kementerian kesihatan malaysia ministry of health malaysia · adalah saya diarahmerujuk perkara...

Date / Tarikh .:14 September 2010

KEMENTERIAN KESIHATAN MALAYSIAMinistry of Health Malaysia

BAHAGIAN PERKmDMATAN FARMASIPharmaceutical Services Division

Lot 36, Jalan Universiti, 46350 Petaling Jaya, Selangor, Malaysia

Your Ref/ Ruj. Tuan:

Our Ref/ Ruj. Kami :KKM-55/BPF/103io01/09 Jld.11(1.:l.)

Semua Ahli Panel Kajisemula Senarai Ubat-ubatan,Kementerian Kesihatan Malaysia

Semua Pengerusi JKK Ubat-ubatan KKM

Pengarah,Biro Pengawalan Farmaseutikal KebanqsaanKementerian Kesihatan Malaysia

Semua Timbalan Pengarah Kesihatan Negeri (Farmasi)

Ketua Pegawai Farmasi,Hospital Kuala Lumpur.

Y.Bhg. Tan Sri/ Puan Sri/ Datuk/ Dato'/ Datin/ Tuan/ Puan,

PindaanlTambahan Kepada:1) Formulari Ubat Kementerian Kesihatan Malaysia - Bil 2120102) Senarai Ubat Klinik 1Malaysia - Bil1/2010

Adalah saya diarahmerujuk perkara di atas dan sukacita memaklumkan bahawa PanelKajisemula Senarai Ubat Kementerian Kesihatan Malaysia telah pun menimbangkanpermohonan-permohonan yang diterima untuk pindaan/tambahan kepada FormulariUbat KKM dan Senarai Ubat Klinik 1Malaysia. Keputusan-keputusanpindaan/tambahan adalah seperti yang dilampirkan.

2. Penggunaanut>at-ubatan yang baru perlu dipantau ciengan rapi dan sebarangkesan advers dilapQrJ<~nk~pada· MAORAC(Jawatankuasa Penasihat Kesan AdversUbat Kebanqsaanldi 8iroP~ngawalan Farmaseutikal Kebangsaan, Petaling Jaya dansatu salinan dihantar ke Bahagia.n ini:<'

3. Penggunaan butiran-butiran yang telah dibatalkan seperti mana terdapat dilampiran boleh diteruskan sehingga stoknya habis di hospital/institusi masing-masingatau sehingga stok baru (bagi yang melibatkan ubat gantian) diperolehi.

4. Harga-harga yanq terdapat di dalam senarai di lampiran adalah harga yangdiberikan ke Bahagian ini untuk menyenaraikan ubat berkenaan ke dalam FormulariUbat KKM. Sebarang kelainan harga yang ditawarkan di peringkat hospital/institusi KKMhendaklah dilaporkan ke Sahagian ini beserta bukti dengan kadar segera supayatindakan selanjutnya dapat diambil.

Alamat Surat Menyurat / Correspondence AddressSea Berkunci No. 924. Peiabat Pos Jalan Sultan. 46790 Petalinq Java. Selanoor. Malavsia.

5. Sukacita dapat Y.Shg. Tan Sril Puan Sril Datukl Dato'l Datinl Tuanl Puanmengambil maklum terhadap ubat-ubatan yang terlibat dan syarat-syarat terhadappenggunaannya dalam hospital/institusi Kementerian Kesihatan. Kerjasama Y.Shg. TanSril Puan Sril Datukl Dato'l Datinl Tuanl Puan adalah juga diminta untuk memastikanbahawa maklumat-maklumat mengenai pindaan/tambahan tersebut diedarkan kepadahospital! institusil klinik kesihatan di negeri masing-masing.

Sekian, terima kasih.

'BERKHIDMAT UNTUK NEGARA'

sa;;~n~ut perintah,

(~ ~INTI A.RAHMAN)Pengarah Kanan Perkhidmatan Farmasi,Kementen . n Mala sia.

s.k.1. Ketua Setiausaha,

Kementerian Kesihatan Malaysia

2. PengarahSahagian Perkembangan PerubatanAras 5-7, Siok E1, Parcel EPresint 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putrajaya

3. Pengarah Kawalan PenyakitKementerian Kesihatan MalaysiaAras 3, Siok E10, Parcel EPresint 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putraiaya

4. SetlausahaBahaglan (Perolehan & Penswastaan)Kementerlan Kesihatan MalayslaAras 7, Siok fZ7,lDarcell;Pr~$int 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putraiaya(u.p Pegawai Farmasi)-

5. Pengarah,Pusat Perubatan Universiti MalayaPetaling Jaya(u.p Ketua Pegawai Farmasi)

6. Pengarah,Hospital Universiti Kebangsaan Malaysia,Sandar Tun Razak, Kuala Lumpur(u.p Ketua Pegawai Farmasi)

7. Pengarah,Hospital Universiti Sains Malaysia,Kubang Kerian, Kelantan(u.p Ketua Pegawai Farmasi)

8. Pengarah Farmasi,Sahagian Perkhidmatan KesihatanKementerian Pertahanan MalaysiaJalan Padang Tembak50634 Kuala Lumpur

9. Pegawai FarmasiSahagian Pembangunan Kesihatan KeluargaAras 5, Siok E6, Parcel EPresint 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putrajaya

10. PengarahPusat Darah NegaraJalan Tun Razak50400 Kuala Lumpur(u.p Pegawai Farmasi)

11. Unit Teknikal Santuan PerubatanPejabat Timbalan Ketua Pengarah Kesihatan (Perubatan)Aras 7, Siok E1, Parcel EPresint 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putrajaya

12. Pegawai FarmasiSahagian Kesihatan dan Perubatan,Jabatan Hal Ehwal Orang AsliKM.24, Jalan Pahang53100 Gombak, Selangor

13. Penolonq Pegawai PerpustakaanAras 4, Siok E7, Parcel EPresint 1, Pusat Pentadbiran Kerajaan Persekutuan62509 Putrajaya

14. Penolong Pegawai PerpustakaanInstitut Pengurusan KesihatanKementerian Kesihatan MalaysiaJalan SangsarKuala Lumpur

15. Semua Ketua UnitSahagian Perkhidmatan Farmasi

anis/azuwana/masitah

TERHAD - Edaran dalaman sahaja

PFUKKM September 2010 - 2/10

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PINDAAN BIL. 2 TAHUN 2010 KEPADA FORMULARI UBAT KKM

1. BUTIRAN-BUTIRAN YANG DIMANSUHKAN DARI FORMULARI UBAT KKM

No MDC Generic Name Trade Name,

Category, Dosage

Remarks

1 A05C000920P3001XX Glucometamine 150 mg Injection

As in the MOH formulary

Supplier unable to continue with supply due to ceased production by manufacturer. Replacements suggested by supplier (Hepavite Capsule and Rawachol Capsule) were not accepted as they are only nutraceutics with no evidences of therapeutic efficacies.

2 A05C000920C1001XX Glucometamine Capsule As in the MOH formulary

3 M05BB03972T1001XX Alendronate Sodium 70mg and Cholecalciferol 2800 IU Tablet

As in the MOH formulary

Deletion effective after tender expires on 2/3/2011. Reasons: Higher dose of cholecalciferol in

line with CPG Cost remain the same

2. UBAT–UBAT BARU YANG DILULUSKAN MASUK KE DALAM FORMULARI UBAT KKM

No MDC Generic Name

Brand name Price quoted

Prescriber Category

Details

1 A10AB04000P5001XX

Insulin Lispro 100 IU/ml Injection in Prefilled syringe/cartridge (Humalog® 3ml Cartridge) Cost RM110 per box of 5 cartridges RM22 per 3 ml cartridge

A* Indication i) As initial therapy in children with Type 1

diabetes ii) Type 1 diabetes patients on basal bolus

regimen, not controlled or experience hypoglycaemia with conventional insulin, to be used in combination with long-acting insulin

iii) Type 2 diabetes patients on basal bolus or premixed regimen, not controlled or experience hypoglycaemia with conventional insulin, to be used in combination with intermediate-acting insulin or long-acting insulin

iv) Patients with diabetes in pregnancy with poor postprandial control or experience hypoglycaemia with conventional short-acting insulin

Dose Dose to be individualized. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight, given within 15 minutes before meal. Precaution Illness or emotional disturbance that increases insulin requirements, renal or hepatic failure, activity or diet changes, hypoglycaemia, transferring from other insulin, children under 12 years old.



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No MDC Generic Name Brand name Price quoted

Prescriber Category

Details

Contraindication In patients with hypersensitivity to insulin lispro or its excipients and in patients having episodes of hypoglycaemia Interaction Corticosteroids, diuretics, oral contraceptives, thyroxine may increase insulin requirement. Oral hypoglycemics, salicylates, sulfa antibiotics, MAOIs, ACE inhibitors, angiotensin II receptor blockers (ARB) may intensify hypoglycemic effect of insulin. Adverse effect Injection site reaction (e.g. lipodystrophy, pruritus, rash), localized allergy (redness, swelling or itching), generalized allergic reactions (less common but may be life-threatening), hypoglycaemia, hypokalaemia. Rapid changes in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value.

2 A10AD04000P5001XX

Insulin Lispro 25% & Insulin Lispro Protamine 75% 100 IU/ml Injection in Prefilled syringe/cartridge (Humalog Mix25 ® 3ml Cartridge) Cost RM110 per box of 5 cartridges RM22 per 3 ml cartridge

A* Indication Patients with Type 2 diabetes whom experience hypoglycemia with the use of human premixed insulin. Dose Dose to be individualized. The average daily insulin requirement is between 0.5 to 1.0 units/kg body weight Precaution Transferring from other insulins, emotional distress, renal or hepatic failure, hypoglycaemia, diet and activity changes, children under 12 years. Contraindication In patients with hypersensitivity to insulin lispro Mix or its excipients and in patients having episodes of hypoglycaemia. Not for IV administration. Interaction Insulin requirements may be increased by oral contraceptives, corticosteroid or thyroid replacement therapy. Requirement may be reduced by oral hypoglycemic agent, salicylate, sulfa antibiotic & certain antidepressant (MAOIs), ACE inhibitors, angiotensin II receptor blockers (ARB) and alcohol. Adverse effect Injection site reactions (lipodystrophy, pruritus, rash), localized allergy (redness, swelling or itching), generalized allergic reactions (less common but may be life-threatening), hypoglycaemia, hypokalaemia. Rapid changes



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Prescriber Category

Details

in serum glucose levels may induce symptoms of hypoglycemia in persons with diabetes, regardless of the glucose value.

3 A10AE05000P5001XX

Insulin Detemir 100 IU/ml Injection in Prefilled syringe/cartridge (Levemir Flexpen® 3ml) Cost RM203.75 per box of 5 pre-filled pens or RM40.75 per pen or 0.1358 per IU.

A* Indication i) Type 1 Diabetes patients on basal bolus

regimen, whom experience hypoglycemia with conventional insulin, to be used in combination with rapid or short-acting insulin.

ii) Type 2 Diabetes patients on oral anti-diabetics and basal insulin regimen or basal bolus insulin regimen whom experience hypoglycemia with conventional basal insulin.

Dose Adult and child over 6 years: Individualised dose, once or twice daily. For twice daily dosing, the evening dose can be administered either with the evening meal, at bedtime, or 12 hours after the morning dose. Precaution Monitor glucose levels in elderly and patients with renal or hepatic impairment. Transferring from other insulin types should be done under strict medical supervision. Concomitant illness especially infection usually increase insulin requirement. Do not administer intravenously. Risk of hyper/hypoglycemia during therapy. Pregnancy and lactation, children. Contraindication Hypersensitivity to insulin detemir or any of its excipients, hypoglycemia Interaction Oral antidiabetics, MAOIs, nonselective β-blockers, ACE inhibitors, salicylates, alcohol, thiazides, glucocorticoids, β-sympathomimetics, thyroid & growth hormones, danazol, octreotide/lanreotide. Adverse effect Hypoglycaemia, allergic reactions, lipodystrophy, pruritus, rash, mild injection site reactions, oedema, weight gain.

4 J01DH04000P4001XX

Doripenem Monohydrate 500 mg Injection (Doribax®) Cost RM95.50 per vial of 500mg

A* Indication Ventilator-associated pneumonia (VAP) patients at risk or involving multidrug resistant pathogens especially Pseudomonas aeruginosa infections Dose 500mg every 8 hours as a one hour infusion for 5 to 14 days according to severity, site of infection and the patient’s clinical response. Use in children below 18 years old not recommended.



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Prescriber Category

Details

Precaution Severe renal impairment, dialysis patients, consider pseudomembranous colitis (in patients with diarrhoea while on doripenem). Avoid prolonged use. Pregnancy & lactation. Contraindication Hypersensitivity to other carbapenems, other β-lactams (e.g. penicillins or cephalosporins). Interaction Valproic acid, probenecid. Adverse effect Diarrhoea, headache disorder, nausea, phlebitis, skin rash, anaemia, pruritus of skin, vulvovaginal candidiasis, abnormal hepatic function tests, anaphylaxis, interstitial pneumonitis, leukopenia, neutropenia, pseudomembranous enterocolitis, renal disease, seizure disorder, Stevens-Johnson syndrome, toxic epidermal necrolysis

5 B01AB10520P5001XX

Tinzaparin sodium 10,000 anti-Factor Xa IU/ml Injection in Prefilled syringe/cartridge (Innohep ® prefilled syringe) Cost RM8.43 (0.35ml syringe) RM11.70 (0.45ml syringe)

A* Indication i) Treatment of deep vein thrombosis (DVT)

and pulmonary embolism (PE), not amounting to hemodynamic instability.

ii) Prevention of post-operative DVT in patients undergoing general and orthopaedic surgery.

Dose i) Treatment of DVT and PE, in conjunction

with warfarin: 175 anti-Factor Xa IU/kg SC once daily for at least 6 days

ii) Thromboprophylaxis in patients with: Moderate risk of thrombosis (general surgery):3,500 anti-Factor Xa IU SC 2 hrs before surgery and postoperatively, 3,500 anti-Factor Xa IU once daily for 7-10 days.

High risk of thrombosis (eg. total hip replacement):4,500 anti-Factor Xa IU SC or 50 anti-Factor Xa IU/kg body weight SC 2 hrs before surgery and then once daily until the patients has been mobilized.

Precaution Renal or hepatic impairment, recent cerebral haemorrhage, trauma, recent surgery to the central nervous system, concurrent spinal or epidural anaesthesia, bleeding disorders, severe thrombocytopenia. Do not administer IM (risk of haematoma). Contraindication Hypersensitivity to sodium bisulfite, treatment of DVT in patient 90 years old and older with

6 B01AB10520P5002XX

Tinzaparin sodium 20,000 anti-Factor Xa IU/ml Injection in Prefilled syringe/cartridge (Innohep prefilled syringe®) Cost RM27.43 (0.5ml syringe) RM44.92 (0.7ml syringe)

A*



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Prescriber Category

Details

renal insufficiency, generalized or local haemorrhagic tendency, uncontrolled severe hypertension, acute cerebral insults, septic endocarditis. Interaction Salicylates, NSAIDs, vitamin K antagonists, dextran. Adverse effect Skin necrosis, erythema, increased liver function test, local pain, major bleeding, granulocytopenic disorder (rare), hematoma, neurological injury with concurrent use of spinal or epidural anaesthesia, pancytopenia, thrombocytopenia anaphylaxis, priapism and death.

7 N06DX01110T1001XX

Memantine HCI 10 mg Tablet (Ebixa®) Cost RM320 per box of 56s or 5.714 per tab

A* Indication As monotherapy or as adjunctive therapy with cholinesterase inhibitors for the symptomatic treatment of patients with moderate to severe Alzheimer’s disease. Dose Adult Initially 5 mg/day on the 1st week, 5mg twice a day on the 2nd week, then 15 mg/day (10mg in the morning and 5mg in the evening) on the 3rd week. From the 4th week on, continue treatment with maintenance dose of 20 mg/day (10mg twice a day). Max: 20 mg/day. Precaution Severe renal impairment, epilepsy, co-administration with N-methyl-D-aspartate (NMDA) antagonists (eg amantadine, ketamine or dextromethorphan), patients with factors that may raise urine pH, recent myocardial infarct, uncompensated congestive heart failure, uncontrolled hypertension, pregnancy and lactation, children. May impair ability to drive or operate machinery. Contraindication Hypersensitivuty to either memantine hydrochloride or any components of the tablet, renal impairment (CrCl <50 mL/min), current or history of seizures. Interaction L-dopa, dopaminergic agonists, anticholinergics, barbiturates, neuroleptics, antispasmodic agents (dantrolene or baclofen), phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine, hydrochlorothiazide. Avoid administration with amantadine, ketamine & dextromethorphan.



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Prescriber Category

Details

Adverse effect Hypertension, constipation, dizziness, somnolence, headache, pain, Stevens-Johnson syndrome, deep venous thrombosis, hepatitis, liver failure, cerebral infarction, cerebrovascular accident, grand mal seizure, intracranial hemorrhage, seizure, transient ischemic attack, acute renal failure, neuroleptic malignant syndrome

8 N07BA01000M7004XX

Nicotine 5 mg/ 16 hour Transdermal Patch (Nicorette Patch®)

A/KK Indication For the treatment of tobacco dependence by relieving nicotine withdrawal symptoms, thereby facilitating smoking cessation in smokers motivated to quit. Dose: Adult over 18 years old:15 mg patch on waking (usually in the morning) and remove 16 hours later (usually at bedtime) for 8 weeks, then 10 mg patch daily for 2 weeks followed by one 5 mg patch daily for another 2 weeks. Apply to dry non-hairy skin site. Application limited to 16 hours in a 24-hr period in each case. Review at 3 months. Precaution Patients with chronic generalised dermatological disorders eg, psoriasis, chronic dermatitis or urticaria should not use the patch. Patients with severe cardiovascular disease (eg, occlusive peripheral arterial disease, cerebrovascular disease, stable angina pectoris and heart failure), vasospasms, uncontrolled hypertension, severe hepatic and/or renal impairment, active duodenal and gastric ulcer. Patients with diabetes mellitus, hyperthyroidism or pheochromocytoma, since nicotine causes the release of catecholamines from the adrenal medulla Contraindication Hypersensitivity to nicotine or any other product component. Patients with recent myocardial infarct; unstable or worsening angina pectoris; Prinzmetal’s angina; severe cardiac arrhythmias; acute stroke. Pregnancy and lactation. Children below 18 years old. Interaction Paracetamol, caffeine, imipramine, oxazepam, pentazocine, propranolol, theophylline, warfarin, oestrogens, lignocaine, phenacetin; may require a decrease in dose at cessation of smoking due to the de-induction of hepatic enzymes on smoking cessation. Subcutaneous insulin absorption may increase with smoking cessation. Adrenergic antagonists (eg. prazosin, labetalol); decrease in circulating

9 N07BA01000M7005XX

Nicotine 10 mg/ 16 hour Transdermal Patch (Nicorette Patch®)

A/KK

10 N07BA01000M7006XX

Nicotine 15 mg/16 hour Transdermal Patch (Nicorette Patch®)

A/KK



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Prescriber Category

Details

catecholamines with smoking cessation. Adrenergic agonists (eg. isoprenaline, phenylephrine); may require an increase in dose at cessation of smoking due to a decrease in circulating catecholamines with smoking cessation. Other effects, associated with smoking, include reduced analgesic efficacy with propoxyphene, reduced diuretic response to frusemide and reduced rates of ulcer healing with H2-antagonists. Adverse effect Mild skin reactions, erythema, itching, oedema and aphtous ulcers, headache, dizziness, nausea and vomiting, palpitations.

11 D08AC52137L9902XX

Chlorhexidine Gluconate 2% in Alcohol 70% Solution (SteriPrep®) Cost RM3.80 per 60ml bottle

C Indication Use in central venous catheter care bundle Dose Skin Preparation: Use Chlorhexidine Gluconate 2% in Isopropyl Alcohol 70% and allow to dry Catheter acces: Apply to catheter ports or hubs prior to accessing the line for administering fluids or injections Precaution Avoid contact with eyes. Contraindication Hypersensitivity to chlorhexidine gluconate or any component of the formulation Interaction Not known Adverse effect Defatting of the skin resulting in dryness, cracking and dermatitis (with repeated or prolonged contact), ingestion may cause gastrointestinal disturbances. Inhalation of high concentration may cause breathing difficulties, headaches, dizziness or unconsciousness.

12 M05BB03972T1002XX

Alendronate Sodium 70mg and Cholecalciferol 5600 IU Tablet (Fosamax Plus®) Cost RM21.31 per tablet

A* Indication Osteoporosis in post menopausal women with a history of vertebral fracture and whom oestrogen replacement therapy is contraindicated Dose/ Precaution/ Contraindication/Interaction /Adverse effect Same as Alendronate Sodium 70mg and Cholecalciferol 2800 IU Tablet



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3. TAMBAHAN DAN PINDAAN FORMULASI/ KATEGORI/ BENTUK DOSEJ/ INDIKASI YANG

DILULUSKAN UNTUK DIMASUKKAN KE DALAM FORMULARI UBAT KKM A. Tambah Formulasi/ Kekuatan No MDC Generic Name

Brand name Price quoted

Prescriber Category

Details

1 C09CA01500T1002XX

Losartan Potassium 100 mg Tablet (Cozaar 100mg®) Cost RM37.50/30’s (1.25 per tab)

A/KK Indications Patients intolerant of ACE inhibitors, only in the treatment of i) Hypertensive patient with left ventricular

hypertrophy ii) Hypertension in diabetics with proteinuria or

nephropathy Dose Hypertension: Usual starting dose: 50 mg once daily. May be increased to 100 mg once daily. Precautions/ Contraindications/ Interactions /Adverse effects Same as Losartan 50mg tablet

2 N05AH04138T5001XX

Quetiapine Fumarate 50 mg Extended Release Tablet

(Seroquel XR®)

Cost RM 4.53 per tablet

A* Indications i) Schizophrenia ii) Moderate to severe manic episodes in bipolar disorder iii) Major depressive episodes in bipolar disorder Dose i) & ii) 300 mg once daily on Day 1 then 600 mg on Day 2. Maintenance dose: 400 to 800 mg once daily. Maximum dose: 800 mg daily. iii) 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3 and 300 mg on Day 4. Recommended daily dose is 300 mg. May be titrated up to 600 mg daily In elderly or hepatic impairment: Start with 50mg/ day, may be increased in increments of 50mg /day to an effective dose. Precautions/ Contraindications/ Interactions/ Adverse effects Same as Quetiapine Fumarate Extended Release 300mg & 400mg Tablets.



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4. PERUBAHAN KEPADA MDC /GENERIC NAME DALAM FORMULARI UBAT KKM A. Perubahan MDC NO GENERIC NAME OLD MDC NEW MDC CODE REASON TO CHANGE

1 Vitamin B Complex Tablet A11EX00 901T1001XX

A11EA00 901T1001XX

The product only contain vitamin B Complex, plain not combination

B. Perubahan Generic name

NO Old Generic name New Generic Name MDC

1 Hyperimmune Gamma Globulin Injection

Human Normal Globulin Injection J06BA02000P3001XX

5. PERMOHONAN-PERMOHONAN YANG TIDAK DILULUSKAN

A. Proforma B NO EXISTING DRUG

(GENERIC NAME) PROPOSED ALTERATION

REASON/S FOR NON-APPROVAL

1 Irbesartan 300 mg/ Hydrochlorothiazide 12.5 mg Tablet

Change prescriber category from A* to A/KK

Alternatives available in the Formulary are sufficient.

2 Losartan Potassium 100 mg/ Hydrochlorothiazide 12.5 mg Tablet

Change prescriber category from A* to A/KK


3 Activated Charcoal 250mg Tablet

i. Add strength and dosage form:

Activated Charcoal 50g Powder

ii. Add indication; acute oral poisoning and drug overdose

Cost of the ready-mix charcoal powder is very expensive (RM52.00 per bottle).

Demand for the product is low. Only kept in Emergency Department and used ‘when needed’ basis.

Product can be requested through ‘KPK request’

if necessary.

4 Activated Charcoal 250mg Tablet

Add strength and dosage form: Activated Charcoal 200mg Capsule

Activated charcoal 250mg tablet which is already available in the formulary is sufficient. No added advantage was proven.

5 Ciclesonide MDI 160 mcg.

Change indication: From: Prophylactic treatment of asthma in adults and adolescents 12 years of age and older To: Prophylactic treatment of asthma in adults, adolescents and children over 6 years

Recommended dose range for children over 6 years old is 80mcg-160mcg per day. Currently only Ciclesonide 160mcg is available in the Formulary thus, proper dose titration in this group of patients will not be possible before listing of the 80mcg MDI.

Several alternatives are already available in the

Formulary.



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NO EXISTING DRUG (GENERIC NAME)

PROPOSED ALTERATION

REASON/S FOR NON-APPROVAL

Non-favourable cost-effectiveness ratio compared to alternatives already available in the Formulary.

A corticosteroid inhaler: Caution on safety in

children until more studies carried out in this group of patients

6 Benzydamine HCl

0.15% Solution Add Formulation: Benzydamine Hydrochloride 3.0 mg/ml Throat Spray

Low usage. Submit a ‘KPK request’ if really needed.

7 Deferiprone 500 mg Tablet

Add Dosage Form : Deferiprone 100mg/ml Oral Solution

Request not supported by JKK Paediatric. Limited evidences on efficacy. Published data on

bioavailability in children not available. Efficacy of standard dose could possibly be lower in children due to higher metabolism.

Limited evidences on safety in children. Low ‘level of evidence’ of the studies presented.

8 Mycophenolate Mofetil 250mg Capsule & 500mg Tablet

Add indication (Off-label): Induction and maintenance treatment for non-renal manifestations of systemic lupus erythematosus (SLE)

Indication has to be approved by DCA first before it can be added to the Formulary.

Submit a KPK request when required.

9 Insulin Glargine 300units/3ml Injection

Change Prescriber Category from A* to A/KK

High prevalence of diabetes. Change in category will have profound budget impact.

Complex diabetic cases requiring Insulin Glargine should be referred to specialists in hospitals.

10 Risperidone 1mg &

2mg Tablets Change Prescriber Category from A to B

Initiation of treatment for psychiatric cases should be done by psychiatrist.

11 Quetiapine Fumarate 200mg Immediate Release Tablet

Change Formulation from IR (immediate release) to XR (extended release)

Tender for Quetiapine Fumarate 200mg Tablet IR is still effective until 11/1/2011

B. Proforma D NO DRUG (GENERIC NAME) REASON/S FOR NON-APPROVAL

1 Moxifloxacin Hydrochloride 400 mg Injection & 400 mg Tablet

No major advantage to current drugs. Reserve for multidrug-resistant tuberculosis. Not supported by JKK Antimicrobial.

2 Topotecan 4 mg Injection Ovarian cancer:

Lack of evidences on efficacy. Tendency of toxicity related to Topotecan usage such as

anaemia, leucopenia and neutropenic fever which will result in increased overall treatment cost.

Needs 5 days infusion compared to only 1 day for other regimens (inconvenient).

Cervical cancer:

There were some setbacks and limitations in the GOG 179



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NO DRUG (GENERIC NAME) REASON/S FOR NON-APPROVAL

study besides small sample size. Dose used was low and life span was lower compared to combination of chemo agents.

GOG protocol 204 study did not show any advantage of Topotecan over other regiments.

Listing not supported by JKK Oncology

3 Paricalcitol 5 mg/ml Injection

Cost is significantly higher than currently available alternatives.

Evidence from randomized controlled trials suggested that the benefits and side effects of Paricalcitol are similar to calcitriol.

For patients who are intolerant to or do not respond to existing calcitriol or alphacalcidol, application to use paricalcitol can be made through ’KPK request’

Listing not supported by JKK Urology & nephrology

4 Paricalcitol 1 mcg & 2 mcg Capsules

5 Cilostazol 50 mg Tablet Limited data on efficacy. Conditions indicated for cilostazol use is not specifically

defined thus usage of drug may not be easily controlled. High Budget Impact: estimated cost for 100 patients per year is RM 65,700.00 to RM 131,400.00

6 Fluticasone Furoate 27.5 mcg/dose Nasal Spray

No major advantage over the currently available corticosteroid nasal sprays in terms of safety and efficacy.


7 Nicotine 10 mg/dose Inhaler

About 50% of adult males are smokers in Malaysia. High Budget Impact: Estimated treatment cost for 100

patients is RM 100,800.00 to RM 268,800.00 for inhaler and RM 60,480.00 to RM 107,856.00 for gum.

Gums are available in retail pharmacy outlets for patients to buy.

8 Nicotine 2 mg & 4 mg Gum

9 Travoprost 40 mg/ml & Timolol 5mg/ml Ophtalmic Solution

Alternatives available in the Formulary are sufficient. Travoprost (single preparation) not yet listed in the

Formulary thus treatment response to the drug not known in our patients.

10 Teriparatide 250mcg/ml Injection

Duration of treatment limited to 18 months due to increased risk of osteosarcoma

18 times more expensive (more if injection pen counselling cost is included).

Cost-effectiveness shown only when used in group of postmenopausal women having severe osteoporosis.

Patients need to be counselled for proper injection techniques.

A cheaper bone forming agent (Strontium Ranelate: oral form) is available in FUKKM.



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6. TAMBAHAN UBAT KE DALAM SENARAI UBAT KLINIK 1MALAYSIA

No Generic Name Details (as in MOH Drug Formulary)

1 Albendazole 200 mg Tablet Indication i) Single or mixed infestations of intestinal parasites ii) Strongyloides infection Dose: i) ADULT and CHILD over 2 years : 400 mg as a single dose ii) 400 mg as a single dose for 3 consecutive days. CHILD 12 - 24

months : half adult dose Precaution Discontinue therapy if liver function test elevations are significant, retinal lesions, cerebral hypertensive episodes, pregnancy, hepatic disease, retinal lesions Contraindication Patients with hypersensitivity to albendazole or to the benzimidazole drug class, pregnancy (avoid pregnancy for at least one month following therapy) Interaction Concurrent use with dexamethasone may result in an increased risk of albendazole adverse effects. Adverse effect Gastrointestinal discomfort, dizziness, headache, erythema multiforme, Stevens-Johnson syndrome, agranulocytosis, aplastic anemia, leukopenia, pancytopenia, thrombocytopenia, hepatotoxicity

2 Albendazole 200 mg/5 ml Suspension

3 Bisacodyl 5 mg Tablet Indication i) Constipation ii) Bowel preparation for radiological procedures and surgery Dose i) ADULT and CHILD over 10 years 5-10 mg, CHILD 4-10 years 5 mg.

To be taken at night for effect on the following morning ii) ADULT 10-20 mg the night before procedures, CHILD over 4 years 5

mg the night before procedures Precaution Prolonged use, abdominal pain, inflammatory bowel disease, sudden, persistent change in bowel habits Contraindication Ileus, intestinal obstruction, acute abdominal conditions, rectal bleeding, appendicitis Interaction Milk, antacids, warfarin Adverse effect Rarely,electrolyte and fluid imblances, abdominal discomfort, diarrhoea, rectal burning, vomiting

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