Vaccine Presentation in the USA: Economics of Prefilled Syringes versus Multidose Vials for Influenza Vaccination

Claudia C Pereira; David Bishai

Disclosures

Expert Rev Vaccines. 2010;9(11):1343-1349. 

In This Article

Safety

Safety is a top concern in vaccination. Paradoxically, there is idiosyncratic variation in the way vaccines are administered, reflecting peculiarities in the way a task can be performed from practice to practice. Although the CDC has issued guidelines for best practices in vaccine administration,[102,103] it is left to individual practices to achieve guideline adherence. Unsafe injection-related practices may not be recognized, but when observed should be obvious and the magnitude of the consequences of unintended deviant practices may not always be understood.[10] According to research conducted at the CDC, improper handling of injectable medications can lead to infections and other severe outcomes in patients.[104] The research from the CDC presented at the Fifth Decennial International Conference on Healthcare-Associated Infections 2010 showed that nosocomial infections can result from inadequate injection safety practices, and such events could be prevented by safer practices. Some of the unsafe practices were related to hygiene and improper storage and labeling. For instance, the CDC identified as safety breaches the use of multidose medications that were accessed multiple times with nonsterile syringes and needles.[105]

The National Center for Immunization and Respiratory Diseases (NCIRD) of the CDC strongly recommends that healthcare workers draw the vaccine only at the time of administration to reduce errors and ensure that the cold chain is maintained and that vaccine is not inappropriately exposed to light.[106] Problems noted by the NCIRD in regard to the practice of drawing vaccine at times other than immediately prior to patient injection (e.g., 'predrawing') include:

  • Misidentification of the contents of an unlabeled syringe;

  • Vaccine wastage;

  • Bacterial contamination, especially of vaccines from single-dose vials that do not contain bacteriostatic agents;

  • Possible reductions in potency from interaction between the plastic syringe and vaccine components;

  • Inability of the person administering the dose to be sure of the composition and sterility of the product.

One example of a medication-switch error happened in January of 2010 in Massachusetts (USA) where several staff members at an elementary school had to be taken to a hospital after being injected with insulin rather than the H1N1 vaccine.[107] In addition, during observation of the clinics for this study, numerous guidelines were not adhered to (further details of these observations are discussed in the results section). Better vaccine and medication labeling, as well as the use of antigens that cannot be predrawn in advance and left in refrigerators with no labeling, would be key factors to counter such events. Furthermore, adequate recording of lot numbers would ensure proper information in the case of adverse events. Recording the correct lot number in the medical record and/or in the patient vaccination card is a task made easier by PFSs in comparison with MDVs because PFSs have a detachable label in the package.

The results of a qualitative survey conducted at five European hospitals showed that approximately 95% of participating hospital workers found PFSs more convenient to use and handle than vials or ampoules, and that PFSs saved time during injections. Furthermore, 67% found PFSs more convenient to discard. Other aspects of PFSs that were highlighted by healthcare professionals were: decreased risk of dosing errors, smaller risk of microorganism transmission to the patient and lower risk of injuries for nurses.[3] The study by Hirayama and Kuroyama in Japan showed that PFSs avoided wastage, made inventory control easier, lowered the risks of nurses making a mistake and also enabled quicker responses in emergency situations.[1] In summary, current literature indicates that PFSs have the potential to be safer and more efficient than vials. But there have been no studies from the USA to support a systematic comparison. This was our rationale for studying the time required to administer vaccines via vials versus PFSs.

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