By Irene Wasilewski, Product Support Specialist
Most hospital pharmacies will likely say they would be interested in adding IV automation, but…
- “Automation is too expensive”
- “We follow the regulations perfectly, so we don’t have a problem”
- “There aren’t enough resources to add automation right now”
- “Automation is too slow”
The pharmacy industry has been somewhat slow to adopt automation even though the manufacturing industry has shown an increase in not only production rates but also quality by the integration of automation over the past decades. The myths listed above usually disappear when one takes an in depth look at the reality of I.V. automation.
“Automation is too expensive”
It is true that IV automation is a relatively expensive piece of equipment, but the alternatives are usually costlier and the benefits can outweigh the initial price tag.
Reduction or Elimination of Outsourcing
Many pharmacies cannot keep up with the demands and/or their cleanroom is not up to standards. One fast solution to these problems is to outsource. However, doses made by a compounder are usually priced at a premium since they have to absorb the cost of the equipment and staff. When reviewed in detail, it may be surprising to find out that the money saved from outsourcing can usually pay off the I.V. automation in a matter of months.
Reduction in Waste
Most pharmacies that have implemented RIVA have seen a reduction in waste. Waste reduction may occur in more than just one fashion.
Pharmacies can use RIVA to make unit doses instead of sending the full vial. For example, a pharmacy may be providing a full vial of an anesthesia to the anesthesiologists but a full vial is rarely required. The excess will likely be discarded.
When adding RIVA, the reduction in labour requirements usually frees up resources to launch a program to add more batches per day. Adding more batches means the dose is made much closer to the time when it is actually required, i.e., Just in Time. Fewer doses are returned to the pharmacy because of discharges or a prescription change.
As with any automation, RIVA is extremely repeatable. It will compound exactly what it is set-up to make and it will do it exactly the same way over and over again. This means far fewer errors that need to be sent back to be re-made.
Avoidance of Adverse Drug Events (ADEs)
ADE’s cost the hospital every day in extended hospital stays and lawsuits. Many hospitals employ a risk management group working actively to reduce ADE’s. The simplest and usually cheapest method to avoid mistakes is to put fail-safes in place to ensure they never happen. Adding I.V. automation reduces the overall time and money spent dealing with compounding errors.
A hospital with an average of 100 patients can prevent 3,244 medication errors per year by using automated IV technology. The prevention of these errors would result in a cost avoidance of $144,350 in direct medical costs.
Moving Pharmacists to Clinical Roles
Pharmacists may spend many hours checking compounded IV doses. It has been shown in studies that moving the pharmacist out of the cleanroom and into a clinical role ultimately saves the hospital money. Checking doses likely becomes a routine job that doesn’t use the pharmacist’s full breadth of knowledge. When the pharmacist works closely with the rest of the health care team that prescribe and care for patients, patients recover faster, experience less pain, do not experience ADEs, all with reduced cost to the hospital.
Although the hospital may have to invest in equipment and possibly in renovations, they can still achieve a financial benefit from buying RIVA.
“We follow the regulations perfectly, so we don’t have a problem”
Even though pharmacies work hard every day to release safe I.V. doses for patients, ADEs still occur routinely.
Most pharmacies don’t currently have an impenetrable process for ensuring a dose is accurate and sterile. Most processes rely largely on “people checking people”, but people inevitably make mistakes. No human-based system can be 100% error-free. If the pharmacy never finds an error, then the checking system does not work or the pharmacy is ignoring the errors. If the pharmacy is finding errors, what is being done to prevent them? Due to hectic schedules, most pharmacies re-make the dose and keep going. It is far better to design the process to make the right dose from the start and then redundant checks are not needed.
Increasing compounding complexity inevitably increases the opportunities for errors to occur. One of the highest risk products to make is an I.V. bag of a diluted concentration. Many times, syringes may be drawn from such a bag which increases the number of patients affected. RIVA can compound the bag using gravimetric checks to ensure the proper concentration. The pharmacy can later give the bag as is to a patient, manually draw syringes from the bag or use RIVA to draw up the required syringes.
Sterility is always a concern where people are involved in the process. People are the largest contributors of dirt and particles in the cleanroom. Per USP<797>, 99.9% sterility is the highest level that can be achieved with manual processes. RIVA routinely undergoes a process validation of 3,000 media fills with no growth. It would likely be a challenge for a technician manually compounding to achieve that level of production with no contamination.
RIVA comes equipped with a patented Port Disinfection System (PDS) that uses high intensity pulsed ultraviolet light source specifically tuned to disinfect critical needle entry sites on vials and bags inside the RIVA compounding area before they are used for compounding. The PDS has been proven to perform a 6 log reduction for bacteria and a 2 log reduction for spores on these critical sites. The RIVA UV disinfection process has been shown to be at least as effective as careful, best-practice manual IPA (alcohol) wiping technique for the reduction of bacteria and spores.
The New England Compounding Center (NECC) tragedy in 2012 where 800 people were sickened and 64 died from infected doses proves contamination can occur even in the pharmacies that are meant to be held to the highest standards.
“There aren’t enough resources to add automation right now”
RIVA does not require a full time technician to run it. A technician is required to set up the orders, load the consumables, retrieve the completed doses and attend to any issues such as a stuck label. The technician can compound doses manually in the cleanroom while RIVA is running.
“Automation is too slow”
RIVA is designed to perform a large number of verifications during the compounding process – including barcode verification, electronically recording consumable images, and weight checks of consumables as well as the final CSP. People cannot keep track of all the data RIVA is processing every time it makes a dose. RIVA also records all that data for the pharmacy to have a full audit trail. If the compounding staff completed all the same verification steps RIVA performs on every dose, RIVA would be faster than the staff. RIVA does not take breaks, go on vacation or call in sick. Nor does it get tired and slow down or make careless errors that require costly re-work as its shift goes on.
Once automation is validated, there is a decreased need for final checks which increases the production rate.
Use of automated IV technology can reduce health care costs, improve reliability, reduce risk, free up resources and improve efficiency in the pharmacy. It may be worthwhile to set aside the myths and perform a personalized in–depth review of your pharmacy’s needs to see if IV automation can be a solution.
[1] Terry F. Urbine, PhD, and Philip J. Schneider, MS, FASHP. Estimated Cost Savings from Reducing Errors in the Preparation of Sterile Doses of Medications, Hospital Pharmacy. 2014;49:731-739.