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Question: What are the practical operability of PV risk control measures, especially special risk control measures?
Answer: Conventional risk control measures include but are not limited to: 1. Revise drug instructions, labels, and packaging. 2. Change the drug packaging specifications. 3. Change the status of drug management. Such as legal status, restricted medical prescriptions, etc. For some important risks, it may be necessary to implement additional risk control measures when conventional risk control measures are insufficient to solve the problem. Additional risk control measures include but are not limited to: 1. Carry out communication and education between medical staff and patients: This part is a supplement to the instructions, labels, and packaging, aimed at positively influencing medical staff and patients to promote risk minimization and improve drug use efficiency. Educational materials can be designed separately according to different audiences and distributed through various media and channels, and cannot be used for promotional activities. 2. Restrictions on drug use: For example, patient registration: Patient registration is a type of accessibility control plan that achieves detailed follow-up procedures for patient systems by inputting specialized data collection systems. 3 Emergency control measures: such as suspending drug production, sales, and recalling products Reference: GVP Chapter 6 Section 1