Healthcare professionals, regulators, and distributors should take note of a critical update related to Relonchem Ltd products. The company has disclosed that certain medicines, including Losartan potassium/Hydrochlorothiazide coated tablets and specific Risperidone products, have been assigned duplicate GTIN and EAN numbers due to an error. This situation may impact supply chain operations and patient safety.
- What changed?
- Who is affected?
- Regulatory considerations
- FAQs
- Conclusion
- Disclaimer
- Announcement link
What changed?
Relonchem Ltd has notified the Medicines and Healthcare products Regulatory Agency (MHRA) of a significant labeling concern involving duplicate Global Trade Item Numbers (GTIN) on some Losartan potassium/Hydrochlorothiazide coated tablets. Similarly, duplicate European Article Numbers (EAN) have been identified on certain batches of Risperidone. Such duplications introduce confusion within inventory management systems, potentially leading to unintended patient risks. The notification, classified as a Class 4 medicines defect, advises relevant stakeholders to assess potential disruptions in product identification and handling processes.
Who is affected?
This issue primarily impacts clinical teams, quality assurance professionals, regulatory affairs departments, and supply chain managers within healthcare and pharmaceutical organizations. Distributors and pharmacies that use automation systems or rely heavily on GTIN and EAN codes for product identification may face operational challenges. Patients may also indirectly encounter risks of delays or errors in dispensing affected medications.
Regulatory considerations
Implications for compliance
Mistakes in product labeling can raise red flags concerning compliance with regulatory standards, such as those outlined in the EU Medical Device Regulation (MDR) and Good Distribution Practices (GDP). Regulators and manufacturers must address labeling errors promptly to ensure consistent product identification, which is crucial for safety and traceability.
Manufacturer action
In its communication to the MHRA, Relonchem Ltd has acknowledged the issue. Regulators and stakeholders are advised to monitor and mitigate risks associated with mislabeled or duplicate codes. Although sufficient steps may be taken by the manufacturer, it is vital for healthcare providers and distributors to remain vigilant to avoid patient safety concerns.
FAQs
1. What are GTIN and EAN numbers?
GTIN numbers, or Global Trade Item Numbers, are unique identifiers used to manage, store, and track product information globally. EAN numbers, or European Article Numbers, are a type of GTIN widely used within Europe for product tracking and identification.
2. Why do duplicate codes matter?
Duplicate codes create confusion in inventory tracking systems and increase the risk of mix-ups in dispensing medications. This could lead to operational inefficiencies and, in worst-case scenarios, patient harm.
3. Is there any immediate action required from healthcare teams?
Healthcare organizations should review their inventory systems and consult MHRA guidelines. Distributors are recommended to flag and isolate potential products impacted by these duplicate codes.
4. Where can I find additional information on this notification?
Further details are available on the MHRA drug safety alert page. Click the provided link below for complete access.
Conclusion
Relonchem Ltd’s duplicate GTIN and EAN numbers on specific medicines have triggered a Class 4 medicines defect notification. Healthcare and regulatory professionals must address inventory management challenges and evaluate potential impacts on dispensing processes. Stakeholders are urged to consult the relevant authorities and follow the official guidance to mitigate associated risks.
Disclaimer
All information in this article is provided for professional and informational purposes only and does not constitute legal or regulatory advice.
Announcement link
For full information about the announcement, see the link below.