I’ve seen my fair share of compliance and operations misses as a pharmacist of nearly 10 years. Having walked into several pharmacies as a new manager, and responsible for helping with operations standardization, and legal and third-party compliance for more than 70 pharmacies, I’ve learned a lot, and can clearly see the gaps in pharmacy education in this area.

Through experience, I’ve come up with my top avoidable operations misses in the pharmacy. While not everything on this list is a law, they are all at least best practices and/or tips to most efficiently comply with a law or regulation, and to get your job done.

Improper storage of vaccines and refrigerated or frozen medications
Vaccine storage and handling is a passion of mine. Unfortunately, even though the CDC Vaccine Storage and Handling Toolkit has been around for quite some time now, this is still an area for improvement in many pharmacies.

The absolute best website for anything related to vaccines, including storage and handling, is the Immunization Action Coalition’s immunize.org. Bookmark it!

Top areas to consider: Temperature monitoring device (TMD) selection, refrigerator selection, record keeping (document temperatures twice daily, including the min/max, and keep logs for 3 years), and handling excursions properly.

Improper handling of hazardous drugs
USP 800 has thankfully brought a lot of attention, and regulation, to the handling of hazardous drugs (HD). However, it is not nearly the first publication about HDs in the pharmacy; NIOSH, for example, has guidelines from over 10 years ago. Still, many pharmacies, chain and independent, fail to fully protect their workers from exposure to HDs.

US Pharmacopeia offers a free copy of USP 800. If you haven’t already done so, download the chapter for reference.1

Top areas to consider: Wear the proper gloves, use a dedicated counting tray, segregate HDs from the rest of your inventory in a proper location that is clearly labeled, define your site-specific list of HDs, and be sure you are decontaminating and deactivating HD contamination on the tray, and in your work area.

Poor Controlled Substance Recordkeeping
Ahh… controlled substances. While it is a hot topic for many people, controlled substances is an important topic for this list because of the myriad ways they can, and have, been diverted. It’s best to think about tracking your controls from ‘birth to death.’ That means from the moment you receive them until you either dispense them or a reverse distributor takes them away, you have procedures in place to reduce the risk of diversion.

Top areas to consider: Using separate login credentials for your distributor’s ordering system, ensuring your computerized inventory matches the actual inventory, requiring 2 signatures on the invoice when receiving controlled substances, and logging and keeping track of controlled substance waste, including dropped or broken tablets.

Hoarding
I don’t know why, but many of the pharmacies I’ve walked into for the first time look like a hoarder’s house. Papers everywhere, way too many office supplies, 8 graduated cylinders of the same size, etc.

If you’ve never heard of 5S, and this sounds like your pharmacy, I encourage you to educate yourself about it. In short, 5S is a Japanese concept that loosely translates to mean Sort, Set in Order, Shine (or cleanliness), Standardize, and Sustain.2

Having a messy and cluttered workspace leads to medication errors, increased wait times due to inefficiency, and confusion from float staff or new hires. In this era of high volumes with little help, maximizing efficiency is 1 of the few areas in your control to quickly make your life at least a little easier at the pharmacy.

Another tool when thinking about workflow design is the acronym DOWNTIME,3 which helps you remember the forms of waste: Defects, Overproduction, Waiting, Nonutilized talent, Transportation, Inventory, Motion, and Excess Processing.

Top areas to consider: Throwing out pharmacy records as soon as you are not legally required to keep them anymore, limiting office supply orders or requiring manager approval first, labeling everything so it’s easy to find, and arranging furniture and items to minimize motion.
 
Alex Evans, PharmD, BCGP is a pharmacist and medical writer based out of Jacksonville, FL. He is the founder of Pharmacy Compliance Specialists, LLC (www.pharmcompliance.com), a company dedicated to the success of community pharmacists. He can be reached at alex.evans.pharmd@gmail.com.


REFERENCES
  1. US Pharmacopeia. USP Healthcare Quality & Safety. USP website. http://go.usp.org/l/323321/2019-05-31/2dfgwl Accessed February 21, 2020.
  2. McFadden B. What is 5S? Graphic Products. https://www.graphicproducts.com/articles/what-is-5s/ Accessed February 21, 2020.
  3. Mcgee-Abe J. The 8 Deadly Lean Wastes - DOWNTIME. Process Excellence Network. https://www.processexcellencenetwork.com/business-transformation/articles/the-8-deadly-lean-wastes-downtime Published August 12, 2015. Accessed February 21, 2020.