How do we ensure drugs un-tampered during the distribution chain from manufacturer to patient?


Drug are manufactured and sent to distributors in batches and large boxes. (e.g. in carton box)
Patient consume drugs in smaller pre-package boxes (e.g. smaller box of 12 pills)
Somewhere between the manufacturing and patient consuming the drug, someone will need to unpack the carton boxes.
How do we ensure, using technology, the unpacking process is un-tampered, and how do drug manufacturers track this?

Zhanwei Chan
11 months ago

5 answers


The answer lies in the DSCA (drug supply chain and securities act) process. Each medication is required to have proof of where it has been to where it lands. The pedigree informatgion should always be available from maniufacturer, shipping company, wholesaler, shipping company , and then to the destination. This was the purpose of the law...
Lori Lotterman

Lori Lotterman, RPh MPH
11 months ago
While it is obvious that pharmaceuticals may have high 'street values', and therefore require strict secure modalities to maintain their shipment integrity from final manufacturing shipping through the entire supply chain to legal end users taking receipt of their meds at hospitals or pharmacies, physical and IT seamless controls may not be enough. It is important that they not be hacked en-route. - Cort M. 11 months ago

Well, so long as the ultimate container of pills that the patient uses is tamper-proof, and is labelled properly, there should be no issue with a distributor unpacking larger boxes and putting individual bottles into smaller boxes. The larger boxes should have tamper indicating seals on them and the smaller boxes could have them as well. And, of course, barcode tracking will ensure that the trail to the ultimate destination is monitored and recorded.

Brandon Price
11 months ago
evel of conWhile common the use of barcode tracking systems should provide a certain confidence in the port-to-port security integrity of Class II, III, and IV Controlled Pharmaceuticals, the novel approaches taking place with asymmetric hacking demands a highly level of forensic IT security vigil looking for signs of unusual activity in the DSCA tracking process. - Cort M. 11 months ago

Usually, blisters and primary packaging are inkjet printed or embossed with unique ID numbers in order to comply with worldwide tracking standards. Knowing also that very often, primary packaging is done on a different site than secondary packaging and serialization could also be done elsewhere.

Franck PAVAN
11 months ago

This will be an area for continuous improvement in addressing tampered drugs or packaging to obtain drugs. Just as we've seen with different addictions, there are shifts, changes, and rapidly emerging new ones that appear in the marketplace.
Supply chain efforts need to be married more closely to end-user issues in addition to just intra-distribution issues traditionally addressed in laws or regulations.

Randy Vogenberg, PhD
11 months ago

The stolen or counterfeit medicine entering the distribution chain and reaching patients has been plauging the pharmaceutical industry for a long time. The solution to this problem lies in the adoption of blockchain technology.
• MediLedger Project, initiated by a group of companies has successfully created blockchain based model to monitor the pharmaceutical supply chain and successfully completed pilot project to demonstrate its suitability.
• Pharmaceutical companies would also be much better off in weeding out counterfeit or keeping track of stolen medicines by employing blockchain based distribution network which would improve accuracy and accountability.
• Patients, especially in developing countries would have full confidence in buying the original drug rather than ending with dubious counterfeits.
• It is estimated the percentage of counterfeit drugs in circulation ranges from 30-40% (or even higher) in developing countries and less than 5-10% in developed countries.The associated cost to adapt to blockchain based system can be recouped easily by the improvement of profit margins by weeding out counterfeit drugs from the healthcare system in a slow and steady manner.
• The adoption of blockchain might also result in the overall decrease and reach of origianal drugs to the patients in the developing regions.

Krishnendu Chatterjee Ph.D.
10 months ago

Have some input?