Standing Prescription Order To Administer Immunizations

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 or 515-270-0713.

Standing Prescription Order to Administer Immunizations

(Pharmacy Name)

2013 Iowa Pharmacy Association - Page 2

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:

2013 Iowa Pharmacy Association - Page 2

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

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

·  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 ³ 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

·  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

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., health-care 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

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)