Pharmaceutical distributors are leading the effort to implement the 2013 Drug Supply Chain Security Act (DSCSA), a federal solution to securely and accurately trace prescription medications throughout the supply chain.
Under DSCSA, a uniform system of federal electronic, unit-level traceability requirements will be phased in to apply to the entire supply chain by 2023.
In partnership with manufacturers, pharmacies, healthcare practitioners, law enforcement and regulators, distributors continuously monitor, protect and enhance the security of our nation’s medicine supply. They have procedures in place to safeguard medicines from theft and diversion and ensure that counterfeit products do not enter the supply chain. As part of their commitment to supply chain security, distributors:
- Review every order and only fulfill requests that come from licensed and Drug Enforcement Administration (DEA)- approved pharmacists and healthcare providers.
- Use advanced technology to continuously monitor the transportation of medicines and healthcare products throughout. The next generation of GPS tracking devices allow distributors to monitor every step of a medicine’s journey. Highly targeted monitoring systems send alerts if there are any alterations during the transportation process.
- Ensure products are properly handled at all times, from the distribution center to the pharmacy shelf. For instance, certain “cold chain” products are stored in separate chilled areas and then packed in special qualified containers that may have temperature monitors or cold packs enclosed in the package.
- Work with state and federal law enforcement officials and regulators to monitor the supply chain, report fraudulent orders and help prevent diversion of medicines.
Distributors operate more than 200 distribution centers across the country, and these state-of- the-art facilities are designed from the ground up with sophisticated security systems and technology solutions. Controlled substances are stored in a high-security vault with special access procedures and regular inventory checks.
Distributors only deliver controlled substances to DEA- licensed entities. Every order of Schedule II and III opioid-based medications is reported to the DEA and catalogued in a consolidated database. Additionally, distributors report suspicious orders to the DEA.
Pharmaceutical distributors have invested heavily in information technology systems to help better identify suspicious orders based on their own individual customer experience and ordering patterns. They also employ team members to track and monitor pharmacy orders and support efforts to improve coordination and communication between the industry, the DEA and other state and federal authorities.
HDA’s Pharmaceutical Cargo Security Coalition (PCSC) provides a forum for industry security and logistics professionals to exchange supply chain risk intelligence; network with peers, law enforcement and regulatory officials at all levels of government; and receive information that advances risk management and mitigation capabilities of all stakeholders.
For more information on DSCSA, PCSC and other HDA security programs, click here.
*Except the few products that are controlled in Schedule IV or V.