Creating an Immunization Niche in the Community Pharmacy Module 4: Communication and Counseling The Patient s Immunization Experience Jonathan G. Marquess, PharmD, CDE, CDM Learning Objectives Discuss the set up of the administration area for a vaccine practice. List and discuss proper questions to have vaccination patients complete prior to receiving a vaccination Discuss counseling and storage tips for 3 commonly given vaccinations Review appropriate pharmacy procedure following patient vaccination 1
Pre-Assessment Question #1 There is a legal requirement in a vaccine niche to: A. Have the patient sign a release or waiver. B. Distribute a vaccination information statement C. Keep the patient under observation for 30 minutes following immunization D. All of the above Correct Answer There is a legal requirement in a vaccine niche to: B. Distribute a vaccination information statement 2
Pre-Assessment Question #2 The vaccine administration area must be a certain size and have particular requirements by law. A. True B. False Correct Answer The vaccine administration area must be a certain size and have particular requirements by law. B. False 3
Pre-Assessment Question #3 Pharmacists in most states are restricted from giving immunizations to which population group: A. Adults B. Pediatric patients C. Nursing home residents D. None of the above Correct Answer Pharmacists in most states are restricted from giving immunizations to which population group: D. None of the above 4
Creating a Patient-Focused Immunization Area Creating a Patient-Focused Immunization Area Administration area Vaccination counseling information 5
Administration Area Identify a location in your pharmacy where patient privacy can be maintained Seated area (chair with arms) is preferred A small worktable is also helpful For vaccine events, a waiting area is preferable Picture of Administration Area 6
First Impressions Greeting the patient Staff should be assigned to greet the patient and direct them to the immunization area Staff should be prepared to answer any questions Have patient complete patient intake form Patient Intake Form Give your patients a detailed form to assess patient health status Form should contain Primary care physician contact information Any allergies etc. Patient should read it over and sign prior to immunization Staff should identify any problems and discuss 7
Sample Patient Intake Form Vaccine Information 8
Two Types of Vaccines Live Attenuated Produced by modification of wild virus or bacteria Has ability to replicate and produce immunity Usually does not cause disease Effective with one dose; exception oral live attenuated vaccines Can cause severe or fatal reactions Inactivated Produced by growing then inactivating virus or bacteria with heat or chemicals Are not alive, therefore, cannot replicate Require multiple doses and boosters Routine Adult Community Pharmacy Vaccines The Flu Shot - Influenza Shingles - Herpes Zoster Pneumonia - Pneumococcal 9
Trivalent Inactivated Influenza Vaccine (TIV) Overview Regimen: Yearly administration for all persons > 6 months Administration: IM Shelf life: Formulated for use during current influenza season only Storage: Refrigerate immediately upon arrival Do NOT freeze Trivalent Inactivated Influenza Vaccine (TIV) Counseling Tips Preferred influenza vaccine for pregnancy and many underlying medical conditions Contraindications: Previous anaphylaxis to this vaccine or to eggs Precautions: Moderate or severe illness History of Guillain-Barré syndrome within six weeks of previous influenza vaccination 10
Guillain-Barré Syndrome (GBS) Neurologic disorder involving inflammatory demyelination of peripheral nerves Characterized by the following: Symmetrical weakness in the legs and arms, with loss of reflexes Sensory abnormalities Involvement of cranial nerves Paralysis of respiratory muscles also can occur 11
Live Attenuated Influenza Vaccine (LAIV) Overview Regimen: Yearly administration for all persons > 2 years old Administration: Each pre-filled nasal syringe contains 1 dose Deliver ½ dose into each nostril Shelf life: Formulated for use during current influenza season only Storage: Refrigerate immediately upon arrival Do NOT Freeze LAIV Administration 12
Live Attenuated Influenza Vaccine (LAIV) Counseling Tips Contraindications: Previous anaphylaxis to this vaccine or to eggs Contraindicated in pregnancy, pulmonary or cardiovascular disease, diabetes, asthma and many other underlying medical conditions Precautions Moderate or severe illness History of Guillain-Barré syndrome within six weeks of previous influenza vaccination 13
Zoster (Shingles) Overview Regimen: Single dose for adults > 60 years old Administration: SC - deltoid region of the upper arm, if possible Storage: Freeze immediately upon arrival Zoster (Shingles) Counseling Tips Not for use in the treatment of active zoster outbreak or postherpetic neuropathy (PHN) Contraindications: Hypersensitivity to vaccine components Anaphylactoid or hypersensitivity reactions to neomycin or gelatin Immunosuppression Precautions: Acute illness 14
Pneumococcal Polysaccharide Vaccine (PPV) Overview Regimen: Variable depending on health status Administration: IM or SC Storage: Refrigerate immediately upon arrival Do NOT freeze 15
PPV Counseling Tips Contraindications: Previous anaphylaxis to this vaccine or to any of its components Precautions: Moderate or severe acute illness 16
Interactive Checkpoint Sally, a 65 year old woman, comes into your pharmacy for a zoster vaccine. When she completes her patient intake form, you notice an allergy to Neosporin. Should you proceed with administering the vaccine? A. Yes B. No C. Maybe Maybe Interactive Checkpoint If the prior allergy was contact dermatitis, it may be ok to administer this vaccine Consult Sally's physician prior to administration 17
Other Adult and Adolescent Vaccines Hepatitis A (HepA) Overview Regimen: One dose and one booster 6 to 18 months later Administration: IM into deltoid muscle of the arm Storage: Refrigerate immediately upon arrival Do NOT freeze 18
Hepatitis A Counseling Tips Contraindications: Hypersensitivity to vaccine or any of its components. Precautions: Hepatitis A has an incubation period of 15-20 days. The vaccine may not protect the individual if administered in this time period. 19
Hepatitis B (HepB) Overview Regimen: Doses are given at 0, 1, and 6 months Administration: IM into deltoid muscle of the arm Storage: Refrigerate immediately upon arrival Do NOT freeze Hepatitis B (HepB) Counseling Tips First dose is given at birth for children of all Hepatitis B + mothers or unknown status A patient is given the pediatric dose until age 19 Contraindications: Hypersensitivity to yeast Precautions: Multiple Sclerosis Immunosuppression All formulations are without preservative 20
Hepatitis A & Hepatitis B (HepA/HepB) Overview Regimen: 1ml doses Primary Immunization: doses at 0, 1 and 6 months Alternative Schedule: doses on days 0, 7, 21, and 30 with a booster dose at 12 months Administration: IM into deltoid muscle of the arm Storage: Refrigerate immediately upon arrival Do NOT freeze Shake well and do not dilute 21
HepA/HepB Counseling Tips Contraindications: Hypersensitivity to yeast or neomycin Precautions: Long incubation periods Tetanus, Diphtheria, & Acellular Pertussis (Tdap) Overview Regimen: One 0.5 ml Tdap and booster every 10 years up to age 64 Administration: IM into deltoid muscle of the arm Storage: Refrigerate immediately upon arrival Do NOT freeze Shake well 22
Tdap Counseling Tips Contraindications: Encephalopathy within 7 days of a previously administered Tdap vaccine with no other discernable cause Progressive neurological disorders, uncontrolled epilepsy or progressive encephalopathy Precautions: Within temporal relationship to previous Tdap dose: Fever over 105 F, inconsolable crying over 3 hours, or collapse or shock-like state within 48 hours Seizures within 3 days Guillain-Barré syndrome within 3 weeks Stable CNS disorder patients 23
Human Papillomavirus (HPV) Overview Regimen: Females ages 9-26 = 0.5 ml at 0, 2, and 6 months Administration: IM Storage: Refrigerate immediately upon arrival Do NOT freeze Human Papillomavirus (HPV) Counseling Provides protection against four strains of HPV Contraindications: Hypersensitivity to papillomavirus recombinant vaccine or any component of the formulation Precautions: Acute illness Bleeding disorders 24
Meningococcal Vaccine (MCV) Overview Regimen: Give one dose to adolescents age 11 through 18 years Administration: MCV4 (conjugate) - IM MPSV (polysaccharide) SC Storage: Refrigerate immediately upon arrival Do NOT freeze 25
MCV Counseling Tips Required vaccination for travel to many areas including Saudi Arabia during the annual Hajj Contraindications: Previous anaphylaxis to this vaccine or to any of its components, including diphtheria toxoid (for MCV4) Precautions: Moderate or severe acute illness. For MCV4 only: history of Guillain-Barré syndrome 26
Travel Vaccines Japanese Encephalitis Typhoid Fever Yellow Fever & More Travel Vaccine Documentation The CDC has released a new International Certificate of Vaccination or Prophylaxis (ICVP) This document is designed to fit into your passport 27
Travel Vaccines by Country CDC website provides an interactive world map to help determine which vaccines are recommended for various countries http://wwwn.cdc.gov/travel/destinationlist.aspx Japanese Encephalitis Overview Regimen: 3 dose series days 0, 7,and 30 Administration: SC Shelf life: Use within 8 hours Storage: Refrigerate immediately upon arrival Do NOT freeze Shake well 28
Japanese Encephalitis Counseling Tips Receive if: Reside or travel where endemic or epidemic Generally 1 month or longer stay Must receive last dose 10 days before travel. Stay in the area (no international travel) for 10 days post vaccination Not for infants < 1 year old Contraindications: Prior angioedema or urticaria to vaccine Hypersensitivity to thimerosal 29
Rabies Overview Regimen: 3 doses Dose 1 - as appropriate Dose 2 - seven days after dose 1 Dose 3-21 or 28 days after dose 1 Administration: IM Storage: Refrigerate immediately upon arrival Do NOT freeze Rabies Counseling Tips Preexposure vaccination is recommended for persons in high-risk groups, such as veterinarians, animal handlers, and certain laboratory workers Contraindications: Hypersensitivity to vaccine or component Developing febrile illness Precautions: Vaccination should be repeated after exposure with rabies immune globulin Bleeding disorders Immunocompromised patients 30
Typhoid Fever Overview Required: Travel to locations with recognized risk Intimate contact with infected individuals Microbiology lab workers Administration: IM PO Storage: Keep both versions in the refrigerator Do NOT freeze Must replace PO capsules into refrigerator after removing a capsule 31
Typhoid Fever Counseling Tips Typhim Vi IM Give 2 weeks prior to exposure Reimmunize in 2 years Contraindications: Hypersensitivity to components Precautions: Not protected against other types of Salmonella Not for chronic carriers Vilvotif PO 4 doses on days 1,3,5,&7 Complete 1 week prior to exposure Must give 1 hour pre-meal with cold/warm drink Contraindications: Hypersensitivity Immunosuppression Precautions: Acute GI illness No antibiotics or sulfonamides Postpone vaccine if patient has significant diarrhea or vomiting 32
Yellow Fever Overview Regimen: 0.5 ml for 9 months of age Re-immunization is required every 10 years Receive if: Yellow fever has been reported in area you are visiting. If you are traveling outside urban areas African countries may require May need certificate of vaccination to pass through other countries Administration: SC Must reconstitute. Will be orange in color. Do NOT shake! Swirl Instead to avoid air bubbles Shelf Life: Use within 60 minutes of reconstitution Does NOT contain a preservative Storage: Refrigerate immediately upon arrival Do NOT freeze Yellow Fever Counseling Tips Contraindications: Under 9 months Hypersensitivity to gelatin, eggs, or egg products Immunosuppresed Precautions: Do a scratch or intradermal test to determine if vaccine is okay if the patient is egg sensitive Corticosteriod therapy may decrease effect Asymptomatic HIV patients must document protective antibody response before traveling 33
Malaria Overview and Counseling Drugs used to prevent malaria (chemoprophylaxis) oral meds only! Chloroquine (Aralen ) Mefloquine (Lariam ) Atovaquone/Proguanil (Malarone ) Doxycyline Proguanil cannot be administered within 10 days of typhoid vaccine 34
Interactive Checkpoint Just as a refresher, which of the following vaccines is live? A. Pneumococcal polysaccharide vaccine B. Human Papillomavirus (HPV) Vaccine C. LAIV influenza vaccine D. Meningococcal vaccine Interactive Checkpoint LAIV influenza vaccine Remember when counseling your patients that they may produce a mild version of the flu. Exercise caution when around immunocompromised individuals because they could contract the disease. 35
Childhood Vaccines Childhood Vaccines Overview Some community pharmacist offer childhood vaccines in the community pharmacy Many pharmacists prefer the role of advocate for children 36
Vaccines for Children Hepatitis B Rotavirus Diphtheria, Tetanus, Pertussis (Dtap) Haemophilus influenzae type b (Hib) Pneumococcal conjugate Inactivated Poliovirus Influenza Measles, Mumps, Rubella (MMR) Varicella Hepatitis A Meningococcal Vaccines and Autism Some advocates claim that vaccines and thimersol cause autism Since 2001, with the exception of some influenza vaccines, thimerosal is not used as a preservative in routinely recommended childhood vaccines As of yet, there has been no decrease in autism rates 37
Interactive Checkpoint Mary brings in her daughter, Lauren aged 6 months, into the pharmacy for a prescription of amoxicillin suspension. What vaccines should you ask if Lauren has received? Interactive Checkpoint Hepatitis B, Rotavirus, DTaP, Hib, PCV, and IPV. Are they other vaccines that should be recommended today? 38
Interactive Checkpoint At six months, Lauren would be due for another round of rotavirus, DTaP, Hib, and PCV. Hepatis B, IPV and influenza are in the range also Vaccine Administration 39
Sites of Administration Subcutaneous (SC) MMR MPSV4 Varicella Zoster SC & IM PPV IPV Oral Rotavirus Intranasal LAIV Intramuscular (IM) All DTaP formulations Tdap Hib HepA HepA/HepB HepB Hib/HepB HPV TIV MCV4 PCV SC Needle Specs Use a 23-25 gauge needle Choose the injection site that is appropriate to the person s age and body mass Age Infants (1-12 months) Children (> 12 months), adolescents & adults Needle Length 5/8 5/8 Injection Site Fatty tissue over anterolateral thigh muscle Fatty tissue over anterolateral thigh muscle or fatty tissue over triceps 40
Age IM Needle Specs Needle Length Injection Site Newborn (1-28 days) Infant (1-12 months) Toddler (1-2 years) Children (3-18 years) >19 yrs (sex/weight) Male/Female < 130 lbs Female (130-200 lbs)/male (130-260 lbs) Female > 200 lbs/male > 260 lbs 5/8 1 1 1 ¼ 5/8 1 5/8 1 1 1 ¼ 5/8 1 1 1 ½ 1 ½ Anterolateral thigh muscle Anterolateral thigh muscle Anterolateral thigh muscle or deltoid muscle of arm Deltoid muscle of arm or anterolateral thigh muscle Deltoid muscle of arm Deltoid muscle of arm Deltoid muscle of arm Administration Sites Deltoid Muscle Anterolateral Thigh Muscle 41
Post Vaccination Patient Monitoring Post-Vaccination Make sure patient is aware that they will need to spend 15-20 minutes in the pharmacy following their vaccination Assign staff member to notify patients when their monitoring period has ended Notify patients that they can call pharmacy with questions or concerns after leaving the pharmacy 42
Possible Post-Vaccination Adverse Events Local reactions Redness Inflammation Pain at site of injection Muscle ache Contact dermatitis Systemic reactions Fever Malaise Fatigue Anaphylaxis Swelling Respiratory distress Itching Vomiting Hypotension Abdominal pain Possible Post-Vaccination Children Concerns Fever Reduce the fever by fluids, fever-reducing medication (not aspirin) and lukewarm baths Discomfort May be due to pain or fever Call pediatrician if persists more than 24 hours Swelling Apply a clean, cool, wet washcloth over the sore area for comfort Call pediatrician if persists more than 24 hours 43
Adverse Events When to Refer If side effect persist more than 24 hours, refer to primary care physician or pediatrician Patient Follow-Up Assess adverse events Physician Update vaccination records 44
Conclusion Giving vaccinations in your community pharmacy requires both front end intake procedures and good follow up You can have a vaccine niche that covers as little or as much as you are prepared to cover from flu to travel and adolescent vaccines Each vaccination has specific storage, handling and counseling requirements 45