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Medicines & Devices
The Dictionary of Medicines and Devices (dm+d) serves as the standard for the National Health Service (NHS) in the identification and description of medicines and medical devices. Two fundamental concepts within dm+d are "Actual vs Virtual" and the group encompassing "Therapeutic Moiety, Medicinal Product, Medicinal Product Pack." The integration of these concepts results in the formation of six distinct concept classes:
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Virtual Therapeutic Moiety (VTM): VTM is an abstract concept representing a medicinal substance without information about strength or form. It is applicable in dose-based prescribing in clinical practice, and chemical formulas or generic names can be used as VTMs.
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Actual Therapeutic Moiety (ATM): ATM refers to an actual physical product that is available for purchase.
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Virtual Medicinal Product (VMP): VMP is an abstract concept providing information about the strength and form of generic products without supplier or trade name details. In clinical practice, VMPs are utilized in generic product-based prescribing, and one VTM may have several associated VMPs.
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Actual Medicinal Product (AMP): AMP is an actual medicinal product made available by a manufacturer based on pharmacopeia. It contains information about the manufacturer and is used for both generic and branded medicines. One VMP may have multiple associated AMPs, and AMP represents exactly what is dispensed.
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Virtual Medicinal Product Pack (VMPP): VMPP is an abstract concept containing information about strength, form, and pack size. One VMP can have multiple associated VMPPs.
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Actual Medicinal Product Pack (AMPP): AMPP is the actual packaged product supplied, representing the tangible product dispensed. One AMP may have many associated AMPPs.
This comprehensive framework ensures standardized identification and prescribing practices for medicines and medical devices within the healthcare system, allowing for clear communication and understanding among healthcare professionals and organizations.
A batch refers to a product manufactured under specific criteria within controlled conditions and for a defined duration, quantity, volume, or time frame. It is a systematic approach to production, ensuring uniformity and adherence to predetermined standards. Within a batch, lots are created as subsets, allowing for more granular control and monitoring. This concept holds particular importance in Quality Failure Management, as batches enable systematic tracking and analysis of any deviations from quality standards. Additionally, the management of batches contributes significantly to reducing product expiry risks, as it allows for precise identification and handling of specific production sets. Moreover, it aids in minimizing mal-distribution issues, ensuring that products are distributed efficiently and according to predetermined criteria, thus maintaining product integrity and customer satisfaction. Overall, the careful consideration of batches is essential for maintaining high-quality standards, reducing the risk of expiration, and preventing distribution-related issues.