Four WMS security concerns for pharmaceutical warehouses
Today’s pharmaceutical supply chain is complex, and the warehouse may be its most intricate and dangerous location when not properly monitored. Your management system will need significant security protocols to mitigate a wide range of safety risks.
The biggest threats you will face include theft, spoilage and contamination, fraudulent products, and management of the end-of-life of drugs where a variety of new statutes come into play. This guide looks at the four most significant concerns as you try to manage goods made from ingredients that traverse the globe to combine into some of the most lucrative products in small, easy-to-move form factors.
1. External and internal theft
When your products are in motion, they have a reduced risk of theft and other threats because it is harder to access them. After arriving at your warehouse and then moving to storage, thieves know more about a potential target and have fewer variables to account for, increasing the threat of large-scale theft of your pharmaceuticals.
Your pharmaceuticals warehouse may be a target if you store the products for a long time because they will typically be unattended. If thieves are targeting a pallet of drugs, they also may have easy access to a forklift or handcart that can assist them in carrying out a significant theft.
A WMS security system needs to be focused on detecting motion and also have the ability to call up work schedules so that your security professionals can verify activity in the location plus if other assets should be in use.
The $80 million theft from an Eli Lilly pharmaceutical warehouse in March 2010 was traced to a group of thieves who allegedly got security blueprints from an insider. Not only were they able to avoid some security measures, but they also used onsite equipment to speed up the collection and removal of the drugs.
2. Environmental controls
Storage areas need to be large enough to handle the volume of pharmaceuticals that you will stock. These products are often sensitive to temperature, humidity, shock, and contamination factors, all of which can occur when stored in an incorrect place. Ensure that all requirements of drugs and of your storage areas are posted.
That means maintaining a proper temperature in your cooler as well as posting, and having your WMS security checking, that no one enters a cooler to store their food or eat it. Not only does the food risk a direct contamination, but it can also attract pests that can providing significant risk of other contamination.
Pharmaceutical WMS security needs to be a part of your overall cleanliness team as well to make sure that drugs are properly stored, that areas of different temperatures are properly separated, and that your space stays clean to limit vermin.
3. Mislabeled products
WMS security for your pharmaceutical warehouse must extend to your vendors and proper tracking from the lab that created your pharmaceuticals all the way to your warehouse’s door. If your wholesaler is buying products from multiple providers, they could be at a higher risk for salting — when fake drugs are mixed in with legitimate drugs.
Salting gives a proper label to the fake drug and can put your company at risk.
In many cases, salting uses packaging that is the same as the manufacturers, though it typically is not on demand so batch numbers and other numbers would not necessarily match records that carried through from the original manufacturer. It is likely that some advanced printing operations could mirror batch and serial numbers.
Proper tracking through your WMS security portal can help mitigate this risk. It can also ensure you’re working with manufacturers who have distribution agreements with specialized pharmaceutical wholesalers, but not those who deal with secondary wholesalers.
The National Center for Biotechnology Information warns that small, secondary wholesalers are not only the weakest point in the current supply chain and that they may be breaking multiple licensing and distribution laws, willfully and unknowingly, which can put your operations at risk.
4. Proper disposal
A pharmaceutical warehouse will face issues related to drugs expiring or becoming damaged at some point. Products fail to sell and accidents occur, which is a natural part of the warehousing process. However, disposal is a chief WMS security concern when it comes to pharmaceuticals because you must adhere to local, state, and/or federal regulations governing the disposal.
While you need to be aware of many dumping and disposal requirements, your WMS security team and platform should also continuously monitor these drugs through the process. Expiration is often listed on the packaging of drugs, so theft may still be common if the drug has a significant street value.
Your team also needs to ensure that drugs are properly stored so that expiration dates are always visible and you follow a modified FIFO rule to address first-to-expire drugs. Not doing this could introduce significant risk for your company due to patient harm.
We don’t normally think of these issues as part of WMS security, but the major threats and potential litigation that a pharmaceutical warehouse could face make them a top priority for any safety team.
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