Balancing Safety and Efficiency: Construction and Justification of a Tiered Batch-Number Management Model for Specially Controlled Drugs in Medical Institutions

DOI: https://doi.org/10.62517/jmpe.202618501

Author(s)

Dan Liu

Affiliation(s)

First Affiliated Hospital, Army Medical University of the Chinese People's Liberation Army, Chongqing, China

Abstract

The clinical value of the special controlled drug, such as narcotic drugs, psychotropic drugs, medical toxic drugs and pharmaceutical precursor chemicals are of great importance and they are also at high risk of abuse and diversion. The batch number (lot number) control is the most effective system that can be used to ensure traceability of all the processes in the whole production process and to reduce the risks of management. In China, the homogenous model of full batch number, full process, uniform standard is being used by the medical institutions when it comes to all the special controlled drugs. This is a safety-based model which is expensive in terms of administration, not efficient enough in terms of operations, and does not align with the amount of resources available versus the level of risk incurred. Based on the concept of risk stratification and experience of other countries in terms of control of controlled substances in terms of addiction potential, harm of abuse, frequency of use of drugs in clinical practice, and possibility of circulation of the drug, this paper will consider these four parameters as the key dimensions and develop a three-level system of batch-number management. Level 1: High-risk medicines must be traced in one unit and processed in full; Level 2: Medium-risk medicines must be tracked through its key nodes; and Level 3: Low-risk medicines must be managed through the summary of the batches. The model is analyzed in a systematic manner through three dimensions, regulatory compliance, scientific rationality and industrial adaptability. The findings show that the model maintains the regulatory safety baseline, matches control intensity to risk, encompasses all types of special controlled drugs, and at the same time ensures full traceability, but maximizes resource use and enhances clinical efficiency. It provides a theoretical framework and practical solution that can be replicated to achieve refined management of special controlled drugs in medical institutions.

Keywords

Narcotic Drugs; Class I Psychotropic Drugs; Class II Psychotropic Drugs; Toxic Drugs; Precursor Chemicals; Batch Number Management; Tiered Management; Risk Control

References

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