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Pindaan FUKKM Bil. 3/2018 (November 2018)

PINDAAN/TAMBAHAN KEPADA FORMULARI UBAT KKM (FUKKM) BIL. 3 TAHUN 2018

A. PERMOHONAN PINDAAN/TAMBAHAN KEPADA FUKKM YANG DILULUSKAN

BIL NAMA UBAT PINDAAN LAMPIRAN

1. Brinzolamide 1% and Brimonidine tartrate 0.2%

ophthalmic suspension D1 – penyenaraian ubat baru 1

2. Tiotropium 2.5mcg and Olodaterol 2.5mcg per

actuation, inhalation (Respimat) D1 – penyenaraian ubat baru 1

3. Rituximab 1400mg/11.7ml solution for subcutaneous

injection D2 – tambahan formulasi 2

4. Indacaterol Maleate 150 mcg Inhalation Capsule

(Breezhaler)

D3 – pindaan kategori

preskriber A* kepada A/KK 3

5. Clopidogrel 75mg tablet D3 – pindaan kategori

preskriber A* kepada A/KK 3

6. Diosmin 450 mg and Hesperidin 50 mg tablet D3 – pindaan kategori

preskriber A/KK kepada B 3

7. Ephedrine 0.5% w/v nasal drop D5 – pemansuhan daripada

FUKKM 4

8. Dexchlorpheniramine 2mg tablet D5 – pemansuhan daripada

FUKKM 4

9. Dexchlorpheniramine 2mg/5ml syrup D5 – pemansuhan daripada

FUKKM 4

B. PERMOHONAN PINDAAN/TAMBAHAN KEPADA FUKKM YANG TIDAK DILULUSKAN *(MOHMF – Ministry of Health Medicines Formulary or FUKKM – Formulari Ubat KKM)

BIL NAMA UBAT CADANGAN

PINDAAN JUSTIFIKASI

1. Perampanel 2mg, 4mg and 8mg tablet

D1 – penyenaraian

ubat baru

i) Sufficient alternatives available in

the MOHMF.

ii) Only small number of patients

currently require this treatment.

2. Tafluprost 0.0015% ophthalmic

solution

D1 – penyenaraian

ubat baru

No added benefit in terms of

effectiveness as compared to

existing therapy in MOHMF.

3.

Fluticasone furoate 100 mcg and

vilanterol 25 mcg, inhalation powder,

pre-dispensed D1 – penyenaraian

ubat baru

Although it is once daily dosing and

easy to administer, this drug (and

device) does not fare better than the

eight existing alternatives in terms of

other criteria. 4.

Fluticasone furoate 200 mcg and

vilanterol 25 mcg, inhalation powder,

pre-dispensed

5. Mesalazine 2g prolonged release

granules

D2 – tambahan bentuk

dosej

i) Although sachet formulation

improves medication

adherence in certain groups of

patients, there are no other


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PINDAAN JUSTIFIKASI

significant advantages over the

tablet formulation.

ii) The daily cost of Mesalazine

sachet formulation is more

expensive than the tablet

(Pentasa) formulation.

6. Prednisolone 10mg/5ml syrup

D2 – tambahan

formulasi

Addition of strength is beneficial in

terms of better medication

adherence and lower sugar

consumption. However, the listing of

additional strength into the

formulary increases risk of

medication error.

7. Perindopril 4mg and Indapamide

1.25mg tablet


preskriber A/KK

kepada B

Cost of fixed dose combination is

higher than other combinations of

two single antihypertensive agents

C. PERMOHONAN PINDAAN/TAMBAHAN KEPADA FUKKM YANG DITANGGUHKAN


PINDAAN JUSTIFIKASI

1. Brinzolamide 1% ophthalmic

suspension

D1- penyenaraian ubat

baru

To obtain more information from

relevant stakeholders on the

rationale to list Brinzolamide 1%

ophthalmic suspension over existing

alternative(s) in the MOHMF

2. Fenofibrate 145mg tablet D1 – tambahan indikasi

diabetic retinopathy

To obtain more information on

available product in the market and

its registered indication.

3. Posaconazole 100 mg modified

released tablet

D2 – tambahan bentuk

dosej

To obtain more information from

relevant stakeholders on the

rationale to list Posaconazole tablet

over existing alternative in the

MOHMF

4.

Indacaterol maleate 110 mcg and

Glycopyrronium bromide 50mcg,

inhalation powder hard capsules

(Breezhaler)


preskriber daripada A*

kepada A/KK

Panel’s decision to change category

of prescriber to A/KK will be subject

to outcome of price negotiation.

5. Olodaterol HCL 2.5mcg/puff, solution

for inhalation (Respimat)


preskriber daripada A*

kepada A/KK

Panel’s decision to change category

of prescriber to A/KK will be subject

to outcome of price negotiation.


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LAMPIRAN 1

UBAT-UBATAN BARU YANG DILULUSKAN UNTUK DISENARAIKAN DALAM FUKKM

NO. MDC GENERIC NAME &

QUOTED PRICE

PRESCRIBER

CATEGORY DETAILS

1. S01EC54-990-

D20-01-XXX

Generic name:

Brinzolamide 1% and

Brimonidine tartrate 0.2%

ophthalmic suspension

Cost/unit (RM):

RM45.00/bottle of 5mL

A* Approved Indication(s):

Decrease of elevated intraocular

pressure (IOP) in adult patients with

open-angle glaucoma or ocular

hypertension for whom monotherapy

provides insufficient IOP reduction.

Dose:

1 drop in the affected eye(s) 2 times

daily.

Precaution(s):

The medicinal product should not be

injected. Patients should be

instructed not to swallow the eye

drops. Precaution on ocular effects,

systemic effects, cardiac disorders,

acid/base disturbances, hepatic

impairment, mental alertness, the use

of benzalkonium chloride and use in

paediatric population.

Contraindication(s):

• Hypersensitivity to the active

substance(s) or to any of the

excipients or to sulphonamides.

• Patients receiving monoamine

oxidase (MAO) inhibitor therapy.

• Patients on antidepressants,

which affect noradrenergic

transmission (e.g. tricyclic

antidepressants and mianserin).

• Patients with severe renal

impairment.

• Patients with hyperchloraemic

acidosis.

• Neonates and infants under the

age of 2 years.


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QUOTED PRICE

PRESCRIBER

CATEGORY DETAILS

Interaction(s):

It is contraindicated in patients

receiving monoamine oxidase

inhibitors and patients on anti

depressants which affect

noradrenagic transmission. Caution is

advised in patients taking medicinal

products which can affect the

metabolism and uptake of circulating

amines (e.g. chlorpromazine,

methylphenidate, reserpine,

serotonin-norepinephrine reuptake

inhibitors), antihypertensives, cardiac

glycosides, systemic medicinal

products which may interact with α-

adrenergic agonists or interfere with

their activity i.e. agonists or

antagonists of the adrenergic receptor

(e.g. isoprenaline, prazosin), CYP3A4

inhibitors (e.g. ketoconazole,

itraconazole, clotrimazole, ritonavir

and troleandomycin) and oral

carbonic anhydrase inhibitors

concomitantly.

Adverse reaction(s):

Ocular hyperaemia, ocular allergic

type reactions (eye allergy, keratitis,

eye pain, ocular discomfort, blurred

vision, abnormal vision, ocular

hyperaemia, conjunctival blanching),

dysgeusia (bitter or unusual taste in

the mouth following instillation) and

dry mouth. The safety profile was

similar to that of the individual

components of brinzolamide 10

mg/mL and brimonidine 2 mg/mL.

2. R03AL06-989-

A10-01-XXX

Generic name:

Tiotropium 2.5mcg and

Olodaterol 2.5mcg per

actuation, inhalation

(Respimat)

Cost/unit (RM):

88.00/unit

A* Approved Indication(s):

As a maintenance bronchodilator

treatment to relieve symptoms in adult

patients with chronic obstructive

pulmonary disease (COPD)

Dose:

2 puffs once daily, at the same time of

the day


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QUOTED PRICE

PRESCRIBER

CATEGORY DETAILS

Precaution(s):

Asthma, acute use, paradoxical

bronchospasm, narrow-angle

glaucoma, prostatic hyperplasia,

bladder-neck obstruction, eye

symptoms, dental caries, patients

with renal impairment, cardiovascular

effects, hypokalemia, hyperglycemia,

anaesthesia.


Hypersensitivity to tiotropium, olodaterol, any excipients, atropine or its derivatives. Interaction(s):

Anticholinergic agents, adrenergic

agents, xanthine derivaties, steroids

or diuretics, beta-blockers, MAO

inhibitors, tricyclic antidepressants,

QTc prolonging drugs,


Common (≥1/100 to <1/10): Dry

mouth

Uncommon (≥1/1,000 to <1/100):

Dizziness, insomnia, headache, atrial

fibrillation, palpitations, tachycardia,

hypertension, cough, constipation.


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LAMPIRAN 2

TAMBAHAN FORMULASI/KEKUATAN/BENTUK DOSEJ YANG DILULUSKAN BAGI UBAT-UBATAN

YANG TERSENARAI DALAM FUKKM.

NO. CURRENT DRUG IN

MOHMF AMENDMENT DETAILS

1. Rituximab 10mg/ml IV

Injection

Approved to add

formulation/strength/dosage

form: Rituximab 1400mg/11.7ml

solution for subcutaneous

injection

Cost/unit (RM):

RM 4,100/unit

MDC:

L01XC02-000-P30-04-XXX

Category of Prescriber:

A*

Approved indication(s):

i) Treatment of patients with relapsed or

chemo-resistant low grade or

follicular B-cell Non-Hodgkin's

lymphoma;

ii) Adjunctive therapy with combination

chemo-agents for aggressive Non-

Hodgkin Lymphoma;

iii) Maintenance in relapsed/ refractory

follicular lymphoma after response to

induction therapy.

Dose:

i) As monotherapy, first cycle with

rituximab (IV formulation) 375mg/m2

administered as an intravenous

infusion, followed by subsequent

cycles with rituximab SC at a fixed

dose of 1400mg per cycle, once

weekly. In total: 4 weeks.

ii) Combination with CHOP

(cyclophosphamide, doxorubicin,

prednisone and vincristine): first dose

with rituximab (IV formulation) 375

mg/m2 administered as an

intravenous infusion followed by

subsequent cycles with rituximab SC

injected at a fixed dose of 1400mg

per cycle. In total: for up to 8 cycles.

Rituximab should be administered on

day 1 of each chemotherapy cycle


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after IV administration of the

glucocorticoid component of CHOP.

iii) 1400mg SC once every 3 months

until disease progression or for a

maximum period of two years.

Note:

Premedication consisting of an anti-

pyretic, antihistamine (e.g.

paracetamol and diphenhydramine)

and glucocorticoids, before each

administration of rituximab.

All patients must always receive their

first dose of rituximab by intravenous

administration (using intravenous

formulation) at a dose of 375mg/m2

body surface area. The

subcutaneous formulation of 1400mg

should only be given at the second or

subsequent cycles.

Patients who were not able to receive

the full rituximab intravenous infusion

dose should continue to receive

subsequent cycles with rituximab IV

doses.

Subcutaneous formulation is not

intended for intravenous

administration and should be given

via subcutaneous injection only. The

1400 mg strength is intended for

subcutaneous use in non-Hodgkin

lymphoma (NHL) only.

Precaution(s):

Administration-related reactions.

Premedication consisting of an

analgesic/antipyretic and an antihistamine

should be always be given before each

dose. Premedication with glucocorticoids

should also be considered. Pulmonary

events. Pre-existing pulmonary conditions

should be closely monitored for possible

infusion-related toxicity. Patients who

experience severe pulmonary events

should have their administration

interrupted immediately and receive

aggressive symptomatic treatment. Rapid

tumour lysis. Hypotension. Patients with a


8 / 15


NO. CURRENT DRUG IN

MOHMF AMENDMENT DETAILS

history of cardiac disease and/or

cardiotoxic chemotherapy should be

monitored closely. Monitor CBC and

platelets counts. Treatment should not be

initiated in patients with severe active

infections. Hepatitis B infections. Hepatitis

B screening should be performed before

initiation of treatment. Patients with active

hepatitis B should not be treated with

rituximab. Progressive multifocal

leukoencephalopathy. Permanently

discontinued in severe skin reactions such

as Toxic Epidermal Necrolysis and

Stevens-Johnson Syndrome. Vaccination

with live virus vaccines is not

recommended. Contraception during and

for 12 months after treatment. Should not

be administered to nursing mothers.


Known hypersensitivity to rituximab, to

any of its excipients or to murine proteins.

Interaction(s):

Limited data on possible drug interactions


Infections, sepsis, pneumonia, bronchitis,

hepatitis B, neutropenia, leucopenia,

anemia, thrombocytopenia, pancytopenia,

granulocytopenia, angioedema,

hypersensitivity, hyperglycemia, weight

decrease, peripheral edema, face edema,

increased LDH, hypocalcemia,

paresthesia, hypoesthesia, agitation,

insomnia, vasodilation, dizziness, anxiety,

lacrimation disorder, conjunctivitis,

tinnitus, ear pain, myocardial infarction,

arrhythmia, atrial fibrillation, tachycardia,

cardiac disorder, hypertension,

hypotension, bronchospasm, respiratory

disease, dyspnoea, nausea, pruritus,

rash, alopecia, hypertonia, myalgia, neck

pain, arthralgia, fever, chills, asthenia,

headache, decreased IgG levels, tumour

pain, flushing, cold syndrome.


9 / 15


LAMPIRAN 3

PINDAAN KATEGORI PRESKRIBER BAGI UBAT-UBATAN DALAM FUKKM YANG DILULUSKAN.

NO. GENERIC NAME AMENDMENT DETAILS

1. Indacaterol Maleate 150 mcg

Inhalation Capsule

(Breezhaler)

Change of category

prescriber from: A* to A/KK

Price/Unit: RM 38.00/unit

Prescribing restrictions:

Initiation of LABA, LAMA and

LABA/LAMA for COPD:

i) The diagnosis of COPD should

be confirmed by spirometry

ii) For Pulmonologist:

COPD patient must be

assessed for suitability for

lung volume reduction

(surgical or bronchoscopic

approach) and lung

transplant before they are

discharged to Klinik

Kesihatan.

iii) For Family Medicines

Specialist:

COPD patients must be

referred to Pulmonologist

for assessment of

suitability for lung volume

reduction (surgical or

bronchoscopic approach)

and lung transplant prior

initiation of LABA, LAMA

and LABA/LAMA in Klinik

Kesihatan.

2. Clopidogrel 75 mg tablet Change of category

prescriber from: A* to A/KK

The Panel has also approved to

revise indication in MOHMF:

Secondary prevention of

atherothrombotic events in:

a) Adult patients suffering from

myocardial infarction (from a

few days until less than 35

days), ischaemic stroke (from 7

days until less than 6 months) or

established peripheral arterial

disease.

Prescribing restriction: as

second/third line treatment in

patients who are sensitive or


10 / 15



intolerant to acetylsalicylic acid

and/or ticlopidine).

b) Adult patients suffering from

acute coronary syndrome:

Non-ST segment elevation

acute coronary syndrome

(unstable angina or non-Q-

wave myocardial

infarction), including

patients undergoing a stent

placement following

percutaneous coronary

intervention.

ST segment elevation

acute myocardial

infarction, in combination

with acetylsalicylate acid

(ASA) in medically treated

patients eligible for

thrombolytic therapy.

Others:

As in MOHMF.

3. Diosmin 450 mg /Hesperidin

50 mg Tablet

Change of category

prescriber from: A/KK to B

Reason: Drug proven to be effective

and safe. Change of prescriber’s

category will improve accessibility to

the drug.

Others: as in MOHMF

4. Diazepam rectal solution Change of category

prescriber from: C to B

Reason: To ensure the prescribing of

psychotropic substance is initiated

by medical officer.


11 / 15



5. Salmeterol 50 mcg and

Fluticasone Propionate 250

mcg Inhalation

Change of category

prescriber from: A/KK to A*

(for indication, chronic

obstructive pulmonary disease

only).

Category of prescriber A/KK is still

applicable for following indication:

i) Regular treatment of reversible

obstructive airways diseases

including asthma.

The following indication is amended

to category of prescriber A*:

ii) Chronic obstructive pulmonary

disease including chronic

bronchitis and emphysema

Note: All newly eligible COPD

patients for ICS/LABA have to be

referred to hospital setting for

initiation.

LAMPIRAN 4

UBAT-UBATAN YANG DIMANSUHKAN DARIPADA FUKKM

No. GENERIC NAME REASON FOR DELISTING

AVAILABLE ALTERNATIVE(S) IN

MOHMF & CATEGORY OF

PRESCRIBER

1. Ephedrine 0.5% w/v Nasal

Drops

Drug is not commercially

available and not used by

otorhinologists due to concern of

side effects.

i) Oxymetazoline HCL 0.05% Nasal

Spray (A)

ii) Oxymetazoline HCL 0.05% Nasal

Drops (A/KK)

2. Dexchlorpheniramine 2mg

Tablet

Not widely used by physicians

compared to current alternatives

in the MOHMF.

i) Chlorpheniramine 4mg Tablet (C)

ii) Loratadine 10mg Tablet (B)

iii) Desloratadine 5mg Tablet (A*)

3. Dexchlorpheniramine

2mg/5ml Syrup

i) Chlorpheniramine 2mg/ml Syrup

(C)

ii) Loratadine 1mg/ml Syrup (A)

iii) Desloratadine 2.5mg/5ml Syrup

(A*)


12 / 15


LAMPIRAN 5

A. LAIN-LAIN PINDAAN YANG DILULUSKAN OLEH PANEL KAJI SEMULA SENARAI UBAT-

UBATAN KKM

No. GENERIC NAME PROPOSED AMENDMENT DETAILS

1. Anti Rhd Gamma Globulin

300mcg/2ml Injection

To amend generic name in

MOHMF - Anti Rhd

Immunoglobulin Injection

Reason: To allow procurement of

different strength due to limited

product available in the market that

may interrupt supply to MOH facilities.

2. Empagliflozin 10mg &

25mg tablet

To amend cut-off point for

creatinine clearance (CrCl)

under prescribing restriction –

from CrCl 60ml/min or EGFR

60ml/min/1.73m2 and above to

CrCl 45ml/min or EGFR

45ml/min/1.73m2 and above.

Reason: To streamlined with updated

package insert of the preparation.

B. PINDAAN KEPADA UBAT-UBATAN RESPIRATORI (INHALERS) DALAM FUKKM

No. AMENDMENT GENERIC NAME DETAILS

1. To state type of inhaler

device in the MOHMF

Inhaled corticosteroids:

i) Beclomethasone

Dipropionate 100

mcg/dose Inhaler (MDI).

ii) Beclomethasone

Dipropionate 200

mcg/dose Inhaler

(Easyhaler).

iii) Budesonide 100 mcg/dose

Inhaler (Easyhaler).

iv) Budesonide 200 mcg/dose

Inhalation (MDI).

v) Budesonide 200 mcg/dose

Inhalation (Easyhaler).

vi) Ciclesonide 160mcg

Inhaler (MDI).

vii) Fluticasone Propionate

125 mcg/dose Inhaler

(MDI).

Long acting beta-2 agonist:

i) Olodaterol HCL

2.5mcg/puff, solution for

inhalation (Respimat).

All respiratory inhalers listed in the

MOH Medicines Formulary will be

named not only according to their

chemical entity(s), but also their type

of device.


13 / 15



ii) Indacaterol Maleate 150

mcg Inhalation Capsule

(Breezhaler).

Long acting muscarinic

antagonist:

i) Glycopyrronium 50mcg,

Inhalation Powder Hard

Capsules (Breezhaler).

ii) Tiotropium 2.5mcg/puff

solution for inhalation

(Respimat).

Fixed dose combination

ICS/LABA:

i) Beclomethasone

dipropionate 100mcg and

formoterol fumarate

dihydrate 6mcg

pressurized inhalation

solution (MDI).

ii) Budesonide 160 mcg and

Formoterol 4.5 mcg

Inhalation (Tubuhaler).

iii) Fluticasone propionate

125 mcg and formoterol

fumarate dihydrate 5mcg

per actuation pressurized

inhalation, suspension

(MDI).

iv) Fluticasone propionate

250mcg and formoterol

fumarate dihydrate 10 mcg

per actuation pressurized

inhalation, suspension

(MDI).

v) Salmeterol 25 mcg and

Fluticasone Propionate

125 mcg Inhalation (MDI).

vi) Salmeterol 25mcg and


50mcg Inhalation (MDI).

vii) Salmeterol 50 mcg and


250 mcg Inhalation

(Accuhaler).


14 / 15



viii) Salmeterol 50 mcg and


500 mcg Inhalation

(Accuhaler).

Fixed dose combination

LABA/LAMA:

i) Umeclidinium 62.5 mcg

and vilanterol 25mcg

inhalation (Ellipta).

ii) Indacaterol maleate 100

mcg and glycopyrronium

bromide 50mcg inhalation

powder hard capsules

(Breezhaler).

2. Addition of prescribing

restriction

Ciclesonide 160mcg Inhaler

MDI

Prescribing is limited to paediatrics

population only.


restriction

Tiotropium 2.5mcg/puff

solution for inhalation

(Respimat)

Prescribing is limited to patients who

intolerant or not responding to

Glycopyrronium


restriction

Salmeterol 25mcg and

Fluticasone Propionate 50mcg

Inhalation (MDI)

Prescribing is limited to paediatrics

population for the purpose of tapering

dose

5. Delist from MOH Medicines

Formulary

Budesonide 100 mcg/dose

Inhaler (Turbuhaler)

Sufficient to have one dry-powder

inhaler in the ICS class

6. Budesonide 200 mcg/dose

Inhaler (Turbuhaler)

Sufficient to have one dry-powder

inhaler in the ICS class

7. Indacaterol Maleate 300 mcg

Inhalation Capsule

(Breezhaler)

Product discontinued by the

manufacturer

8. Tiotropium 18mcg Inhalation

Capsules (Handihaler)

Product discontinued by the

manufacturer

9. Budesonide 320 mcg and

Formoterol 9 mcg Inhalation

(Turbuhaler).

Not for use as maintenance and

reliever therapy (MART) and it is

sufficient to have lower strength,

which has MART advantage.


15 / 15


LAMPIRAN 6

PENGEMASKINIAN SENARAI UBAT TROLI KECEMASAN KLINIK 1MALAYSIA /KLINIK KOMUNITI

Penyenaraian lignocaine 2% jelly.

No. Nama Generik Kuantiti Minimum

(amp/vial)

Kuantiti Maksimum

(amp/vial)

1. Atropine Sulphate 1mg/ml Injection 3 8

2. Hyoscine N-Butylbromide 20 mg/ml Injection 3 8

3. Dextrose 50% Injection (10ml) 3 8

4. Sodium Bicarbonate 8.4% 10ml Injection 3 8

5. Adrenaline Acid (Epinephrine) Tartrate 1mg/ml

Injection

3 8

6. Hydrocortisone 100 mg Injection 3 8

7. Lignocaine HCl (Lidocaine) 2% Injection 3 8

8. Aminophylline 25 mg/ml Injection 3 8

9. Chlorpheniramine Maleate 10 mg/ml Injection 3 8

10. Water for Injection (10ml) 2 5

11. Lignocaine 2% jelly

* penyimpanan hanya bertujuan untuk prosedur

penggantian kateter bagi pesakit yang dirujuk oleh

hospital/klinik kesihatan

1 tube 2 tube

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