Vaccine Update for Healthcare Providers

News and Views About Vaccine

• Wall Street Journal Highlights Outbreak Concerns Apr. 2012
• 2012-2013 Influenza Strains and Bill Moyers Essay Mar. 2012
• Two-Dimensional Barcoding in Pediatric Offices Feb. 2012
  • 1D versus 2D barcodes
  • 2D Barcodes and Patient Safety
  • 2D Barcodes and Practice Efficiency
  • Rollout of 2D Barcoding
  • Opportunity to Participate in Pilot Project
  • Additional Resources
• New Study Does Not Find Correlation Between Receipt of HPV Vaccine and Sexual Activity Jan.2012

Wall Street Journal highlights outbreak concerns

Charlotte A. Moser, Assistant Director, and Paul A. Offit, Director, Vaccine Education Center at The Children’s Hospital of Philadelphia

In March 2012, Vermont legislation to remove philosophical exemptions was not approved. In California legislators continue to hear protests to legislation that would require a doctor’s signature before a child could be exempted from vaccines. Efforts to easily exempt children from receiving vaccines continue despite numerous reports of vaccine-preventable disease outbreaks throughout the country.

At the end of March, an article titled “Where Could the Next Outbreak of Measles Be?” written by Valerie Bauerlein and Betsy McKay was published in the Wall Street Journal. The article presented an in-depth discussion of herd immunity and the “hot pockets” of concern throughout the country. In addition, the authors discussed recent outbreaks and interviewed multiple healthcare providers. A map of the 48 contiguous states provided a good visual of the pockets of concern.

Supporting materials posted online included two videos:

• New Outbreak Risks due to Low Vaccination Rates (4:26) – Interview with co-author Valerie Bauerlein
• A Brief History of Vaccines (4:57) – Christina Tsuei discusses how vaccines were developed using the story of smallpox.

Editor's Note: Consider referencing this article as you address vaccine hesitancy in your practice. We have posted links to the article and videos on our website in the “In the News” section, so that parents can easily access the article online. Just give them this vanity URL: http://vaccine.chop.edu/inthenews.

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2012-2013 Influenza strains and Bill Moyers essay

Charlotte A. Moser, Assistant Director, and Paul A. Offit, Director, Vaccine Education Center at The Children’s Hospital of Philadelphia

2012-2013 Influenza strains

In the midst of dealing with the current influenza season, albeit mild, it may seem odd to be thinking about next season’s influenza vaccine; but the vaccine manufacturers must start production now in order to have sufficient vaccine supplies ready by the fall. As such, each year the Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the Food and Drug Administration (FDA) analyzes influenza virus circulation in the Southern Hemisphere and determines which strains should be included in the next season’s vaccine.

In late February 2012, the FDA announced that two of the three strains of influenza virus contained in the vaccine will be changed for the 2012-2013 influenza season. Typically, the vaccine contains three strains – two A strains (H1N1 and H3N2 types) and one B strain.

The 2012-2013 version of the vaccine will include: 

• The H1N1-like A strain will remain the same; it is designated A/California/7/2009 (H1N1)-like virus.
• The H3N2-like A strain will be A/Victoria/361/2011 (H3N2)-like virus.
• The B strain will be B/Wisconsin/1/2010-like virus.

Although it will not be available for the 2012-2013 flu season, VRBPAC also approved a quadrivalent version that will include an additional B strain. This should enhance efficacy of the annual vaccine by inducing immunity to a fourth type of influenza virus.

Bill Moyers essay: Are Immunization Exemptions Fair to All?

In a brief video, Bill Moyers recently used the movie Contagion to discuss what would happen if the number of people choosing to exempt themselves from vaccines increased. Unfortunately, the comments that follow the episode are full of remarks blasting Moyers for the piece – in a sense, proving his point.

Check out the video»

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Two-dimensional barcoding in pediatric offices

Edward N. Zissman, MD, FAAP, Assistant Professor of Pediatrics, University of Central Florida College of Medicine and Co-Chair American Academy of Pediatrics Ad-Hoc Committee on Automated Identification of Vaccine Products

The new technology of 2D vaccine barcoding on individual vaccine vials and syringes, which launched in December 2011, is designed to reduce medical errors and help healthcare providers document vaccine information in patient records with greater accuracy. Vaccine barcoding not only can improve patient safety during the vaccine administration process, it also has the potential to greatly increase practice efficiency by automatically recording the required immunization information, assuring timely and correct chart entry, charge entry and registry submission, as well as streamlining management of vaccine inventory and ordering.

1D versus 2D barcodes

Currently there are linear (1-dimensional) barcodes on all vaccine vials and syringes. Linear barcodes do not include all of the information that practices are required to record in a patient’s chart. The 2D barcode includes:  

• Global Trade Identification Number (GTIN), which houses the National Drug Code and can be used to determine manufacturer and name of the vaccine
• Lot/Batch Number
• Expiration Date

Staff will still need to record administration site, route and administering personnel.

Changing to this technology constitutes a label change for manufacturers, which must be approved by the Food and Drug Administration (FDA). Thanks to meetings between the FDA, AAP and manufacturers, the FDA has set up guidance for manufacturers to apply for an exception to the linear barcoding rules for vaccines only. As of November 2011, manufacturer guidance has been finalized and applications for exceptions should follow soon. It is important to note that, at this time, 2D barcodes are only being promoted on the vaccine vial or syringe (unit dose). Because of federal efforts around serialization to prevent counterfeit drug distribution, the outer packaging of vaccines will not yet include this technology.

The Centers for Disease Control and Prevention (CDC) is also planning to add 2D barcodes to their Vaccine Information Statements (VIS), so the VIS publication date can be easily scanned into a medical record or registry.  

2D barcodes and patient safety

2D barcoding should benefit practices and patients by improving patient safety. Replacing manual data entry with an electronic system equipped with checks and balances helps to minimize the chances for error:  

• Recording lot numbers - Previous reporting to the Vaccine Adverse Events Reporting System (VAERS) contained numerous omissions or mis-recordings of lot numbers, making it hard to detect patterns or problematic lots.
• Use of expired vaccines - 2D barcoding can also help more easily identify and prevent any outdated or expired product from accidentally being administered to a patient.
• Allergies or contraindications - 2D barcoding can prompt alerts for patients with certain conditions.
• Use of appropriate vaccine - 2D barcoding can also serve as a double check that the vaccine being administered is truly the one ordered, decreasing the risk of medication delivery errors and duplicate vaccine administration.

2D barcodes and practice efficiency

Barcoding also improves practice efficiency translating into financial savings for practices. Built-in algorithms in electronic health records (EHR) or registries can determine timeliness of administration of a particular product and reduce wastage. Inventory control modules allow “just in time” ordering to decrease inventory on hand and increase the practice’s return on investment. Smaller inventories also mean decreased losses after power outages or other mishaps. Better electronic documentation of vaccine product administered can also increase revenue by decreasing “missed billing.” Additionally, Vaccines for Children (VFC) reporting should be easier if certain lot numbers can be coded as VFC when they enter the office. 

• Efficiency in billing - 2D barcodes will allow a practice to reconcile the physical count of vaccine product with vaccine product billed. Further, billing information can be linked to the correct patient or sent to the payer through a practice management system (PMS).
• Efficiency in maintaining inventory - Electronic Inventory Control could result in increased vaccination rates by improved product availability or control and reduction in errors if an alarm alerts the user when duplicate or inappropriate vaccine is ordered.
  
  With an EHR, the inventory module directs new vaccine inventory entry as a vaccine shipment arrives at the office. A vial from the shipment is scanned with verification that the lot number, expiration date, and product name and National Drug Code (NDC) have populated correctly.
  
  With no EHR, inventory control could be done through a PMS with a robust inventory module. When vaccine product is administered, the product is scanned into the PMS for billing as well as transmission to the immunization registry. At pre-determined intervals, the physical vaccine count can be reconciled with the vaccine products billed.
  
  The clinical process and workflow should improve once the learning curve is achieved.  

• Efficiency in VFC systems - Another potential advantage of 2D barcoding will be the separation of VFC and ‘Private Purchase’ vaccines. Although 2D barcoding alone is not able to separate VFC and privately purchased vaccines, by programming and assigning certain lot numbers or expiration dates to VFC or ‘private’ stock, EHRs or PMSs can assist with inventory control of each separate stock. When the vaccine (with lot number assigned in the EHR) is scanned for administration and the incorrect (VFC versus ‘private’) vaccine is scanned, the EHR vaccine inventory control system will alert the provider. Currently, providers rely on human recognition of alphanumeric lot numbers of multiple digits or some ‘in-office applied’ unique marking of the labels in order to keep the inventories separate.  
• Efficiency in using registries - This technology can be used to prepare data for the state registry. Time spent in duplicate data entry is greatly reduced as information which is currently hand recorded in the chart will be easily scanned into the registry. Further, providers can consider using the registry for clinical decision support to validate that the correct dose of vaccine is being administered.
  
  With no EHR, improvements might initially be less dramatic. Automated registry upload with automated data entry will be from the PMS. If the State registry does not support PMS upload, staff will have to log in to the registry, access the patient’s record, and scan the vial.
  
  States will also benefit from better identification of under-vaccinated areas (“pockets of need”) in order to target these areas for intervention and be aware of places at high risk for disease or outbreaks. Practices would more easily access the reminder/recall and decision-support tools that some registries offer.
• Efficiency in vaccine delivery -
  • With an EHR, when the patient enters the facility:
    • Reception staff can access either the state immunization registry or the EHR to determine if the patient is in need of any immunizations.
    • If so, staff can offer the parent/patient appropriate VIS sheets and suggest they review them and discuss any questions or concerns with the physician or nurse. This step helps to avoid missed opportunities and is another way to give the message that the office cares about a family’s concerns.
    • When the patient is examined, the physician or other appropriate professional can order the immunization(s) to be administered. The EHR checks the order against the patient’s record for verification of need (algorithm checks for interval, duplication and appropriateness).
    • Staff receives the order, obtains the vial and scans it to determine if it is the correct vial by matching it to the order.
    • Performing the scan from the patient’s ‘chart’ enters the immunization into the patient’s permanent record, uploads it to the registry, and subtracts the dose from the practice inventory.
    • Vaccine and administration are billed electronically through the practice management system.
  • With no EHR, when the patient enters the facility:
    •  The physician or other provider orders immunization(s) to be administered.
    • Staff receives the order, verifies the need by checking the patient record or state registry, obtains the vial and scans it to determine if it is the correct vial. If peel off label is available, it could be pasted onto the immunization log in the paper chart or a new immunization log could be printed.
    • Scanning the barcode automatically enters the record of administration and charges into the PMS when the patient’s account number is entered and automatically subtracts the dose from the PMS inventory module if operable.

Rollout of 2D barcoding

While 2D barcoding is being rolled out, offices will likely have a combination of vaccines that do and do not have 2D barcoding. Electronic systems need to be prepared to handle both manual data entry and the scanned entry. Some practices may choose to create their own barcodes for products without 2D in the interim. Talk to your software vendors about how to accomplish this.

The technology will first be introduced on two Sanofi Pasteur vaccines:  

• Pediatric Diphtheria and Tetanus Toxoid Adsorbed (DT) vaccine,
• Menactra® Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate vaccine

Other vaccine manufacturers are expected to begin launching products with 2D barcodes later this year.  

In 2011, the CDC launched a pilot project designed to assess challenges and determine best practices for labeling and tracking vaccines using 2D barcodes. The pilot will test implementation of 2D barcodes on selected vaccines, and evaluate the impact of 2D barcoding on manufacturers, immunizers and reporting systems. Participants in the pilot will receive scanning devices, software and training. The pilot project will also address implementation opportunities with electronic health records and state immunization information systems.  

Opportunity to participate in pilot project

The project is enrolling:  

• One to three manufacturers
• 10 states/grantees
•  300 public, private and commercial immunizers

The team is looking for participants from Alaska, Florida, Iowa, Michigan, New Jersey, New York, New York City, Oregon, Washington and Wyoming, who will report to their respective state/grantee registries. Those interested in participating should e-mail 2Dbarcodepilotinfo@CDC.gov.

The enrollment process for manufacturer, grantee and immunizer candidates is expected to be completed by the end of February, after which time equipment will be installed and participants will be trained. The pilot is anticipated to begin in August of 2012 and will be conducted for eight months. The AAP is a partner on this project and will share information as it becomes available. A recent symposium, CDC 2D Barcode Vaccine Manufacturers Forum, was held at the CDC with full participation by the many stakeholders.

Vaccine barcoding example

Additional resources

Guides for additional information about 2D barcoding are available:

• For clinicians - Final document was approved on 12/21/11 and includes information on getting your office ready and choosing a scanner.
• For manufacturers - Final document will be available shortly and will include guidance relating to the technical aspects of adding standardized 2D barcodes to packaging.

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New Study Does Not Find Correlation Between Receipt of HPV Vaccine and Sexual Activity

New study does not find correlation between receipt of HPV vaccine and sexual activity

In January 2012, researchers from the Centers for Disease Control and Prevention (CDC) published a study evaluating the relationship between receipt of human papillomavirus (HPV) vaccine and sexual activity (Liddon NC, Leichliter JS, Markowitz, LE. "Human Papillomavirus Vaccine and Sexual Behavior Among Adolescent and Young Women," Am J Prev Med. 2012 Jan;42(1):44-5.

To put this study in perspective, following licensure of HPV vaccine in 2006, several concerns were raised. The media carried stories claiming that HPV vaccine caused chronic fatigue syndrome as well as blood clots with consequent strokes and heart attacks. However, post-licensure studies have exonerated HPV vaccine as a cause of any of these severe adverse reactions. Another question that was raised was whether receipt of HPV vaccine would cause adolescents and young women to increase sexual activity. To answer this question, CDC researchers surveyed 1,243 women between 15 and 24 years of age. Not surprisingly, they found "no association between HPV vaccination and risky sexual behavior."

In truth, the concern about increased sexual activity following vaccination never made much sense. First, no vaccine is 100 percent effective. Second, the HPV vaccine doesn’t prevent all types of HPV. Third, the HPV vaccine doesn’t prevent other sexually transmitted diseases, such as Chlamydia, herpes, gonorrhea, or syphilis. Still, the concern persisted.

The HPV vaccine has been recommended for routine use in 11- to 13-year-old girls for about five years. Unfortunately, uptake has been poor. Only about one-third of those for whom the vaccine is recommended get it. With this latest study, clinicians can offer further reassurance about this much-needed vaccine.

Listen to Dr. Offit discussing this paper in a short video on Medscape»

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