Inclusion of Progestin Subdermal Implant as One of the Modern Methods Recognized by the National Family Planning Program ( DOH Administrative Order No. 2015-0006 )

February 09, 2015

February 9, 2015


SUBJECT : Inclusion of Progestin Subdermal Implant as One of the Modern Methods Recognized by the National Family Planning Program


I. Rationale

The Philippines continues to have a high level of maternal mortality and has low likelihood of meeting its Millennium Development Goals of reducing maternal deaths by three quarters and in providing universal access to reproductive health services (5th MDG Progress Report, 2014). Despite the increasing number of facility based births, the number of maternal deaths has remained essentially the same in the past 50 years (Philippine Civil Registry and Vital Statistics 1960-2010). The high level of maternal mortality could be driven by high unmet need for modern family planning services. It is estimated that 5.7 million Filipino are at risk from unplanned, mistimed pregnancies due to unmet needs for modern FP (NDHS 2013).

The passage of the Responsible Parenthood and Reproductive Health (RPRH) Act of 2012 (RA 10354), mandated the universal provision of reproductive health services, particularly family planning and safe delivery services, as a means to reduce maternal mortality. Pursuant to its mandate in Section 19.2 of the RPRH Law and Rule 12 of the IRR, the Department of Health shall ensure access to modern FP services which include the inclusion of new and modern methods of FP in its national program. By broadening the range of effective modern FP methods available for clients, the DOH provides a wider set of options for couples to choose from that is consistent with their beliefs and appropriate to their health status, in order to achieve their desired family size.

Among the new and modern methods are progestin subdermal implants. These are long-acting reversible hormonal contraceptives that inhibit ovulation by suppressing the luteinizing hormone surge. It also increases cervical mucus viscosity, making it difficult for the sperm cells to pass through. The method is effective for three years upon application and has a low failure rate of 5 per 10,000 users. Progestin subdermal implants also have a high continuation rate of 84%. (Trusell J, 2011) as well as high satisfaction rating among users, along with that of intrauterine devices (Peipert, et al., 2011). aHADTC

The Food and Drug Administration (FDA) consider progestin subdermal implants (Etonogestrel) as safe, effective and of good quality by issuing a Certificate of Product Registration as early as January 19, 2011. The FDA has also re-certified Etonogestrel implants as required under the provisions of RA 10354 and Supreme Court decision in James M. Imbong, et al. vs. Paquito N. Ochoa, et al., G.R. No. 204819.

II. Objective

This Order provides for the inclusion of progestin subdermal implants in the list of modern FP methods deemed to be safe and effective by the National Family Planning Program.

III. Scope and Coverage

This Order shall apply to the whole health sector, inclusive of public and private sectors: DOH Central Office, Regional Offices, and DOH-retained hospitals; Central office and regional units of the Commission on Population (POPCOM), Philippine Health Insurance Corporation (PhilHealth), and other DOH attached agencies; LGUs; ARMM; Development Partners; private health care providers; and all others concerned.

IV. Definition of Terms

A. Progestin Subdermal Implant (PSI) — progestin subdermal implant is a long-acting reversible contraceptive effective for at least three years usually inserted in the inner aspect of the arm.

B. Private Health Care Providers (PHCPs) — are health providers (both for-profit and not-for profit) that are not operated or controlled by the state or any of its instrumentalities. PHCPs may be natural or juridical persons, and may either provide health care services or goods and include practicing health professionals, and non-government organization clinics among others.

V. General Guidelines

A. The implementation of this Order shall be aligned with the continuing implementation of RA 10354, its implementing rules and regulations, the National Strategy Towards Reducing Unmet Need for Modern Family Planning as a means to Achieving MDGs on Maternal Health (AO No. 2012-0009) and the Philippine Reproductive Health Program (AO No. 1-A, s. 1998) and other related policies.

B. Progestin subdermal implant shall be included as one of the modern methods of the National Family Planning Program pursuant to Sec. IV.A.3 of AO No. 2012-0009, which mandates the provision of affordable and accessible counseling, supplies, commodities, and services of all safe and effective methods to couples desiring to space or limit family size.

C. Use of progestin subdermal implants shall adhere to the Philippine Clinical Standards Manual on Family Planning 2014 Edition (DM 2014-0311), or its subsequent updated versions.

D. The following are essential elements of a strategy that shall be put in place to introduce the use of progestin subdermal implants:

a. orientation and engagement of program stakeholders,

b. baseline evaluation and integration into SDN,

c. selection and preparation of health facilities plus the referral hospital,

d. social preparation and demand generation activities,

e. preparation of training and IEC materials,

f. preparation of updated clinic records and reporting forms,

g. training of service providers (MDs), nurses/midwives, BHWs/CHTs,

h. quality service provision, EAcTDH

i. Supportive supervision and monitoring.

Recommended specifications for each element of the strategy to introduce the use of progestin subdermal implants in a local health system is described in Annex A.

VI. Specific Guidelines

A. The procurement of progestin subdermal implants shall be guided by mechanisms and steps specified in relevant issuances, which include but are not limited to Rule 4, Sec. 4.10 of the RPRH IRR, the Guidelines on the Estimation of Unmet Need for Family Planning (AO 2014-0043), and AO 2012-0009.

B. Distribution of modern FP commodities and supplies, including progestin subdermal implants, shall be done through a full-service logistics management system with deliveries made direct to service delivery points, pursuant to the Guidelines on Engaging the Services of a Full Service Logistics Provider (DO 2014-0184).

C. Provision of progestin subdermal implants shall be primarily carried out by frontline skilled health professionals in health facilities of LGUs and the DOH, as well as those of the private sector within the service delivery network (SDN).

D. The DOH shall exercise technical oversight and supervision as well as facilitate the establishment of a SDN following the Guidelines in Establishing Service Delivery Networks (DM 2014-0313).

E. Provision of progestin subdermal implants, as well as other modern FP services shall adhere to the principles of informed choice and voluntarism as mandated in DO 2011-0005.

F. Progestin subdermal implants and related counseling services shall be provided at service delivery points (e.g., RHUs, private clinics, public or private hospitals) as part of the full range of modern FP methods. These service delivery points shall include all DOH-retained hospitals except special and specialty hospitals not focusing on women's health, pursuant to the Guidelines in Setting Up Family Planning Services in Hospitals (DM 2014-0312). Progestin subdermal implants shall also be provided in outreach settings following the Guidelines on Implementation of Mobile Outreach Services for Family Planning (AO 2014-0002).

G. The FP clinical competencies of skilled health professionals shall be continually enhanced, and shall include training on the provision of progestin subdermal implants. Furthermore, this training shall include systems for monitoring and evaluation of performance prior to certification.

H. All DOH regional hospitals and medical centers shall be designated as training centers on the provision and use of progestin subdermal implants. Other training institutions may also be recognized as providers following the Guidelines on the Recognition of Family Planning Trailing Providers of the DOH (AO 2014-0041). ITcCaS

I. Social and behavioral change communication (SBCC) activities shall include information on progestin subdermal implants, and shall be customized and targeted for direct delivery at the interpersonal level to prospective clients with unmet need. Modern FP program information and education materials as well as family health use plans shall be revised/amended to include the necessary materials on progestin subdermal implants.

J. Recording and reporting of data on progestin subdermal implants shall be through existing Field Health Services Information System (FHSIS) recording and reporting forms including FP Form 1. All public FP health care providers shall follow the existing FHSIS guidelines in the submission of reports from the different levels of care. Private sector and NGO providers shall submit reports on service statistics to their designated LGU health facilities.

VII. Roles and Responsibilities

A. The Disease Prevention and Control Bureau Women and Men's Health Development Division (WMHDD) shall ensure the implementation of this Order. Specifically, it shall:

1. Develop, in coordination with the Health Policy Development and Planning Bureau (HPDPB), policies, standards, guidelines and tools relative to the provision of progestin subdermal implants;

2. Develop training design and curriculum including instructional materials, in coordination with the Health Human Resource Development Bureau (HHRDB) and other partners;

3. Ensure the conduct of training to qualified providers, as allowed by law, on the provision of progestin subdermal implants by DOH-accredited institutions at the regional, provincial, and city levels;

4. Provide technical inputs to the development of a communications plan and IEC materials, in coordination with the Health Promotion and Communications Service (HPCS);

5. Provide technical assistance on the implementation of this Order to DOH Regional Offices (DOH-ROs) as well as other implementing partners;

6. Ensure the availability of progestin subdermal implants at identified health facilities of LGUs, in coordination with the DOH-ROs;

7. Mobilize technical assistance and leverage resources from development partners to support the mainstreaming of activities; and

8. Establish a comprehensive FP reporting and recording system to include progestin subdermal implants, in coordination with the Knowledge Management Information Technology Service (KMITS) and Epidemiology Bureau with the goal of developing an FP database to monitor reach and utilization of family planning services.

B. The Logistics Management Division (LMD) shall be responsible for overseeing a full-service logistics management system to be implemented by a competent, capable, efficient, and affordable public and/or private sector provider, subject to procurement and contracting laws, rules, and regulations. It shall also be responsible in monitoring and evaluating the use of a logistics database management information system such as NOSIRS.

C. The Health Promotion and Communications Service (HPCS) shall develop and implement an FP communication plan and prototype materials at the national, regional and local levels, particularly on the use of progestin subdermal implants, in coordination with DPCB, POPCOM, and other development partners.

D. The Epidemiology Bureau shall:

1. Provide technical oversight on the implementation of the FHSIS to include data collection, processing, and reporting on modern FP use (including progestin subdermal implants); and

2. Assist the program in estimating unmet need for modern FP services for various methods in aid of commodity forecasting.

E. The DOH-Regional Offices and the DOH-ARMM shall be responsible for the implementation of this Order at local health systems. Specifically, they shall:

1. Coordinate and provide technical assistance (including assistance on logistics management within the overall system used by LMD) to LGUs, NGO partners, and other stakeholders; IEAacS

2. Reproduce and distribute IEC and training materials;

3. Monitor and evaluate the implementation of this Order by LGUs, NGOs, and other partners, including the use of information systems (i.e., FHSIS) to streamline data collection, processing, and reporting;

4. Ensure capacity building and quality service provision at provincial/city/municipal levels; and

5. Certify and accredit both training institutions and service providers.

F. All DOH-retained hospitals except special and specialty hospitals not focusing on women's health shall:

1. Include progestin subdermal implants in the full range of modern FP methods available at their level;

2. Create FP outreach teams and make them available for dispatch to respond to the needs for insertion/removal of progestin subdermal implants, especially in urban and rural poor communities;

3. Serve as resource and learning centers for technical assistance, training, and research on progestin subdermal implants;

4. Serve as referral facilities that will complement progestin subdermal implant services provided by LGU hospitals and other health facilities, including management of complications.

G. The Food and Drug Administration (FDA) shall continually conduct appropriate tests on all prospective progestin subdermal implants prior to the issuance of appropriate authorizations to ensure safety, efficacy, quality, and its non-abortifacient property.

H. The Philippine Health Insurance Corporation (PHIC) shall review its existing benefit packages for modern FP and give due consideration to developing mechanisms to finance the provision of progestin subdermal implants.

I. The Commission on Population (POPCOM) shall assist in generating demand for modern family planning services including progestin subdermal implants, in coordination with DPCB and HPCS. POPCOM shall also ensure that identified prospective clients with unmet need are referred to the appropriate health care providers.

J. Local Government Units (LGUs) are encouraged to be responsible for the management of program implementation at the provincial/city/municipal level, by:

1. Ensuring the availability of modern FP services including progestin subdermal implants in all local government hospitals and other health facilities;

2. Ensuring service quality and patient safety throughout the continuum of care, through supportive supervision;

3. Leading efforts for advocacy and demand generation;

4. Coordinating with the DOH and aligning its data management and information systems;

5. Monitoring and evaluating program implementation within their respective jurisdictions; and

6. Identifying functional referral facilities for appropriate modern FP services within their service delivery networks.

K. Private-sector health care providers are encouraged to provide modern FP services and products including progestin subdermal implants to clients within their respective service delivery networks.

L. Development Partners shall ensure that their assistance and support to the family planning programs and activities of the DOH shall be consistent with the provisions of this Order. International development partners shall coordinate FP-related projects and activities with the Bureau of International Health Cooperation (BIHC) and the DPCB.

VIII. Repealing and Separability Clause

All other orders, rules, regulations, and other related issuances inconsistent with or contrary to this Order are hereby repealed, amended, or modified accordingly. All provisions of existing issuances such as AO No. 1-A, s. 1998, AO No. 43, s. 2000, AO No. 50-A, s. 2001, AO No. 2011-0005, and AO No. 2012-0009, among others which are not affected by this Order shall remain valid and in effect.

In the event that any provision or part of this Order is declared unauthorized or rendered invalid by any Court of law or competent authority, those provisions not affected by such declaration shall remain valid and effective.

IX. Effectivity

This Order shall take effect fifteen (15) days after its approval and publication in a newspaper of general circulation and filing of a copy thereof at the National Administrative Register.

(SGD.) JANETTE LORETO-GARIN, MD, MBA-HActing SecretaryDepartment of Health


Recommended Strategy for Introducing the Use of Progestin Subdermal Implants in a Local Health System

This recommended strategy for rolling out the use of progestin subdermal implant is based on the ongoing "Cohort Study and Implementation Research in the Introduction of Subdermal Implants in the DOH Family Planning Program" in the Province of Cavite. The cohort study is being implemented by the Department of Health in partnership with the Philippine Council for Health Research and Development with technical assistance from USAID. The study was initiated in six sites (two cities and two municipalities) in Cavite to assess operational issues that affect the implementation of the single-rod etonogestrel implant as a new FP program method and to determine the factors that affect acceptance and continuing use of progestin subdermal implants among clients. EHScCA

The following are essential elements that need to be in place in order to initiate the roll out of progestin subdermal implant use in a given local health system: a) orientation and engagement of program stakeholders, b) baseline evaluation and integration into SDN, c) selection and preparation of health facilities plus the referral hospital, d) social preparation and demand generation activities, e) preparation of training and IEC materials, f) preparation of updated clinic records and reporting forms g) training of service providers (MDs), nurses/midwives, BHWs/CHTs h) quality service provision, i) supportive supervision and j) monitoring and evaluation.

1. Orientation and engagement of program stakeholders:

a. Stakeholders (LGU officials, PHOs, CHOs, MHOs, rural health physicians, and hospital physicians from the pilot sites) shall be oriented on the plans to roll out the introduction of the progestin subdermal implants as a new family planning program method. The orientation will include the objectives, expected outputs, and key interventions of the program.

b. Engagement of LGUs for program support.

i. The PHO, with the assistance of the DOH Regional Office and partners, will orient the individual LGUs on the plans to conduct the rollout of implants in the FP program.

ii. The Plan will specify the objectives, expected outputs, and program inputs necessary for the rollout. It is recommended that LGU officials, PHO staff, CHOs, MHOS, and Chief of Hospitals be invited to attend the orientation.

iii. Meetings with the LCEs shall be arranged to secure the commitment of individual LGUs to provide manpower and resources for the rollout. These include, but are not limited to, assisting in the integration of FP services in the service delivery network (SDN), supporting CHT deployment, strengthening the logistics management system, promoting the use of FP commodities and services through SBCC/social mobilization activities, and making these available to all prospective FP users.

c. Securing counterpart support needed from the LGU

i. participation of LGU facilities (RHUs, CHOs, district hospitals) as providers for FP services (including implant insertion and removal) and the provincial hospital as a referral center for cases that need further medical management.

ii. counterpart sharing for additional medical supplies for implant insertion and removal as well as in the provision of other methods.

iii. support for the training of physicians, nurses and midwives.

iv. TEV for Community Health Teams.

2. Integration of progestin subdermal implants into the Service Delivery Network (SDN)

a. The referral system in the pilot sites will be strengthened, such that the RHUs and hospitals are able to provide the full range of FP methods, including progestin subdermal implants, within the SDN.

b. The rural health units (RHUs) shall serve as the primary service points for FP services.

c. Clients who choose to avail of NSV or BTL or those who experience complications from progestin subdermal implant use shall be promptly referred to the provincial or district hospital whichever is nearer.

d. The provincial hospital and respective district hospitals shall also be equipped to provide the range of FP services and prepared to handle adverse events and complication from progestin subdermal implant use.

3. Integration of subdermal implants into the existing logistics management system

a. The DOH ROs shall assist the LGUs in integrating the logistics requirements of progestin subdermal implants with the current logistics management system for FP commodities.

b. Designated individuals in the RHUs and hospitals shall see to it that there are no stock-outs. They shall also monitor the receipt, delivery, storage, monitoring and resupply of FP commodities.

4. Training of Health Care Providers and CHTs

a. The physicians from the RHUs, district hospitals and the provincial hospital shall undergo a two day training program conducted by certified trainers.

b. The training program shall cover the following:

i. Proper FP counselling on all available FP methods, to include progestin subdermal implants.

ii. Skills based training to include the following: insertion of progestin subdermal implant on dummy arms, guided insertion of two live patients, and insertions on eight additional patients.

iii. Upon completion of the requirements, the physician-trainee will be given a certificate of proficiency.

iv. After completion of the two-day training program, selected physicians from the provincial hospital may be chosen as potential trainers or supervisors on the provision of progestin subdermal implants.

c. Refresher Training of midwives and nurses on FP IPCC

i. Midwives and nurses from the RHUs and BHS with prior training on FP Competency Based Training 1 (FP CBT 1) shall be given a refresher course on FP IPCC. This is to better equip the nurses and midwives on counselling of FP clients on all methods. EScIAa

ii. Training of nurses and midwives will be facilitated by provincial core trainers.

d. Orientation/Refresher Training of CHTs on Roles for FP. CHT members shall undergo a one-day refresher course or orientation on the CHT roles and responsibilities in order to:

i. Reinforce the CHT's participation/involvement

ii. Reorient the CHTs in guiding families to access FP/MNCHN services and refer them to the nearest FP service points in the SDN

iii. Familiarize the CHT on the use of FP Health Use Plan (HUP) forms to better assist clients in availing FP services.

iv. Assist in reminding clients to return for follow up visits or FP method resupply as needed

5. Social and Behavioural Change Communication (SBCC) Activities

SBCC activities shall be conducted to promote the use of FP services, including progestin subdermal implants.

a. Deployment of community health workers (BHWs/CHTs) shall be the primary strategy for information dissemination.

i. The community health workers (BHWs/CHTs) shall have the following roles:

1. The BHWs/CHTs shall do house visits to assigned NHTS households to inform women of the need for FP and the available FP services. They shall be provided with IEC materials to disseminate during household visits.

2. CHTs shall refer or accompany women to the nearest service facility for FP services.

3. CHTs shall follow-up clients who have not returned for appointments.

ii. Organized group counselling sessions for FP shall be conducted by midwives or nurses ("small group assemblies") on a regular basis. Appropriate FP methods will be provided as needed.

6. Service Delivery: The Clinical Standards Manual on Family Planning, 2014 edition, shall be the main reference for delivering FP services, including progestin subdermal implants.

a. During consultation in the facilities, all clients in need of family planning services shall be provided with balanced information on FP methods, taking into consideration their reproductive intent. Appropriate IEC materials like cue cards, brochures, and flipcharts, video will be used.

b. The following activities will be undertaken: FP counseling, history taking, screening according to chosen method, explanation and signing of consent forms as needed (e.g., implant, IUD, and parental consent for adolescent clients), method provision, post FP provision instructions, check-up/revisit schedule, chart completion and recording.

c. A process flow for providing progestin subdermal implant services is shown in Figure 1 below.

7. Monitoring and supportive supervision of service providers will be done every six months or as necessary by the FP coordinator and by consultants from the Provincial Hospital.

Fig. 1: Flowchart for Service Provision