How Scan Plus is Enhancing Patient Data Management in Healthcare

In today's complex healthcare environment, preserving the integrity of medications is the primary concern for patient safety. The negative impacts of the rise of counterfeit medicines include inadequate care and severe health issues. This issue has been addressed through the implementation of regulatory measures such as the Falsified Medicines Directive (FMD), which requires advanced solutions for managing and distributing patient information. Supporting compliance with these regulations, Scan Plus provides robust pharmaceutical serialization and anti-counterfeit solutions that streamline processes for Contract Manufacturing Organizations (CMOs) and Marketing Authorization Holders (MAHs).

The Challenge of Counterfeit Medicines

Falsified drugs have become a global issue, with the World Health Organization estimating that about 10% of drugs worldwide are counterfeit. Falsified drugs undermine trust among patients and lead to unsafe medicinal products on the market. The Falsified Medicines Directive was established to combat this by requiring unique identifiers and tamper-evident features on prescription drugs. The directive ensures that genuine drugs reach patients, thereby protecting public health.

Scan Plus: A Comprehensive Solution

Scan Plus offers a suite of features designed to enhance patient data management and ensure compliance with global regulations:

  • Prevent Counterfeiting: By implementing robust serialization processes, Scan Plus guarantees the safety of distribution channels, effectively safeguarding against counterfeit drugs.
  • Boost Efficiency: The platform simplifies operations by fostering seamless collaboration between MAHs and CMOs, enhancing overall productivity.
  • Stay Globally Compliant: Scan Plus adheres to major regulatory standards, including those outlined in the Falsified Medicines Directive, ensuring that all processes meet international compliance requirements.
  • Tailored for CMOs: Recognizing the unique needs of CMOs, Scan Plus provides customized solutions that facilitate smooth onboarding and integration.

Real-World Impact

Consider a mid-sized pharmaceutical company that faced challenges navigating the complexities of the Falsified Medicines Directive. The risk of counterfeit medications entering the supply chain increased as manual procedures for data handling and serialization proved not only time-consuming but also susceptible to errors. The company underwent a complete transformation with the introduction of Scan Plus:

  • Enhanced Serialization Management: The intuitive interface allowed for effortless handling of products, batches, and serial numbers, providing end-to-end visibility.
  • Flexible Data Submission: With support for various formats like Direct Access (DA), shipment, and end-of-batch files, workflows became more streamlined.
  • Seamless EU Serialization: Integration with Topia EU-Serialization provided advanced functionality, ensuring compliance with EU regulations.

This implementation not only strengthened the company's defense against counterfeit medicines but also optimized its operational efficiency, ultimately contributing to improved patient safety.

The Importance of Compliance and Collaboration

In the battle against counterfeit medicines, regulatory compliance, such as the Falsified Medicines Directive, is non-negotiable. Scan Plus simplifies compliance by delivering comprehensive reporting and secure audit trails to meet stringent regulatory requirements. Moreover, the platform enhances communication between MAHs and CMOs by consolidating product, batch, and serial number data, creating the transparent environment necessary for preserving the integrity of the pharma supply chain.

Conclusion

The spread of counterfeit drugs poses a severe threat to patient safety and public health. Solutions like Scan Plus are critical for improving patient data management by implementing strong pharmaceutical serialization and anti-counterfeit measures. By facilitating compliance with global regulations and efficiently orchestrating operations for MAHs and CMOs, Scan Plus plays a vital role in delivering genuine medicines to patients, thus maintaining the integrity of the healthcare system.

FAQs

Pharmaceutical serialization involves assigning a unique identifier to each medicine package, allowing for tracking and verification throughout the supply chain. It is crucial for preventing counterfeit medicines from reaching patients and ensuring compliance with regulations like the Falsified Medicines Directive.

Scan Plus implements robust serialization processes that enable the verification of each medicine's authenticity, effectively identifying and preventing the distribution of fake drugs.

MAHs are responsible for ensuring that the medicines they market comply with regulatory standards and are free from counterfeit products. They collaborate with CMOs and utilize tools like Scan Plus to maintain the integrity of the supply chain.

The Falsified Medicines Directive mandates that pharmaceutical companies implement safety features like unique identifiers and tamper-evident packaging to prevent counterfeit medicines from entering the supply chain, thereby ensuring patient safety.

Yes, Scan Plus offers tailored solutions that facilitate smooth onboarding and integration, accommodating the unique requirements of various CMOs.

Scan Plus adheres to major regulatory standards, including the Falsified Medicines Directive, and provides comprehensive reporting and secure audit trails to meet international compliance requirements.

References

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