Tablets & Capsules May 2019 11
References
1. www.tracelink.com/global-drug-supply-report/
2017-report.
2. www.securingindustry.com/pharmaceuticals/fda-
eyes-blockchain-as-dscsa-pilot-programme-starts/s40/
a9236/#.XHmbcIhKjIV.
3. www.fda.gov/downloads/regulatoryinformation/
guidances/ucm206075.pdf.
4. www.marketwatch.com/press-release/pharmaceuti
cal-industry-packaging-serialization-lagging-as-dscsa-
enforcement-deadline-looms-2018-10-18.
PMMI is the association for packaging and processing tech-
nologies (571 612 3200, www.pmmi.org). The association
represents more than 850 North American manufacturers and
suppliers of equipment, components, and materials as well as
providers of related equipment and services to the packaging
and processing industry.
accept only serialized pharmaceuticals and, by 2020,
dispensaries must also only accept serialized pharma-
ceuticals. It remains to be seen whether these require-
ments will be rigorously enforced on this timeline. An
October 2018 assessment by GS1 found only 20 per-
cent of pharmaceuticals to be fully compliant [4].
While blockchain may eventually offer a solution for
establishing a secure traceability process for pharma,
many companies are forging ahead using other, much
more mature and proven technologies for serialization
and traceability. Additionally, the blockchain data struc-
ture is extremely slow for searching. Using blockchain for
traceability will require a shadow database optimized for
searching for instances such as product recalls or to find
the chain of custody for a particular serialized unit. In
fact, users will need to combine blockchain with a num-
ber of other technologies to achieve the desired results.
Blockchain does provide strong immutability, however,
meaning that, once written, the data can never be modi-
fied. That provides a very robust audit trail that can help
deter fraud in the supply chain. T&C
