Vaccine Update for Healthcare Providers

News and Views About Vaccine

• Influenza Update Dec. 2012
• Global Routine Vaccination Coverage, 2011 Nov. 2012
• Update on Vaccine Shortages and Vaccine Storage and Handling Oct. 2012
• CDC Releases National Immunization Survey Data for Infants, Kindergarteners and Teens Sept. 2012
• Pertussis, Novel Swine Influenza and West Nile Virus Aug. 2012
• Updates Regarding Pneumococcal (high-risk adults), Influenza (children less than 9) and Hepatitis B (healthcare workers) Vaccines July 2012
• Vaccine Storage Temperatures June 2012
• Vaccine Shortages, 2D Bar Codes on MMR VIS, and Screening and Treatment Updates May 2012
• 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

Influenza update

National Influenza Immunization Week (NIIW) was the week of December 2. One activity scheduled by the Centers for Disease Control and Prevention (CDC) was an influenza update for members of the press. While the transcript of the entire call is available online, the take-home messages were as follows:

Related to disease:

• Diagnoses of influenza are increasing throughout the country.
• This increase is about one month earlier than is typically observed.
• The predominant strain is H3N2.
• This earlier increase and the predominance of an H3-based strain are suggestive of a more severe season than we have seen in recent years.

Related to vaccine:

• This year’s vaccine strains appear to be a good match with those that are circulating in the community.
• Approximately 123 million doses of vaccine have been shipped throughout the U.S. and estimates suggest administration of about 112 million of these doses to date.
• About half of pregnant women have been immunized at this point, but the greatest predictor of which pregnant women will get the vaccine is directly related to whether their obstetricians are giving the vaccine in their offices.
• Regarding healthcare workers, about 80 to 90 percent of pharmacists, doctors and nurses have been immunized, but many allied health workers, aids and nursing-home personnel still need to get the influenza vaccine.

According to the report ending December 8, six children have died of influenza during the 2012-2013 influenza season.

Stay up to date on influenza rates and geographic spread as new data is posted weekly by the CDC on its FluView website.

Resources for patients

• Influenza-related information:
  • Vaccine Education Center - “Influenza: What you should know,” available in English and Spanish. Note that “Thimerosal: What you should know” is also available in English and Spanish should you encounter patients who are concerned about exposure to mercury.
  • CDC resources – various formats and options
  • Immunization Action Coalition - “When to seek emergency care” handout
     
• Personal stories and help with grief:
  • Families Fighting Flu is a group comprised of families personally affected by influenza, most often due to the death of a child following infection with influenza. Their website has many resources including informative webinars, video clips and public service announcements (PSAs), personal stories and a toolkit that includes resources on grief and emotional support following loss.
  • Other personal stories:
    • American Lung Association - “Faces of Influenza” campaign
    • Immunization Action Coalition - “Unprotected People” series
    • California Immunization Coalition – Shot by Shot - stories of families who have been affected by vaccine-preventable diseases.
• Not offering influenza vaccine in your office? Send your patients to the vaccine locator, offered by the American Lung Association, which allows patients to find locations offering influenza vaccine simply by entering their zip code.

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Global Routine Vaccination Coverage, 2011

The November 2, 2012 issue of Morbidity and Mortality Weekly (MMWR) provided annual rates of global immunization coverage during 2011. While global vaccine coverage is not something we might often consider as we try to get children in the United States immunized, it is important to realize how small the globe can be with the ease of international travel. Many countries do not struggle with a complex immunization schedule, but the healthcare providers in those countries might wish they did have such an issue because the truth of the matter is, if they are not struggling with the vaccinations, they are likely struggling with the diseases.

The Global Routine Vaccination Coverage report provides an opportunity to review the data from other immunization programs in other parts of the world:

• Coverage with three doses of DTP by 12 months of age serves as a good measure for vaccine coverage because DTP recommendations are among the oldest. In 2011, about 83 percent of children received the three recommended doses. While this coverage level is similar to previous years, the reality is that 22.4 million children throughout the world did not get three doses of DTP by 12 months of age. Of additional concern, 14 million did not even get a single dose.
• Of the children who did not receive the three doses of DTP, more than half of them were from three countries: India, Nigeria and Indonesia. Note that one of these three countries is also on the list of countries in which natural polio transmission has never ceased (Nigeria) and another (India) just celebrated one year without natural transmission in January 2012.
• Polio vaccine coverage (three doses) was estimated at 84 percent as was one dose of measles-containing vaccine.
• Vaccines for hepatitis B, Haemophilus influenzae type b, rotavirus and pneumococcus continue to be introduced in new areas around the world:

*Percent countries represents percent of 194 WHO member states offering the vaccine.

If you compare vaccine use around the world with the top causes of childhood mortality, you find that many of the leading causes of death in children could be decreased with an increased use of vaccines. For this reason, programs promoting vaccination in other countries are of the utmost value. And without much of a leap, the potential for those diseases to spread into the United States (e.g., international adoption, business travel, learning-abroad experiences) becomes obvious, necessitating continued vigilance in keeping families in our country – starting with families in our own practices – protected through vaccination.

Read the complete report

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Update on vaccine shortages and vaccine storage and handling

Vaccine shortages update

The CDC announced continued decreased supplies of Sanofi Pasteur’s Pentacel® and DAPTACEL® vaccines. The shortages are expected to last at least through March 2013. No changes are recommended for immunizations; providers can use individual vaccines (DTaP, IPV and Hib) or other combination vaccines containing DTaP and Hib. Additional guidance, originally published in May 2012, is available in the CDC’s “Guidance for Vaccinating Children During the 2012 Pentacel® and Daptacel® Shortage.”

Additional information:

• Stay current with CDC’s shortage announcements
• Site map for administering multiple vaccines

Vaccine storage and handling

The CDC recently updated the guidelines for vaccine storage and handling; major changes include:

• Temperature measurements should be made using either a biosafe glycol-encased probe or other buffered probe rather than measuring ambient air temperature.
• Temperature measurements should be via digital data loggers that operate at frequent programmable intervals over each 24-hour period rather than non-continuous monitoring. Twice daily monitoring by staff should still be continued.
• Refrigerator-freezer combination units should be replaced with stand-alone units designed for storage of biologics.
• Small, dorm-style or bar-style freezers may no longer be used for vaccine storage, even as a temporary storage location.
• Vaccine stocks should be rotated weekly and monitored for expiration.

Detailed descriptions of these requirements are outlined in an interim guidance document.

Additional information:

• Frequently asked questions related to interim guidelines
• Video guidance for proper vaccine storage and handling
• Related information on CDC’s website

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CDC releases National Immunization Survey data for infants, kindergarteners and teens

Each year the Centers for Disease Control and Prevention (CDC) conducts the National Immunization Survey (NIS) to monitor immunization rates throughout the country.  Data related to infants and teens are collected via random-digit dialing with a follow-up survey to providers to confirm data accuracy. Data related to kindergarteners are collected from health department reports.  All three of these reports were released in recent weeks.

Infants (19-35 months):

The 2011 survey covered children born between January 2008 and May 2010. Measures of vaccine coverage included at least one dose of MMR and varicella vaccines, at least three doses of hepatitis B and polio vaccines, and at least four doses of DTaP and pneumococcal vaccines. Likewise, full coverage for the Hib vaccine was also measured.

The following is a partial summary of data from 2010 and 2011:

*Up-to-date (routine coverage) included at least:  four doses of DTaP (or similar), three doses of polio, one dose of measles-containing vaccine, full series of Hib (three or four doses depending upon product used), three doses of hepatitis B, one dose of varicella, and four doses of pneumococcal.

To view the entire report or check coverage in your area, see the September 7, 2012 MMWR.

Kindergarteners:

Data reported was for the 2011-12 school year and was collected via departments of health. Vaccines measured included MMR, DTaP (or related), polio, hepatitis B, and one or two doses of varicella. Exemption rates were also reported.

*Exemptions increased from 1.1 percent in the 2009-2010 reporting period.

While coverage rates were relatively high, pockets of lower coverage are sources of concern.  Access the full report, published in the August 24, 2012 issue of MMWR to see how your state or area compares.  

Teens:

Data collected for the teen survey reflects the immunization coverage for adolescents born between January 1993 and February 1999. Vaccines measured included meningococcus, Tdap, HPV, influenza, hepatitis B and varicella. Below is a partial summary of data from 2010 and 2011 reports:

*History of disease or two or more doses.

Wide variability by state and vaccine continues to be a concern for public health officials. Access the full report to view data specific to your region in the August 31, 2012 MMWR. 

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Pertussis, novel swine influenza and West Nile virus

Pertussis continues to be diagnosed throughout the country. Increases in the number of cases have led to many questions related to why the disease is gaining momentum. Vaccine refusal, vaccine effectiveness, and the cyclical nature of the disease have all been mentioned. Several items should be useful in understanding the situation:

• Dr. Offit on Medscape – “What the US Needs Now: Pertussis Boosters”
  Note that Dr. Offit will also address this issue in the upcoming VEC webinar
• CDC Telebriefing – Pertussis Epidemic in Washington State
• Article in Journal of the American Medical Associastion – Number and Order of Whole Cell Pertussis Vaccines in Infancy and Disease Protection

Novel swine influenza

The Centers for Disease Control and Prevention (CDC) recently provided updates regarding cases of a novel strain of swine influenza circulating in the United States. Since July 2011, numbers of people infected with a novel variant of influenza A, called H3N2v, have been increasing. Most of these were reported in recent weeks. Importantly, the recent cases occurred in only four states — Ohio, Indiana, Illinois and Hawaii — and all involved people who had recently been around pigs. However, given that this is the time of year for many state fairs and considering the recent jump in cases, providers should be aware of the following:

• Only 2 people have been hospitalized this year and no one has died; however, CDC officials expect to see additional hospitalizations, particularly in people who have conditions that increase their risk for influenza.
• Clinically, patients cannot be distinguished from people with seasonal influenza.
• Many cases have been in children.
• This strain is similar to the 2009 pandemic H1N1 strain in a gene that codes for a matrix protein on the viral shell. Because the “variant” gene is related to viral replication and release, the potential for it to transfer from pigs to humans is higher.
• Unfortunately, the variant strain is not similar enough to the 2009 H1N1 pandemic strain or either of the other two strains in this year’s vaccine to expect much cross-protection.
• Thus far, no sustained human-to-human transmission has been found, but the CDC will continue to monitor trends and expects a low number of exposures through this means.
• Farmers or others who may come in contact with pigs should be advised to:
  • Wash their hands before and after coming into contact with pigs
  • Refrain from eating or drinking in areas that contain pigs
  • Avoid close contact with pigs that appear to be ill
• People at increased risk of serious complications from influenza should be advised to avoid contact with pigs; these groups include:
  • Children younger than five years old
  • Adults who are 65 years or older
  • Pregnant women
  • People with chronic illnesses such as asthma or heart disease
• Oseltamivir and zanamivir appear to be effective against this variant.

For more information:

• CDC’s telebriefing»
• MMWR»
• FluView Updates»
• “Healthy Fairs” Webinar by United States Department of Agriculture’s 4-H National Headquarters, Division of Youth & 4-H, National Institute of Food and Agriculture»
• CDC Spotlight»
• Fact sheet for patients and families»

West Nile virus

The CDC recently announced that West Nile virus infections have been reported in 42 states this year. As of August 1, 2012, 241 cases and 4 deaths had been reported. Most cases (80 percent) were from Texas, Mississippi, and Oklahoma.

West Nile virus is transmitted by the bite of a mosquito and results in fever, headache, body aches, joint pains, vomiting, diarrhea or rash in about 20 percent of infected individuals. People at greater risk include those 50 years of age or older and people with the following conditions:

• Cancer
• Diabetes
• Hypertension
• Kidney disease
• Organ transplants

Read the CDC’s press release»
Read more about West Nile Virus»
Print out CDC Fact Sheet for your patients»

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Updates regarding pneumococcal (high-risk adults), influenza (children less than 9) and hepatitis B (healthcare workers) vaccines

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

At the end of June, members of the Advisory Committee on Immunization Practices (ACIP) met at the Centers for Disease Control and Prevention (CDC) in Atlanta. Two votes were taken during the meeting that will impact vaccine delivery; one related to the use of pneumococcal vaccine in high-risk adults and the other, the use of influenza vaccine in children less than 9 years old.

Pneumococcal vaccine for high-risk adults

The ACIP recommended one dose of the conjugate pneumococcal vaccine (PCV-13) for adults 19 years and older at high risk of invasive pneumococcal disease such as those who have:

• Functional or anatomic asplenia
• Renal disease
• Cerebrospinal fluid leaks
• Cochlear implants

The suggested paradigm for offering vaccine was as follows:

• Patients who never received any doses of pneumococcal vaccine: One dose of PCV13 followed by two doses of the polysaccharide version (PPSV23); one eight weeks after first receipt of PCV13 and one five years after the initial dose.
• Patients who previously received PPSV: A one-year period should be allowed between previous dose of PPSV and a subsequent dose of PCV13.

No routine recommendation was made for adults 50 years and older even though PCV13 is now licensed for this age group.

Influenza vaccine for children less than 9 years old

Two of three strains of influenza in the 2012-2013 vaccine will be different from last year’s version. As a result, the ACIP voted to revise the practice standards for vaccine delivery to children less than 9 years old:

• Those who have never had influenza vaccine or for whom receipt of two doses since 2010 is questionable, should get two doses of the 2012-2013 influenza vaccine separated by at least four weeks.
• Children who have received two doses since July 2010 require only one dose.

Meeting minutes and formal recommendations have not yet been published. Slides from the meeting can be viewed on the CDC website.

Also, the CDC has published updated versions of the influenza-related Vaccine Information Statements (VIS) for the 2012-2013 season. Be sure your office is using influenza-specific VIS dated 7/2/12 when you begin administering influenza vaccine in the fall.

Hepatitis B-infected healthcare workers

In the July 6, 2012 issue of Morbidity and Mortality Weekly (MMWR, Vol. 61, No. 3), the CDC published updated recommendations for protecting patients from hepatitis B virus infection during “exposure-prone invasive procedures,” such as certain surgeries and some obstetrical and dental procedures (list is included in report).

Typically, three circumstances must be present for transmission of hepatitis B from healthcare workers (HCW) to their patients:

• HCW must have sufficient quantities of hepatitis B in his or her bloodstream
• HCW must have an injury or condition that would provide opportunity for exposure
• Exposure must be via the patient’s wound, mucous membranes, or other port of entry known to allow infection

Updates to the previous recommendations (originally published in 1991) were necessary due to changes in disease epidemiology and medical management of those with chronic hepatitis B infections.

Highlights of changes include:

• Patients no longer need to be pre-notified of the HCW hepatitis B-positive status
• Use of serum hepatitis B levels rather than hepatitis B antigen status to monitor infectivity
• Specific guidance for developing policies related to the oversight of chronically infected HCW
• Dealing with medical and dental students who are chronically infected is also addressed

Read the full report»

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Vaccine storage temperatures

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

When the Office of the Inspector General (OIG) reported that inspections of 45 doctors’ offices revealed inconsistent temperatures and expired vaccines, news outlets across the country carried stories. Here are related materials:

• OIG Report including appendices outlining vaccine-specific storage temperatures and the Vaccines for Children (VFC) program management requirements.
• AAP response calling for additional resources and education
• Sample media report – “Government Study Finds that Some Vaccines for Kids are Stored Improperly,” by Bonnie Rochman, published on 6/8/12 by Time.  

Resources for keeping your office on track

The IOG report provides an opportunity to evaluate how your office practices measure up. Several resources are available if you find areas of vaccine storage and handling that need improvement:

• Immunization Action Coalition (IAC) offers a wide variety of resources including:
  • Checklist for Safe Vaccine Storage and Handling
  • Don’t Be Guilty of These Errors in Vaccine Storage and Handling
  • Web page with links to temperature logs and numerous related resources
     
• The CDC offers several resources:
  
  • CDC’s Vaccine Storage & Handling Guide
  • CDC video clip related to vaccine storage and handling (25 minutes)
  • Pink Book chapter
• California's VFC program has a helpful training course:
  
  • EZIZ.org storage and handling resources

Reassuring Parents

Parents may come into the office with questions related to the integrity of vaccines offered in your practice. After re-evaluating your own procedures, you will be comfortable assuring them that your office has systems in place to ensure that vaccine doses are viable.

Looking at the larger picture, they can be reassured that the vast majority of vaccines being administered throughout the country are viable as we have not witnessed outbreaks suggestive of improper storage and handling of vaccines. Recent outbreaks tend to center around unvaccinated pockets within communities; however, you can also point out that the IOG report provided a good opportunity for healthcare providers to evaluate vaccine storage practices.

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Vaccine shortages, 2D bar codes on MMR VIS, and screening and treatment updates

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

Vaccine shortages

Pentacel® (DTaP-IPV/Hib) and DAPTACEL® (DTaP), both produced by Sanofi Pasteur, are expected to be in short supply through September 2012. This shortage has not affected immunization recommendations. The Centers for Disease Control and Prevention (CDC) suggests the following options:

• Use DTaP, IPV and Hib for children who were previously given Pentacel.
• Use other combination vaccines containing DTaP and Hib 

The CDC has published guidelines that include sample schedules for dealing with the current situation. You can always stay abreast of vaccine supply issues by bookmarking the CDC’s “Current Vaccine Shortages and Delays” page.

2D Bar Codes Now on MMR VIS

The CDC recently released the first Vaccine Information Statement (VIS) with a 2D barcode; it is for the MMR vaccine in English.  The 2D bar code allows providers with barcode readers and software to scan the sheet before giving it to families rather than entering the VIS name and edition date manually. To read more about 2D bar codes, refer to the February 2012 Vaccine Update article.

Screening and Treatment Updates

• Cervical Screening – Medscape offers two short videos discussing revised guidelines for screening women for cervical health.
  • Cervical Screening: Whom to Screen and When - Three-minute video by Dr. Maurice Markman from the Cancer Treatment Centers of America.
  • Updated Guidelines for Cervical Cancer Screening: Less is More - Five-minute video by Dr. Andrew Kaunitz from the Department of Obstetrics and Gynecology at the University of Florida College of Medicine.
• Hepatitis C – The American Association for the Study of Liver Diseases (AASLD) recently updated treatment guidelines for chronic hepatitis C, genotype 1 as a result of new direct-acting antivirals becoming available as well as the identification of several single-nucleotide polymorphisms associated with clearance of the infection. To review the guidelines, visit the AASLD website. The AASLD website maintains a list of practice guidelines for several liver-associated conditions.
• Treatment and Prevention of Community-Acquired Pneumonia (CAP) in Children – U.S. Pharmacist recently published an article by Elias B. Chachine and M. Steven Mayberry titled “Update on the Treatment and Prevention of Community-Acquired Pneumonia in Children” which aims to educate pharmacists and pharmacy technicians. The article may be of interest to other clinicians, particularly the summary tables:
  • Common Causes of Childhood CAP (Table 1)
  • Empiric Therapy for Childhood CAP (Table 2)
  • Selected Adverse Reactions Associated with Antimicrobials Commonly Used to Treat Childhood CAP (Table 3)
  • Recommended Vaccines for Prevention of Childhood CAP (Table 4)

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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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