Guia Final da Lei de Segurança da Cadeia de Fornecimento de Medicamentos (DSCSA)

A falsificação de medicamentos é um problema global de longa data e talvez os EUA tenham a pior parte. De acordo com o PSI (Pharma Security Institute, Instituto de Segurança Farmacêutica), os casos de falsificação, roubo e desvio ilegal de medicamentos alcançaram a cifra recorde de 4.405 em todo o mundo em 2019, o dobro dos casos observados em 2014. A América do Norte teve o maior número de apreensões (1.750) devido a medicamentos falsificados durante o ano, seguida pela Ásia.

Para combater esse problema crescente e reforçar a segurança da cadeia de distribuição de medicamentos, a FDA apresentou a Lei de segurança da cadeia de suprimentos de medicamentos (DSCSA). Assinada pelo então presidente Obama em 27 de novembro de 2013, a lei segue um plano de implementação em fases durante 10 anos, com prazos de conformidade anuais. Já deixamos atrás alguns desses prazos custosos e desafiantes. No entanto, os mais complicados ainda estão por vir.

Se você faz parte do setor farmacêutico, compreender essa lei fundamental e suas implicações é essencial para avaliar a prontidão de sua organização perante a DSCSA.

Apresentamos a seguir um guia completo da DSCSA, com os principais prazos e exigências obrigatórias.

O QUE É A LEI DE SEGURANÇA DA CADEIA DE SUPRIMENTOS DE MEDICAMENTOS (DSCSA)?

Em 2004, o estado da Califórnia tomou as primeiras medidas para tornar os medicamentos que exigem receita médica seguros para os pacientes, sendo que a serialização estava no centro dessa iniciativa. Todos os fabricantes farmacêuticos e fornecedores do estado foram obrigados a serializar embalagens individuais e fornecer uma prova eletrônica da origem de cada produto que se movimentava pela cadeia de suprimentos.

A ideia por trás dessa iniciativa era facilitar a detecção de falsificações e iniciar retiradas caso necessário.

Após observar o sucesso do método na Califórnia, a FDA solicitou formalmente uma solução nacional para a falsificação de medicamentos na forma da Lei de segurança da cadeia de suprimentos de medicamentos (DSCSA).

Essencialmente, a lei estabelece exigências vitais para construir um sistema eletrônico para o rastreamento e identificação de medicamentos que exigem receita médica comercializados nos EUA. A lei prevê:

• O intercâmbio interoperável e eletrônico de declarações transacionais e informações transacionais entre membros de uma cadeia de suprimentos farmacêutica
• O rastreamento interoperável de declarações transacionais e informações transacionais até o fabricante de cada unidade comercializada
• A verificação interoperável do identificador do produto, incluindo número de série, número do lote, GTIN/NDC e data de validade.

O foco aqui está na interoperabilidade. A DSCSA busca proporcionar um fluxo de dados contínuo, seguro e confidencial entre parceiros comerciais.

WHAT IS 3T DOCUMENTATION?

In the pharmaceutical supply chain, all trading partners are licensed either by the FDA or a State Board of Pharmacy. Members of the supply chain can buy or sell products only to those parties with active licenses.

This effectively means that each partner in the supply chain is regularly evaluating the licenses of its customers and suppliers.

Along with the licenses, the seller must provide standardized transaction documents to their customers for each shipment. These documents include:

TRANSACTIONAL INFORMATION (TI)

This document describes the specifics of the current transaction. It includes:

• The name of the product
• Dosage and strength of the product
• NDC (National Drug Code)
• Lot number
• Date of transaction
• Date of shipment
• Container information
• Number of containers

If more than 24 hours have passed since the transaction date, the Date of shipment is to be included.

TRANSACTIONAL HISTORY (TH)

The TH outlines all the transactions a product has gone through, starting from the manufacture. This is essentially a bunch of TIs attached together for reviewing a product’s entire supply chain journey.

TRANSACTIONAL STATEMENT (TS)

The TS is a declaration confirming that the seller:

• Is authorized and registered
• Has received the product from a registered and authorized party
• Did not purposefully change the transaction history
• Did not purposefully ship any ineligible, counterfeit, or suspicious product
• Has acknowledged the transaction statement and information from the previous seller in the supply chain

WHAT ARE THE SERIALIZATION REQUIREMENTS UNDER DSCSA?

By November 27, 2020, all key players in the pharma supply chain, including repackagers, manufacturers, distributors, and dispensers, must generate, authenticate, and verify serial numbers for all packages traveling through the chain.

As for the serial numbers themselves, the Standardized Numeric Identifiers (SNI) must be generated as per the 2009 FDA directive.

SNIs consist of the 20-character NDC (National Drug Code) and serial number.  Apart from SNIs batch/lot number, Global Trade Item Number (GTIN), and expiration date are required.

Also, the smallest saleable unit needs to be packaged with a 2D Barcode Matrix with human-readable text. Shipping cases also require an SNI with a Serial Shipping Container Code (SSCC).

WHAT ARE THE AGGREGATION REQUIREMENTS UNDER DRUG SUPPLY CHAIN SECURITY ACT (DSCSA)?

DSCSA’s end goal is aggregation. What is it? With both drugs and transport units (bundle, pallets, and containers) serialized, a system of hierarchical serialization is achieved.

In a bundle of cartons carrying bottles, for instance, each bottle features a unique serial number, as does the carton. This forms an aggregate relationship between the carton and the bottle.

REASON FOR AGGREGATION

The hierarchical serialization makes it possible to identify items accurately in the supply chain and to detect suspicious activities. However, that’s not it.

Aggregation also confers time and cost-saving benefits on pharmaceutical manufacturers and packagers. For instance, repackagers don’t need to spend time scanning every smallest saleable unit, and can only scan the parent. This, naturally, results in substantial time savings.

REQUIREMENT AND TIMELINE

Pharmaceutical manufacturers and supply chain members must achieve complete, interoperable track-and-trace aggregation by November 27, 2023. However, it’s better to set things in motion early so you have enough time to resolve operational roadblocks and ensure smooth sailing.

HOW TO MANAGE DATA EXCHANGE WITH TRADE PARTNERS

Once the DSCSA is in full effect, serialization compliance will affect your business far beyond the production line. In reality, you will have to exchange data with different organizations, each with its own system and data formats.

To build such an interoperable system, you’ll need:

• Processes and systems to inspect the product down to the item-level
• Systems to reliably process transaction history
• To handle various file formats such as CSV, XML, EPCIS
• An interoperable tracing system
• Data exchange protocols such as EDI, SFTP, or APIs
• A system to exchange 3T documentation

Investing in intelligent supply chain software can help you achieve robust serialization, traceability, and aggregation capabilities and prepare you for the final DSCSA deadline.

EXEMPTIONS UNDER DSCSA

Not all medical products fall into the DSCSA jurisdiction. Here are some medical products exempt from the requirements of the Act:

• Intracompany distributions
• Distribution of product samples
• Distribution of over-the-counter drugs
• Medical convenience kits
• Anesthetics, Anti-coagulants, Vasopressor, IV solutions, Sympathomimetics
• Approved animal drugs
• Medical gas distribution
• Blood and blood components for transfusion

If you want to understand more and how to put the systems in place to meet these compliance requirements. Our expert will be more than happy to assist you.