Republic of the Philippines

Department of Health
OFFICE OF THE SECRETARY

JUN 2 5 2021
ADMINISTRATIVE ORDER
No. 2021- ..0..,...0Lk)...L.><....--

SUBJECT: Implementing Guidelines on the establishment of Pharmacy and

Therapeutics Committee (PTC) in Provincial and City Health
Offices

I. RATIONALE

Essential medicines are an integral component of Universal Health Care (UHC)

because they are needed for the delivery of health services and for the provision of
high quality care.

However, given the devolved set-up of the Philippine health system along with
limited resources and capacity of the Local Government Units (LGUs), medicine
supply management still remains a challenge. This results in either overstock or
undersupply of essential medicines. To help address these gaps, Pharmacy and
Therapeutics Committees (PTCs) were established across all levels of the healthcare
system by virtue of the Administrative Order (AO) No. 51 series of 1988 or the
"Implementing Guidelines for the Department of Health (DOH) Compliance with the
Generics Act of 1988 (Republic Act No. 6675)." One of their main functions is to
develop and maintain a list, based on the current edition of the Philippine National
Formulary (PNF), which serves as the basis of medicines that will be procured,
prescribed and used in the health facility. In the hospital setting, PTCs ensure that
medicines are used in a safe, appropriate, and cost-effective manner. PTCs are also
required for the licensing of hospitals and other health facilities as stipulated in AO
No. 107 s. 2000 (Amendment/ Addendum to AO 51 Sec. 9.1, 9.3, 9.4 and I 0.2 s
1988, Reconstitution and Strengthening of the Membership of the Therapeutics
Committee at the Centers for Health Development, Special Hospitals, National
Medical Centers, Regional Medical Centers, Regional Hospitals and Sanitaria).

This Order is aligned with the UHC Act (RA 11223) in its goal to strengthen
primary care service including the provision of safe and quality medicines at an
affordable cost. Particularly, Section 28(d) of the UHC Act requires drug outlets at all
times to carry the generic equivalent of all drugs in the Primary Care Formulary. The
PNF Manual for Primary Health Care currently exists to serve as guide for
procurement and rational use of essential medicines at the primary level where PTCs
play a vital role most especially in terms of drug selection and use which is crucial in
medicine supply
Building I, San Lazaro Compound, Rizal Avenue, Sta. Cruz, I 003 Manila • Trunk Line 651-7800 local 1108, 1111, 1112,13 Direct Line: 711-9502; 711-
9503 Fax: 743-1829 • URL: http://www.doh.gov.ph; e-mail:
 management. Subsequently, AO 2011-0009 or the "National Policy and Program on
Pharmacovigilance" was issued to institutionalize good pharmacovigilance practices
and to improve the reporting of adverse drug reactions (ADR) which are both crucial
aspects of medicine supply management.

In anticipation of the full implementation of the Supreme Court's Mandanas

ruling under G.R. No. 199802 (April 10, 2019) in 2022, increasing the Internal
Revenue Allotment (IRA) share of Local Government Units (LGUs), would therefore
capacitate the implementation of projects, programs, activities and the national
government's directives e.g., establishment of PTC in provincial and city levels.

II. OBJECTIVES

This Order aims to:

A. Provide guidance for the local government units (LGUs) in the creation of PTC in
the provincial and city health offices; and,
B. Define the roles and functions of the PTC in the provincial and city health offices.

III. SCOPE OF APPLICATION

This Order shall apply to the Department of Health (DOH) offices, Centers for
Health Development (CHDs), Ministry of Health - Bangsamoro Autonomous Region in
Muslim Mindanao (BARMM) as provided for in RA No. 11054 Organic Law for the
BARMM, the LGUs [including Provincial Health Offices (PHOs), City Health Offices
(CHOs), rural health units, health centers], private sectors, patient groups, non
governmental organizations (NGOs), civil society organizations (CSOs) and other
stakeholders.

IV. DEFINITION OF TERMS

A. Annual Operational Plan (AOP) refers to the yearly translation of the Local
Investment Plan for Health, which details the programs, plans and activities (PPAs)
and systems interventions that are to be implemented by the LGU in a particular
year.

B. Local Investment Plan for Health (LIPH) refers to a medium-term public

investment plan for health that specifies the strategic direction of the concerned LGU
(Provinces, Highly-urbanized Cities and Independent Component Cities) for three
years in terms of improving health service delivery, strengthening the health systems
operations and addressing social determinants of health, and specifies actions and
commitments of different local stakeholders.
 C. Pharmacovigilance refers to the science and activities relating to the detection,
assessment, understanding and prevention of adverse effects or any other possible
drug-related problems.

D. Pharmacy and Therapeutics Committee (PTC) refers to a multidisciplinary

committee with the main objective of promoting and ensuring the safe and effective
use of good quality drugs and is the approving authority on drugs and related
matters.

E. Primary Care refers to the initial-contact, accessible, continuous, comprehensive,

and coordinated care that is accessible at the time of need including a range of
services for all presenting conditions, and the ability to coordinate referrals to other
health care providers in the health care delivery system, when necessary.

F. Primary Care Facility refers to the institution that primarily delivers primary care
services which shall be licensed or registered by the Department of Health.

G. Primary Care Formulary refers to the Philippine National Formulary for primary
care level. It includes essential medicines that may be procured and administered in
primary care facilities.

V. GENERAL GUIDELINES

A. A PTC shall be established in all provincial and city health offices, as required
under AO 51 s. 1988, to improve the management and use of medicines in the
primary care setting.

B. The PTCs in the PHOs/CHOs shall focus on medicines management in the rural health
units and health centers. They shall not have jurisdiction over individual hospitals
under their catchment area pursuant to the provisions of AO 51 s. 1988, which
mandates special hospitals, national medical centers, regional medical centers,
regional hospitals and sanitaria to have their own PTCs.

C. The PTCs in the PHOs/CHOs and hospital-based PTCs shall coordinate with each
other as necessary.

D. The PTC shall ensure that patients are provided with the best possible cost-effective
and quality care by determining what medicines will be available, at what cost, and
how they will be used.

E. The PTC shall adhere to the principle of good governance, and as such, each
member should not be influenced by inappropriate drug advertisements, promotional
activities or personal financial interests.

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 F. The members of the PTC shall be technically competent and should employ
evidence based medicine in their recommendation and decision making.

G. Data from the PTC reports shall be analyzed and used as basis for planning, policy
and decision-making by both the DOH and LGUs.

H. The PTC members shall facilitate partnership among stakeholders, such as but not
limited to consumers, civil society groups, NGOs and patient groups who may serve
as resource persons during decision-making processes and medicines management.

I. The organizational development and performance of the PTCs shall be documented

and monitored continuously. The PTC shall adapt its own indicators and measures
based on the Monitoring and Evaluation tools formulated by the DOH to be used in
evaluating their impact to the community.

J. The creation of PTC shall be reflected in the LIPH and AOP where the source of
funding for the operation of the PTC is reflected. The specific fund source shall be
decided upon by the LGU.

K. The DOH shall coordinate with other agencies in ensuring good governance to
sustain the PTCs in all government health facilities.

VI. SPECIFIC GUIDELINES

A. Creation of the PTC

1. LGUs shall create a PTC at the provincial and city levels, in accordance with
the implementing guidelines of the Generics Act of 1988, with clearly defined
functions relating to procurement and supply chain management of medicines,
through an Executive Order. A sample is provided in Annex A.

2. The PTC at the provincial level shall have jurisdiction over the municipalities
and component cities that committed to the integration in the province-wide
health systems (PWHS).

3. The municipality and component city of a province may establish their own
PTC adopting the composition and functions stated in this Order, as deemed
necessary.

B. Composition of the PTC

Mem7
I. Provincial Level

a. Ex-officio Non-Voting

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 a.I Provincial Health Officer
a.2 Association of Municipal Health Officers of the Philippines (AMHOP)
Chapter President or his/her duly designated representative
a.3 Public Health Nurse
a.4 Midwife

b. Voting Members (technical experts):

b.1 Infectious disease expert

b.2 Pediatrician
b.3 Obstetrician-Gynecologist
b.4 Pharmacist
b.5 Family Medicine
b.6 Public health specialist
b.7 Psychiatrist

c. Resource Persons to be identified by the PTC may be invited such as DOH

representative, representative of the Food and Drug Administration (FDA),
Bids and Awards Committee (BAC) representative/Procurement Officer,
logistics officers, Medical technologist, Medical specialists, patient groups,
and CSOs, among others.

2. City Level

a. Ex-officio Non-Voting Members:

a.1 City Health Officer

a.2 Public Health Nurse
a.3 Midwife
a.4 Medical technologist (if available)

b. Voting Members (technical experts):

b.1 Infectious disease expert

b.2 Pediatrician
b.3 Obstetrician-Gynecologist
b.4 Pharmacist
b.5 Family Medicine
b.6 Public health specialist
b.7 Psychiatrist

c. Resource persons to be identified by the PTC may be invited such as DOH

---
representative, FDA representative, BAC representative/Procurement Officer,

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 logistics officers, Medical technologist, Medical specialists, patient groups, and
CSOs, among others.

3. The voting members mentioned above are the minimum technical experts required
in the PTC and the PHO/CHO may include additional members as deemed
necessary. The technical experts may be sourced from the hospitals (private or
public), local professional societies, or the academe.

4. The voting members shall elect among themselves a Chairperson and Vice
Chairperson.

5. As per RA No. 10918, otherwise known as the "Philippine Pharmacy Act,"

supervision by a duly registered and licensed pharmacist, per establishment, is
required in government units, including local government, city, first to third class
municipal health units, nongovernment organizations and/or associations involved
in the procurement, distribution, dispensing and storage of pharmaceutical
products. For fourth, fifth and sixth class municipal health units, pharmacist is not
required per establishment, instead, a supervising pharmacist can provide oversight
to several outlets.

6. In cases where the LGU does not have its own pharmacist, the public health
pharmacist in the Human Resource for Health Deployment Program of the DOH or
as may be designated by the CHO Director, can be tapped to be part of the PTC
upon official request.

7. To support the operations of the PTC, the PHO/CHO shall form a secretariat with
at least 2 members, depending on the available human resource of the LGU. It
shall perform the following functions:

a. Organize the PTC meetings;

b. Document the meetings, directives and recommendations of the PTC;
c. Compile and make available to the Committee past and existing decisions,
policies, recommendations, directives, and resolutions;
d. Liaise with other stakeholders on data/ information needed by the PTC; and,
e. Perform other functions deemed necessary by the PTC.

C. Functions of the PTC

1. Act as an advisory and recommending committee to the Local Health Board

(LHB) on all issues, policies and guidelines concerning the selection, distribution
and use of medicines.

y
2. Develop/adopt medicines policies and protocols. At the least all LGUs shall have
policies concerning the following:

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 a. criteria for inclusion of medicines on the essential medicines list (EML)
shall be based on the Primary Care Formulary and the needs of the
community;
b. standard treatment guidelines (STGs) and treatment algorithms, which shall
be the basis of formulary selection of medicines;
c. expensive or dangerous medicines, such as third-generation antibiotics or
oncological drugs, which are restricted to certain practitioners, departments
or patients; and,
d. recommendations to the P/CHB for adopting national implementing
guidelines on pharmaceutical management and price monitoring.
3. Evaluate and select essential medicines for procurement based on the needs of the
community and the primary care formulary. It shall ensure that prices are within
the price range set by current drug pricing policies.
4. Assess medicines use through drug utilization review.
5. Collate and assess reports on pharmacovigilance from the municipalities/cities.
6. Disseminate information about its activities, decisions and recommendations to
the responsible person who must implement them.
7. Adhere to pertinent guidelines issued by the DOH (e.g., pharmaceutical supply
chain management, rational use of medicines, Good Pharmacy Practice,
treatment guidelines).
8. Perform other functions related to proper medicines use and management.

D. Conduct of Meetings and Other Processes

1. The PTC shall set regular meetings or as frequent as possible depending on the
pressing needs. At least two (2) meetings must be conducted in a year.
2. The agenda, supplementary materials and minutes of the previous meeting shall
be prepared and disseminated to all members one (1) week before the next
meeting.
3. To protect the process from outside interference, the PTC and other invited
resource persons shall conform with the principles of integrity and shall therefore
declare all circumstances with real or potential conflicts of interests (COi),
subject to the existing guidelines for declaring and managing these conflicts. The
LGUs may opt to adopt the guidelines of the DOH on the management of COis.
4. All PTC recommendations, once accepted by the LHB, shall be disseminated to
the RHUs and other concerned parties and P/CHB for adoption and
implementation.
5. All PTC operating guidelines, policies and decisions shall be documented and
made available to stakeholders in accordance to policies related to Freedom of
Information (FOi).
6. The PTC shall maintain the integrity and transparency of all their records which
shall be submitted to the LGU and shall be made available whenever asked by the
CHD concerned, MOH-BARMM, DOH and other regulatory units.

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 E. Performance Assessment of PTC

1. The organizational development and performance of the PTC shall be

continuously monitored and documented by using an assessment tool (Annex B).
2. The DOH, CHDs and MOH-BARMM shall be the lead units in monitoring the
performance of all PTCs nationwide and shall have the authority to check on their
pharmaceutical inventory records. Monitoring reports shall be semi-annually
submitted by the PTCs to their respective CHDs and MOH-BARMM, and
forwarded to the DOH-Pharmaceutical Division (PD).

VII. ROLES AND RESPONSIBILITIES

A. The Health Human Resource Development Bureau (HHRDB) shall ensure

deployment of Public Health Pharmacists as part of the Human Resource for Health
Deployment Program under the National Health Workforce Support System in
priority areas of need as determined by the HHRDB and in coordination with the
DOH-PD, CHDs and MOH-BARMM.

B. The PD shall:

1. Monitor the creation of the PTCs at the primary care level;

2. Provide capacity building activities on rational use of medicines; and,
3. Ensure the regular updating of the Primary Care Formulary and Drug Price
Reference Index.

C. The CHDs and MOH-BARMM shall:

1. Oversee the creation and function of the PTC;

2. Provide training on supply chain management, rational use of medicines and
Good Pharmacy Practice, among others;
3. Allocate budget for the hiring of additional Public Health Pharmacists as deemed
necessary; and,
4. Submit annual monitoring reports to the DOH-PD on the status of the program
implementation.

D. The LGU shall ensure adequate funding for the institutionalization and
operationalization of the PTC in its area of jurisdiction in coordination with the
CHDs and MOH-BARMM.

VIII. SEPARABILITY CLAUSE

In case any provision in this Order shall be declared invalid, illegal or unenforceable,
the validity, legality and enforceability of the remaining provisions shall not be affect /
impaired thereby. 'fl{

( 1 B
IX. REPEALING CLAUSE

All orders, rules, regulations, and other related issuances inconsistent with or contrary
to this Order are hereby repealed, amended, or modified accordingly. All other provisions of
existing issuances which are not affected by this Order shall remain valid and in effect.

X. EFFECTIVITY

This Administrative Order shall take effect after fifteen (15) days following its
publication in a newspaper of general circulation and upon filing with the University of the
Philippines Law Center of three (3) certified copies of this Order.

DUQUE III, MD, MSc

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Annex A. Sample Policy on the Creation of a Pharmacy and Therapeutics Committee

Republic of the Philippines

Province/ City of
Executive Order

CREATING THE PHARMACY AND THERAPEUTICS COMMITTEE OF

THE PROVINCE/ CITY OF

WHEREAS, 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".

WHEREAS, 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".

WHEREAS, several policies and laws have been passed that includes Republic Act No.
6675 known as the Generics Act of 1988 that was enacted to ensure the adequate supply of
drugs with generic names of the lowest possible cost.

WHEREAS, Administrative Order No. 51 s. 1988, entitled, Implementing Guidelines for

Department of Health Compliance with RA 6675 prescribed the organization of Therapeutics
Committees at the Regional Health Offices, Provincial Health Offices, District Health
Offices, City Health Offices, special hospitals, national medical centers, regional medical
centers, regional hospitals and sanitaria;

WHEREAS, Administrative Order No. 163 s. 2002, entitled, Implementing Guidelines and
Procedures in the Procurement and Requisitions of Drugs and Medicines by the Department
of Health pursuant to Executive Order No. 49, was issued that provides procedural basis that
ensure requisition of essential medicines by the government sector and the decision system
for the inclusion and deletion of drugs in the Philippine National Formulary (PNF);

WHEREAS, Chapter V. Sec. 19 of the Republic Act No. 11223, known as the Universal
Health Care Act, provides that the DOH, Department of the Interior and Local Government
(DILG), PhilHealth and the LGUs shall endeavor to integrate health systems into province
wide and city-wide health systems. The Provincial and City Health Boards (P/CHBs) shall
oversee and coordinate the integration of health services for province-wide and city-wide
health systems, to be composed of municipal and component city health systems, and city-
wide health systems in highly urbanized and independent component cities,
respective!

1
WHEREAS, Local Government Units (LGUs) are mandated to enforce all laws and policies
enacted and issued by competent government agencies that will protect and promote the
health of the people and instill health consciousness among them and in promoting the general
welfare of the populace;

WHEREAS, it is the duty of every LGU to assist concerned national government agencies in
enforcing policies that will regulate the sale and distribution of quality medicines within its
territorial jurisdiction to ensure that medical goods and services available in the market are
compliant with national standards;

NOW THEREFORE, I, _, Provincial Governor/City Mayor, by virtue

of the powers vested in me by law do hereby order the Creation of Pharmacy and
Therapeutics Committee in the

Section 1: Composition. The Pharmacy and Therapeutic Committee shall be composed of

the following:
Chairperson:
Co-Chairperson:
Members

Section 2. Duties and Functions. The Pharmacy and Therapeutic Committee shall perform
the following duties and functions:

I. Act as an advisory and recommending committee to the Local Health Board on all
issues, policies and guidelines concerning the selection, distribution and use of
medicines.
2. Develop/adopt medicines policies and protocols. At the least all LGUs shall have
policies concerning the following:
a. criteria for inclusion of medicines on the essential medicines list (EML) shall be
based on the Primary Care Formulary and the needs of the community;
b. standard treatment guidelines (STGs) and treatment algorithms, which shall be
the basis of formulary selection of medicines;
c. expensive or dangerous medicines, such as third-generation antibiotics or
oncological drugs, which are restricted to certain practitioners, departments or
patients;
d. recommendations to the P/CHB for adopting national implementing guidelines
on pharmaceutical management and price monitoring
3. Evaluate and select essential medicines for procurement based on the needs of the
community and the primary care formulary. It shall ensure that prices are within the
price range set by current drug pricing policies.
4. Assess medicines use through drug utilization review.
5. Collate and assess reports on pharmacovigilance from the municipalities/cities.
6. Disseminate information about its activities, decisions and recommendations to the
responsible person who must implement them.
 7. Adhere to pertinent guidelines issued by the DOH (e.g., pharmaceutical supply chain
management, rational use of medicines, Good Pharmacy Practice, treatment
guidelines).
8. Perform other functions related to proper medicines use and management.

Section 3. Meetings. The Committee shall meet at least twice every year or as often as
necessary.

Section 4. Effectivity. This order shall take effect immediately.

Done this_ day of m _

City Mayor/Provincial Governor

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Annex B. Indicators to Assess PTC Performance and Impact

1. Is there a PTC document that indicates its terms of reference, including its goals,
objectives, functions and membership?
2. Is the PTC in the organizational chart of the health facility?
3. Is a budget regularly allotted to PTC functions?
4. Does the PTC have established criteria and authority concerning medicine selection?
a. How many medicines are there in the EML procured by LGU?
5. Has the PTC organized educational activities about medicines?
a. Have there been any organized training and lectures for health care staff?
b. Is there an established library/online resource accessible to staff?
c. Is there continuing medical education?
d. Is there a medicine information service available to staff?
e. Are there training programs for the staff?
6. Have any intervention studies to improve medicine use in the community been
undertaken?
7. Has the PTC been involved in medicines budget allocation?
a. Was the PTC consulted during medicine budget allocation?
b. Was PTC clearance needed prior to medicine budget approval?
8. Has the PTC developed a policy for controlling the access of medicine representatives
and promotional literature to staff?

Reference: World Health Organization (2003). The Drugs and Therapeutics Committee: Practical
Guide. Retrieved from http://apps.who.int/medicinedocs/en/d/Js4882e/