Small Business Losing Patience with New Drug Supply Automation Regulations

By Apollo Fuhriman, Region 10 Advocate

In December, I met with Meishelle Haverkamp who works for a local affiliate of Swisslog Healthcare, a company that provides automation solutions for pharmacies, including those in hospitals.

In her role, she has seen that a possible upcoming guidance regulation could actually increase time and costs within healthcare, especially with hospitals and clinics that have a decreased capacity to absorb these costs (or even to find enough qualified people given geographic constraints).

Congress passed the Drug Supply Chain Security Act in 2013.  The Food and Drug Administration is working on guidance for the implementation and rollout of the act. If guidance includes that every dose of a medication must be tracked every time it is touched within the hospital walls (from the time it is received from the wholesaler until the time it is administered to the patient), this will have an adverse impact on the workflow productivity of hospital pharmacy staff, without providing much value, according to Haverkamp.

“The burden will be excessive for small, independent hospitals,” she added. They can’t afford the radio-frequency identification technology that will most likely be employed by large health systems if the DSCSA guidance requires per dose tracking within the hospital walls.” (An RFID tag can cost more per dose than some of the medications.)

The DSCSA’s purpose is to keep counterfeit medications from entering into the supply chain. How often do counterfeit medications enter the supply chain within a hospital’s walls? Haverkamp could not find even anecdotal evidence to suggest this has ever happened in the United States.

Haverkamp explained the typical process for the majority of medications that are in a hospital:

  1. Once a medication is received from a wholesaler, it is staged for put away.
  2. Then it is restocked in the carousel or on a shelf.
  3. Then it is picked and sent to an Automated Dispensing Cabinet on the nursing floor.
  4. And then it is picked and administered to the patient.

With the exception of the final administration, each of these steps is done in bulk, and common practice is to scan one dose and then key in the total quantity of doses being picked or put away. If the pharmacy technician had to scan every dose, it would take an exceedingly long time and be a highly repetitive process.

Sometimes, well-intentioned regulations can create a greater burden and in some instances, possibly reduce time that medical professionals have to spend with patients.

Apollo Fuhriman is the Office of Advocacy’s regional advocate representing Washington, Idaho, Oregon and Alaska. Our Regional Advocates in the 10 SBA regions stand ready to hear from you about small business concerns and to help you level the playing field for small businesses in your state.