“Across the country, pharmacies have been seeing a significant uptick in patients seeking to extend 30-day prescriptions to 90 days to ensure access to their medications amid the growing COVID-19 crisis. While stakeholders say they have been able to meet these requests, several indicate that it’s only a matter of time before the supply chain buckles under these new pressures.”
“Blockchain startup Mediledger has published the results of its FDA blockchain pilot for the pharmaceutical supply chain. Numerous separate groups applied to the FDA and ran pilots for the Drug Supply Chain Security Act (DSCSA) 2023 milestone for package-level tracing, with this being one of the largest groups. Mediledger’s participants included all three major U.S. wholesalers, seven out of ten of the world’s largest pharmaceutical companies, massive dispensers Walgreens and Walmart, as well as logistics firms such as FedEx.”
Another industry that is feeling the impact of the coronavirus is the pharmaceutical industry. The average buffer inventory for the pharmaceutical industry is between three and six months. However, this does not tell the full story. Gaurav mentioned that China is responsible for producing 40 percent of the active pharmaceutical ingredients (APIs) for the pharmaceutical world. Additionally, China supplies 80 percent of key starting materials (KSM’s), which are the chemicals in APIs, to India. Put together, this represents 70 percent of all APIs across the world.
“After a search, the board of directors at the Healthcare Distribution Alliance has chosen Chester “Chip” Davis to be president and CEO. John Gray, HDA CEO since 2004, announced his retirement last year; Davis will take over next month. Davis comes to HDA from president and CEO of the Assn. for Accessible Medicines (the former Generic Pharmaceuticals Assn.), which appointed him in 2015. Formerly, he was EVP for advocacy at the Pharmaceutical Research and Manufacturers of America.”
“The Trump Administration wants to start a drug-importation program from Canada for both small-molecule and biologic products. The program would be a “time-limited Section 804 importation program” (SIP), with the SIP program sponsored by “a pharmacist, a wholesaler, or another State or non-federal governmental entity” and subject to FDA review. Additional language in the notice of proposed rulemaking (NPRM) gives guidance on how manufacturers themselves could set up reimportation. The NPRM is available in draft form today (Dec. 18), and is expected to be published officially in the Federal Register on Dec. 23.”
“The US FDA published a compliance policy final guidance document on September 23, 2019, announcing a one-year enforcement discretion for the Wholesale Distributor Verification Requirement for Saleable Returned Drug Product.
If you’re a wholesaler or a manufacturer rushing to meet the November 2019 deadline, this guidance is significant. But before you breathe a sigh of relief, you need to read the entire guidance document and the entirety this LSPediA article.”
“DHL Supply Chain, the Americas leader in contract logistics and part of Deutsche Post DHL Group, is expanding its pharmaceutical and medical device distribution network by 40 percent this year with an investment of $150 million. With the ultimate goal of bringing critical healthcare products closer to trade partners and patients, DHL Supply Chain plans for nine new sites by the end of 2019. The investment includes costs to invest in new buildings and technology, as well as the fit-out and start-up of new or expanded operations.”
“Supply chain theft is estimated at $35-40 billion per year in the US, and today’s threats to the commercial supply chain are different than those of the past. Logistics companies are perfect targets, and those that aren’t aware of the changes are more likely to fall prey.”
“Brandman discussed why theft-related loss is getting worse, and said that the value of the product plus a low risk factor, lax security and an inadequate criminal justice system equals high gain, low risk. Plus, says Brandman, the internet combined with small parcel delivery service make it easy to distribute stolen goods. Thieves – often internal – who work together can result in significant loss to the company.”
The Growing Trend of PBM Track-And-Trace Audits – Frier Levitt
“Pharmacies are being asked [to] provide transaction history, transaction information, and transaction statement, and to maintain such records for not less than six years after the transaction.”
“Pharmacies are expected to ensure that wholesalers provide the aforementioned information at the time of purchase or be in a position to provide this information at the time of a request. Such requests are being made despite pharmacies having purchased from duly, licensed, and verifiable wholesalers.”