深度报告-2026-01-30-世界卫生组织-Timor-Leste_Essential_Medicines_List_TLEML_2025_English_81页_2mb

Summary of Timor-Leste Essential Medicines List (TLEML) 4th Edition, February 2025

Core Content

The Timor-Leste Essential Medicines List (TLEML) is a comprehensive and updated document that outlines the medicines deemed essential for the health care system of Timor-Leste. It is a key component of the National Drug Policy and is designed to ensure the safe, effective, and affordable availability of medicines across the country. The 4th edition was developed through a collaborative and transparent process involving national and international experts.

Main Points

1. Purpose of the TLEML

• The TLEML is a critical tool for managing medication use, ensuring rational prescribing, and supporting cost-effective procurement.
• It aligns with WHO recommendations, international best practices, and the specific health needs of Timor-Leste.
• The list aims to improve universal health coverage and help achieve health-related sustainable development goals.

2. Review Process

• The TLEML is reviewed every three to five years by the Commission for the Selection of Medicines, Products and Medical Equipment (CSMPEM).
• The process includes consultative meetings, national workshops, and systematic analysis of efficacy, safety, and cost-effectiveness.
• A standardized format is used for applications and external reviews to ensure transparency and consistency.

3. Procedures for Adding or Removing Medicines

Adding New Medicines

• Applications are submitted via the Application Form for Addition/Deletion of Medicines.
• Criteria for evaluation include:
  • Pharmacological classification
  • Therapeutic indications
  • Dosage forms
  • Pharmacokinetics and pharmacodynamics
  • Dosage regimen
  • Adverse events and toxicities
  • Cost-effectiveness
  • Annual consumption rate
• The CSMPEM evaluates the request and may invite the requesting professional to a meeting for discussion.

Removing Medicines

• A written request for deletion is submitted to the Chairperson of CSMPEM.
• The Drug Information Unit gathers additional information and forwards the application to the CSMPEM.
• The requesting professional may be invited to a meeting to discuss the removal.

4. Procedures for Non-Listed Medicines

• Non-listed medicines are those not included in the TLEML but may be required for specialized treatments or patients who have been stabilized on non-listed medicines.
• A Request Form for Non-Listed Medicines is used to apply for such medicines.
• The form must be completed accurately and submitted to the Pharmacist in-Charge at the relevant facility.
• After use, a feedback report on the effectiveness of the non-listed medicine must be submitted within seven days.
• If the medicine is effective and requested at least three times, it may be considered for inclusion in the TLEML.
• A register of non-listed medicine requests is maintained by health facilities and shared with the National Institute of Pharmacy and Medicines (INFPM) and the Department of Pharmacovigilance.

5. Structure of the TLEML

The TLEML includes the following key elements:

1. Active Ingredient, Pharmaceutical Strength, and Preparation

• Active ingredients are the core substances responsible for therapeutic effects.
• Pharmaceutical strength is quantified in units such as mg, g, ml, IU, etc.
• Preparations refer to the final dosage forms, including tablets, capsules, solutions, injections, etc.
• The list contains 331 active ingredients, 460 pharmaceutical strengths, and 426 preparations.

2. Vital, Essential and Non-essential Categories (VEN)

• V (Vital): Life-saving medicines; unavailability leads to serious harm. These must be 100% available.
• E (Essential): Medicines for serious conditions; unavailability leads to major discomfort or irreversible harm.
• N (Non-essential): Medicines that are important but can be delayed or substituted if alternatives are available.

3. Access, Watch and Reserve Categories (AWaRe)

• Access group: Antibiotics with broad activity and lower resistance potential.
• Watch group: Antibiotics with higher resistance potential or at high risk of promoting resistance.
• Reserve group: Antibiotics reserved for multi-drug-resistant infections; considered "last resort" options.

4. Level of Use (LoU)

• Medicines are categorized by the level of health facility where they can be used.
• Examples include:
  • Spec: Specialist restricted medicines (only for use in National Hospital Guido Valadares).
  • HNGV: For use in National Hospital Guido Valadares (includes medicines from HP1, HP2, CHC1, and CHC2).
  • Hosp: For use in hospitals (includes medicines from HP1 and HP2, and CHC1, CHC2, and CHC3).
  • CHC3, CHC2, CHC1, HP2, HP1: Define the scope of medicine availability at different levels of health facilities.

5. Anatomical Therapeutic Chemical (ATC) Classification

• Medicines are classified based on their anatomical, therapeutic, and chemical properties.
• The classification includes five levels, from broad anatomical groups down to specific chemical substances.
• Example: Metformin is classified as A10BA02 under the ATC system.

6. Medicines Restriction (Age and Weight)

• Certain medicines are restricted based on age and weight.
• Examples include:
  • Atropine: >3 months
  • Doxycycline: >8 years (except for serious infections)
  • Metoclopramide: Not for neonates
  • Ceftriaxone: >41 weeks corrected gestational age

Key Information

• The TLEML is updated through a systematic and transparent process.
• The VEN classification helps prioritize medicines based on clinical need and economic considerations.
• The AWaRe system is used to combat antimicrobial resistance.
• The LoU system ensures that medicines are available at the appropriate level of care.
• The ATC system provides a standardized classification for easy identification and management.
• Age and weight restrictions are applied to ensure safe use of certain medicines.

Conclusion

The TLEML 2025 is a vital resource for healthcare providers, policy makers, and development partners in Timor-Leste. It supports equitable access, cost-effective procurement, and rational use of medicines. The document reflects a collaborative effort between national and international experts, ensuring that the list is current, relevant, and aligned with global standards.