Implementation of traceability in a public drug supply … · Implementation of traceability in a public drug supply policy Challenges and opportunities from Remediar, Arg. Day 3:

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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160

200

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Serie

Lote

+400%

© GS1 2015

How REMEDIAR works?

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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

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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

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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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120

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160

180

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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

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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

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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

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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

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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

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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

[email protected]

+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)

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Remediar @RemediarNacion