Microsoft word - clinical volunteer guide_updated october 17 2009 930am kbl

AU Adult Screening and Immunization Documentation Form
2009 H1N1 Influenza Monovalent Vaccination Program
******CLINICAL VOLUNTEER GUIDE********
(For Physicians, Pharmacists, Nurses, and Healthcare Students)
Patient Information:
Last Name:
Please make sure the patient records their name. We will be filing records for each vaccination date and the records will be filed in alphabetical order based on the patient’s last name. First Name:
Again, please make sure the patient records their name. Date of Birth:
Date of birth is required. We must have at least one patient identifier other than name. AU Banner ID Number:
Auburn employees and students will have a Banner ID number. Dependents will not. If a patient does not have their ID card in their possession, or if they do not know their Banner ID number, then this field can be left blank. We will not withhold vaccine from the patients if they cannot provide proof of AU affiliation. E-mail Address and Phone #:
We need a method of contacting the patient if there is any recall on the lot number of the vaccine that they received. Please obtain an e-mail address and / or a phone number of their choice to facilitate this process. If the patient asks, their contact information will not be shared or sold. It is simply in case we need to contact them after the screening. The AUPCC rules for protection of protected health information (PHI) is outlined in the AUPCC privacy policies that are provided for patient review before vaccination, and a copy is available for the patients to take home for their records. Please Carefully Read and Answer the Following Questions: (circle your answer)
Are you between the ages of 10 and 49 years?

The H1N1 live intranasal vaccine is approved to be administered to patients between
the ages of 2 and 49 years of age who meet specific criteria. However, patients
between the ages of 2 and 9 require two doses, the initial dose and a booster that is
administered a month apart. AU Crisis Management made the decision to only offer
the LAIV vaccine to students, employees, and dependents that are between the ages
of 10 and 49 years. If an employee’s child is under the age of 10 (6 months to 9
years), the child should be referred to the Public Health Department or the child’s
pediatrician for vaccine administration. If the child is aged 10 to 13 years, parental
written consent is required before we can administer the vaccine. Any minor who is 14
years of age or older, or has graduated from high school, or is married, or having
been married is divorced or is pregnant may give effective consent to any legally
authorized medical, dental, health or mental health services for himself or herself, and
the consent of no other person shall be necessary. Individuals over the age of 49
years will need to take the H1N1 injection which should be available in mid November.
We will be keeping the AU family updated on the availability of all vaccine received
from the ADPH, and it will be distributed as quickly as possible.
Patients between the ages of 6 months and 2 years should receive the injectable
H1N1 vaccine. Caregivers of children under the age of 6 months should be vaccinated
since their baby cannot be vaccinated. The parents can receive the LAIV nasal dosage
form or injectable dosage form based on the parent’s patient-specific factors such as
age, concomitant disease states, pregnancy status, and current medications. Each of
these exclusions will be outlined in detail through the questions in this clinical volunteer
guide.
Summary:
Patient Characteristics:
0 to 5 months and 6 days of age (less than 6 AU will not be vaccinating this age range.
2 years of age through 9 years of age
AU will not be vaccinating this age range.
10 years to 49 years
AU will be providing LAIV vaccine to
students, employees, and dependents in
this age range that meet patient-specific
criteria for the live vaccine after careful
screening for appropriateness and patient
education by a healthcare provider.
Above 49 years and patients who are
excluded from receiving the LAIV due to age, anticipating that the vaccine will be released in mid to late November. AU will be offering it as soon as possible when it is delivered. An action plan for delivery is already being created. NO live LAIV nasal vaccine! Wait until negative pregnancy test or wait on inactivated vaccine. Parents with a child less than 6 months of age at home (daycare workers, teachers, etc. vaccine to babies less than 6 months of children less than 6 months.) of age, it is very important that the child’s caregivers get vaccinated. They can receive live or inactivated vaccine based on their personal criteria. For instance, if a woman has a baby that is 5 months old, and she is pregnant again, she cannot receive the live vaccine. If a man has a 3 month old, but he has severe asthma, he cannot receive the live vaccine. In these cases, the parents should be counseled to return for the Again, we will only be vaccinating students, employees, and dependents
between 10 years and 49 years of age that meet the criteria for live vaccine
administration. Anyone in the Auburn family can receive the free vaccine (TES
employees, contractors, volunteers, and anyone else who routinely comes in
contact with our students) if they meet the screening criteria for live vaccine
administration.
If you are between the ages of 10 and 17 years, do you take aspirin or aspirin
containing medications daily? (Please inform the healthcare provider of any
medications you take daily so we can carefully screen for any aspirin containing
products)
Pediatric and adolescent patients who take chronic aspirin (or salicylate containing
medications) are at increased risk of Reye’s syndrome since the LAIV intransal vaccine
is live. Therefore, if we have any patients between the ages of 10 and 17 who take any
of the following medications on a daily basis should not receive the LAIV today. This
list is published by the Reye’s Syndrome Foundation. Also be aware that some labels
for OTC medications might not say “aspirin” but might say ASA, acetylsalicylate,
acetylsalicyclic acid, salicyclic, salicytamide, phenyl salicylate, etc. If you have any
questions concerning whether a pediatric patient between the ages of 10 to 17 is taking
a medication that which might make LAIV contraindicated, consult a faculty
preceptor immediately!

Have you received the 2009-2010 seasonal influenza vaccine? If so, did
you receive the nasal_____ or injection_____. How long has it been since
this vaccination?________(days)

Live vaccines should not be given at the same time. So, if the patient received an
intranasal seasonal flu vaccination (live) or (any other live vaccine) within the past 4
weeks, or if they plan to get any live vaccine within the next 4 weeks, they should not
receive the LAIV today. It is okay to give the H1N1 LAIV today if the patient has
recently received the seasonal flu vaccine injection (inactivated). The injectable
seasonal injection (inactivated) and the injectable H1N1 (inactivated) can be given on the same day. Live vaccines that should not be given at the same time or
within 4 weeks (before or after) of the LAIV vaccine are listed below:
Measles, Mumps, Rubella (MMR)
Oral polio vaccine (OPV)
Varicella
Smallpox
Yellow fever
Typhoid
GBS (Tuberculosis Vaccine)
Live seasonal intranasal influenza (FluMist®).
Most vaccines are inactivated. The most common vaccines that have been questioned
so far are in our immunization effort have been the following (all inactivated and not
contraindications for LAIV administration): If you have any questions at all about
whether the LAIV vaccine can be given today due to a recent vaccine the patient has
received or a vaccine they are scheduled to receive, call a faculty preceptor now for
assistance!
Td
Tdap
Rabies
HPV
Do you currently feel sick or have a fever?
If the patient has a mild cold or minor illness, then there is no need to wait to receive the vaccine. However, if the patient is moderately or severely ill; running a temperature above 99.9 degrees F; feels ill enough to seek medical care for the condition…….then the patient should postpone receiving the vaccine until they feel better. Are you taking any prescription medications to prevent or treat influenza?
(Amantadine, Rimantidine, Tamiflu®, Relenza®) Have you taken any
antivirals in the past 48 hours?
Recent use of antiviral medication might decrease the immune response to the
vaccine. If the patient has taken a dose of an antiviral medication in the past 48 hours,
the vaccine administration should be postponed. Also, the patient should be instructed
not to initiate antivirals after the vaccine administration in order to allow the body to
develop an immune response to the attenuated virus.
Have you ever had a serious reaction to the flu vaccine? Please
describe:_______________
A serious reaction would be an allergic reaction characterized by a drop in blood
pressure; rash; trouble breathing; shortness of breath; swelling of the tongue, throat, or
face; or trouble swallowing. Fainting due to needles or fear of injections is not
considered a severe reaction. Mild flu like symptoms including low fever, muscle aches
and pains; fatigue; and malaise are anticipated effects and would not be considered
severe adverse reactions. If the patient has ever had a severe reaction to a vaccine,
especially the seasonal flu vaccine, please call a faculty preceptor now!

Do you have an allergy to any of the following: eggs, chicken or egg
protein, gentamicin, gelatin, arginine, neomycin, polymyxin B, thimerosal,
formaldehyde? List any allergies:______________
If the patient has a severe allergy to eggs (rash, swelling, SOB, dyspnea, anaphylaxis,
etc.) then this vaccine should not be administered. If the patient does not like eggs or
does not eat eggs, this is usually not a problem. If the patient can eat egg containing
foods such as cake, cookies, cornbread, etc. without an allergic reaction, then they can
receive the vaccine. Also screen for other ingredients listed above. If the patient has
any questions about possible allergy, has a history of allergies to foods or
medications, please call a faculty preceptor now!

Do you have a chronic health problem such as: heart disease, lung
disease, asthma, kidney disease, diabetes, anemia, or other blood
disorder?
If a patient has any of these health problems, please call a faculty
preceptor now to assist you!
DIABETES
If the patient has been diagnosed with diabetes (DM), then the LAIV should not be given, however, it is highly encouraged that they receive the injectable dosage form. Patients are bringing their medication lists. Screen for any DM medications: ORAL DM MEDICATIONS
INJECTABLE DM MEDICATIONS
Patients with a diagnosis of asthma; who take chronic medications for asthma (inhaled corticosteroids); or who have recurrent wheezing should not receive the live vaccine. However, these patients are in the high priority group to receive the inactivated H1N1 injectable as soon as it comes available. o Influenza A (H1N1) vaccine live, intranasal, or FluMist should not be administered to any individuals with asthma or children <5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefits outweighs the potential risk o Do not administer Influenza A (H1N1) vaccine live, intranasal, or FluMist to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.
Also do not give if patient has liver or kidney disease, chronic anemia, or other blood
disorders.
Do you have an active neurological disease (a disease of the brain,
nervous system, etc.)?
Do not give the live vaccine to patients with certain musculoskeletal disorders that can
lead to trouble breathing or trouble swallowing. Screen for history of paralysis, nerve
conduction disorders, cerebral palsy, myasthenia gravis, or Guillain-Barre Syndrome
(GBS). If a patient has a neurological disorder, call a faculty preceptor now for
guidance. It might be acceptable to give the vaccine today to some patients with some
neurological illnesses such as migraine headaches and seizures, but this must be
reviewed by a faculty preceptor before the patient is cleared. Call a faculty preceptor
now!

Do you have a history of Guillain-Barre Syndrome (GBS)?

Do not give the vaccine to any patient who has s history of paralysis or paralytic
disorder such as GBS. In 1976, an earlier version of inactivated swine flu was
associated with an increased incidence of GBS. However, this has not been observed
with the LAIV. Call a faculty preceptor now!

Has your doctor ever told you that you have an immune system disorder?
Are you currently taking long-term corticosteroids (prednisone,
methylprednisolone, etc.); immunosuppressants; chemotherapy; biologic
immune modulating medications such as Remicaide®, Enbrel®, Humira®,
etc? If you have an inflammatory condition such as arthritis, asthma,
psoriasis, inflammatory intestinal disease, etc.
Please tell the healthcare provider now.
General categories of medications that are considered immunosuppressive • High-dose corticosteroids (> 2 mg/kg body weight or 20 mg/day of prednisone • Other immunosuppressive medications, immune suppressing antibodies and SEE APPENDIX A.
If you have any questions concerning a patient’s eligibility due to
immunosuppressive medications, please call a preceptor now.
Do you have HIV, cancer, or have you received an organ transplant?
Patients who have HIV, Cancer, or who have received an organ transplant are immunosuppressed and should not receive the LAIV nasal vaccine. Most are candidates for the inactivated virus (unless they have a vaccine allergy, etc.). Do you live with, care for, or have close contact with anyone who is
severely immunocompromised or someone who has to be in protective
environment (such as transplant patients)?

The live nasal vaccine deposits in the nose and there is virus shedding for 3 to 7 days
after the dose. The virus can shed when the patient coughs, sneezes, etc., so they
should cover their cough and use tissues. If patients who receive LAIV come in contact
with a severely immunocompromised patient, then the immunocompromised individual
could become seriously ill. Therefore, do not give the live vaccine to caretakers or
contacts of these individuals.
After receiving the live vaccine, patients should avoid visiting hospitals, nursing homes,
organ transplant units, dialysis units, critical care units, high risk nurseries, and special
care nurseries for 7 days. Also, they should avoid any friends or family who are
severely immunocompromised such as patients who are post organ transplant, on
chemotherapy, receiving radiation therapy, etc.
The most common question that we are receiving is “I know someone who takes an
immunosuppressive drug such as Remicaide, Enbrel, Humira, high dose steroids,
chemotherapy, etc. Should I not receive this medication if there is a chance I will see
this person over the next week.” Generally, this is not a contraindication to receiving
the vaccine. Casual contact with someone who is on an immunosuppressive is not a
problem (like going to class, attending social functions, riding in a car, etc.). However,
if someone lives for or routinely cares for a patient who takes one of these medications,
then they might choose to wait to receive the injectable dosage form to err on the side
of caution.
Have you received any vaccines in the past 30 days or do you plan to
receive any vaccines in the next 4 weeks?

Screen for any live vaccines. The LAIV should not be given within 4 weeks of another
live vaccine. (See Above in number 3 for more detailed information). Provide patient
counseling on this issue.
Is there any chance that you are currently pregnant?
Live vaccine is contraindicated in pregnancy. Vaccination is recommended with the injectable, inactivated vaccine. If there is any question about pregnancy, the vaccination with the live vaccine should be postponed until the patient’s pregnancy status is confirmed (pregnancy is ruled out). Please list all of the medications that you currently take for any disease state (so the
healthcare provider administering the vaccine can conduct a medication screening to
ensure you are a candidate)?

Screen for DM medications, asthma medications, immunosuppressants, etc. as outlined above. Please
take note if the patient is taking a beta blocker because if an allergic / anaphylactic reaction developed
post immunization, a higher dose of epinephrine is required in patients who take beta blockers.


“I have read (or have had explained to me) the information in the 2009 H1N1 Influenza Monovalent Information Statement (VIS). I have also had an opportunity to ask questions and they were answered to my satisfaction. I understand the benefits and risks of the influenza vaccine, and I consent to receive the vaccine. I have also been provided a copy of the Auburn University Pharmaceutical Care Center (AUPCC) privacy policy for my review before vaccine administration and offered a copy for my records.” Signature________________________________________________Date:________________________ Make sure the patient has read the VIS and the Privacy Statement and been
offered a copy for their personal records. Make sure the patient has printed his or
her name above, and then signs and dates the consent form.
ASSESSMENT BY IMMUNIZATION CERTIFIED HEALTHCARE PROVIDER:
Give injectable H1N1 flu vaccine today
Vaccine Information Statement (VIS) Provided:
Give intranasal Live H1N1 flu vaccine today
_____Inactivated, H1N1 Influenza Monovalent Vaccine _____Live, H1N1 Influenza Monovalent Vaccine Mark one of these 3 boxes for your clinical
Clinical screener must sign and
assessment of if the patient should receive
date after reviewing each question
the H1N1 LAIV today.
with the patient and verifying
eligibility to receive the LAIV
vaccine.
DOCUMENTATION OF VACCINE ADMINISTRATION
Live Intranasal H1N1 Influenza (MedImmune)
Inactivated H1N1 Influenza:
NDC# 66019-200-10 Lot #: 500757
Manufacturer:(circle) Sanofi-Pasteur Novartis CSL
Expiration Date: January 25, 2010
NDC# _________Lot#:__________Exp Date:___________ Dose: 0.2 ml Route: Intransal
Dose: 0.5 ml Route: IM Site: Left/ Right Deltoid

Check lot number of dose administered and
match to the form used. This will be important if
a recall of a specific lot is issued. We must know
which lot each patient received.
Administered By:_______________________________
Preceptor:

Be sure to print name of immunizer, sign, and
If a student, have your clinical preceptor co-sign.
Date:__________________________________________
Auburn University Students, Employees, and Dependents
Date of Last Form Revision: 10/13/2009
APPENDIX A
General categories of medications that are considered immunosuppressive • High-dose corticosteroids (> 2 mg/kg body weight or 20 mg/day of prednisone for > 2 weeks). • Other immunosuppressive medications, immune suppressing antibodies and interferons GENERIC DRUG
BRAND NAME DRUG
CATEGORY
*EQUIVALENCY NUMBER TO
PREDNISONE
Thioguanine Aminopurine-6-Thiol-Hemihydrate A = Antineoplastic Agent AV = Antiviral Agent C = Corticosteroid D = DMARD (Disease Modifying Anti-Rheumatic Drug) I = Immunosuppressive M = Monoclonal Antibody Drug T = treats immunosuppressive diseases or used for them prophylactically Derm = Dermatologic use *Equivalency Number To Prednisone = represents a number which when divided into the dose of a similar drug will yield a dose that is approximately equal to the prednisone dosage. http://www.bt.cdc.gov/agent/smallpox/vaccination/immuno_suppress_meds.asp 

Source: http://pharmacy.auburn.edu/aupcc/pdf/clinical_vol_guide.pdf