POLICY BRIEF

Report to: Honorable Alberto Romualdez, Secretary, Department of Health

From: ABC, Policy Analyst
Re: Amending DOH Administrative Order 1-A s, 2000 to improve
nationwide implementation of newborn screening

Executive Summary

Newborn Screening is an essential public health program for the early

identification of disorders that can lead to mental retardation and death.
Newborn screening is now recognized as an important component of quality
newborn care. Although the National Institutes of Health (NIH) is the major
agency in its implementation, the Department of Health (DOH), recognizing its
significance, has issued Administrative Order (AO) 1-a, s 2000 on the ‘Policies
on the Nationwide Implementation of Newborn Screening’. This is a milestone
towards providing newborn screening available to every Filipino newborn. In
the December 2000 consultative meeting at the Department of Health,
newborn screening has been declared a ‘program’ rather just a ‘project’.

Recently concluded program surveys presented the following concerns:

(1) the number of newborns undergoing newborn screening remains very low
despite the issuance of AO 1-a, s 2000; (2) money has been identified as a
major obstacle; (3) there is a delay in recalling patients with a positive
screening result; (4) there is poor support from the health professionals and (5)
there is no financial scheme that covers newborn screening nor a budget
appropriated supporting the project.

This policy analysis recommends that the Department of Health assumes

a more aggressive stand for the institutionalization of the newborn screening
program. The following policy alternatives are put forward for consideration in
terms of amending provisions of the DOH Administrative Order: 1) Maintain
status quo with the National Institutes of Health as the major implementor of
the program; 2) Department of Health as the sole implementor of the program
and 3) Sharing of responsibilities between the two agencies in the
implementation of the program.

Background

Historical Beginnings

For the past 4 decades, newborn screening has been practiced as a

component of quality newborn care as thousands of newborns have been saved
from the damaging sequelae of mental retardation and death.
 In some developed countries like the United States, newborn screening
has been mandated by legislation and still, in other countries, newborn
screening has been declared a policy of the health ministry or department, as
in Australia and Japan. A near 100% coverage has been reached by countries
like the United States, Japan, Australia, New Zealand, Singapore, Hong Kong,
and other countries of similar standard of health care. Among developing
countries, the performance of screening has ranged from nothing to a high 90%.
Thailand screens 40% of its newborn population for 2 conditions (congenital
hypothyroidism and phenylketonuria) and ambitiously aims to reach 90% by the
end of 2001. Malaysia screens 50% of its newborn population for 2 conditions
(congenital hypothyroidism and glucose 6 phosphate dehydrogenase deficiency)
and likewise aims to reach 90% by 2002. It is interesting to mention that
Uruguay was performing poorly until they implemented newborn screening in
coordination with the BCG immunization schedule and now, they boost of a
›99% screening coverage.

In the Philippines, newborn screening was introduced in June 1996 by

the Newborn Screening Study Group. The project was called the Philippine
Newborn Screening Project. Initiated primarily by the private sector, the Study
Group devised a system of operations for implementation of the Project in the
hospital setting. Currently being implemented in more than 150 hospitals
nationwide on a voluntary basis, newborn screening is still finding its way as
part of routine newborn care. Newborn screening is offered on a voluntary
basis. There are four major areas of implementation: private sector, DOH
retained hospitals, provincial/district hospitals and community-based. There
are different dynamics in the implementation in the different sectors. The
National Institutes of Health is the major agency responsible for the
implementation of newborn screening in the country.

Covered in the package for newborn screening are the following

disorders: congenital hypothyroidism, congenital adrenal hyperplasia,
galactosemia, phenylketonuria, homocystinuria, glucose 6 phosphate
dehydrogenase deficiency. These disorders may cause irreversible mental
retardation or death if not diagnosed at the appropriate time. However, when
newborns are timely screened, within the first 48 hours
Of life, the affected newborns are saved and will live normal lives.

DOH Participation

The Department of Health recognized the significance of the initial

results of the Philippine Newborn Screening Project and acknowledged the
importance of new as part of quality newborn care. Initiatives of the
Department of Health are the following: 1) inclusion of newborn screening in
the Child 2025 document; 2) creation of a Task Force on Newborn screening; 3)
issuance of administrative order 1-a, s 2000 on the policies on the nationwide
implementation newborn screening; 4) assignment and training of regional
coordinators for newborn screening.

The Department of Health acknowledged the impact of savings lives

after reviewing newborn programs overseas and reviewing the initial data of
the group. Recognizing that indeed newborn screening must be included in the
standards of quality newborn care, the Department of Health has recently
stamped newborn screening as a program rather than just a project. No longer
time-bound now, the Department seeks to completely operationalize newborn
screening in the country.

Implementation

The National Institutes of Health assume a major role in the

implementation of newborn screening in the country. All hospitals and
communities sent their samples to NIH for testing. NIH nurses releases results
back to hospitals and monitors follow up of patients with a positive screen.
Database, professional education, recruitment of hospitals and networking are
likewise responsibilities of NIH. The DOH has very minimal participation in the
implementation of newborn screening – limited to an encouraging order for
assigned regional coordinators to include newborn screening in their advocacy
work and for DOH-retained hospitals to offer newborn screening.

Statistics/ Cost Benefit Analysis

After 4 ½ years of implementation, data show that less than 10% of the
population has availed of newborn screening. In this small population that has
screened, 53 newborns have been saved from mental retardation and death.
Nine hundred twenty-two (922) newborns have been saved from the crisis of
hemolysis. Dans et al has presented the cost benefit analysis for screening of
congenital hypothyroidism in the Philippines. This paper presents net benefits
of P688M if screening covers the 2M babies born every year.

Policy Issue

In the Philippines, despite the vigilance of the prime movers of newborn

screening, newborn screening is only being performed in less than 5% of the
newborn population annually. Based on the initial data obtained by the group,
it is estimated that IF the 2M babies born annually are offered newborn
screening, at least 1500 newborns can be saved from retardation and death and
at least 27,000 newborns can be saved from hemolytic crisis of glucose 6
phosphate dehydrogenase deficiency.
 A review of the implementation issues has identified the following
problems:
 The number of newborns undergoing newborn screening remains very
low;
 Money has been identified as a major obstacle;
 Correct information is lacking both at the level of the health
practitioners and the public
 There is poor support from the health professionals
 There is a delay in recalling patients with a positive screening result;
 There is no financial scheme that covers newborn screening nor a budget
appropriated supporting the project.

Involvement of the Department of Health has been limited in scope with

the National Institutes playing a bigger role in the implementation of the
program. The AO is weak for the following reasons:
 It encourages newborn screening. It offers voluntary screening. But
newborn screening MUST NOT be a choice for newborns. Newborn
screening MUST be offered routinely.
 The AO is primarily hospital based and this covers only less than 30% of
babies born every year.
 There is no incentive for hospitals/health practitioners to offer newborn
screening
 There are no strict rules and regulations. There is no sanction for
hospitals which do not offer newborn screening.
 There is no desk at the DOH; only a contact person
 Task delineation has been limited to NIH, regional coordinators and DOH
retained hospital coordinators. The total success of this program will
need the full cooperation of DILG as well as all the other professional
societies.
 There is no budget allocated to the project; parents have to pay the
newborn screening fee
 Advocacy component has no budget. All coordinators were encouraged
to ride on other existing projects.
 There is no financial scheme that covers the cost of newborn screening

Policy Goals

What then should be appropriate goals for assessing the best policy
alternative? The most important goal is for the government to make newborn
screening available to ALL Filipino newborns. Both hospital-born and home
deliveries must have equal opportunities for the benefits of newborn screening,
there being no other substitute screening method for the early detection of
disorders that cause mental retardation and death. Reasonable goals of 50%
coverage in 5 years and 100% coverage in 10 years will be targets.
Additionally, government must ensure efficient and quality in the
implementation of the program. Affordability must be explored either through
reasonably priced user fees, direct subsidy or financial schemes. Incentives
must be offered to stake. Incentives must be provided to stakeholders and
participating units and sanctions be given to non-participating health facilities
and health providers.

Approaches to Solutions

The policy analyst will assess qualitatively the potential efficiency gains
and losses of the policy alternatives. The distributional impact will be
reviewed, in particular, how the policy alternatives will be made available to
home-delivered newborns and to the poor. Analysis will identify criteria that
will qualitatively assess the efficiency of each of the policy alternatives. A
multi goal analysis will be performed.

Policy Alternatives

I am pressing three policy alternatives that may be feasible in the next

10 years in the country. In all alternatives presented below, it is assumed that
1) number of disorders being tested will be decided based upon results of
quantitative cost benefit analysis; 2) various stakeholders will be consulted on
the implementation/operation of newborn screening both at the hospital level
and the community level; and 3) appropriate and feasible financial schemes
will be included.

Alternative 1. Maintain the Status Quo

At present, the National Institutes of Health is the major player in the

implementation of newborn screening in the country. It runs the only
laboratory which serves all the hospital and communities nationwide. Through
the leadership of the Institute of Human Genetics, policies are recommended
and implemented by the hospital and community coordinators of newborn
screening. Advocacy, sample collection, transport of samples, recall of
patients and monitoring of patients identified, remain the primary
responsibility of the hospital and the community.

The existing Administrative Order 1-a, s 2000 on the ‘Policies on the

Nationwide Implementation of Newborn screening’ details the role of the DOH
on advocacy at the regional level and identifies possible areas of involvement
in the implementation. There is a need to operationalize parts of the
Administrative Order.

Alternative 2. Department of Health as the sole implementor of the program

 The Newborn Screening Program has several components – advocacy,
patient recruitment, sample collection, transport of samples. Laboratory
processing, release of results, recall of patient with a positive screening and
monitoring of patients diagnosed with the disorders. Inasmuch as newborn
screening is now a national program, the Department of Health assumes
responsibility for all components of the program.

Alternative 3. National Institutes of Health and Department of Health share

responsibility in the implementation of the program

Existing networks, facilities, operations may be used to improved

coverage of screening and improve efficiency of the program. The National
Institutes of Health will continue to serve as the laboratory of the program and
will assist in the development of other laboratories in the country. The
National Institutes of Health will run the quality assurance program of newborn
screening, both at the operations as well as laboratory component. Hospitals
and communities will implement improved operations. The Department of
Health will integrate newborn screening in all existing health programs and
utilize existing networks for advocacy, patient recall and monitoring.

Evaluation of Alternatives

In evaluating the 3 alternatives, I would like to address the issues of

equity and efficiency. Alternative 1 offers a very limited scope of coverage.
To cover the 2M births every year, it will be imperative to establish a network
especially for recall and treatment monitoring. The main organizer (NIH) is
considered a ‘private’ entity and does not have power to demand increased
coverage as a policy. Efficiency is thus compromised on the operations level.
On the other hand, NIH runs the only laboratory for newborn screening in the
country.

Alternative 2 may be able to improve coverage of newborn screening

since the Department of Health can issue administrative orders ensuring that
every health facility offers newborn screening, thus making newborn screening
available to every newborn in the country. Also the Department of Health has
the network already in place for recall and treatment monitoring. Efficiency
may be improved in terms of operations. The only weakness of Alternative 2 is
the absence of the technical capability in running the tests.

Alternative 3 offers sharing of responsibility between the DOH and the

NIH. The strengths of both agencies will yield to improved efficiency and
improved coverage for the program.
Recommendations

This policy analysis recommends that the Department of Health assumes

a more aggressive stand for the institutionalization of the newborn screening
program. The following policy alternatives are put forward for consideration:
1) Maintain status quo with the National Institutes of Health as the major
implementor of the program; 2) Department of Health as the sole implementor
of the program and 3) Sharing of responsibilities between the two agencies in
the implementation of the program.

The policy analyst recommends a sharing of responsibility between the

Department of Health and the National Institutes of Health. The specific
elements of the proposal are:
 National Institutes of Health will continue to serve as the laboratory of
the program and will assist in the development of other laboratories in
the country.
 National Institutes of Health will run the quality assurance program of
newborn screening, both at the operations as well as laboratory
component. Hospitals and communities will implement improved
operations.
 Department of Health will integrate newborn screening in all existing
health programs and utilize existing networks for advocacy, patient
recall and monitoring.