CSOS (Control Substance Order) Framework

Within United States, Drug Enforcement Administration (DEA) regulates the manufacturing and distribution of Control Substance products. As obligated with social responsibility to streamline the pharmaceutical supply chain and related functions, Controlled Substances Act was enacted by DEA  for secure electronic transmission of Schedule II controlled substance orders without the supporting paper Form 222. The regulatory control is designed to streamline the operations and aimed to prevent the illegitimate pharmaceutical drugs into illegal routes and also ensuring the required supply for the legitimate medical uses. Control Substance Ordering System (CSOS) was designed to support the Pharmaceutical companies and bring transparency and efficiency in the distribution of controlled substance orders for Schedule II substances and supporting DEA 222 regulated requirements.

 In collaboration with Pharmaceutical industry DEA developed a technologically advanced system by using the Public Key Infrastructure (PKI) technology to interface the companies system and completely automate the enrolment, certificate issuing, certificate validation etc and enable the complete electronic order processing. CSOS system interface brings enormous flexibilities and help to establish a robust interface which not only speed up the transaction time but also brings the security into the processes.

 CSOS Framwork

There have been enormous challenges confronting the pharmaceutical manufacturers and suppliers to manually comply to the regulatory requirement of DEA. Manual handling of form222 faced unintentional errors which delays the order processing. Responding to the industry needs and keeping the long term view of the situation to meet the challenges CSOS (control Substance Ordering System) was developed and integrated into the supply chain processes. Numerous benefits were achieved with the implementation of CSOS system integration..

  • Reduced the errors in order processing of Control Substance Products.
  • More line items in the single order can be accommodated within CSOS framework.
  • Less consolidation required as compared to before. And this increased the overall order frequencies.
  • Helped in maintaining the optimum level of inventory. This reduced the unnecessary inventory cost.

 Integration to the Internal Processes : Industry Adaptation

This was the biggest challenge to make the integration easy to adapt with various ERP systems in the different company. A very robust internal system was developed to help facilitate the processes. Various critical elements were developed which considered the overall supply chain security aspects and also making sure the smooth adaptation within the industry players. The below process architecture can help in facilitating the critical aspects of CSOS framework integration to the various internal systems/processes.

Control Substance Industry Perspective_7

 

Depending on the internal ERP systems (SAP, Oracle, NetSuite, etc) a straightforward integration design framework can be developed and supported. The various ERP systems have diverse adaptability and suit to a diverse range of middleware and even data communication platforms. It is extremely important to understand the security elements while CSOS integration apart from the ordering efficiencies. The below design element is provided with some assumptions and will not be suitable for every CSOS integration. But it certainly provides an inputs from the enterprise system and/or process perspectives.

Process control 1, 2 and 3 are provided to accommodate any manual/auto interventions which may/will require fulfilling the regulated requirements in this regard. These controls may even fulfill any internal control requirements.

  • Data map can be internal or even external. Value added network (VAN) is assumed to provide the data transmitting services in the below design
  • Various pull and push elements are designed to support the established data transfer mechanism. It can be used in design as per internal technical design elements.
  • The third party validation requirement is provided to put in place any other validation requirements.

 Like any other adaptations, CSOS integration also requires utmost care and careful studies of the internal systems before adapting or even concluding any of the above design elements and trying to fit in the internal systems/processes.

DEA has clearly defined some Industry obligation in this regard. It is important to note here that it has social implications and it is extremely important for the companies to fully understand and comply with these obligations. Few very high level obligations can be summarized as below.

  • Customer Status Validations: It is responsibility of the supplier to validate the customer status before supplying the control substance schedule II products to them. Orders must be rejected if customer digital certificate has been revoked.
  • Signature Validation on the Order: It is responsibility of the supplier to confirm and validate if the order has not been altered/forged. Suppliers should reject the orders if tempered, altered or forged.
  • Data Archive for 2 Years: IT is also specified that all suppliers must maintain the related data for at least 2 years. An electronic archived must be maintained for the required data as specified by DEA.
  • Submit required info to DEA: Upon completion of the order, schedule II information is required to be submitted to DEA.

 DEA has also defined obligations for customers. All the related parties defined and customers in the process must understand and adhere to the regulated requirements.

Also please refer to the below DEA official website for more information: http://www.deaecom.gov/ordering.html

 Note: The purpose of writing this article is only to facilitate the related knowledge to the interested parties. Use the above information only for the reference and with deliberate caution in line with your system complexities and related processes. The above article is written only to support the technology companies to gain insight and develop capabilities to support the related government regulations. If you don’t understand or even agree to the suggestion, please don’t use this.

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