inihrpz2.moh.gov.my/v3/uploads/farmasi/surat edaran dan pekeliling... · pejabat pengarah kan-an...

KEMENTERIAN KESIHATAN MALAYSIA(!rliltigtry of Health Mataysia)Pejabat Pengarah Kan-an Perkhidmatan Farmasi(Offi99 of the Senior Director of pharmaceuticatseruices)Lot 36, Jalan Universiti46200 Petaling JayaSelangorMALAYSIA

Ruj. TuanRuj. KamiTarikh

:

: KKM.600-34t4t04 Jtd. 2 (t+): 29 Julai 2018

No. TelefonNo. FaksimiliPortal RasmiE-mel

03 - 7841 320103 - 7968 2248http ://www. p h a rm acy. g ov, m yC r" al- a n b ara@rirerh€ey, mYpejabatpkpf@moh. gov.my

SEPERT! SENARAI EDARAN

YBhg. Datuk/Dato'/Datin/Tuan/puan,

PEKELILING PINDAAN/TAMBAHAN KEPADA FORMULARI UBAT-UBATANKEMENTERIAN KESTHATAN MALAYSIA BILANGA N 212018

saya dengan segala hormatnya merujuk kepada perkara di atas.

2. Sukacita dimaklumkan bahawa Mesyuarat Panel Kaji Semula Senarai UbatKKM Bil. 212018 yang diadakan pada 12 Julai 2o1B telah mempertimbangkanpermohonan-permohonan pindaan/tambahan kepada Formulari Ubat KKM(FUKKM)" Keputusan pindaan/ tambahan tersebut adalah seperti berikut:

2.1 Pindaanffambahan kepada FUKKM yang diluluskan (JadualA):Lampiran 1: penyenaraian ubat baru ke daram FUKKM.Lampiran 2: Tambahan indikasi bagi ubat-ubatan dalam FUKKM.Lampiran 3: Pindaan kategori preskriber bagl ubat-ubatan dalamFUKKMLampiran 4: Pemansuhan indikasi bagi ubat yang tersenarai dalamFUKKM.

2.2 Permohonan-permohonan yang tidak diluluskan (Jadual B).

3' Penggunaan ubat-ubatan yang terdapat dalam FUKKM perlu dipantaudengan rapi dan sebarang kesan advers hendaklah dilaporkan kepadaJawatankuasa Penasihat Kesan Advers Ubat Kebangsaan (MADRAC) di BahagianRegulatori Farmasi Negara (NpRA).

4. Sebagai makluman, harga yang terdapat datam senarai di lampiran adalahharga yang diisytiharkan oleh pihak syarikat kepada bahagian ini untukmenyenaraikan ubat berkenaan ke dalam FUKKM. Sebarang perbezaan harga(melebihi harga yang ditawarkan) di peringkat hospital/ institusi KKM hendaklahdilaporkan beserta bukti dengan kadar segera supaya tindakan selanjutnya dapatdiambil.

5' Sehubungan dengan itu, diharapkan YBhg. Datuk/Dato'lDatinl-fuan/puandapat menyampaikan maklumat ini kepada fasiliti yang berkaitan di negeri ataujabatan masing-masing. segara kerjasama yang diberikan amaflah dihargai.

Sekian, terima kasih.

,BERKHIDMAT UNTUK NEGARA'

Saya yang menurut perintah,

(DR. RAMLI BIN ZATNAL) *rn. roo/Pengarah Bahagian Regulatori Farmasi Negarab.p. Pengarah Kanan Perkhidmatan FarmasiKementerian Kesihatan Malaysia

FAMY/sar/shmd

X [email protected]/[email protected]/[email protected] +603 - 7841 3366/36'14/3619E *ooa -7g\azz22

2ls

SENARAI EDARAN

1. Timbalan pengarah Kesihatan Negeri (Farmasi)Johor/ Kedah/ Kerantan/ Meraka/ Negeri sembiranT pahang/ perak/sabah/ sarawak/ serangor/ Terengganu/ wirayah persekutuanPutrajayal Wilayah persekutuan Labuan

2. Ketua pegawai FarmasiHospital Kuala Lumpur

3. Ketua Pegawai Farmasilnstitut Kanser Negara

4. Pegawai Farmasi y/mlnstitut Perubatan Respiratori.

5. Pegawai Farmasi y/mPusat Darah Negara

s.k.

1. Ketua SetiausahaKementerian Kesihatan Malaysia

2. Ketua Pengarah KesihatanKementerian Kesihatan Malaysia

3. Setiausaha Bahagian (perolehan & penswastaan)Kementerian Kesihatan MalaysiaAras 7, Blok E7, parcel EPresint 1, pusat pentadbiran Kerajaan persekutuan62509 Putrajaya(u.p Pegawai Farmasi)

4. Pengarah Kanan (Kesihatan pergigian)Kementerian Kesihatan MalaysiaAras 5, Blok E10, pusat pentadbiran Kerajaan persekutuan62590 Putrajaya

5. PengarahBahagian perkembangan perubatanAras 5-7, Blok E1, parcel EPresint 1, Pusat pentadbiran Kerajaan persekutuan62509 Putrajaya

Pulau Pinang/ perlis/Kuala Lumpur dan

3t5

6. PengarahBahagian Pembangunan Kesihatan KeluargaAras 5, Blok E6, Parcel EPresint 1, Pusat Pentadbiran Kerajaan persekutuan62509 Putrajaya

7. PengarahBahagian Kawalan penyakit

Kementerian Kesihatan MalaysiaAras 3, Blok E10, parcel E

Presint 1, Pusat pentadbiran Kerajaan persekutuan62509 Putrajaya

8. Semua Pengarah Kesihatan NegeriKementerian Kesihatan Malaysia

9. Semua Pengerusi JK Kerja Ubat-ubatanKementerian Kesihatan Malaysia

10. Semua Ahli Panel Kajisemuta Senarai Ubat-ubatanKementerian Kesihatan Malaysia

11. PengarahBahagian Regulatori Farmasi NegaraKementerian Kesihatan Malaysia

12. Semua Timbalan PengarahBahagian Amalan & perkembangan FarmasiKementerian Kesihatan Malaysia

13. Ketua Penolong Pengarah KananSektor Bekalan FarmasiCawangan Dasar Polisi perkhidmatanBahagian Perkembangan Kesihatan AwamKementerian Kesihatan Malaysia

14. Timbalan PengarahCawangan Teknologi Maklumat & lnformatik FarmasiBahagian Dasar dan perancangan Strategik Farmasi(bagi tujuan pengemaskinian sis/em phts).

15. Ketua PustakawanKementerian Kesihatan MalaysiaAras 4, Blok E7, Parcel EPresint 1, Pusat Pentadbiran Kerajaan persekutuan62509 Putrajaya

4t5

16. Penolong pegawai perpustakaanlnstitut Pengurusan KesihatanKementerian Kesihatan MalaysiaJalan Rumah SakitOff Jalan Bangsar59100 Kuala Lumpur

17. Unit Teknikat Bantuan perubatanPejabat rimbalan Ketua pengarah Kesihatan (perubatan)Aras 7, Blok E1, parcel EPresint 1, pusat pentadbiran Kerajaan persekutuan62509 Putrajaya.

18. Pengarah FarmasiBahagian perkhidmatan KesihatanKementerian pertahanan MalaysiaJalan padang Tembak50634 Kuala Lumpur

19. Ketua Jabatan FarmasiHospital Canselor Tuanku MukhrizPusat Perubatan Universiti Kebangsaan MalaysiaJalan Yaacob LatifBandar Tun Razak56000 Cheras, Kuala Lumpur

20. Ketua Pegawai FarmasiPusat Perubatan Universiti MalayaLembah Pantai59100 Kuala Lumpur

21. Ketua Pegawai FarmasiHospital Universiti Sains MalaysiaJalan Raja perempuan Zainab ll16150 Kubang Kerian, Kelantan

22. Ketua Pegawai FarmasiPusat Perubatan Universiti rsram Antarabangsa Maraysia (ppurAM)Jalan Sultan Ahmad Shah,25200 Kuantan, pahang

23. Pegawai Farmasilnstitut Jantung Negara

5t5

TERHAD - Edaran dalaman sahaja

PINDMN/TAMBAHAN KEPADA FORMULARIUBAT KKM (FUKKM)BIL,2 TAHUN 2018

PERMOHONAN PINDMN/TAMBAHAN KEPADA FUKKM YANG OILULUSKAN

B, PERMOHoNAN P|NDMN/TAMBAHAN KEPADA FUKKM YANG IIUK_g.lluLusKAN*M _ Formulari Ubat KKM)

1t8

NAMA.UBAT. ." '' ,

losfomycin trometamol 3llranules D1 - penyenaraan uOat OaruVortioxetine 10 mg tablet Dl - penyenaraianlGt baru

Tegafur 100 mg & uracil 224 mgcapsule

Leucovorin Calcium (Calcium Folinate) 15 mg tabletD1- tambahan -lndikasr,

Secukinumab 1S0 mg lnjection (pre_fiiled syringe/pen)

Cetirizine 10 mg tabtetpreskriber A/KK ke B

Etanercept 25 mg and 50 mg injection

BIL NAMA UBAT CADANGAN

PINDAAN JUSTIFIKASI

1

Eribulin Mesilate 0.S mg/mlsolution forinjection

D1 - penyenaraian

ubat baruMarginal clinical benefit

2Pertuzumab 420 mgl14 ml-concentration for solution for infusion

Trastuzumab 440 ng injection

D1 - penyenaraian

ubat baru

a) Moderate effectiveness; no

changes in quality of life despitelonger overall survival whencompared to Trastuzumab +

Docetaxelalone.

b) High budget imptication that isnot sustainable to MOH.

?D1 - tambahan indikasi

(metastatic breastcancef

4.Pomalidomide t mg7 mg 3 mg & 4mg capsules

D1 - penyenaraian

ubat baru

High budget imptic-tion to trrtOH wrtfr

marginal benefit.

E Racecadotrit 10 mg (infant) and 30 mg(children) granules for oral suspension

D1 - penyenaraian

ubat baru

HO1unctive for symptomatic

treatment and non essential

medicine for treatment of acutediarrhoea in infant and children.High drug cost.

a)

b)

6.PembrolizumaO tOO m[ soiution torinfusion

D1 - penyenaraian

ubat baru

Flrgn budget implication which is notsustainable to MOH

7.Ezetimibe/ Atorvastatin (10 mg/20 mg& 10 mgl40 mg)tabtet

D1 - penyenaraian

ubat baru

a) Sufficientalternatives availablein the MoHMF.

b) No added therapeutic/ clinicalbenefit as compared to co_

administration of separate

tablets.

Pindaan FUKKM Bit. 2/2018 (Jutai2018)


UBAT.UBATAN BARU YANG DILULUSKAN UNTUK DISENARAIKAN DALAM FUKKM

LAMPIRAN 1

BIL NAMA UBATCADANGAN

PINDMN JUSTIFIKASI

8. Golimumab'l 2.5 mg/ml injectionD2 - tambahan

formulasi

Sufficient alternatives available in

the MoHMF

0 Etoricoxib 90 mg tablet

D3 - pindaan kategori

preskriberI Etoricoxib 90 mg is a recommended

dose for Rheumatoid Arthritis and

not recommended for otherindications (as listed in MoHMF

based on registration details by

Drug Control Authority).

With the change of category ofprescriber from A* to A, there is

possibility that Etoricoxib gOmg will

be used for unregistered indlcations,

Ihis wlll make monitoring difficult.

Pindaan FUKKM Bil.2/2018 (Jutai 2018)2t8


fosfomycin trometamol hrve=hownl;hazard to the foetus. Fosfomycin should onlybe used in pregnancy when the expectedbenefit outweighs the risk.

Fosfomycin has been shown to cross intobreast milk. lt should not be given to lactatingwomen except in the case of real need.

Severe renal impairment (creatinineclearance < 10ml/min) and patientsundergoing haemodialysis - fosfomycintrometamol is contraindicated.

Contraindication(s):

Documented hypersensitivity to the drug,

Severe renal impairment (creatinineclearance < 10 ml/min)

Patients undergoing haemodialysis.

lnteraction(s):

Meal can decrease levels of fosfomycin in

blood and urine. Hence it should be taken on

an empty stomach,

Metoclopramide can decrease levels in urineand should be avoided.

Probenecid can decrease renal clearanceand excretion of fosfomycin and should beavoided.

Adverse reaction(s):

Fosfomycin is generally well tolerated by

adults and overdose data is limited.

Common: Diarrhea, nausea, dyspepsia,vulvovaginitis, headache and dizziness

Uncommon: Vomiting, abdominal pain, rash,urticaria, pruritus, paraesthesia and fatigue.

Rare: Tachycardia.

Pindaan FUKKM Bit.2/2018 (Julai 2018)

J/O


eta:,lil;trrr:iir:i:rllll,iiirti:ulllr:iitllluuutii:jl:'-rirt,'uri:ri:lrl

g1;ij]tr,l::::ltt,ir::.it:;iiaitrt,::,{31::i..:::t;L:t,.,1::;::r:rl.:1ltlt:,:!sr,.:t,irti\!trailtu:,]utiiali.r::,ruN06AX26-

330-T32-

O1-XXX

Generic name:

Vortioxetine 10 mg

tablet

Cost:

RM4,71ltablet

Treatment of major depressive episodes in

adults.

Dose:

1Omg once daily in adults less than 65 years

of age. Depending on the individual patient

response, the dose may be increased to amaximum of 20mg vortioxetine once daily ordecreased to a minimum of Smg vortioxetine

once daily. After the depressive symptomsresolve, treatment for at least 6 months isrecommended for consolidation of the anti-depressive response.

Precaution(s):

Suicide/suicidal thoughts or clinicalworsening, seizures, serotonin syndrome orneuroleptic malignant syndrome,

hyponatraemia, renal lmpairment, hepaticimpairment, elderly & paediatric populations,

pregnancy & lactation.


Hypersensitivity to the active substance or toany of the excipients. Concomitant use withnon-selective monoamine oxidase inhibitors(MAOls) or selective MAO-A inhibitors,

Interaction(s):

Vortioxetine is extensively metabolized in theliver, primarily through oxidation catalysed by

CYP2DO and to a minor extend Cyp3A4/5and CYP2C9, and subsequent glucuronic

acid conjugation.

No inhibitory or inducing effect of vortioxetinewas observed in the drug-drug interaction

studies for the CYP isozymes CyplA2,CYP2A6, CYP286, CYP2C8, CYP2Cg,

CYP2C1 9, CYP2D6, CYPZEI or Cyp3A4/S.Vorlioxetine is a poor P-gp substrate and

inhibitor. The major metabolite of vortioxetine

is pharmacologically inactive.

Pindaan FUKKM Bil. 2/2018 (Jutai Z01B)

4t8


LAMPIRAN 2

TAMBAHAN INDIKASIYANG DILULUSKAN BAGI UBAT.UBATAN YANG TERSENARAIDALAM FUKKM.


Nausea, decreased appetite, abnormaldreams, dizziness, diarrhoea, constipation,vomiting, generalized pruritus.

CURRENT DRUG,IN

MoHMF

Secukinumab 150

mg/ml injection (pre-

filled syringe/pen)

Approved to add indication(s):Plaque psoriasis

Secukinumab is indicated for thetreatment of moderate to severeplaque psoriasis (PsO) in adultpatients who are candidates for

systemic therapy orphototherapy

Cost:

RM 1,400 per 150m9/ml solution

for injection in a pre-filled syringe

or pre{illed pen

Category of Prescriber:

A*

Dose:

Plaque psoriasis:

The recommended dose is 300 mg bysubcutaneous injection with initial dosingat weeks 0, 1, Z and 3, followed bymonthly maintenance dosing starting atweek 4. Each 300 mg dose is given as twosubcutaneous injections of 150 mg.

For some patients, a dosage of 150mgmay be acceptable.

Precaution(s):

. Pregnancy: Secukinumab should be

used during pregnancy only if thebenefits clearly outweigh the potential

risks,

. Breastfeeding: lt is not knownwhether secukinumab is excreted in

immunoglobulins are excreted inhuman milk, caution should beexercised when secukinumab is

administered to a woman who isbreastfeeding.

Patients with hepatic and renalimpairment: Secukinumab has not

been studied specifically in thesepatient populations,

Elderly patients: Based on population

PK analysis, clearance in elderly

Pindaan FUKKM Bit. il2018 (Jutai2018)

5/8


. DETAILS

patients and patients less than 65years of age was similar. Therefore,

no dose adjustment is required.

. Paediatric patients: Safety and

effectiveness in paediatric patients

below the age of 18 years have notyet been established.


Severe hypersensitivity reactions to theactive substance or to any of theexcipients.

lnteraction(s):

Live vaccines should not be

concurrently with Secukinumab.


Upper respiratory tract infection,

nasopharyngitis, rhinitis, pharyngitis, oral

herpes, rhinonhoea, diarrhoea, urticaria.

Tegafur 100 mg &

uracil224 mg capsule

Approved to add indication(s):Tegafur Uracil plus folinic acid

(leucovorin) combination therapy

is indicated for the treatment ofcolorectal cancer in:

a) Metastatic stage,

b) Adjuvant setting,

c) Concurrent setting.

Cost:

RM 3.97/capsule

Cateqory of Prescriber:

A*

Dose:

a) Adjuvant setting

300m9/mz/day , Day 1-28, rest Z

days; Leucovorin Calcium Ts

mg/day, Day 1-28, rest 7 days for 5cycles;

b) Concurrent setting

300m9/m2lday; Leucovorin Calcium

25 mg lday, D8- D3O, for 4 weeks;

c) Metastatic stage

300mg/mz/day , Day 1-28, rest 7

days; Leucovorin Calcium Ts

mg/day, Day 1-28, rest 7 days for 5cycles.

Precaution(s):

Bone marrow depression. History of CV

disease. Hepatic & renal disorders.lnfectious complications, varicella, Gastric

or duodenal ulcers. Abnormal glucose

Pindaan FUKKM Bil. 2/2018 (Jutai2018)6/8


tolerance. Patients on chemotherapy.

Children and elderly.


Patient with serious bone marrow, serious

diarrhea, serious infectionl, patient

receiving treatment with tegafur, gimeracil,

oteracil potassium combination product orwithin 7 days after withdrawal of thisproduct , pregnancy and lactation.

lnteraction(s):

lncreased action of phenytoin, warfarin,

other antineoplastics or radiatron therapy.


Gastrointestinal disturbances, blood

dyscrasias, pigmentation, severe hepatic

disorder eg fulminant hepatitis, hepatic

cirrhosis, dehydration, severe enteritis,

cardiovascular disease, acute renal

failure, nephrotic syndrome, anosmia,

interstitial pneumonia, acute pancreatitis,

severe stomatitis, gastrointestinal

ulceration & haemorrhage, Stevens-

Johnson syndrome, Lyell's syndrome,

Leucovorin Calcium

(Calcium Folinate) 15

mg tablet

Approved to add indication(s):

Folinic acid (leucovorin) plus

Tegafur-Uracil combination

therapy is indicated for the

treatment of colorectal cancer in:

a) Metastatic stage,

b) Adjuvant setting,

c) Concurrent setting

Cost:

RM 3,50/tablet

Cateqory of Prescriber:

A*

Dose:

a) Adjuvant settingLeucovorin Calcium 75 mg/day, Day1-28, rest 7 days for 5 cycles;Concurrent settingLeucovorin Calcium 25 mg /day, DB-D36, for 4 weeks;

Metastatic stageLeucovorin Calcium 75 mg/day, Day1-28, rest 7 days for 5 cycles.

Precaution(s):

Pregnancy, lactation, seizure disorder

Pindaan FUKKM Bil.2/2018 (Julai 2018)7 t8


LAMPIRAN 3PINDAAN KATEGORIPRESKRIBER BAGI UBAT.UBATAN DALAM FUKKM YANG DILULUSKAN.

LAMPIRAN 4INDIKASI YANG DILULUSKAN UNTUK DIMANSUHKAN DARIPADA FUKKM

Hypersensitivity to leucovorin, pernicious

anaemia or megaloblastic anaemia wherevitamin B'12 is deficienr.

lnteraction(s):

May diminish the effect of anti-epileptic

substances such as phenobarbitone,

phenytoin. When calcium folinate is given

in conjunction with a folic acid antagonist(e.9. cotrimoxazole, pyrimethamine) theefficacy of the folic acid antagonist mayeither be reduced or completelyneutralised. Concomitant administration

with S-fluorouracil may enhance theefficacy and toxicity of S-fluorouracil


Nausea, vomiting, mucosal toxicity,diarrhoea

ru0. CURRENT DRUG.IN MoHMF AMENDMENT .DETAILS

1 Cetirizine 10 mg tablet Approved to amend category

of prescriber from IVKK

kepada B

Alldetails as in MoHMF

/Vo.CARRENT DRUG,/IV]'

MoHMFA;MENDMENT REASO,VFOR APPR?VAL

1. Etanercept 25 mg lnjection

& Etanercept 50 mg

lnjection

Approved to remove indication:Moderate to severe plaque psoriasis

who failed to respond to, or who have acontraindication to, or are intolerant to

other systemic therapy including

cyclosporine, methotrexate or pUVA.

Etanercept shows the lowest

effectiveness as compared to

other alternatives available in

MoHMF

Pindaan FUKKM Bil. 2/2018 (Jutai 201 8)

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