AO 2018-0020 (EDPMS)

Health Benefit Packages

PhilHealth program for which the price information in the EDPMS is needed for its design

Procuring Entities

Procurement Service, Regional Offices, hospitals, and Committees on Bids and Awards

PhilHealth

granted access levels and rights by the PD for verification/checking submitted medicine prices for reimbursement by the govt and private health facilities and other purposes

Secretary of Health and Pharmaceutical Division

has full unrestricted access to the EDPMS for price monitoring functions

suspension/revocation of LTO

imposed by Secretary of Health; duration shall not exceed one (1) year

Erroneous Submission of Data

incomplete and wrong or incorrect data submitted/uploaded to the EDPMS

price data available to the consumers

prices confined to the final selling prices of medicines in drug chains and retail outlets

Luzon

uploads in EDPMS annually every April

Metro Manila

uploads in EDPMS annually every January

Visayas

uploads in EDPMS annually every July

Mindanao

uploads in EDPMS annually every October

drug outlet having 2 or more branches

uploads selling prices and inventory through the EDPMS on a quarterly basis

drug outlet with only 1 branch

uploads their selling prices and inventory in the EDPMS once a year according to the geographical clusters: Metro Manila - January Luzon - April Visayas - July Mindanao - October

drug outlet in hospitals

uploads their selling prices and inventory through the EDPMS on a quarterly basis; understood that medicines prices are consistently applied for both in-patient and out-patient care

Electronic Drug Price Monitoring System; EDPMS

used as a vital reference of the DOH in formulating pricing policies for essential medicines to ensure its affordability and availability in the market

Government Mediated Access Price; GMAP

voluntary price reduction of selected drugs and medicines pursuant to Resolution 2009-001 of the Advisory Council for Price Regulation

National Drug Policy Compliance Officer; NDCPO

DOH ROs through this body: assess and review quarterly report of non-complying drug establishments/outlets prepare endorsement letter to FDA regional office covering the list of non-complying drug facilities/establishments for issuance of warning, notice, and/or report of violation; submit list of non-complying facilities to FDA ROs

Regional Drug Price Monitoring Officer; RDPMO

DOH ROs through this body: generate and submit compliance reports; orient and train drug establishments how to operate the system; monitor and evaluate implementation; validate request for user names and passwords and endorse them to PD; prepare/generate quarterly report of non-complying drug outlets/establishments to be submitted to NDP compliance officer; randomly monitor compliance of drug establishments/outlets

Access Programs

DOH program for which the price information in the EDPMS is needed for its design

quarterly basis

EDPMS uploading schedule for drug outlets with 2 or more branches, drugs outlet in hospitals, and other drug establishments;

EDPMS

Electronic Drug Price Monitoring System

additional penalty

FDA imposed: P2,500 per day if violation continues after having received an order from DOH, or other appropriate body, notifying and penalizing the offending person/company for the infraction

5th and succeeding violations

FDA imposed: administrative fine of P1,000,000; recall of product; recall of violator's License to Import and Distribute; blacklisting of the drug establishment/outlet

2nd violation

FDA imposed: administrative fine of P10,000-P50,000

4th violation

FDA imposed: administrative fine of P200,000-P500,000; recall of product; recall of violator's License to Import and Distribute; blacklisting of the drug establishment/outlet

3rd violation

FDA imposed: administrative fine of P60,000-P150,000; recall of product; suspension of Certificate of Product Registration (CPR)

1st violation

FDA imposed: written warning

Procuring Entities

granted access levels and rights by the PD for checking current medicine prices in the market

Rule 78 of the IRR (RA 9502)

all fees collected, charges imposed, and administrative fine that have accrued as a consequence of the implementation of this AO shall be for the account and income of FDA

Manufacturer

any establishment engaged in any/all operations involved in the production of drug products

Drug Distributor Exporter

any establishment that exports raw materials, active ingredients, and finished products for distribution to other drug establishments outside the country

Drug Distributor Importer

any establishment that imports raw materials, active ingredients, and/or finished products for wholesale distribution to other local FDA-licensed drug establishment

Drug Distributor Wholesaler

any establishment that procures raw materials, active ingredients, and/or finished products from a local FDA-licensed drug establishment for local distribution on wholesale basis

Manufacturer Trader

any establishment which is a registered owner of a drug product and the formulation and procures raw materials and packing components, and provides the production monographs, QC standards and procedures but subcontracts the manufactures of such products to a licensed manufacturer

Scope

applies to all bureaus in the DOH Central Office, attached agencies, regional offices, LGUs, govt. and private health facilities, drug establishments and drug outlets, and other agency data beneficiaries

Pharmaceutical Division; PD

assign and issue user names and passwords unique to each drug establishment and outlet that is going to use the system

Monitoring Team

authorized to conduct monitoring activities done regularly or if need arises through spot monitoring and checking

Manufacturer

can distribute and/or export in wholesale its own drug products and import raw materials for its own production

Maximum Drug Retail Price; MDRP

ceiling prices imposed for drugs and medicines sold in all retail outlets, whether public or private, pursuant to EO No. 821

drug establishments/outlets covered by EDPMS

comply strictly with the SOP in uploading/submitting reports to the EDPMS; attend trainings, workshops, meetings, or conferences related to the system implementation; register personnel who are authorized to use the system to PD and RO; report issues, concerns, or problems in the system implementation to the PD and RO

Monitoring Team

composed of personnel from PD, KMITS, and ROs

Electronic Drug Price Monitoring System; EDPMS

computer-based solution with functionalities to capture, process, store, and generate reports on essential drug companies, establishments, and outlets

latest transaction per item

data to be uploaded that is recorded during the month before the uploading month

Selling Price

data uploaded by all drug outlets and establishments

Inventory

data uploaded by all drug outlets and establishments EXCEPT manufacturers and manufacturer traders

Acquisition Price

data uploaded by distributors ONLY (importer, exporter, and wholesaler)

Pharmaceutical Division; PD

defines users authorized to use the system, define access level and permission rights, review, and approve request to access the system/data

Office for Health Regulation

develop appropriate mechanism that ensure all relevant policies and plans are implemented by ROs; resolve issues elevated to the Cluster on EDPMS; support technical assistance packages necessary to enhance capacity of the ROs and regional partners in providing assistance in the EDPMS to the LGU

Drug Outlets

drugstores, pharmacies or botica, including hospital pharmacy/dispensary, where registered drugs, chemical products, active principles, proprietary medicines, or pharmaceutical specialties and dental medicinal, galenical, or veterinary preparations are compounded and/or dispensed

Drug Establishment

either sole proprietorship, partnership, corporation, institution, association, or organization engaged in manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of drug products including facilities and installations needed for its activities

Toll Manufacturers

exempted to upload because they only process raw materials or semi-finished goods for another company

partnerships with research institutions, academe, and other pertinent agencies

forged for third party/external validation of the EDPMS data and analysis

Blacklisted Status

given due to consistent non-compliance with the uploading requirement to the EDPMS

Food and Drug Administration; FDA

investigate, prosecute, hear, and decide on administrative cases; validate submitted reports of violation, suspend/revoke LTOs and impose other appropriate sanctions; thru FDA Regional Office: issue written warning to non-complying facilities and submit list of non-complying facilities to the FDA Central Office

DOH Regional Offices

issue certificates of compliance signed by the RO Director for drug establishments;

Blacklisted Status

it will be lifted upon compliance

Electronic Drug Price Monitoring System; EDPMS

its primary aim is also to empower patients/customers in exercising intelligent choices when purchasing medicines from both public and private retail outlets

EDPMS

its primary aim is to address the information asymmetry in medicine price

list of medicines uploaded in the EDPMS

medicines listed in the formulary (PNF) and the PNF for Primary Health Care that the facility carries

medicines uploaded in EDPMS

medicines selected to address leading causes of mortality and morbidity in the country

April

month of the annual uploading into EDPMS for Luzon

January

month of the annual uploading into EDPMS for Metro Manila

October

month of the annual uploading into EDPMS for Mindanao

July

month of the annual uploading into EDPMS for Visayas

January, April, July, October

months for quarterly uploading schedule

Knowledge Management and Information Technology Service; KMITS

provide technical support in software maintenance, implementation, deployment, and operations; train the trainers from ROs and PD, and/or users on how to operate the software train System Administrators on mechanics of technical assistance, database administration, and other relevant tech support; monitor operations and performance of the system; generate reports regarding EDPMS implementation

Pharmaceutical Division; PD

provides direction and guidance; conducts orientation and trainings on matters related to the use or operation of the system; review and analyze reports of price information and review complaints/reports of violations; act appropriately on reported violation in coordination with ROs, OHR, FDA, and DOH-legal service; issue certificate of compliance; monitor and evaluate the system implementation based on reports of the monitoring team

Electronic Drug Price Monitoring System; EDPMS

provides essential medicines price information to patients and consumers to enable exercise of informed choice when purchasing medicines

Electronic Drug Price Monitoring System; EDPMS

provides the price information which the govt, shall use in developing pricing policies for medicines and in guiding the design of access programs (of DOH) and health benefit packages (of PhilHealth)

Certificate of Compliance to the EDPMS

requirement to all drug establishment owners who wish to participate in all government tendering activities for drugs and medicines

DOH AO 2018-0020

revised implementing guidelines on Electronic Drug Price Monitoring System (EPDMS)

list of medicines uploaded in the EDPMS

shall include drugs listed under the DOH mandatory and voluntary price reduction schemes (MRP, GMAP)

Blacklisted Status

shall not exceed one (1) year

Bids and awards Committees (of the DOH and its ROs) and PITC Pharma Inc.

shall require a certificate of compliance with the EDPMS for all suppliers participating in govt tendering and other modes of procurement

Pharmaceutical Division; PD

shall review and assess requests of other agencies, offices, units, departments, and other orgs to have access in the system; assign and issue appropriate access level and rights

Distributors, Importers, Exporters, and Wholesalers

shall upload through the EDPMS their purchase/acquisition price, selling price, and inventory data on a quarterly basis

Manufacturers and Manufacturer Traders

shall upload through the EDPMS their selling price based on the largest volume on a quarterly basis

sub-allotment of funds to ROs

source of fund for the EDPMS training, monitoring, and other activities and expenditures related to it; it is incorporated in the local health systems development

Manufacturer

this term shall not apply to the compounding and filling of prescription in drugstores and hospital pharmacies

Objective

to set guidelines for a more effective and efficient implementation of EDPMS