USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM Procurement and Supply Management Implementation of Global Standards for Traceability in Global Health
Lack of standards in daily life is inefficient and annoying… USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 2
..in healthcare, it is inefficient and dangerous! USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 3
Inconsistent identifiers necessitate slow and manual mapping exercises System Type Item ID Item Name for 2-Rod Implant(s) Country A - Warehouse PRH0010 Jadelle 2x75mg rods, Pack of 10 Pairs Management System Country A - Internal Stock FP003700 Jadelle implant (levonorgestrel 75mg) (Piece) Report Country A - LMIS NA Jadelle, Implant set Country B - Drug Register 3085 Indoplant (Contraceptive Implant) / Levonogestrel 75mg 4439 Zarin Sino II Implant / Levenorgestrel 75mg Country B - LMIS RH0025 Trocar, Sterile For Jadelle Insertion / Pack of 10 RH0005 Levonogestrel Implant Contraceptive 10 rods, 750mcg/rod, Sub-dermal / 1 Implant Procurer A 100130GYV01S03W (English/Spanish), Levonorgestrel 75 mg/Rod w/ Trocar, 5 Year Efficacy, 2 Rod Implant, 1 Each [Bayer] [Jadelle] / 100130GYV01S08P (English/French) English/Spanish 103915GYV01S2C7 (English/French) Levonorgestrel 75 mg/Rod w/ Trocar, 3 Year Efficacy, 2 Rod Implant, 1 Each [Shanghai Dahua] 103915GYV01S2CA (English/Portuguese) [Levoplant] 103915GYV01S2CB (NAFDAC) 103915GYV01S2CC (Tailored PIL) 103915GYV01S2CD (Zambia Registration) Procurer B LNG_IMPL_75MG Levonorgestrel 75mg x 2 Donor Coordination Tool 1001 Levonorgestrel 75mg/rod, 2 Rod Implant, 3 Year Efficacy 1002 Levonorgestrel 75mg/rod, 2 Rod Implant, 5 Year Efficacy USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 4
Manual entry causes delays and mistakes Manual vs automated data entry 1 keystroke (input) error in every 300 to 500 keystrokes versus 1 error in 350,000 on the low end (linear symbology) …to… 1 error in 10,500,000 on the high end (2D/Matrix symbologies) 5 USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
GS 1 is a system of global standards to enable traceability USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
What do we seek to achieve through implementing global data standards? Vision To enable identification of every item procured at every point in the supply chain, through administration to the patient Goal To enable a secure and efficient supply chain from source through to service delivery Objectives • To enable end-to-end data visibility and traceability • To identify and implement supply chain efficiencies • To ensure supply chain security • To increase patient safety USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
Implementing traceability is a complex endeavour Governance & Advocacy Regulatory & Policy Supply Chain Operations Systems & Technology Service Delivery USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
GHSC- PSM’s leadership in global standards & traceability Global Supply Chain Mandated standard identification, labeling, and master data synchronization for all pharmaceuticals, medical devices, sterile kits, and reagents Donor Coordination Convened a global health donor working group to build consensus and align requirements between procuring organizations Country Implementation Developed a set of frameworks and tools to aid stakeholders in planning and implementing a successful traceability vision USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 9
Compliance requirements in the USAID/GHSC-PSM supply chain Phase 1 Phase 4 Phase 2 Phase 3 30 Dec 20 1 8 30 June 2020 30 June 2022 GS 1 Data Matrix or GS 1 - 1 28 Homogenous barcode also encoded with Trade Item (21) Serial Number • GS 1 Data Matrix or GS 1 - 1 28 barcode Homogenous encoded with: TERTIARY Mixed or Partial GS 1 - 1 28 barcode encoded with: Trade Item • (0 1 ) GTIN Trade Item • (00) SSCC PACKAGING • ( 1 0) Batch/lot 30 Dec 20 1 9 • ( 1 7) Expiration Date GS 1 - 1 28 barcode encoded with: Logistic Unit • (00) SSCC GS 1 Data Matrix also SECONDARY GS 1 Data Matrix Trade encoded with: encoded with: Item PACKAGING Trade • (2 1 ) Serial Number • (0 1 ) GTIN Item • ( 1 0) Batch/lot • ( 1 7) Expiration Date GTIN for each unit of Trade Items measure Identify Items and locations Pharmaceuticals MASTER All item master data Trade Medical Devices, Sterile Kits & DATA submitted through Capture data in barcode label Item Laboratory Reagents the GDSN* • (4 1 6) GLN Sold- Share data with trading partners From • (4 1 5) GLN Locations Invoice-From • (4 1 4) GLN Production USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 10
Standardized identifiers available on product today USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 11
Joint donor guideline • Single primary reference document for technical requirements to meet requirements for implementation of global standards for product and location identification, labeling, and data exchange • Endorsed by the Global Drug Facility/StopTB, Global Fund, UNDP, UNFPA, and USAID USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 12
International procurement agency timelines – pharmaceuticals & vaccines Agency Phase 1 Phase 2 Phase 3 Phase 4 Global Drug Facility 31 Dec 2019 31 Dec 2019 30 Jun 2020 30 Jun 2022 The Global Fund 31 Dec 2019 31 Dec 2019 30 Jun 2020 30 Jun 2022 UNDP Voluntary but preferred UNFPA 31 Dec 2019 31 Dec 2020 Voluntary but preferred USAID GHSC-PSM 30 Dec 2018 30 Dec 2019 30 Jun 2020 30 Jun 2022 USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 13
GHSC-PSM global approach The “ Why ” The “ What ” The “ How ” Awareness and Architecture Vision and Strategy Implementation Plan Advocacy Use a management tool that Develop data and system Develop a declaration of details the critical steps, Raise awareness of global models to enable the reason for milestones, and resources standards and traceability implementing traceability, implementation of the required to execute on the and what it takes for establish short-term and stated vision. strategy. implementation. long-term objectives and goals, and identify what Policy strategic initiatives need to be undertaken to launch the work. Define and develop policies that enable implementation of the stated vision. USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 14
There are different approaches to achieving these objectives Safe and Secure Supply Chain Is the chain-of- Is the item to be custody or chain-of- dispensed/used ownership of the genuine? item intact? Verification Traceability Verify Item Authenticate Item Track Item Trace Item Is the item identifier valid? Does the item have the expected Where is the item now, and where Where did the item come from, overt or covert security features? is it going? and who had custody/ownership of it? Content Source: GS1 Global Office USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
Illustrative example only Each country will develop an implementation plan based on their vision and strategy Illustrative implementation roadmap G Traceability Event-based Data Exchange E C Logistic Unit Identification, Labeling, and Scanning Trade Item Barcode Labeling and Scanning A Trade Item and Location Identification Verification Serial Number Management Transaction Data Exchange F D Master Data Management B USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management 16
Accompanied by capabilities matrix for each road marker USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
USAID / GHSC-PSM technical assistance footprint USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management *2019 still tentative
Traceability supports a number Patient Supply Chain Supply Chain Data Security Efficiency Safety Visibility of supply chain objectives SF or stolen product detected in the legitimate supply chain ADDRESS Theft or diversion of products from the legitimate supply chain SF or stolen product that is obtained by the patient/end user Accuracy and efficiency of procurement operations Efficiency of “reverse” logistics processes (e.g. , those used for returns, recalls) Visibility of product “status” (e.g., expiry, recalls) IMPROVE Efficiency of inventory management and distribution Efficiency of payment and payment monitoring processes Pharmacovigilance and control of treatment outcomes Visibility into where the product is within the supply chain ENABLE Visibility to decrease or eliminate reimbursement fraud Harmonized trade/customs clearance procedures for pharmaceutical products Content Source: GS1 Global Office USAID GLOBAL HEALTH SUPPLY CHAIN PROGRAM - Procurement and Supply Management
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