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INTRODUCTION

According to the Centers for Disease Control and Prevention (CDC), annual influenza vaccine dose availability has been and is expected to continue to exceed 150 million doses.¹ Annually, health care providers safely administer millions of vaccine doses in the United States, including those listed in CDC's pediatric immunization schedule.^2,3 Fortunately, 24 infectious diseases are now preventable with safe, effective vaccines used across the lifespan either as routine or for special, at-risk circumstances, making vaccination 1 of the top 10 public health achievements of the last century.⁴ For every year we immunize children born in the United States (U.S.), we prevent 42,000 deaths and 20 million cases of disease, with net savings of nearly $14 billion in direct costs and $69 billion in total societal costs.⁴ It's no wonder, therefore, that the National Vaccine Advisory Committee (NVAC) has called upon all health care professionals, including those who do not administer vaccines, to encourage patients to be immunized (Table 1).⁵ With the growth in both the number and types of vaccines available, and a broader range of providers administering immunizations, CDC has renewed its emphasis on appropriate storage, handling, and vaccine administration.

Table 1. Adult Immunization Practice Standards for All Health Care Professionals5 ASSESS immunization status of all your patients at every clinical encounter. Stay informed. Get the latest CDC recommendations for immunization of adults. Implement protocols and policies. Ensure that patients' vaccine needs are routinely reviewed and patients receive reminders about vaccines they need. Strongly RECOMMEND vaccines that patients need. Share tailored reasons why vaccination is right for the patient. Highlight positive experiences with vaccination. Address patient questions and concerns. Remind patients that vaccines protect them and their loved ones against a number of common and serious diseases. Explain the potential costs of getting sick. ADMINISTER needed vaccines or REFER your patients to a vaccination provider. Offer the vaccines you stock. Refer patients to providers in the area that offer vaccines that you don't stock. DOCUMENT vaccines received by your patients. Participate in your state's immunization registry. Help your office, your patients, and your patients' other providers know which vaccines your patients have had. Follow up. Confirm that patients received recommended vaccines if you referred them to other immunization providers.

Source: Reference 5.

Vaccine Storage and Handling

Vaccine storage and handling is critical to ensure vaccine antigens remain viable and can elicit an immune response in recipients. Unlike many drug products, inappropriately stored vaccines will often visually look no different from correctly stored vaccines—the vaccine simply will not prevent the disease it was designed to prevent.^6,7 Manufacturers, distributors, and health professionals share vaccine storage and handling responsibilities. Failure to store vaccines correctly at any point, called a break in the "cold chain," may reduce the vaccine's potency. Patients who receive improperly stored vaccine and are exposed to the corresponding vaccine-preventable disease (VPD) may contract that disease needlessly.

Within a pharmacy practice, all pharmacy staff with responsibility for inventory management or vaccine administration should be fully aware of vaccine storage and handling requirements. Table 2 provides the accepted storage temperatures for vaccines. When a vaccine has been inadvertently stored outside of the recommended temperature range, the responsible pharmacy employee should place the vaccine in a bag or bin marked "Do Not Use," and separate it from remaining vaccine supply. Pharmacy staff should contact the manufacturer (Table 3) as the very first course of action for recommendations on use, return, or discarding of the doses.⁷ Additional actions pharmacists can take to ensure that vaccines are stored appropriately include:

Table 2. Vaccine Storage Temperatures
Refrigerated Vaccines	Ideally, 5°C (40°F). Range 2°C to 8°C (35°F to 46°F)
Frozen Vaccines	Range –50°C to –15°C (–58°F to 5°F)
Diluents	Never freeze diluents. Many diluents are packaged to be stored with their refrigerated vaccine. Some diluents may be stored at room temperature up to a maximum of 25°C (77°F). Consult manufacturer-specific labeling.
Note: Pharmacy personnel should consult product labeling for FDA approved storage ranges for each vaccine. Source: Reference 7

Table 3. Contact Information for Major U.S. Vaccine Manufacturers For Storage- and Handling-Related Questions
Berna	800-533-5899
GlaxoSmithKline	888-825-5249
MedImmune	800-457-4626
Merck & Co, Inc.	800-637-2590
Novartis	877-683-4732
Pfizer/Wyeth	800-438-1985
Protein Sciences	203-686-0800
Sanofi	800-822-2463

• Develop and implement a practice-site specific storage and handling plan, and ensure everyone (including custodial staff) reviews the plan. The CDC has a checklist for developing a plan in its Vaccines Storage and Handling Toolkit, available at http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf.⁷
• Store vaccines in their original packaging until the time of use. This will ensure ease of identification, and protect vaccines sensitive to light from exposure.⁷
• Store diluents for vaccines at the manufacturer's recommended temperature (i.e., consult the product labeling). Some diluents may be stored either in the refrigerator or at room temperature, while others must be refrigerated. As a best practice, CDC recommends storing diluents, whenever possible, with their corresponding vaccines if refrigeration is required. Diluents should never be stored in a freezer.⁷
• CDC recommends using continuous monitoring devices with data logging for each vaccine storage unit, rather than storage units that only record minimum and maximum temperatures. These devices should have a digital display on the outside so staff can monitor temperature without opening the unit's door. The digital display should show the current temperature, and the minimum and maximum temperatures recorded.⁷  Staff must not use room thermometers or thermometers designed for human or food temperature measurement. Only thermometers equipped with glycol-immersed probes are appropriate, and these should be placed in a central location within the unit. Please consult CDC's Vaccines Storage and Handling Toolkit for specific information.^6,7
• Visually inspect and record vaccine storage unit temperatures at least 2 times each day (morning and evening), even if the unit has automatic temperature recording. Post the log on each unit, and record the temperature for both the refrigeration and freezer compartment if the unit has both functions. Note that CDC recommends the use of stand-alone units that perform either the function of refrigeration or freezing. Take immediate corrective action as necessary for temperatures outside of the recommended range.⁷ 
• Only store vaccines in units that meet CDC's guidelines for storage and handling of vaccines and biologics. Many commercially available refrigeration units designed for in-home use, including dormitory-style refrigerators, are unacceptable.^6,7 As previously stated, CDC recommends using stand-alone units that perform either the function of refrigeration or freezing. Vaccines intended for refrigeration should not be frozen, as freezing may render the vaccine ineffective.⁷ The unit should have a reliable seal that is checked regularly for its continued integrity. The seal should not leak to room air which can lead to possible temperature variations.
• Post instructive signs on vaccine-storage units which warn others, "Do not adjust unit temperature and do not unplug!"⁷
• Place vaccines in the center of the unit. Avoid placement near the back of the unit (where temperatures may be colder than appropriate) and avoid placement in the door of the unit (where temperature fluctuations can result in warmer than appropriate storage). Never place vaccines in deli, fruit, or vegetable drawers typical of consumer units, nor on the unit's floor (e.g., if the drawers were removed).⁷
• Insulate the door and top shelf of the unit with water bottles (refrigeration units) or ice packs (freezer units). This helps ensure temperature continuity if power interruptions occur. Additionally, prohibit storing food or drinks in any refrigeration unit in which vaccines or other drugs are stored.
• Develop and implement an emergency plan in the event power is interrupted for an extended period (generally more than 2 hours). Having an emergency plan is a step many pharmacists often overlook. For example, if your pharmacy were to lose power, do you have a back-up generator to provide power? Do you have an agreement with a hospital or another community pharmacy to store vaccines temporarily for your practice? These are just 2 important considerations in the emergency preparedness realm.^7,8

Careful vaccine storage can prevent dispensing and administration errors, and good inventory management will ensure that immunizers administer only vaccine that is within the recommended use date. Because many vaccines have sound-alike names and look-alike packaging, these tips can reduce the risk of product selection errors, and ensure inventory is managed appropriately^7,9:

• From the time vaccine arrives in the pharmacy until it is administered to the patient, pharmacy staff should  manage and record vaccine inventory carefully. Records may be maintained electronically or in writing, and should include the date the vaccine and diluent were received; the name or initials of the person who unpacked the delivery and completed the stocking records; a notation as to whether or not the vaccine arrived at the appropriate temperature; and cold-chain monitoring records from the shipping container. Additionally, pharmacies should be able to retrieve the names of all vaccines in inventory easily, along with the name of the manufacturer, and the lot numbers and expiration dates in stock or previously in stock in the event of a recall or other safety issue. If doses in a multidose vial were wasted for any reason (e.g., not used), this should also be recorded.⁷
• Store each vaccine product in a color-coded plastic bin. Do not store more than 1 vaccine product in each bin.
• Clearly label the outside of each bin to list the product within the bin.
• Store vaccines with similar names on different shelves in different color-coded bins.
• Whenever possible, store vaccines separately from other drugs. If this is not possible, store vaccines on separate shelves from other drug products (e.g., insulin, other biologics).
• Rotate inventory as new inventory arrives, placing the newest inventory behind the older inventory.
• Check expiration dates carefully before administering any vaccine. Note that some vaccines are labeled with expiration dates that include the month, day, and year of expiration. These vaccines can be used through the day listed. Other vaccines are labeled with expiration dates that include only the month and year of expiration. In this case, the vaccine can be used through the last day of the month listed.
• Never reconstitute vaccines that require mixing until after the patient has made final payment for the vaccine and the patient is verifiably present to receive the vaccine. Most reconstituted vaccines must be administered within several minutes to a few hours following reconstitution; otherwise, the product must be discarded. Immunizers should mark vaccines in multidose vials with the date they use the first dose. Consult product-specific manufacturer recommendations for the last date after opening by which the remaining doses must be used.⁷

Vaccine Administration

The Accreditation Council on Pharmacy Education has required doctor of pharmacy degree programs to train PharmD candidates to administer injectables since 2007.^10,11 While many pharmacy schools were teaching pharmacy students how to administer intramuscular and subcutaneous injections before then, we can only say with certainty that all pharmacy students learned injection technique as a part of the curriculum after 2007. Between 1996 and 2007, injection technique training was a core component of the American Pharmacists Association's Pharmacy-Based Immunization Delivery: A National Certificate Program for Pharmacists, and other programs designed to bring pharmacists up to speed with vaccine practice.¹² Pharmacists who have never administered vaccines or who have not practiced the technique for select routes of administration should ensure their administration technique competency before immunizing patients. Additionally, Idaho in 2017 became the first state to allow selected pharmacy technicians to administer vaccines under the supervision of a pharmacist.¹³

Shoulder Injury Related to Vaccine Administration (SIRVA) is believed to occur when vaccines are unintentionally injected into the subacromial bursa space high in the shoulder and beneath the deltoid muscle.^14-16 This injury, now reportable through the Vaccine Injury Compensation Program (VICP; discussed further below), has resulted in 522 claims between 2011 and 2016 to the VICP and more than $22 million in compensation to patients for their injuries likely due to SIRVA.¹⁷ It is critical that pharmacists and other healthcare personnel administering intramuscular vaccines maintain optimal technique in administering vaccines. Suggestions for preventing SIRVA include the following:
• Follow CDC guidance for appropriate needle length selection.¹⁸
• Ensure proper administration technique for intramuscular injections, administering in the central portion of the deltoid and avoiding the top third of the muscle.^18,19
• Conduct comprehensive, skills-based training and integrate it into existing staff education programs such as new staff orientation and annual staff education requirements.¹⁹
• Persons administering vaccine should be in the same seated position as the patient. Avoid standing to administer vaccine to a patient who is seated.19

States also have differing baseline or continuing professional education requirements for administering vaccines. In addition to which injection technique training for pharmacists is acceptable, states bestow the authority for pharmacists to administer vaccines and the individual state's board of pharmacy typically regulates the practice. Because of this, pharmacists should always refer to their state pharmacy practice acts to identify specific restrictions or requirements that may be in place.

Currently, vaccines on the U.S. market are available in 4 distinct routes of administration. The vast majority of inactivated vaccines are administered intramuscularly in the deltoid muscle, while all live-attenuated injectable vaccines are administered subcutaneously in the anterior aspect of the arm, midway between the elbow and armpit. One vaccine, FluMist Quadrivalent (influenza vaccine live, intranasal; MedImmune), is administered intranasally by the health care provider.²⁰ Another vaccine, Fluzone Intradermal Quadrivalent Influenza Vaccine (inactivated, quadrivalent flu vaccine; Sanofi) is administered intradermally into the upper arm using the manufacturer-supplied unit dose administration unit.²¹

Pharmacists who provide comprehensive adolescent and adult immunization services should also consider vaccine safety and efficacy in the timing and spacing of vaccine doses. According to CDC's General Practice Recommendations for Vaccines, 2 inactivated vaccines may be administered on the same day or at any time interval in relation to each other.²² Two live vaccines for the same patient must be administered either on the same day, or separated by 28 days to reduce the possibility of interfering with the body's immune response. A dose of a live vaccine and a dose of an inactivated vaccine may be administered simultaneously (defined as the same clinic day), or at any time interval in relation to each other. Patients receiving more than 1 vaccine product on the same day should receive those doses at different anatomic sites and using different syringes for each vaccine.²² Pharmacists should always document each vaccine's injection site to assist with monitoring for local adverse reactions. As with any general recommendation, pharmacists should review product-specific administration recommendations diligently before administering any vaccine.

Vaccine Adverse Events

Serious adverse events associated with vaccines are rare. However, despite the many proven benefits of vaccinations  and the extremely safe vaccine supply in the U.S., use of vaccines in certain patients and patient populations poses some risks. For example, administering live vaccines to patients who are immunocompromised is generally contraindicated, whether attributable to an underlying disease condition or iatrogenic cause. Table 4 lists some conditions and therapies that CDC and manufacturers consider contraindications related to vaccine administration. Additionally, pharmacists are encouraged to visit the CDC's website on Vaccine Safety and Adverse Events for up-to-date information at http://www.cdc.gov/vaccines/vac-gen/safety/default.htm. Suggestions for pharmacists to help ensure vaccine safety are found in Table 5.

Table 4. Immunocompromising Conditions that May Serve as A General Contraindication to the Use of Live Vaccines
HIV/AIDS (CD4 count-dependent)	Lymphoma
Leukemia	Patients undergoing cancer chemotherapy
Solid organ transplant recipients	Hematopoietic cell transplants (Consult CDC for time intervals)
Monoclonal antibody recipients	High-dose corticosteroid recipients (>20 mg of prednisone or equivalent per day)
Complement disorders	Pregnancy (note: pregnancy of a household contact is generally not a contraindication for vaccination of a non-pregnant individual)
Source: Reference 7. *The above list is not intended to be a comprehensive list of all general contraindications to the use of live vaccines. Certain vaccine-specific contraindications and patient-specific factors should be taken into consideration. In many cases the conditions listed are temporary contraindications, and immunization may be possible following resolution of the condition (e.g., pregnancy, cancer, drug therapies). Consult the manufacturer's product-specific labeling for more information. Additionally, consult more detailed information from CDC related to immunosuppressive conditions in children. Reference: 7 Abbreviation: CDC = Centers for Disease Control and Prevention; HIV/AIDS = human immunodeficiency virus/ acquired immunodeficiency syndrome.

Table 5. Recommendations for Pharmacists to Reduce Risk of Adverse Events and Errors Associated with Vaccines Review vaccination needs with every patient at every care encounter; be especially diligent to include review of vaccine needs as part of a medication therapy management visit. Prior to administering any vaccine, make a reasonable effort to determine the patient's immunization history. Check the state's immunization registry (for more information about registries, see http://www.cdc.gov/vaccines/programs/iis/contacts-locate-records.html). Screen each patient for relevant drug or vaccine allergies. For example, previous allergic reaction to any vaccine component would be a contraindication to future doses. Gelatin and neomycin allergy are a contraindication to receipt of varicella, herpes zoster, and MMR vaccines. Patients with serious allergic reactions to egg protein should not receive yellow fever vaccine (see http://www.chop.edu/centers-programs/vaccine-education-center/vaccine-ingredients/egg-products#.VsikE30rJD8). Screen each patient for conditions that may indicate a contraindication to vaccine. For example, pharmacists administering herpes zoster (shingles) vaccine should defer immunization in patients undergoing radiation therapy, cancer chemotherapy, in patients taking high dose corticosteroids or who are on monoclonal antibody therapy, in patients with HIV (based upon CD4 count), and in a host of other immunocompromising conditions.22 Use single use, prefilled syringes whenever possible for vaccine doses to reduce errors. When using multi-dose vials or administering multiple vaccines to the same patient, use color-coded stickers or printed labels to mark syringes. Prepare doses at the time of individual patient need; generally avoid mass-prefilling of syringes.23Review the Institute for Safe Medication Practices website (ISMP.org) periodically for tips on improving system safety. Follow CDC's storage and handling recommendations for vaccines. Take time to have every member of the pharmacy team who is involved in product receiving, storage or dispensing to view CDC's You Call The Shots Storage and Handling training program: http://www2a.cdc.gov/nip/isd/ycts/mod1/courses/sh/ce.asp. Document every dose of vaccine given according to the VICP. Ensure these records are permanent and will not be purged with other dispensing records over time. Also ensure that you have documented all doses with your state's immunization information system or registry.

Sources: References: 7–9, 22, 23. Abbreviations: CDC = Centers for Disease Control and Prevention; HIV = human immunodeficiency virus; MMR = measles, mumps, rubella; VICP = Vaccine Injury and Compensation Program.

The Vaccine Adverse Event Reporting System (VAERS) is an important step in the process of notifying federal agencies and manufacturers about adverse effects that may be the result of vaccination. It is not the provider's responsibility to determine the event's causality; however, it is important that vaccine providers report adverse effects that are outside of the vaccine's normal, expected profile and occur within days to weeks of vaccination. For example, redness, pain, swelling at the injection site, limitation of arm movement, fatigue, and fever are commonly associated with a number of vaccines and would not be something normally reported to VAERS. On the other hand, certain serious adverse events, when they occur in relation to the receipt of a vaccine, are required by statutory regulation to be reported to the VAERS program. The current VAERS Table of Reportable Events Following Vaccination is available online at https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf. When providers or patients are uncertain if an effect was related to vaccination, they should always report it so health officials can investigate further.

For a more detailed description of VAERS and how to complete a VAERS report, pharmacists can view a video available at https://www.youtube.com/watch?v=a9bXB3R2qP8&feature=youtu.be.

In addition to VAERS, the Institute for Safe Medication Practices (ISMP) offers a National Vaccine Errors Reporting Program (VERP). (verp.ismp.org.) The VERP program is a surveillance system designed to identify possible vaccine administration or dispensing errors. The program aggregates reports so it can identify  errors that occur frequently and propose solutions to prevent further errors. Reporting to VERP is a voluntary, nonpunitive process designed to improve patient care.

Recipients who experience certain specific adverse events secondary to a vaccine may file for injury compensation consideration through the VICP. ²⁴ Established in 1986 by the National Childhood Vaccine Injury Act (NCVIA), the program provides a no-fault mechanism for individuals to have claims heard without going through the normal legal system. The idea is to ensure adequate vaccine supply and reasonable vaccine cost by limiting health care provider liability. Cases are heard by the U.S. Court of Federal Claims (sometimes referred to as the "Vaccine Court"), and the program is operated by the Health Resources and Services Administration (HRSA), a division of the Department of Health and Human Services (HHS). Under NCVIA, health care providers who administer vaccines must maintain permanent medical records for each vaccine dose administered. The records should include the administration date, the vaccine's manufacturer and lot number, the name and address (and if appropriate, title) of the health care provider administering the vaccine, and any information the Secretary of HHS may determine appropriate in the future.²⁵

In addition to these recordkeeping requirements, providers must provide a copy of the CDC's current Vaccine Information Statement (VIS) to patients with each vaccine administered. Current VISs are available online at http://www.cdc.gov/vaccines/hcp/vis/index.html. Additionally, the Immunization Action Coalition (www.immunize.org) offers VISs in languages other than English.

Related to the VICP program, it is important for pharmacists to be aware of the more serious adverse events that may occur so they can screen patients appropriately before vaccination. Never administer a dose of a vaccine to an individual who has experienced a previous anaphylaxis or anaphylactic shock reaction after vaccination. VICP defines anaphylaxis and anaphylactic shock to mean an acute, severe, and potentially lethal systemic allergic reaction. Most cases resolve without sequelae. Signs and symptoms begin minutes to a few hours after exposure. Death, if it occurs, usually results from airway obstruction caused by laryngeal edema or bronchospasm and may be associated with cardiovascular collapse. Other significant clinical signs and symptoms may include the following: cyanosis, hypotension, bradycardia, tachycardia, arrhythmia, or edema of the pharynx, trachea, and/or larynx with stridor and dyspnea.²⁴

Because it may be difficult (if not impossible) to discern whether the causative component of anaphylaxis was the vaccine antigen, a component used in vaccine production, or even something completely unrelated to the vaccine, certain screening questions beyond asking about previous reactions to vaccines are important. For example, immunizers should ask patients if they have ever had an anaphylactic allergic reaction to neomycin or gelatin before they receive the live-attenuated measles– mumps–rubella (MMR), varicella, or varicella zoster vaccines; MMR vaccine contains approximately 25 mcg of neomycin per dose, while varicella and varicella zoster vaccines contains trace amounts of neomycin.^26-28 Additionally, MMR vaccine contains 14.5 mg of hydrolyzed gelatin, varicella vaccine contains 12.5 mg of hydrolyzed gelatin, and varicella zoster vaccine contains 15.58 mg of hydrolyzed porcine gelatin.^26-28 Note that dermatologic reactions to neomycin or any other component are not contraindications to vaccine administration.

Screening patients who will receive live vaccines for the presence of contraindications is critical. Contraindications are patient-specific factors that are more likely to predict an adverse effect or outcome should the patient receive the vaccine.

For example, patients who are immunosuppressed for any reason generally should not receive live vaccines such as MMR, varicella, varicella zoster live vaccine, intranasal flu vaccine, oral typhoid vaccine, oral cholera vaccine, or yellow fever vaccine. For some live vaccines, immunosuppression may represent a precaution for use depending on the degree of altered immune competence. Thus, pharmacists should always consult the manufacturer's product labeling and CDC guidelines before administering live vaccines to patients with any degree of altered immune competence. The reason: live vaccine virus must replicate to produce immune responses. In a patient whose immune system is not functioning normally, vaccine virus has the potential to cause serious infection with the disease it was designed to prevent.

For pharmacists, this screening is becoming more complex as an increasing number of immunosuppressive drug therapies are brought to market. According to CDC's General Practice Recommendations, doses of prednisone 20 mg per day (or 2 mg/kg of body weight) or equivalent for 2 weeks or longer constitute substantial immunosuppression that creates contraindications for live vaccines.¹⁵ Use of immunobiologic therapies for the treatment of a host of autoimmune disorders, cancers, and other conditions is also a temporary contraindication to use of live vaccines. CDC and the Infectious Diseases Society of America (IDSA) provide different guidance on this issue, largely because information about these agents has evolved since the last general practice recommendations from CDC. IDSA has provided guidance indicating receipt of certain biologic immune modulators such as tumor necrosis factor-alpha blockers and rituximab to be high-level immunosuppression. Detailed, vaccine-specific information is available in the full IDSA guidelines; the organization provides the following key general recommendations related to immunization of immunosuppressed patients and their household contacts²⁹:

• All vaccines should be administered before planned immunosuppression if feasible.
• Live vaccines should be administered more than 4 weeks before immunosuppression and avoided within 2 weeks of initiation of immunosuppression.
• Inactivated vaccines should be administered more than 2 weeks before immunosuppression.
• Individuals who live in a household with immunocompromised patients older than 6 months of age should receive influenza vaccine annually.
• Highly immunocompromised patients should avoid handling infants' diapers for 4 weeks after infants have been vaccinated with rotavirus vaccine.
• Healthy immunocompetent household contacts of immunocompromised patients can safely receive any live vaccine based on CDC's annual schedule. CDC notes 2 exceptions. Live attenuated influenza vaccine should not be used in household contacts of patients who have had hematopoietic stem cell transplants in the previous 2 months; if the patient has graft versus host disease; or if the patient has severe combined immune deficiency. Oral polio vaccine (which is no longer marketed within the United States) should not be administered to individuals who live in a household with immunocompromised patients.

Pharmacists are frequently involved in campaigns to immunize patients against pertussis using the combined tetanus, diphtheria, and pertussis (Tdap) vaccines. Tdap, containing inactivated vaccines, is generally safe for any adult patient. Pharmacists should take certain precautions when screening patients. A precaution is not a contraindication; however, it does require that there be some waiting period prior to vaccinating due to potential harm to the patient. In patients who have progressive or unstable neurologic disorders, uncontrolled seizures, or progressive encephalopathy, defer Tdap or diphtheria, tetanus, and acellular pertussis (DTaP) vaccination until a treatment regimen has been established and the condition has stabilized. Also, in the event a patient may have experienced an arthus-type hypersensitivity reaction after a previous dose of tetanus-toxoid containing vaccine, defer vaccination with Tdap or tetanus and diphtheria (Td) vaccine until at least 10 years have elapsed since the last tetanus-toxoid containing vaccine.¹⁵ The only absolute contraindication is encephalopathy not attributable to another cause occurring within 7 days of administration of a previous dose of diphtheria–tetanus–pertussis (DTP) vaccines, DTaP, or Tdap.²²If a patient experiences new onset encephalopathy due to the pertussis component following the receipt of Tdap or DTaP vaccine, the event is a mandatory-reporting event under the National Childhood Vaccine Injury Act of 1986, and must be reported to the VICP.²⁴

The issue of immunizing patients during pregnancy is of tremendous importance. Pregnancy is an indication for both Tdap and influenza vaccine. For many other vaccines, including all live-attenuated antigen vaccines, pregnancy is considered a temporary contraindication to vaccination because of a largely theoretical increased risk to the fetus. For other vaccines, including pneumococcal, hepatitis vaccines, and most other inactivated vaccines, pregnancy constitutes a precaution for administration; we generally either immunize the patient fully prior to pregnancy or defer vaccination until after delivery. Pharmacists can administer influenza (inactivated formulations but not including high-dose) and Tdap vaccine to pregnant patients without concern.

CDC reports that pregnant women and their babies are at increased risk for influenza-related complications, including premature labor and preterm birth. Influenza vaccine may be administered at any time during pregnancy to reduce the morbidity and mortality associated with influenza illness.³⁰ Tdap vaccine is recommended between 27 and 36 weeks of gestation during each pregnancy, regardless of the interval since the last pregnancy. Tdap is administered in this manner because strong evidence shows it transfers critical maternal antibodies that protect the newborn during the first few months of life until the baby can receive his or her own vaccination with DTaP vaccine series.³¹

Finally, for many years pharmacists and other health care providers have screened patients is egg allergy before receipt of influenza vaccine. Through the 2015–16 season, CDC advised providers to screen patients carefully for egg allergy and depending upon patient specific factors, use a decision tree to determine if a patient with possible egg allergy should be immunized.²⁹ However, at its February 2016 meeting, ACIP voted to remove the egg allergy warnings for all influenza vaccines for the 2016–17 season based on overwhelming data that demonstrates individuals with egg allergy are at no increased risk of anaphylaxis following influenza vaccine.³² The one caveat is that those individuals with a history of serious egg allergy should be administered the vaccine in a physician’s office and monitored for an appropriate length of time following vaccination.³⁴The final recommendation along with the scientific evidence presented that formed the basis of this decision will be available on the ACIP webpage at http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html in mid- to late 2016 and will be included in CDC's seasonal influenza vaccination recommendations for the 2016–17 season. This decision is consistent with similar decisions made by public health authorities in other countries, including Canada, which have also recently removed the egg allergy contraindication for flu vaccine.³⁵

Summary

Vaccines are safe, effective public health interventions. Pharmacists have an increasingly important role to play in ensuring access to vaccines, and especially among adolescent and adult patients. Understanding complete storage and handling recommendations, and having a plan for storage and handling both routinely and during emergency situations is critical to keeping the vaccine supply safe. Additionally, pharmacists have a responsibility to administer vaccines competently by the correct route and at correct intervals to optimize protection against vaccine-preventable disease. Pharmacists should be familiar with the VICP and its reporting requirements. While unusual, adverse events can occur with vaccines. Pharmacists who screen patients diligently for contraindications or precautions will likely avoid these situations. Regardless, pharmacists must familiarize themselves with the VAERS reporting system and are strongly recommended to participate in ISMP's VERP. Through good reporting and program participation pharmacists can help improve future vaccine development and immunization programs.

REFERENCES

1. Seasonal Influenza Vaccine Supply for the U.S. 2017-2018 Influenza Season webpage. Center for Disease Control and Prevention website. https://www.cdc.gov/flu/about/qa/vaxsupply.htm. Accessed June 19, 2018.
2.  VAERS Data webpage. Vaccine Adverse Event Reporting System website. Accessed at https://vaers.hhs.gov/data/index, May 10, 2016. 
3. Recommended Immunization Schedule for Children and Adolescents Aged 18 Years or Younger, United States, 2018. Centers for Disease Control and Prevention website. https://www.cdc.gov/vaccines/schedules/hcp/child-adolescent.html. Accessed June 19. 2018.
4. CDC. Ten great public health achievements – 2001-2010. MMWR Morb Mortal Wkly Rep. 2011:60(19);619-623.
5. National Vaccine Advisory Committee. Recommendations from the national vaccine advisory committee. Standards for adult immunization practice. Public Health Rep. 2014;129:115-123.
6. National Institute of Standards and Technology. Storage and handling of vaccines, 2012. Accessed at http://www.nist.gov/pml/div685/grp01/vaccines.cfm, June 19, 2018.
7. Centers for Disease Control and Prevention. Vaccine storage & handling toolkit, January 2018. Atlanta, Georgia. Accessed at http://www.cdc.gov/vaccines/hcp/admin/storage/toolkit/storage-handling-toolkit.pdf, June 19, 2018.
8. Association of Immunization Managers. AIM Statement on Vaccine Storage and Management. Accessed at http://c.ymcdn.com/sites/www.immunizationmanagers.org/resource/resmgr/docs/aim_statement_on_vaccine_sto.pdf, June 19, 2018.
9. Institute of Safe Medication Practices. Confusion abounds: 2-year summary of the ISMP National Vaccine Errors Reporting Program (Part 1). Accessed at https://www.ismp.org/newsletters/acutecare/showarticle.aspx?id=95, June 19, 2018.
10. Accreditation Council on Pharmacy Education. Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree (Standards 2007). Chicago, Illinois. Accessed at https://www.acpe-accredit.org/pdf/FinalS2007Guidelines2.0.pdf, June 19, 2018.
11. Accreditation Standards and Guidelines for the Professional Program in Pharmacy Leading to the Doctor of Pharmacy Degree (Standards 2016). Chicago, Illinois. Accreditation Council on Pharmacy Education. Accessed at https://www.acpe-accredit.org/pdf/GuidanceforStandards2016FINAL.pdf, June 19, 2018.
12. Hogue MD, Grabenstein JD, Foster SL, Rothholz MC. Pharmacist involvement with immunizations: a decade of professional advancement. J Am Pharm Assoc. 2006;46(2):168-179.
13. Flumist [product labeling]. Gaithersburg, MD: MedImmune, Inc.; 2015. Accessed at http://www.azpicentral.com/flumistquadrivalent/flumistquadrivalent.pdf#page=1, June 7, 2016.
14. Fluzone Intradermal Quadrivalent [product labeling]. Swiftwater, PA: Sanofi; 2015. Accessed at https://www.vaccineshoppe.com/image.cfm?pi=IDQIV&image_type=product_pdf, June 7, 2016.
15. Kroger AT, Sumaya CV, Pickering LK, Atkinson WL. General practice recommendations on immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep. 2011; 60(RR02): 1-60.
16. National Vaccine Injury Compensation webpage. Health Resources and Services Administration website. Accessed at www.hrsa.gov/vaccinecompensation/index.html, May 10, 2016. 
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18. 42 USC Chapter 6A, Public Health Service, Title 42, The Public Health and Welfare. Chapter 6A, Public health Service, Subchapter XIX, Vaccines. Accessed at http://www.hrsa.gov/vaccinecompensation/authoringleg.pdf, May 10, 2016. 
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26. Health Resources and Services Administration. Prevention of SIRVA. Accessed at http://www.hrsa.gov/advisorycommittees/childhoodvaccines/meetings/20150604/sirva.pdf. March 24, 2016.
27.  Centers for Disease Control and Prevention. Vaccines for pregnant women. Accessed at http://www.cdc.gov/vaccines/adults/rec-vac/pregnant.html, May 10, 2016.
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29. Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices, United States, 2015-16 Influenza Season. MMWR Morb Mortal Wkly Rep. 2015; 64(30):818-825.
30. Centers for Disease Control and Prevention. Advisory Committee on Immunization Practices February 2016 meeting agenda. Accessed at http://www.cdc.gov/vaccines/acip/meetings/meetings-info.html, March 24, 2016.
31. National Advisory Committee on Immunization (NACI). Canadian immunization guide chapter on influenza and statement on seasonal influenza vaccine for 2015-2016. Available at http://www.phac-aspc.gc.ca/naci-ccni/assets/pdf/flu-2015-grippe-eng.pdf, May 10, 2016.

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