Ministry of Health Medicines Formulary (MOHMF)
Introduction
The Ministry of Health Medicines Formulary (MOHMF), “Formulari Ubat Kementerian Kesihatan Malaysia (FUKKM)", or sometimes known as Blue Book, is a list of medications that we can use in Ministry of Health (MOH) facilities.
- It is typically updated 2-3 times a year to add, modify or delist the medications in it.
- However, the information such as indications, dosages, adverse reaction, contraindications, interactions, precautions and method of purchase, in FUKKM is continuously being updated throughout the year.
- The updated website version can be accessed here.
Before we continue further, please remember that:
- MOHMF is not a list of medications available in Malaysia.
- MOHMF is not equivalent to your hospital drug formulary.
- MOHMF is not applicable in private clinic or hospital setting, only in government facilities.
Regarding MOHMF, there are 3 important concepts that you should be aware of:
- Category of prescribers
- KPK
- Dossier
Category of Prescribers
In Malaysia Ministry of Health settings, the drug prescribing is categorized into few prescriber categories. It restricts the prescribing of a medical officer, where only a specialist or consultant can prescribe certain medications.
It is a policy and administrative approach to control and promote the rational and quality use of medicines in all hospitals, clinics and MOH institutions. Thus, the expenditure used for drug procurement can be controlled and the available financial allocation is used optimally.
As an overview, the category of prescribers who can initiate prescriptions as follows.
- A* - Consultant/Specialists for specific indications only
- A - Consultant/Specialists
- A/KK - Consultant/Specialists/Family physician specialists
- B - Consultant/Specialists/Family physician specialists/Medical officers
- C - Consultant/Specialists/Family physician specialists/Medical officers/Paramedics
- C+ - Consultant/Specialists/Family physician specialists/Medical officers/Paramedics/Paramedics doing midwifery
* Paramedics can only supply medicine with/without prescription and is not allowed to write a prescription.
As of July 2022, about 64% of medications in MOHMF can only be started by consultants or specialists (that is, falls under A*, A, A/KK).
NOTE: Not to be confused with legal classification of drugs as in Poisons Act 1952.
Medicines Special Approval Form
Medicines Special Approval Form is used to obtain and use medicines that require special approval (UKK - "Ubat Kelulusan Khas") from the Director General of Health (KPK - "Ketua Pengarah Kesihatan") or Senior Director of Pharmaceutical Services (PKPF - "Pengarah Kanan Perkhidmatan Farmasi").
Medicines Special Approval Form is subdivided into
- Named-patient basis
- Registered with Drug Control Authority but not listed in MOHMF
- Registered with Drug Control Authority and listed in MOHMF but off label use from MOHMF.
- Registered with Drug Control Authority and listed in MOHMF but off label use from Drug Control Authority.
- Not Registered with Drug Control Authority and not listed in MOHMF = Needs import permit
- Stock basis
- Not Registered with Drug Control Authority but listed in MOHMF = Needs import permit
- Medicine is not listed in MOHMF but there is a need to kept for emergency cases and no alternatives available in MOHMF
Ideally, the use of these special approval medicines should be limited to situations where it is the last resort where patients are not responding or having adverse drug reactions to the registered medicines in Malaysia market.
NOTE: For applications to import or manufacture unregistered products for the treatment of life-threatening illnesses by private or other than MOH institutions, please visit this link.
Submission of Dossier For Listing Into the MOHMF
Dossier for listing a new medicine, indication, dosage form or strength into MOHMF should be submitted by the production registration holder (PRH) or a locally registered company authorised in writing by the PRH.
- D1 - To list new medicine or new indication(s) for existing medicines (with a fee of RM 5000 or RM 3000 respectively)
- D2 - To add dosage form or strength (with a fee of RM 2000)
Dossier for changing prescriber category and delisting of medicine or indication should be submitted by consultants/specialists/medical officers/dentists/pharmacists working in MOH facilities or chairman of MOH Drug Working Committee.
- D3 - To change category of prescriber
- D4 - To delist approved medicine or indication
The corresponding eligible applicants from MOH is only limited to D3, D4 and D5.
Any suggestion(s) to update medicine information in the MOH Medicines Formulary can be submitted by completing the MOHMF Information Update Request Form.
- Information that can be proposed to be amended are such as generic name, drug interactions, indication, prescribing restriction (only by MOH personnel), adverse drug reactions (ADR), dose and contraindications.
External Links
- Ministry of Health Medicines Formulary (MOHMF), 2023
- Drug Control and Formulary Management in Malaysia, 2008
- Guidelines for Submission of Dossier for Listing into the Ministry of Health Medicines Formulary, 2024
- Medicines Special Approval Form
- Application To Import/Manufacture Unregistered Products For The Treatment of Life-Threatening Illnesses (Private/Non-MOH Institutions)
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