Vaccine Update for Healthcare Providers

Technically Speaking - Archive

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

Vaccinations and pregnancy

Twenty-five years ago, vaccines generally were not recommended for pregnant women. My, how things have changed! Although certain vaccines should not be given during pregnancy, two vaccines are specifically recommended during this time, and a few additional vaccines are recommended for pregnant women when indicated because of certain risk conditions.

So how do you keep these variations straight? This column provides an overview of the immunization recommendations for pregnant women and gives links to helpful resources, including a new handout, “Vaccinations for Pregnant Women,” created collaboratively by the American College of Obstetricians and Gynecologists (ACOG) and the Immunization Action Coalition (IAC). This great handout was designed to share with pregnant women to remind them about the vaccines they need.

Vaccines recommended during pregnancy

Two vaccines — inactivated influenza vaccine and Tdap (tetanus-diphtheria-acellular pertussis) — are specifically recommended for pregnant women.

Vaccines that should be administered during pregnancy when indicated

Several inactivated vaccines fall into a middle ground. Although they are not recommended for all pregnant women, they should be given if the woman has a particular risk condition — health, occupational, or other — indicating a need for a particular vaccine. These vaccines include hepatitis A, hepatitis B, meningococcal, and pneumococcal (PCV13 and PPSV23), all of which are safe to administer during pregnancy.

Vaccines that should not be administered during pregnancy

The vaccines that should not be given to pregnant women include

Healthcare professionals should try to ensure all women of childbearing age are up to date with their recommended vaccines before they try to conceive.

General resources about vaccination during pregnancy

Resources about influenza and Tdap vaccination during pregnancy

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Temperature monitoring – the “vital sign” for vaccine storage

A patient's physical exam usually begins with checking vital signs of pulse, respiratory rate, blood pressure and temperature. But when checking your vaccine supply, only one “vital sign” — temperature — must be monitored to assure your vaccines remain viable. Regular monitoring of vaccine storage temperatures is critical to ensuring quality patient care.

The November 2012 issue of Technically Speaking highlighted the Centers for Disease Control and Prevention’s (CDC) Vaccine Storage & Handling Toolkit(PDF), which covers topics including routine storage and handling practices, proper storage and monitoring equipment, and inventory management. The toolkit also includes CDC's recommendation that only stand-alone units, i.e., self-contained units that only refrigerate or only freeze, be used for vaccine storage.

As a companion resource to the toolkit, CDC and the Immunization Action Coalition (IAC) have updated the popular vaccine temperature logs:

These logs provide a convenient tool for documenting storage unit temperatures a minimum of twice each workday, as recommended by CDC. They also have space to document daily minimum/maximum temperature readings. Twice-a-day monitoring is important even if temperatures are being assessed with a digital system. This proactive approach can prevent inadvertent loss of vaccine and the potential need for revaccination by assuring that temperature excursions are identified quickly so that immediate corrective action can be taken. This physical inspection also provides an opportunity to visually examine the storage unit, reorganize any vaccines that are inadvertently misplaced, and remove any expired vaccines.

In spite of appropriate monitoring, unacceptable vaccine storage events sometimes occur. For these instances, CDC and IAC have developed a new Vaccine Storage Troubleshooting Record(PDF). This one-page form leads clinic staff through a series of pertinent questions so they can document both the circumstances of the event and the subsequent actions taken. Most importantly, the form helps users identify ways to prevent similar problems from occurring in the future. The form is available both as a stand-alone document and as part of the vaccine temperature logs.

Be sure to use these updated resources to assist your clinic staff in monitoring storage unit temperatures, a “vital” aspect of ensuring vaccine viability.

More storage and handling resources

For additional resources on vaccine storage and handling, visit the following:

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What to do if the wrong dose of a vaccine is administered

Sometimes healthcare personnel inadvertently administer the wrong dose of a vaccine to a child or adult patient. This often happens with vaccines that come in both pediatric and adult formulations, such as hepatitis A and hepatitis B vaccines, which are available in both 0.5 mL and 1.0 mL formulations. Routinely used injectable influenza vaccines come in two dosing amounts as well, with 0.25 mL for use in children younger than age 3 years and 0.5 mL for people age 3 years and older. Below is some guidance on what to do when such dosing errors occur, and how to avoid these errors in the future.

If you administer too large a dose

If you’ve administered too large a dose (e.g., you’ve given an “adult” dose to a child) instead of the correct dose of hepatitis A, hepatitis B, or influenza vaccine, inform the patient, parent or guardian of the administration error and document it in the medical record. This dose counts as valid. Although it is unlikely that your patient will suffer any untoward side effects from receiving a “double dose” of vaccine, using larger-than-recommended dosages can result in excessive local or systemic concentrations of antigens or other vaccine constituents. When errors of this nature occur, it is important to assess how the error happened and to implement strategies to ensure they will not be repeated. Administering larger-than-recommended doses of any vaccine does not negate the need for subsequent recommended doses.

If you administer too small a dose

If you’ve administered a pediatric dose or half dose of a vaccine in error, consider the dose invalid and repeat it. Giving less than a full dose might result in inadequate protection. Revaccinate the patient with the appropriate dose according to recommendations specific to inactivated and live-virus vaccines. You may give the additional dose during the same visit if the error is discovered while the patient is still in the office.

If you administer the wrong brand of influenza vaccine

If you’ve administered an injectable influenza vaccine product that is not licensed for use in a child the age of the child you have vaccinated, this is an administration error. In such a case, if you administered the correct dosage to the child, even though it is the wrong product, consider the dose valid and do not repeat it. Inform the patient, parent or guardian of the error and document it in the medical record.

Resources that can help

Here are examples of some strategies you can implement to prevent administering the wrong dose of vaccine:

Finally, remember you can report vaccine administration errors confidentially to the National Vaccine Error Reporting Program, which is part of the Institute for Safe Medication Practices.

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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 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 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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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 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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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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