Medicine transporters to combat supply chain threats with stability data
Over 75% of temperature controlled logistics practitioners surveyed voted in favor of increasing the use of product stability budgets for decision making in the supply chain
This overwhelming consensus was noted in Pharma Logistics IQs 2017 report Optimizing The Path Form Lab To Patient and gathered insights from over 140 industry professionals.
What is stability data:
Pharmaceutical manufacturers can create stability profiles for a drug after conducting a range of studies to determine the amount of time a medicine can spend out of its labelled storage conditions without being damaged.
The integrity of the cold chain is threatened during transportation by hazards such as natural disasters, handovers and unforeseen delays.
Stability budgets calculated correctly prevent shippers from wrongfully discarding medicines in the case of a temperature deviation in transit.
A medicine’s actual Time spent Out of Storage (TOS) conditions is compared to the allowable excursion time depicted in its stability budget. With this stakeholders can make quality-based data driven decisions on what to do with a material and whether it is safe for consumption.
Stability protocols will inform handlers of a product’s failure boundaries due to extreme temperatures. Senstitech notes that the stability budget – pertaining to time and temperature - should ideally be distributed through the entire lifecycle, with fixed periods dedicated to manufacturing and storage. Excess time should be utilized upon distribution.
ELPRO explained the benefits of stability budget: “ “By proactively setting up and managing a stability budget, you solve the issue of QA running around doing manual investigations with CROs and LSPs for multiple legs of a shipment taking days, sometimes weeks.
“Quicker decisions at the end of shipment avoids delays to patient administration, and keeps the supply chain in control.”
Regulators are likely to enquire about stability and the protocol deployed to generate the data and the implementation of a stability budget. In a previous whitepaper, Dr. Rafik Bishara Ph.D, Technical Advisor, Retired Director, Quality Knowledge Management and Technical Support, Eli Lilly and Company."stresses that to avoid implementing a stability budget is in fact taking on a risk – dependent on the inspector they are allocated and whether that inspector decides to focus on the stability budget.
Some experts have proposed that the stability budget should be left solely for any excursions in the last mile. Stephen Mitchell, E2E LP Quality Lead, GlaxoSmithKline notes: “The only point I would make on this is that the stability budget should be built into the last mile. It is not something that people should be using to plan for their core distribution process centre.
“At the end of the day, you do not know what your patient is going to do with the product once they have received it. The stability budget really is intended [for] that end of the supply chain.”
Companies are often reluctant to run stability studies, due to their expense. These studies are being conducted for more and more new products, but less so for older products.
Manufacturer importers can be reluctant to share the complete stability data with some stakeholders in the chain because they are the ones legally responsible for any adverse events caused by the product. As wholesalers and such do not have information on the history of the product’s transit, to make a decision without contacting the manufacturer importer could be taking a big risk.