RX PREP - Chapter 24 - Review for Immunizations

This review will cover information related to pharmacist-administered vaccines, but it does NOT include the CDC.gov charts for vaccinations (found on the website and mobile app).  You should study those in addition to this. Pay special attention to the footnotes under the charts as well.

State Authorizations for Pharmacists to Immunize

State Authorizations

Pharmacists may administer vaccines in most states in the US, however, state laws vary, so be sure to check with your state licensing bureau to determine what you are allowed to do and what you are not.

Some states restrict which vaccines may be administered by pharmacists, or what ages to whom they may be given.

Other states allow pharmacists to administer any immunization with a physician prescription or order.

Finally, there are states that allow the pharmacist latitude to screen patients and decide which immunizations are needed and then administer those, as long as the pharmacist has a collaborative practice agreement with a physician, clearly stating such.

Create a study plan to review the laws for the state in which you expect to be licensed to determine which  vaccine administration rules will apply to you.

Laws regarding administration of vaccines will appear on each state's MPJE, but Naplex will ask questions pertaining to schedules and vaccine-specific issues.

References to Study for Immunizations

in Access Pharmacy (on the LECOM portal) - McGraw-Hill's NAPLEX® Review Guide, 2e

ISBN 9780071813426 

Chapter 69: Vaccines and Immunizations

Infant, child, adolescent, & adult schedules; Conditions requiring special schedules or vaccines (pregnancy, immune-compromised, diabetes, etc);  catch up schedules; contraindications.

https://www.cdc.gov/vaccine   or the mobile app "CDC Vaccine Schedules"  

The Pink Book has epidemiology and prevention.  I recommend reading every single chapter of this resource, the appendices, and supplement.  Especially notable are the boxes and "General Rules".

Documentation and Record-keeping.

CMS Info - Medicare Part B vs. Part D

Everything you need to know about travel vaccines

APhA's best practices, tips for administration, recommendations, and news

VIS's, FAQs, handouts, screening tools, ingredients and adjuvants, info about autism, and Alternative medicine.

PPCN Toolkit for Immunizations

Where would you look for contraindications for the PPSV23 vaccine?

  • CDC.gov/vaccines or the mobile app
  • Pink Book
  • CDC.gov/Travel
  • Pharmacist.com Immunization Center
  • Immunize.org

Vaccine Safety

Immunizer's Role in Safety

Vaccine storage, administration, timing and spacing of vaccines, dosing, contraindications & precautions, management of adverse reactions, reporting to VAERS, benefit and risk assessment & education of them to the patient - all these are the responsibility of the Immunizer - YOU the pharmacist! 

Safety standards are higher for vaccines than for medications because they are given to healthy people to prevent them becoming sick (instead of giving medicine to sick people to make them healthy).  This is especially important in infants and children.

Before approval for release, vaccines go through intense studies in thousands of people. All side effects, even rare ones, are addressed before becoming available  in a much more time-intensive and safety-focused process than regular drug approval.

Ongoing monitoring of vaccines is very important in maintaining public confidence.  ANY adverse event must be reported through the VAERS.

VAERS = Vaccine Adverse Event Reporting System, jointly run by the CDC and FDA

VAERS gets about 30,000 reports a year and detects --new or rare events, --increases in rates of known side effects, and --patient risk factors.  This is what implements changes in schedules and footnotes on schedules.

Which of the following is NOT part of the VAERS reporting form?

  • patient's current Rx and OTC profile
  • patient's allergies, chronic health conditions, and overall health on the day of vaccine administration, and up to one month prior
  • all vaccines that were given the day of the event, with lot numbers, routes, body sites, and doses
  • medical tests and labs related to the adverse event
  • the result of the adverse event (ER visit, Hospitalization, Death)
  • any vaccines received within 1 year of the day of the adverse event
  • all of these are on the form.

VICP = Vaccine Injury Compensation Program - provides compensation to patients injured by vaccines in a "no fault" way (they do not have to prove negligence on the part of the provider or manufacturer).

Concerns about Autism or heavy metals as preservatives are major barriers to overcome when discussing immunizations.  Note: the original researcher that published the information has admitted that it was false data. Read the next article for more...

VIS statements

Federal law mandates that any patient receiving a vaccine receive the most recent Vaccine Information Statement (VIS) for that vaccine.  Those can be found here: https://www.cdc.gov/vaccines/hcp/vis/index.html 

Contraindications and Adverse Events

Precautions

Precautions MAY increase the risk of an adverse event with a vaccine or its components

The precautions include:  

--Acute Illness (moderate to severe).  Minor illness (like sniffles or slightly sore throat) are not included.

--Recent receipt (1 month) of blood products or live vaccines

--high fever, shock, or seizure with a previous vaccine

--Guillain-Barre' Syndrome within 6 weeks of a previous vaccine

--For Tdap or DTaP: developing/recent neurological concerns

--For MMR: hx of TTP or thrombocytopenia 

Contraindications

Contraindications strongly increase the risk of an adverse event and also decrease the likely effectiveness of the vaccine.

Contraindications include:

--anaphylaxis to any previous immunization

--for Live Vaccines:

     --Immunosuppression, pregnancy, or active/untreated TB.

Note: pregnancy is a contraindication for other vaccines as well - refer to the CDC schedules for the most up to date information.

Adverse Reactions

The most common side effect of any vaccination is a localized topical reaction of pain, itching, swelling, or redness at the injection site.  These can occur immediately or up to 3 days after, and resolve on their own.  

Systemic reactions are much less common but include malaise, myalgia, headache, and fever.  Again, these usually resolve on their own.  Sometimes they are very mild versions of symptoms of the disease the immunization is given to prevent.  

Allergic reactions are rare, but must be documented and reported to VAERS within 30 days.  Some of these can be life-threatening.  It is important to monitor the patient for 15 minutes following the vaccination to watch for an allergy or fainting.  

In Case of Emergencies: 

Have someone call 911.  The pharmacist MUST remain with the patient at all times.

Three epinephrine auto-injectors should be nearby (0.3mg) just in case.  Note: patients on beta-blockers may need multiple doses.  [If needed, these may be given 5 minutes apart.]

Additionally, diphenhydramine liquid can be given to patients who can swallow it, or diphenhydramine can be injected if this is available. 

Have patient lie down, unless there is a risk of choking or trouble breathing.

Check blood pressure and if low, elevate legs.

Health Care Provider CPR training

Maintaining current CPR training is mandatory to be an immunizing pharmacist.  Following is a good article about this...

PPAJournalNovember2015-CPR reqs

Co-Administration

Inactivated + Live vaccines can be given together, in any combination, at any time, with any interval between.  

Live + Live vaccines may be given at the same time, or separated by at least 4 weeks - with one exception.  Oral Live Vaccines (Rotavirus and Oral Typhoid) can be given together or at any interval with any Live vaccine).  

Inactivated + Inactivated may be given simultaneously or at any interval between.  

One caution:  Live vaccines should be separated from therapy with antibodies (blood, blood products, or immune globulins).  Inactivated vaccines do not have this requirement.  

Storage and Handling

Pink book

Storage and administration: the PinkBook has a great chapter on this:  https://www.cdc.gov/vaccines/pubs/pinkbook/vac-storage.html 

Managing Vaccine Inventory

Follow manufacturer recommendations on original packaging for storage temperature, and monitor the temperature (and log it) twice per day - using a calibrated thermometer - and keep these logs for at least 3 years (some states require longer time frames for record-keeping).

Refrigerated vaccines must be between +36 and +46 degrees Fahrenheit, and frozen vaccines should be between -58 and +5 degrees Fahrenheit.  

Expiration Dates - be sure to check the expiration date before use and add the vaccine refrigerator to the regular inventory audit to pull outdates. 

Additional notes:  

--never store vaccines on the refrigerator door.

--try to keep vaccines away from the sides of the refrigerator or freezer. The most stable temperatures are in the center.  

--rotate your stock:  when new vaccine arrives, put it in the back and keep the "oldest" in the front (so that you use the vaccine that will expire first before those that will expire last). 

Reconstitution

Why should vaccines be administered immediately upon being drawn up, instead of pre-drawn and used later?

  • increased risk of dosing errors
  • waste of vaccine is increased
  • increased risk of bacterial growth
  • administration syringes are not designed for storage
  • All of the Above

Vaccine Details

General Info

Schedules are updated yearly by the Advisory Committee on Immunization Practices (ACIP).  These are the BEST times to administer vaccines, but they also publish "catch up" schedules if children or teens miss doses.  These are at https://www.CDC.gov/vaccines/schedules  

Most of the time vaccines that require a series of injections have a 4-week minimum interval between doses, and giving immunizations faster than that will decrease protection because the body does not have time to create the antibody response.  However, giving them at a greater interval does no harm and does not change effectiveness.  In fact, only Oral Typhoid must be re-started at the beginning of the series.  All the other series-vaccines have "catch up" schedules instead of a need for all doses to be given again from the beginning.  

quick-chart

quick chart - vaccines - McGrawHill NaplexReview2e