To:
Immunizing Pharmacists
From:
Anthony Pudlo, PharmD, MBA, BCACP
Vice President, Professional Affairs
Date:
September 2013
Re:
Sample Immunization Protocol and Policy & Procedures
On behalf of the Iowa Pharmacy Association, thank you for your interest in serving the
patients of your community by establishing an immunization protocol in accordance
with the Iowa Administrative Code (657 IAC 8.33 (155A)).
The following sample immunization protocol provides you with the opportunity to
collaborate with a supervising prescriber to administer CDC recommended adult
vaccines to patients 18 years and older, and child/adolescent influenza vaccinations to
patients 6 years and older.
This document includes a sample policy and procedures to review with your
supervising physician to handle emergency care for adverse events from a vaccination.
In addition, this document provides a sample needle stick protocol to guide your
pharmacy’s process for this emergency situation.
This document is provided to you as a framework to assist your pharmacy in providing
immunizations in your community. You may alter this document to fit the needs of
your pharmacy.
If you should have any questions or comments, please contact Anthony at
apudlo@iarx.org or 515-270-0713.
2013 Iowa Pharmacy Association - Page 1
Standing Prescription Order to Administer Immunizations
(Pharmacy Name)
The subsequent list of immunizing pharmacists have completed all training requirements
and updated certifications required by the Iowa Board of Pharmacy pertinent to vaccine
administration in Iowa and are authorized on the basis of this protocol to deliver vaccines
in Iowa under the medical direction of (supervising prescriber), (prescriber’s title) for
(prescriber’s practice name). Please note that the qualified trained pharmacists listed
below may delegate administration of a vaccine to another qualified and trained
pharmacist or student pharmacist that assist our pharmacy in our immunization services.
Registered Pharmacists:
Last Name
First Name
License Number
Agreement Description:
To protect people from preventable infectious diseases that cause needless death and disease, the
afore listed pharmacists may administer the following immunization to eligible patients within the state
of Iowa, according to indications and contraindications recommended in current guidelines from the
Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control &
Prevention (CDC) and in accordance with product labeling. Other vaccines may be added to or
deleted from this list by written supplementary instruction from the undersigned.

influenza inactivated virus vaccine 0.5 ml intramuscular

influenza inactivated virus vaccine 0.1 ml intradermal

influenza live attenuated vaccine 0.2ml intranasal

recombinant influenza vaccine 0.5 ml intramuscular

23-valent pneumococcal vaccine polyvalent (Pneumovax 23) 0.5 ml intramuscular

13-valent pneumococcal conjugate vaccine (Prevnar 13) 0.5 ml intramuscular

zoster vaccine live 0.65 ml subcutaneous

varicella virus vaccine live 0.5 ml subcutaneous Injection in a 2-dose schedule at 0
and 4-8 weeks

human papillomavirus vaccine 0.5 ml intramuscular in a 3-dose schedule at 0, 2, and
6 calendar months

meningococcal conjugate vaccine quadrivalent (MCV4) 0.5 ml intramuscular

meningococcal polysaccharide vaccine (MPSV4) 0.5 ml subcutaneous

tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap) 0.5
ml intramuscular

tetanus toxoid, reduced diphtheria toxoid 0.5 ml intramuscular

measles, mumps, rubella 0.5 ml subcutaneous

hepatitis A 0.5-1.0 ml intramuscular

hepatitis B 0.5-2.0 ml intramuscular in a 3-dose schedule at 0, 1, and 6 calendar
months
2013 Iowa Pharmacy Association - Page 2
Criteria:
Influenza Inactivated Virus Vaccine
The inactivated influenza vaccine (IIV) or influenza live, attenuated virus vaccine (ILAVV) may be
given annually to all consenting individuals 6 years of age and older in whom the vaccine is not
contraindicated. Priority will be given to high-risk populations during years of vaccine shortage and
as directed by CDC. Specific intramuscular or the intradermal administrated IIV are also options for
adults ages 18-64 years. Adults aged 65 years and older can receive the standard dose IIV or the
high-dose IIV (Fluzone High-Dose).
High-risk populations are distinguished by the following:

Persons aged 50 years and older

Long-term care facility residents

Children aged 6-59 months

Healthcare workers

Anyone 6 months or older with certain chronic illnesses

People 6 months to 18 years old on chronic aspirin therapy

Pregnant Women

Morbidly obese (BMI >40)

Caregiver of persons with medical condition with higher risks for complications
Chronic Illnesses Include:

Pulmonary (e.g., emphysema, COPD, asthma)

Cardiovascular (e.g., CHF, post-MI, heart anomalies)

Metabolic (e.g., diabetes)

Renal dysfunction, hemoglobinopathies (e.g., sickle cell)

Immunosuppression (e.g., HIV infection)

Any condition (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, or other
neuromuscular disorders) that can compromise respiratory function or the handling of respiratory
secretions or can increase the risk for aspiration
Contraindications / Ineligible Patients for Inactivated Virus Vaccine

Allergy to eggs

Persons with known severe allergic reaction (e.g., anaphylaxis) after previous dose or to a
vaccine component
Precautions for Inactivated Virus Vaccine

Moderate or severe acute illness with or without fever

Previous paralysis by Guillain-Barre Syndrome

Persons who experience only hives with exposure to eggs should receive vaccine with
additional safety precautions
Influenza Live, Attenuated Virus Vaccine
The live, attenuated influenza vaccine may be given annually to all consenting individuals aged 6 to
49 years old in whom the vaccine is not contraindicated.
Contraindications/Ineligible Patients For Live, Attenuated Virus Vaccine

Immunocompromised Individuals
2013 Iowa Pharmacy Association - Page 3







Close contacts and family members of severely immunocompromised individuals (i.e.,
patients with hematopoietic stem cell transplants who require care in a protected
environment)
Allergy to eggs
Persons aged <2 years or those aged  50 years
Persons with asthma, reactive airways disease or other chronic disorders of the pulmonary
or cardiovascular systems; persons with other underlying medical conditions, including
such metabolic diseases as diabetes, renal dysfunction, and hemoglobinopathies; or
persons with known or suspected immunodeficiency diseases or who are receiving
immunosuppressive therapies
Children or adolescents receiving aspirin or other salicylates
Pregnant women
Persons with a history of hypersensitivity, including anaphylaxis, to any of the components
of LAIV
Precautions For Live, Attenuated Virus Vaccine

Moderate or severe acute illness with or without fever

Previous paralysis by Guillain-Barre Syndrome

Receipt of specific antivirals (i.e., amantadine, rimantadine, zanamivir, or oseltamivir) 48
hours before vaccination. Avoid use of antivirals for 14 days after vaccination.
Recombinant Influenza Vaccine
The recombinant influenza vaccine may be given annually to all consenting individuals aged 18-49
years old in whom the vaccine is not contraindicated.
Contraindications/Ineligible Patients for Recombinant Influenza Vaccine
• Severe allergic reaction (e.g., anaphylaxis to any component of the vaccine
Precautions for Recombinant Influenza Vaccine

History of Guillan-Barre syndrome that occurred within 6 weeks of receipt of a prior
influenza vaccine

Safety and effectiveness of recombinant influenza vaccine has not been established in
pregnant women or nursing mothers
23- Valent Pneumococcal Polysaccharide Vaccine
The 23-valent pneumococcal polysaccharide vaccine (PPSV23) may be given to all consenting
individuals 18 years of age and above in whom the vaccine is not contraindicated. Each dose is 0.5ml
administered intramuscularly or subcutaneously.
Pneumococcal polysaccharide vaccinations should be given at a higher priority to the following
patients due to increased risk of pneumococcal infection:

Persons aged 65 years old and older, who have not received the vaccine within the
previous 5 years

Persons aged 18-64 years who have the following chronic illnesses/conditions: chronic
cardiovascular disease, chronic pulmonary disease (asthma, COPD or emphysema),
diabetes, cochlear implants, chronic alcoholism or liver disease (cirrhosis), cerebral spinal
fluid leaks

Persons aged 19-64 years who smoke or have asthma
2013 Iowa Pharmacy Association - Page 4


Persons aged 19-64 years who have functional or anatomical asplenia
Persons aged 19-64 years who are immunocompromised; HIV infection, leukemia,
lymphoma, Hodgkins disease, multiple myeloma, generalized malignancy, chronic renal
failure, nephrotic syndrome, or other conditions associated with immunosuppression (e.g.,
organ or bone marrow transplantation); and persons receiving immunosuppressive therapy,
including long-term systemic corticosteroids. If earlier vaccination status is unknown,
immunocompromised persons should be administered pneumococcal vaccine. Also,
persons with asymptomatic or symptomatic HIV infection should be vaccinated as soon as
possible after their diagnosis is confirmed.
Revaccination of pneumococcal polysaccharide vaccine:

A second dose of PPSV23 is recommended 5 years after the first dose for persons aged
19-64 with functional or anatomic asplenia and for persons with immunocompromising
conditions.

Persons who received 1 or 2 doses of pneumococcal polysaccharide vaccine before age
65 years, for any indication, should receive another dose of the vaccine at age 65 years or
older if at least 5 years have passed since their previous dose
Contraindications/Ineligible Patients for Pneumococcal Polysaccharide Vaccine

Persons with known severe allergic reaction (e.g., anaphylaxis) after previous dose or to a
vaccine component
Precaution for Pneumococcal Polysaccharide Vaccine

Moderate or severe acute illness with or without fever
13- Valent Pneumococcal Conjugate Vaccine
The 13-valent pneumococcal conjugate vaccine (PCV13) is recommended for adults aged 19 years
or older with immunocompromising conditions (including chronic renal failure and nephrotic
syndrome), functional or anatomic asplenia, CSF leaks or cochlear implants, and who have not
previously received PCV13 or PPSV23 should receive a single dose of PCV13 followed by a dose of
PPSV23 at least 8 weeks later. Adults aged 19 years or older with the aforementioned conditions who
have previously received one or more doses of PPSV23 should receive a dose of PCV13 one or
more years after the last PPSV23 dose was received. For those that require additional doses of
PPSV23, the first such dose should be given no sooner than 8 weeks after PCV13 and at least 5
years since the most recent dose of PPSV23.
Contraindications/Ineligible Patients for Pneumococcal Conjugate Vaccine

Persons with known severe allergic reaction (e.g., anaphylaxis) after previous dose or to a
vaccine component or any diphtheria toxoid-containing vaccine
Precautions for Pneumococcal Conjugate Vaccine

Moderate or severe acute illness with or without fever
Zoster Vaccine
Zoster (shingles) vaccine may be given to adults 60 years old or older, whether or not the patient
reports a prior episode of shingles. Persons with chronic medical conditions may be vaccinated
unless a contraindication or precaution exists for their condition
2013 Iowa Pharmacy Association - Page 5
Contraindications/Ineligible Patients for Zoster Vaccine

Persons with a history of anaphylactic/anaphylactoid reaction to gelatin, neomycin, or any
other component of the vaccine

Persons with a history of primary or acquired immunodeficiency state, including leukemia,
lymphoma, or other malignant neoplasm affecting the bone marrow or lymphatic system, or
with acquired immunodeficiency syndrome or other clinical manifestation of infection with
human immunodeficiency viruses;

Persons receiving immunosuppressive therapy, including high-dose corticosteroids

Persons who are or may be pregnant
Precautions for Zoster Vaccine

Moderate or severe acute illness with or without fever
Varicella vaccine
All adults without evidence of immunity to varicella (as defined below) should receive 2 doses of
single-antigen varicella vaccine or a second dose if they have received only 1 dose. The second dose
should be administered 4-8 weeks after the first dose.
Special Populations

Persons who have close contact with persons at high risk for severe disease (e.g., healthcare personnel and family contacts of persons with immunocompromising conditions) or
are at high risk for exposure or transmission (e.g., teachers; child care employees;
residents and staff members of institutional settings, including correctional institutions;
college students; military personnel; adolescents and adults living in households with
children; nonpregnant women of childbearing age; and international travelers).

Pregnant women should be assessed for evidence of varicella immunity. Women who do
not have evidence of immunity should receive the first dose of varicella vaccine upon
completion or termination of pregnancy and before discharge from the health-care facility.
The second dose should be administered 4–8 weeks after the first dose.
Evidence of immunity to varicella in adults includes any of the following:

Documentation of 2 doses of varicella vaccine at least 4 weeks apart

U.S.-born before 1980 except health-care personnel and pregnant women

History of varicella based on diagnosis or verification of varicella disease by a health-care
provider

History of herpes zoster based on diagnosis or verification of herpes zoster disease by a
health-care provider

Laboratory evidence of immunity or laboratory confirmation of disease.
Contraindications/Ineligible Patients for Varicella Vaccine

Persons with a history of anaphylactic/anaphylactoid reaction to this vaccine or to any of its
components

Persons who are or may become pregnant within 4 weeks

People on long-term immunosuppressive therapy or who are immunocompromised
because of malignancy and primary or acquired immunodeficiency, including HIV/AIDS
2013 Iowa Pharmacy Association - Page 6
Precautions for Varicella Vaccine

Moderate or severe acute illness

If blood, plasma, and/or immune globulin (IG or VZIG) were given in past 11 months

Receipt of specific antivirals (i.e., acyclovir, famciclovir, or valacyclovir) 24hrs before
vaccination, if possible; delay resumption of these antiviral drugs for 14 days after
vaccination.
Human papillomavirus (HPV) vaccination
The human papillomavirus vaccine may be given to any of the following adults

Females age 18 through 26 years

Males age 18 through 21 years

Males age 22 through 26 years meeting any of the following conditions:
Immunocompromised as a result of infection (including HIV), disease, or medications; has
sex with other males, or wants to be vaccinated and lacks any of the above criteria
A complete series for either HPV4 or HPV2 consists of 3 doses. The second dose should be
administered 1–2 months after the first dose; the third dose should be administered 6 months after
the first dose (at least 24 weeks after the first dose). Females can receive either HPV2 or HPV4.
Males can receive HPV4.
Contraindications/Ineligible Patients for Human papillomavirus Vaccine

Persons with a history of anaphylactic/anaphylactoid reaction to this vaccine or to any of its
components (e.g. yeast for Quadrivalent HPV vaccine or latex for bivalent HPV vaccine)

Persons who are or may become pregnant within 4 weeks

People on long-term immunosuppressive therapy or who are immunocompromised
because of malignancy and primary or acquired immunodeficiency, including HIV/AIDS
Precautions for Human papillomavirus Vaccine

Moderate or severe acute illness with or without fever

Pregnancy; delay vaccination until completion of the pregnancy
Meningococcal Vaccination
The meningococcal conjugate vaccine quadrivalent (MCV4) or meningococcal polysaccharide
vaccine (MPSV4) may be given to adults 18 years and older in need of vaccination against
meningococcal disease based on any of the following criteria:

First-year college student, age 19 through 21 years, living in residence hall, and lacking
documentation of receipt of MCV4 at age 16 years or older.

Anticipated travel to a country in the “meningitis belt” of sub-Saharan Africa or other
location of epidemic meningococcal disease, particularly if contact with the local population
will be prolonged

Persons with diagnosis of anatomic or functional asplenia, including sickle-cell disease, or
persistent complement component deficiency, an immune system disorder, should receive
2 doses of MCV4 at least 2 months apart

Employment as a microbiologist with routine exposure to isolates of N. meningitidis

Anticipated travel to Mecca, Saudi Arabia, for the annual Hajj

Military recruits

Revaccination with MCV4 every 5 years is recommended for adults previously vaccinated
with MCV4 or MPSV4 who remain at increased risk for infection (e.g., adults with anatomic
or functional asplenia or persistent complement component deficiencies)

Any other adult wishing to decrease their risk for meningococcal disease
2013 Iowa Pharmacy Association - Page 7
Meningococcal conjugate vaccine quadrivalent (MCV4) is preferred for adults with any of the
preceding indications who are aged 55 years and younger. Meningococcal polysaccharide vaccine
(MPSV4) is preferred for adults aged 56 years and older.
Contraindications/Ineligible Patients for Meningococcal Vaccine

Persons with a history of anaphylactic/anaphylactoid reaction to this vaccine or to any of its
components
Precautions for Meningococcal Vaccine

Moderate or severe acute illness with or without fever
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine (Tdap)
Tdap vaccine may be given to adults aged 19 to 64 years as a single dose to replace tetanus and
diphtheria toxoids vaccine (Td) for booster immunization against tetanus, diphtheria, and pertussis if
they received their last dose of Td >10 years earlier and they have not previously received Tdap.
Intervals shorter than 10 years since the last Td may be used for booster protection against pertussis.
Special Populations:

Adults who have or who anticipate having close contact with an infant aged <12 months
(e.g., parents, grandparents aged <65 years, child-care providers, and health-care
personnel) should receive a single dose of Tdap to reduce the risk for transmitting
pertussis. When possible, women should receive Tdap before becoming pregnant. Women
who have not previously received Tdap should receive a dose of Tdap in the immediate
postpartum period.

Health-care personnel who work in hospitals or ambulatory care settings and have direct
patient contact should receive a single dose of Tdap as soon as it is feasible if they have
not previously received Tdap. An interval as short as 2 years from the last dose of Td is
recommended; shorter intervals may be used.
Contraindications/Ineligible Patients for Tdap

Persons with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose
of Td or to a Td or Tdap component

Persons with a history of encephalopathy within 7 days following DTP/DTaP/Tdap not
attributable to another identifiable cause
Precautions for Tdap

Persons with a history of Guillain-Barré syndrome within 6 weeks of previous dose of
tetanus toxoid-containing vaccine

Persons with a history of an arthus-type hypersensitivity reaction after a previous dose of
tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years
have elapsed since the last tetanus toxoid-containing vaccine

Persons with moderate or severe acute illness with or without fever

Persons with progressive or unstable neurologic disorder, uncontrolled seizures or
progressive encephalopathy until a treatment regimen has been established and the
condition has stabilized
Td
2013 Iowa Pharmacy Association - Page 8
Td vaccine should be given to adults 19 years and older as a single dose booster to DTaP or Tdap
every 10 years. Td may be administered to an individual who sustains a severe cut or burn if the
person has had Tdap previously, if Tdap is not available, children between the ages of 7-9 who
finished the childhood DTaP series, or adults > 65 years old.
Special Populations:

Pregnant women who already received Tdap and require a booster during their pregnancy
should receive Td.

Individuals who experienced a coma or seizures within 7 days or receiving either DTP or
DTaP should receive Td rather than Tdap unless another cause was identified.
Contraindications:

Persons with a history of a severe allergic reaction (e.g., anaphylaxis) after a previous dose
of Td or to a Td or Tdap component
Precautions:

Persons with a history of Guillain-Barré syndrome within 6 weeks of previous dose of
tetanus toxoid-containing vaccine

Persons with a history of an arthus-type hypersensitivity reaction after a previous dose of
tetanus or diphtheria toxoid-containing vaccine; defer vaccination until at least 10 years
have elapsed since the last tetanus toxoid-containing vaccine

Persons with moderate or severe acute illness with or without fever
MMR
MMR vaccine should be given in 1 or 2 doses to adults older than 18 who were born after 1956 if they
have not been vaccinated previously or have had each of the three diseases. MMR vaccine may also
be given to those who fit the following criteria:

Persons who work in the healthcare industry

Persons with HIV infection and a CD4 T-lymphocyte count of >200 cells/μl

Men who have sex with men (MSM)

Persons with Type I or Type II Diabetes

Person with chronic liver disease

Persons with kidney failure, end-stage renal disease (ESRD), or those who receive
hemodialysis

Persons with heart disease

Persons with chronic lung disease including COPD and chronic bronchitis (emphysema)

Persons with chronic alcohol abuse

Persons with asplenia including those who have elective splenectomy and persistent
complement component deficiencies
Contraindications:

Individuals who have suffered a severe allergic reaction (e.g., anaphylaxis) after receiving
their first dose or a component of the vaccine

Women who are pregnant

People who are severely immunocompromised, such as those with HIV and a CD4 Tlymphocyte count of <200 cells/μl, receiving chemotherapy or long-term
immunosuppressing drug therapy, or tumors
Precautions:

Individuals should receive a Tb test prior to vaccine administration

Persons with a history of thrombocytopenia or thrombocytopenia purpura
2013 Iowa Pharmacy Association - Page 9


Persons with moderate or severe acute illness with or without fever
Individuals who, within the last 11 months, were administered blood products containing
antibodies
Hepatitis A Vaccine
Hepatitis A vaccine should be given in 2 doses to all people 18 years and older who want to be
protected from hepatitis A virus infection and lack a specific risk factor are eligible for vaccination.

People who travel or work anywhere EXCEPT the U.S., Western Europe, New Zealand,
Australia, Canada, and Japan.

People with chronic liver disease; injecting and non-injecting drug users; men who have
sex with men; people who receive clotting-factor concentrates; people who work with HAV
in experimental lab settings; food handlers when health authorities or private employers
determine vaccination to be appropriate.

People who anticipate close personal contact with an international adoptee from a country
of high or intermediate endemicity during the first 60 days following the adoptee’s arrival in
the U.S.

Adults age 40yrs or younger with recent (within 2 wks) exposure to HAV. For people older
than age 40yrs with recent (within 2 wks) exposure to HAV, immune globulin is preferred
over HepA vaccine.
Contraindications:

Individuals who have suffered a severe allergic reaction (e.g., anaphylaxis) after receiving
their first dose or a component of the vaccine
Precautions:

Persons with moderate or severe acute illness with or without fever
Hepatitis B Vaccine
Hepatitis B vaccine should be administered in 3 separate doses to all adults over the age of 18 at risk
for hepatitis B infection and who have not previously received the vaccine. Those at risk for hepatitis
B are:

Persons with a sex partner or housemate currently infected with hepatitis B, are men who
have sex with men (MSM), have more than one sexual partner, or inject illicit street drugs

Persons with chronic liver disease

Persons with chronic kidney disease or dialysis patients

Persons who have Type I or II Diabetes and are <60 years old

Persons who work with or near human blood or body fluids

Persons who work in establishments with the developmentally disabled

Persons who travel to endemic countries

Persons infected with HIV
For the dosing schedule, the second dose is given 1-2 months following the first dose and the third
dose is given 6 months after the first dose.
Special Populations:

Pregnant women who want protection from Hepatitis B and were not previously immunized
or are at risk for contracting the illness should be vaccinated
Contraindications:

Individuals who have suffered a severe allergic reaction (e.g., anaphylaxis) after receiving
their first or second dose or a component of the vaccine
2013 Iowa Pharmacy Association - Page 10
Precautions:

Persons with moderate or severe acute illness with or without fever
Documentation
In the course of providing vaccines, the pharmacist must maintain perpetual records of all
vaccines administered. Before vaccine administration, vaccine candidates will be questioned
regarding previous adverse events following vaccine administration, food or drug allergies, as well as
questioned regarding appropriate vaccine contraindications and precautions. In addition, vaccine
history will be verified against the statewide immunization registry (except for annual influenza
vaccines). All vaccine candidates will be informed of the specific benefits and risks of the vaccine
offered and will sign a consent form. All vaccine recipients will be observed for a suitable period of
time after immunization for adverse events.
All vaccine recipients will be offered a written immunization record. The immunization will be
reported to the physician issuing this written protocol and the patient’s primary care provider (if
designated by the patient) by fax or mail. The immunization will also be reported to the statewide
immunization registries as made available.
Emergency Care
Emergency care will be given if needed using the Protocol for Allergic and Anaphylactic
Reactions to Injectable/Intranasal Medications Administered by (pharmacy name) Pharmacists. The
healthcare professional will maintain current certification in cardiopulmonary resuscitation. The
emergency physician on call can be reached at pager number: _______________ if needed.
Referrals
The pharmacist will endeavor not to disrupt existing patient-physician relationships. The
pharmacist will refer patients needing medical consultation to a physician. The pharmacist will make
special efforts to identify susceptible people who have not previously been offered immunizations.
As the authorizing physician, I will review, on an annual basis, the activities of the pharmacists
administering vaccines under this protocol. The authorization shall be valid until one year from the
date indicated below, unless revoked in writing sooner or unless extended in writing.
The following (pharmacy name) pharmacists: Add Pharmacists names here…… having completed
the appropriate training for administration of vaccines and CPR certification as delegates for
supervising prescriber) according to and in compliance with the State of Iowa Board of Pharmacy
may administer the medication(s) listed above on the premises of the (pharmacy name) and at other
Iowa community locations and for a fee.
Prescriber Name: __________________
NPI #: _________________
DEA #: ________________
Prescriber Signature:________________________________________
Date:__________________
Add address of supervising physician here
Local Telephone Number(s) for Consultations:
Pharmacist Signature:___________________
Pharmacist License #:_______________
Date:______________
2013 Iowa Pharmacy Association - Page 11
Protocol for Allergic and Anaphylactic Reactions to Injectable/
Intranasal Medications Administered by (pharmacy name) Pharmacists
If an allergic reaction to a medication occurs, the following standing orders will be used:
Procedures
1. Be prepared to call 911.
2. Take a thorough history for allergies and prior adverse events before any immunization.
3. Allow adequate physical space for fainting or collapse without injury and to lay patient flat on a
hard surface in the event cardiopulmonary resuscitation (CPR) is needed.
4. Maintain current competency in immunization; observe all vaccine recipients for a suitable
period of time after immunization; remind vaccine recipients to report any adverse events to
you.
*If an allergic reaction is suspected, and the patient is fully alert and not in respiratory
distress, do not hesitate to give diphenhydramine to the patient.
Supplies to Stock
1. (2) Epinephrine Auto-Injector devices, USP, (1:1000), 0.3 mg dose
2. Diphenhydramine hydrochloride liquid
3. Blood pressure measuring equipment
Recognition of Anaphylactic Reaction
1. Sudden onset of itching, redness, with or without hives, within several minutes after injecting
vaccine. The symptoms may be localized or generalized.
2. Angioedema (swelling of the lips, face, throat), anxiety, difficulty swallowing, syncope, fall in
blood pressure, light-headedness, paresthesia, flushing, sweating, palpitations
3. Bronchospasm, wheezing, tightness in chest, shock
Emergency Treatment
1. If suspect allergic response (i.e., welts, itching, hives, etc.) and in no respiratory distress give
oral diphenhydramine1mg/kg body weight immediately, observe patient closely for 30 minutes,
watching for generalized symptoms.
2. If symptoms are generalized, activate the emergency response system (9-1-1) and call the
consulting physician for instructions. Another person should do this while the immunizer treats
and observes the patient.
3. Administer epinephrine 0.3mg subcutaneously or intramuscularly. Site of administration can be
the anterior thigh or deltoid area.
4. Monitor the patient closely until EMS arrives. Perform CPR and maintain airway, if necessary.
a. Keep patient in supine position unless he/she is having breathing difficulty. If breathing
is difficult, patient’s head may be elevated, provided blood pressure is adequate to
prevent loss of consciousness.
b. Monitor vital signs frequently
2013 Iowa Pharmacy Association - Page 12
5. If EMS has not arrived and symptoms are still present, repeat dose of epinephrine every 15
minutes, depending on patient’s response.
6. Refer patient for medical evaluation, even if symptoms resolve completely. Symptoms may
reoccur after epinephrine and diphenhydramine wear off, as much as 24 hours later. After the
event is concluded complete a VAERS form.
*If physician direction is needed the on call provider can be reached at pager:____________.
The following (pharmacy name) pharmacists: ADD PHARMACIST Name Here having completed the
appropriate training for administration of vaccines and CPR certification as delegates for (supervising
prescriber) according to and in compliance with the State of Iowa Board of Pharmacy, may administer
the medication(s) listed above in the event of allergic and/or anaphylactic reaction.
Prescriber Name: _________________
NPI #: ______________
DEA #:______________
Prescriber Signature:________________________________________
Date:__________________
Add Supervising Prescriber Address here
Pharmacist Signature:___________________
Pharmacist License #:_______________
Date:______________
2013 Iowa Pharmacy Association - Page 13
IM Immunization Supply Checklist
Supplies
___Vaccine
___Safety Syringes (3 ml)
___Safety Syringes (1ml)
___Needles
___Red “Sharps” Containers
___Hazardous waste bags
___Alcohol wipes
___Cotton balls
___Adhesive bandages
___Disposable gloves
___ 2- Epinephrine Auto-Injector Devices
___Diphenhydramine (liquid oral)
___Dosing cup for diphenhydramine
Equipment
___Medication refrigerator & freezer
___Blood pressure cuff
___Stethoscope
Documentation
___Consent form / Vaccine administration record/ Vaccine Information Statement
___Record keeping software, files or other record storage devices
___CDC text and ACIP recommendations
___Reference materials
2013 Iowa Pharmacy Association - Page 14
Needle Stick Incident – What To Do?
You have been involved in an accidental needle stick or sharps injury and may have come into contact with
infected blood or other potentially infectious materials. The risk to you is that you may have been exposed to
the Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV). (Pharmacy
Name) will provide you with a confidential post-exposure medical evaluation and post-exposure medication and
follow-up, including antibody and antigen testing, and safe and effective post-exposure prophylaxis, as
medically indicated, at no cost to you.
It is important that you do not panic. The risk of transmission to you is low; however, (pharmacy name) is
committed to providing you with the necessary post-exposure treatment to further reduce your risk of
transmission.
Clean the Injury:
o Immediately cleanse the injury with soap and water.
o If contact is to the eye(s), irrigate the eye(s) with water, saline, or other sterile irrigant for several
minutes.
Gather Information:
o Work with your supervisor to identify and document the name and information of the source
individual, if possible.
o If possible, ask the source individual to complete the NEEDLE STICK EXPOSURE INCIDENT
SOURCE INDIVIDUAL INFORMED CONSENT FORM, Appendix C to obtain consent.
o The results of the source individual's blood test will be made available to you.
Employee Consent:
o Complete the ACCIDENTAL EXPOSURE INCIDENT EMPLOYEE CONSENT TO
TREATMENT AND POST-EXPOSURE FOLLOW-UP FORM, Appendix B.
o If you consent, your blood will be collected and tested for HIV, HBV and HCV.
o Note: if you do not consent immediately at the initial collection of your blood to HIV serologic
testing, (pharmacy name) will maintain your blood sample for at least 90 days. In case you later
change your mind, that blood sample will be tested as soon as possible.
Report:
o Call compliance officer (pharmacy supervisor name, title, pharmacy name) to report the
incident at (xxx) xxx-xxxx.
2013 Iowa Pharmacy Association - Page 15
Appendix A
Occupational Exposure
Incident Reporting Form
Store or Event Location: _________________________
Date of Incident:___________________________
Immunization Administered by: _________________________________
Supervising Pharmacist (if applicable):____________________________
License #____________________
License #____________________
Exposed Employee Information
Name: ______________________________________ ________________
DOB:
Address:
Phone:
Gender:
If Student Intern, note University: __________________________________________________________________
Exposed Employee’s Physician Information
Name:
Address:
Phone number:
Assessment of source individual’s history and status for HBV, HCV, HIV infection, if known:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
__________________________________________________________________________________________
If source individual’s history and status for HBV, HCV, and HIV infection is unknown, was source individual presented
with consent to test (Appendix C). Y_________ N_________
Summary of Incident:
__________________________________________________________________________________________________
__________________________________________________________________________________________________
________________________________________________________________________________
Summary of Action Taken:
 Employee was provided copy of PATIENT TESTING INSTRUCTIONS
 Employee’s MD was notified on __________________________at ________am/pm by _______
__________________________________________________________________________________
__________________________________________________________________________________
_______________________________
Employee’s Signature
2013 Iowa Pharmacy Association - Page 16
_________________________________
Date
Appendix B
ACCIDENTAL EXPOSURE INCIDENT
EMPLOYEE CONSENT TO TREATMENT
AND POST-EXPOSURE FOLLOW-UP
I, _______________________, understand that I have been involved in an accidental exposure incident which may
involve contaminated blood or other potentially infectious materials. This incident occurred on _________ at
_____am/pm at the Store _____________ or Event Location _________________________________.
I, ________________________, acknowledge that I have been provided with a copy of (pharmacy name)’s Bloodborne
Pathogens Exposure Policy and have had the opportunity to ask questions. I consent to have my blood collected and
tested pursuant to (pharmacy name)’s Bloodborne Pathogens Exposure Policy. I hereby consent to have my blood
samples
drawn
within
72
hours
of
the
accidental
exposure
incident,
at
__________________________________________________, for the purpose of screening for HBV, HCV, and HIV.
I, ______________________________, have been informed that (pharmacy name) will provide the necessary laboratory
testing and any additional medical evaluation and post-exposure medication and follow-up, including antibody and
antigen testing and safe and effective post-exposure prophylaxis, as medically indicated, at no cost to me.
If I, ___________________________, elect to seek testing, medical evaluation, and follow-up through my own physician,
I will send all invoices related to this accidental exposure incident that occurred on _____________ at the Store
_____________ or Event Location _________________________________and will submit such invoices to (pharmacy
supervisor) at (pharmacy name), (pharmacy address), within 30 days of the laboratory testing and related medical
evaluation and post-exposure medication and follow-up as medically indicated.
Printed Name: ________________________________ Date: ______________
If a Student, I am in Attendance at _____________________________________
Signature: ________________________________________________________
2013 Iowa Pharmacy Association - Page 17
Appendix C
NEEDLE STICK EXPOSURE INCIDENT
SOURCE INDIVIDUAL INFORMED CONSENT
As you are aware, you have been involved in an accidental needle stick incident which may result in harm to the treating
(pharmacy name) employee. As a result, (pharmacy name) requests that you provide your consent to have your blood
collected and tested for the purposes of screening your blood for the Hepatitis B Virus (HBV), the Hepatitis C Virus
(HCV), and the Human Immunodeficiency Virus (HIV). The results of this blood test will result in information about your
health condition with respect to these three viruses, known as Protected Health Information (PHI).
(Pharmacy Name) is required by law to maintain the privacy of PHI and to provide you with details of our legal duties
and privacy practices concerning PHI. PHI is information that identifies you and relates to your past, present, or future
physical or mental health condition related to health care services. (Pharmacy Name) will not use or disclose PHI about
you without YOUR written authorization. This consent to release PHI is limited to the release of your status with respect
to the HBV, HCV, and HIV only, and will be shared with the treating (pharmacy name)employee only, for the purposes
of his/her own post-exposure medical evaluation and follow-up treatment protocol.
CONSENT TO COLLECTION AND TESTING OF BLOOD
I, __________________________, understand that I have been involved in a needle stick incident that may cause harm to
the (pharmacy name) employee who was administering my care at Store _______________ or Event Location
____________________ on _____________ at ____________am/pm.
I, ______________________________, consent to have a sample of my blood drawn within 72 hours of this needle stick
incident, at _____________________________________________________, for the purpose of screening for HBV,
HCV, and HIV.
(pharmacy name) will pay for the costs of collecting and testing my blood for this purpose.
CONSENT TO PROVIDE PHI TO (PHARMACY NAME) FOR LIMITED PURPOSE
I, ______________________________, consent to have the results of my blood tests regarding my infection status with
respect HBV, HCV, and HIV shared with (pharmacy name), pursuant to its legal obligations with respect to maintaining
the confidentiality of PHI to be provided to the (pharmacy name) employee only, involved in this needle stick incident,
for the purposes of the (pharmacy name) employee’s post-exposure medical evaluation and follow-up treatment
protocol.
Printed Name: ________________________________ Date: ______________
Signature: ________________________________________________________
2013 Iowa Pharmacy Association - Page 18