By: Amod Gurjar, Sr. Specialist - Life-Science Practice, LTIMindtree

This blog post delves into the complexities of using controlled substances in the pharmaceutical industry, discussing regulatory requirements and technological challenges and introducing an integrated solution to help companies implement a Controlled Substance Diversion Prevention Program. Targeted readers include procurement heads, license management heads, and sales managers in the pharmaceutical industry.

Background:

Controlled substances, drugs, or chemicals with highly regulated manufacture, possession, or distribution are restricted in the open market due to their addictive properties. The misuse and abuse of these substances pose serious public health and safety concerns, causing severe psychological or physical dependence. The United States Department of Health and Human Services (HHS) and the Centers for Disease Control and Prevention (CDC) report that opioids killed more than 42,000 people in 2016, with drug overdose deaths nearing one million since 2000. The federal budget for drug control in 2020 was $35 billion. These alarming statistics make it evident that substance abuse is a widespread issue. However, controlled substances hold immense potential within the pharmaceutical industry, as they are integral to the life-science sector. The global market size is anticipated to grow to US$ 116 Billion by 2027.

Role of the Regulatory Authorities:

The Drug Enforcement Administration (DEA) in the USA recognizes five frequently abused drugs: opioids, depressants, hallucinogens, stimulants, and anabolic steroids. The DEA has established a closed system for distributing controlled substances through the Controlled Substance Act (CSA), requiring all supply chain players, such as pharmaceutical manufacturers, distributors, retailers, and hospitals, to register with the DEA. These enforcement agencies continue to focus on substance addiction, resulting in increased scrutiny of pharmaceutical companies and the entire supply chain. The imposition of monitors in CSA cases makes it clear that the US DOJ is willing to aggressively pursue severe sanctions against pharmaceutical companies, which can potentially lead to closure.

LTIM Controlled Drug Compliance System:

LTIM has developed a Controlled Drugs compliance solution on the SAP BTP platform to ensure regulatory compliance and streamline digital transformation in the Life Science Industry segment. This solution checks license period validity and stock validity at various supply chain stages, reviews manufacturing plant-level licenses, and employs Machine-Learning Regression Classification modeling to flag potentially suspicious sales orders for further investigation. Online documentations related to the customer are available for quick reference. A cloud-based dashboard provides real-time information about the licenses of Business Partners (Vendors and Customers), including material name, quantity allowed, quantity purchased or sold to date, license validity period, and license status.

Where this solution can be used:

• Pharmaceutical Manufacturing Industry dealing in Controlled drugs
• Large distributors/pharmacy chains dispensing drugs under controlled drugs schedule using EPCS (Electronic Prescription of Controlled Substances that meets the 21CFR-1311 -subpart-C requirements)

Deployment Approach and Next Steps:

The LTIM Controlled Drugs Compliance solution offers significant benefits to the pharmaceutical industry. To explore how this solution can help your business, follow these steps:

• Write an email to LTIM_LIFE@ltimindtree.com to connect with our team.
• Speak with our SMEs.
• View our video and brochure for a deeper understanding of the solution.
• If the solution meets your requirements, sign an NDA to proceed.