A Comprehensive Approach to Unit Dose Packaging


May 2019 - Vol. 16 No. 5 - Page #14

Q&A with Arpit Mehta, PharmD, MPH
Director of Pharmacy
Allegheny General Hospital
Pittsburgh, Pennsylvania

Pharmacy Purchasing & Products: What strategies does Allegheny General Hospital pharmacy utilize to provide patients with medications in unit of use?

Arpit Mehta, PharmD, MPH: Our goal is to provide patients with all of their medications in bar coded unit of use. To achieve this objective, multiple strategies are necessary. The simplest approach is to purchase as many medications as possible in bar coded unit of use. However, not all medications are available in this form, and some that are offer significant cost savings when purchased in bulk and then packaged in-house using a tabletop repackaging machine or manual methods, or when sent for repackaging to an outsourced service. Thus, Allegheny General Hospital utilizes a combination of these approaches to provide patients’ medications in unit of use.

Historically, we have purchased as many medications as possible in unit of use and then utilized in-house repackaging for the majority of medications that are not available in unit dose. However, a recent financial analysis demonstrated an opportunity for significant savings by expanding our use of outsourced repackaging. Our plan moving forward is to increase the number of medications we are repackaging, and rely on an outsourced vendor to
accomplish this.

After performing an analysis of the costs involved in the various repackaging options, pharmacy determined that purchasing in bulk and outsourcing the repackaging process would provide considerable savings, compared with purchasing medications in bar coded unit of use. In fact, we project an annual savings of approximately $400,000 by using the repackaging service compared with purchasing in bar coded unit of use. The analysis also identified the potential for an additional savings of $100,000 per year were we to shift repackaging in-house using our tabletop repackaging machine for these same medications; however, we do not have sufficient operational capacity in-house at this time to consider such an approach.

To assure fiscal responsibility, pharmacy presents a savings plan annually to hospital administration. This year, we have identified opportunities for savings regarding medication repackaging. Our long-term goal is to target the costliest 20% of unit dose drugs that would deliver the most significant savings when they are purchased in bulk and repackaged by the outsourced vendor. To launch this initiative, we are currently focusing on the top 10% of drugs that will deliver the strongest margins by purchasing in bulk versus unit dose.

When developing a strategy to provide safe, cost-effective unit dose medications to patients, be sure to consider expenses in their entirety. While repackaging medications in-house may be more affordable than purchasing in unit of use, the cost of the materials is not the sole consideration—it is also necessary to take into account the salaries of the technicians performing the repackaging and the pharmacists checking the medications, the time required for repackaging and verifying accuracy, and the potential for errors compared with purchasing in unit of use.

Finally, it is critical to note that regardless of the strategies chosen to provide patients with medications in unit of use, the need for manual repackaging will never be completely eliminated. For example, although we attempt to purchase oral chemotherapy, other hazardous drugs (HDs), and medications that may cause allergies in bar coded unit of use, some are simply not available in this form. Therefore, Allegheny General Hospital manually repackages oral chemotherapy in unit dose blister packs, as these medications cannot be repackaged using the tabletop repackaging machine due to risks associated with HD residue. Our approach is to manually repackage all drugs that appear in Table 1 and some medications (based on evaluation) from Tables 2 and 3 of the NIOSH HD list, if they are not available in unit dose.1 Common allergens, including penicillin and sulfonamide antibiotics, are also manually repackaged.

PP&P: What were your considerations for choosing a vendor to supply the necessary tools to support safe and efficient manual unit dose packaging?

Mehta: We evaluated a variety of tools and chose a solution that is effective, simple, and convenient. Moreover, the system does not require extensive staff training. Featuring a blister-pack design with clear labeling, it offers various color-coded options to distinguish HDs from non-HDs. The bar coded labels are configurable to include all the required information: drug name, NDC number, lot number, expiration date, and hospital name. Because some medications require light-sensitive or tamper-evident packaging, we made the decision to employ these options for all of our manually repackaged medications. Standardizing the packaging simplifies the process for our technicians, as it eliminates the need to remember which products get special packaging and there is no need to switch packaging during a run.

The software that accompanies the system is easy to use; once we built the formulary at one hospital, we rolled it out throughout the health system. Robust documentation was one of our most critical requirements; the software includes a searchable electronic log that facilitates the efficient location of medications, which is especially important in the event of recalls.

PP&P: What staff training is provided?

Mehta: Repackaging in-house, whether manually or using the tabletop repackaging machine, may seem from the outside to be a simple task that does not require much effort, but this is simply untrue. When errors occur, they are typically the result of insufficient training or practice drift. In addition to extensive pharmacist oversight, it is crucial to provide staff with sufficient training and emphasize the importance of maintaining alertness throughout every step of the repackaging process.

To ensure safety, pharmacy focuses on standardizing the repackaging process to the greatest degree possible. To achieve this, we utilize a small group of seven expertly trained repackaging technicians who are the only staff members permitted to perform repackaging tasks. We developed a repackaging policy and procedure that includes images of each step of the process. Once the policy and procedure is developed, it is key that the training competency be created from this document to avoid practice drift. Both the policy and procedure and the training competency tools have been crucial to properly training staff. Staff members must pass the competency evaluation when they are first hired and trained, as well as annually thereafter. Important tasks include changing out the materials in the repackaging machine, ensuring that each tablet is packaged correctly (eg, that there are no missing or double doses), and that each packet contains the correct medication.

Pharmacist verification is key to ensuring accuracy; to prevent distractions during this process, verification has been standardized to specific times throughout the day. Because technicians may repackage hundreds of medications each day, error prevention requires that the pharmacist checking the medications remain vigilant.

PP&P: What are the principal benefits of manual unit dose packaging?

Mehta: We are confident that our staff training and standardization efforts result in a comprehensive, safe approach to in-house, manual repackaging. Clearly one of the most significant benefits of manually repackaging medications is the substantial cost savings this practice confers. However, with limited staff available for repackaging duties, it is critical to balance cost savings with the organization’s capacity to repackage medications into bar coded unit of use.

FDA’s draft guidance for expiration dating of unit-dose repackaged solid drug products is available at: www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070278.pdf.


Reference

  1. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings, 2016. US Department of Health and Human Services, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication Number 2016-161 (Supersedes 2014-138). www.cdc.gov/niosh/docs/2016-161/pdfs/2016-161.pdf?id=10.26616/NIOSHPUB2016161. Accessed March 19, 2019.

Arpit Mehta, PharmD, MPH, is the director of pharmacy at Allegheny General Hospital in Pittsburgh, Pennsylvania. He received a PharmD from Lake Erie College of Osteopathic Medicine School of Pharmacy in 2012 and completed a PGY1/PGY2 health system pharmacy administration residency at West Penn Allegheny Health System. Arpit received his MPH from University of Pittsburgh–Pitt Public Health in 2013. His professional interests include leadership development, health system pharmacy administration, pharmacy informatics, and preceptorship/mentorship.


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