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Participant Tool-Kit August 2013

Table of Contents

TOOL/RESOURCE Page

Practice Assessment Worksheet 1 Immunization Service Development/Expansion Action Plan 4 Pneumoccoccal Immunization Service Budget Planning Worksheet 6 Immunization Service Tracking Form (Flash Report) 7 Standing Orders and Protocols ‐ Necessary Elements 8 Pneumococcal Immunization Collaborative Drug Therapy Management Agreement 9 Immunization Encounter Form 13

PRACTICE ASSESSMENT WORKSHEET For each of the following immunization service areas, identify the strengths, weaknesses, opportunities and threats that should be considered in planning to develop or expand your pneumococcal immunization services. PATIENT DEMOGRAPHICS

Strengths

Weaknesses

Opportunities

Threats

STAFFING

Strengths

Weaknesses

Opportunities

Threats

SCHEDULING

Strengths

Weaknesses

Opportunities

Threats

1

WORKFLOW

Strengths

Weaknesses

Opportunities

Threats

REGULATORY AUTHORITY/COMPLIANCE

Strengths

Weaknesses

Opportunities

Threats

VACCINE STORAGE

Strengths

Weaknesses

Opportunities

Threats

RECORD KEEPING

Strengths

Weaknesses

Opportunities

Threats

2

SUPPLIES

Strengths

Weaknesses

Opportunities

Threats

FACILITY/PHARMACY LAYOUT

Strengths

Weaknesses

Opportunities

Threats

OTHER PRACTICE ELEMENT:

Strengths

Weaknesses

Opportunities

Threats

OTHER PRACTICE ELEMENT:

Strengths

Weaknesses

Opportunities

Threats

3

IMMUNIZATION SERVICE DEVELOPMENT/EXPANSION ACTION PLAN For each of the suggested work tasks, primary person responsible for completing the task and target completion date. Utilize this action plan to track your progress. Blank lines and page are provided to add additional items

WORK TASK PERSON RESPONSIBLE

TARGET DATE

STATUS

Designate project leader/champion within the pharmacy.

Complete a practice assessment SWOT analysis

Identify and complete required staff education/training

Identify/recruit additional personnel

Develop/Revise Service Delivery Policies and Procedures

Prepare budget projections

Identify collaborators/partners and initiate outreach

Develop and implement patient recruitment/marketing plan

Complete site modifications

Execute billing agreements

Secure collaborative drug therapy management agreements.

Launch pneumococcal immunization service.

4

IMMUNIZATION SERVICE DEVELOPMENT/EXPANSION ACTION PLAN

WORK TASK PERSON RESPONSIBLE

TARGET DATE

STATUS

5

PNEUMOCOCCAL IMMUNIZATION BUDGET PLANNING WORKSHEET REVENUE

(# of patients times average payer reimbursement rate) Income Expense

Medicare Part B patients

Medicare Part D patients

Commercial insurance patients

Private pay patients

Other

Total Annual Revenue Projected

EXPENSES

Assigned/allocated personnel Income Expense

Pharmacists

Technicians/Clerks

Clerks

Staff development/education

Marketing (print, media, on‐line)

Sales/marketing events, meetings

Community outreach events, activities

Vaccine (projected number immunizations times cost per dose)

Medicare Part B patients

Medicare Part D patients

Commercial insurance patients

Private pay patients

Other

Vaccine Administration (supply costs per projected immunization)

Documentation and billing systems

Office supplies/printing

Office equipment/services

Total Annual Expenses Projected

NET PROFIT/LOSS

6

IMMUNIZATION SERVICE TRACKING FORM

Template is courtesy of Hartzell ‘s Pharmacy, Catasauqua, PA

WEEKLY IMMUNIZATION ACTIVITY REPORT – Due Date:

Week Ending > > > Week 1 Week 2 Week 3 Week 4

PHARMACY Target Rolling 4

Scrip’s Process

# Vaccinations

PNEUMOCOCCAL Target Rolling 4

Patients Identified Eligible

Patients >65 Eligible

Patients 19‐64 w/Risk Eligible

Offers for Vaccination

% Eligible Patients Offered

# Pneumococcal Vaccinations

% Eligible Patients Vaccinated

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STANDING ORDERS and PROTOCOLS ‐ Necessary Elements from APhA Immunization Handbook

The standing order and protocols for each vaccine to be administered in the pharmacy should include the following: Vaccine Administration

Names and credentials of the individuals administering the vaccine Name of the practice site or location where the vaccine will be administered Effective dates of the standing order Name of vaccine to be administered Dose and route of the vaccine Criteria that must be met for a patient to receive the vaccine (e.g., age, risk factors, recurring

dose in a series) Specified number of patients to whom the standing order applies, if applicable Screening process for contraindications and precautions Patient education to be provided, including delivery of the vaccine information statement (VIS) Documentation process Physician name, credentials, and signature Date signed

Medical Management of Adverse Vaccine Reactions Names and credentials of the individuals administering the vaccine Name of the practice site or location where the vaccine will be administered Effective dates of the protocol Reporting process to the Vaccine Adverse Event Reporting System (VAERS) Types of reactions possible, symptoms to expect, and management of such symptoms

o Localized reaction o Syncope o Anaphylaxis

Emergency management of anaphylactic reactions o Signs and symptoms to expect o Supplies needed to manage anaphylaxis o Epinephrine dose and administration o Diphenhydramine dose and administration, if applicable o Notification of the emergency medical system (EMS) o Monitoring process and use of cardiopulmonary resuscitation (CPR), if necessary o Record keeping and physician follow‐up

Physician name, credentials, and signature Date signed

8

PENUMOCOCCAL IMMUNIZATION SERVICES COLLABORATIVE DRUG THERAPY MANAGEMENT TEMPLATE The[State} Pharmacy Practice Act allows pharmacists to practice under a Collaborative Drug Therapy Management (CDTM) agreement with individual physicians. Pharmacists may participate in the practice of managing and modifying drug therapy according to a written protocol between the specific pharmacist and the individual physician(s) who is/are responsible for the patient’s care and authorized to prescribe drugs. By signing this document, the named physicians agree that the named pharmacist may enter into a Collaborative Drug Therapy Management role for their patients as detailed in the standing orders attached to this agreement and so executed by the undersigned physician. This agreement pertains only to the pharmacists listed below and the approving physician. Pharmacists: ________________________________ [INSERT PHARMACIST NAME] R.Ph. ________________________________ [INSERT PHARMACIST NAME] R.Ph. ________________________________ [INSERT PHARMACIST NAME] R.Ph. PHYSICIAN: ________________________________ ________________________________ Physician Name: Physician Signature . DATE OF IMPLEMENTATION: ___________ DATE OF EXPIRATION:

9

Purpose: To reduce morbidity and mortality from invasive pneumococcal disease by vaccinating all children who meet the criteria established by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate children who meet any of the criteria below.

Procedure 1. Identify infants and children in need of vaccination against invasive pneumococcal disease based on the following criteria: a. age 2 through 59 months and generally healthy b. age 2 through 71 months with any of the conditions described below: i. chronic heart disease (particularly cyanotic congenital heart disease and cardiac failure) ii. chronic lung disease (including asthma if treated with prolonged high-dose oral corticosteroids) iii. diabetes mellitus iv. cerebrospinal fluid leak v. candidate for or recipient of cochlear implant vi. functional or anatomic asplenia (i.e., sickle cell disease or other hemoglobinopathy, congenital or acquired asplenia, or splenic dysfunction)

vii. immunocompromising condition, including HIV infection; chronic renal failure and nephrotic syndrome; disease associated with treatment with immunosuppressive drugs or radiation therapy (e.g., malignant neoplasms, leukemias, lymphomas, and Hodgkin’s disease; or solid organ transplantation); congenital immunodeficiency (includes B-[humoral] or T-lymphocyte deficiency; complement deficiencies, particularly c1, c2, c3, and c4 deficiency; and phagocytic disorders [excluding chronic granulomatous disease])

c. age 6 through 18 years with any of the conditions described in categories iv through vii above.

2. Screen all patients for contraindications and precautions to pneumococcal conjugate vaccine: a. Contraindications: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of PCV, to a PCV component, or to any diphtheria toxoid-containing vaccine. For a list of vaccine components, go to www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf. b. Precautions: moderate or severe acute illness with or without fever; a child who has received pneumococcal polysaccharide vaccine (PPSV23) previously should wait at least 8 weeks before receiving PCV13. 3. Provide all patients (parent/legal representative) with a copy of the most current federal Vaccine Information Statement (VIS).

You must document, in the patient’s medical record or office log, the publication date of the VIS and the date it was given to the patient (parent/legal representative). Provide non-English speaking patients with a copy of the VIS in their native language, if available; these can be found at www.immunize.org/vis.

4. Provide vaccination with PCV13 for all healthy children ages 2 through 59 months and for children with a medical condition according to guidance on page 2 (“Recommendations for Pneumococcal Vaccine Use in Children and Teens”).

5. Administer 0.5 mL PCV13 intramuscularly in the anterolateral thigh muscle for infants and toddlers (deltoid may be used for tod-dlers with adequate muscle mass) or in the deltoid muscle of the arm for children ages 3 yrs and older (anterolateral thigh muscle may be used if deltoid is inadequate). Use a 22–25 g needle. Choose needle length appropriate to the child’s age and body mass: infants younger than age 12 mos: 1"; toddlers 1–2 yrs: 1–13" (anterolateral thigh) or e–1" (deltoid muscle); children ages 3–4 yrs: e–1" (deltoid) or 1–13" (anterolateral thigh). A e" needle may be used in toddlers and children if inserted in the deltoid muscle at 90° angle to the skin, which is stretched flat between thumb and forefinger.

6. Document each patient’s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and

route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal).

b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic.7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency

medical protocol available, as well as equipment and medications. To prevent syncope in older children, vaccinate patients while they are seated or lying down and consider observing them for 15 minutes after receipt of the vaccine.

8. Report all adverse reactions to PCV13 to the federal Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov or by calling (800) 822-7967. VAERS report forms are available at www.vaers.hhs.gov.

This policy and procedure shall remain in effect for all patients of the ______________________________________ untilrescinded or until _______________________ (date).

Medical Director’s signature: ____________________________________ Effective date: ________________________

For standing orders for other vaccines, go to www.immunize.org/standing-orders

Standing Orders for Administering Pneumococcal Conjugate Vaccine to Children

www.immunize.org/catg.d/p3086.pdf • Item #P3086 (4/13)

Immunization Action Coalition • 1573 Selby Ave. • St. Paul, MN 55104 • (651) 647-9009 • www.immunize.org • www.vaccineinformation.org

Technical content reviewed by the Centers for Disease Control and Prevention

(name of practice or clinic)

(Page 1 of 2)

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Purpose: To reduce morbidity and mortality from pneumococcal disease by vaccinating all children and teens who meet the criteria established by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate children and teens who meet any of the criteria below.

Procedure 1. Identify children and teens ages 2 years and older in need of a first dose of pneumococcal polysaccharide vaccine (PPSV)

based on having any of the following conditions: a. chronic cardiovascular disease (e.g., cyanotic heart disease, cardiac failure, cardiomyopathies) b. chronic pulmonary disease (e.g., emphysema or chronic obstructive pulmonary disease [not asthma]) c. diabetes, alcoholism, chronic liver disease (cirrhosis), or cerebrospinal fluid leaks d. functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) e. immunocompromising condition (e.g., HIV infection, congenital immunodeficiency, hematologic and solid tumors) f. immunosuppressive therapy (e.g., alkylating agents, antimetabolites, long-term systemic corticosteroids, radiation therapy) g. organ or bone marrow transplantation h. chronic renal failure or nephrotic syndrome i. candidate for or recipient of cochlear implant

2. Identify children and teens who were vaccinated at least 5 years earlier with PPSV and who are at highest risk for serious pneumococcal infection or are likely to have a rapid decline in pneumococcal antibody levels (i.e., categories d–h above) and are in need of a second dose of PPSV.

3. Screen all patients for contraindications and precautions to PPSV: a. Contraindications: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of PPSV or to a PPSV

vaccine component. For a list of vaccine components, go to www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf. A child who has received pneumococcal conjugate vaccine (PCV) previously should wait at least 2 months before receiving PPSV.

b. Precautions: moderate or severe acute illness with or without fever

4. Provide all patients (parent/legal representative) with a copy of the most current federal Vaccine Information Statement (VIS). Although not required by federal law, it is prudent to document in the patient’s medical record or office log, the pub-lication date of the VIS and the date it was given to the patient (parent/legal representative). Provide non-English speaking patients with a copy of the VIS in their native language, if available. These can be found at www.immunize.org/vis.

5. Administer 0.5 mL PPSV vaccine intramuscularly in the anterolateral thigh for toddlers age 24–35 mos (deltoid may be used if adequate muscle mass) or in the deltoid muscle of the arm for children ages 3 yrs and older (anterolaterial thigh muscle may be used if deltoid is inadequate). Use a 22–25 g needle. Choose needle length appropriate to the child’s age and body mass: 24–35 mos: 1–11/4" (anterolateral thigh) or 5/8–1" (deltoid muscle); children 3–18 yrs: 5/8–1" (deltoid) or 1–11/4" (an-terolateral thigh). A 5/8" needle may be used in toddlers and children if inserted in the deltoid muscle at 90° angle to the skin which is stretched flat between the thumb and forefinger. PPSV may also be given subcutaneously (23–25 g, 5/8" needle) in the posterolateral fat of the upper arm.

6. Document each patient’s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and

route, and the name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal).

b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic.

7. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications.

8. Report all adverse reactions to PPSV to the federal Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov or by calling (800) 822-7967. VAERS report forms are available at www.vaers.hhs.gov.

This policy and procedure shall remain in effect for all patients of the _____________________________ untilrescinded or until ___________________ (date).

Medical Director’s signature:____________________________________ Effective date:__________________


Standing Orders for Administering Pneumococcal Polysaccharide Vaccine to Children & Teens

www.immunize.org/catg.d/p3075a.pdf • Item #P3075a (2/09)


Technical content reviewed by the Centers for Disease Control and Prevention, February 2009.


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Purpose: To reduce morbidity and mortality from pneumococcal disease by vaccinating all adults who meet the criteria established by the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices.

Policy: Under these standing orders, eligible nurses and other healthcare professionals (e.g., pharmacists), where allowed by state law, may vaccinate adults who meet any of the criteria below.

Procedure 1. Identify adults in need of vaccination with pneumococcal polysaccharide vaccine (PPSV23) based on the following criteria: a. Age 65 years or older with no or unknown history of prior receipt of PPSV b. Age 64 years or younger with no or unknown history of prior receipt of PPSV and any of the following conditions: i. cigarette smoker ii. chronic cardiovascular disease (e.g., congestive heart failure, cardiomyopathies) iii. chronic pulmonary disease (e.g., chronic obstructive pulmonary disease, emphysema, asthma) iv. diabetes mellitus, alcoholism or chronic liver disease (cirrhosis), v. candidate for or recipient of cochlear implant; cerebrospinal fluid leak vi. functional or anatomic asplenia (e.g., sickle cell disease, splenectomy) vii. immunocompromising condition (e.g., HIV infection, congenital immunodeficiency, hematologic and solid tumors) viii. immunosuppressive therapy (e.g., alkylating agents, antimetabolites, long-term systemic corticosteroids, radiation therapy) ix. organ or bone marrow transplantation; chronic renal failure or nephrotic syndrome

2. Identify adults in need of an additional dose of PPSV23 if 5 or more years have elapsed since the previous dose of PPSV and the patient meets one of the following criteria: a. Age 65 years or older and received prior PPSV vaccination before age 65 years b. Age 64 years or younger and at highest risk for serious pneumococcal infection or likely to have a rapid decline in pneumococcal antibody levels (i.e., categories 1.vi.-ix. above)

3. Identify adults age 19 years and older in need of vaccination with pneumococcal conjugate vaccine (PCV13) who are at highest risk for serious pneumococcal infection or likely to have a rapid decline in pneumococcal antibody levels (i.e., categories 1.v.–1.ix. above).

4. Screen all patients for contraindications and precautions to pneumococcal vaccine:a. Contraindication: a history of a serious reaction (e.g., anaphylaxis) after a previous dose of pneumococcal vaccine (PPSV or PCV) or

to a vaccine component. For a list of vaccine components, go to www.cdc.gov/vaccines/pubs/pinkbook/downloads/appendices/B/excipient-table-2.pdf.

b. Precaution: moderate or severe acute illness with or without fever

5. Provide all patients with a copy of the most current federal Vaccine Information Statement (VIS). Although not required by federal law, it is prudent to document in the patient’s medical record or office log, the publication date of the VIS and the date it was given to the patient. Provide non-English speaking patients with a copy of the VIS in their native language, if available; these can be found at www.immunize.org/vis.

6. Administer vaccine as follows:

a. For adults identified in 1. and 2. above, administer 0.5 mL PPSV23 vaccine either intramuscularly (22–25g, 1–1½" needle) in the deltoid muscle or subcutaneously (23–25g, 5/8" needle) in the posterolateral fat of the upper arm.

b. For adults identified in 3. above, administer 0.5 mL PCV13 intramuscularly (22–25g, 1–1½" needle) in the deltoid muscle. For adults previously vaccinated with PPSV, give PCV13 at least 12 months following PPSV. If not previously vaccinated with PPSV, give PCV13 first, followed by PPSV23 in 8 weeks.

(Note: A 5/8" needle may be used for IM injection for patients who weigh less than 130 lbs [<60kg] for injection in the deltoid muscle, only

if the subcutaneous tissue is not bunched and the injection is made at a 90-degree angle.)

7. Document each patient’s vaccine administration information and follow up in the following places: a. Medical chart: Record the date the vaccine was administered, the manufacturer and lot number, the vaccination site and route, and the

name and title of the person administering the vaccine. If vaccine was not given, record the reason(s) for non-receipt of the vaccine (e.g., medical contraindication, patient refusal).

b. Personal immunization record card: Record the date of vaccination and the name/location of the administering clinic.

8. Be prepared for management of a medical emergency related to the administration of vaccine by having a written emergency medical protocol available, as well as equipment and medications.

9. Report all adverse reactions to PPSV23 and PCV13 to the federal Vaccine Adverse Event Reporting System (VAERS) at www.vaers.hhs.gov or by calling (800) 822-7967. VAERS report forms are available at www.vaers.hhs.gov.

This policy and procedure shall remain in effect for all patients of the_____________________________________ until rescinded or until __________________ (date).

Medical Director’s signature: _______________________________________ Effective date: _____________________

Standing Orders for Administering Pneumococcal (PPSV23 and PCV13) Vaccine to Adults

www.immunize.org/catg.d/p3075.pdf • Item #P3075 (8/12)



Technical content reviewed by the Centers for Disease Control and Prevention,.


12

IMMUNIZATION ENCOUNTER FORM

template is courtesy of Hartzell ‘s Pharmacy, Catasauqua, PA

Patient Name: DOB:

CATEGORY Billing Code

Diagnosis or Quantity

FEE / Copay

Vaccine Clinic – Vaccine Fees

□ Hepatitis A vaccine, adult dosage, for intramuscular use 90632 V05.3

□ Hepatitis B vaccine, adult dosage, for intramuscular use 90746 V05.3

□ Hepatitis A and hepatitis B (Twinrix), adult dosage, for intramuscular use 90636 V05.3

□ Zoster (shingles) vaccine, live, for subcutaneous injection 90736 V04.89

□ Human Papilloma virus (HPV) vaccine, types 6, 11, 16, 18 (quadrivalent) 3 dose schedule, for intramuscular use

90649 V04.89

□ Influenza virus vaccine, split virus, for use in individuals 3 years of age and above, for intramuscular use

90658 V04.81

□ Influenza virus vaccine, split virus, preservative free, for use in individuals 3 years of age and above, for intramuscular use

90656 V04.81

□ Influenza virus vaccine, live, for intranasal use 90660 V04.81

□ Influenza virus vaccine, split virus, preservative free, enhanced immunogenicity via increased antigen content, for intramuscular use (high dose seasonal)

90662 V04.81

□ Meningococcal conjugate vaccine, serogroups A, C, Y and W‐135 (tetravalent), for intramuscular use

90734 V03.89

□ M‐M‐R (Measles, Mumps, Rubella) 90707 V06.4

□ Pneumococcal polysaccharide vaccine, 23‐valent, adult or immunosuppressed patient dosage, for use in individuals 2 years or older, for subcutaneous or intramuscular use

90732 V03.82

□ Poliovirus vaccine, inactivated, (IPV), for subcutaneous or intramuscular use 90713 V040.0

□ Tetanus and diphtheria toxoids (Td) adsorbed, preservative free, for use in individuals seven years or older, for intramuscular use

90714 V06.5

Tetanus, diphtheria toxoids and acellular pertussis vaccine (Tdap), for use in individuals 7 years or older, for intramuscular use

90715 V06.1

□ Typhoid vaccine, Vi capsular polysaccharide (ViCPs), for intramuscular use 90691 V03.1

Vaccine Clinic ‐ Administration Fees

□ Administration by subcutaneous or intramuscular route (initial) 90471

□ Administration by subcutaneous or intramuscular route (each additional) 90472

□ Administration by oral or intranasal route (initial) 90473

□ Administration by oral or intranasal route (each additional) 90474

Summary of Services Provided

Provider: Date of Service:

Total Patient Charge:

Amount Paid:

Total Due:

Please note that Medicare does not utilize some CPT billing codes and hence are not indicated on this sheet:

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