The Technician s Role in Pharmacy-Based Vaccination Programs

By: Celeste D. Briones, PharmD Candidate 2015 Western University of Health Sciences College of Pharmacy Jeff Dai, PharmD Candidate 2015 Western University of Health Sciences College of Pharmacy Vanessa Diaz, PharmD Candidate 2015 Western University of Health Sciences College of Pharmacy Thanh (Tanya) Nguyen, PharmD Candidate 2015 Western University of Health Sciences College of Pharmacy Karl Hess, PharmD, FCPhA, CTH Associate Professor of Pharmacy Practice and Administrtation Director of Community Practice Experiences Western University of Health Sciences, College of Pharmacy Cleste Briones, Jeff Dai, Vanessa Diaz, Thanh Nguyen, and Karl Hess report no actual or potential conflicts of interest in relation to this continuing pharmacy education activity. With the growth and expansion of pharmacy-based vaccination services, the role of the pharmacy technician is becoming more important in the success of these programs. This CPE activity reviews the history of pharmacy-provided vaccination programs, discusses current laws and regulations that impact this practice, and reviews key operational components of pharmacy-based vaccination programs, all aiming to enhance the technician s role in this important public health service. Upon completion of this activity, Pharmacy Technicians will be able to: 1. Review the establishment of pharmacy-based vaccination programs in the U.S. 2. Identify needed operational components of pharmacy-based vaccination programs 3. Identify special considerations and requirements for pharmacy-based vaccination programs 4. Explain the technicians role in the administration of vaccines in the pharmacy 5. Given a case, choose the most appropriate course of action that should be undertaken CPE Information: UAN #: 0107-0000-15-003-H05-T CEUs/Hours: 1 contact hour (0.1 CEU) Target Audience: Pharmacy Technicians Activity Type: Application-based Initial Release Date: 1/1/2015 Planned Expiration Date: 1/1/2018 The Technician s Role in Pharmacy-Based Vaccination Programs introduction Immunizations are one of the most cost-effective, preventative health care tools available and have significantly contributed to steady rises in life expectancy since the 20 th century. 1 Furthermore, an economic analysis found that administering routine immunizations to children born in a given year reduces direct health care costs by $14 billion and societal costs by $69 billion. 2 In addition to the financial benefits, routine vaccination has been attributed to significant reduction in the rates of disease and death. For example, the development of the pneumococcal vaccine prevented approximately 211,000 serious cases of pneumonia and approximately 13,000 deaths between 2000 to 2008. 2 The reduction of vaccine preventable diseases is also included as one of the 28 Healthy People 2020 focus goals. 1 Despite the availability of vaccines (see Table 1), the United States population still remains vulnerable to many preventable diseases. For instance, influenza and pneumonia, both vaccine preventable, continue to be among the top ten leading causes of death according to data from the Centers for Disease Control and Prevention (CDC). 3 As seen in Figure 1, the percentage of adults who have received recommended vaccines remains well below goal. It is also important to continually vaccinate to keep rates of preventable disease low or nonexistent as illustrated by the rise in cases of pertussis (whooping cough). According to the CDC, 48,277 cases were reported in 2012, the most since 1955 when 62,756 cases were reported. This rise may be attributed to delays and/or lapses in vaccination. 4 Figure 1. Selected adult vaccination rates and Healthy People 2020 Focus goals. 1,5 The Collaborative Education Institute is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. This activity has been developed specifically for pharmacy technicians and is one of 10 activities in the TEAM series. 2015 TEAM SERIES 1

The Use of Over-The-Counter Drugs During Pregnancy Therefore, in order to attain this 2020 focus goal, immunizations need to be more accessible and the public needs to be continuously educated on the importance of vaccines. A solution to this issue is the developing popularity of pharmacies as immunization centers in the community. History of pharmacy/pharmacist provided vaccinations In the past, pharmacies were only involved with the storage, procurement, and patient education of vaccines. Thus, leaving administration duties to other health care professionals. This changed in 1994 when 50 pharmacists gathered to attend the first formal immunization training program in Seattle, Washington. A year later, pharmacists, operating under collaborative practice agreements, began administering influenza vaccine. 6 In 1996, the American Pharmacists Association (APhA), established the CDCendorsed Pharmacy-Based Immunization Delivery Program and continues today as the primary source of immunization certification for pharmacists. Twenty years later, the pharmacy has seen a rise in popularity as a source for administrating immunizations. According to the National Immunization Survey and National Internet Flu Survey, the pharmacy is the third most common place for influenza vaccine to be administered. 7 This can be attributed to the availability and accessibility of pharmacies when most clinics are traditionally closed. A recent study looked at data from Walgreens over a one year period and found that of the total immunizations administered, 30.5% were conducted when other clinics were likely closed such as during the evenings, weekends, or on holidays. 8 State/national vaccine legislation trends Currently, the law authorizes pharmacists to administer vaccinations in all 50 states. However, the extent of this authority will vary with regard to patient age and vaccine type from state to state depending on specific regulations in place. For example, pharmacists in New Mexico are authorized to administer any vaccination whereas pharmacists in South Dakota are only allowed to administer influenza and zoster vaccines. Pharmacists in Iowa are limited to administering influenza vaccine to patients aged six through seventeen, but are authorized to administer any Advisory Committee on Immunization Practices (ACIP) recommended vaccine to patients over the age of 18. 12-14 Before implementing an immunization service, it is important to check with your State Board of Pharmacy for specific laws and regulations. The authority to vaccinate continues to shift as new legislation is introduced and new laws are passed. In 2013, for example, California passed SB 493 which recognized pharmacists as providers and allowed them to administer all routinely recommended ACIP vaccines to individuals aged three and up without the need for a physician-pharmacist protocol. In that same year, Oregon passed HB 3138 which allowed pharmacists to prescribe and administer vaccines to persons at least 11 years of age. To obtain the most upto-date information regarding regulations in a specific state, visit the National Association of Boards of Pharmacy (NABP) website (http://www.nabp.net/) or APhA website (http:// www.pharmacist.com/immunization-center). POLICY AND PROCEDURE OF VACCINATION ADMINISTRATION As legislative trends move toward increasing the pharmacist s authority to administer immunizations, it is important that all pharmacy staff are aware of the policies and procedures to ensure patient safety. The purpose of an immunization policy is to identify populations in need of vaccines and ensure that all patients receive a good quality and safe immunization service. Examples of policy and procedure documents can be found free of charge on the Immunization Action Coalition s website at www.immunize.org. IMMUNIZATION TRAINING AND WORKFLOW OF VACCINATION ADMINISTRATION The following sections are important topics that should be discussed with all staff involved in the immunization process. The following steps are general guidelines for developing an individualized workflow that best fits the practice site. Immunization training Proper training is required for all persons administrating vaccines. In order to be certified to administer vaccines, a certificate from an appropriate immunization-training program must be attained. The American Pharmacists Association (APhA) offers the only nationally recognized training program for pharmacists and student pharmacists and provides the skills necessary to become a primary source for information and administration. In order to receive the certificate of completion, participants must complete all components of the program including the self-study, the self-study assessment, the pharmacy-based immunization delivery live training seminar, the final examination and the injection technique assessment. 15 Supplies, inventory and ordering All staff should be responsible for determining the needs of their specific practice setting, including maintaining all necessary immunization supplies (e.g. syringes, gloves, alcohol swabs, bandages and vaccines), managing inventory and ordering vaccines/supplies as needed. It is critical to maintain a good inventory report in order to ensure proper supplies sufficient for the practice and reduce loss and wastage of materials/vaccines. The Immunization Action Coalition provides a summarized hand out for supplies needed for a community immunization clinic. 16 Storage and handling of vaccines It is important that vaccines be stored at proper temperatures to protect quality and potency. A more detailed description of proper storage and handling of vaccines will be discussed later in this article. 2015 TEAM SERIES 2

Vaccine administration It is important health care professionals be knowledgeable and well trained before administering immunizations. Prior to the administration of any vaccines, the person administering the vaccine must ensure the right patient, right vaccine, right time, right dosage, right route and right needle length. Immunizations not administered properly may result in reduced efficacy because the patient may not be able to establish an adequate immunity response. Vaccine information statement (VIS) It is federal law that patients receive a VIS prior to the administration of any vaccine. VIS s are documents that state the benefits and risks of the vaccine. All VIS forms can be downloaded from the website of the Immunization Action Coalition or from the CDC s website at www.cdc. gov/vaccines/hcp/vis/index.html. Forms are also available in more than 30 different languages at the Immunization Action Coalition website. Documentation of vaccination All vaccines administered should be fully documented in the patient s permanent medical record. Health care providers who administer vaccines must document the following: date of administration, vaccine manufacturer, vaccine lot number, route and site of administration, name and title of the vaccine administrator, date of VIS and date the VIS was given to patient. There are also state immunization registries that record all immunization doses administered by participating providers. These state registries are intended to provide consolidated immunization histories, reduce vaccine preventable diseases, improve vaccination rates and determine appropriate future vaccinations. 17 Reminders (Appointments/follow ups) Immunization automated reminder/recall systems can help increase vaccination rates. Reminder/recall systems can potentially track future and missed appointments. Pharmacy staff can play a vital role in reminding and screening patients for upcoming vaccines and promoting routinely recommend vaccines. Chart reminders, phone calls, mail reminder cards and electronic reminders (e.g. email) are all different methods to identify population in need of vaccinations and remind those of follow-up appointments. Vaccine adverse event reporting system The Vaccine Adverse Event Reporting System (VAERS) is a U.S. national vaccine post-marketing safety surveillance program. VAERS aims to gather information about any adverse event or reaction occurring after administration of any vaccine and analyze trends of adverse events from immunization. Information through VAERS is used to continuously evaluate vaccine safety and to minimize or reduce the risks associated with vaccines. 18 All events of medical significance, particularly, those which lead to hospitalization, disability or death warrant a VAERS report. The health care provider need not be certain that the occurrence was vaccine-related in order to report the event. It is not necessary to report minor adverse reactions such as low-grade fever or local injection site reactions. 20 Reports can be submitted online through the VAERS website, called to the VAERS information line, at www.vaers.hhs.gov/index, or written on the paper VAERS report form. 18 VACCINES: SPECIAL CONSIDERATIONS 19 Vaccine storage and handling In order to best protect individuals and communities from vaccine-preventable diseases, vaccine quality and potency must be safeguarded from the time the vaccine was manufactured until it is administered to the patient. Vaccine efficacy and, thus, immune response may be reduced once there is compromise in vaccine integrity through inadequate storage. Therefore, proper storage and handling practices play a very important role. It is always best to refer to the package inserts of each vaccine for specific storage and handling recommendations from the manufacturer. Storage and handling plans Every pharmacy should develop and maintain written routine and emergency storage and handling plans to secure quality assurance of proper vaccine management. These should be updated annually and should be easily accessible to all staff. In general, well-written plans provide guidelines for: 1) Ordering and accepting vaccine deliveries 2) Storing and handling vaccines 3) Storage unit temperature monitoring 4) Inventory management 5) Receiving and unpacking vaccine deliveries 6) Transporting vaccines in an emergency or to off-site/ satellite facilities 7) Managing potentially compromised vaccines 8) Proper disposal of vaccines and supplies 9) Identifying an alternative location or facility for vaccine storage and retrieval, in emergency cases The cold chain The vaccine cold chain is an uninterrupted series of storage and distribution procedures, which include all of the materials and equipment used to maintain vaccines in their required temperature range from the time of manufacture until administration to the patient. Some of the consequences of vaccine cold chain breach or failure are as follows: 1) Excessive heat, cold or light exposure can damage vaccines resulting in reduced potency. Inadvertent administration of these vaccines may result in patients not receiving full protection against diseases. ACIP recommends re-immunization in this setting. 2) Re-immunization and vaccine wastage incur increased costs to both the patient and the provider. 3) Vaccine failure can lead to damage to public confidence in vaccines. 2015 TEAM SERIES 3

Vaccine Storage Equipment Requirements: Careful selection, proper use, regular monitoring and maintenance of vaccine storage equipment are all necessary to ensure vaccine quality and potency. It is always good practice to keep a logbook for each piece of equipment with records of the serial number, date of installment and dates of any routine maintenance tasks or of any repairs or servicing maintained. 1) Refrigerators and Freezers: 19-20 a) Stand-alone freezers and refrigerators without freezers, or pharmacy grade/purpose-built units are recommended. b) Both freezer and refrigerator compartments should have their own thermometer. CDC recommends using a continuous temperature monitoring device, as this provides the length of time a unit has been operating outside the recommended temperature and when that excursion occurred, as opposed to a minimum/ maximum thermometer which only provides data about the warmest and coldest temperatures reached. c) Refrigerators should maintain temperatures between 35 F and 46 F (2 C and 8 C). Setting the temperature to achieve an average of 40 F (5 C) provides the best safety margin. A refrigerator temperature below 35 F (2 C) is not acceptable because vaccines could freeze and be rendered ineffective. d) Freezers should maintain temperatures between -58 F and +5 F (-50 C and -15 C). e) Immediate corrective action should be taken when a storage unit temperature is outside the recommended range. Label the vaccines Do NOT use, then call the manufacturer (for privately purchased vaccine) or state immunization program (for Vaccines for Children or VFC vaccine) for further instructions. Temperature monitoring Regular temperature monitoring of both freezer and refrigerator units should be performed. Temperatures should be read twice a day (i.e. in the morning and at the end of the workday) with readings recorded in a temperature log posted on the door of the storage unit. CDC recommends keeping these logs for at least three years, unless state law requires a longer period. The information on these logs may help evaluate the need for new storage units or if there is potential need for recall and revaccinate patients because of improperly stored vaccines. 19-21 Storing vaccines and diluents Health care professionals should know which vaccines should be refrigerated and which should be frozen. In general, live virus vaccines are stored at freezer temperature, while inactivated virus vaccines are stored at refrigerator temperature. Table 2. Vaccines Storage Recommendations Store in Freezer Varicella Herpes Zoster Measles, Mumps, Rubella Measles, Mumps, Rubella and Varicella (MMRV) Store in Refrigerator Measles, Mumps, Rubella Hepatitis A, Hepatitis B and combination vaccine Haemophilus influenza vaccine Human Papillomavirus Influenza Inactivated polio vaccine Meningococcal Pneumococcal Rotavirus Diphtheria toxoid-, Tetanus toxoid- and Pertussiscontaining vaccines It is also important to know which vaccines must be reconstituted and how diluents should be stored. Some vaccine diluents must be stored in the refrigerator, while others may be stored at room temperature (no more than 77 F [25 C]) or in the refrigerator. Always store diluents as directed in the manufacturer s product information. Vaccine diluents are not all the same; some [i.e. Pentacel (DTaP-IPV/ Hib) and Menveo (MCV4)] contain antigen. These diluents are packaged together with their corresponding vaccine and must be stored (and used) together. Diluents should never be stored in the freezer because the vials are not designed for freezer storage and could crack. 19-20 Expiration dates and beyond-use dates All vaccines and diluents have expiration dates by which the product should be used. When the expiration date is marked with only a month and a year, the vaccine or the diluent may be used up to and including the last day of the month indicated. If a day is included with the month and year, the vaccine or the diluent should only be used through that day. 19 There are instances when vaccines should be used prior to the labeled expiration date. This date or time after which the vaccine cannot be used anymore is referred to as the beyond-use date or BUD. 1) Reconstitution: There is a limited timeframe in which a lyophilized (freeze-dried) vaccine can be used once it is mixed with its diluent and becomes a liquid form. As the beyond-use-date varies for reconstituted vaccines, it is always best to refer to the product package insert for the manufacturer s specific recommendations. 2) Multi-dose vials (MDV): As long as there is no contamination or compromise in vaccine integrity, most MDV s may be used up to the labeled expiration date. Some, however, have Pharmacy 2015 TEAM SERIES Series 4 4

specified timeframe for use once the vial is entered with a needle. Again, it is best to follow directions as indicated by the specific manufacturer. 3) Manufacturer shortened expiration date: Vaccines that were exposed to inappropriate conditions may have a reduced potency before the labeled expiration date. The manufacturer may determine that the vaccine can still be used, but with a shortened expiration date. Otherwise, the vaccine should be properly discarded. Inventory should always be rotated in their corresponding storage units so that the ones with the shortest expiration date are physically placed in front and used first to avoid wastage from expiration. Transporting vaccines to off-site locations The CDC states that the number of times vaccines are handled and transported should be minimized, if possible. If transportation to another location is required, it is very important to protect the vaccine by maintaining the cold chain at all times. While no exact recommendation for the number of times a vaccine may be transported to different sites exists, each transport increases the risk of exposure to inappropriate conditions. The CDC does not recommend transporting varicella-containing vaccines to off-site locations because of vaccine fragility. If, however, vaccine must be transported, the use of a portable freezer unit that maintains a temperature between -58 F and +5 F (-50 C and -15 C) should be used. Dry ice should never be used as a substitute for a portable freezer, even for temporary storage or emergency transport, because it may expose the vaccine to temperatures colder than -58 F (-50 C). 19-21 If necessary, varicella-containing vaccines that have not been reconstituted may be transported at refrigerator temperatures between 36 F and 46 F (2 C to 8 C) for up to 72 continuous hours prior to reconstitution. A calibrated temperature-monitoring device which is capable of continuous monitoring and recording should be placed in the container as close as possible to the vaccine during transport. Because this is considered a temperature excursion, CDC recommends contacting the vaccine manufacturer for guidance upon arrival at the off-site facility. 21,24 Therefore, patients who pick up any vaccine from a pharmacy and simply transport it in a bag for administration in a clinic is never an acceptable practice. 19 CASE SCENARIO #1 Vaccine transport: VD, a 70 year old female, presents to your pharmacy in the morning with a written prescription for Zoster vaccine #1, SIG: immunization to be administered by physician. She says her physician wants to administer it that same morning. As the technician-on-duty, what is the best way to respond to this scenario? a) You should process the prescription as usual. Inform the patient that she should store the vaccine in a container which maintains the temperature at -15 C using dry ice. b) You should process the prescription as usual. The pharmacy should store the vaccine in a container which maintains the temperature between 36 F and 46 F (2 C to 8 C) for up to 72 hours prior to reconstitution. c) You should inform the patient that the vaccine cannot be transported according to federal law and return the prescription back to the patient. d) You should inform the patient that the vaccine can only be administered at the pharmacy due to a loss of vaccine potency of the once it has been removed from the freezer Answer: The most appropriate answer is B. Although not recommended by the CDC, varicella containing vaccines can be transported offsite. Vaccine may be transported at refrigerator temperatures between 36 F and 46 F (2 C and 8 C) for up to 72 continuous hours prior to reconstitution. Vaccine not used within this time frame must be discarded. Dry ice should not be used since it may subject the vaccine to temperatures below -58 F (-50 C). A loss of potency may occur if the vaccine is exposed to temperatures outside of this range and as a result, pharmacies may choose to not dispense vaccines to patients for administration outside of the pharmacy. VACCINE ERRORS AND SAFETY The Institute of Safe Medication Practices (ISMP) is a national non-profit organization focused on medicationerror prevention efforts and data collection about the type and reason vaccine errors occur. ISMP encourages health care providers as well as consumers to report medication or vaccine errors, preventable adverse reactions, near misses and hazardous conditions. ISMP currently operates three confidential, voluntary, national reporting programs, one of which is the ISMP National Vaccine Errors Reporting Program (VERP). All reports to this program are forwarded in confidence to the VAERS program, the FDA and the vaccine manufacturers when necessary. Examples of vaccine-related errors that are encouraged to be reported include: errors in prescribing, transcribing, dispensing and administering vaccines; errors with vaccines that are captured before reaching the patient; potential or actual confusion regarding sound-alike and look-alike vaccines, packaging similarities or label ambiguity; misuse, non-use or malfunction of medication-related tools (e.g. syringes, needles). 22-23 Vaccine errors can be reported online at http://verp.ismp.org/. Possible sources of vaccine errors In November 2013, ISMP provided a summary report analysis of error reports submitted through the VERP during its first year. A total of 433 reports were submitted from September 2012 through October 2013, 90% of which actually reached the patient. 24 The ISMP has identified the following vaccines that were most frequently involved with errors, including: tetanus/diphtheria/pertussis containing vaccines, Haemophilus influenzae type b (Hib) and human papillomavirus (HPV2 and HPV4) vaccines. It was not surprising that given its widespread use annually, errors with the influenza vaccine were also among the most commonly reported. 22-23 2015 TEAM SERIES 5

The ISMP also identified the most common contributing factors associated with the reported vaccine errors. Contributing factors related to age were reported most often and these include confusion between numerous age-dependent formulations that target the same disease, unfamiliarity with dosing and timing of vaccines based on the patient s age and failure to verify the patient s age prior to administration of the vaccine. Other common factors that lead to vaccine errors include unfamiliarity with the dose/ dosing schedule/route of administration of vaccine, similar and confusing vaccine names or abbreviations and vaccine labeling and packaging. 22-23 Best practices There are many things that immunization providers can do in order to minimize the risk of vaccine errors. To ensure vaccine safety and efficacy, ISMP has provided the following practice recommendations: 22 1) Easy-to-read, up-to-date immunization schedules should be available and easily accessible as a quick reference for all staff. 2) A VIS and education about the vaccine should be provided prior to vaccination. 3) For frequently administered vaccines, it is recommended to create standard order sets or protocols to ensure consistency with vaccine administration that appropriate candidates receive immunization at the right age/time (e.g. hepatitis B vaccine for newborns). 4) Educate all immunizers and those who handle vaccines by training them and having them demonstrate competencies about vaccines handling and administration. 5) To reduce errors from expiration and wastages, make sure to check inventory and expiration dates and maintain the cold chain at all times. 6) To avoid confusion between vaccines, separate pediatric and adult formulations, or those with similar names or abbreviations (e.g. DTaP, DT, Tdap). Affix auxiliary labels when necessary. 7) It is not recommended in outpatient or immunization units to draw vaccines into syringes well in advance of administration because of uncertainty in stability. However, CDC suggests that a small number of vaccine doses may be pre-drawn and labeled if they are prepared directly at the clinic site by the practitioner administering the vaccines. Any remaining vaccine in pre-drawn syringes should be discarded at the end of the workday. A good alternative to pre-drawn syringes is the manufacturers pre-filled syringes, particularly for large immunization events. 8) It is important to label all vaccines prepared in syringes unless it was prepared in front of the patient. ISMP encourages the use of peel-off labels from the manufacturers. 9) Implement a time-out process and involve the patient in the verification process prior to vaccine administration. This ensures that the right vaccine is being given to the right patient, at the right time. 10). Use only the standard vaccine abbreviations by CDC and not ad hoc abbreviations to avoid misinterpretation or confusion (e.g. H Flu for Haemophilus influenza may be misinterpreted as influenza vaccine). The full generic and/or brand name should be listed on all electronic and pre-printed forms to reinforce the correct use of abbreviations. 11). Keep vaccines with their diluents together by using a rubber band or putting them in a sealable plastic bag. Auxiliary labels should be affixed to remind staff to use both vials. ISMP also encourages vaccine manufacturers to revise their packaging and labeling so that expiration dates are displayed in a standard, straight-forward way that can be understood by all. Manufacturers should also provide clear instructions for mixing vaccines that require reconstitution. The diluent, if provided, should include a bold statement that it is only a diluent and not an actual vaccine. Other actions that can be taken by manufacturers include improving the labeling of vaccines to clearly differentiate adult from pediatric formulations, using peel-off labels for pre-filled syringes and packaging vaccines in unit doses to minimize the need to prepare individual doses. 22 Vaccine errors can be reported online at http://verp.ismp.org/. CASE SCENARIO #2 Vaccination Error: BS is a 19 year old male returning to the pharmacy for a Tdap vaccine. Tdap vaccine was processed by the pharmacy but DTaP was administered instead. There was no patient harm. How should this error get reported? a) DTaP and Tdap are interchangeable; therefore no error has been made. b) The error needs to be documented and reported to VAERS c) The error must be reported to VERP according to federal law d) Immediately after learning about the error, pharmacy personnel must inform the patient and the physician and are encouraged to report the error to VERP Answer: The most appropriate answer is D. Upon learning about the error, the pharmacy personnel must inform the patient and the physician that an error has been made. VERP is a voluntary reporting program; it does not require reporting of the error, but it highly encourages consumers and/or health care professional to report them, even if there was no patient harm. DTaP is approved for children under 7 years of age and Tdap is considered a booster vaccine for adolescents and adults greater than age 11. Although both vaccines contain the same antigens, they are not interchangeable. ROLE OF TECHNICIAN IN THE DELIVERY OF VACCINE SERVICES Pharmacy technicians play key roles in pharmacy operations. Under the supervision of a licensed pharmacist, technicians provide key logistical support and maintain pharmacy operations to allow pharmacists to spend more time with their patients. 25 The main roles of the technicians in the 2015 TEAM SERIES 6

delivery of vaccine services include, but are not limited to, patient intake, billing and insurance processing, document preparation, scheduling follow-up appointments, inventory control and promotion. Patient intake Scheduling Technicians may schedule patients for immunization in person, over the phone, or through online services. Acquisition of general patient information should be obtained and updated into the system for both new and returning patients. Other pertinent information to acquire includes prior immunizations, allergies, prescription and nonprescription medication use, past medical history, information about the primary care provider, insurance information. Many pharmacies may schedule appointments for patients at a future time and date to help manage resources and vaccine inventory. However, walk-in-visits can create more opportunities to improve the rates of immunization. Insurance information and billing One of the most challenging aspects of providing vaccination services is billing and processing insurance claims. With so many insurance plans available, it is important for pharmacy technicians and other pharmacy personnel to become familiar with what vaccinations are covered and to identify individuals who may not need to pay a co-pay through their insurance plan. For instance, Medicare Part B will pay for influenza, pneumococcal and hepatitis B vaccines. Medicare Part D however covers all other vaccinations. Under the Affordable Care Act vaccines are typically provided free of charge to patients when they are administered by an in-network provider. Whenever uncertain, insurance companies should be contacted to find out which vaccination would be covered under that particular plan. 26 Some vaccines may be considered a medical benefit rather than a pharmacy benefit and may need to be administered at the patient s physician s office. Screening In most cases, patients are referred to pharmacy immunization clinics by their primary care provider or through friends and families. However, targeting new and returning patients during in-person visits to the pharmacy or over the phone can create opportunities to identify more patients who would benefit from the pharmacy s immunization program. Pharmacy staff should document patient s vaccination status and evaluate patient eligibility for vaccinations, especially those at risk for certain infections, like travelers, health care providers, students and the elderly. After establishing eligibility and completing the appropriate documentation, technicians would input and process vaccination prescriptions into the computer system just like any other medication prescription. Documentation Prior to the vaccine administrations, technicians should prepare the proper paperwork such as the VIS, consent form and the screening checklist for the pharmacist and the patient to complete. 27 This will save time and allow for pharmacists to focus on direct patient care. After vaccine administration, pharmacy technicians should print and send out the pertinent documentations to the patient s primary care physician in a timely and consistent manner. Follow-up appointments Certain vaccines are given in multiple series for adequate protection, which would require patients to come back to the pharmacy for follow-up visits (see table 1). The pharmacy should have procedures to log visits and remind the patients about their follow-up visits. Inventory control As mentioned before, all vaccinations have special storage requirements. One key way to ensure efficacy and maintain optimal shelf life of the vaccines is to monitor the temperature of the refrigerator or freezer twice a day. If designated to be responsible for inventory control, the pharmacy technician should check for expiration dates of the vaccines and the diluents approximately once a month, just as with other medications. Also, pharmacy personnel should anticipate and prepare for times when there may be increased demand for multiple vaccines (e.g. influenza and pneumococcal vaccines during fall). 28-29 A visual inspection of the refrigerators and freezers should be done periodically to account for any possible discrepancies in the inventory and to ensure all vaccine materials and supplies are well organized. Patient communication and messaging/promotion of service Pharmacy personnel can help promote pharmacy immunization services through phone calls, emails, faxes, in-store advertisements and collaborating with physicians for patient referrals. Whether in-person or over the phone, pharmacy technicians are usually the first and last encounter the patient has with a pharmacy staff member. They have multiple opportunities to interact with the patient and inform them about the various vaccine services available at the pharmacy. One of the best times to approach the patient is during patient prescription processing, during which pharmacy personnel can review the patient s history and help identify if he or she is eligible for vaccinations. Immunization schedules provided by the CDC may help pharmacy technicians identify such eligible patients. It also may be advantageous to provide patients with educational materials to read to bring awareness and attention to immunization services. Sending out thank you letters and brochures can be one of the many ways for the pharmacy to express gratitude for the customer s loyalty and business. When patients feel appreciated, they may feel more likely to return to the same clinic for future vaccinations and/or refer their friends and family members to the pharmacy as well. CONCLUSION In conclusion, while there are numerous vaccine-preventable diseases, the rates of vaccination, particularly for the adult population, are suboptimal. Pharmacy based vaccination programs, once small in number, have now expanded to become a popular vaccination destination for individuals to 2015 TEAM SERIES 7

receive vaccines. From routine vaccines such as influenza and pneumococcal to specialty ones like Japanese encephalitis, pharmacies can provide the communities they serve with all necessary vaccines. At the heart of these vaccination programs lies the pharmacy technician who has a range of responsibilities to help to ensure not only a successful program, but that the program maintains and stores its vaccines accordingly. By incorporating pharmacy technicians into the vaccination program, the pharmacist is allowed to focus on direct patient care, which allows everyone to function at their highest level of practice and ability. Overall, pharmacy technicians play key roles in providing much needed supported to the pharmacist in the delivery of immunization services. Table 1. ACIP General Recommended Routine Vaccinations 9-11 Vaccine Trade Name(s) Vaccination Schedule Tetanus, diphtheria, pertussis Daptacel Infanrix Tripedia Adacel, Boostrix Age < 7: 5 dose DTaP series given at ages 2,4,6,15-18 months and 4-6 years Age > 7: 1 dose of Tdap at 11 years if completed DTaP series. 1 dose during each pregnancy (3rd trimester). Influenza Fluzone Fluvirin Afluria Flumist Afluria 1 dose given annually at age 6 months Fluarix FluLaval Shingles Zostavax 1 dose at > 60 years Measles, mumps, rubella Pneumococcal Hepatitis A Hepatitis B Poliovirus Rotavirus Haemophilus influenzae type b (HiB) Human papillomavirus (HPV) Varicella M-M-R II Prevnar 13 (PCV13) Prevnar 13 Pneumovax 23 (PPSV23) Havrix, Vaqta Recombivax HB Engerix B IPOL RotaTeq (RV 5) Rotarix (RV 1) ActHiB PedaVaxHiB MenHibrix Cervarix Gardasil Varivax 2 dose series: Given at ages 12-15 months and 4-6 years Pediatrics: 4 dose series given ay 2, 4, 6, and 12-18 months Individuals 2 to < 65 years with certain chronic medical conditions: 1 dose of PPSV23 Adults > 65: 1st dose with PCV13 followed by PPSV23 6-12 months later 2 dose series: 1 st dose given at 12 months, 2 nd dose given 6 months later 3 dose series: Given at ages: 0,1-2, and 6-18 months 4 dose series: Given at ages: 2, 4, and 6-18 months 3 dose series: Given at ages: 2, 4, and 6 months 2 dose series: Given at ages 2 and 4 months 3 or 4 dose series (depending on vaccine brand): Given at ages 2, 4, 6, and 12-15 months 3 dose series for 9 to 26 year olds: Given 0, 1-2, and 6 months 2 dose series: Given at 12-15 months and 4-6 years 2015 TEAM SERIES 8

REFERENCES: 1. U.S. Department of Health and Human Services. Immunization and Infectious Disease: Overview. HHS. http://healthypeople.gov/2020/topicsobjectives2020/ overview.aspx?topicid=23. Published September 24, Accessed September 24, 2. Center for Disease Control and Prevention (CDC). Ten Great Public Health Achievements--United States, 2001-2010. MMWR, May 20, 2011, Vol. 60(19):619-23. 3. Center for Disease Control and Prevention (CDC). FastStats: Leading Causes of Death. CDC. http://www. cdc.gov/nchs/fastats/leading-causes-of-death.htm. Published January 27, 2103. Accessed September 24, 4. Center for Disease Control and Prevention (CDC). Noninfluenza Vaccination Coverage Among Adults United States, 2012. MMWR. http://www.cdc.gov/mmwr/ preview/mmwrhtml/mm6305a4.htm#tab1. Published February 7, Accessed September 24, 5. Center for Disease Control and Prevention (CDC). Pertussis (Whooping Cough) Fast Facts. CDC. http:// www.cdc.gov/pertussis/fast-facts.html. Published February 13, Accessed September 24, 6. Hogue MD, Grabenstein JD, Foster SL, Rothholz MD. Pharmacist involvement with immunizations: a decade of professional advancement. J Am Pharm Assoc. 2006;46:168-182. 7. Center for Disease Control and Prevention (CDC). National Early Season Flu Vaccination Coverage, United States, November 2013. CDC. http://www.cdc.gov/ flu/fluvaxview/nifs-estimates-nov2013.htm, Published December 12, 2013. Accessed September 24, 8. Goad JA, Taitel MS, Fensterheim LE, Cannon AE. Vaccinations administered during off-clinic hours at a national community pharmacy: implications for increasing patient access and convenience. Ann Fam Med. 2013;11(5):429 436. 9. Center for Disease Control and Prevention (CDC). Pinkbook. CDC. http://www.cdc.gov/vaccines/pubs/ pinkbook/downloads/appendices/b/us-vaccines.pdf. Published February 22, Accessed September 24, 10. Center for Disease Prevention (CDC). Recommended Immunization Schedules for Persons Aged 0 Through 18 Years. CDC. http://www.cdc.gov/vaccines/schedules/ downloads/child/0-18yrs-child-combined-schedule.pdf. Published January 1, Accessed September 24, 11. Center for Disease Control and Prevention (CDC). Recommended Adult immunization schedule. CDC. http://www.cdc.gov/vaccines/schedules/downloads/ adult/adult-combined-schedule.pdf. Published February 7, Accessed September 24, 12. American Pharmacist Association. Pharmacist Administered Vaccines. APhA. http://www.pharmacist. com/sites/default/files/pharmacistizauthority.pdf. Published October 1, 2013. Accessed September 24, 13. The Iowa Legislature Bill Book. Senate File 353. http:// coolice.legis.iowa.gov/cool-ice/default.asp?category= billinfo&service=billbook&menu=false&hbill=sf353. Published March 28, 2013. Accessed November 3, 14. Iowa Board of Pharmacy. Pharmacist Administration of Immunizations. http://www.iowa.gov/ibpe/pharmacists/ immunizations.html. Published August 28, 2013. Accessed November 3, 2014 15. Center for Disease Control and Prevention (CDC). Possible Side Effects from vaccines. CDC. http://www. cdc.gov/vaccines/vac-gen/side-effects.htm. Published August 19, Accessed September 24, 16. American Pharmacist Association. Pharmacist Administered Vaccines. APhA. http://www.pharmacist. com/sites/default/files/pharmacistizauthority.pdf. Published October 1, 2013. Accessed September 24, 17. Center for Disease Control and Prevention (CDC). Information Immunization System (IIS). CDC. http://www. cdc.gov/vaccines/programs/iis/about.html Published May 15, 2012. Accessed September 25, 18. Vaccine Adverse Event Reporting System (VAERS) Website. https://vaers.hhs.gov/about/index. Accessed September 19. U.S. Department of Health and Human Services, Center for Disease Control and Prevention (CDC). Vaccine Storage and Handling Toolkit. May http://www. cdc.gov/vaccines/recs/storage/toolkit/storage-handlingtoolkit.pdf. Accessed September 20. American Academy of Pediatrics: Immunization Training Guide & Practice Procedure Manual For Pediatricians, Physicians, Nurse Practitioners, Physician Assistants, Nurses, Medical Assistants and Office Managers. July 2013. http://www2.aap.org/immunization/pediatricians/ pdf/immunizationtrainingguide.pdf. Accessed September 21. Center for Disease Control and Prevention (CDC) Website. Provider s Role: Importance of Vaccine Administration and Vaccine Storage & Handling. http://www.cdc.gov/ vaccines/recs/vac-admin/providers-role-vacc-adminstorage.htm. Accessed September 22. Recommendations for Practitioners And Manufacturers To Address System-Based Causes Of Vaccine Errors. March http://www.ismp. org/newsletters/acutecare/showarticle.aspx?id=74. Accessed September 23. ISMP Website. ISMP National Vaccine Errors Reporting Program. http://verp.ismp.org. Accessed September 24. First Annual Review Of Data Submitted To The ISMP National Vaccine Errors Reporting Program (VERP). November 2013. http://www.ismp.org/newsletters/ acutecare/showarticle.aspx?id=64. Accessed September 25. Chain Drug Review PTCB highlights pharmacy technicians role in vaccine efforts. http://www. chaindrugreview.com/front-page/newsbreaks/ptcbhighlights-pharmacy-technicians-role-in-vaccine-efforts Published August 24, 2010. Accessed September 10, 2015 TEAM SERIES 9

26. Center for Disease Control and Prevention (CDC). Finding and Paying for Vaccines. CDC. http://www.cdc. gov/vaccines/adults/find-pay-vaccines.html. Published February 27, Accessed September 20, 2014 27. IAC. Adult Vaccination Guide. Immunization Action Coalition. http://www.immunize.org/guide. Published 2004. Accessed September 15, 28. Merck. Help improve your pharmacy s adult vaccination process. https://www.merckvaccines.com/is-bin/ intershop.static/wfs/merck-merckvaccines-site/-/ en_us/professional-resources/requestmaterials/ VACC-1083223-0001.pdf. Published September 2013. Assessed September 29. ASHP. Model Curriculum for Pharmacy Technician Education and Training Programs. http://www.ashp.org/ doclibrary/accreditation/model-curriculum.pdf Published 2013. Assessed September 15, 2015 TEAM SERIES 10

POST ASSESSMENT QUESTIONS: 1. Which pharmacy organization established the immunization training program that all pharmacists and student pharmacists use today? a. American Society of Health-System Pharmacists (ASHP) b. American Pharmacists Association (APhA) c. American Association of Colleges of Pharmacy (AACP) d. American College of Clinical Pharmacists (ACCP) 2. Pharmacists can currently vaccinate in how many states: a. 10 b. 20 c. 30 d. 40 e. 50 3. Which of the following is NOT required to be documented when administering a vaccine? a. Date of vaccine administration b. Dose of vaccine administered c. Name of vaccine manufacturer d. Route and site of administration e. Date printed on the VIS 4. Which of the following collects information on potential adverse reactions from vaccines? a. NCVIA b. VERP c. VAERS d. FDA MedWatch program 5. Vaccine storage and handling plans should include: a. Ordering and accepting vaccine deliveries b. Storing and handling vaccines c. Storage unit temperature monitoring d. Managing potentially compromised vaccines e. All of the above 6. How often should the temperature be monitored in refrigerators and freezers storing vaccine? a. Once daily b. Twice daily c. Once a week d. Once a month e. As long as the temperature is being monitored, the exact frequency doesn t matter 7. Which of the following collects information about vaccine errors and patient safety? a. NCVIA b. VERP c. VAERS d. FDA MedWatch program 8. According to the ISMP, best practices to avoid vaccine errors include all of the following, except: a. Separate pediatric and adult formulations in storage units to avoid confusion between vaccine products b. Use only standard abbreviations recognized by the CDC and list the full generic and/or brand names on all electronic and pre-printed forms c. Keep vaccines with their diluents and keep them together by using a rubber band or putting them in a sealable plastic bag d. Draw vaccine into syringes well in advance of their administration at health fairs or immunization clinics in order to ensure speed and efficiency during the event 9. Influenza, pneumococcal and hepatitis B vaccines are covered under which Medicare program for eligible beneficiaries? a. Medicare Part A b. Medicare Part B c. Medicare Part C d. Medicare Part D 10. Pharmacy technicians can help with all of the following, except a. Screening patients prior to vaccine administration b. Billing the patients insurance plan and collecting a co-pay c. Administering vaccines to patients d. Scheduling patients for subsequent vaccine doses CPE Instructions: 1. Go to www.gotocei.org. click on Technician tab 2. Scroll down to Pharmacy TEAM Series 2015 and click on Register and Log-In (if this is your first time in CEI s website you will need to set up a quick profile by clicking New To CEI ) 3. Click on the box to select the TEAM Series 2015 and click Register 4. On the Payment Transaction Page, scroll down to Pay With An Access Code and type in the access code given to you by your association and click Continue 5. You can now start the TEAM Series right away by clicking Click Here to Go to Activity. Scroll down to activity and all 10 TEAM articles are within your profile! 6. Whenever you want to go back in and complete a TEAM Series activity, go to www.gotocei.org, Log-In, and click on your Profile. Any questions, please contact Cindy Smith at csmith@gotocei.org or 515-270-8118. 2015 TEAM SERIES 11