Unit Dose Repackaging Tips

September 2021 - Vol.18 No. 9 - Page #6
Category: Unit Dose Pharmaceuticals

TIP #1

Repackaging for Cost Savings

A thorough analysis of medication repackaging options can elicit opportunities for cost savings. While the goal of most pharmacies is to purchase as much inventory as possible in bar coded unit-of-use, savings may be realized by identifying high cost items and then reviewing both in-house and outsourced repackaging options. To ensure fiscal responsibility, target the top 10-20% of costly unit dose drugs that would deliver strong margins if purchased in bulk rather than unit dose. The additional costs of packaging materials, technician and pharmacy salaries, and time required must be included as part of the analysis. If the margins are significant, but the staff requirements are too steep, consider the use of outsourced repackaging vendors.

For more information, see A Comprehensive Approach to Unit Dose Packaging

TIP #2

FDA’s Expiration Guidance

The last few decades have seen an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which allow for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products. This guidance describes the circumstances under which FDA generally does not intend to take action regarding required stability studies for these repackaged products and appropriate expiration dates under those circumstances.

The full FDA document is available at: https://www.fda.gov/media/70985/download/

TIP #3

Selecting an Outsourced Repackaging Vendor

Since repackaging is the sole focus of the outsourced vendor, these sources offer the expertise, equipment, staff training, and knowledge of specific repackaging regulatory requirements to ensure safety and quality.

When choosing a repackaging vendor, consider the importance of performing due diligence, including a site visit. The vendor must be compliant with FDA guidance and state board of pharmacy requirements, as well as USP regulations. Quality considerations should include how the vendor maintains standard operating procedures, handles complaints, ensures quality control, and trains staff. In addition, investigate how long the vendor has been in business and ensure its licensure is current and liability insurance is in place. Search the vendor’s history for FDA warning letters and any product liability claims, and review its recall policies and procedures. Finally, be sure to discuss contract length, billing and payment terms, and turnaround time.

For more information, see Assessing Unit Dose Packaging Options

TIP #4

Staff Training for Unit Dose Packaging

While operating unit-dose repackaging machines is a fairly uncomplicated process, thorough training for new technicians is necessary to ensure proper technique and efficient in-house repackaging workflow. It is important to explain the purpose of the repackaging process, how the machines work, proper technique, what information must be included in the labeling, and the cleaning and maintenance process for the machines. For example, it is critical that the technician perform the steps in the correct order, that they verify that there is enough tape for the job, and that the plates are clean. Establishing a checklist will help ensure the technician follows the process in proper sequence. In addition, provide training to a sufficient number of staff to create redundancies, so that unexpected FTE changes do not impact your ability to supply medications in unit of use. Training should extend beyond technicians to include pharmacists as well, in the event that it is necessary for the latter to assist in order to keep up with workflow.

For more information, see Develop a Unit Dose Packaging Strategy

Deanne Halvorsen is the editorial director and founding partner of Ridgewood Medical Media, publisher of Pharmacy Purchasing & Products and MedicalLab Management. She can be reached at dhalvorsen@ridgewoodmedia.com.


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