Deborah L. Wexler, MD, Executive Director, Immunization Action Coalition
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.
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.
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.
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.
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.
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.
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.
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.
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:
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):
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:
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:
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:
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.
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.
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.
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.
Two childhood vaccines require a bit more explanation regarding scheduling:
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.
Before giving a dose of any vaccine, healthcare providers should carefully question patients or parents about contraindications and precautions to vaccination.
A table in ACIP's "General Recommendations on Immunization" lists contraindications and precautions to commonly used vaccines. This information is also available as an online chart on CDC’s website.
The Immunization Action Coalition (IAC) offers this same information in a formatted page and also offers a version covering only vaccines recommended for adults.
IAC also has ready-to-copy screening questionnaires that can help healthcare providers identify contraindications and precautions prior to administering vaccines. Parents or patients fill out the questionnaire while waiting to be seen by their healthcare provider. Having patients do this ahead of time saves time and ensures that all necessary questions are reviewed.
To access all of IAC’s screening questionnaires and their translations, visit IAC’s web page of screening questionnaires.
Sometimes healthcare providers misperceive certain health conditions (e.g., antibiotic use, mild upper respiratory or ear infections) as contraindications when they are not. This can result in missed opportunities to vaccinate. To make sure healthcare providers know the health conditions that are not contraindications to vaccination, CDC offers an online chart titled "Conditions Commonly Misperceived as Contraindications to Vaccination."
With appropriate screening for true contraindications and precautions to vaccination, clinicians will ensure they provide all recommended vaccines while minimizing risk to their patients and keeping them on schedule.
The Immunization Action Coalition (IAC) frequently receives email inquiries from immunization staff asking if they can draw up vaccine into syringes ahead of time, especially before busy influenza or back-to-school vaccination clinics. The Centers for Disease Control and Prevention (CDC) discourages the practice of prefilling syringes because it can result in these undesirable outcomes:
Prefilling syringes might also violate basic medication administration guidelines, which state that an individual should administer only those medications he or she has prepared and drawn up him or herself.
Although pre-drawing vaccine is discouraged, immunization staff may pre-draw a limited amount of vaccine in a mass-immunization clinic setting if the following conditions apply:
At the end of the clinic day, discard any remaining syringes prefilled by staff. Never save these syringes for another day, and never attempt to put the vaccine dose back into a vial.
As an alternative to personally prefilling syringes, CDC recommends using manufacturer-supplied prefilled syringes, which are designed both for storage and administration. However, keep in mind that once you remove the syringe cap or attach a needle, the sterile seal is broken. You should either use the syringe or discard it at the end of the clinic day.
Vaccination providers often see patients who think their or their children's vaccinations are up to date but who do not have documentation of these vaccinations. According to the CDC, healthcare providers should only accept written records as evidence of vaccination – with two exceptions: Self-reports of receipt of influenza vaccine (given to any age person) and pneumococcal polysaccharide vaccine (PPSV; given to adults) can be accepted. Self-reports for any other vaccines without written and dated documentation should not be accepted. You should attempt to locate missing records whenever possible by:
If records cannot be located or will never be available because of the patient's situation (e.g., immigrant with no access to immunization records), revaccinate the patient using the age-appropriate vaccination schedule. Receiving extra doses of a vaccine does not pose a significant medical risk; instead it provides a boost to immunity if the patient was previously vaccinated.
Serologic testing for immunity is an alternative to vaccination for certain antigens (e.g., measles, rubella, hepatitis A, and tetanus). However, commercially available testing may not always be sufficiently sensitive or standardized to detect vaccine-induced immunity. Further, if the test does not indicate seroconversion, you will need to administer the needed vaccines anyway, likely requiring an additional appointment and, for the patient, possible increased out-of-pocket expenses.
ACIP's General Recommendations on Immunization (pages 27-29) includes detailed guidance on the use of questionable vaccination records for people vaccinated outside of the U.S. When you need to catch up an inadequately vaccinated person quickly, you can administer doses of all routine vaccines simultaneously (at the same visit, not in the same syringe). For children, use CDC's catch-up schedule to determine the necessary minimal intervals for additional doses.
Finally, remember to always give patients a record of any vaccines you administer to avoid confusion and receipt of unnecessary doses in the future. Print-outs from registries will serve this purpose. Also, some state health departments and medical practices make record cards available free of charge. If such cards are not available to you, and you would like to consider purchasing them, you can order them from the Immunization Action Coalition’s shopping page. You can choose from three styles of cards—for children, for adults, and for people of any age. If you would like to receive samples, send a request to IAC at email@example.com.
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