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Dossier d4 Form - 0

The dossier form collects information on the proposed medicine or indication including its generic name, dosage form and strength, approved indications and prescriber category, existing treatment alternatives, costs and budget implications, and requires signatures of support from the head of department, head of pharmacy, and final approval or non-approval by the institution's Drugs and Therapeutics Committee.

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chai min choo
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124 views

Dossier d4 Form - 0

The dossier form collects information on the proposed medicine or indication including its generic name, dosage form and strength, approved indications and prescriber category, existing treatment alternatives, costs and budget implications, and requires signatures of support from the head of department, head of pharmacy, and final approval or non-approval by the institution's Drugs and Therapeutics Committee.

Uploaded by

chai min choo
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Dossier D4 - form

DOSSIER D4
To Add Medicines/Indication Listed in the MOH Medicines Formulary into Institution’s
Medicines Formulary

Background:

A medicine/ indication is eligible for consideration to be added into the institution’s Medicines
Formulary only when it is listed/ approved in the MOHMF.

Dossier D4 is to be used by the applicant (consultant/ specialist/ medical officer/ pharmacist)


for the purpose of listing into their institution’s Medicines Formulary.

The form should be submitted to the Secretariat of the institution’s Drug and Therapeutic
Committee (DTC). The Secretariat will present a brief review of the application in the DTC
meeting for approval.

The Secretariat should take into consideration the following matters:


 Current available alternatives in the institution’s Medicines Formulary.
 Available budget for each discipline/ activity.
 Impact of adding the new medicine(s) to the overall medicine budget.
 Estimated number of patients to be treated with the new medicine.
 Training required in handling the new medicine (if any).

Pharmacist should monitor the utilization, costs and adverse effects of the newly approved
medicine.

Approval for the said medicine for the Institution Medicines Formulary should be of the same
prescriber category as the MOHMF or higher.

1. MEDICINE PARTICULARS (to be filled by applicant)


1. Generic name Provide full generic name as available in MOHMF with
[specify dosage form(s) & the dosage form(s), strength(s) and concentration(s).
strength(s)/ concentration(s)]
2. Indication(s) approved for State all indication(s) to be proposed for listing in the
MOH Medicines Formulary institution’s Medicines Formulary. The indications
should be the indications approved.
3. Approved category of State the approved prescriber category as in the
prescriber MOHMF.
4. Proprietary name State the medicine trade name as marketed in Malaysia
5. Dosing, frequency and
duration of treatment
6. Existing medicine(s) with the Generic name 1: ……………………………………………
same/ similar indication &
annual procurement Year: ……………… RM ……………………
Dossier D4 - form

Add more lines if there are Generic name 2: ……………………………………………


more than 3 alternatives
currently available in the Year: ……………… RM ……………………
institution’s Medicines
Formulary
7. The main reason(s) to list Has therapeutic advantage over an existing
the product: drug
Please tick the main reason A cheaper alternative to an existing drug
of the proposal.
Improve compliance

Others (please specify below):


8. Is this a replacement for
existing medication? No Yes: …………………………….
(medicine(s) that proposed to be deleted from
the institution’s formulary )

9. Other details on rationale of application:

2. COSTS AND BUDGET IMPLICATION TO THE INSTITUTION


1. Estimated number of patients per 1. (for therapeutic discipline 1)
year (a) 2. (for therapeutic discipline 2)
2. Price per pack size (RM) State the SKU and the medicine costs per SKU
unit agreed for MOHMF.
3. Dosing, frequency and duration of Refer to sec. A
treatment
4. Total medicine cost per patient per
year (b)
5. Estimated total cost of medicine
incurred per year (a x b)
6. Available budget for the relevant The budget available for disciplines that are
discipline/activity going to use the medicines should be stated
1.
2.

3. APPLICANT’S STATEMENT OF DECLARATION

STATEMENT OF DECLARATION
Dossier D4 - form

I, the undersigned, declare herewith that to my best knowledge and professional


responsibility all information submitted within this dossier is complete and correct.

Signature: …………………………… Date: …………………………

Name of Officer: ……………………………… Contact Number: …………………….


Designation: ………………………………… Email Address: ……………………….

Official Stamp:

4. HEAD OF DEPARTMENT

SUPPORT NOT SUPPORT

Comment:
………………………………………………………………………………………………….………
…………………………………………………………………………………………………….

Signature: ………………………………….

Date: ………………………….

Name & Stamp: ……………………………

5. HEAD OF PHARMACY DEPARTMENT

SUPPORT NOT SUPPORT

Comment:
………………………………………………………………………………………………….………
…………………………………………………………………………………………………….

Signature: ………………………………….

Date: ………………………….

Name & Stamp: ……………………………

6. APPROVAL BY DRUGS & THERAPEUTICS COMMITTEE


Dossier D4 - form

APPROVE NOT APPROVE

Comments:
…………………………………………………………………………………………………………
…………………………………………………………………………………………………………

Signature (Chairperson): ………………………………

Meeting Date: ………………………….

Name & Stamp: ……………………………

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