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Revised 08-2017 This order expires July 31, 2018 OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS Diphtheria and Tetanus Toxoids * Td 1, 2 Tdap 3, 4 Update 08-02-2017 Addition of section IV. C. table and footnotes I. OREGON IMMUNIZATION PHARMACY PROTOCOL: 1. Check the ALERT Immunization Information System (IIS) to determine whether the patient needs this vaccine and any other vaccines. 2. Screen for clients ≥7 years for contraindications. 3. Provide a current Vaccine Information Statement (VIS), answering any questions. 4. Record all required data elements in the client’s permanent health record. 5. Give Td, Tdap vaccine 0.5 ml intramuscularly (IM) according to the age-appropriate schedule and situation to persons ≥7 years of age. a. The deltoid muscle of the upper arm should generally be used. 6. May be given with all ACIP-recommended vaccinations. 7. Observe client for 15 minutes after vaccination to decrease the risk for injury should they faint. _________________________________________________________ Pharmacist Signature Date For multiple signatures see: http://1.usa.gov/PharmacyImmunizationProtocols II. A. LICENSED COMBINATION VACCINE (Td) 1, 2,

OREGON HEALTH AUTHORITY IMMUNIZATION ... · Revised 01-2016 This order expires July 31, 2018 OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS Diphtheria

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Revised 08-2017 This order expires July 31, 2018

OREGON HEALTH AUTHORITY IMMUNIZATION PROTOCOL FOR PHARMACISTS

Diphtheria and Tetanus Toxoids* Td1, 2 Tdap 3, 4

Update 08-02-2017 Addition of section IV. C. table and footnotes

I. OREGON IMMUNIZATION PHARMACY PROTOCOL:

1. Check the ALERT Immunization Information System (IIS) to determine whether the patient needs this vaccine and any other vaccines.

2. Screen for clients ≥7 years for contraindications.

3. Provide a current Vaccine Information Statement (VIS), answering any questions.

4. Record all required data elements in the client’s permanent health record.

5. Give Td, Tdap vaccine 0.5 ml intramuscularly (IM) according to the

age-appropriate schedule and situation to persons ≥7 years of age.

a. The deltoid muscle of the upper arm should generally be used.

6. May be given with all ACIP-recommended vaccinations.

7. Observe client for 15 minutes after vaccination to decrease the risk for injury should they faint.

_________________________________________________________ Pharmacist Signature Date For multiple signatures see: http://1.usa.gov/PharmacyImmunizationProtocols

II. A. LICENSED COMBINATION VACCINE (Td) 1, 2, ◊

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Product name Vaccine components

Acceptable age range

Thimerosal

Tetanus & diphtheria toxoids1

(Mass Biologicals)

Tetanus & diphtheria

toxoids ≥7 years

<0.3 μg/0.5 ml Not as a

preservative

Tenivac2*◊ (Sanofi Pasteur)

Tetanus & diphtheria

toxoids ≥7 years No

*Available in a 0.5 ml single−dose syringe or vial.

◊For persons 7 years of age and older, without contraindications, Tap is preferred. When pertussis is contraindicated, Tetanus and Diphtheria Toxoids Adsorbed for Adult Use (Td) is

preferred.5, 6

II. B. LICENSED COMBINATION VACCINE (Tdap) 3, 4 *

Product name Vaccine components

Acceptable age range Thimerosal

Boostrix3◊ (GSK)

tetanus toxoid,

diphtheria toxoid,

acellular

pertussis

FDA licensed

ACIP recommended

off-label use No

≥10 years ≥7years§

Adacel4◊ (sanofi

pasteur)

tetanus toxoid,

diphtheria

toxoid,

acellular

pertussis

10–64*

Years

≥7 years§ No

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II. A–B footnotes cont.

*Neither Boostrix3 nor Adacel4 is licensed for use in children <10 years of age.

◊Licensed only for a single dose at this time.3, 4

§Off-label age range. Currently Boostrix® is FDA-licensed for persons ≥10 years of age and

Adacel for persons 10–64 years of age; however, ACIP has endorsed the use of a single dose of these vaccines in all persons ≥7 years of age who have not been fully immunized against

pertussis. There is no upper age limit.7

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III. RECOMMENDATIONS FOR USE: Td and Tdap: Tenivac®, Boostrix ®and Adacel® A. All persons ≥10 years of age who have not received Tdap should receive a single dose of Tdap at the first opportunity, regardless of whether and when they have received a Td booster. If a Tdap is given as part of wound management to a person ≥10 years of age, the

next Td booster should not be administered for 10 years. 7*

If Td is indicated but unavailable, Tdap should be administered in place of Td, and administration should include persons who previously received Tdap.7

B. Persons ≥7 years old with*, ◊:

• No documentation of a childhood Diphtheria Tetanus or acellular Pertussis schedule; or,

• Unknown vaccination status

These patients should receive one dose of Tdap. Any additional doses needed to complete a primary tetanus/diphtheria vaccination series should be Td vaccine.5 * This recommendation also applies to unvaccinated adults ≥65 years of age (FDA approved for Boostrix®, but either Tdap vaccine product can be used).12

◊A 7–10 year old may have a TdaP as part of the catch-up schedule and then receive an adolescent dose at 11–12 years of age.14

C. Pregnant women should be vaccinated during each pregnancy with Tdap to prevent pertussis in the infant.8

• Pregnant women who never have been vaccinated against tetanus should receive three doses of tetanus and diphtheria-containing vaccine. The recommended schedule is at times 0, 4 weeks, and 6–12 months.

• Tdap should replace 1 dose of Td, preferably at 27–36 weeks’ gestation.8

• For wound management, Tdap may be administered any time during pregnancy. Vaccination during the third trimester provides the highest concentration of maternal antibodies to be transferred closer to birth. After receipt of Tdap, a minimum of 2 weeks is required to mount a maximal immune response to the vaccine antigens.8

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• If Tdap is not administered during pregnancy; it should be administered immediately postpartum. The postpartum dose is only recommended for women who have not previously received Tdap.8

D. All health care personnel, regardless of age, should receive a single dose of Tdap regardless of the date since their last Td dose 12

E. Wound Management: Use Tdap for routine tetanus and diphtheria booster or wound management if no prior Tdap dose.13

F. Persons experiencing an Arthus-type hypersensitivity reaction or a fever higher than 103°F (39.4°C) following a prior dose of tetanus toxoid usually have high serum tetanus antitoxin levels. Because these persons are at increased risk of hypersensitive reaction to immunization, do not give them DT or emergency doses of Td more frequently than every 10 years, even if

they have a wound that is neither clean nor minor.1-4

G. Administer Tdap (or Td) simultaneously with other vaccines when indicated and available.14

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IV. A. ROUTINE VACCINATION SCHEDULE FOR Td VACCINE (Tenivac1)

Dose *◊ Minimum Age

Recommended Age

Recommended Interval

Tenivac

1 7 years ≥7 years

2§ 7 years ≥7 years 8 weeks after dose #1

3 ‡** 7 years ≥7 years 6 months after dose #2

Booster

Doses ◊◊§§‡‡ 10 years ≥10 years ≥5 years from last dose of a

tetanus and diphtheria-containing vaccine

* For unvaccinated persons ≥7 years of age (including persons who cannot document prior

vaccinations), the primary series is three doses.8

◊ For retrospective checking, doses that violate the minimum interval or age by 4 or fewer days do not need to be repeated. Doses administered 5 days or earlier than the minimum

interval or age should be repeated, as age-appropriate.14

§ Persons ≥7 years of age who have not completed the DTP/DT/DTaP series should have

previous doses counted and should complete the series using Tdap or Td.8

‡ If the 3rd dose of a tetanus and diphtheria-containing vaccine (includes previous doses of DTaP, DTP or DT) is administered on or after the 7th birthday, and the 1st dose was given at ≥1 year of age, a 4th dose is not required as long as dose 3 was given at least 6 months after dose two. If the 1st dose was given at <1 year of age, a total of 4 doses are needed for the initial

series. The minimum interval between doses 3 and 4 is 6 months.5

** The first booster dose may be given at 10–18 years of age if ≥5 years have elapsed since the last dose of a tetanus-containing vaccine. If Tdap was part of the initial series and was given to a person ≥10 years of age, the next booster dose is due ≥10 years after the last dose of tetanus-containing vaccine.8

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IV. A. Footnotes cont.

◊◊If a booster dose is given at a time sooner than the minimum interval but to a person at least 10 years of age, as part of wound management, the next booster should be given 10

years later.8

§§ If ≥6 doses of a diphtheria- or tetanus-containing vaccine is given before 7 years of age, a

booster is due 5 years after the 6th or last dose.13

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IV. B. ACIP RECOMMENDED VACCINATION SCHEDULE FOR Tdap VACCINE (Boostrix3 and

Adacel4)*

Age Group Minimum Age Dose‡ Recommended Age

Adolescents 7 years ◊§‡** 1 10–18 years‡

Adults◊◊§§ 19 years 1 ≥19 years

Pregnant Women ‡‡***◊◊◊

None 1

Tdap during each pregnancy is preferred at 27–36 weeks’ gestation

‡‡***◊◊◊

* Tdap should be administered with other vaccines that are indicated during the same visit

when feasible.14

◊ A single dose of either Boostrix or Adacel may be administered to those who are not fully vaccinated against pertussis (5 doses of DTaP or 4 doses of DTaP if 4th dose was administered

on or after the 4th birthday) and who have no contraindications.9

§ If additional doses of tetanus and diphtheria toxoid-containing vaccines are needed, then children should be vaccinated according to catch-up schedule, with Tdap preferred as the first

dose.9

‡Adolescents 10–18 years of age who have completed the recommended childhood DTP or DTaP vaccination series ≥4 years ago should receive a single dose of Tdap instead of Td. If a Tdap dose is given as part of wound management to a person ≥10 years of age, the next Td

booster should not be administered for 10 years.8

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IV. B. Footnotes cont.

** Adolescents who have never been vaccinated against tetanus, diphtheria or pertussis should receive a series of 3 vaccinations. The preferred schedule is a single Tdap dose, followed by a dose of Td 4 to 8 weeks after the Tdap dose and a second dose of Td ≥6 months after the Td dose. However, Tdap may substitute for any one (and only one) of the 3 Td doses

in the series.12

◊◊ A single Tdap dose should replace the currently recommended Td vaccine that is used as the adult booster vaccine. When another tetanus and diphtheria booster is needed, Td should

be administered.8, 12

§§ Grandparents, child-care providers, health-care providers, and other unvaccinated adults in contact with infants <1 year of age should receive a Tdap booster. Either Boostrix or

Adacel may be used for ≥65 years of age.7

‡‡“To ensure protection against maternal and neonatal tetanus, pregnant women who never have been vaccinated against tetanus should receive three vaccinations containing tetanus and reduced diphtheria toxoids. The recommended schedule is 0, 4 weeks, and 6 through 12 months. Tdap should replace 1 dose of Td, preferably between 27 and 36 weeks gestation to

maximize the maternal antibody response and passive antibody transfer to the infant."11

*** If Tdap is not administered during pregnancy; it should be administered immediately postpartum. The postpartum dose is only recommended for women who have not previously

received Tdap.11

◊◊◊" Tdap may be administered any time during pregnancy, but vaccination during the third trimester would provide the highest concentration of maternal antibodies to be transferred closer to birth. After receipt of Tdap, a minimum of 2 weeks is required to mount a maximal

immune response to the vaccine antigens."11

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IV. C. ACIP RECOMMENDED VACCINATION SCHEDULE FOR Tdap VACCINE (Boostrix6 and

Adacel7)*

Age Group Minimum Age Dose‡ Recommended Age

Adolescents 7 years ◊§‡** 1 10–18 years‡

Adults◊◊§§ 19 years 1 ≥19 years

Pregnant Women ‡‡***◊◊◊

None 1

Tdap during each pregnancy is preferred at 27–36 weeks’ gestation

‡‡***◊◊◊

* Tdap should be administered with other vaccines that are indicated during the same visit

when feasible.18

◊ A one-time dose of either Boostrix or Adacel may be administered to those who are not fully vaccinated against pertussis (5 doses of DTaP or 4 doses of DTaP if 4th dose was

administered on or after the 4th birthday) and who have no contraindications.13

§ If additional doses of tetanus and diphtheria toxoid-containing vaccines are needed, then children should be vaccinated according to catch-up schedule, with a one-time Tdap preferred

as the first dose.13

‡Adolescents 10–18 years of age who have completed the recommended childhood DTP or DTaP vaccination series ≥4 years ago should receive a one-time dose of Tdap instead of Td. If a Tdap dose is given as part of wound management to a person ≥10 years of age, the next Td

booster should not be administered for 10 years.1

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IV. C. Tdap Footnotes cont.

** Adolescents who have never been vaccinated against tetanus, diphtheria or pertussis should receive a series of 3 vaccinations. The preferred schedule is a one-time Tdap dose, followed by a dose of Td 4 to 8 weeks after the Tdap dose and a second dose of Td ≥6 months after the Td dose. However, Tdap may be substituted for any one (and only one) of the 3 Td

doses in the series.16

◊◊ A one-time Tdap dose should replace the currently recommended Td vaccine that is used as the adult one-time dose of Tdap vaccine. When another tetanus and diphtheria booster is

needed, Td should be administered.12, 16

§§ Grandparents, child-care providers, health-care providers, and other unvaccinated adults in contact with infants <1 year of age should receive a one-time dose of Tdap. Either Boostrix

or Adacel may be used for ≥65 years of age.11

‡‡“To ensure protection against maternal and neonatal tetanus, pregnant women who never have been vaccinated against tetanus should receive three vaccinations containing tetanus and reduced diphtheria toxoids. The recommended schedule is 0, 4 weeks, and 6 through 12 months. Tdap should replace 1 dose of Td, preferably between 27 and 36 weeks gestation to

maximize the maternal antibody response and passive antibody transfer to the infant."17

*** If Tdap is not administered during pregnancy; it should be administered immediately postpartum. The postpartum dose is only recommended for women who have not previously

received Tdap.17

◊◊◊" Tdap may be administered any time during pregnancy, but vaccination during the third trimester would provide the highest concentration of maternal antibodies to be transferred closer to birth. After receipt of Tdap, a minimum of 2 weeks is required to mount a maximal

immune response to the vaccine antigens."17

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V. Tdap and Td CONTRAINDICATIONS 2, 3, 4

1. Severe allergic reaction to any vaccine component of Td or Tdap vaccine or following a prior

dose.*

2. Encephalopathy (e.g. coma, prolonged seizures) within 7 days of administration of a pertussis-containing vaccine that is not attributable to another identifiable cause is a

contraindication to Tdap.◊

* Because of the importance of tetanus vaccination, individuals with this history should be referred to an allergist to determine whether they can be desensitized to tetanus toxoid.

◊ Td vaccines should be administered for the remaining doses in the vaccination schedule to ensure protection against diphtheria and tetanus.

VI. Tdap and Td PRECAUTIONS AND WARNINGS

1. Persons who experience an Arthus-type reaction following a previous dose of a tetanus toxoid-containing vaccine should not receive a tetanus toxoid-containing vaccine more

frequently than every 10 years, even for tetanus prophylaxis as part of wound management.1, 2

2. History of an Arthus-type hypersensitivity reaction following a previous dose of tetanus or

diphtheria toxoid-containing vaccines, including MCV4 (Menactra® or Menveo®).3

3. Unstable neurological condition, uncontrolled epilepsy, or progressive encephalopathy. 1, 2

4. Severe latex allergy. (The Boostrix pre-filled needleless syringes contain latex, as do tip

caps of Tenivac.)1, 3

5. History of Guillain-Barré syndrome within 6 weeks after a previous dose of tetanus toxoid-containing vaccine.1-4

6. ACIP does not consider a history of brachial neuritis to be a precaution or contraindication for administration of tetanus toxoid--containing vaccines.4

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VII. A. SIDE EFFECTS AND ADVERSE REACTIONS FOR Td: MassBiologics (no trade name)1

Number followed for safety: N/A

Recipients: ≥7 years of age

Adverse Reaction %: N/A

Local Reaction, Injection site

Pain Yes Redness Yes Swelling Yes Systemic Complaints Yes Fever Yes Chills Yes

Convulsions Yes

Nausea Yes Tiredness Yes Headache Yes Body ache Yes Sore and swollen joints Yes Rash Yes Package insert text on page 2

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VII. B. 1. SIDE EFFECTS AND ADVERSE REACTIONS FOR Boostrix3 and Adacel4 (Tdap)

Boostrix6 Adacel7

Number followed for Safety

N =3032* § N=1170—1175◊ § Adverse Reaction % Adverse Reaction %

Age in Years 10—18 years 11—17 years Local Reaction, Injection site

Pain 75.3 77.8 Redness 22.5 20.8 Swelling 21.1 20.9 Systemic Complaints Fever ≥99.5°F (37.5°C) 13.5 5.0 Fever >102.2°F (39.0°C)

1.4 0.9

Chills 15.1

Alteration in appetite 26.0 13.3 Tiredness 37.0 30.2 Headache 43.1 43.7 Body ache 30.4 Sore and swollen joints

11.3

Rash 2.7 *Boostrix package insert Table 1 page 7. ◊Adacel package insert Table 1 page 7—8 and Table 2 page 9 § Generally begins 2–8 hrs after injection; most often in adults; particularly in those who have received frequent doses of diphtheria or tetanus toxoid.6, 11

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VII. B.2. SIDE EFFECTS AND ADVERSE REACTIONS FOR Boostrix3 and Adacel4 (Tdap)

Boostrix®4 Boostrix®4 Adacel®5

Number followed for safety: N=1480*

Adverse Reaction %

N=882*

Adverse Reaction %

N=1697–1698◊

Adverse Reaction %

Recipients age: 19–64 years ≥65 years 18–64 years % Local Reaction, Injection site

Pain 61.0 21.5 65.7 Redness 21.1 10.8 24.7 Swelling 17.6 7.5 21.0 Systemic Complaints Fever ≥99.5°F (37.5°C) 5.5 2.0 Fever ≥100.4°F (38°C) 1.4 Fever ≤103.0°F (38.8–≤39.4°C)

0.1 0.0 0.4

Fever ≥102.2°F (≥39.5°C) 0

Chills 8.1

Alteration in appetite 15.9 7.6 9.2 Tiredness 28.1 12.5 24.3 Headache 30.1 11.5 33.9 Body ache 21.9 Sore and swollen joints 9.1 Rash 2.0 *Boostrix package insert, Table 4 page 10. ◊Adacel package insert, Table 1, pages 7—8 and Table 2 page 9.

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VII. C. SIDE EFFECTS AND ADVERSE REACTIONS FOR Td2: Tenivac®

Number followed for safety

Tenivac®

N=491–492 Adverse Reaction

%

N=247 Adverse Reaction

%

N=688–695 Adverse Reaction

%

Recipients age: 11–18 years 19–59 years ≥60 years

Local Reaction, Injection site*

Pain 80.1 74.9 35.3 Redness 25.6 15.8 18.1 Swelling 15 17 12.1 Systemic Complaints Fever ≥99°F (≥37.5°C) 4.3 5.7 2.5 Fever ≥100.4°F (≥38.0°C–<39°C)

0.8 1.6 0.6

Fever ≥103°F (≥39°C) 0.0 0.0 0.1 Tiredness 14.5 17.0 8.9 Headache 23.0 25.1 11.7 Muscle weakness 32.3 17.4 4.9 Sore and swollen joints 15.7 10.9 8.5 *Tenivac package insert, table 2, pages 8–9. ◊Side effects were more common among younger participants (11-18 years) than in older recipients (≥60 years).

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VIII. A. OTHER CONSIDERATIONS FOR DT

A. Epinephrine Injection (1:1000) and other appropriate agents and equipment must be available for immediate use in case an anaphylactic or acute hypersensitivity reaction

occurs.14

B. Normally no more than 6 doses of a diphtheria/tetanus-containing vaccine are recommended by 7 years of age. However, in some situations, the benefits of a pertussis containing vaccine being added to a DT series needs to be weighed against the risk of a local reaction occurring after receiving 7 or 8 doses of a DT-containing

vaccine.13

C. Infants under 12 months of age: Should additional doses of pertussis-containing vaccine become contraindicated after a DTP/DTaP series has been initiated, DT should be

substituted for each of the remaining scheduled DTP/DTaP doses.14

VIII. B. OTHER CONSIDERATIONS FOR Tdap and Td

A. History of pertussis: Adolescents or adults with a history of pertussis disease generally should receive Tdap according to the routine recommendations. However, if the illness was <5 years ago and the diagnosis was culture confirmed, it is reasonable to wait 3–5 years before

administration of Tdap, unless tetanus and diphtheria toxoids are needed. 6, 17

B.Tetanus disease does not confer immunity because of the very small amount of toxin required to produce illness. Persons recovering from tetanus disease should begin or complete

active immunization with tetanus toxoid (Td) during convalescence.8

C. Inadvertent administration of Tdap or Pediatric DTaP: Adults who inadvertently receive DTaP do not need to be revaccinated. Tdap doses given to children inadvertently for doses 1, 2 or 3 of the primary DTaP series need to be repeated with DTaP. If Tdap was inadvertently

given for dose 4 or 5 of the primary DTaP series, it does not need to be repeated.3

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IX. TETANUS WOUND MANAGEMENT RECOMMENDATIONS 18

History of adsorbed tetanus toxoid doses

Clean, minor wounds All other wounds*

TdaP or Td◊ TIG§ TdaP or Td◊ TIG§

Unknown or <3 doses Yes No Yes Yes

>3 doses‡ No** No No◊◊ No

* Such as (but not limited to) wounds contaminated with dirt, feces, soil, and saliva; puncture wounds; avulsions; and wounds resulting from missiles, crushing, burns, and frostbite.

◊ For children younger than 7 years of age, DTaP is recommended; if pertussis vaccine is contraindicated, DT is given. For persons 7-9 years of age Td is recommended. For persons >10 years, Tdap is preferred to Td if the patient has never received Tdap and has no contraindication to pertussis vaccine. For persons 7 years of age or older, if Tdap is not available or not indicated because of age, Td is preferred to TT. § TIG is human tetanus immune globulin. Equine tetanus antitoxin should be used when TIG is not available.

‡ If only three doses of fluid toxoid have been received, a fourth dose of toxoid, preferably an adsorbed toxoid, should be given. Although licensed, fluid tetanus toxoid is rarely used.

** Yes, if it has been 10 years or longer since the last dose.

◊◊ Yes, if it has been 5 years or longer since the last dose. More frequent boosters are not needed and can accentuate side effects. TIG=tetanus immune globulin. TT=tetanus toxoid

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X. Storage and Handling

All clinics and pharmacies enrolled with the Vaccines for Children (VFC) Program must immediately report any storage and handling deviations to the Oregon Immunization Program at 971-673-4VFC (4823).

Vaccine Notes Temp Storage Issues

Tenivac 2

Boostrix 3

Adacel4

Tip caps may contain latex

Store at 2°–8°C

(36˚F–46˚F)

Do not use if vaccine has been frozen.

Do not use after expiration date. Td1

MassBiologics

No latex

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XI. ADVERSE EVENTS REPORTING Adverse events following immunization must be reported to the Vaccine Adverse Events Reporting System (VAERS). The VAERS online report form is available at https://vaers.hhs.gov/reportevent.html

A pharmacist who administers any vaccine must report the following elements to the OHA ALERT Immunization Information System in a manner prescribed by OHA within 15 days of administration. This replaces the former requirement to notify the primary health care provider. A pharmacist is not required to notify the primary health care provider. Oregon

Administrative Rule 855-019-0290-(2)(3).19

VAERS Reporting Table*: https://vaers.hhs.gov/docs/VAERS_Table_of_Reportable_Events_Following_Vaccination.pdf Tetanus

A. Anaphylaxis or anaphylactic shock (7 days) B. Brachial neuritis (28 days) C. Shoulder Injury Related to Vaccine Administration (7 days) D. Vasovagal syncope (7 days) E. Any acute complications or sequelae (including death) of above events (interval - not applicable) F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert) A. Anaphylaxis or anaphylactic shock (7 days) B. Encephalopathy or encephalitis (7 days) C. Shoulder Injury Related to Vaccine Administration (7 days) D. Vasovagal syncope (7 days) E. Any acute complications or sequelae (including death) of above events (interval - not applicable) F. Events described in manufacturer’s package insert as contraindications to additional doses of vaccine (interval - see package insert)

Pertussis

Effective date: March 21, 2017. The Reportable Events Table (RET) reflects what is reportable by law (42 USC 300aa-25) to the Vaccine Adverse Event Reporting System (VAERS) including conditions found in the manufacturer package insert. In addition, healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the

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vaccine caused the event) for any vaccine, whether or not it is listed on the RET.

Electronic copy of this protocol available at: 1.usa.gov/PharmacyImmunizationProtocols

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REFERENCES

1. Tetanus and Diphtheria Toxoids Adsorbed package insert (2009).Mass Biologics. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM164127.pdf . Accessed 11 July 2017.

2. Tenivac® (Tetanus and Diphtheria Toxoids Adsorbed). Sanofi. 2013. Available at www.fda.gov/downloads/BiologicsBloodVaccines/UCM152826.pdf . Accessed 11 July 2017.

3. Boostrix® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed. Glaxo Smith Kline, 2013. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/UCM152842.pdf . Accessed 11 July 2017.

4. Adacel® Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed). Sanofi. 2014. Available at: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142764.pdf . Accessed 11 July, 2017.

5. CDC. Preventing tetanus, diphtheria, and pertussis among adolescents: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccines. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2006; 55(RR-3); 1–43. Available at: www.cdc.gov/mmwr/PDF/rr/rr5503.pdf Accessed 11 July 2017.

6. CDC. Preventing tetanus, diphtheria, and pertussis among adults: Use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine. Recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of tdap among health-care personnel, 2006. MMWR 2006; 55(RR17);1–33. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/rr5517a1.htm Accessed 11 July 2017.

7. CDC. Updated recommendations for use of tetanus toxoid reduced diphtheria toxoid, and acellular pertussis (Tdap) vaccine in adults aged 65 years and older — Advisory Committee on Immunization Practices (ACIP), 2012. MMWR 2012; 61:468–70. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6125a4.htm Accessed 11 July 2017.

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8. Tetanus. In: Epidemiology and Prevention of Vaccine Preventable Diseases. (“Pink Book”). Atkinson W, Hamborsky J, Wolfe S, eds. 13th ed. Washington DC: Public Health Foundation, 2015: p 341–52. Available at: www.cdc.gov/vaccines/pubs/pinkbook/tetanus.html . Accessed 11 July 2017.

9. Diphtheria. In: Epidemiology and Prevention of Vaccine Preventable Diseases. (“Pink Book”). Atkinson W, Hamborsky J, Wolfe S, eds. 13th ed. Washington DC: Public Health Foundation, 2015: p 107–118. Available at: www.cdc.gov/vaccines/pubs/pinkbook/dip.html . Accessed 11 July 2017.

10. CDC. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis (Tdap) vaccine from the Advisory Committee on Immunization Practices, 2010. MMWR 2011; 60(01);13—15. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6001a4.htm?s_cid=mm6001a4_w . Accessed 11 July 2017.

11. CDC. Updated recommendations for use of tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap) in pregnant women—Advisory Committee on Immunization Practices (ACIP), 2012. MMWR 2013; 62:131–135. Available at:

www.cdc.gov/mmwr/preview/mmwrhtml/mm6207a4.htm?s_cid=mm6207a4_e . Accessed 11 July 2017.

12. CDC. Immunization of health-care personnel—Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2011. MMWR 60 RR07); 1–45. Available at:

www.cdc.gov/mmwr/preview/mmwrhtml/rr6007a1.htm?s_cid=rr6007a1_e . Accessed 11 July 2017.

13. Immunization Action Coalition Ask the experts: Diseases and vaccines. Diphtheria, Tetanus, Pertussis. Available at: www.immunize.org/askexperts/experts_per.asp , accessed 11 July 2017.

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14. CDC. General Recommendations on Immunizations. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 2011; 60 (RR-2):1–48. Available at: www.cdc.gov/mmwr/pdf/rr/rr6002.pdf Accessed 11 July 2017.

15. CDC. FDA Approval of expanded age indication for a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine from the Advisory Committee on Immunization Practices (ACIP) 2011. MMWR 2011; 60(37):1279–80. Available at: www.cdc.gov/mmwr/preview/mmwrhtml/mm6037a3.htm. Accessed 11 July 2017.

16. Pertussis. In: Epidemiology and Prevention of Vaccine Preventable Diseases. (“Pink Book”). Atkinson W, Hamborsky J, Wolfe S, eds. 13th ed. Washington DC: Public Health Foundation, 2015: p 261–78. Available at: www.cdc.gov/vaccines/pubs/pinkbook/pert.html . Accessed 11 Julyl 2017.

17. Immunization Action Coalition. Atkinson W and Kroger A. 2006. Vaccinate Adults! 2006;10:1–12. Available at: www.immunize.org/va/va17.pdf Accessed 11 July 2017.

18. Tiwari, T. VPD Surveillance Manual, 5th Edition, 2011. Tetanus: Chapter 16.Table 1. Guide to tetanus prophylaxis in routine wound management. CDC. 2014. Available at: www.cdc.gov/vaccines/pubs/surv-manual/chpt16-tetanus.html . Accessed 11 July 2017.

19. Oregon Administrative Rule. Board of Pharmacy. Division 19. Licensing of pharmacists: 855-019-0270 –0280 –0290 (2). Available at: http://arcweb.sos.state.or.us/pages/rules/oars_800/oar_855/855_019.html Accessed 05 July 2017.

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APPENDIX: Tetanus containing vaccines; total antigen DTP, Td, Tdap. Pertussis Components

Antigens P/ A

Tetanus Toxoid

Diphtheria Toxoid PT FHA Pertactin Fimbriae

types 2, 3 Td1

Mass Bio A 2 Lf 2Lf

Tenivac2

Sanofi A 5 Lf 2Lf

Adacel3

Sanofi A 5 Lf 2 Lf 2.5mcg 5mcg 3mcg 5 mcg

Boostrix4

GSK A 5 Lf 2.5Lf 8mcg 8 mcg 2.5 mcg

A = Adult 1. Tetanus and Diphtheria Toxoids Adsorbed (no trade name). Mass Biologics. 2009.

Available at: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM164127.pdf . Accessed 11, July 2017.

2. Tenivac ® (Tetanus and Diphtheria Toxoids Adsorbed). Sanofi. 2013. Available at:

www.fda.gov/downloads/BiologicsBloodVaccines/UCM152826.pdf . Accessed 11 July 2017.

3. Adacel ® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine

Adsorbed). Sanofi. (nd). Available at: www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM142764.pdf . Accessed 11 July, 2017.

4. Boostrix® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine,

Adsorbed. Glaxo Smith Kline, (nd). Available at: www.fda.gov/downloads/BiologicsBloodVaccines/UCM152842.pdf . Accessed 11 July 2017.