Guidelines on the Institutionalization and Implementation of the National Clinical Practice Guidelines Program

July 2, 2018

DOH ADMINISTRATIVE ORDER NO. 2018-0019

 

I. RATIONALE

Clinical practice guidelines (CPGs) are evidence-based recommendations used to optimize patient care by reducing inappropriate variations in practice and ensuring efficient use of limited resources. However, the lack of standardized process for developing and assuring quality of CPGs has resulted to their limited availability and large variations in quality. HTcADC

In line with the Department of Health's (DOH) mandate as the lead agency in ensuring quality of health care through policy formulation, standards development and regulations as stated in Executive Order No. 102 s. 1999, there is a need for the DOH to facilitate the development of high quality CPGs that will be used to guide clinical practice of healthcare providers and provide guidance in the development of public health programs, health facilities and health workers standards, and benefit packages of the National Health Insurance Program.

II. OBJECTIVE

This Order aims to provide a framework for the continuous development of quality-assured CPGs. Specifically, this Order aims to institutionalize a standardized process for prioritization, generation, appraisal, dissemination, and implementation of CPGs through the establishment of a National Clinical Practice Guidelines Program (NCPGP).

III. SCOPE AND COVERAGE

This Order shall apply to all DOH Central Office Bureaus and Services, DOH Regional Offices, DOH Hospitals and Treatment Rehabilitation Centers, DOH attached agencies, and all other public and private entities involved in CPG development including but not limited to health care providers, academe, researchers and research institution and professional societies.

IV. DEFINITION OF TERMS

A. Clinical Practice Guidelines (CPGs) — recommendations intended to optimize patient care, which are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options. (IOM, 2011) DETACa

B. Conflict of Interest — set of situations that creates a risk that professional judgment or actions regarding a primary interest shall be unduly influenced by a secondary interest. (IOM, 2011) HEITAD

C. Health Technology Assessment (HTA) — the systematic evaluation of properties, effects, and/or impacts of health technology to inform policy decision making. (AO 2016-0034)

D. Manual for CPG development — pertains to the handbook containing the standards and prescribed methods set by the Department of Health on developing CPGs.

V. GENERAL GUIDELINES

A. The NCPGP shall standardize CPG development in the Philippines, encompassing the following processes in the CPG development: (1) Prioritization, (2) Generation, (3) Appraisal and Approval, and (4) Implementation and Dissemination (Annex A).

B. The NCPGP shall publish a Manual for CPG Development to inform the technical process of creating CPGs. The Manual shall outline specific methods for adapting existing guidelines, synthesizing and appraising evidence, developing recommendations, and writing the guideline manuscript. ATICcS

C. Only CPGs that have met the quality standards as appraised by the National Guideline Clearinghouse and approved by the Secretary of Health (SOH) shall be recognized as DOH-endorsed CPGs or "National Guidelines."

D. DOH-endorsed CPGs or "National Guidelines" shall be used by healthcare providers, academe, and payers of healthcare to guide clinical practice and policy development.

E. The NCPGP shall develop and implement a monitoring and evaluation framework.

F. The CPGs shall be disseminated to relevant stakeholders through various effective channels identified by the DOH.

VI. SPECIFIC GUIDELINES

A. NCPGP Governance Structure

1. National Guideline Clearinghouse (NGC) shall appraise CPG manuscripts submitted by the CPG developers and endorse CPGs to the Secretary of Health for approval. The NGC shall be assembled by the NCPGP secretariat for each CPG that requires appraisal. The NGC shall be composed of the following: one (1) DOH representative, two (2) content experts, and two (2) methodologists. TIADCc

2. NCPGP Secretariat shall manage and ensure effective implementation of the program.

3. Lead CPG Developer, the main point person or group who will spearhead the development of a CPG for a particular topic which may be a DOH Program Manager, a content expert and/or a methodologist, shall convene working groups to support CPG development. The working groups to be formed are as follows:

a. A ConsensusPanel composed of 10-15 multi-sectoral representatives from health care practitioners (specialists, generalists, primary care providers), patients and/or patient advocates, methodologists and other DOH representatives whose practice may be affected by the guideline or who can influence the uptake of CPG recommendations.

b. EvidenceReviewExperts(ERE) with at least one CPG/GRADE (Grading of Recommendations Assessment, Development and Evaluation) methodologist, clinical epidemiologist or evidence-based practitioner and biostatistician. EREs shall conduct the review of existing CPGs, creating evidence summaries and formulating evidence-based draft recommendations. AIDSTE

B. The National Clinical Practice Guideline Development Process

1. Prioritization. DOH programs, health care providers, professional societies, and other relevant stakeholders may nominate topics to be considered for prioritization. The NCPGP secretariat shall facilitate a topic selection workshop to determine priority conditions that merit DOH funding for CPG development that shall be funded by the DOH based on a defined set of criteria (Annex B).

2. CPGGeneration. CPG Developers shall convene working groups that are free from conflicts of interest. CPGs should be developed in accordance to the prescribed methods in the Manual for CPG Development. Completed CPG manuscripts shall be submitted to the NGC for appraisal. SDAaTC

3. AppraisalandApproval. The NGC shall use GRADE approach in appraising CPG manuscripts. CPGs that pass the quality assessment shall be endorsed to the SOH for approval and adoption, while those that do not pass the review shall be turned over to the CPG developer for improvement.

4. DisseminationandImplementation. The NGC shall ensure that there is a dissemination plan for DOH-endorsed CPGs or "National Guidelines." A full text, pocket guide, and laymanized versions of the CPG shall also be produced by the CPG developers. The NCPGP secretariat shall keep a library or repository of DOH-endorsed CPGs.

C. Management of Conflicts of Interest

1. Declaration and management of conflicts of interest shall be mandatory for all groups and persons involved in the NCPGP. All stakeholders involved in the CPG development process shall comply with existing DOH guidelines on the management of conflict of interest (COI). acEHCD

2. All CPGs submitted by CPG developers shall undergo an assessment of COI. CPGs that violate the COI policy shall be recommended for disapproval and shall not be endorsed by the DOH.

D. Integration with the Health Technology Assessment Program

1. The NCPGP shall collaborate with the Health Technology Assessment (HTA) program to ensure consistency in the outputs, evidence used, and recommendations.

2. The NCPGP may inform or be informed by the evidence generated through the HTA Program.

VII. ROLES AND RESPONSIBILITIES

A. The HealthPolicyDevelopmentandPlanningBureau(HPDPB) shall act as the NCPGP secretariat who shall provide technical and administrative support to the NCPGP such as but not limited to the following: (1) facilitation of the topic prioritization process for DOH-funded CPG development (2) provision of technical support during NGC meetings, and (3) ensure monitoring and evaluation of the NCPGP.

B. The HealthFacilityDevelopmentBureau(HFDB), Disease Prevention and Control Bureau (DPCB) and the Philippine Health Insurance Corporation shall (1) provide appropriate financial and technical support in the development of National CPGs, (2) utilize National CPGs in the design of DOH programs and PHIC policies, and (3) aid in the dissemination, implementation, monitoring, and evaluation of National CPGs.

VIII. REPEALING CLAUSE

All issuances inconsistent with the provisions of this Order are hereby revised, modified or rescinded accordingly. All other provisions of existing issuances which are not affected by this order shall remain valid and in effect.

IX. SEPARABILITY CLAUSE

If any provision of this Order is declared invalid, unenforceable or unconstitutional, the validity or enforceability of the remaining provisions shall not be affected, and this Order shall be interpreted as if it did not contain the particular invalid, enforceable or unconstitutional provision.

X. EFFECTIVITY

This Order shall take effect immediately.

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

ANNEX A

Clinical Practice Guidelines Development Process

 

ANNEX B

Prioritization Criteria

Criteria	Definition
1. Disease Burden	The prevalence, co-morbidity, mortality, quality of life and effectiveness of the preventive service on patients, their families, and communities
2. PublicContention	Public interest surrounding the topic or disease condition
3. Cost-effectiveness	Economic evaluation
4. New evidence	Recent evidence that can potentially change previous recommendations
5. Potential impact	Potential to improve health outcomes and quality of life, or in decision-making resulting in practice change
6. Interest of public or care providers	Recommendations by practitioners or stakeholders
7. Variation in care	Potential to decrease variation in care (i.e. prevention, diagnosis or treatment)
8. Sufficiency of evidence	Availability of clearly defined and high quality evidence
9. Timeliness	Urgency for guideline to be developed