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