Case Study: In-House Unit Dose Repackaging


December 2015 - Vol. 12 No. 12 - Page #20

Florida Hospital (FH) in Orlando, one of the largest not-for-profit facilities in the US with 2,247 beds, is part of the 44-hospital Adventist Health System. FH treats more patients than any other hospital in the country, with more cardiology, neurology, and vascular surgery inpatients than any other nationally recognized hospital. FH is committed to dispensing medications in ready-to-administer dosage forms whenever possible, as recommended by the ASHP guidelines on preventing medication errors in hospitals.1 To this end, FH purchases the majority of its medications in ready-to-administer, unit-of-use form. However, some products are not available in unit of use and consequently must be repackaged in-house.

Approximately 25% of all solid and liquid oral medications utilized at FH are repackaged in-house using unit-dose packaging technology; the most commonly packaged medications include oral solutions unavailable in unit dose, such as Lovaza, Ranexa, Renvela, vancomycin oral solution, and vitamin B12. About 10% of our IV medications (eg, insulin bags and vancomycin) are compounded by a central distribution center that provides unit dose IVs to all seven Adventist Health System hospitals in Florida.

The Repackaging Process
Given its large size, repackaging a quarter of the medications utilized within FH is a time-consuming job that requires one FTE technician, Monday through Friday. When volume is particularly high, pharmacy students assist the packaging technician.

Proper training of technicians and students involved in repackaging operations is integral to maintaining a safe and efficient process. All staff members who will repackage medications receive training using our training manual and are required to pass a competency evaluation prior to engaging in any repackaging activities. Using a competency checklist is useful to ensure staff members understand the correct procedures and to document training (see FIGURE 1). Training occurs one-on-one, with the technician and trainer moving from machine to machine as the trainee demonstrates correct procedure to the trainer.  Certain staff members are designated as super-users, and are specially trained to add medications to the repackaging machine formulary and assist with repackaging challenges.

Three machines are used in the repackaging process: a solid unit-dose tablet repackager, a fluid unit-dose repackager, and a printer. When a medication enters the facility it is scanned by the buyer to ensure the bar code is in the BCMA system and that it scans correctly; if not, the buyer requests that the IT system pharmacy team add the bar code to the system. After the bar code has been added, the medication is sent to the technician in charge of repackaging, who again scans the bar codes on the bottle and the package as a secondary check and proceeds with packaging the medication. If the bar code is not in the system, the technician follows the procedure for adding and packaging the medication. The pharmacist then scans the prepackaged medication in the BCMA system, verifies that the manufactured bottle and the prepackaged label match, and signs off on the medication electronically in the unit dose packaging software system.    

The bar coding software is integrated with a drug data library, which includes medication imprints, NDC numbers, and images. The library also standardizes medication naming using Tall Man lettering, as recommended by ISMP.2 Although the drug library subscription is optional, it is highly recommended to ensure medication safety and the efficient addition of medications. The technician locates the medication in the drug library, prints the label, and packages the medication, which is then loaded into a queue to await pharmacist verification. Thereafter, the pharmacist scans the end product again, checks to ensure it is the correct medication and dose and that it has been properly packaged, and signs off. At the end of each shift, a report is run that shows all of the medications that have been packaged. The report is filed and saved for our records.

Click here to see FIGURE 1.

Troubleshooting
Maintaining a productive working relationship with the unit dose packaging machine vendor is critical to ensuring efficient packaging. Our vendor is proactive at addressing any issues and helpful when we have questions about our machines. Typically, challenges are resolved using screen sharing, which ensures swift resolution.

It is important that a backup system be in place in the event a repackaging machine goes down. In our case, the pharmacy created backup emergency labels that include all the necessary information about the drug and can be utilized if the repackaging machine is unavailable for any reason. When the manual labels are used, it is important to manually document this to ensure accurate records in the event of an audit or a recall.

Keeping the repackaging machines clean is critical to continued and efficient functioning. The technicians wipe down the machines each morning and in between each batch, and then clean them thoroughly at the end of each workday. In addition, the machines must be serviced regularly to keep them operating as intended; the vendor services our repackaging machines every 6 months. Experience has shown that the machines are extremely robust and can withstand continual use; however, components occasionally must be replaced.

Finally, collaborating with the hospital’s IT department is vital to ensure the necessary updates to the drug library. The library is updated every 3 months to ensure accuracy, but these updates will not run if an IT security firewall prevents Internet access. Working closely with the IT department ensures they are aware of our requirements and that updates will run as required.

Looking Forward
The preponderance of drug shortages will likely increase the number of products that require repackaging in the near future. In the long term, the centralized distribution center will be designated to supply unit dose oral and IV vials for ADC replenishment, and expand its repackaging of medications that are unavailable in unit dose from the manufacturer. Centralizing the repackaging operation will improve efficiency and safety by creating standardization across all seven hospitals.

Until the centralized repackaging operation becomes a reality, purchasing as many medications as possible in ready-to-administer, unit-of-use form is the goal at FH. For those medications that require repackaging, effective management of in-house repackaging operations is integral to ensuring a safe medication-use process.

References

  1. ASHP Guidelines on Preventing Medication Errors in Hospitals. In: Best Practices for Hospital & Health-System Pharmacy. Position & Guidance Documents of ASHP. Bethesda, MD: American Society of Health-System Pharmacists; 2008;163-171.
  2. FDA and ISMP Lists of Look-Alike Drug Names with Recommended Tall Man Letters. https://www.ismp.org/tools/tallmanletters.pdf. Accessed November 12, 2015.

Jason Newberry, PharmD, CPh, is the IT clinical specialist pharmacist at Florida Hospital Orlando Pharmacy. He received his degree from Palm Beach Atlantic University. Jason’s professional interests include big data analytics and Lean Six Sigma methodology.

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