FMEA Action Plans for High-Speed Packagers

May 2011 - Vol.8 No. 5 - Page #8
Category: High-Volume Unit Dose Packaging Machines

In the central pharmacy at The Johns Hopkins Hospital, we prepare a daily cartfill for over 800 patients, sending out 5000 to 6000 patient-specific medication doses each day, with an additional 2000 doses sent to refill automated dispensing cabinets (ADCs). We use robot and carousel automation to enable our cartfill process, and 75% of our patient-specific doses are distributed by the robot. While this technology is essential to handle our workload, the time required to repackage and stock the robot is significant. In order to improve efficiency and free up staff to focus on patient-related tasks, we made the decision to purchase and implement a high-speed, high-volume, unit dose solid medication packager to supplement our distribution model.

Performing Failure Modes and Effects Analyses
Our new high-volume packager is currently used almost entirely to package for the robot. We have 350 line items in the robot and try to keep a three-day supply stocked; we also maintain a seven-day, offline inventory of our robot medications, from which we pull to restock. Monday through Friday, our technicians monitor and manage approximately 3000 daily doses of packaged inventory.

Prior to the implementation of our packager, a group of pharmacy staff, including the medication safety officer, a PGY-2 health-system pharmacy administration resident, and the operations manager (myself) reviewed the complete packager workflow in order to identify possible failure modes. Failures can occur due to staff error, deficiencies in the packager design, or both, and our goal in this pre-implementation phase was to identify those potential failure points and develop action plans to decrease the risks posed by them. Among the results of our analysis were the following key findings. 

Key Failure Risks and Attendant Action Plans
Failure Risk: Refilling Empty Canisters/Canister Refill Check Our most acute concern with this process was that a canister would be refilled with an incorrect drug, because once the canister is checked by pharmacy and placed back into the machine, it is unlikely the error would be caught by staff down the line. Many oral medications are visually similar, and after the tablets are packaged and labeled, it would be difficult to identify an incorrect medication. There are multiple points in the process of refilling empty canisters where errors can occur, such as the wrong medication being placed into the canister and the wrong data—including lot number and expiration dates—being entered into the database. If errors are not caught immediately, the potential for the wrong medication to reach the patient quickly escalates.

Action Plan: Change the workflow to prevent the wrong medication from being refilled into a packaging canister. 
Each canister is calibrated to accommodate a specific manufacturer’s medication, and the packaging canister is labeled with that NDC number, as well as a unique bar code. During the refill process, both the bar code on the source medication container and the bar code on the canister are scanned; a warning pops up to alert staff if the scans do not match. 

The next step we took to prevent canister fill errors was to affix a sample medication tablet in the lid of the corresponding container for reference. After refilling the canister, the technician places the lid of the canister face up with the reference pill visible next to the source container to allow the checking pharmacist to visually compare the pills to ensure that the correct medication is in the canister. In addition, the checking pharmacist enters the generic name, NDC number, and the expiration date and lot number of the medication into a refill history report to ensure the information entered matches the source container. Once the check is complete, the pharmacist signs off on the refill history report and places the lid back onto the canister to indicate that the canister has been checked. If any errors are discovered during the check, the canister is immediately isolated for correction.

Failure Risk: Returning the Canister to the High-speed PackagerOnce the canister is refilled and checked, it is placed back into the unit. Should the canister be placed in the wrong location within the packager, the corresponding medication would be packaged and labeled incorrectly.
Action Plan: Ensure accuracy when placing canisters back into the packager.Ideally, if the canister has been placed in the wrong slot, an error alert would be generated before packaging could begin, but currently our packager does not provide that functionality. To reduce the possibility of a canister being misplaced, we require two individuals to load the refilled canisters into the unit. The first individual reads aloud the number on the canister, and the second individual reads aloud the number listed in each individual storage slot into which the canister will be placed. Both parties observe and verify that the canister has been placed into the correct slot, thereby ensuring accuracy. 

Failure Risk:
Multiple Tablets or Missing Tablets in Packaging
Action Plan: Catch all empty packages and packages containing multiple tablets. 
To avoid producing empty packages or packages with multiple tablets, the technician carefully reviews the medications to see if any packages are empty or contain multiple tablets. Photos of incorrectly packaged medications are placed next to the unit to serve as a visual reminder for staff, and any such packages are immediately removed. Because there is also a small chance that tablets from one batch could overlap with the next batch, the packager precedes each new medication with a label pre-pack drug header—a blank, unit dose package that contains a description of the medication. The technician identifies the blank header that precedes the medication and separates the batches at that point. Lastly, the pharmacist checks the first tablet and the last tablet of each batch to confirm the same medication is in the entire batch, and initials the report verifying that the medications have been checked.

Failure Risk:
Special Tablet System (STS) Tray Packaging Process
The STS tray allows packaging of medications that are not packaged via the canisters. The tray has a capacity of 60 tablets, and once filled, the tablets are packaged just as they would be if they were feeding from a canister. Despite the simplicity of this action, it is possible to align the tray improperly causing packages to be produced incorrectly, either missing tablets or packaging multiple tablets into a single package.
Action Plan: Ensure the STS Tray Is Aligned Correctly
To aid this process, we labeled the tray with the word “top” at the top of the tray and “bottom” at the bottom. In addition, we added instructions on the right side of the tray stating that the tablet release should not be placed on that side. Similarly, a picture with a green check mark next to it was added to the left side of the tray to indicate that side is correct.

Maintaining Consistent Practices
Monitoring and managing these action plans to make sure staff are not bypassing procedures is an ongoing endeavor. To bolster training and education, the above-mentioned processes were documented in the policy and procedures manual created for our high-volume packager. Likewise, staff were trained on the importance of following proper procedures and the consequences to our patients if errors are made. There is ongoing monitoring by supervisors and administration to make sure staff adhere to the action plans, with corrective measures taken on those rare occasions when a staff member does not follow procedure. 

For ongoing compliance, we document and investigate all reported packaging errors to determine the cause, and to make this process more efficient, we add the technician’s name and packaging date to the label to better pinpoint where in the process any errors occurred. 

Packager Elements to Consider
If you are considering purchasing a high-volume, unit dose packager, it is important to understand how the vendor factors into ongoing maintenance. For example, with our packager, each canister is calibrated to a specific NDC code. If a drug is unavailable due to shortage, we can package another brand using the STS tray, but if the drug is permanently discontinued or a significant cost savings can be realized by purchasing a different product, the canister needs to be sent to the vendor for recalibrating. Since installing our packager two years ago, the process for recalibrating canisters has greatly improved. We use new online tools for selecting the new medication to assign to the returned canister, and turnaround time between sending a container to the vendor and receiving a recalibrated version is about one week. In working with this process, we now send canisters to be recalibrated immediately when a generic drug comes available or if our preferred brand has been discontinued; we also review our other canister/drug combinations quarterly to see if there is a cost justification for canister recalibration.

In addition to using the high-speed packager to stock the robot, we now use it to package medications to be stocked in our ADCs. This functionality is especially valuable when drug shortages develop suddenly. For example, we experienced a recent, sudden shortage of unit-dosed docusate sodium 100 mg capsules and our satellite pharmacies began to run out. In that case, we were able to package and distribute capsules we had in our central pharmacy to our other pharmacy divisions to support them during the shortage. When it comes to stocking our ADCs, we are beginning to expand the number of unit dose products available for that function. With a total capacity of 400 canisters available in the packager, we have plenty of capacity to add items as needed. 

As the hospital pharmacy environment becomes increasingly automated, additional technology must be added to support new projects, keeping in mind that many types of automation rely on each other to maximize performance. Our high-volume, high-speed packager has allowed us to keep up with the packaging demands of our robot, which in turn has improved our overall efficiency in quickly providing proper medications to patients. We are now starting to explore other ways in which the packager can be utilized, and are excited about expanding this technology to additional areas of our operation.

The author would like to recognize Dr. Bob Feroli and Dr. Morgan Walker for their participation in the FMEA.

David Stimler, PharmD, is an operations manager and clinical pharmacist at The Johns Hopkins Hospital in Baltimore, Maryland. He received his PharmD from the University of Maryland School of Pharmacy.


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