Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and Patient - Packaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient s

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Vaccine Packaging at the Clinical Interface of Vaccine, Healthcare Worker, and Patient
Packaging vaccines using prefilled syringes can increase dosing efficiency, reduce costs, and improve patient safety. This article is part of a special section on vaccines.


BioPharm International
Volume 25, Issue 10, pp. 34-36


Brian Lynch
Vaccines are one of the greatest achievements in public health. A recent economic analysis indicated that vaccination of each US birth cohort with the current childhood immunization schedule prevents approximately 42,000 deaths and 20 million cases of disease, with net savings of nearly $14 billion in direct costs and $69 billion in total societal costs (1).


Philip Song
The success of vaccination, particularly in developed nations, has been based on public recognition of their benefits, access to vaccines, and continuing efforts to promote their use as an integral component of health and preventative care.

Despite these successes, opportunities remain to improve vaccination coverage in the US. In 2010, the National Vaccine Plan was revised and updated, setting vaccination goals and strategies aimed to ensure a stable supply of, access to, and better use of recommended vaccines in the US (2). Thus, any way to enhance or improve the systems to help ensure safe and more efficient vaccination should be pursued.

THE EVOLVING VACCINATION SETTING

The vaccination setting in the US is rapidly evolving from its traditional medical home to nontraditional ones, such as retail outlets, schools, and pharmacies. As an example, during the 2010–2011 influenza vaccination campaign, 18.5% of adults received their flu shot in a retail setting (3). Along with the change in the setting is a change in the profile of vaccinators in these new settings, with those individuals possessing different and varying clinical experience and education. Another reality is that the immunization enterprise is facing increasing cost pressures throughout healthcare. Furthermore, all vaccination venues are seeking opportunities to lower the costs of delivering vaccination.

To help ensure consistent, efficient, and cost-effective vaccinations, all means to simplify the vaccination process should be considered. In this light, the vaccine package—which plays an important role at the clinical interface between vaccine, patient, and caregiver—is increasingly viewed as a crucial component of vaccination. Today there are three types of vaccine packages in use: prefills (PFSs), multi-dose vials (MDVs), and single-dose vials (SDVs). Each package has different implications for clinical practice, efficiency and cost, and, potentially, patient outcomes.

EFFICIENCY AND PRACTICE IMPLICATIONS—A CLOSER LOOK

A 2010 time-motion study performed by The Johns Hopkins University Bloomberg School of Public Health demonstrated the safety and workflow advantages of PFSs (4). Investigators observed more than 1500 vaccine injection preparations, and determined time differences and subsequent cost differences associated with the use of PFSs vs. MDVs. They also observed preparation and handling practices.

Investigators found that preparing a dose using MDVs took 37 seconds longer than with PFSs because of the increased number of steps required to prepare a vaccine packaged in a vial. Assuming standard costs for materials and labor, researchers concluded that administration of vaccines via PFSs could save a clinic approximately $1100 per 1000 doses assuming the same price per vaccine dose.

More significantly, PFSs reduce the risks associated with deviation from best practices as established by the US Centers for Disease Control and Prevention (5). For example, researchers observed the following deviations from best practices with MDVs:

  • Neglecting to write on a vial the date it was opened
  • Not properly sterilizing the rubber stopper before withdrawing vaccine dose
  • "Trusting" memory for transcribing lot number
  • Predrawing the day before or using leftover predrawn syringes from a previous day
  • Predrawn syringes were often left out (not refrigerated) for long periods of time and, in some cases, for a whole day
  • Drawing vaccine from multiple vials, especially without checking if the lot numbers were the same (6).

By eliminating the preparation steps required with a vial, a prefilled syringe is simpler and easier to use. Vaccination workflow may be faster and smoother for clinicians and may improve speed of patient throughput.

An additional and important advantage offered by PFSs is that they come from the manufacturer, labeled by the manufacturer. All too often, syringes predrawn from vaccine vials are left unlabeled, or are subject to variable labeling practices, clinic by clinic or perhaps even clinician by clinician. This variability increases the risk of a wrong or improperly stored injectable vaccine being given; dosing errors also increase when vaccine is prepared and labeled by hand (7). Prefilled and prelabeled syringes avoid these errors and omissions, ensure accurate dosing, and offer clinics a ready-to-use, safe, and simple time-saving alternative to predrawing several vaccine syringes in advance.


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