be required to establish a sound evidence base for combination therapy. As atomoxetine and methylphenidate have different mechanisms of action, there is theoretical support for synergistic effects. As the elimination pathways are different one would not expect interactions between these two pharmaceutical agents, although appropriate clinical monitoring should always be provided. We therefore submit that this requirement should be removed. If necessary, this requirement could be replaced with a requirement that all children receiving Special Authority approval for atomoxetine should receive an adequate trial of monotherapy with an appropriate and effective daily dose of atomoxetine before combined therapy is considered. It should be noted that the data sheet recommends that atomoxetine dosage is graded up over two to four weeks. Stimulant medication is withdrawn during this period. Humalog The Paediatric Society supports the proposed changes. Olanzapine and Pioglitazone The Paediatric Society has no comments specific to this part of the proposal. General comments on medications for use in paediatric settings The importance of having formulations appropriate for use in paediatric settings available, cannot be overemphasised. Children, especially infants, children aged less than 6 years and children with disability and swallowing dysfunction, are often unable to take tablets or capsules. Palatable liquid formulations are essential for this group. The number of children requiring liquid formulations of medications more commonly used in adult settings is small; for example very few children are on antihypertensives, diuretics or thyroxine. However those that do need these medications should have access to appropriate paediatric formulations. While retail pharmacies will make up solutions for parents, there are a number of potential problems with this practice: Risk of measurement errors leading to dosage errors Risk that parents/caregivers will not ensure suspensions are adequately shaken prior to administration leading to dosage errors Short shelf life of extemporaneously compounded formulations, so that parents have to collect new supplies on a very frequent basis. This is particularly difficult for families with limited resources, a heavy burden of care or poor organisational skills, and those living in rural or remote areas. Paediatric Society members have particular concerns at present, with formulations of thyroxine (for infants with congenital hypothyroidism) and hydrocortisone (for infants with congenital adrenal hyperplasia). Our Diabetes and Endocrinology Special Interest Group is developing a position paper on this to assist with future decision-making. Pliszka SR, Crismon ML, et al. The Texas Children's Medication Algorithm Project: Revision of the Algorithm for Pharmacotherapy of Attention-Deficit/Hyperactivity Disorder. J Am Acad Child Adolesc Psychiatry 2006; 45(6): 642-657.  Rosemary Marks President THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Proposal for Strattera (atomoxetine), Humalog (insulin lispro with insulin lispro protamine suspension),  PAGE 2 Zyprexa and Zyprexa Zydis (olanzapine) and Actos (pioglitazone) THE PAEDIATRIC SOCIETY OF NEW ZEALAND Secretariat: Email:Denise Tringham P O Box 22 234 Wellington 6441 Tel: (04) 938 4827 Fax: (04) 976 4827 psnz@paradise.net.nz  Proposal for Strattera (atomoxetine), Humalog (insulin lispro with insulin lispro protamine suspension),  PAGE 2 Zyprexa and Zyprexa Zydis (olanzapine) and Actos (pioglitazone)  Health of our children: Wealth of our nation  Health of our children: Wealth of our nation 8z|`0r`ΪHЮҮNP$& `b & F' & F# & F#+DyK $geraldine.macgibbon@pharmac.govt.nzyK nmailto:geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c+DyK $geraldine.macgibbon@pharmac.govt.nzyK nmailto:geraldine.macgibbon@pharmac.govt.nzyX;H,]ą'c1234tKjLlLLLL"M$M&M*MMOO8Ol]n]*ddddPee&ffstttt u u"u$unupuruuuxvzv|vvv½멣}}5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH jUmHCJmH B*CJmH nH CJH*5CJ0JCJj+CJU jCJUCJ5CJj0JCJU 0JCJmH1vwxyz{KKKKK LL8LXLZL&M(M*MMMOO8O$ ! !((((((((Jb:BHr(+D3&} [QEQEQEQEQEQEQEQEQY1topqk+fS ?3}3EVNy-m]"3}:9z}Z}P '>S֭EQEQEQEQEQEQEQEQEE412,!A,oX 4z@zLzNzPzRzTzz{{չ5 jUmH5B*CJOJQJB*CJOJQJ5B*CJ(OJQJ5B*CJ$OJQJ 5OJQJj5OJQJUmH 0JCJmH0JCJj0JCJUCJ#~xxxxy,yVyXyZy\ydyfyTzzzzzzzzz $ !n# ! $$ u+#$ $  $ !Sn# $ !Sn#z@{B{D{F{{{{{{{ !$ ! 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Submissions

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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