Prefilled syringe use offers advantages that can help pharmacists improve quality of care.
Overview
The use of manufacturer-filled syringes (prefilled syringes [PFSs]) for vaccine doses offers many advantages to providers who are looking to better operational efficiency, minimize risk, and improve patient safety in the clinical administration of vaccines. The growing recognition of the advantages of PFSs has resulted in a major shift in the marketplace away from the use of multidose vials (MDVs) for all vaccine types, but most significantly, influenza. The percentage of flu vaccine packaged in prefilled syringes more than doubled, from about 21% during the 2006-2007 flu season to approximately 48% during the 2012-2013 season.1

While PFSs have been widely adopted in the broader market, retail-based clinics (RBCs) have lagged behind. Unlike other clinical settings, RBCs have storage constraints that may need to be overcome to allow the wholesale stocking of PFSs compared with MDVs, which have a much smaller footprint.

About PFSs
It is essential to understand how PFS doses differ from vaccines packaged in MDVs. PFS doses offer a means for vaccine delivery that supports RBCs’ ability to:
Reduce or eliminate vaccine waste. PFS packaging can help ensure doses purchased are administered. PFSs remove the variation inherent in drawing from an MDV, where the yield obtained may be fewer than 10 doses per vial.2
Increase administrative consistency. Some clinicians are more adept than others at drawing from vials in terms of time and dose yield per vial, resulting in variation across an organization. By removing the need to draw at all, prefills allow for consistency in administration across all locations and clinicians.
Improve efficiency. Because prefills do not need to be drawn up, the amount of time required to prepare is decreased. Studies support that when PFSs are compared with MDVs, prefills save between 37 and 43 seconds per dose in preparation time.
Increase patient safety. The use of PFSs improves patient safety, as supported by the Centers for Disease Control and Prevention, which recently updated its vaccine preparation guidelines3 to highlight the benefits of utilizing PFSs over MDVs, particularly in busy clinic settings. With their inherently simple design, PFSs do not have to rely on consistently flawless techniques and aseptic practices to reduce injection-related risks.

Additionally, some patients are now specifically seeking preservative-free vaccine options. Due to the nature of the packaging, no preservative is needed for PFS doses, allowing RBCs to readily meet competitor offerings and patient demand.

Challenges and Opportunities for Utilization of PFSs
2011 Pilot: Partnering with The Little Clinic to Gauge Clinician Preference

In 2011, The Little Clinic (TLC), a retail‐based clinic operation with 90 locations across 6 states (Arizona, Colorado, Georgia, Kentucky, Ohio, and Tennessee), partnered with the Convenient Care Association (CCA) and BD, a PFS packaging manufacturer, to pilot the use of PFS influenza doses in order to understand clinician preference relative to vaccine packaging and storage. At the end of that flu season, clinicians were surveyed, with the results showing an overwhelming preference for PFS doses over MDVs, based on ease of use and preparation and improved clinical safety compared with MDV use. With such a positive clinical response, TLC decided to further explore what changes would be needed to adopt PFS doses wholesale across its organization.

The Little Clinic: Use of PFSs During the 2012-2013 Flu Season
In 2012, TLC embarked on a project to determine how to operationalize the use of PFS doses for its 2012‐2013 flu season. Facing storage space constraints, operational and inventory-management process challenges, and changes that would need to be made to ordering and inventory management processes, TLC partnered with CCA, vaccine manufacturer Sanofi Pasteur, vaccine distributor Vaxserve, and BD to examine and implement these. The Verden Group (a health care consulting firm) studied the steps involved in the ordering, stocking, and administration of PFS influenza vaccine doses over the course of the flu season.

In order to facilitate the transition from exclusively using MDV flu vaccine doses, as done in prior years, to a mix of 80% PFS and 20% MDV doses for the pilot study, TLC made several adjustments to ordering, inventory management, and administration processes. It was also important to quantify the efficiency gains inherent in PFS use.

Operational Change and Inventory Management
TLC modified several aspects of its operations to successfully implement the stocking and administration of PFS flu vaccinations. Those operational changes included ordering, invoicing, and storage processes.

Ordering
The biggest difference between utilizing PFS doses and MDVs was the ordering frequency. When using only MDVs, a typical season might require that TLC order only once, receiving just 2 to 3 shipments of stock during a flu season. Stock in excess of what the individual clinics needed to have on site was held in storage, which required additional logistics and transportation to keep clinics supplied as stock was used up. With the change to PFSs, shipments were smaller because of the larger storage footprint of PFSs and the fact that refrigerators are generally small in RBC settings.

TLC inventory needed to be tightly managed to ensure that locations had sufficient stock. However, it was a fine balance between too much and too little, as overstocking a small refrigerator can compromise the cold chain. This situation required frequent monitoring of stock levels and more frequent ordering to ensure that there would be adequate levels on hand to meet demand.

Vaxserve and TLC were able to manage this process effectively by first moving to a weekly ordering process, then creating the ability to process twice-weekly orders, as necessary, for those locations that needed extra stock to accommodate periods of high demand during the peak of the season. This flow ensured that orders would be small enough to be accommodated at TLC locations, but also would arrive frequently enough (in some cases via overnight delivery) to ensure that locations did not run out of product. The ability to process small orders quickly and efficiently meant that the potential for overstock was minimized and the considerable time and manpower that had previously been spent managing large orders were saved.

Invoicing
Due to the increased frequency of orders required, increased overhead associated with invoicing was also addressed. Rather than have invoices triggered for every order placed, Vaxserve rolled invoices up into combined monthly statements for processing.

The pilot also revealed further opportunity to streamline the ordering process should TLC decide to continue its ordering relationship with Vaxserve, as the distributor utilizes an online ordering system that allows users different levels of authority. Individual clinicians at each location have the ability to enter stock amounts needed without additional ordering authority. The ability for those in the field to input inventory levels directly into the ordering system means significant time saved.

Storage
With the larger space requirements needed for storing PFS doses, TLC used the pilot as an opportunity to analyze its existing refrigerator capacity. In some cases, replacement equipment was purchased; in other cases, it was determined that much larger refrigerators could be accommodated with some minor retrofitting.

However, purchasing new refrigerators and renovating exam rooms requires a significant investment. In cases where only small refrigerators are available for use, care must be taken to manage inventory needs and store doses appropriately. If there is little opportunity within an RBC to incorporate larger refrigerators, or there is a preference to order less frequently, an RBC may want to consider storing a greater number of doses in locations that can accommodate large refrigerators, moving doses (per state requirements) to smaller sites as demand dictates.

Administrative Efficiency
In 2010, a time-motion study performed by The Johns Hopkins University Bloomberg School of Public Health4 demonstrated the safety and efficiency advantages of administering influenza vaccines using PFS doses. More than 1500 vaccine injection preparations were observed in order to determine time and cost differences associated with the use of PFSs versus MDVs. It was calculated that preparing a dose using an MDV took 37 seconds longer than when utilizing a PFS because of the increased number of steps required to prepare a vaccine packaged in a vial.

That 2010 study was based on observations during a “flu clinic.” That is, measurements were performed when clinicians were drawing up one dose after another in a uniform and uninterrupted manner in preparation for a high-volume flu vaccine administration event, a best-case scenario for the speed of MDV preparation.

In order to determine whether the same results and time-saving benefits could be replicated during a typical routine in the RBC setting, TLC agreed to allow The Verden Group’s consultants to observe preparation and administration of PFS doses on site at 12% of its locations. These PFS time-motion studies were compared with a baseline study of MDV drawing and administration times performed at 1 TLC location during the same time period. The findings corroborated the 2010 study: the average time saved during a typical routine in the RBC setting was calculated at approximately 43 seconds per dose.

One of the most significant opportunities for RBCs may be in translating the time saved directly to reduced wait times for patients, a critical success factor for those whose business model is fundamentally based on efficiency and convenience.

Cost and Revenue
Purchasing
It is important to source the best pricing for PFSs to minimize the variation in top line costs. There are always manufacturer discounts for volume and prompt payment; however, it is also prudent to check pricing with buying groups and alliances to ensure that you are securing the lowest cost per dose.

When calculating bottom line costs, in addition to noting the savings per PFS dose of 1 needle and 1 syringe, RBCs must also attempt to quantify the value of time saved to their organization. For example: in a survey of TLC clinicians about the potential 37 to 43 seconds saved per PFS dose over the administration of MDV doses, when asked to complete the following, “With the time savings accrued by using prefilled doses versus drawing up from multidose vials, on my busiest days that extra time allowed me to…”:
• 100% stated that using PFS doses allows for more time to be spent with patients
• 88% responded that using PFS doses would allow them to add an extra patient to the schedule (during high demand)
• 100% stated that by using prefills they are less hurried when performing clinical tasks
• 92% believe that using prefills reduces patient wait time.

This suggests a high probability of improved patient experience and the ability of an RBC to deliver on the efficiency promise inherent in its business model.

Improved yield realized through PFS use should also be quantified. In order to ensure a high yield from MDVs, organizations rely upon clinician skill in drawing up precise quantities from each vial. By comparing the number of doses purchased with the number of doses administered during previous seasons, wastage estimates can be calculated. In the case of TLC, 77% of clinicians surveyed reported that they routinely obtained fewer than 10 doses from multidose vials. Thus, we can conclude that the use of PFS doses maximizes yield and that any expense calculated for past wastage can be added to the cost-savings calculations.

Payment
Before transitioning to prefills, organizations should check with each of the insurance carriers with whom the organization participates to determine their reimbursement rates. Billing codes may vary between MDV influenza vaccines and PFS influenza doses, which may affect reimbursement.

Conclusion
Transitioning a vaccine business from vial doses to prefilled ones requires some forethought and planning; however, utilizing the tips and findings stemming from TLC’s experience will ensure a successful transition for any organization.


Eileen Myers, MPH, is vice president, affiliations and patient-centered strategies, The Little Clinic LLC.

Sarah Rosenberg, JD, is deputy director of the Convenient Care Association.


References
  1. Lynch B, Song P. Vaccine packaging at the clinical interface of vaccine, healthcare worker, and patient. BioPharm International. 2012;25(10):34-36.
  2. The Verden Group. TLC Clinician Survey—Experience in transitioning from multi‐dose vials to the use of prefilled syringe vaccines. November 2012.
  3. Centers for Disease Control and Prevention. Vaccine storage and handling. May 2012. www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html.
  4. Pereira CC and Bishai D. Vaccine presentation in the USA: economics of prefilled syringes versus multidose vials for influenza vaccination. Expert Rev Vaccines. 2010;9(11):1343-1349.