All health care professionals should receive comprehensive, competency-based training before administering vaccines. The total time for transport alone or transport plus clinic workday should be a maximum of 8 hours. For certain purpose-built units, it is recommended that vaccine be stored outside of the packaging. Once the syringe is filled, label it with the name of the vaccine in the syringe. Draw up vaccines only at the time of administration. However, check and comply with state requirements regarding disposal. The cold chain begins with the cold storage unit at the manufacturing plant, extends to the transport and delivery of the vaccine and proper storage at the provider facility, and ends with administration of the vaccine to the patient. Mothers who are breastfeeding should be encouraged to breastfeed children age 2 years or younger before, during, and after vaccination. Notes from the Field: Vaccine Administration Errors Involving Recombinant Zoster Vaccine – United States, 2017-2018. Because pain can increase with each injection, the order in which vaccines are injected matters. In some instances, such as when a manufacturer indicates there is a beyond-use date (BUD), vaccines must be used before the expiration date on the label. Some MDVs vials have a specified period for use once they have been punctured with a needle. Insert the needle at a 45-degree angle into the subcutaneous tissue and inject the vaccine. If the vaccine has no BUD, use the vaccine by the expiration date indicated by the manufacturer. Note any protective measures in place at the time of the event (water bottles, battery-powered TMD, transport to alternative facility, etc.). An intranasal sprayer is used for the live, attenuated influenza vaccine. It may be that the child’s anxiety level is reduced, which, in turn, reduces the child’s perception of pain. Apply an adhesive bandage to the injection site if there is any bleeding. If using a TMD that does not display minimum and maximum temperatures, then the current temperature should be checked and recorded a minimum of two times (at the start and end of the workday). Hand hygiene should be performed before vaccine preparation, between patients, and any time hands become soiled (e.g., when diapering). Emergency vaccine storage, handling, and transport – outline steps to be taken in the event of equipment malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage conditions. Routinely recommended vaccines administered by IM injection include: IPOL and Pneumovax 23 can be administered by IM or subcut injection. If using a household-grade unit, avoid storing vaccines and diluents in any part of the unit that may not provide stable temperatures or sufficient air flow, such as directly under cooling vents, in deli, fruit, or vegetable drawers, or on refrigerator door shelves. Providers should also have a plan in place to contact emergency medical services immediately if there’s an anaphylactic reaction to vaccination, and staff members should know their individual roles in the event of an emergency. No immediate adverse events were reported with either injection technique. The VIS must be given: CDC encourages the use of all VISs, whether the vaccine is covered by the law requiring VIS or not. Notes from the Field: Injection Safety and Vaccine Administration Errors at an Employee Influenza Vaccination Clinic—New Jersey, 2015. Keep SOPs near vaccine storage units and make sure staff knows where to find them. Using the patient’s immunization history, health care providers should assess for all routinely recommended vaccines as well as any vaccines that are indicated based on existing medical condition(s), occupation, or other risk factors. Compare contents against the packing list. Vaccine stock should be rotated and checked for expired doses regularly. Ensure that lyophilized vaccines came with the correct type and quantity of diluents. Error reporting provides opportunities to discover how the errors occur and to share ideas to prevent or reduce those errors in the future. These units often have a single exterior door and an evaporator plate/cooling coil, usually located in an icemaker/freezer compartment. The infant should receive the remaining recommended doses of rotavirus vaccine following the routine schedule. Administration of expired vaccine remains one of the top vaccine storage and handling errors, so it is crucial for staff to understand how to read expiration dates to prevent patients from receiving invalid vaccine doses. Place the TMD in the center of the unit with the vaccines surrounding it. If the vial is entered on June 1, 2020, the BUD is June 29, 2020. This “blame-seeking” approach fails to address the root cause, potentially causing the error to recur. Aspiration can increase pain because of the combined effects of a longer needle-dwelling time in the tissues and shearing action (wiggling) of the needle. For adults, the deltoid muscle is recommended. While defrosting, store vaccines temporarily in another unit with appropriate freezer temperatures. Vaccine providers are strongly encouraged to participate in an IIS, and some states mandate documenting vaccinations in an IIS. These products should be used only for the ages recommended and as directed by the manufacturer. Health care providers should be familiar with identifying immediate-type allergic reactions. Vaccines that are the most reactive and more likely to cause an enhanced injection site reaction (e.g., DTaP, PCV13) should be administered in different limbs, if possible. Deviation from the recommended route may reduce vaccine efficacy or increase local adverse reactions. Determining factors for ordering include projected demand, storage capacity, and current vaccine supplies. Another acceptable technique for pediatric and geriatric patients is to grasp the tissue and “bunch up” the muscle. Complete documentation of the event, including actions taken and results. Jacobson R, St Sauver J, Griffin J, et al. Preparing vaccine properly is critical to maintaining the integrity of the vaccine during transfer from the manufacturer’s vial to the syringe and, ultimately, to the patient. Once the maximum number of doses has been removed, the vial should be discarded – even if there is residual vaccine in the vial. The mechanism for this is thought to be that the sensation of touch competes with the feeling of pain from the injection and, thereby, results in less pain. MDVs are labeled by the manufacturer and typically contain an antimicrobial preservative to help prevent the growth of microorganisms. Once the sterile seal has been broken, the vaccine should be used or discarded by the end of the workday. Changing the needle between preparing and administering the vaccine is not necessary unless the needle is contaminated or damaged. Transport involves the movement of vaccine over a short time frame and distance between providers. Moderate tactile stimulation (rubbing or stroking the skin) near the injection site before and during the injection process may decrease pain in children age 4 years or older and in adults. VFC providers or those who have other vaccines purchased with public funds should contact their immunization program for guidance regarding routine and emergency SOPs. Instead of saying “What do you want to do about shots today,” an approach using presumptive language would be to say, “Your child needs three vaccines today.”. A different diluent, a stock vial of sterile water, or normal saline should never be used to reconstitute vaccines. To receive email updates about this page, enter your email address: Centers for Disease Control and Prevention. Detachable probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®), Current, minimum, and maximum temperature display, Recommended uncertainty of +/-0.5°C (+/-1°F), Logging interval (or reading rate) that can be programmed by the user to measure and record temperatures at least every 30 minutes, Backup (with a different calibration testing schedule) in case a primary device malfunctions or is out for calibration testing, Date of calibration (report or issue date), Confirmation that the instrument passed testing (or instrument in tolerance), Recommended uncertainty of +/-0.5°C (+/-1°F) or less. Skin-to-skin contact for infants up to age 1 month has been demonstrated to reduce acute distress during the procedure. Physical interventions and injection techniques for reducing injection pain during routine childhood immunizations systematic review of randomized controlled trials and quasi-randomized controlled trials. A manufacturer-filled syringe (MFS) is prepared with a single dose of vaccine and sealed under sterile conditions by the manufacturer. The muscles of the buttock are not used for administration of vaccines in infants and children because of concern about potential injury to the sciatic nerve, which has been well-documented after injection of antimicrobial agents into the buttock. Some facilities have a no-interruption zone, where health care professionals can prepare medications without interruptions. MFSs are prepared with a single dose of vaccine and sealed under sterile conditions by the manufacturer. Perform proper hand hygiene. IM injections are administered at a 90-degree angle to the skin and, for most adult patients, the skin is spread and the tissues are not bunched. CDC recommends the following types of refrigerators and freezers: All units should have enough space to store the largest inventory expected at the busiest point in the year (e.g., flu season) without crowding. Even for off-site clinics, vaccine manufacturers do not recommend predrawing vaccines. Children and adults often need more than one vaccine at the same time. Always follow the manufacturer’s directions, located it the package inserts. KATHMANDU: The Himalayan nation of Nepal launched its largest immunisation campaign on Wednesday with its first coronavirus vaccinations for medical workers, following a gift of one million doses from giant neighbour India. It may take two to seven days to stabilize the temperature in a newly installed or repaired refrigerator and two to three days for a freezer. CDC recommends facilities develop and maintain clearly written, detailed, and up-to-date storage and handling standard operating procedures (SOPs). Vaccine administration errors can have many consequences, including inadequate immunological protection, possible injury to the patient, cost, inconvenience, and reduced confidence in the health care delivery system. Whenever possible, store diluent with the corresponding refrigerated vaccine. A single-dose vial (SDV) contains one dose and is used one time for one patient. The temperature may become very cold in some parts of the unit. Used needles should not be recapped or cut or detached from the syringes before disposal. The dose does not need to be repeated if an infant regurgitates, spits out the vaccine, or vomits during or after administration. Avoids frightening children by embracing them rather than overpowering them, Allows the health care professional steady control of the limb and the injection site, Prevents children from moving their arms and legs during injections, Encourages parents to nurture and comfort their child. Research also shows when a strong recommendation is given by a health care provider, a patient is four to five times more likely to be vaccinated. Predrawing vaccines can also result in vaccine waste. Verify the vaccine has been stored at proper temperatures. If a documented immunization history is not available, administer the vaccines that are indicated based on the patient’s age, medical condition(s), and other risk factors, such as planned travel. Some vaccine doses are not valid if administered using the wrong route, and revaccination is recommended. Detailed information about inventory accounting, as well as sample stock records and daily tally sheets, are available in CDC’s Vaccine Storage and Handling Toolkit. Spread the skin tight to isolate the muscle. CDC twenty four seven. Suragh T, Hibbs B, Marquez P, et al. Aspiration is not recommended before administering a vaccine. Contact the state or local immunization program or state environmental agency for guidance. A supply of needles should be available in varying lengths appropriate for the facility’s patient population. The Goat Vac CDT 40280 Goat Vaccine is for use in healthy goats as an aid in the prevention of and enterotoxemia caused by Clostridium perfringens types B, C, and D. Cl. (Water bottles are not recommended for use with certain pharmaceutical-grade units, follow manufacturer’s directions.). Everyone, including adults, should be given the appropriate VIS when receiving a vaccine covered under the law. If other medications and biological products must be stored in the same unit as vaccines, they must be clearly marked and stored in separate containers or bins from vaccines. The vaccine achieved an average efficacy rate of 70 per cent among the 11,636 participants in the phase 3 trials in the UK and Brazil. Putting water bottles in the unit can help maintain stable temperatures. Saving Lives, Protecting People, Epidemiology and Prevention of Vaccine-Preventable Diseases, Vaccine Storage and Handling Standard Operating Procedures (SOPs), Vaccine Storage and Temperature Monitoring Equipment, Organizing and Storing Vaccine in Storage Unit, Conditioned Water Bottle Transport System, Recommendations and Guidelines: Storage and Handling, General Best Practice Guidelines for Immunization, National Center for Immunization and Respiratory Diseases, Chapter 2: General Recommendations on Immunization, Chapter 3: Immunization Strategies for Healthcare Practices and Providers, Appendix A: Schedules and Recommendations, Appendix C: Vaccine Information Statements, U.S. Department of Health & Human Services, Transport to Off-Site Clinic or Satellite Facility or for  Relocation of Stock, Manufacturer’s Original Shipping Container. Participants in the Vaccines for Children (VFC) program or providers with any vaccines purchased with public funds should consult their state or local immunization program to ensure all state storage and handling requirements are met, since there may be requirements that are specific or tailored to the jurisdiction. CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Use a safety-lock plug or an outlet cover to prevent the unit from being unplugged. Pain relievers can be used to treat fever and injection-site pain that might occur after vaccination. Vaccine administration errors requiring revaccination include: Vaccine administration errors not requiring revaccination include: The editors would like to acknowledge Beth Hibbs and Andrew Kroger for their contributions to this chapter. MMR must be used within 8 … Needle selection should be based on the: Needle Length and Gauge for Subcutaneous Injection, Needle Length and Gauge: Children and Adolescents (birth – 18 years) for Intramuscular Injection, Needle Length and Gauge: Adults (age 19 years or older) for Intramuscular Injection. Children (age 2 years or younger) who are not breastfed during vaccination may be given a sweet-tasting solution such as sucrose or glucose one to two minutes before the injection. Holding infants during vaccination reduces acute distress. Parent participation has been shown to increase a child’s comfort and reduce the child’s perception of pain. Therefore, vaccines packaged as SDVs are intended to be punctured once for use in one patient and for one injection. Never store loose vials or manufacturer-filled syringes outside of their packaging. Health care providers who administer vaccines covered by the National Vaccine Injury Compensation Program (which include all vaccines listed on the ACIP recommended child and adolescent immunization schedule) are required by law to ensure the permanent medical record of the recipient indicates: Vaccine administration best practices also include documenting the route, dosage, and site. When the expiration date has only a month and year, the product may be used up to and including the last day of that month unless the vaccine was contaminated or compromised in some way. For toddlers, the vastus lateralis muscle in the anterolateral thigh is preferred. Clinical judgment should be used when selecting needle length. Notes from the field: rotavirus vaccine administration errors–United States, 2006-2013. An environment that values the reporting and investigation of errors (and “near misses”) as part of risk management and quality improvement should be established. Temperature monitoring devices experience “drift” over time that affects accuracy. All vaccine providers should be certified in cardiopulmonary resuscitation (CPR) and be skilled in administering epinephrine. Prepare vaccines in a designated, clean medication preparation area away from space where potentially contaminated items are placed. Vaccine should be reconstituted just before administering by following the instructions in the vaccine package insert. It is acceptable in geriatric patients to grasp the tissue and “bunch up” the muscle. Care should be taken to avoid triggering the gag reflex. Transport only the amount of vaccine needed for the workday. There are no reports of any person being injured because of failure to aspirate. The exact mechanism behind this phenomenon is unknown. Hibbs B, Miller E, Shi J, et al. In addition, some studies have suggested these medications might suppress the immune response to some vaccine antigens. Remove the rubber tip of the nasal sprayer and place the tip of the applicator just inside the patient’s nostril. Potential life-threatening adverse reactions that can occur immediately after vaccination are severe allergic reactions and syncope (fainting). Note: CCMs are for one-time use and should be thrown away after being checked. Taylor L, Greeley R, Dinitz-Sklar I, et al. Designate a primary vaccine coordinator who will be responsible for ensuring all vaccines are stored and handled correctly. Rotavirus vaccine should never be injected. Refrigerator or freezer thermostats should be set at the factory-set or midpoint temperature, which will decrease the likelihood of temperature excursions. If not addressed, these fears can have long-term effects such as preprocedural anxiety and avoidance of needed health care throughout a person’s lifetime. Gender and weight (for adults age 19 years or older). Vaccine information statements (VISs) are documents that inform vaccine recipients or their parents about the benefits and risks of a vaccine. If a noncommercial vehicle must be used, place the transport containers in the passenger compartment—not the trunk. Package inserts can also be found the FDA websiteexternal icon. Medical waste disposal requirements are set by state environmental agencies. In addition, preventing excess doses of vaccines may decrease the number of adverse reactions. This increases the risk of administration errors, exposes vaccine to light, and makes it more difficult to track expiration dates and manage inventory. Pain is a subjective phenomenon influenced by multiple factors, including an individual’s age, anxiety level, previous health care experiences, and culture. Vaccine-related pain: randomized controlled trial of two injection techniques. If a temperature excursion is suspected, label vaccines “DO NOT USE” and store them in the appropriate vaccine storage unit, separated from other vaccines, until a vaccine viability determination is made. January 26, 2021 xls Label exposed vaccines “DO NOT USE,” and place them in a separate container apart from other vaccines in the storage unit (do not discard these vaccines). CDC is not responsible for Section 508 compliance (accessibility) on other federal or private website. Leaving the door open can cause the thermostat to respond to warmer room temperatures, and the unit will work harder to maintain the correct temperature inside. The BUD should be noted on the label, along with the initials of the person making the calculation. Once reconstituted, the vaccine should be administered within the time frame specified for use in the manufacturer’s package insert; otherwise, the vaccine should be discarded. Giving more than one vaccine at the same clinical visit is preferred because it helps keep patients up-to-date. Never combined leftover vaccine from one SDV with another to obtain a dose. This does not necessarily mean they will not accept vaccines. Potentially contaminated items (e.g., blood, urine, stool) should be properly contained and stored below vaccines to avoid contamination from drips or leaks. Set up a separate administration station for each vaccine type to prevent medication errors. In addition to the actions outlined above, in an emergency situation: If an emergency can be anticipated (e.g., weather event), suspend immunization activities before the onset of emergency conditions to allow adequate time for packing and transport. In these instances, certain actions must be taken to protect the vaccine supply. Ezeanolue E, Harriman K, Hunter P, Kroger A, Pellegrini C. The Centers for Disease Control and Prevention (CDC) cannot attest to the accuracy of a non-federal website. The vaccine was designed with two recombinant adenovirus vectors and was developed as two formulations (frozen [Gam-COVID-Vac] and lyophilised [Gam-COVID-Vac-Lyo]). Place a TMD (preferably with a probe in a thermal buffer) as close as possible to the vaccines and check and record temperatures hourly. Store vaccines and diluents with similar packaging or names or with pediatric and adult formulations on different shelves. Adjustments to correct accuracy are not recommended. Cleaning must be done quickly to minimize the risk of the temperature going out of range. Determining when a vaccine or diluent expires is an essential step in the vaccine preparation process. Vaccines are one of the safest and most effective ways to prevent diseases. Sometimes unused vaccine and diluent doses, unopened vials, expired vials, and potentially compromised vaccine may be returned for credit, even if they must be discarded. The unit should be firm and level, with the bottom of the unit above the floor. Washington, D.C.: American Pharmacists Association;2007. Health care providers should be competent in treating these events at the time of vaccine administration. Detailed information about transport, including how to pack vaccines, can be found in CDC’s Vaccine Storage and Handling Toolkit. Vaccines should be reconstituted according to manufacturer guidelines using only the diluent supplied for a specific vaccine. Immediately after use, all used syringe/needle devices should be placed in biohazard containers that are closable, puncture-resistant, leakproof on sides and bottom, and labeled or color-coded. A comforting hold: A combination of interventions, holding during the injection along with patting or rocking after the injection, is recommended for children up to age 3 years. Contact the state or local immunization program or the vaccine manufacturer for vaccine-specific information. Harrington J, Logan S, Harwell C, et al. Vaccine preparation is the final step in the cold chain before administration. Once initial training has been completed, accountability checks should be in place to ensure staff follow all vaccine administration policies and procedures. Less than a year to develop a COVID vaccine – here’s why you shouldn’t be alarmed November 25, 2020 5.27am EST. Some MDVs have a specific number of doses that can be withdrawn. Draw up vaccines only after arriving at the clinic site or mass vaccination event. Instilling air into a multidose vial prior to withdrawing a vaccine dose is not necessary. Some patients and parents may have questions or concerns about vaccination. An adverse vaccine reaction is an untoward effect caused by a vaccine. Patient and parent education should also include a discussion of comfort and care strategies after vaccination. There are only two recommended sites for administering vaccines by IM injection: Injection at these sites reduces the chance of involving neural or vascular structures. An oral applicator is for use with oral vaccines and contains only one dose of medication. Immediately upon arrival at the off-site location, vaccines should be stored in an appropriate storage unit with a TMD. A multidose vial (MDV) contains more than one dose of vaccine. CDC’s Vaccine Storage and Handling Toolkit contains detailed information on best practices and recommendations from the Advisory Committee on Immunization Practices (ACIP), vaccine manufacturers, and scientific studies. Name and title of the person who administered the vaccine and the address of the facility where the permanent record will reside, The edition date of the VIS distributed and the date it was provided to the patient, Doses administered too early (e.g., before the minimum age or interval), Wrong vaccine (e.g., Tdap instead of DTaP), Wrong dosage (e.g., pediatric formulation of hepatitis B vaccine administered to an adult), Wrong route (e.g., MMR given by IM injection), Vaccine administered outside the approved age range, Vaccine administered to a patient with a contraindication, Wrong diluent used to reconstitute the vaccine or only the diluent was administered, Hepatitis B vaccine administered by any route other than IM injection, or in adults at any site other than the deltoid or anterolateral thigh, HPV vaccine that is administered by any route other than IM injection, Influenza vaccine administered subcutaneously, Any vaccination using less than the appropriate dose (e.g., pediatric formulation hepatitis A vaccine given to an adult) does not count and the dose should be repeated according to age unless serologic testing indicates an adequate response has developed (however, if two half-volume formulations of vaccine are administered on the same clinic day, these 2 doses can count as 1 valid dose), If a partial dose of an injectable vaccine is administered because the syringe or needle leaks or the patient jerks away, Any vaccination using more than the appropriate dose (e.g., DTaP administered to an adult) should be counted if the minimum age and minimum interval have been met, Hepatitis A vaccine and meningococcal conjugate vaccine administered by the subcutaneous route, if the minimum age and minimal interval have been met. Su J, Miller E, Duffy J, et al. To protect the storage unit’s power supply: Storage units and temperature monitoring devices need regular maintenance to ensure proper operation, maintain required temperatures, and extend the useful life of the equipment. Research shows that children age 3 years or older are less fearful and experience less pain when receiving an injection if they are sitting up rather than lying down. In the setting of the COVID-19 pandemic, gloves should be worn when administering intranasal or oral vaccines. Products that have been contaminated or compromised should not be used, regardless of the expiration date. For both children and adults, the best position and type of comforting technique should be determined by considering the patient’s age, activity level, safety, comfort, and administration route and site. There are numerous strategies for effectively educating and talking to patients and parents about the need to vaccinate. See the “Predrawing Vaccines” section for more information. Laws regarding using an IIS vary by state or region. CDC recommends DDLs with the following characteristics: Temperature data from a DDL can be downloaded to a computer using special software or retrieved from a website for user review, which is critical to ensuring vaccine safety. You will be subject to the destination website's privacy policy when you follow the link. Rotavirus vaccines (RV1 [Rotarix], RV5 [RotaTeq]) are administered orally. Place vaccines and diluents with the earliest expiration dates in front of those with later expiration dates. Vaccines should not be used after the BUD. Parents should be counseled that sweet-tasting liquids should only be used for the management of pain associated with a procedure such as an injection and not as a comfort measure at home. Inconsistent messages from health care personnel about the need for and safety of vaccines may cause confusion about the importance of vaccines. The expiration date printed on the vial or box should be checked before preparing the vaccine. SDVs with any leftover vaccine should never be saved to combine leftover contents for later use. Saving Lives, Protecting People, Needle Length and Gauge: Children and Adolescents (birth – 18 years) for, Needle Length and Gauge: Adults (age 19 years or older) for, Epidemiology and Prevention of Vaccine-Preventable Diseases, Screen for Contraindications and Precautions, Educate Patients or Parents about Needed Vaccines, Patient Care after Vaccine Administration, https://www.aap.org/en-us/documents/immunization_refusaltovaccinate.pdf, Australian Technical Advisory Group on Immunization (ATAGI). Document all training completed per organizational and VFC requirements. Although pain from vaccination is to some extent unavoidable, there are some things that parents and health care providers can do to help. In addition, many state and local immunization programs and professional organizations, including the American Academy of Pediatrics, have resources. Fully enrolled at about 30,000 participants, their study included 3,000 African American participants (10% of total) and twice as many Hispanic/Latinx participants for a total of 36% enrollees of color. Nothing should block the cover of the motor compartment. Monitor patient flow to avoid drawing up unnecessary doses. The cap on the top of an unopened vaccine vial functions as a dust cover. Although there is no national law, it is also important to document when parents or adult patients refuse vaccines despite the vaccine provider’s recommendation.