Revised Implementing Guidelines for the Philippine National Formulary System (PNFS)

October 24, 2012

DOH ADMINISTRATIVE ORDER NO. 2012-0023

 

I. Rationale

The 1987 Philippine Constitution mandates the right of every Filipino to health. It enunciates the policy that "the State shall protect and promote the health of the people and instill health consciousness among them" (Article II Section 15). Furthermore, it provides the adoption by the State of an "integrated and comprehensive approach to health development which shall endeavor to make essential goods, health and other social services accessible to all the people at affordable cost" (Article XII Section 15). CTcSAE

To support these goals, several policies and laws have been passed. These include Republic Act No. 6675 known as the Generics Act of 1988 that was enacted to "ensure the adequate supply of drugs with generic names at the lowest possible cost." It further states that "in the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drugs List to be prepared within one hundred eighty (180) days from approval of this Act and updated quarterly by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria."

Executive Order No. 49 (dated 21 January 1993, entitled "Directing the Mandatory Use of the Philippine National Formulary Volume I as the Basis for Procurement of Drug Products by the Government") strengthened the advocacy of the Generics Act by ensuring that only essential medicines identified in their generic names will be procured by all government institutions.

Administrative Order No. 163 s. 2002 (entitled "Implementing Guidelines and Procedures in the Procurement and Requisition of Drugs and Medicines by the Department of Health pursuant to Executive Order No. 49") provides the procedural bases that ensure requisition of essential medicines by the Government sector and the decision system for the inclusion and deletion of medicines in the Philippine National Drug Formulary (PNDF).

The Philippine Health Insurance Corporation (PHIC) Board Resolution No. 265 (dated 15 July 1999) likewise provides that the PNDF Volume I shall be the basis for claims reimbursements for medicines.

The more recent RA 9502 enacted in 2008 provides additional power to the President of the Philippines to impose, upon the recommendation of the Secretary of Health, maximum retail prices over medicines that include, among others, the "drugs and medicines that are included in the Philippine National Drug Formulary Essential Drug List."

The Philippine National Drug Formulary continues to serve as the national reference for quality and rational selection of the medicines which are vital in achieving the best health outcomes. Given the importance of the PNDF in the attainment of universal access to quality essential medicines, the systems, procedures and processes to formulate and update the previous Administrative Orders, AO 2006-0018 Implementing Guidelines for the Philippine National Formulary System (08 May 2006) and two addenda AO 2006-0018-A (17 April 2008) and AO 2006-0018-B (07 October 2010) need to be reviewed and enhanced. aHDTAI

II. Objectives

This issuance aims to:

A. Describe the new systems and procedures for:

1. the selection of medicines to be included in or deleted from the Essential Drug List hereafter referred to as the National Essential Medicines list;

2. the development of a new format of the Philippine National Formulary that integrates all three volumes of the previous PNDF, namely, the National Essential Medicines List, the Formulary Monographs and the Cross-Reference Index, and which shall be referred to as the PNF Manual; and

3. the promotion of the use of the Formulary among the different levels of healthcare managers and providers and the consumers.

B. Reconstitute the Formulary Committee and describe the implementation arrangements of the Philippine National Formulary System (PNFS).

III. Scope

This Order shall be applicable to all health facilities, units and offices of the entire government sector insofar as drug procurements are concerned and shall be applicable to the entire health sector (both government and private) insofar as the Philippine Health Insurance Corporation claims for drug reimbursements are concerned. AHDacC

IV. Definition of Terms

A. Essential Medicines — These are medicines that satisfy the priority health care needs of the population and which are selected based on the evidence of their efficacy, safety and comparative cost-effectiveness. These medicines shall be made available and affordable at all times. The prioritization of the health care need shall be based on the burden of the disease.

Essential medicines are classified into:

1. Core Medicines — These are the most efficacious, safest and most cost-effective medicines for priority diseases and health care needs. These are intended to be available at all times in adequate quantities in appropriate dosage forms and at the lowest possible cost.

2. Complementary Medicines — These are medicines used:

a. as alternatives when medicines in the core list are ineffective or inappropriate for a given individual or when core medicines cannot be made available;

b. for priority diseases for which specialized diagnostic or monitoring facilities and/or specialized medical care, and/or specialized training are needed;

c. for non-prevalent diseases that are life-threatening (i.e., likely to cause death if untreated) or that are disabling (i.e., likely to cause permanent disability if untreated);

d. for diseases or conditions prevalent in a sector of the population with special needs; and SHTEaA

e. for diseases that are endemic in a particular area or for diseases confined in a limited setting at a given time.

V. General Guidelines

A. The new edition of the Philippine National Drug Formulary shall be referred to as the Philippine National Formulary (PNF) with its inputs, processes and outputs collectively referred to as the Philippine National Formulary System (PNFS).

B. The Formulary Committee shall be reconstituted and hereafter referred to as the Formulary Executive Council (FEC).

C. The PNFS shall be operationalized through the FEC with assistance from independent evidence review groups (ERGs) and a pool of specialty experts. The National Center for Pharmaceutical Access and Management (NCPAM) through its Policy, Planning, Program Development and Research Division shall provide secretariat support to the FEC.

D. The PNF shall be developed and updated using the Formulary Selection Algorithm which shall describe the step-by-step selection procedure to be employed in determining the medicines to be included in or deleted from the Formulary.

E. For a medicine disapproved for inclusion in the PNF or deleted from the PNF, interested parties may submit an application for reconsideration provided that new or additional evidence-based data on the medicine are presented. The FEC may consider holding a public forum when deliberating on the reconsideration of an application.

F. All evidence summaries, proceedings of meetings of the FEC and the decisions of the Secretary of Health shall be published in the DOH-NCPAM website.

G. The FEC shall conduct periodic reviews of the Formulary with assistance from the ERG and/or the specialty experts as needed. DTISaH

H. The PNF Manual shall include the following: the Guidelines on the Rational Use of Medicines, the National Essential Medicines List, the Formulary Monographs and the Cross-Reference Index.

1. The previously named PNDF Volumes 1-3 (Essential Medicines List, Formulary Monographs and Cross-reference Index) shall cease to exist as independent publications. Together with succinct guidelines on the rational use of medicines, the content of these previous volumes shall be integrated into a concise PNF Manual.

2. The PNF Manual shall be published upon the recommendation of the Assistant Secretary or Undersecretary of Health in charge of NCPAM and the approval of the Secretary of Health in accordance with the prescribed timelines established in the Generics Act of 1988 and the Cheaper Medicines Act of 2008. The NCPAM shall be responsible for the cost of publication and dissemination of the PNF Manual.

I. Only medicines listed in the PNF Manual shall be procured by all government entities in accordance with Executive Order No. 49 s. 1993. However, exemptions may be granted upon submission of the completed application form by the end user, e.g., DOH national programs and government hospitals, with justification and subject to the approval of the NCPAM Program Director upon recommendation of the FEC based on the prescribed criteria.

J. The PNF Manual shall be reviewed and updated regularly in accordance with established timelines as provided in RA 6675.

K. The PNF Manual shall be made available in downloadable format from the official websites of the DOH, www.doh.gov.ph, and NCPAM, http://uhmis2.doh.gov.ph/doh_ncpam/.

L. Medicines withdrawn from the Philippine market due to safety reasons shall be deemed delisted from the PNF Manual effective on the date of the order for withdrawal by the Food and Drug Administration. THaDEA

M. The FEC shall recommend to the NCPAM guidelines for a more comprehensive dissemination of the PNF. Monitoring of the dissemination and use of the Formulary Manual will be conducted regularly by the NCPAM.

N. The FEC shall recommend to the NCPAM guidelines in the monitoring and evaluation of the PNF.

VI. Specific Guidelines

A. Formulary Executive Council

1. Composition:

a. The Formulary Executive Council (FEC) shall consist of eleven (11) members representing the broad scientific and societal perspectives that may impact on the judicious selection and use of medicines. It shall have as members respected individuals whose collective expertise shall cover the fields of pharmacology, toxicology, clinical epidemiology, pharmacy, clinical medicine, public health, law and medicine, health economics and health social science.

b. The members of the committee shall have a maximum term of three (3) years each without prejudice to reappointment.

c. The FEC shall have a Chairperson selected by the Secretary of Health from the eleven members. The chair shall hold his/her position for a period not exceeding three (3) years.

2. Qualifications:

a. Persons of moral and intellectual integrity.

b. Recognized specialists in their field of expertise.

c. Willingness to disclose conflicts of interest.

3. Disclosure of Conflicts of Interests: cCaIET

The FEC members shall conform with the principles of integrity and shall therefore declare all circumstances with real or potential conflicts of interests and shall comply with the policy set up for declaring and managing such.

4. Specific Functions:

a. The FEC shall identify the diseases for which medicines need to be included in the Formulary based on a continuing review of disease statistics from public and private hospitals and other health facilities, advice from the different specialty societies and input from the programs and offices of the Department of Health and other stakeholders. The selection of these diseases shall be based on their burden, i.e., their frequency and severity. The frequency of disease shall be measured by its prevalence or incidence. Disease severity shall be determined by disability-adjusted life years (DALY) or, in its absence, a consensus of experts.

b. The FEC shall identify the diseases and conditions for which medicines will be listed in the different levels of healthcare.

c. The FEC shall deliberate on whether the applications will require further expert evaluation by the evidence review groups (ERG) following the criteria it has approved. The FEC then reviews applications for medicines that will not require further evaluation by the ERG and recommend inclusion in or deletion from the PNF or exemption from EO no. 49 s. 1993.

d. The FEC shall forward requests for medicines that it has determined as requiring further evaluation to one of the evidence review groups (ERG) for review. The ERG, through its consultants, shall prepare an evidence summary (ES) considering the set of criteria for inclusion in the Formulary. These criteria will include the medicine's benefit-risk assessment, cost-effectiveness as well as health system and budgetary impacts that are to be based on systematic reviews of the medical literature and other references such as clinical practice guidelines and post-marketing surveillance data. aCATSI

e. The FEC shall prepare a recommendation based on the evidence summary prepared by the ERG, position papers of the stakeholders and the input of the relevant specialty experts. All recommendations will be submitted to the Assistant Secretary or Undersecretary of Health in charge of NCPAM, who after review of the recommendation, will then forward the same to the Secretary of Health for action.

f. The FEC shall ensure that all final decisions and prioritization of medicines for inclusion and retention in the formulary are based on feasibility, affordability and suitability properties of each medicine.

B. Evidence Review Groups

1. Compositions and Qualifications:

a. The evidence review groups (ERG) will be composed of experts in clinical epidemiology, toxicology, pharmacoeconomics, health economics, health technology assessment, evidence-based medicine (EBM) and other relevant fields.

b. Qualifications of an evidence review expert include:

i. Completion of participation in at least one (1) evidence-based medicine workshop under a recognized consultancy group;

ii. Active practice or teaching of evidence-based medicine;

iii. Willingness to declare and manage conflicts of interests; and

iv. Willingness to sign the contract of service. TcDAHS

2. Functions:

The evidence review experts are tasked as necessary by the FEC to review and analyze the results of benefit-risk and efficiency analysis of medicines obtained from controlled clinical trials and sound epidemiologic studies.

C. Pool of Specialty Experts

1. Composition and Qualifications:

They are specialty experts in various clinical and related disciplines with relevant years of experience and distinction in their fields appointed by the Secretary of Health to assist the FEC when the need arises.

2. Functions:

a. They shall provide expert opinion regarding a particular medicine;

b. They shall review and assist in the formulation of relevant clinical guidelines; and

c. They shall provide assistance in the formulation of systems and procedures.

D. Specific Guidelines for the Formulary Selection Algorithm

1. The FEC shall ensure that each medicine considered for inclusion in the PNF shall be assessed based on its quality, benefit-risk assessment (efficacy and safety) and pharmacoeconomic assessment.

a. The FDA shall provide the initial necessary data to the FEC to this effect, i.e., records of all medicines registered in the Philippine market covered with a Certificate of Product Registration (CPR). The FDA shall likewise provide data on whether the medicine is available in the Philippine market or is still in the process of being registered. SECAHa

b. In the event that an application for inclusion of a medicine already registered with the FDA is disapproved by the FEC due to unsatisfactory therapeutic efficacy or safety reasons where the toxicity or suspected toxicity, potential for abuse and dangerous interactions of the medicine outweigh its therapeutic value, the FEC shall recommend review of its CPR to the Secretary of Health through the Assistant Secretary or Undersecretary of Health in charge of NCPAM. Likewise, if registration of a disapproved medicine is still under process, the FEC shall recommend disapproval of such application for CPR through the same channels. The FEC shall attach all justifications for such recommended actions.

c. Medicines not registered in the Philippines may still be considered for inclusion in the PNF provided they satisfy the criteria for inclusion and can be modified to adapt to local conditions when necessary. Bases for selection will include data obtained from the drug regulatory agency of the country where the medicine is marketed or the certification that it conforms to the provisions of the ASEAN Harmonization.

2. The FEC shall review the list of medicines in the PNF on a quarterly basis. At least two (2) weeks before the end of each quarter, the FEC shall submit to the Assistant Secretary or Undersecretary of Health in charge of NCPAM the list of recommended medicines for inclusion in or deletion from the PNF. Such shall be published in the DOH-NCPAM website, upon the approval of the Secretary of Health, in the month succeeding the end of each quarter.

3. Bases for medicine selection will include the following:

a. Burden of disease that will be measured by its frequency, as indicated by its prevalence or incidence, and by its severity, as indicated by its disability-adjusted life years (DALY) or, in its absence, a consensus of experts; DacASC

b. Efficacy and safety that will be based on objective results and on adequate pharmacological studies including at least Phase III clinical trials;

c. Pharmacoeconomic assessment of drug treatment regimen that will consider not only therapeutic effects but also adverse events and quality economic evaluations;

d. Appropriateness to the capability of health workers at different levels of health care, taking into consideration the level of expertise required for prescribing, dispensing, administering and monitoring the safety and adverse effects of the medicines as well the competence of local personnel in making a correct diagnosis; and

e. Local health problems when concomitant or prevalent diseases or conditions in a special population or in a particular setting may influence pharmacokinetic and pharmacodynamic parameters and modify therapeutic responses.

4. For medicines belonging to the same pharmacologic class, the following preferential factors shall be used in choosing the best possible medicine:

a. The medicine is the most thoroughly investigated and therefore the best understood with respect to its benefits and risks;

b. The medicine possesses clinical utility for the treatment of more than one condition or disease;

c. The medicine has the most favorable pharmacokinetic properties, e.g., factors promoting better compliance or leading to lesser risk in various pathophysiological states;

d. The medicine has dosage forms that are easy for the health staff to dispense or that are easily and safely administered to the patient; HCSEIT

e. The medicine is easy for the patient to take or promotes better compliance among most patients;

f. The medicine and its dosage forms have favorable stability under the anticipated local conditions in storage facilities;

g. The medicine is produced in local manufacturing facilities certified by FDA to have conformed with good manufacturing practices.

5. The medicines should be formulated as single compounds. Fixed-dose combinations are acceptable only when:

a. The value of concomitant use of more than one medicine is rational and clinically documented;

b. Plus all of the following:

i. The combination provides an additive, synergistic and/or complementary action;

ii. The combination has no additional adverse drug reactions;

iii. The combination provides dosage convenience for better patient compliance; and

iv. The cost of the combination product is less than or does not exceed the cost of the sum of the individual products of the active ingredients of the combination. ETIcHa

6. Criteria for inclusion of new medicines in the PNF are as follows:

a. The medicine is needed for the prevention and/or treatment of diseases and/or conditions not yet covered in the existing list;

b. The medicine is more effective and/or less toxic than, but, is at least as cost-effective as another medicine listed for the same indication; and

c. The medicine is more cost-effective and as safe as another medicine listed for the same indication.

7. The Core List of the PNF shall include medicines of proven quality, efficacy and safety that will fulfill either of the following criteria:

a The medicine is the most efficacious, safest and most cost-effective medicine indicated for a priority disease or priority health care need in the Philippines; or

b. The medicine indicated for a priority disease or condition belongs to a pharmacologic class that is not yet included in the PNF.

8. The Complementary List of the PNF shall include medicines of proven quality, efficacy and safety that will fulfill any of the following criteria:

a. The medicine is used as an alternative when the core medicines are ineffective or inappropriate for a given individual or when core medicines cannot be made available;

b. The medicine is used for priority diseases or conditions for which specialized diagnostic or monitoring facilities and/or specialized medical care and/or specialized training are necessary;

c. The medicine is indicated for a non-prevalent disease that is life-threatening (i.e., likely to cause death if untreated) or disabling (i.e., likely to cause permanent disability if untreated); DIETcH

d. The medicine is indicated in diseases or health conditions that are prevalent in a sector of the population with special needs; or

e. The medicine is indicated for a disease that is endemic in a particular area or confined in a limited setting at a given time.

9. Criteria for the exclusion or deletion of medicines from the PNF are as follows:

a. The medicine has been withdrawn from the FDA registry due to safety reasons;

b. A more effective or equally effective but less toxic medicine becomes available;

c. In light of further knowledge, the therapeutic efficacy of the medicine is found to be unsatisfactory;

d. Toxicity, suspected toxicity, potential for abuse and dangerous interactions outweigh the medicine's therapeutic value;

e. The medicine is no longer deemed cost-effective compared to other therapies; or

f. The medicine is a fixed-dose combination that does not satisfy the requirements of A.O. 96 s. 1990 and the prescribed criteria of the FEC.

10. Exemptions

a. EO No. 49 s. 1993 states that only medicines listed in the PNDF shall be procured by all government entities. Requests for exemptions will be considered provided that the medicine proposed for exemption is of proven efficacy and safety. There should also be a simultaneous application filed by the proponent for inclusion of the medicine in the PNF. ADCEaH

b. The application for exemption shall have the following as attached documents:

i. Justification for the request;

ii. Scientific evidence of the medicine's efficacy and safety supported with literature;

iii. Report on the disease burden and its ranking relative to the common diseases seen in the community or health facility;

iv. A comparison of costs for the total regimen of the medicine or its full course of therapy with other comparable medicines listed in the current edition of the PNF Manual; and

v. Copy of Certificate of Product Registration from the FDA or proof that the medicine has conformed with the World Health Organization Certification Scheme on Quality of Pharmaceutical Products Moving in International Commerce.

c. The justification for the request for exemption will include the following:

i. The medicine will be used for a national health program;

ii. The medicine will be used for a current or potential urgent health situation, where urgent is defined as requiring immediate action to prevent death, permanent disability or a major or irreversible organ dysfunction;

iii. The medicine is needed for the prevention and treatment of priority conditions not yet covered in the existing list;

iv. The medicine is more effective and/or less toxic than a medicine listed for the same indication; and CEIHcT

v. The medicine is at least as effective and safe and of lower cost than a medicine listed for the same indication.

d. The Program Director of NCPAM shall approve or disapprove the request based on the recommendation of FEC.

e. Validity of the exemption is for a period of one year, unless an adverse decision has been rendered regarding the application for inclusion.

E. Facilitation of Request for Inclusion or Deletion of Medicines in the PNF

1. The following individuals or parties, hereto referred as the proponents, may request for application for inclusion or deletion of medicines; for additional indications, formulation, route of administration, dosage strength, net content and/or immediate packaging; as well as for exemptions: FEC; Units, Offices and Health Facilities directly under the supervision of the DOH and Health Facilities under the Local Government Units (LGUs); pharmaceutical establishments; and others such as health professionals, members of the academe, non-government organizations, professional societies, officers or staff of health facilities, patient organizations and consumers.

2. All major application for inclusion submitted after the deadline set by the FEC will be considered as new application for the next edition of the Formulary.

3. The proponents shall submit Letters of Requests and accomplish the appropriate Proposal Forms prescribed by the FEC. These are the following forms:

a. PNF Form No. 1 (Letter of Request and Proposal Form for Inclusion of New Medicine, or New Indication, Formulation or Route of Administration of existing medicine in the PNF — Major Application for Inclusion) hereto appended as Annex A.

b. PNF Form No. 2 (Letter of Request and Proposal Form for Inclusion of New Dosage Strength, Net Content or Immediate Packaging of existing medicine in the PNF — Minor Application for Inclusion) hereto appended as Annex B. It shall contain the same elements as PNF Form No. 1. STaCcA

c. PNF Form No. 3 (Letter of Request and Proposal Form for Deletion of Medicine from the PNF) hereto appended as Annex C. It shall contain the same elements as PNF Form No. 1.

d. PNF Form No. 4 (Letter of Request and Proposal Form for Exemption from E.O. No. 49 s. 1993) hereto appended as Annex D. It shall contain the same elements as PNF Form No. 1.

4. The proponents shall likewise submit two (2) hard and soft copies each of the following documents required by the FEC, to wit:

a. Accomplished proposal form;

b. FDA Certificate of Product Registration and colored photograph or video of product, when appropriate;

c. FDA-approved product information;

d. FDA Certificate of Good Manufacturing Practice; and

e. Appended journal articles and other pertinent publication.

5. Proposal Forms shall include the following:

a. General information on the medicine;

b. Specific request;

c. Summary of justification for request;

d. References for clinical efficacy and safety profile;

e. Details required for cost-effectiveness assessment; IcDCaT

f. Evidence Table (PNF Form No. 9-A) that contains the list of all cited references together with a summary of the study design, description of participants, interventions and their consequent results and outcomes and the Level of Evidence, when appropriate;

g. The GRADE Evidence Profile Table (PNF Form No. 9-B) that is utilized in the determination of Level of Evidence, when appropriate; and

h. Copies of all the cited scientific journal articles, entries, other accepted legal documents and other supporting publications.

6. Each proponent for major application for inclusion shall pay a processing fee of PhP200,000.00 to the DOH cashier. This amount shall be subject to inflation rate until a new guideline is published.

7. Medicines that are deemed essential for a specific DOH health facility or are for specific DOH program/project must be explicitly certified as essential by the DOH requesting unit. These medicines shall be given priority for evaluation by the FEC. The certificate shall be submitted by the DOH unit concerned together with the accomplished appropriate PNF Forms and all the necessary proofs, including the Evidence Table together with the journal articles and other pertinent publications.

8. Pharmaceutical establishments which intend to accomplish Proposal Form No. 1 shall be likewise required to execute an agreement that the same shall submit a monthly inventory and price report on the drugs that they are requesting to be included in the PNF. A database shall be set-up by the NCPAM to ensure electronic submission of the said data requirement. caEIDA

9. The FEC, upon receipt of the Letter of Request and Proposal Form duly classified by the Secretariat, shall proceed with the deliberation on the request.

F. PNF Formats and Publication

1. The PNF Manual shall consist of integration of the following:

a. National Essential Medicines List;

b. Formulary Monographs;

c. Cross-Reference Index.

2. The Formulary lists the medicines according to Therapeutic Categories and classifies these as Core or Complementary Medicines. The following information will be provided for each medicine in the Manual:

a. Generic name;

b. Brief pharmacodynamic and pharmacokinetic data;

c. Accepted indications;

d. Contraindications;

e. Precautions;

f. Adverse reactions;

g. Clinically significant drug interactions;

h. Weight and/or age specific dosage recommendations and dose adjustments for patients with renal or hepatic disease;

i. Preparations available in the Philippine market; TcDAHS

j. Other recommendations regarding proper intake;

k. Unit cost.

3. Succinct guidelines on the safe and rational use of medicines for the management of the priority diseases will be included.

4. A List of Primary Care Medicines for all Rural Health Units shall be appended to the PNF Manual.

5. The Cross-Reference Index includes:

a. Instructions on the use of the PNF;

b. Symbols and abbreviations; and

c. Index of generic names and categories. The brand names will be available online.

6. The PNF Manual shall be reviewed every quarter. Updates shall be posted in the DOH website. Such shall be considered as an integral part of the currently published PNF. Publication of hardcopies of PNF Manual shall be on an annual basis, subject to the availability of funds and the usual accounting and auditing rules and regulations.

G. Documentation and Forms

1. The FEC, for purposes of documentation shall accomplish the following forms. These will include:

a. PNF Form No. 5 (Evaluation Form for Inclusion of New Medicines, New Indications, Formulations or Route of Administration of existing medicines in the PNF — Major Application for Inclusion) which is hereto appended as Annex E for all medicines evaluated for inclusion in the PNF. This form shall be chronologically numbered as they are accomplished and shall be logged in an official logbook. PNF Form No. 5 shall have the following data elements: HICEca

i. Date when the Form was accomplished

ii. Serial No. of the Form

iii. Generic Name

iv. Therapeutic Classification

v. Indication

vi. Dosage Form/Strength

vii. Route of Administration

viii. Manufacturer

ix. Importer/Trader

x. Distributor

xi. Compliance Checklist

xii. Evidence Tables

xiii. Recommendations

b. PNF Form No. 6 (Evaluation Form for Inclusion of New Dosage Strength, Net Content or Immediate Packaging of existing medicines in the PNF — Minor Application for Inclusion) which is hereto appended as Annex F for all medicines with new dosage strength, net content and packaging and chronologically numbered as it is accomplished and logged in an official logbook. It shall contain the same data elements as PNF Form No. 1.

c. PNF Form No. 7 (Evaluation Form for Deletion of Medicines from the PNF) hereto appended as Annex G for all medicines evaluated for deletion from the PNF. It shall be chronologically numbered as it is accomplished and logged in an official logbook. It shall contain the same data elements as PNF Form No. 1. DHTCaI

d. PNF Form No. 8 (Evaluation Form for Exemption of Medicines from E.O. No. 49 s. 1993 and A.O. No. 163 s. 2002) hereto appended as Annex H for all medicines evaluated for exemption. It shall be chronologically numbered as it is accomplished and logged in an official logbook. It shall contain the same data elements as PNF Form No. 1.

e. Duly accomplished PNF Forms No. 5, 6, 7 and 8 shall be appended to the Chronological Summary of Drugs to be Included in or Deleted from the PNF (PNF Form No. 10) that shall be submitted quarterly by the FEC if there is any. It is hereto attached as Annex J. It shall likewise be chronologically logged in a separate record book. The PNF Form 10 shall have the following data elements:

i. Date of accomplishment;

ii. Covered Quarter;

iii. Name of the Assistant Secretary or Undersecretary of Health in charge of NCPAM to whom the summary report is addressed;

iv. Column for the chronological numbering of medicines that were evaluated;

v. Column of the chronologically listed generic name of medicines that were evaluated together with their dosage form, strength, route of administration;

vi. Column for the general recommendation for inclusion, deletion or exemption; CTSHDI

vii. Proponent for the application for inclusion, deletion of exemption of the medicine;

viii. Column for the Proponent's main reason for inclusion or deletion or exemption recommendation on a subject medicine;

ix. Column of the FEC's action on the request. Such may mean concurrence with the Proponent's argument or the denial of the request;

x. Signature/s of the FEC Members and Chairperson or his/her designee.

2. The FEC on a quarterly basis shall likewise submit an Alphabetical Summary of the Drugs for Inclusion/Deletion (PNF Form No. 11) hereto appended as Annex K. It shall have similar data elements as that of PNF Form 10, except that the medicines are alphabetically instead of chronologically listed.

3. The NCPAM, as FEC Secretariat, shall maintain copies of the duly accomplished PNF Forms and shall maintain a database system that shall be linked with the DOH-NCPAM website.

VII. Implementation Arrangements

A. Roles and Responsibilities

1. Office of the Secretary

The Secretary of Health shall make the final review and shall approve or disapprove the recommendations of the FEC through the Undersecretary or Assistant Secretary on the PNF.

2. Undersecretary or Assistant Secretary

The Assistant Secretary or Undersecretary of Health in charge of NCPAM shall provide oversight functions to the FEC. CSHEAI

3. NCPAM

a. Program Director

i. Shall assist the Undersecretary or Assistant Secretary in the provision of oversight functions to the FEC;

ii. Shall undertake overall management of the PNFS Secretariat function including but not limited to the planning, budgeting, controlling and monitoring processes;

iii. Shall undertake overall coordination with internal and external partners.

b. Division Chief of the Policy, Planning, Program Development and Research Division

i. Shall undertake day to day management of the PNFS Secretariat function;

ii. Shall monitor implementation of the plan of the PNFS Secretariat and address potential and actual delays in implementation;

iii. Evaluates performance of the PNFS Secretariat.

c. The Policy, Planning, Program Development and Research Division

i. Shall provide technical and administrative support to the FEC; SEcADa

ii. Shall formulate the annual work and financial plan pertinent to the updating of the PNFS;

iii. Shall implement the above-mentioned plan, monitor implementation and formulate catch up plans in case of delay in implementation.

4. Formulary Executive Council

a. The FEC shall establish the systems and procedures of the PNFS.

b. The FEC shall review all applications submitted for inclusion in or deletion from the PNF or exemption from E.O. No. 49 s. 1993 and make appropriate recommendations to the Secretary of Health thru concerned Undersecretary or Assistant Secretary.

5. Evidence Review Groups (ERGs) will prepare the evidence summaries pertaining to the medicines under deliberation as requested by FEC.

6. A pool of specialty experts on various disciplines will provide input during the deliberations when called by FEC.

7. A representative from the FDA, the Philippine Health Insurance Corporation (PHIC), Research Institute for Tropical Medicine (RITM) and other agencies that may be deemed necessary by the FEC chairperson or the Secretary of Health may be called upon to serve as resource persons during FEC deliberations.

8. The following Bureaus and Centers of this Department are instructed to fully support the PNFS and comply with the provisions stated in Executive Order No. 49 as applicable:

a. The Food and Drug Administration (FDA) — shall provide the necessary technical input and essential data requirements such as relative availability of drugs in terms of inventory, prices and market authorizations to the FEC and its Secretariat. SDTIHA

b. Philippine Health Insurance Corporation (PHIC) — shall condition the use of the PNF as the basis for payments of in-patient and out-patient benefits schemes for medicines and in the accreditation of health facilities and pharmacies for drug reimbursements.

c. Research Institute for Tropical Medicine (RITM) — shall provide timely information on the trends in resistance rates of antibiotics to microorganisms and latest researches in the prevention, diagnosis and treatment of tropical diseases including vaccines for the control of vaccine-preventable diseases of public health importance.

d. National Center for Disease Prevention and Control — shall provide information on trends of diseases being monitored by its different offices: (a.) Infectious Disease Office (IDO) (b.) Degenerative Disease Office (DDO) (c.) Family Health Office (FHO) (d.) Environmental and Occupational Health Office (EOHO). It shall likewise promote the use of PNF in all its programs specifically ensuring that medicines used in the clinical practice guidelines (CPGs) or standard treatment guidelines (STGs) are those listed in the PNF.

e. National Center for Health Facilities Development — shall ensure that public health facilities through their Drug Therapeutic Committees (DTCs) comply with the mandatory use of the PNF. It shall also assist in monitoring compliance with PNF use in health facilities.

f. Bureau of Health Facilities and Services — shall ensure that the tool in licensing public and private health facilities include compliance with the mandatory use of the PNF.

g. Health Human Resource Development Bureau (HHRDB) — shall advocate for a transformative curricula for health professionals which will adopt the use of the PNDF. They shall develop and provide continuing professional education trainings that promotes the use of the PNDF. IcEACH

h. Central Office Bids and Awards Committee/Material Management Division (COBAC/MMD) — shall ensure the use of PNF as basis for objective, transparent and efficient processes in the DOH procurement and distribution of medicines.

i. Center for Health Development — shall implement and monitor the mandatory use of PNF in its procurement. It shall also report and give feedback on the status of PNF use in their areas of jurisdiction.

9. This Department shall closely coordinate with the Department of Interior and Local Government (DILG) to ensure compliance with the mandatory use of PNF in the procurement of medicines by LGUs and to assist the DOH in the monitoring and evaluation of the use of the PNF.

10. The Local Government Units (LGUs) shall comply with the use of PNF by their Bids and Award Committees (BAC) in the procurement of medicines for government institutions, facilities and shall submit reports to the DOH on the monitoring and evaluation of the use of the PNF in LGUs.

11. Government entities including Government Owned and Controlled Corporations and those under public-private partnership arrangement with these agencies shall comply with the mandatory use of PNF in procuring medicines.

12. The Commission on Audit (COA) shall ensure the use of PNF as the basis for the procurement of medicines by all government agencies. aSIAHC

B. Mandatory Use of the PNF

1. All pharmaceutical establishments and health facilities must have a copy of the PNF Manual. The PNF Manual shall be the basis of the drug establishment's in-patient counseling and shall be used in giving consumer advice when information about essential medicines is demanded. Such shall form part of the essential documentary requirements that shall be monitored by FDA for purposes of issuing or renewing their License to Operate (LTO) in the Philippine market.

2. Only medicines that are reflected in the PNF Manual can be requisitioned in the procurement of medicines by all government agencies, i.e., national government agencies and the health facilities under their supervision, government health facilities under the supervision and control of the DOH, devolved health facilities under the Local Government Units and Government Owned and Controlled Corporation.

3. Every Requisition and Issue Slip (RIS) and Procurement Request (PR), including purchases in times of emergency and authorized under the General Appropriations Act, shall be accompanied by a certification from the requisitioning officer or by the duly authorized officer that the products being requisitioned and procured fall within and conform with the latest edition of the PNF Manual.

4. Medicines not reflected in the latest edition of the PNF Manual may still be procured as long as these are approved by the Secretary of Health for inclusion in the upcoming edition of the PNF and if such products are already posted in the DOH website. Medicines approved for inclusion in an upcoming edition of the PNF Manual must be covered with the appropriate Department Memorandum and other instruments of announcements. CAaDSI

5. Only medicines listed in the PNF Manual shall be considered for reimbursement or subsidy by the Philippine Health Insurance Corporation (PHIC) for the entire health sector — government and private.

6. Medical practitioners and all potential end-users shall avail of a copy of the PNF Manual or download it from the DOH or NCPAM website.

C. Coordinating Instructions and Transitory Provisions

1. The NCPAM shall coordinate with the Commission on Audit so that auditors/heads of auditing units shall monitor compliance thereto and shall disallow claims/reimbursements either from regular budget, local/trust funds covering the procurements of drugs and medicines which are not within the latest edition of the PNF.

2. The NCPAM shall conduct an Information, Education and Communication (IEC) campaign targeting all drug establishments, within one (1) year from the effectivity of this Order to ensure smooth compliance.

3. Any violation in the compliance of this Order may be subject to the penalties provided in Section 12 of RA 6675.

VIII. Separability Clause

If any provision in these Guidelines, or application of such provision to any circumstance, is held invalid, the remainder of` these Guidelines shall not be affected thereby.

IX. Repealing Clause

The provisions of AO Nos. 2006-0018, 2006-0018-A, and 2006-0018-B and all other issuances inconsistent with the provisions of this Order are hereby repealed/rescinded and modified accordingly. HaIATC

X. Effectivity

This Order shall be effective within fifteen (15) days from publication in the Official Gazette.

 

(SGD.) ENRIQUE T. ONA, MDSecretary of Health

Published in The Philippine Star on October 31, 2012.

Attachments available upon request.