Mauricio Monsalvo, Executive Coordinator
REMEDIAR, Ministry of Health
Argentinian Rupublic
Implementation of
traceability in a public drug
supply policyChallenges and opportunities from Remediar, Arg.
Day 3: Thursday 22 October , 2015.-
© GS1 2015
Context Implementation
2
Argentine health
system
• High consumption of drugs: 63% (27,7 M) of the population consume drugs every month.
• Federal division: 24 provinces provide Health Service. The Federal Government finances (partly) the supply of the drugs.
• Public heath centers produces 58,5 M of patients visits to physicians and 19 M of prescriptions.
• Dispensing points: 5.758 Primary healthcare Centers, 477 Hospitals and 115 others. Receiving points: 93 local warehouses
© GS1 2015
Context Implementation
3
Argentine health
system
• High consumption of drugs: 63% (27,7 M) of the population consume drugs every month.
• Federal division: 24 provinces provide Health Service. The Federal Government finances (partly) the supply of the drugs.
• Public healthcare centers produces 58,5 M of patient visits to physicians and 38 M of prescriptions
• Dispensing points: 5.758 Primary healthcare Centers, 477 Hospitals and 115 others. Receiving points: 93 local warehouses
© GS1 2015
Context Implementation
4
Argentine health
system
• High consumption of drugs: 63% (27,7 M) of the population consume drugs every month.
• Federal division: 24 provinces provide Health Service. The Federal Government finances (partly) the supply of the drugs.
• Public healthcare centers produces 58,5 M of patient visits to physicians and 38 M of prescriptions
• Dispensing points: 5.758 Primary healthcare Centers, 477 Hospitals and 115 others. Receiving points: 93 local warehouses
© GS1 2015
Context Implementation
5
Pharmaceutical
Industry: traceability
• More than 250 nationalpharmaceutical manufactures (1% global market and 4to. LATAM market)
• ANMAT (Federal Agency) regulatesthe pharmaceutical activities.
• Requirement of batch number recorded in all the Commercial Documentation among wholesalers and public providers.
• In 2011, a Track & Trace Systemthat allows to establish and record the way followed by a particular retail unit from its manufacture to its final destination was implemented.
© GS1 2015
How REMEDIAR works?
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Selection
• 79 items included in List of Essential Medicines for Primary Healthcare Providers for 16 M.
• Selected drugs (mostly high cost) by vertical healthcare programs:
- IHV/AIDS, Hepatitis: 81 items for 43.000 people;
- TB, Leprosy, Chagas: 23 items for 12.400 people;
- Transplants: 9 items form 4.000 people;
- Sexual Healthcare: 6 items for 800.000 females.
- 19 vaccines for 40 M Argentinians.
- And so on…
Selection
Procurement
Distribution
Utilization
© GS1 2015
Selection
Number of items by
tracking type
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Operation
• The Ministry of Health purchase and delivery using REMEDIAR channel 191 drugs.
• In 2011, 58 items was involved by Tracking Act.
• In 2014, 49,8 M pharmaceutical units were processed:
- 9,7 M batch every month (onaverge).
• 74 items required tracking byserial code number.
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40
80
120
160
200
2002 03 04 05 06 07 08 09 10 11 12 13 14 2015
Serie
Lote
+400%
© GS1 2015
How REMEDIAR works?
8
Procurement
• Centralized acquisition by ICD (international common denomination).-
• Technical Specifications of packaging defined by clinical treatment criteria, not tradable.
• 98% in values purchased to local providers (manufacturers).
• Suppliers are selected by technical skills (GMP) and awarded by lower prices.
Selection
Procurement
Distribution
Utilization
© GS1 2015
Acquisition process
9
Key tools
(mandatory)
• With GS1 Arg we elaborated a Guide to Identifying Products and it was incorporated to the bidding process.
• Elaboration of Manual Arts and Styles in order to standardize the packaging.
• Incorporation of GTIN codes for tenders to optimize inventory management.
• Starting of negotiations for incorporation of EDI (!!!).
© GS1 2015
Acquisition process
10
Key tools
(mandatory)
• With GS1 Arg we elaborated a Guide to Identifying Products and it was incorporated to the bidding process.
• Elaboration of Manual Arts and Styles in order to standardize the packaging.
• So, we incorporated GTINscodes for tenders to optimize inventory management.
• We are moving forward to incorporation of Electronic Data Interchange (EDI!!!).
© GS1 2015
Labels & Data Carriers
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(01)07790001000019
(10)ABC123456
(17)31/12/20
(90)REME001
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GTIN: 07798030232746
(02)07790001000026(17)30/06/20
(37)900
(10)279(90)REME002
NOMBRE GENERICO DEL PRODUCTO
Forma farmacéutica y concentración de los principiosactivos. N° de Registro Sanitario. Número de lote opartida. Fecha de vencimiento. Condiciones de conservación. Temperatura. Nombre del laboratorio elaborador y/o importador.Cantidad de envases secundarios por pallet. País de procedencia. Director Técnico.Indicar ubicación del código de barras
Medicamento gratuito – Su venta será penada
Ministerio de Salud de la Nación
Fecha de Vencimiento: 30/06/20
Código Remediar E.S. : REME002
Lote: 279
Cantidad de E.S. : 900
GTIN Packs: 07790001000026
SSCC: 077900010000000026
(00)077900010000000026
SSCC
CONTIENE PRODUCTOS CON TRAZABILIDAD POR N° DE SERIE
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© GS1 2015
How REMEDIAR works?
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Distribution
• Centralized reception (many
REMEDIAR) of tertiary package and pallets (using SSCC) one-product one-batch, certified by ISO standards.
• Storage and inventory management.
• Preparation of 30.000 kits composed by multi-items multi-batch every month (using SSCC).
• 11 deliveries annually direct to healthcare providers and local warehouse (REMEDIAR n),
(using GNL)
Selection
Procurement
Distribution
Utilization
© GS1 2015
Distribution process
Millions of
pharmaceutical units
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40
60
80
100
120
140
160
180
200
0
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10
15
20
25
30
35
2003 04 05 06 07 08 09 10 11 12 13 14 2015
No trace
Serial
Batch
6,4 M retail units tracking by unambiguous code.
Distribution
• Centralized reception (many
REMEDIAR) of tertiary package and pallets (using SSCC) one-product one-batch, certified by ISO standards.
• Storage and inventory management.
• Preparation of 30.000 kits composed by multi-items multi-batch every month (using SSCC).
• 11 deliveries annually direct to healthcare providers and local warehouse (REMEDIAR n),
(using GNL)
© GS1 2015
Distribution process
14
Key tools
• An evaluation was conductedusing GS1 GTSH for processimprovement (2012: 32%
2014: 94%).
• Incorporation of technology and improvement of the information system for the management information supply chain (tracking)
• Incorporation of Standards and Technology capture.
• KPIs in elaboration process.
© GS1 2015
Global Traceability ConformanceHealthcare
15
Compliance Non-Compliance
2012 32 65
2014 94 3
MandatoryMandatory
(Cond.)Optional Recommended
100 100 80 97
SI SI SI SI
Audits
© GS1 2015
Distribution process
16
Key tools
• An evaluation was conductedusing GS1 GTSH for processimprovement (2012: 32%
2014: 94%).
• Incorporation of technology and improvement of the information system for the management information supply chain (tracking)
• Incorporation of Standards and Technology for capture.
• KPIs in elaboration process.
© GS1 2015
Distribution process
17
Key tools
• An evaluation was conducedusing GS1 GTSH for processimprovement (2012: 32%
2014: 94%).
• Incorporation of technology and improvement of the information system for the management information supply chain (tracking)
• Incorporation of Standards and Technology capture.
• We are moving forward to incorporation of KPI.-
© GS1 2015
How REMEDIAR works?
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Utilization
• 1 of 2 ambulatory patients received a prescription in Primary Care: 88% obtained his/her medicines for free.
• 9000 doctors were trained in a Rational Use Trained Program.
• 21 millions of prescriptions were registered in paper support in 2014, but…
• In this year, 1200 healthcare providers were equipped with a computer and an optical capture device.
• Ongoing challenges involved patient compliance and promotion of rational consumption.
Selección
Adquisición
Distribución
Utilización
© GS1 2015
Utilization
19
Key tools
• A soft to the electronic recording of the dispensed using identification standards (datamatrix) was developed.
• Allows defining alert systems for chronic, pregnant women assisted with contraceptives, among others.
• Training materials for the health team and delivering of useful information to the community.
© GS1 2015
Main Conclusions
• Management of drug supply chain in the Public Sector requires a
strong partnership with the Private Sector: The use of standards
and quality certified process (ISO-like) play a critical role to
strengthen this relationship.
• For both Public and Private operators, compliance with
regulations designed to ensure the legality of all transactions in
the supply chain seems to be possible.
• It is necessary to investing in technology and training at local
level (Healthcare Providers) to ensure proper dispensation,
because it allows: patient safety, developing of warning
systems, monitoring, identification of drugs interactions, cost
reduction, etc
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© GS1 2015
Thank you!
Contact Information
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+54 (0)11 4382 0553
www.remediar.msal.gov.ar
+54 (0)11 4382 0206
Mauricio Monsalvo, Executive Coordinator
Programa REMEDIAR
Secretaría de Salud Comunitaria
Ministerio de Salud, Av. 9 de Julio 1925
Ciudad de Buenos Aires (Argentina)
T
T
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Remediar @RemediarNacion