In the pharmaceutical industry, traceability has become an essential element due to the opioid crisis and subsequent laws created in response. Companies need to ensure that their products are tracked appropriately in order to comply with these laws.

In line with the Drug Supply Chain Security Act (DSCSA), healthcare organizations now must track all pharmaceuticals and components across the entire pharmaceutical and healthcare supply chain better. This ensures that each drug is traceable and provides safety for everyone involved.

New Supply Chain Regulations & Their Implications on Traceability in Healthcare

In an effort to protect customers from being exposed to fake, stolen, or contaminated medicines, the DSCSA was passed by Congress in 2013. This law established a 10-year plan for its phased implementation. The legal text has certain requisites for producers, repackagers, vendors, distributors, and third-party logistics facilitators (trading allies).

The DSCSA implements regulations for the biopharmaceutical trade which guarantee that all prescription drugs are properly identified, numbered, and tracked as they travel through the US distribution channel. Come November 2023, the last phase of the DSCSA will take effect.

Product Tracing is where 3PLs & EDI Providers have a part to play

Traceability in healthcare is a significant plus as it decreases the potential use of drugs that have already expired and guarantees the health safety of those receiving treatment.

Inventory software and visibility systems are great tools for keeping track of products nearing their expiration dates. They send out notification alerts to warehouse workers & distributors so they can take necessary action to ensure stock is managed effectively.

Replace the hours spent on inventory count with bar codes & scanners. Product bar codes and scanners can ensure that the right medicines are removed from the shelves at specified times which will save a lot of time and energy. Full inventory counts can now be done in just a few hours instead of days!

Traceability is a pivotal element for ensuring that drugs retain their effectiveness throughout the entire supply chain. It helps to ensure the safety and efficacy of drugs from source to consumer.

Berlinger's recent publication, Beyond the Cold Chain, revealed that mishandling during shipping may lead to drug degradation and make them potentially hazardous. It additionally highlighted how this could impact the potency of medications and render them ineffective.

Advance Ship Notice for Healthcare Suppliers

Having traceability can be a lifesaver for suppliers and buyers alike. If there are any potential problems, suppliers can easily alert the buyer in time and help them to avoid shortages. Furthermore, they can request a second shipment of the product to make sure that the supply is not affected.

Traceability requirements are now starting to include Advance Shipping Notifications (ASNs), which have been tremendously helpful for retailers and grocery stores. ASNs provide pharmaceutical companies with real-time notifications and updates about their incoming ingredients. This enables manufacturers to accurately plan ahead of time and ensure that they will have the material necessary to fulfill orders in a timely manner.

Furthermore, ASNs can effectively communicate all important details related to contamination, such as production date & place, lot numbers, expiration dates, and other information that is essential in determining the chain of custody.

Despite it being a legal requirement in the healthcare industry, there are a plethora of advantages to traceability. The main ones are decreased errors, amplified drug efficacy, and even lowered drug toxicity risks. Thus, it serves the interests of suppliers, buyers, and patients alike.

EDI by Design offers numerous cloud-based products which can help firms in the pharmaceutical and healthcare industries gain inventory visibility and better manage their inventory.