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Minimum Ages & Intervals Clarified

The Oregon Immunization Program responded to a request to clarify the terms recommended and minimum in the standing orders and pharmacy protocols. The issue of spacing also came up for clarification.

Do you know the difference between the preferred (recommended) age and the (minimum) acceptable age, the preferred (recommended) spacing and the (minimum) acceptable spacing as noted in the Oregon Model Standing Orders for Immunization, the Oregon Pharmacy Protocols and the Centers for Disease Control and Prevention (CDC) Recommended Immunization Catch-up Schedules?

Look at this section from the HPV vaccine schedule:Capture.JPG- Dose and route 1

 

The Preferred Age and spacing are established by the manufacturer through vaccine safety trials and approved by the Advisory Committee on Immunization Practices (ACIP); a group of medical and public health experts from across the US. The ACIP determines preferred age, minimum acceptable age, preferred spacing and minimum acceptable spacing intervals based many factors, including the safety and effectiveness of a vaccine(s) and situational identifiers. The ACIP recommendations do not become policy until they are published in the Morbidity and Mortality Weekly Report (MMWR). The MMWR is the CDC’s primary vehicle for scientific publication of timely, reliable, authoritative, accurate, objective and useful public health information and recommendations.

For HPV the recommended age is 11-12 years, as this coincides with the adolescent well visit which allows plenty of time for clients to complete the 2-dose series before age 15.

The Minimum Acceptable Age and spacing are based on the expert opinion of the Advisory Committee on Immunization Practices (ACIP); which are used under exceptional circumstances whereas the preferred age and spacing are for the general population identified for a specific vaccine.

Once the MMWR is published these same recommendations are available in the Oregon Model Standing Orders for Immunization and Pharmacy Protocols.

The standing orders and pharmacy protocols are updated as soon as new recommendations are made by the ACIP. The full ACIP meets three times a year to review, discuss and vote on vaccine issues and recommendations. Subcommittees of the ACIP work throughout the year.

The CDC publishes childhood and adult guidelines and vaccine schedules annually.

Vaccinators should ensure that they are following the most current schedules from CDC.

When to use a shorter interval than Recommended Spacing1

Minimum Acceptable Spacing: Administration of a multidose vaccine series using intervals that are shorter than preferred might be necessary in certain circumstances, such as impending international travel or when a person is behind schedule on vaccinations but needs rapid protection. In these situations, an accelerated schedule can be implemented using intervals between doses that are shorter than intervals preferred for routine vaccination. The minimum acceptable spacing and ages for scheduling catch-up vaccinations are available at www.cdc.gov/vaccines/schedules/hcp/index.html. Vaccine doses should not be administered at intervals less than these minimum acceptable intervals or at an age that is younger than the minimum acceptable age.

There is one more exception to the minimum acceptable spacing and age and that is the 4-day rule or grace period.1

Vaccine doses administered ≤4 days before the minimum acceptable interval or age are considered valid; however, local or state mandates might supersede this 4-day guideline. Day 1 is the day before the day that marks the minimum acceptable age or minimum acceptable interval for a vaccine. Because of the unique schedule for rabies vaccine, the 4-day guideline does not apply to this vaccine. Doses of any vaccine administered ≥5 days earlier than the minimum acceptable interval or age should not be counted as valid doses and should be repeated as age appropriate. The repeat dose should be spaced after the invalid dose by the minimum acceptable interval.

If the first dose in a series is given ≥5 days before the minimum acceptable age, the dose should be repeated on or after the date when the child reaches at least the minimum acceptable age. If the vaccine is a live vaccine, ensuring that a minimum interval of 28 days has elapsed from the invalid dose is preferred.

What is Time? 2

The ACIP introduced guidelines in 2002:  If the interval is less than 4 months, it is common to covert months into days or weeks. (e.g., 1 month = 4 weeks = 28 days).

For intervals of 4 months or longer, you should consider a month a “calendar month” – the interval from one calendar date to the next a month later. (e.g., 6 months from October 1 is April 1).

Make sure you check the exact wording on the CDC’s immunization schedules.

The 4-day “grace period” should not be used when scheduling future vaccination visits, and should not be applied to the 28-day interval between live parenteral vaccines not administered at the same visit. It should be used primarily when reviewing vaccination records (for example, when evaluating a vaccination record prior to entry to daycare or school).

Outbreaks

Sometimes outbreaks of certain vaccine preventable diseases take place. This may create exceptions to the standing orders and pharmacy protocols. Meningococcal B vaccine is one of these exceptions.

Here is a section of the vaccine schedule for an outbreak situation:Schedule for Outbreaks

And, here is the general recommendation for Meningococcal B vaccine:Schedule for Mening B JPG*The same edition of the MMWR covers both contingencies.

 

When you choose the age and timing of a vaccine you need to consider the optimal response.  The optimal response to a vaccine depends on multiple factors, including the type of vaccine, age of the recipient, and immune status of the recipient. Recommendations for the age at which vaccines are administered are influenced by age-specific risks for disease, age-specific risks for complications, age-specific responses to vaccination, and potential interference with the immune response by passively transferred maternal antibodies. “Vaccines are generally preferred for members of the youngest age group at risk for experiencing the disease for which vaccine efficacy and safety have been demonstrated.” This minimum age is not just for those persons aged from birth through 18 years.

Look at the new Shingrix vaccine: 

Shingrix® vaccine (RZV) by GlaxoSmithKline for immunocompetent adults at 50 years of age and older.

Schedule for Shingrix JPG

The preferred spacing interval of the first dose of Shingrix after Zostavax® (ZVL) is ≥5 years. This is the time period studied by the manufacturer and identified in the package insert. The minimum acceptable spacing between the most recent Zostavax® and the first dose of Shingrix® is 8 weeks. This has been determined by ACIP expert opinion. The MMWR states that: “Studies examined the safety and immunogenicity of RZV vaccination administered ≥5 years after ZVL; shorter intervals have not been studied… Clinical trials indicated lower efficacy of ZVL in adults aged ≥70 years; therefore, a shorter interval may be considered based on the recipient’s age when ZVL was administered. Based on expert opinion, RZV should not be given <2 months after receipt of ZVL”. The 4-day rule does not apply to the minimum spacing of Shingrix®.

What do you hope to avoid by paying close attention to age and spacing intervals?2

  • Avoid harm to the vaccinee from a side effect or vulnerability to disease;
  • Avoid the inconvenience to the parent/patient and perhaps ill will;
  • Avoid the unreimbursed cost to the provider; and
  • Avoid the loss of trust in the provider, with possible negative publicity or even legal action.

Helpful Hints:

  1. Schedule clients using the preferred age and preferred spacing to provide optimal protection.1
  2. Do not schedule your routine vaccine appointments by the minimum acceptable age, spacing or the 4-day rule. The Minimum Acceptable Age and spacing are used under exceptional circumstances, not general scheduling.
  3. Check the Oregon Model Standing Orders and the Oregon Pharmacy Protocols for the most current recommendations.

References

  1. Vaccine Recommendations and Guidelines of the ACIP. General Best Practice Guidelines for Immunization: Best Practice Guidance of the Advisory Committee on Immunization Practices (ACIP) https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/timing.html

Accessed 17 April 2018

  1. Immunization Action Coalition. Available at http://www.immunize.org/catg.d/s8025.pdf Slide 17, 19.  Accessed 17 April 2018

 

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A few new faces at Oregon VFC

The Oregon Vaccines for Children (VFC) Program has transformed the way compliance site visits will be conducted around the state. Routine site visits and unannounced visits will now be administered by one of our friendly new compliance specialists.

This new structure will help Oregon meet the Center for Disease Control (CDC) program requirements. The VFC health educators will now be available for primarily new VFC clinic enrollment, education and quality improvement projects. Please join us in welcoming Gil, Marc, Isabel and Gaby to the VFC compliance team! In addition to our four new compliance specialists, we are also excited to introduce our newest health educator, Sara Kiely!

 

gil-1

Gillis Garrott- Compliance Specialist

Before joining the VFC team, Gil served as a chemical officer in the United States Army. He graduated from the University of Colorado, Boulder with a degree in Integrative Physiology. Gil is excited to be living in Portland Oregon and supporting the immunization compliance program. He was interested in this position because it offered the opportunity to help people gain access to proven and fundamental healthcare. He looks forward to seeing more of Oregon and getting to experience some of its many hiking trails. He also plans on increasing his current level 9 trainer status in Pokémon GO, go red team!

 

marc

Marc Taylor- Compliance Specialist

Marc is a Compliance Specialist who has worked for the State of Oregon for over four years.  He comes to the VFC team from the Department of Human Services where he investigated assisted living facility complaints. Marc has a diverse background, ranging from Oregon Paramedic to Law Enforcement officer. He is active in amateur radio, photography, Search & Rescue, and is excited to join a group dedicated to the health and safety of all Oregonians.

 

isabel

Isabel Stock- Compliance Specialist

After interning with the Immunization Program to improve HPV vaccination efforts across the state, Isabel is now a Compliance Specialist who will be conducting unannounced storage and handling visits. Isabel is a Eugene native and a recent graduate from Colorado State University, where she studied Health and Exercise Science with a concentration in Health Promotion and a minor in Business Administration. In her free time she enjoys hanging out with her friends and family and traveling the world.

 

 gaby

Gabriela Tanaka- Compliance Specialist

Gaby is a Compliance Specialist who has worked with the Oregon Health Authority for three years. She comes to the VFC team with experience in many different facets of healthcare, having worked with insurance companies, home health care agencies, and with Biomerieux, a life sciences company. A native Bostonian, Gaby enjoys bicycling around Portland, Visual Arts and Theatre. She has bicycled from Seattle to Portland and has her sights set on one day completing a bicycle tour from NYC to Niagara Falls.

 

sara-1

Sara Kiely- Health Educator

Sara joined the Immunization Program as a Health Educator in November of 2016.  She is a native Oregonian who comes to us with a strong background in Public Health Education and Human Resources. Sara recently returned to Oregon after spending two years in West Africa working at a Nutrition Center for Liberian refugees. She has experience in health education, volunteer management, nutrition counseling, human resource services, and working with diverse populations. She has a passion for public health and for serving the underserved. She is looking forward to working with our partners across the state to improve the health of all Oregonians.

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ACIP drops recommendation of LAIV/nasal spray for 2016-2017 flu season

 

As many of you already know, ACIP voted to remove Flumist® from the list of recommended flu presentations for the 2016-2017 season. More specifically:

“CDC’s Advisory Committee on Immunization Practices (ACIP) today voted that live attenuated influenza vaccine (LAIV), also known as the “nasal spray” flu vaccine, should not be used during the 2016-2017 flu season. ACIP continues to recommend annual flu vaccination, with either the inactivated influenza vaccine (IIV) or recombinant influenza vaccine (RIV), for everyone 6 months and older. ACIP is a panel of immunization experts that advises the Centers for Disease Control and Prevention (CDC). This ACIP vote is based on data showing poor or relatively lower effectiveness of LAIV from 2013 through 2016.”

-www.cdc.gov/media/releases/2016/s0622-laiv-flu.html

 

To help you better communicate this message to your patients and staff, here are two excellent primer articles:

1. “No Flu Nasal Spray Next Season: Why Is This Vaccine Not Working?” Livescience.com, June 23, 2016, www.livescience.com/55176-flu-nasal-spray-not-working.html

2. “Intranasal FluMISSED its target.” aappublications.org, July 12, 2016, www.aappublications.org/news/2016/07/12/LAIV071216

If you have further questions about how this will affect your clinic’s state-supplied flu order, please call Jennifer Steinbock at 971-673-0309.

 

 

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2015-2016 Flu Season Update

Fall has arrived and along with the shorter days, colder weather and rain comes the season for influenza-like-illnesses (ILI) and pneumonia. This article includes updates from the Oregon Health Authority (OHA), Centers for Disease Control and Prevention (CDC), and flu-related highlights from the Advisory Committee on Immunization Practices’ (ACIP) final meeting of 2015.

OHA Flu Season Activity Findings

The OHA monitors flu activity in Oregon and reports weekly on the number of incidents and spread of ILI throughout the state from the first day of the 40th week of the year through the last day of 20th week of the following year. This year flu activity reporting began on September 28, 2015 and will end May 22, 2016.

The FluBites report for week 44, ending November 7, 2015, reported no positive influenza tests, a minimal level of ILI activity, and no reported outbreaks.

CDC Flu Season Activity Findings

The CDC monitors flu and pneumonia activity in the United States all year long but they report weekly on the incidents and spread of these illnesses throughout flu season.  There is a lot of good news this flu season. Here are a few of the highlights from the CDC weekly report as of week 44, ending November 7, 2015.

  • This year’s flu vaccine offers significantly more protection than last year’s vaccine because it includes two or three additional flu strains in the vaccine mix and those strains are similar to the circulating strains of flu this year.
  • The percentage of respiratory specimens testing positive for influenza in clinical laboratories is low. Of the 10,271 specimens tested in week 44, only 1.2% of the specimens were positive for influenza viruses.
  • None of the 2015 tested influenza viruses in circulation were found to be resistant to the three major anti-viral medications.

Flu graphic

http://www.cdc.gov/flu/weekly/index.htm#S1

 

ACIP Meeting Highlights Related to Flu

The October ACIP meeting included a presentation on the cost-effectiveness of high-dose influenza vaccine in adults aged 65 years and older.  The presenters concluded that high-dose flu vaccine is more cost effective than standard doses of flu vaccine based on the reduction in cardiovascular complications seen in patients 65 years and older who received the high-dose vaccine versus those who received the standard flu vaccine dose.1,2

A new influenza vaccine currently under FDA review was discussed.  The new vaccine, an adjuvanted trivalent vaccine, is expected to enhance immune response and have a safety profile similar to other licensed vaccines.

 

1 DiazGranados C A, et al: Efficacy of high–dose versus standard–dose influenza vaccine in older adults. New England Journal of Medicine: 2014;371:635–45. Available at:  http://www.nejm.org/doi/full/10.1056/NEJMoa1315727?query=featured_home&  Accessed 5 November 2015.

2CDC. Fluzone High-Dose Seasonal Influenza Vaccine. Questions and answers. Available at http://www.cdc.gov/flu/protect/vaccine/qa_fluzone.htm  Accessed 5 November 2015.

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Know Before You Immunize – Advice From A Breast Cancer Survivor

– By Lisa Stember, RN, BSN

It’s hard to avoid the color pink during the month of October when even football stadiums are decorated to raise awareness of breast cancer. As a two-time survivor of the disease, I don’t need pink ribbons to raise my awareness, but the pink ribbons do help me to stay focused on prevention of one of the more devastating side effects of cancer treatment: lymphedema.  This is especially important during flu season when I’m thinking about getting my annual flu vaccine.

Surgery to remove breast cancer frequently includes removal and examination of axillary lymph nodes for spread of disease.  The removal of or damage to lymph nodes can result in lymphedema, the abnormal buildup of fluid in soft tissue due to a blockage in the lymphatic system.  Lymphedema can develop immediately after surgery or radiation, but it may occur months or years after cancer treatment has ended. Swelling can cause pain, numbness and limit movement in the affected limb.  In severe cases, the skin becomes tight and the scarring causes hyperkeratosis.  Although treatment to reduce the swelling and relieve symptoms is available, once symptoms have occurred it’s usually a lifelong condition.

As a breast cancer survivor I have been instructed to avoid any blood draws, injections or blood pressure measurements on the affected side, as well as taking steps to avoid skin infections. This advice presents a dilemma when getting a vaccination because the Advisory Committee on Immunization Practices (ACIP) recommends the deltoid muscle area of the upper arm as the best route for adult vaccines. So what is the solution?

While ACIP discourages variations from the recommended route, site, volume, or number of doses of any vaccine1, when a patient has either lymph node removal or damage to the lymph system, using the thigh muscle as the vaccine injection site might become necessary.  If the vaccine needed is for hepatitis B or rabies, use of any site other than the deltoid muscle is considered an invalid dose.  For these vaccines, doses given in a nonstandard site can be verified by titer for efficacy.

After my first occurrence of breast cancer, I carefully protected my arm, avoided injuries, promptly treated cuts, and redirected health care personnel to my unaffected side for immunizations. When my breast cancer reoccurred on the opposite side resulting in the loss of more lymph nodes, I decided it was in my control to ask for help in preventing lymphedema and made a plan.   Although it isn’t always convenient, I now ask for immunizations in an alternate site.   Blood pressure can be done on a lower extremity.  Although not many women and men are bilateral breast cancer survivors, any person with loss of lymph nodes needs consideration.  If you are a breast cancer survivor or have loss of lymph nodes, check with your personal care provider for what adult vaccines you need, and where best to have them administered.

http://www.cancer.net/navigating-cancer-care/side-effects/lymphedema

http://www.breastcancer.org/treatment/lymphedema/reduce_risk/avoid

Lisa Stember is a registered nurse. She graduated with her nursing degree in 1986 from OHSU School of Nursing and also holds a Bachelor of Science degree in health education from Oregon State University. She is currently a public health nurse on the certification team for the Oregon School-Based Health Centers, Adolescent and School Health Program. Prior to that she worked for 17 years as a school nurse and spent 11 years in inpatient care in maternal and pediatrics at OHSU.

1 http://www.cdc.gov/mmwr/preview/mmwrhtml/rr6002a1.htm

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Immunizations and SBHCs

Thirty years ago, five School-Based Health Centers (SBHC) opened their doors in Oregon with the goal of providing patient centered health care services for all students, whether or not they have health insurance coverage.  Today Oregon has 75 certified SBHC’s that operate in urban, suburban and rural school districts.  Oregon SBHC Map

SBHCs are medical clinics that offer primary care services within or on the grounds of a school.  Each SBHC is staffed by a primary care provider, other medical, mental, and/or dental health professionals and support staff.

SBHCs focus on reducing barriers that can keep youth from accessing health care such as transportation, cost and concerns about confidentiality.  SBHCs bill Medicaid and many are credentialed with private insurance, but students may not be denied service for inability to pay for services.

Since inception, preventative health services such as immunizations have remained a core function for Oregon SBHCs.  Certified SBHCs participate in the Vaccines for Children (VFC) program and offer all ACIP routinely recommended vaccines at each site.   Bringing vaccines to the school results in fewer missed opportunities for all vaccines as well as preventing school exclusion due to incomplete immunization status. Parent involvement and consent is managed by frequent communication between the SBHC and home.

Ceci Robe, manager for Rogue Community Health SBHCs in Jackson County, describes the importance SBHCs place on vaccine education and outreach.  “We get the word out to students and staff in many ways, such as targeting 11th and 12th graders for meningococcal vaccine and HPV. We also outreach for Hepatitis A, and offer immunizations to siblings of students.  We provide flu clinics for all district students and staff. We have a close partnership with the school’s registrar and create a system of referral.  We get going in September and by February all students are compliant and no one is excluded from school.  This is a great benefit to the student and schools.”

Ceci feels all encounters are an opportunity to evaluate and discuss vaccination status.  “It only takes about 15 minutes, so we can update a student at school, during lunch. We are constantly monitoring the immunization status of all students that come into the health center for any reason.  We update ALERT in a timely manner, so when the student transfers schools they have an updated record in hand.”

 

 

 

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Back to School Immunization Guide

Exemption Rates

 

Summer is winding down and it’s time to gear up for a new school year. That means more kids coming in for vaccines. What do you need to know about immunizations for back to school this year?

  • Old religious exemptions to immunization signed prior to March 2014 are no longer valid. Senate bill 895 removed the provision that allowed old religious exemptions that were in place before the implementation of the new nonmedical exemption process. This is a great opportunity to discuss vaccines with parents who claimed an exemption for their child years ago. Parents will have two options:
    1. If the child has received the vaccines, the parent needs to fill in the vaccine dates on the Certificate of Immunization Status, sign the form and turn it into the school.
    2. If the parent wants a nonmedical exemption for their child, they need to get education about the benefits and risks of immunization from a health care practitioner or the online vaccine education module. If you are a health care practitioner and provide education to the parent, print off and complete the Vaccine Education Certificate available at healthoregon.org/vaccineexemption (go to the “For Providers Only” section at the bottom of the page). Mark “yes” next to each vaccine you provided education about for which the parent wants to claim an exemption. The online vaccine education module is also available at the same web address.
  • Remind parents to update immunization records with their child’s school or daycare every time their child receives a vaccine.
  • Make sure to screen for and give all recommended vaccines when you give school-required vaccines. When a student comes in for Tdap vaccine, give HPV and meningococcal vaccines as well. Adolescents can be a hard population to reach, and you might not see the patient again for several years. And don’t forget about flu vaccine!

Update from the 2014-2015 school year

For the first time in more than a decade, Oregon’s nonmedical exemption rate decreased: 5.8% of kindergartners had a nonmedical exemption to one or more vaccine in 2015 compared to 7.0% in 2014. Check out the graph above to see the nonmedical exemption rate over time. Thank you to clinics, schools and child care programs for helping to implement the new process for claiming a nonmedical exemption, and helping protect more kids against vaccine preventable diseases!

 

 

 

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