Have you ever stopped to think about where your prescription drugs come from? As a pharmacist, you have a responsibility to ensure your patients receive safe and legitimate medications, but are you confident that your drug supply chain is secure? The Drug Supply Chain Security Act (DSCSA) was enacted in 2013 to create a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found.
At Outcomes®, we understand the importance of remaining compliant with the DSCSA. That's why we provide our clients with all the tools they need to understand the inner workings of the act and ensure their pharmacies remain in compliance.
Did you know that the DSCSA includes requirements that pharmacies must follow to protect patients from receiving harmful drugs, such as counterfeit or other illegitimate drugs? As a dispenser under the DSCSA, you must know your responsibilities to protect your patients from receiving harmful drug products. Here are some key requirements that pharmacies must follow:
- Confirm the entities you do business with are licensed or registered.
- Check the registration of manufacturers and repackagers. Check the licensing of wholesale distributors and third-party logistics providers. Check the licensing of pharmacies through the respective state authority.
- Receive, store, and provide product tracing documentation.
- The law requires drugs to be traced as they move through the supply chain, and pharmacies must only accept prescription drugs that are accompanied by three pieces of product tracing documentation – transaction information, transaction history, and transaction statement. If the trading partner you purchased the drugs from does not provide all this documentation, work with them to promptly get it. Store the product tracing documentation you receive in paper or electronic format for six years. Generate and provide all product tracing documentation with the transaction if you sell a prescription drug to a trading partner. You do not need to provide this information when you dispense a prescription drug to a patient or if you sell to a pharmacy for dispensing to a specific patient.
- Investigate and properly handle suspect and illegitimate drugs.
- Pharmacies must have a process to investigate and handle suspect and illegitimate prescription drugs, which includes drugs that may be or have evidence that it is counterfeit, diverted, stolen, intentionally adulterated, or unfit for distribution. This includes steps to quarantine and investigate suspect prescription drugs to determine if they are illegitimate. If they are illegitimate, pharmacies should work with the manufacturer and take specific steps to ensure patients do not receive the illegitimate drugs. Pharmacies must also notify FDA and the trading partners they bought the drug from and sold the drug to.
It's critical that pharmacies understand these requirements to protect their patients and avoid any legal issues. At Outcomes, we offer Pharmacy Management Systems (PMS) that can help our clients remain in compliance with the DSCSA. Our PMS systems, including Computer Rx and Rx30, provide pharmacies with the tools they need to track, manage, and dispense prescription drugs while ensuring compliance with the DSCSA.
In addition to the current DSCSA requirements, the pharmaceutical industry will face even more complex regulations in the coming years. The final phase of the 10-year rollout of the DSCSA, known as "DSCSA 2023", will require the implementation of an "enhanced system" for the electronic tracing of drugs by November 27, 2023. This new requirement adds an additional layer of complexity for dispensers, who must now ensure that their Pharmacy Management Systems are capable of interfacing with the enhanced electronic tracing system. Failure to comply with these new requirements could result in serious consequences for pharmacies, including fines and loss of license.
By partnering with Outcomes, you can rest assured that your pharmacy will be prepared for the DSCSA 2023 requirements. Our Pharmacy Management Systems are designed to meet the evolving needs of the pharmaceutical industry and comply with all current and future DSCSA regulations. Our systems are regularly updated to ensure compliance with the latest regulations, and our team of experts is always available to provide guidance and support. We understand the importance of staying ahead of regulatory changes and are committed to helping our clients meet the complex requirements of the DSCSA.
Contact Outcomes today to learn more about our Pharmacy Management Systems and how they can help your pharmacy remain compliant and protect your patients.
