Vaccine Update for Healthcare Providers

Technically Speaking

Deborah L. Wexler, MD, Executive Director, Immunization Action Coalition

A new program for reporting vaccine errors

Over the years, the Immunization Action Coalition has received hundreds of questions about vaccination procedural errors and what to do about them or where to report them. Some common errors include administering the wrong vaccine or the wrong dose; giving a vaccine before the minimum age or interval; administering the vaccine by the wrong route or at the wrong anatomic site; reconstituting a vaccine improperly; using expired or improperly handled vaccine; or even vaccinating the wrong patient. The Institute for Safe Medication Practices recently launched an online website to report vaccine errors.

ISMP is a nonprofit, federally-certified patient safety organization, respected worldwide as the premier resource for medication safety information. Founded in 1994, ISMP works closely with healthcare practitioners and institutions, regulatory agencies, consumers and professional organizations to provide education about medication errors and prevention.

With the assistance of the California Department of Public Health, ISMP developed the ISMP Vaccine Error Reporting Program (VERP). VERP was created to allow healthcare professionals to report vaccine errors anonymously; ISMP guarantees confidentiality concerning the information it receives. The purpose of VERP is to capture the unique causes and consequences of vaccine-related errors. By collecting and quantifying information about these errors, ISMP will be better able to advocate for changes in vaccine names, labeling or other appropriate modifications that could reduce the likelihood of vaccine errors in the future.

The reporting system asks for detailed information about the occurrence, including:

The system also requests that users share their recommendations for prevention of similar errors.

VERP is not to be confused with VAERS, the Vaccine Adverse Events Reporting System. VAERS, a national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration, is intended to be the location for reporting adverse events that occur following the administration of a vaccine to a patient. VAERS reports should be submitted regardless of whether or not the reporter believes the adverse event was vaccine-related. Although healthcare professionals have sometimes reported vaccine administration errors to VAERS in the past, the new VERP system provides a more logical location for these reports, allowing for a clear separation between reporting of adverse events in a patient (VAERS) from procedural errors that may or may not result in adverse events (VERP). Of course, both VAERS and VERP may be used for the same event when the situation warrants it.

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CDC publishes FAQs about new vaccine storage and handling guidelines

In early October, the Centers for Disease Control and Prevention (CDC) released Interim Guidelines for Vaccine Storage and Handling, Frequently Asked Questions. Written by CDC experts, these 19 questions and answers (FAQs) give practical information often asked by people who provide immunization services and handle vaccines. The FAQs include these topics:

CDC published these FAQs shortly after releasing Vaccine Storage and Handling Interim Guidance to provide a preview of CDC's Vaccine Storage and Handling Toolkit, which is planned for release in the next few weeks. The toolkit will address such topics as the types of thermometers to use in vaccine refrigerators and freezers, the importance of digital data loggers, the types of refrigerator and freezer units to select for future purchase, and the need to rotate vaccine stock in refrigerators and freezers to prevent expired vaccines from being administered.

Here are links to many more useful resources related to vaccine storage and handling:

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New recommendations for the use of pneumococcal vaccines in adults with certain health conditions

On October 12, 2012, the Centers for Disease Control and Prevention (CDC) published new recommendations for the use of pneumococcal conjugate vaccine (PCV13/Prevnar 13, Pfizer) and pneumococcal polysaccharide vaccine (PPSV23/Pneumovax, Merck) in adults with certain health conditions, including immunocompromising ones. The questions and answers below provide additional details about these new recommendations and how PCV13 should be used in conjunction with PPSV23.

Which adults are now recommended to receive a dose of PCV13?

Adults 19 years and older who have any of the following conditions and who have not previously received PCV13 should receive one dose of PCV13 during their next vaccination opportunity:

Adults with these conditions should also receive one or more doses of PPSV23.

Which patients in the groups listed above need two doses of PPSV23, and which need only one dose?

Patients ages 19 through 64 years who have any of the immunocompromising conditions listed above or have functional or anatomic asplenia, need two doses of PPSV23 spaced at least five years apart. Patients with CSF leaks or cochlear implants need only one dose of PPSV23. All patients will need a final dose of PPSV23 at age 65 years or older if the previous dose(s) were administered when the patient was younger than 65 years and at least five years have elapsed since the previous PPSV23 dose.

During an office visit, can a healthcare provider administer PCV13 and PPSV23 to an adult patient who needs both vaccines but who has had neither? If not, what is the recommended interval between doses?

PCV13 and PPSV23 should not be given at the same visit. Patients who need both PCV13 and PPSV23 and who have received neither should receive PCV13 first, followed by a dose of PPSV23 at least eight weeks later. If a second PPSV23 dose is recommended, it should be administered at least five years after the first PPSV23 dose.

What is the recommended interval between doses for adult patients who have already received one dose of PPSV23 and now need PCV13?

For patients who have already had one or more doses of PPSV23, it is recommended to wait at least one year after receipt of PPSV23 before administering PCV13. If the patient is recommended to receive a second dose of PPSV23, delay that second PPSV23 dose for at least eight weeks following PCV13 and at least five years after receipt of the first dose of PPSV23.

Do patients who were vaccinated with one or two doses of PPSV23 before age 65 need an additional dose of PPSV23 at age 65 or later?

Yes. Patients who received PPSV23 for any indication at age 64 years or younger should receive an additional dose of PPSV23 vaccine at age 65 years or older if at least five years have elapsed since their previous PPSV23 dose.

If patients who are in a recommended risk group for PPSV23 or PCV13 aren’t sure if they previously received these vaccines, should healthcare providers vaccinate?

Yes. If patients do not have a documented vaccination history for these two vaccines and their records are not readily obtainable, you should administer the recommended doses.

To obtain a copy of the newly published recommendations for the use of pneumococcal vaccines in adults, visit either of the links below:

Both of these versions include a helpful table indicating pneumococcal vaccine recommendations based on patients’ medical conditions.

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One dose or two? How many doses of influenza vaccine do children need in the 2012-13 season?

For several years in a row, the Centers for Disease Control and Prevention (CDC) has adjusted its vaccination recommendations regarding which children need two doses of influenza vaccine.

Here are some simple rules to follow when vaccinating children against influenza this season:

The CDC has also developed an alternative approach that healthcare providers can use for children with WELL-DOCUMENTED immunization histories (e.g., those maintained in electronic registries) of receiving influenza vaccine. Children age 6 months through 8 years need only one dose of influenza vaccine in 2012-13 if they have received:

Otherwise, they will need two doses this season.

For an easy-to-use guide to post in your clinic to help determine which children need two doses, see Guides for determining the number of doses of influenza vaccine to give to children ages 6 months through 8 years during the 2012-2013 influenza season.

For further details on who needs two doses, consult the following official recommendations:

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CDC Recommendations for Use of Tdap Are Now Simpler! Everyone Age 11 and Older Needs a Dose

With pertussis widely circulating throughout the nation and infant hospitalizations and deaths escalating, the Centers for Disease Control and Prevention (CDC) has further expanded its recommendations for the use of Tdap vaccine. In June CDC published its latest Tdap recommendations, which added adults age 65 years and older to the list of people who should be vaccinated against pertussis. This means that every person in the U.S. age 11 years and older now is recommended to receive a one-time dose of Tdap vaccine the next time they see their healthcare provider (i.e., not waiting 10 years or until their next Td is due). Furthermore, CDC advises administering Tdap regardless of the interval since the person last received Td.

As seen in the timeline below, CDC has gradually expanded Tdap recommendations so that they now cover every adolescent and adult in the U.S.

The recommendations have been challenging to stay up to date with, but now they’ve evolved into something quite simple to follow.

CDC recommends a single Tdap dose for all people age 11 years and older who have not previously received it. This includes pregnant women who are at 20 weeks or more gestation, as well as adults age 65 years and older.

Here are a few additional recommendations from CDC:

  1. People who anticipate being in contact with an infant should be vaccinated at least 2 weeks ahead of time.
  2. Providers may administer either of the Tdap vaccines they have available in their offices. When feasible, Boostrix® (GSK) should be used for adults age 65 years and older because it is licensed for this age group; however, CDC says either Tdap product (Adacel® [sanofi], or Boostrix) may be used; both are immunogenic and would provide protection. A dose of either should be considered valid.
  3. Currently, only one dose of Tdap is recommended. Thereafter, resume giving a Td booster every 10 years.
  4. If you cannot verify whether a patient has ever received a dose of Tdap, CDC recommends administering a dose of Tdap.

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Recording vaccinations – what is required by federal law?

It is important to know the federal requirements for documenting the vaccines administered to your patients. The requirements are defined in the National Childhood Vaccine Injury Act enacted in 1986. The law applies to all routinely recommended childhood vaccines, regardless of the age of the patient receiving the vaccines. (The only vaccines not covered under this law are pneumococcal polysaccharide, zoster and certain infrequently used vaccines, such as rabies and Japanese encephalitis.)

By law, the following information must be documented on the patient’s paper or electronic medical record (or on a permanent office log):

  1. The vaccine manufacturer.
  2. The lot number and expiration date of the vaccine.
  3. The date the vaccine is administered.
  4. The name, office address, title and signature (electronic is acceptable) of the person administering the vaccine. Initials of the vaccine administrator will suffice as long as the office keeps a record of the person to whom the initials refer.
  5. The Vaccine Information Statement (VIS) edition date located in the lower right corner on the back of the VIS. When administering combination vaccines, all applicable VISs should be given and the individual VIS edition dates recorded.
  6. The date the VIS is given to the patient, parent or guardian.

The federally required information should be both permanent and accessible.

Federal law does not require a parent, patient or guardian to sign a permission statement to receive a vaccination; providing them with the appropriate VIS(s) and answering their questions is sufficient.

Here is some additional information you may want to permanently record even though it is not required by law:

  1. Anatomic site: RA (right arm), LA (left arm), RT (right thigh), LT (left thigh)
  2. Route: IM (intramuscular), SC (subcutaneous), ID (intradermal), IN (intranasal), or PO (oral)
  3. The funding source of your vaccine: federal (F), state (S) or private (P)

Finally, for long-term clarity in documenting vaccinations, it is preferable to record the generic abbreviation (e.g., Tdap) in addition to or instead of the trade name (e.g., Adacel® or Boostrix®). It can be difficult to ascertain the components a vaccine contains if only the brand name is recorded, particularly when a specific brand is no longer used. When administering combination vaccines, record all components in the combination (e.g., DTaP-HepB-IPV).

Before the patient leaves your office, be sure to provide a record of the vaccines administered during that visit.

The Immunization Action Coalition has created free, downloadable vaccine administration records for medical charts. They include space for all federally required information and can be used "as is" or altered as per practice needs. Sample pages that demonstrate how to fill them out are also included.

Additional resources regarding vaccine documentation:

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Responding to requests for personal belief exemptions – some helpful resources

All states have immunization requirements for entry into schools, which have led to our nation’s great success in reaching high immunization levels. School entry laws and mandates vary from state to state, but they typically are in place for entry into childcare, kindergarten, middle school, high school and (less frequently) post-secondary institutions. The specific vaccines that are required vary from state to state as well.

Unfortunately, despite your best efforts to educate parents about the important protection vaccines provide, some will decline to have their child vaccinated and will request a personal belief exemption (PBE) or a religious exemption.

All states and the District of Columbia allow immunization exemptions due to medical contraindications, and 48 of 50 states allow exemptions for religious beliefs. Approximately 20 states allow exemptions based on parents' personal beliefs. A map of the United States with exemptions indicated by color coding is available at the website of the Institute for Vaccine Safety at Johns Hopkins University.

Here are some excellent resources related to PBEs that may be useful to you in responding to these parents’ requests.

Here are additional links to valuable resources on PBEs.

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Try these free email services to stay up to date on immunization information

Keeping up with new vaccines licensed by the FDA, new and expanded vaccine recommendations, new and revised Vaccine Information Statements (VISs), etc., can make your head spin! How can you keep up? Help is just a click away!

The Email News Service section on the Immunization Action Coalition’s main website, contains descriptions of and gives subscription information for more than 25 free immunization-related e-newsletters published by government agencies, professional societies and others. Here are a few of them:

Be sure to browse IAC's complete selection of e-newsletters and email updates for healthcare professionals. Subscribe to as many as you’d like!

Do you have additional email news services to recommend for inclusion on immunize.org? Please email your suggestion(s) to Mary Quirk at IAC.

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Guidance for preventing fainting and associated injuries after vaccination

Immunization providers should be aware of the potential for syncope, or fainting, associated with vaccination, particularly among adolescents. Providers should take appropriate measures to prevent syncope and to readily respond to the patient who feels faint. Here are some things your practice can do to prepare:

The May 8, 2008, issue of the Morbidity and Mortality Weekly Report included an article titled Syncope After Vaccination — United States, January 2005-July 2007 in which the Centers for Disease Control and Prevention (CDC) reported that since 2005, the Vaccine Adverse Events Reporting System had received a greater number of reports of syncope compared with the number reported in 2002–2004. The increase coincided with the licensure of three vaccines for adolescents — HPV, MCV, and Tdap. The increase in syncopal episodes had occurred primarily in females age 11-18 years. Though rare, serious injuries have occurred, including one fatality in a 15-year-old boy who had an intracranial hemorrhage caused by head trauma from a fall. Among all age groups, 80 percent of reported syncopal episodes occurred within 15 minutes of vaccine administration.

The CDC’s General Recommendations on Immunization: A Report of the Advisory Committee on Immunization Practices states, “Vaccine providers, particularly when vaccinating adolescents, should consider observing patients (with patients seated or lying down) for 15 minutes after vaccination to decrease the risk for injury should they faint. If syncope develops, patients should be observed until the symptoms resolve."

The Immunization Action Coalition has developed two educational pieces on the medical management of adverse reactions (including syncope) to vaccination:

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Minimum ages and minimum intervals between doses of vaccines in a series – why does it matter?

Overview

Immunization providers often ask about minimum ages and minimum intervals between doses of vaccine in a series, e.g., DTaP #1 and DTaP #2. Or said another way, when is a child too young to receive a vaccine, and when is an interval too short or too long?

Immunizations are usually recommended for members of the youngest age group at risk for a disease for whom efficacy and safety of a vaccine have been demonstrated. Vaccination schedules generally are determined prior to vaccine licensure, with the spacing of doses in the clinical trial being adopted as the recommended schedule. Shorter than the recommended interval, the “minimum interval” is the shortest time between two doses of a vaccine series in which an adequate immune response to the second dose can be expected. The concern is that a dose given too soon after the previous dose may reduce the response.

Maximum intervals — they don't exist

First, let’s clear up one popular misconception; there is no such thing as a "maximum interval." With very limited exceptions (e.g., oral typhoid vaccine in certain circumstances), you do NOT need to restart a vaccine series because an interval is longer than recommended. Doses given even years later than recommended are still valid because the body has “immunologic memory.” The real problem with longer than recommended intervals is not the validity of the doses or their immunologic effect. It is that, until the series is complete, the person may remain susceptible to the associated vaccine-preventable disease.

Minimum intervals – how to use them

In contrast, maintaining minimum intervals between vaccine doses is critically important. When doses are given too close together, the body may have insufficient time to mount an immune response, and the vaccine's efficacy cannot be assured. Even though doses given at the minimum intervals are considered valid, it is preferable to maintain the longer “recommended” interval whenever possible, with a few exceptions. You should intentionally schedule patients at the minimum intervals only in certain circumstances:

CDC has developed a great table generally referred to as Table 1 of the ACIP's General Recommendations to help you determine the minimum ages and intervals for all routinely recommended vaccines.

What's the 4-day grace period?

The Advisory Committee on Immunization Practices has established one small exception to minimum intervals — "the 4-day grace period” — that allows vaccine doses administered up to four days before the minimum interval or age to be counted as valid. However, the 4-day grace period does not apply in all situations. It should not be used when scheduling future vaccination visits. It also should not be applied to the 28-day interval recommended when live parenteral vaccines are not administered at the same visit or when giving rabies vaccine. The grace period should be used primarily when reviewing historical vaccination records. Importantly, use of the grace period may be in conflict with your state’s school or child care entry requirements or with immunization registry standards, so be sure to check with your state immunization program to determine what is acceptable.

Special cases of minimum ages and intervals

Two childhood vaccines require a bit more explanation regarding scheduling:

What if a dose is given too early?

What should a provider do if a dose was inadvertently given at too young an age or at less than the minimum interval? The dose is not considered valid and must be repeated. The repeat dose should be spaced after the invalid dose by an interval at least equal to the recommended minimum interval. In these cases, providers should be prepared to reassure parents that the extra dose of vaccine is not harmful for their child.

In short, rigorously adhering to minimum ages and intervals is vital to making certain your patients receive vaccines on a schedule that ensures vaccine effectiveness. For more information about minimum intervals and ages, consult the ACIP's General Recommendations on Immunization.

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Visit EZIZ.org for practical tools on vaccine administration, storage and handling 

EZIZ.org is the e-learning website of the California Department of Public Health, Immunization Branch. This great website provides a wealth of practical information to help you in the delivery of vaccination services, including free training and print resources covering important topics in vaccine administration, storage and handling.  

The website’s free Video Training includes:

EZIZ.org also includes the following valuable print resources on vaccine administration and storage and handling:  

Though some of the information on the EZIZ website is California-specific, most of it is applicable and useful for healthcare professionals across the nation. Be sure to check out the EZIZ website soon to find great materials to help you in your immunization practice!

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Additional resources

The Immunization Action Coalition also has ready-to-copy materials for healthcare staff covering practical aspects of vaccine administration, storage and handling. Bookmark these useful pages for future reference:  

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“Immunization Techniques” DVD — Every medical practice should own a copy!

Deborah L. Wexler, MD, Executive Director, Immunization Action Coalition

The award-winning DVD "Immunization Techniques: Best Practices with Infants, Children, and Adults," created by the California Department of Public Health, Immunization Branch, is available from the Immunization Action Coalition (IAC) for a nominal cost.

Updated in 2010, the 25-minute program can be used to train new employees who administer vaccines and to refresh the skills of experienced staff. The DVD demonstrates the skills and techniques needed to administer vaccines to patients of all ages and includes these topics:

A single copy of the DVD is only $17 including shipping and handling. Great discounts are available on orders of 10 or more copies.

Learn more about the DVD, watch a two-minute video clip or place an order on the IAC website. IAC is the sole national distributor of this DVD. However, if you practice in California, you can contact your local health department's immunization program for a free copy.

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