U.S. Public Health Service Scientific and Training Symposium

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U.S. Public Health ServiceScientific and
Training Symposium

• Pharmacy Category Day
• June 5, 2007

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A Community PharmacyImmunization Program

• Brad Welage, Pharm.D.
• The Kroger Co.
• Cincinnati, OH

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Objectives

• Importance of accessible vaccines in the
  community
• Challenges to implementation of a company-wide
  immunization program
• Practical strategies for improving immunization
  rates

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Importance of Vaccines

• One of the greatest public health achievements of
  the 20th century
• Prevent disability and death from infectious
  diseases for individuals
• Control the spread of infections within
  communities

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Importance of Vaccines

• Eradication/near-elimination of many devastating
  diseases in the U.S. and the world
• Smallpox
• Polio
• Measles, mumps and rubella

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Importance of Vaccines

• In the U.S., many doctors have never seen these
  diseases first-hand
• This is a "testament to the success of
  vaccinations
• Dr. Lance Rodewald, CDC Director of Immunization
  Services
• Can make diagnosis difficult if disease does
  appear

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Importance of Vaccines

• In the U.S., the publics perception of a
  diseases threat fades as the disease disappears
• In other parts of the world, many of these
  diseases are still widespread
• With our mobile society, diseases can easily
  return to the U.S. in the absence of vaccination

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Importance of Vaccines

• An individuals decision to NOT vaccinate can put
  an entire community at risk
• Continued protection from these diseases requires
  
• Persuasion of the public health authority
• A community effort

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Healthy People 2010

• An initiative to identify the most significant
  preventable threats to health
• Focus efforts to address these threats
• Goals
• Increase the quality and years of healthy life
• Eliminate health disparities

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Healthy People 2010

• Provides a set of 10-year, evidence-based
  objectives for improving the health of all
  Americans
• Ten Leading Health Indicators reflect the major
  health concerns in the U.S. at the beginning of
  the 21st century
• 28 Focus Areas with specific objectives for
  improving health

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Healthy People 2010

• Immunization
• One of the ten Leading Health Indicators
• Immunization and Infectious Diseases
• One of the 28 Focus Areas/Objectives

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Healthy People 2010

• Immunization goal
• Prevent disease, disability, and death from
  infectious diseases, including vaccine-preventable
  diseases
• Immunization strategies
• Improve the quality and quantity of vaccination
  delivery systems
• Increase community participation, education and
  partnership
• Improve monitoring of disease and vaccination
  coverage

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Healthy People 2010

• Some diseases once considered practically
  eradicated have re-emerged in recent years
• New infectious agents and diseases are being
  detected
• Infectious diseases remain major causes of
  illness, disability, and death

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Influenza and Pneumococcal Disease

• Influenza
• Infects 5-20 of the U.S. population annually
• 36,000 deaths per year
• 200,000 hospitalizations per year
• Pneumonia
• 30,000 deaths per year
• 175,000 hospitalizations per year

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Influenza and Pneumococcal Disease

• Combined, influenza and pneumonia are the
• 8th leading cause of death in people of all ages
• 7th leading cause of death in people ages 65
• Influenza causes more morbidity and mortality
  than all other vaccine-preventable diseases
  combined

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Influenza and Pneumococcal Disease

• An increasing number of adults are at risk
• Aging population
• Increasing number of persons with high-risk
  conditions
• Medicare costs for influenza-related
  hospitalizations
• Approximately 1 billion per year

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Influenza and Pneumococcal Disease

• Healthy People 2010 specific immunization
  objective
• Increase the proportion of adults who are
  vaccinated annually against influenza, and who
  are ever vaccinated against pneumococcal disease,
  to 90

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Influenza and Pneumococcal Disease

• Methods to accomplish this goal
• Implement Standing Orders for vaccination
• Increase vaccination outside of primary care and
  other traditional health care settings
• Improve tracking and communication of
  vaccinations

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Pharmacy and Immunizations

• In early 1990s, the American Pharmacists
  Association (APhA) reported that pharmacists
  interventions in one year
• Increased influenza vaccination rates 74
• Saved Medicare 280,000
• Prevented 139 hospitalizations, 63 deaths
• per 100,000 enrollees

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Pharmacy and Immunizations

• In 1996, the APhA House of Delegates passed
  policy that supported pharmacist involvement in
  vaccine administration and in improving
  immunization rates

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Pharmacy and Immunizations

• APhA Guidelines for Pharmacy-Based Immunization
  Advocacy (1997)
• Prevention Pharmacists should protect their
  patients health by being vaccine advocates
• Educate, facilitate, and/or administrate
• Focus efforts on diseases that are the most
  significant sources of preventable mortality
• Determine immunization status of patients
• Identify high-risk patients

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Pharmacy and Immunizations

• APhA Guidelines for Pharmacy-Based Immunization
  Advocacy (continued )
• Partnership administer immunizations in
  partnership with the community
• Quality achieve and maintain competence to
  administer
• Documentation fully document immunizations and
  report any significant events
• Empowerment educate patients and respect
  patients rights

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Pharmacy and Immunizations

• In 1998, APhA received CDC recognition for their
  educational program, Pharmacy-Based Immunization
  Delivery A National Certificate Program for
  Pharmacists
• Clinical and practical development guidelines for
  preparing and implementing immunization programs
  in a pharmacy setting

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Pharmacy and Immunizations

• Pharmacists can make significant contributions to
  improving immunization rates, especially in adult
  populations
• Assist the CDC and public health officials in
  increasing vaccine delivery by expanding sites
  where vaccines are available using existing
  infrastructure and health care personnel
• Reduce associated morbidity and mortality
• Decrease associated health care costs

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Pharmacy and Immunizations

• Currently, 44 states allow pharmacists to
  administer vaccinations
• Often limited to specific, common vaccines and
  certain age groups
• Influenza, pneumonia, hepatitis
• Adults 18 and older

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Pharmacy and Immunizations

• Pharmacists must complete a certified training
  course in immunization delivery
• APhA, state pharmacy associations, pharmacy
  colleges, employer, etc.

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Pharmacy and Immunizations

• Courses must meet specific criteria
• Immunology review
• Disease-associated morbidity and mortality
• Vaccine-specific indications, target populations,
  contraindications, precautions, dosing schedule,
  route of administration, etc.
• Administration technique intramuscular,
  subcutaneous, intranasal
• Product storage and handling
• Safety
• Emergency training allergic reactions, basic
  life support (CPR)
• OSHA, accidental needlestick, VAERS

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Pharmacy and Immunizations

• Pharmacists practice under an established
  protocol and a physicians Standing Order or
  Collaborative Practice Agreement
• Pharmacists maintain documentation and provide
  notification back to patients primary care
  provider

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Pharmacy and Immunizations

• Pharmacist must evaluate a particular vaccine to
  determine its appropriateness for each patient
• Is the patient in the recommended high-risk
  category?
• Is the patient in the recommended age range?
• What is the patients vaccination history?

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Pharmacy and Immunizations

• Ohio pharmacy legislation 2001
• Pharmacy Practice Act permitted pharmacists
  certified in immunization delivery to provide
  influenza, pneumonia, hepatitis and tetanus
  vaccines to adults

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Pharmacy and Immunizations

• Ohio pharmacy legislation 2007
• Updates include addition of diphtheria, pertussis
  and meningococcal vaccines influenza vaccine
  administered to people ages 14 influenza
  vaccine administered by certified pharmacy
  interns notification of PCP for all vaccines
  administered other than influenza
• Passed House and Senate, awaiting Governors
  signature

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ChallengesPharmacists Willingness

• Reasons for initial resistance
• Im too busy.
• Not enough staff.
• Will interrupt our work flow.
• Im not a nurse.
• This is not what I went to school for.
• I dont like needles.
• Im afraid Ill hurt someone.

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ChallengesTime Constraints

• In 2005, retail pharmacies in the U.S. filled
  nearly 3.2 billion prescriptions
• Patient counseling
• HIPAA constraints
• Educate patients on Medicare Part D and many 3rd
  party payer plans, formularies
• Medication Therapy Management, Disease State
  Management, etc.

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ChallengesMarketing

• Determine most effective way to advertise this
  new service
• Appropriate use of funds
• Target high-risk population and others most
  affected by influenza disease

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ChallengesPublics Perception

• Initially, some apprehension
• Youre not a nurse.
• My doctor gives me all of my shots.
• Are pharmacists allowed to do this?
• I dont need/want a vaccine.

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ChallengesOpposition From Other Providers

• Youre interfering with the patient/doctor
  relationship.
• Youre taking jobs away from nurses.
• Pharmacists dont know enough about medications.

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ChallengesReimbursement

• Obtain Medicare Mass-Immunizer Provider Number
• Anticipate sufficient rates to cover all
  associated costs
• Determine appropriate price for cash-paying
  customers
• May not charge less than what is submitted to
  Medicare
• Wait for Medicare reimbursement funds

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ChallengesReimbursement

• Collect complete, accurate patient information at
  time of service
• Proof of Medicare Part B coverage, but lack of
  Medicare HMO coverage
• Name
• Date of birth
• Medicare I.D. number
• Medicare help desk unable to supply information
  to pharmacy to expedite processing

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ChallengesDocumentation

• Paper and electronic record keeping
• Much data to organize and retain
• Notifying patients physician
• Faxing, phoning or mailing very time-consuming
  and costly
• Board of Health for those without a PCP

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ChallengesSupplies

• Sufficient vaccine product in stock when needed
• Even when ordered early, vaccine shipping dates
  and quantities are subject to change
• Seasonal demand, limited timeframe for
  administration
• Syringes, gloves, paperwork

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ChallengesWorkflow

• Education of all staff to manage patient
  questions and issues
• When to offer vaccinations
• Limit to designated clinic days and times
• Integrate into daily prescription-filling
  activities

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Kroger PharmacyWho We Are

• Largest grocery chain in U.S.
• Operating under several different names
• Cincinnati Division
• Over 100 locations with pharmacies
• Located in greater Cincinnati, Dayton,
  Springfield, Northern Kentucky, and south-eastern
  Indiana areas
• Over 300 pharmacists
• The first chain pharmacy in this area to offer
  pharmacist-administered immunizations

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Kroger PharmacyImmunization Beginnings

• Prior to 2001
• Hosted nurse-administered influenza and pneumonia
  vaccination clinics periodically during flu
  season
• In 2001
• Only a few pharmacists certified for
  immunizations through APhA
• Traveled daily, different locations each day
• Visited over half of our locations
• Administered limited number of influenza vaccine
  doses at each of those locations approximately
  16,000 doses total
• Advertised within stores, local newspapers and
  weekly store ads

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Kroger Pharmacy Immunization Accomplishments

• In 2006
• All of our pharmacists are now certified in
  immunization administration
• During each of the last two flu seasons,
  administered over 100,000 influenza vaccinations
  and approximately 5000 pneumonia vaccinations

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Kroger Pharmacy Immunization Accomplishments

• Other health care providers refer patients to
  pharmacy
• Patients begin questioning us for flu
  appointments in late summer
• Recognized as the destination for flu shots
• Continue to advertise within stores, local
  newspapers and weekly store ads

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Kroger Pharmacy Overcoming Pharmacists
Willingness

• Decision by pharmacy management to certify all
  pharmacists in immunization administration
• Necessary to offer consistent vaccine access
  within all locations in all communities
• Initially time-constraining to staff pharmacy
  while pharmacists participated in certification
  course
• Offered multiple re-training and practice
  opportunities in improve pharmacist comfort level

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Kroger Pharmacy Overcoming Pharmacists
Willingness

• Pharmacists who were initially hesitant and
  skeptical now enjoy the additional hands-on
  patient care aspect
• Now considered just part of our job
• In recent focus groups, immunizations listed as a
  positive aspect of working as a pharmacist for
  Kroger sets us apart from other community
  pharmacies

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Kroger Pharmacy Overcoming Pharmacists
Willingness

• All newly-hired pharmacists are trained in
  immunization delivery
• Kroger-modified course approved by Ohio State
  Board of Pharmacy
• Course offered on as-needed basis
• Pharmacy students are certified as part of
  pharmacy curriculum
• Refresher courses prior to flu season

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Kroger PharmacyOvercoming Time Barriers

• Decision to offer majority of influenza vaccines
  by appointment, especially at beginning of flu
  season
• Specified clinic days and times
• Includes evenings and weekends
• Appointment intervals set to allow time for
  screening, counseling, reimbursement
  documentation, administration, etc.
• Time-consuming for entire staff to perform
  scheduling activities
• Negatively affected normal pharmacy business

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Kroger PharmacyOvercoming Time Barriers

• Walk-in vaccines are administered on as-needed
  basis at pharmacists discretion
• Can be disruptive to workflow
• Only one pharmacist on duty
• Customer presents during busiest part of day
• Act in best interest of the patient

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Kroger PharmacyOvercoming Time Barriers

• Now outsource our telephone appointments to a
  national answering service
• Uses a toll-free 1-800 telephone number
• Promoted in all of our marketing materials
• Appointments made on-line based on clinic
  schedules provided by Kroger
• Answering service operators and our staff have
  access to appointments at on-line, real-time
  website
• Has dramatically reduced pre-season work load
• Allows pharmacists to better serve patients

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Kroger Pharmacy Overcoming Publics Perception

• Vaccine administration presented as just a type
  of prescription drug dispensing
• Customers soon became comfortable receiving a
  shot from their pharmacist whom they knew by
  name
• Public appreciates the convenience of receiving
  this service at their local pharmacy

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Kroger Pharmacy Overcoming Opposition From
Other Providers

• Have been blamed for hoarding influenza
  vaccine, withholding from high-risk patients
• In reality, majority of people vaccinated at
  pharmacies are high-risk
• Many people would not have gone to physician just
  to receive vaccine, especially those not
  necessarily considered high-risk themselves
• Pharmacists comply with CDC guidelines to
  prioritize vaccine distribution during times of
  shortages/delays

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Kroger Pharmacy Overcoming Opposition From
Other Providers

• Pharmacists now recognized as another avenue for
  people to obtain influenza vaccination
• Actually a relief for physicians offices who
  were typically flooded with flu shot patients
• Allows physicians to focus on other seasonal
  illnesses
• Felt it was unnecessary to receive notification
  of every influenza vaccine administered

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Kroger Pharmacy Overcoming Reimbursement
Challenges

• Pharmacists not recognized as providers by
  Medicare HMO plans, employers third party plans
• Vaccines considered a medical benefit rather
  than a pharmacy benefit
• Paper claims slow, cause delay in reimbursement
  time
• Uncertain accuracy of information submitted

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Kroger Pharmacy Overcoming Reimbursement
Challenges

• Medicare billing now performed on-line, similar
  to all other prescriptions
• Assures that accurate information is obtained at
  time of service
• Guarantees reimbursement
• Provides faster time for reimbursement
• Assists with patients vaccination history
• Contract with one local Medicare HMO plan

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Kroger Pharmacy Overcoming Reimbursement
Challenges

• Recent increases in Medicare reimbursement rates
  for vaccine administration help to offset our
  costs
• Recognizes our efforts to provide this service to
  the public
• Allows pharmacists to continue to offer similar
  services

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Kroger Pharmacy Overcoming Supply Challenges

• All Kroger divisions offer influenza
  immunizations
• Our large demand for vaccine supply caught
  attention of vaccine manufacturers
• Work directly with designated account managers to
  handle supply and shipping issues
• Our order is placed early in the year (March,
  April) for later that season
• Work closely with supplier to determine shipping
  dates, and quantity of each shipment

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Kroger PharmacyContinuing Challenges

• Keep all staff and personnel educated of new
  immunization guidelines
• Many assume that pharmacists can now administer
  any and all vaccines
• Regulations vary between states
• Continue involvement with local and state
  legislature
• Gain recognition for our accomplishments
• Collaborate with other medical boards
• Support changes in regulations that may expand
  our role to further benefit the public

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Improving Immunization Rates

• Each year, more Americans are vaccinated for
  influenza than for any other disease
• Despite product shortages and delays, millions of
  people are vaccinated within a short time period
  each year
• Health care workers and the public have acted
  responsibly in targeting vaccine to those who
  need it most in times of shortage

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Improving Immunization Rates

• National influenza and pneumococcal vaccination
  rates for all people ages 65
• 1998
• Influenza 64
• Pneumococcal 46
• 2005
• Influenza 65.5
• Pneumococcal 65.7
• Healthy People 2010 goal 90

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Improving Immunization Rates

• Of the more than 185 million persons recommended
  for annual influenza vaccine, fewer than half are
  vaccinated

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StrategiesEducate Public

• Target high-risk groups
• Emphasize benefits
• Dispel myths
• Reinforce appropriate time frame

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StrategiesEducate Public

• Leading self-reported reasons for not receiving
  influenza vaccination among Medicare
  beneficiaries ages 65
• Didnt know it was needed.
• Could cause influenza.
• Could cause side effects.
• Didnt think it would prevent influenza.
• Didnt think of it/missed/forgot.
• Vaccine shortage/not available.

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StrategiesEducate Public

• Leading self-reported reasons for not receiving
  influenza vaccination among Medicare
  beneficiaries ages 65 (continued )
• Not at risk of getting influenza.
• Dont like shots or needles.
• Doctor recommended against.
• Doctor didnt recommend.
• Unable to get to location.

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StrategiesEducate Public

• All health care providers should offer a
  consistent message of vaccine necessity at every
  health care encounter
• Pharmacy counter
• Physician check-ups
• Lab work, tests
• Hospital stays
• E.R. visits

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StrategiesEducate Public

• Patients may need to hear the same message
  several times from several sources before they
  consider it to be relevant
• Community groups
• Senior centers
• Churches
• Schools
• Employers
• Grocery stores, shopping malls
• Public service messages through news media

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Strategies Vaccinate Health Care Workers

• Current influenza immunization rates are 43
  among health care providers
• Source of influenza in high-risk patient care
  settings organ transplant units, long-term care
  facilities, neonatal ICU
• Continue to work with flu symptoms, thus exposing
  co-workers and patients
• Feel need or pressure to perform vital
  tasks/sense of irreplaceability

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Strategies Vaccinate Health Care Workers

• Reasons for avoiding influenza vaccine are
  similar to general public
• Misconception that vaccine causes illness
• Perception of low personal risk
• Inconvenience
• Ignorance of CDC recommendations
• Dislike of needles

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StrategiesVaccinate Health Care Workers

• Health care employers must demonstrate vaccine
  priority
• Commit resources
• Educate employees
• Remove barriers access, costs

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StrategiesVaccine Supply

• A sufficient and predictable influenza vaccine
  supply is critical for a successful prevention
  program
• Over 100,000 million doses available last season
• Uncertainties jeopardize the ability to plan and
  make program improvements
• Shipping dates and projected amounts often
  fluctuate at the last minute

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StrategiesVaccine Supply

• Current production capacities are insufficient to
  support an increase in vaccine demand
• Promote expansion of production technologies
• Provide incentives for manufacturers to increase
  the supply and availability of vaccines

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StrategiesVaccine Supply

• However, even when vaccine supply is adequate,
  there is no evidence of a trend toward higher
  vaccine coverage

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StrategiesVaccine Supply

• Make influenza vaccine purchase less of a
  financial burden and risk for providers
• Providers concerned about cost of purchasing and
  administering influenza vaccine
• Often left with un-used, un-returnable product

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StrategiesReimbursement

• Health plan reimbursement rates should be
  adequate to cover all associated costs
• Vaccine product
• Administration
• Documentation, billing
• Staff support

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Strategies Incorporate Other Healthy People
2010 Objectives

• Immunization-related goals beyond influenza and
  pneumonia
• Maintain current childhood vaccination rates
• Improve adolescent and adult vaccination rates
  for meningococcal disease, TDaP, hepatitis A and
  hepatitis B, etc.
• Recommend new vaccines, including shingles and
  cervical cancer

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Strategies Incorporate Other Healthy People
2010 Objectives

• Health Communication
• Goal Use communication strategically to improve
  health, including building and using the
  information infrastructure
• Improve communication and transfer of patient
  data among health care providers

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Strategies Incorporate Other Healthy People
2010 Objectives

• Public Health Infrastructure
• Goal Ensure that health agencies have the
  infrastructure to provide essential public health
  services effectively

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Strategies Incorporate Other Healthy People
2010 Objectives

• Access to Quality Health Services
• Goal Improve access to comprehensive,
  high-quality health care services

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Community Pharmacy Immunization Programs

• Pharmacists are ideally positioned to increase
  immunization rates
• Visible, knowledgeable health care professionals
• Vaccine advocates, educators, and administrators

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Community PharmacyImmunization Programs

• Pharmacists are one of the most accessible health
  care professionals
• Increase convenience of vaccine administration
  within communities
• Pharmacists are one of the most trusted
  professions
• Increase public education, vaccine advocacy

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• Questions?