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Administrative Order No. 2006-0018, dated May 8,2006, was formulated in order to revise the inputs, processes, and outputs of the Philippine National Drug Formulary System (PNDFS), collectively referred to, thereafter as the Philippine National Drug Formulary System (PNDFS) This was intended to provide systems and procedure for the selection of drugs to be included in or deleted from the Essential Drugs List (EDL) that would be an essential part of the PNDF Manual. The manual which is currently being developed integrates the three volumes of the old PNDF, namely the EDL, Essential Drug Monograph and cross - reference Index. It also aims to identify roles and responsibilities of various units of the Department of Health and other stakeholders in the continuous development of

Through the Philippine Health Insurance Corporation (PHIC) Board Resolution No. 265 dated July 15, 1999, the PNDF Volume 1 became the basis for claims reimbursements for drugs and medicines. PHIC intends to broaden its responsibilities in the implementation of the PNDF for the provision of the necessary administrative and secretary functions of the Epidemiology and Pharmacology Committees of the Formulary Study Group (FSG).

II. SCOPE AND COVERAGE
This Order shall be applicable to all Health Facilities/Units/Offices of the entire Government Sector insofar as drug procurement is concerned and shall be applicable to the entire Health Sector (Government and Private) insofar as PHIC claims for drug reimbursement is concerned.

III. GENERAL GUIDELINES
A. Addendum to Section V (E), page 4 of AO No. 2006-0018, which states that:

"(E) The PNDF Manual shall be published upon the recommendation of the Undersecretary of Health for Regulations and the approval of the Secretary of Health in accordance with the prescribed timelines established in the Generics Law. The PHIC shall be responsible for cost of dissemination and publication of the PNDF Manual."

The foregoing provision is hereby amended and read as follows:

"(E) The PNDF Manual shall be published upon the recommendation of the Undersecretary of Health for Regulations and the approval of the Secretary of Health in accordance with the prescribed timelines established in the Generic Law. The PHIC shall be responsible for cost of dissemination and publication of the PNDF Manual. PhilHealth shall be allowed to char-ge fees. Provided that the same shall not exceed the cost of printing and distribution of the PNDF Manual."

B. Addendum to Section VI (A), No. 5, page 6 of AO No. 2006-0018, which states that:

"5. The Formulary Executive Council shall consist often core members representing the broad societal perspectives on the selection and use of Pharmaceuticals. It shall have as members physicians and specialists from different fields of expertise with relevant years of experience and distinction in their respective fields. These members shall represent the following disciplines/ institutions:

a. Pharmacology
b. Toxicology
c. Clinical Epidemiology
d. Pharmacy (preferably in the academe)
e. Health economy
f. Clinical Pharmacy
g. Sociology/anthropology
h. pharmacovigilance
i. Head of the National Drug Information Center
j. NDP Program Manager

Specialty consultants shall be hired by FEC as non-permanent members and shall attend the meetings from time to time depending on the assigned topic for review, evaluation and updating. Said experts shall serve as the eleventh member of the Council,

The Secretary of Health shall appoint a Chairperson from the eligible members of the FEC, and upon acceptance, the Chairperson shall coordinate the work of the other members, as well as preside over meetings and facilitate discussions. The Chairperson shall hold his/her post for a period not exceeding three years. The other members of FEC shall also have terms of three years each, except that of the Head of the National Drug Information Center and the NDP Program Manager."

The foregoing provision is hereby amended and read as follows:

"5. The Formulary Executive Council shall consist of thirteen core members representing the broad societal perspectives on the selection and use of pharmaceuticals. It shall have as members physicians and specialists from differ ent fields of expertise with relevant years of experience and distinction in their respective fields. These members shall represent the following disciplines/ institutions:

a) Pharmacology
b) Toxicology
c) Clinical Epidemiology
d) Pharmacy (preferably in the academe)
e) Health economy
f) Clinical Pharmacy
g) Sociology/anthropology
h) Pharmacovigilance
j) Head of the National Drug Information Center
k) Philippine Health Insurance Corporation
I) Medico-Legal
m) Bureau of Food and Drugs

Specialty consultants shall be hired by FEC as non-permanent members and shall attend the meetings from time to time depending on the assigned topic for review, evaluation and updating. Said expert shall serve as the fourteenth member of the Council.

The Secretary of Health shall appoint a Chairperson from the eligible members of the FEC, and upon acceptance, the Chairperson shall coordinate the work of the other members, as well as preside, over meetings and facilitate discussions. The Chairperson shall hold his/her post for a period not exceeding three years. The other members of FEC shall also have terms of three years each, except that of the Head of the National Drug Information Center and the NDP Program Manager."

C. Addendum to Section VI (B) No. 2, page 8 of AO No. 2006-0018, which states that:

"2. The FSG, on its own initiative, shall review the list of drugs reflected in the current essential drugs list as embodied in the latest edition of the PNDF Manual during every quarter of the year. At least two (2) weeks before the end of each quarter the FSG shall submit the recommended drugs that are for inclusion or deletion from the latest edition of the PNDF Manual to the Undersecretary of Health for Regulations through the Program Manager of the NDP. Such shall be published in the DOH and PHIC websites, upon the approval of the Secretary of Health, in the month succeeding the end of each quarter."

The foregoing provision is hereby amended and read as follows:

"2. The FSG, on its own initiative, shall review the list of drugs reflected in the current essential drugs list as embodied in the latest edition of the PNDF Manual during every quarter of the year. At least two (2) weeks before the end of each quarter the FSG shall submit the recommended drugs that are for inclusion or deletion from the latest edition of the PNDF Manual to the PhilHealth President and the Undersecretary of Health for Regulations through the Program Manager of the NDP. Such shall be published in the DOH and PHIC websites, upon the approval of the Secretary of Health, in the month succeeding the end of each quarter,"

D. Addendum to Section VI (B), No. 12 b) Hi, page 12 of AO No. 2006-0018, which states:

"iii. The Name of the Undersecretary of Health to which the summary reports is addressed to..."

The foregoing phrase in the cited provision is hereby amended and read as follows:

"iii. The Names of the PhilHeatth President and the Undersecretary of Health to which the summary reports are addressed to..."

E Addendum to Section VI (C), No. 6, page 14 of AO No. 2006-0018, which states that:

"6. The FSG, upon receipt of the PNDF Forms as described in VLB and C, shall evaluate the request(s) and shall include the same as annexes to PNDF Form No. 2"

The foregoing provision is hereby amended and read as follows:

"6 The FSG, upon receipt of the PNDF Forms as described in VLB and C, shall evaluate the request(s) and shall include the same as annexes to PNDF porm No. 2. PhilHealth may charge an application fee to be determined by the Corporation."

IV. SEPARABILITY CLAUSE
If any provision in these Guidelines, or application of such provision to any circum-held invalid, the remainder of this order shall not be affected.

V. REPEALING CLAUSE
The provisions of previous issuances, which are inconsistent with those provided in mis Order shall be deemed repealed and modified accordingly.

VI. EFFECTIVITY

This Order shall take effect immediately.

Adopted: 17 April 2008

(SGD.) FRANCISCO T. DUQUE III, MD. MSc.
Secretary of Health