Genuine medicines contain clearly identified ingredients as per the formulation with proper quality and must be manufactured and packaged under strict regulations to ensure safety and effectiveness. Spurious drugs on the other hand would either have no active ingredients or diluted ingredients/ wrong ingredients/ poisons that could harm the health or take the life of the patient.
Though the US is considered as the market with the safest pharmaceutical supply chain structures in the world, it is plagued by the menace of spurious drugs that kills or harms scores of people annually. To protect patients from this menace, governments around the world have put serialization and tracking & traceability norms in place.
In the US, the DSCSA (Drug Supply Chain Security Act) law works towards complete tracking & traceability in the supply chain of medicines from a lot level currently to an item level eventually. Each and every hospital, pharmacy, clinic, physician as well as a long-term care facility that handles prescription medicines needs to follow a set of DSCSA compliance requirements. Failure to comply with the requirements of the law can result in penalties.
As per DSCSA norms, beginning July 1, 2015, pharmacies must be able to capture and maintain transaction information (TI), transaction history (TH), and a transaction statement (TS) for each drug received for 6 years from the date of the transaction. Beginning July 1, pharmacies may not accept product from trading partners unless it is accompanied by the three Ts- TI, TH, and TS. Pharmacies can contract with their wholesale distributors/ cloud based vendors to maintain the records electronically for them as long as the pharmacy can access and retrieve the data when required in a secure manner and is backed by a written agreement that takes DSCSA conformance into account. FDA has clarified in draft guidance that internet based solutions are acceptable means to meeting the requirement if the information storage method has no access or retrieval issues for required stakeholders. The cloud based DSCSA compliant solution offers the advantage of minimal infrastructure/ maintenance costs with anytime and anywhere secure access.
The biggest challenge is the management of these diverse silos of data for a single-store owner/manager when it is being held by many wholesalers in different portals or solutions where we have different usernames and passwords. It has the potential to be a very time-consuming administrative task that adds to the long list of work duties that they would have to complete -managing different solutions, data portability, and duplication of effort especially in data entry and in report generation.
Some of the imperatives for DSCSA as per the FDA are:
Product identification
Manufacturers and re-packagers put a unique product identification code on certain prescription drug packages like using a bar code that can be easily read and traced electronically.
Product tracing
Manufacturers, wholesalers, re-packagers, and pharmacies in the drug supply chain must be able to provide information about a drug and who handled it at each stage in the U.S. market.
Product verification
Manufacturers, wholesalers, re-packagers, and pharmacies must be able to establish conformant systems and processes to be able to verify the product identifier on prescription drug packages.
Detection and response
Manufacturers, wholesalers, re-packagers, and pharmacies must be able to quarantine and promptly report tracking & traceability information about a spurious drug.
Notification
Manufacturers, wholesalers, re-packagers, and pharmacies must be able to establish systems and processes to notify FDA and other stakeholders with all the relevant information to take action if a spurious drug is found.
Wholesaler licensing
Wholesale drug distributors must be able to report their licensing status and contact information to FDA that should also be made available on a public database.
Third-party logistics provider licensing
Third-party logistics providers, those who provide storage and logistical operations related to drug distribution, must obtain a state or federal license.
According to a study, 80% of counterfeit drugs in the US come from overseas locations via routes such as internet ordering. The US medicines market is estimated to be worth over $ 370 billion thus making it a very attractive target for counterfeiters. The DSCSA seems an effective way to tackle the menace for the present. The DSCSA compliant system will improve the detection and removal of potentially hazardous drugs from the drug supply chain.
The development of the future ready DSCSA compliant system will be phased in with newer requirements over a 10 year period. To add to these complexities, international country specific deadlines and compliance requirements are currently being considered too.
We at Versa have created a DSCSA compliant one stop comprehensive ERP solution that will grow with your business and compliance needs while optimizing all your business functions. You no longer need two solutions for your business; Versa can help you migrate to a single solution for all your needs
To know more, please go to www.versaclouderp.com
Reference:
http://pharmacytoday.org/article/S1042-0991(15)30263-2/fulltext
https://www.thebalance.com/how-to-comply-with-the-drug-supply-chain-security-act-4005301