The full force of the US Drug Supply Chain Security Act (DSCSA) is looming. It has big implications for anyone involved in the supply of pharmaceuticals. Here we explore the DSCSA 2023 requirements and how smart devices powered by smart data capture can help.
What is DSCSA and why is it important?
DSCSA applies to anyone in retail, logistics and healthcare that manufactures, distributes or sells pharmaceuticals, whether on shelves, over the counter or dispensed. Due to be fully implemented in 2023, the DSCSA requirements provide the framework to electronically identify and trace prescription drugs throughout the US supply chain.
The aim of the act is to better protect consumers against harmful exposure to potentially dangerous pharmaceuticals. Improving the detection and removal of unsafe drugs – such as counterfeit, contaminated, expired, and stolen medicines – reduces the risk of any serious threat to public health.
Why smart devices?
Labor shortages have been widespread across retail, and the pharmacists that operate within them are also in demand. The need for pharmacy technicians has been increasing in recent years due to a growing aging population, the expansion of the healthcare sector, and increased demand for prescription medications.
According to a report published by the National Association of Chain Drug Stores (NACDS) in 2021, the demand for pharmacy technicians is projected to grow by 12% between 2019 and 2029.
Pharmacies must find ways to enable their existing workforce to be more productive and tackle their list of tasks that DSCSA compliance will only add to.
Due to their ubiquitous nature and ease of use, smart devices are becoming the tool of choice for many retailers. This device strategy gives all workers the capability they need instead of sharing fixed terminals and dedicated devices.
And powered by the right scanning and data capture technology, pharmacists can seamlessly switch between different tasks such as inventory management and dispensing.
Boosting their flexibility and productivity when demands are high.
Below we explicitly look at the role of smart devices and smart data capture in meeting DSCSA requirements.
DSCSA requirement: Track and trace
To comply with DSCSA requirements, retail pharmacies must provide information about a drug and its handlers every time it is sold. The tracing must go all the way back to the manufacturer.
The product identification requirements ensure that prescription drugs must have a unique product identifier on their packaging at the item level. Barcode and DataMatrix scanning provides the mechanism for all parties to have an interoperable system in place so they can respond to tracing requests from a regulator.
Every time prescription drugs are received into a retail pharmacy they can be scanned and entered into their system. And when they are dispensed, drugs are scanned again and information is recorded against the customer and their prescription. A final check completes the process.
Faced with doing this multiple times a day and the importance of getting it right, scanning speed and accuracy are paramount for the pharmacist.
A web or native app on a smart device powered by Scandit Smart Data Capture guarantees both criteria. Whether scanning dispatched or received goods, or at awkward angles on shelves, or with small or damaged codes, high-performance scanning from Scandit accurately captures data associated with each pharmaceutical product.
Furthermore, scanning medication straight into an Electronic Document Management (EDM) system ensures full traceability. The scan captures data such as quantities, serial numbers, expiration dates and LOT or batch numbers. Combined with logging data on the movement of drugs, this reduces errors and maintains an accurate view of what is where at any given time.
Recalls and detecting counterfeit pharmaceuticals
Counterfeit and unapproved drugs pose a significant risk to health. Despite less than 1% of medicines sold in the US being counterfeit, the need to eliminate these dangerous drugs from the US supply chain remains critical.
Under the DSCSA pharmacy requirements, distributors and dispensers of drugs are obliged to notify the US Food and Drug Administration (FDA) and other stakeholders of any illegitimate drugs they come across. Verifying medication authenticity is simple with a Scandit-powered smart device. It quickly captures unique product identifiers on the packaging, including 1D and 2D codes or DataMatrix codes.
If suspect pharmaceuticals are detected, they can immediately be withdrawn from the supply chain and quarantined. Retail pharmacies can then ensure the suspect drugs are promptly investigated and safely disposed of, if applicable, maintaining the safe supply of drugs.
Also, the ability to trace products across the entire supply chain facilitates quick and precise recalls. Any drugs with manufacturing or labeling issues are efficiently tracked and can be withdrawn before they reach unsuspecting consumers.
Expiration date management
Retail pharmacies need to keep careful track of expiry dates so that they only dispense drugs that are well within usage dates. Tracking by expiration date also ensures that drugs are dispensed in the right order, with the earliest to expire being used first.
Scandit Smart Data Capture offers retail pharmacies the ability to capture and track this data to ensure the safety and efficacy of the products they dispense.
Efficient inventory management is also vital to upholding the healthcare revenue cycle. Drugs cannot be reimbursed until they have been dispensed. Consequently, there is a significant financial impact associated with holding large quantities of drugs.
Oncology drugs, for example, are extremely expensive and have a short shelf life. With the ability to easily take inventory, a pharmacist can closely monitor usage levels and shelf life. This helps to maintain optimum inventory levels to service patient needs without unnecessarily tying up cash by holding too much inventory.
Get in touch to find out how Scandit’s data capture solutions can help you meet DSCSA requirements and ensure your workers have the right capabilities to tackle a variety of retail pharmacy tasks.