Saturday, July 13, 2024

Anvisa Approves National Prescription Control System to Enhance Safety and Traceability of Controlled Drugs

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The Board of Directors of National Health Surveillance Agency (Anvisa) has approved a new regulation establishing the National Prescription Control System (SNCR). This new system aims to improve the allocation and control of prescription numbers for medications and products subject to special control (controlled drugs). The resolution, RDC 873/2024, was published in the Official Gazette of the Union on June 3, 2024.

Anvisa will provide sanitary authorities with an online platform to allocate numbers for notifications used by prescribers. These numbers will come from a single national database, ensuring that are valid throughout Brazil, regardless of the state in which they were issued, as stipulated by Law 13.732/2018.

Sanitary authorities will continue to be responsible for granting and controlling these numbers, now with the added benefit of an online tool for automated management. This system will enhance the traceability and origin identification of all prescription notifications, bringing greater security for pharmacists during medication dispensation and helping prevent fraud and forgery.

Anvisa to Launch SNCR System for Prescription Number Control by 2025

It is important to note that the SNCR will not function as an electronic prescription issuance platform but will solely provide and control the numbering. The system was developed and tested with input from sanitary authority representatives, coordinated by Anvisa’s Sanitary Surveillance Working Group. The proposal underwent Public Consultation 588/2018 and directed consultations with the National Sanitary Surveillance System (SNVS).

Once the SNCR is available, sanitary authorities can begin using it to issue new prescription numbers by the end of 2024. From January 1, 2025, using the system will be mandatory for all sanitary authorities. To support the implementation, Anvisa will conduct training sessions and webinars with state and Federal District (DF) sanitary authorities and publish a comprehensive manual on the agency’s website.

Printed prescription booklets without SNCR-issued numbers will be valid until January 1, 2025, with a two-year transition period for gradual replacement. There are no changes to the procedures for prescribers to request prescription numbers or booklets, which will continue to follow established regulations.

Prescription

Anvisa Enhances Control Measures for Controlled Substances with New System

Ordinance SVS/MS 344/1998 outlines control measures for narcotics, precursors, psychotropics, and other substances under special control. The regulation mandates various types of controlled prescriptions based on the substance classification.

Local authorities are responsible for overseeing the production, sale, and use of these substances within their jurisdictions, ensuring compliance with federal regulations. They issue prescription booklets and numbers to registered professionals and institutions.

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The control of these medications and prescriptions is crucial due to the risks posed by these substances, including potential dependence and misuse. The legislation aims to prevent diversion for illicit use, aligning with Brazil’s anti-drug laws. This new system by Anvisa represents a significant step towards modernizing and securing the control of controlled drug prescriptions, ensuring better public health safety and regulatory compliance.

 

Respurce: National Health Surveillance Agency, June 03, 2024

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