Implementing Guidelines in Assuring the Efficacy, Quality and Safety of Pharmaceutical Products in the Public Health Facilities

October 4, 2019

DOH ADMINISTRATIVE ORDER NO. 2019-0041

 

I. RATIONALE/BACKGROUND:

Medicines have been essential throughout history for the treatment of illnesses and prevention of disease. Over the course of time, the oversight by the national government has assured that those medicines are safe, quality and effective through regulatory reforms by the Philippine Food and Drug Administration (FDA).

In recent years, strategies to institutionalize good governance in pharmaceutical management have been initiated by the Department of Health (DOH) to improve access to medicines in the health sector following earlier WHO reports which showed weaknesses and inefficiencies in procurement as evidenced by the low mean availability of essential medicines and widely varying procurement prices at all levels of the public healthcare system. These reforms build on the momentum created by Republic Act 9502 or the Universally Accessible Cheaper and Quality Medicines Act of 2008 as well as the commitment of the Philippine Government to pursue reforms in regulatory management as a pilot country for the WHO Good Governance in Medicine (GGM) program. aDSIHc

Assuring the safety, efficacy and quality of medicines is vital to the needs of the public health objectives of bringing cure to patients across the health system. Poor-quality medicines affect the clinical outcomes of patients. To ensure that those involved in the manufacture and distribution of pharmaceuticals comply with accepted practice standards, governments must create regulatory standards and a climate in which medicine quality is valued and ensured along the entire supply chain especially in the public health sector where patients depend on free access to medicines.

In the FOURmula One Plus for Health (F1+), enforcing the standards, accountability and transparency is one of the strategies that the government wants to achieve. The purpose of quality assurance in pharmaceutical supply systems is to help ensure that medicines reaching patients are safe, effective and of acceptable quality. The most important characteristics of a pharmaceutical product are identity, purity, strength, potency, uniformity of dosage form, bioavailability, and stability.

In view of the above, implementing guidelines need to be developed and aligned with emerging FDA and DOH reforms and necessary investments on essential medicines. This Order aims to set guidelines to assure the efficacy, quality and safety of pharmaceutical products being procured by the government agencies and made available to the patients through all public health facilities at all stages and levels of the supply chain.

II. OBJECTIVE

A. GENERAL OBJECTIVE:

This Order aims to set the implementing guidelines in assuring the safety, efficacy and quality of pharmaceutical products along the entire supply chain in all public health facilities.

B. SPECIFIC OBJECTIVES:

1. To standardize the technical specification and process in the bidding of pharmaceutical products that will assure product efficacy, quality and safety.

2. To achieve an optimum level of competition in the sourcing of essential medicines through the different modes of procurement as stipulated in RA 9184 and its IRR.

3. To assure the maintenance of the product safety, efficacy, and quality of essential medicines throughout the supply chain by providing standards and procedures from screening of qualifications of suppliers to post marketing surveillance.

4. To provide standards and procedures on the performance evaluation of suppliers.

III. SCOPE AND COVERAGE

This Order shall apply to the entire public health sector, which includes the DOH bureaus and offices, Centers for Health Development, DOH hospitals, Corporate/Specialty Hospitals, Treatment and Rehabilitation Centers, Sanitaria, and DOH-Attached Agencies.

IV. DEFINITION OF TERMS

1. Clearing House refers to the technical offices designated to clear specifications and scopes of work to ensure comprehension of technical details, complementation of efforts and limit duplication.

2. Good Distribution Practice refers to that part of quality assurance that ensures that the quality of a pharmaceutical product is maintained by means of adequate control of the numerous activities which occur during the distribution process as well as providing a tool to secure the distribution system from counterfeits, unapproved, illegally imported, stolen, counterfeit, substandard, adulterated, and/or misbranded pharmaceutical products.

3. Good Storage Practice refers to that part of quality assurance that ensures that the quality of pharmaceutical products is maintained by means of adequate control throughout the storage thereof.

4. Pharmaceutical Products/Drugs and medicines refers to any chemical compound or biological substance, other than food, intended for use in the alleviation of symptoms and the treatment, prevention or diagnoses of diseases in humans or animals, including but not limited to:

a. Articles recognized in the current official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopeia of the United States, Philippine Pharmacopeia, official Philippine National Drug Formulary (PNDF), British Pharmacopeia, European Pharmacopeia, Japanese Pharmacopeia, Indian Pharmacopeia, any national compendium or any supplement to any of them;

b. Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals;

c. Articles other than food intended to affect the structure or any function of the human body or animals;

d. Articles intended for use as a component of articles specified in clauses (1), (2), or (3) of IV.D. of this Order not including devices or their components, parts, or accessories; and Herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine that are:

i. Recognized in the Philippine National Drug Formulary Vol. (Essential Drugs List)

ii. Intended for use in the treatment, cure or mitigation of disease symptoms, injury or body defects in humans;

iii. Other than food, intended to affect the structure or any function of the human body;

iv. In finished or ready-to-use dosage form;

v. Intended for use as a component of any of the articles specified in clause IV.D.4.a-d.

5. Philippine National Formulary (PNF) refers to a list of essential drugs prepared and periodically updated by the DOH on the basis of health conditions present in the Philippines as well as on internationally-accepted criteria. It consists of a core list and a complementary list. ETHIDa

6. Primary packaging refers to those packaging components that are in direct contact with the dosage forms.

7. Testing refers to either (1) quality control testing, (2) clinical trial, (3) bioavailability and bioequivalence testing, (4) and such other analyses to determine the safety, efficacy, and/or quality of drug products.

8. Shelf-life refers to the period of time during which a product is expected, if stored correctly, to remain within specification as determined by stability studies on a number of batches of the product. The shelf-life is used to establish the expiry date of each batch.

V. GENERAL GUIDELINES

1. All pharmaceutical products shall fall under the specifications of the current edition of the Philippine National Formulary (PNF). Exemptions to this list may be permitted by the DOH on a case to case basis as per A.O. No. 2016-0034 dated August 9, 2016.

2. There shall be no added specifications in the standard terms of reference for bidding that will suggest a certain brand or supplier to ensure an optimum level of competition.

3. All DOH designated clearing houses shall evaluate the medicine procurement request of end-users using the following criteria:

a. Drugs to be procured must be included in the current edition of the Philippine National Formulary;

b. The Approved Budget for the Contract (ABC) must be within the latest Drug Price Reference Index (DPRI); and

c. The Purchase Request (PR) to be submitted by the end-user must include the required packaging, delivery schedule, delivery site and labeling instruction.

4. The following documents shall be submitted during the bidding of drugs and medicines:

a. Certificate of Product Registration (CPR) — Valid and current Certificate of Product Registration (CPR) issued by the Philippine Food and Drug Administration.

b. License to Operate (LTO) issued by the FDA for Suppliers, Distributors and Traders.

5. All pharmaceutical products to be delivered shall be of fresh commercial stock as reflected in the Certificate of Product Registration (CPR) issued by the FDA; upon receipt at the designated delivery place. In general, standard for tablet/capsule is 24-18 months and 18-16 months for syrup/solutions. Table 1 describes the acceptable remaining shelf life.

Table 1. Acceptable Remaining Shelf Life

 

CLAIMED SHELF LIFE	MINIMUM REMAINING SHELF LIFE
60 months	42-60 months
48 months	34-48 months
36 months	30-36 months
24 months	18-24 months
18 months	12-18 months
12 months	12 months

 

6. All primary packaging of pharmaceutical products shall be the FDA commercially approved packaging (Manufacturer's Packaging) specified in the approved CPR. For specific packaging requirements (i.e., DOH Central Office Maintenance Medicines), the end-user/s shall submit justification for clearance in their respective clearing houses.

7. The DOH shall adopt a risk based approach in requiring additional laboratory test (physical, chemical, bacteriological test) prior to distribution to health facilities.

8. All health facilities shall follow the latest FDA guidelines on Good Distribution and Storage Practice (GDSP) as stipulated under AO 2013-0027 and its amendment and the DOH Warehouse Operation Manual.

9. A standard monitoring tool shall be used to monitor the performance and integrity of the suppliers unless otherwise amended by the Procurement and Supply Chain Management Team (PSCMT).

VI. SPECIFIC GUIDELINES

A. Selection of products

1. The designated DOH clearing houses for drugs and medicines are the following:

a. For DOH Central Office-Pharmaceutical Division

b. For Regional Offices-Regional Therapeutics Committee

c. For Specialty and Retained Hospitals-Therapeutics Committee

2. The CPR must be valid for the entire period of the award. If the CPR is about to expire, the supplier must have submitted a copy of an application of renewal to the FDA at least 3 months before the expiry date (a copy of the expiring CPR which is stamped with an "extension of validity" shall be submitted as proof);

3. If applicable, requirement for WHO Pre-qualification shall be imposed for essential drugs and vaccines procured for special DOH programs such as the EPI, TB, HIV/AIDS program and Rabies program. cSEDTC

B. Receipt, inspection and testing

1. For drugs requiring tests before distribution, sampling of products by the FDA shall be done at the DOH or supplier's warehouse. Delivery to the DOH warehouse or health facilities shall only be allowed after FDA has already released clearance on the safety, efficacy and quality of drugs.

2. Testing of samples shall be done through random batch testing, with samples collected by the trained pharmacist of the health facility or a member of the Inspection Committee for the DOH Central Office following the FDA protocols for laboratory testing.

3. The following products shall be targeted for routine sampling and testing by the FDA or its accredited laboratories:

a. Antibiotics;

b. Are from new suppliers in the market with no history of supplying its host country or reference countries with stringent regulatory authorities (in accordance with FDA's latest policy);

c. Have been documented to have Reports of Products Failures and Violations by the FDA;

d. Drugs with narrow therapeutic index (refer to the latest Philippine National Formulary list); and

e. All foreign donations of drugs/medicines (following the latest policy issued by the Bureau of International Health Cooperation).

4. The Inspection Committee of the DOH Central Office shall consist of but not limited to the representative/s from the End-user, Administrative Service (General Services Division), Financial Management Service-Accounting Division and a pharmacist from the SCMO.

5. The Chief Pharmacist or his/her assigned representative (for DOH hospitals), the Licensed Pharmacist in-charge of the warehouse (for Regional Offices) or the assigned Pharmacist in the SCMO (for DOH Central Office) shall submit a Request for Analysis Form to the FDA (see Annex A). The health facility shall conform with the standard protocol for laboratory testing following the required number of samples to be submitted to the FDA in accordance with latest policy of the FDA (FDA Circular No. 2014-014).

6. The FDA shall disseminate the results of testing in its website and notify the requesting health facility not more than thirty-five (35) calendar days after the request has been made thru the SCMO. SCMO shall then cascade the report/data to the DOH health facilities. The FDA will provide original copy of the result of testing to SCMO for the payment of the supplier.

7. The Chief Pharmacist or his/her assigned representative (for DOH hospitals), the Licensed Pharmacist in-charge (for Regional Offices) or the Inspection Committee (for DOH Central Office) shall routinely conduct a physical inspection of the purchased drugs and medicines upon delivery using the standard Inspection Checklist (see Annex B) as reference.

C. Good Distribution and Storage Practices (GDSP)

1. The Pharmacist in charge and/or his/her authorized Pharmacy Assistant (PA) shall check and monitor compliance with the GDSP of their respective warehouses and storage areas on a monthly basis using the prescribed form of the Health Facility Supply Chain Management (SCM) Performance Monitoring Tool as reference (refer to Department Memorandum No. 2016-0222 dated June 21, 2016).

2. The logistics officer of the health facilities and/or his/her representative shall check and monitor the distribution of the pharmaceutical products up to the service delivery units/point of care.

D. Post Marketing Surveillance

1. The Chief Pharmacist (for DOH hospitals), the Pharmacist in-charge of DOH regional warehouses (for Regional Offices) or the assigned Pharmacist in the SCMO (for DOH Central Office) shall conduct random sampling in coordination with the FDA if there is a suspicion upon physical inspection or upon receipt of complaints from health facilities. The FDA shall subject all pharmaceutical products procured by the DOH under post marketing surveillance in accordance with its existing guidelines.

2. The Chief Pharmacist or his/her assigned representative (for DOH Hospitals) shall continuously monitor issued FDA Advisories on Pharmaceuticals and properly inform Therapeutics Committee and end-users on drug safety information.

3. In case of Adverse Events, drugs with findings of ADR/ADE shall be reported to the FDA by the Therapeutics Committee (refer to the latest policy of FDA on Pharmacovigilance — AO No. 2011-0009 and its amendment).

E. Disposal and Recall

1. In instances of product recalls due to failures of suppliers and manufacturers to comply with standards of safety and quality, the cost associated with the proper disposal/destruction, handling or pull out from health facilities where these products have already been distributed shall be borne by the supplier (subject to the latest policy for disposal); and

2. In cases of expired drugs, the health facility shall bear the cost for disposal. The disposal of the expired goods shall be coordinated through a third-party accredited by the Department of Environment and Natural Resources (DENR), engaged by the Administrative Service (AS) of the DOH health facility, subject to compliance to applicable laws.

F. Monitoring of Suppliers Performance

1. The DOH health facilities/end users shall monitor the performance of suppliers using the latest template of the Supplier Performance Evaluation Form (see Annex C) furnishing a signed copy to the DOH — Procurement and Supply Chain Management Team (PSCMT).

2. The following are the Key Performance Indicators for monitoring the performance of the suppliers:

a. Suppliers meet quality and service standards specified in the Terms of Reference (TOR)/Purchase Order (PO)/Contract (whichever is applicable);

b. Timeliness of delivery;

c. Completeness of quantity delivered; and

d. Zero defects;

e. Relevant additional services provided to the DOH (e.g., disposal, recall).

G. Complaints Handling and Resolutions (see Annex D)

1. All complaints related to this Order shall be in writing and submitted to the DOH-Office for Strategy Management (OSM), and endorsed to the appropriate office.

2. All documents trail shall be in accordance with RA 11032, otherwise known as the "Ease of Doing Business and Efficient Government Service Delivery Act of 2018."

3. Complaints of violation regarding product quality shall be filed with the FDA. All complaints shall be in writing and must include the information in accordance with Sec. 3 Art. IV, Book III of the IRR of RA 9711. SDAaTC

4. Complaints of violation regarding the anti-competitive practices, illegal acts of price manipulation, profiteering and other similar cases shall be endorsed to the Philippine Competition Commission (PCC) by the DOH through the Pharmaceutical Division.

5. Complaints of violation regarding the performance of the suppliers (i.e., delay in delivery, incomplete delivery) for the procurement of medicines shall be endorsed to the Supply Chain Management Office (for Central Office concerns) and to the Bids and Awards Committee (for DOH Regional Office and DOH Hospitals concerns).

6. Complaints of the end-users on the performance of the service provider (logistics) on the delivery of medicines shall be endorsed to the Supply Chain Management Office.

7. All complaints shall be in writing and sanctions imposed shall be in accordance with IRR of RA 9184, RA 7581 and other relevant laws.

VII. ROLES AND RESPONSIBILITIES

The following roles and responsibilities of all parties concerned shall be observed for the purpose of the implementation of the system:

1. Health Regulation Team-Pharmaceutical Division

a. Develop policy and guidelines that will assure the supply chain management of pharmaceutical products in all public health facilities in coordination with SCMO;

b. Act as the Clearing House for the procurement of drugs and medicines for the DOH Central Office.

2. Procurement and Supply Chain Management Team-Supply Chain Management Office

a. Oversees the pharmaceutical supply chain activities of the department;

b. Develop standard tools that will assure the supply chain management of pharmaceutical products in all public health facilities;

c. Manages, monitors and evaluates the performance and service delivery of all stakeholders within the supply chain process of drugs and medicines from planning and forecasting, to procurement and warehousing up to delivery and distribution of commodities as well as monitoring and evaluation.

3. Office for Strategy Management

a. Screen and endorse to the appropriate offices all written complaints related to this Order.

4. Food and Drug Administration

a. Ensure the compliance of all establishments involved in the supply chain management to the standards of good practices to ensure the safety, efficacy, and quality of their products; and

b. Handle complaints on product quality, therapeutic failure and adverse events.

5. Legal Service

a. Investigate the complaints on DOH Central Office procurement of drugs and medicines for appropriate recommendation and legal action. AaCTcI

6. Field Implementation and Coordination Team

a. Oversee the implementation of the compliance of all DOH health facilities to the standards on safety and quality of the pharmaceutical products along the entire supply chain management.

7. DOH Centers for Health Development

a. Implement and monitor the compliance of all DOH health facilities to the standards on safety and quality of the pharmaceutical products along the entire supply chain management;

b. The Regional Director shall designate the Regional Therapeutics Committee as the Clearing House for drugs and medicines for the procurement of the RO.

8. Hospitals (DOH Retained and Specialty)

a. Ensure compliance to the guidelines as part of their mandate on rational use of medicines and post marketing surveillance and pharmacovigilance through the Therapeutics Committee;

b. The Hospital Chief shall designate the Therapeutics Committee as the Clearing House for drugs and medicines for the procurement of medicines of the hospitals.

VIII. REPEALING CLAUSE

All issuances particularly Administrative Orders No. 14, s. 2001 (Interim Accreditation Guidelines for DOH Drugs and Medicines Suppliers), No. 2005-0033 (Procedural Guidelines on the Procurement, Inspection, and Distribution of Various Drugs and Medicines under the Low-Cost Medicine Program of the DOH in collaboration with the Philippine International Trading Corporation and other Government entities mandated and authorized to undertake procurement and distribution in favor of the DOH), No. 9B, s. 1998 (Guidelines for Acceptance for Drugs, Medicines, Reagents, and Other Medical Supplies Relative to the Expiration Date) which is 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. EFFECTIVITY

This Order shall take effect immediately.

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

ANNEX A

Guide in Filling-Out Request for Analysis Form

 

ANNEX B

Inspection Checklist for Pharmaceutical Products for the Department of Health (DOH): Procured or Donated

 

ANNEX C

Supplier's Performance Evaluation Form

 

ANNEX D

Grounds for Complaints (Pharmaceutical Products)