Drug Supply Chain Security Act (DSCSA) and Its Impact on Surgery Centers
Summary
To comply with the Drug Supply Chain Security Act (DSCSA), surgery centers must obtain a Global Location Number (GLN), which uniquely identifies their facility within the pharmaceutical supply chain. Wholesale distributors, such as AmerisourceBergen, can assist in this process.
Contact Your Wholesale Pharmacy: Start by reaching out to your account representative at AmerisourceBergen or another wholesaler. They can guide you on the requirements for obtaining a GLN and help determine if your facility is already assigned one.
Register with GS1: GLNs are issued by GS1, an international standards organization. If your surgery center doesn’t already have a GLN, AmerisourceBergen can provide assistance or resources to help with the registration process through GS1.
Integration with Wholesaler Systems: Once the GLN is obtained, it must be integrated into the wholesaler’s system to ensure that your facility is properly identified during all transactions. This is essential for meeting DSCSA traceability and compliance requirements.
Streamlining Compliance: By working with a wholesaler like AmerisourceBergen, the process of registering, managing, and using a GLN is made more straightforward. The wholesaler can also help facilitate electronic data exchange, simplifying DSCSA compliance.
Using a GLN through a wholesale pharmacy partnership improves transparency, ensures compliance with DSCSA, and enhances the efficiency of drug tracking and verification processes.
What is the DSCSA?
The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to create a secure pharmaceutical supply chain by enhancing traceability, ensuring the integrity of prescription drugs, and preventing counterfeit medications from reaching patients. Under the DSCSA, all entities in the pharmaceutical supply chain, including manufacturers, wholesalers, and dispensers like surgery centers (ASCs), must comply with certain requirements by November 2024. This regulation aims to protect patients by improving the security and transparency of the drug supply chain.
How Will the DSCSA Affect Surgery Centers?
Surgery centers are classified as 'dispensers' under the DSCSA. While ASCs are not major players in the pharmaceutical supply chain, they are required to comply with specific regulations to ensure drug safety and traceability.
Key Requirements for Surgery Centers
1. Verification of Trading Partners
- ASCs must ensure that all drugs they receive are from authorized trading partners—entities that are licensed or registered under federal or state law. This ensures the legitimacy and safety of all products purchased.- To verify their trading partner status, ASCs need to provide their Global Location Number (GLN), which serves as a unique identifier for their facility.
2. Transaction Documentation
- Surgery centers must receive and maintain detailed transaction information (TI), transaction history (TH), and transaction statements (TS) for all prescription drugs received. - Transaction Information (TI): Includes details about the drug, like lot number, product identifier, and shipment details. - Transaction History (TH): A record of all previous transactions involving the drug, tracing it back to the manufacturer. - Transaction Statement (TS): A declaration from the seller that they have followed DSCSA requirements.- These records must be kept for six years and be easily accessible for audits or verification requests.
3. Handling of Suspect or Illegitimate Products
- ASCs must establish procedures to identify, report, and handle suspect or illegitimate products (e.g., counterfeit or tampered drugs).- If an ASC identifies a suspect product, it must quarantine the drug, notify trading partners, and report to the FDA if necessary.
4. Product Tracing
- Surgery centers must have a system in place to track drugs, ensuring they can verify product identifiers and retrieve transaction records when needed. Implementing electronic systems for tracking drugs can be essential for compliance.
5. Staff Training and Written Procedures
- ASCs should train staff who handle medications and ensure they are familiar with DSCSA requirements.- Written policies must be developed to cover procedures for verification, receiving drugs, handling suspect products, and ensuring traceability.
Obtaining a Global Location Number (GLN)
Steps to Obtain a GLN for a Surgery Center
1. Register with GS1: (this costs $$$)- GLNs are issued by GS1, an international standards organization.- To obtain a GLN, register with GS1 through your local GS1 member organization. For example, in the U.S., contact GS1 US via [www.gs1us.org](https://www.gs1us.org).
2. Work with Your Wholesale Pharmacy: (this can be for free!)- Wholesale distributors, such as AmerisourceBergen, can assist with obtaining or utilizing a GLN.- Contact your account representative at AmerisourceBergen to discuss your needs regarding DSCSA compliance. They can help determine whether you need to obtain a GLN or if your facility is already identified within their systems.- AmerisourceBergen may also provide support and resources to assist in the registration process with GS1 and ensure your GLN is integrated into their records.
3. Pay Registration Fees:- Registering with GS1 typically involves paying a registration fee, which may vary based on the number of GLNs required or your location. GS1 US offers different pricing models for issuing GLNs.
4. Receive and Use Your GLN:- After registration, GS1 will issue your GLN. This number is unique to your facility and is used to identify your surgery center in transactions, particularly when purchasing or transferring medications.- Provide your GLN to AmerisourceBergen or other trading partners to update their systems, ensuring smooth transactions and compliance with DSCSA requirements.
Medication Transfers Between Surgery Centers
If two ASCs under the same corporate ownership need to transfer medications, the process must comply with DSCSA standards:
Documentation Requirements
- Each medication transfer must be documented with TI, TH, and TS records, which should accompany every transfer.- The GLNs for both the sending and receiving centers should be included in the records to maintain transparency and traceability.
Intra-Company Transfers
- Intra-company medication transfers are generally allowed if both facilities are authorized as dispensers. Ensure compliance by retaining all relevant documentation and adhering to DSCSA standards.
Practical Steps for Surgery Centers to Comply with DSCSA
1. Audit Suppliers: Verify that all suppliers are registered trading partners by checking licensing information.2. Register for a GLN: Obtain a GLN through GS1 and work with your wholesale distributor to integrate it into transactions.3. Establish Documentation Procedures: Create and maintain transaction records (TI, TH, TS) for at least six years, including information for medication transfers.4. Handle Suspect Products: Have procedures in place to identify, report, and manage any suspect or illegitimate drugs.5. Train Staff: Ensure that your staff members are trained on DSCSA requirements, including documentation processes and how to handle suspect products.6. Consider Technology Solutions: Implement an electronic system to help manage and track medications, supporting compliance with DSCSA requirements.
Conclusion
The DSCSA imposes specific requirements on surgery centers to enhance drug traceability, safety, and compliance. These include verifying trading partners, documenting transactions, and obtaining a Global Location Number (GLN) to ensure traceability. By working closely with wholesale distributors like AmerisourceBergen, ASCs can simplify the process of obtaining and managing a GLN, streamline drug transactions, and meet DSCSA requirements effectively.
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