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VAN BUREN/CASS COUNTY DISTRICT HEALTH DEPARTMENT
PRE-EXPOSURE PROPHYLAXIS OF SMALLPOX OR MONKEYPOX
STANDING ORDERS for ADMINISTRATION of
DRYVAX® SMALLPOX VACCINE (VACCINIA VIRUS)
Michigan Department of Community Health
STANDING ORDER
I.
INDICATIONS
A. Dryvax® Smallpox Vaccine is a live, vaccinia virus vaccine indicated for
active immunization against human smallpox disease (variola). Individuals
who should be offered vaccine are members of
1. Regional Public Health Response Teams
2. Hospital-Based Healthcare Response Teams
3. EMS Transport Teams
B. All vaccinators, vaccinator assistants, and “take” evaluators need to be
vaccinated with smallpox vaccine before functioning in any of these positions.
C. Only individuals >18 years of age and < 65 years of age are eligible for
vaccination.
D. Persons investigating suspected human and animal monkeypox cases,
including veterinary and animal control personnel, are recommended to
receive smallpox vaccination.
E. HCWs who may be asked to care for monkeypox patients in the future
F. Vaccination is on a voluntary basis.
At the current time, all use of the vaccinia vaccine for monkeypox pre- or postexposure will be conducted under an Investigational New Drug (IND) protocol.
This includes a requirement each vaccinee signs an informed consent. The
physician, under whose signature these standing orders are implemented, should
assure that all requirements of the IND protocol are met.
II.
CONTRAINDICATIONS FOR NON-EMERGENCY VACCINE USE
Smallpox vaccine should not be administered to:
A. Individuals diagnosed with a heart condition with or without symptoms,
including coronary artery disease, heart failure, cardiomyopathy, stroke,
transient ischemic attack, chest pain or shortness of breath with activity, or
other heart conditions under medical care. Also, individuals with 3 or more of
the following cardiovascular risk factors (high blood pressure, high blood
cholesterol, diabetes, first degree relative who had a heart condition before
age 50, current cigarette smoking) should not receive the smallpox vaccine.
B. Individuals with a history of prior adverse reaction to smallpox vaccine.
C. Individuals who are allergic to any component of the vaccine or diluent (e.g.,
phenol, glycerin), including the four antibiotics in Dryvax® vaccine:
1. polymyxin B (polymyxin B sulfate)
2. streptomycin (dihydrostreptomycin sulfate)
3. tetracycline (chlortetracycline hydrochloride)
4. neomycin (neomycin sulfate)
D. Persons < 18 years of age and > 65 years of age.
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E. Individuals with eczema / atopic dermatitis, Darier’s Disease
(http://www.capederm.com/info_darier_disease.htm), or a past history of
eczema/atopic dermatitis. Individuals with household contacts with these
conditions should not be vaccinated. (Household contacts include anyone
living in a household and anyone with whom there is close physical contact
such as a sexual partner.)
F. Individuals who have other acute, chronic, or exfoliative skin conditions (e.g.,
contact dermatitis, wounds, burns, impetigo, or varicella zoster). Individuals
with household contacts with these conditions should not be
vaccinated. Persons with any of these conditions may be vaccinated when
their condition or that of their household contact is completely resolved.
G. Individuals receiving therapy with systemic corticosteroids within the last
month at immunocompromising doses (eg. > 2mg/kg body weight or > 20
mg/day of prednisone for > 2 weeks), with immunosuppressive drugs (e.g.,
alkylating agents, antimetabolites), or with radiation. Individuals with
household contacts with these conditions should not be vaccinated.
Note: This does not apply to potential vaccine candidates or individuals with
household contacts who are receiving only inhaled corticosteroids.
H. Individuals with congenital or acquired deficiencies of the immune system,
including individuals with HIV/AIDS. Individuals with household contacts
with these conditions should not be vaccinated.
I. Individuals with immunosuppression (eg. leukemia, lymphomas of any type,
generalized malignancy, solid organ transplantation, hematopoietic stem cell
transplantation, cellular or humoral immunity disorders, agammaglobulinemia
or other malignant neoplasms affecting the bone marrow or lymphatic
systems). Individuals with household contacts with these conditions
should not be vaccinated.
J. Persons with severe autoimmune conditions such as systemic lupus
erythematosus (SLE) that may significantly suppress the immune system.
K. Women who are pregnant, suspect they might be pregnant, or are planning a
pregnancy in the next month. Individuals with household contacts with
these conditions should not be vaccinated.
L. Breastfeeding mothers.
M. Individuals with severe, life-threatening reaction to latex (anaphylaxis).
G. Individuals receiving topical ocular steroid medications
III.
PRECAUTIONS
A. The vial stopper contains dry, natural rubber that may cause hypersensitivity
reactions when handled by, or when the product is administered to, persons
with known or possible latex sensitivity.
B. The vaccine vial, its stopper, the needle to release the vacuum, the diluent
syringe, the vented needle used for reconstitution, the bifurcated needle used
for administration, and all gauze, cotton, and gloves that came in contact with
the vaccine should be burned, boiled, or autoclaved before disposal, as
according to policy for treatment of bio-hazardous waste.
C. Prevention of contact transmission of vaccinia
Many site care instructions prevent the spread of vaccinia virus and are
listed in this section. For additional site care instructions, see section V.
page 10 of this document.
1. Vaccinia virus may be cultured from the site of primary vaccination
beginning at the time a papule develops (2 to 5 days after
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vaccination) until the scab separates from the skin lesion (14 to 21
days after vaccination). During this entire time, care must be taken
to prevent spread of the virus to another area of the body or to
another person.
2. Thorough handwashing with soap and warm water is the most
important measure to prevent inadvertent implantation and contact
transmission from vaccinia virus. Wash your hands after direct
contact with vaccine, the vaccination site, or anything that might be
contaminated with live virus, including bandages, clothing, towels,
or sheets that come in contact with the vaccination site. This is vital
in order to remove any virus from your hands and prevent contact
spread.
Alcohol-based hand rubs may also be used for handwashing when
soap and water are not readily available.
3. The vaccination site should be covered with a porous bandage (i.e.,
gauze) that is held in place with tape until the scab has separated
and the underlying skin has healed. An airtight bandage should
NOT be routinely used.
4. When working in a health care setting, cover the gauze with a semipermeable dressing (e.g., Opsite®, Tegaderm®). Change the
gauze and semi-permeable dressing as needed (i.e., at least every
3-5 days) when the gauze is visibly soiled, when borders are no
longer intact, or when it is no longer waterproof.
When not at work in a health care setting, the vaccinee need only
wear the gauze dressing held in place with tape. Change the
gauze bandage frequently (every 1-3 days).
5. If satellite lesions are forming, remove the semi-permeable
dressing and cover all lesions with gauze. Then cover with semipermeable dressing. Keeping the vaccination site dry will prevent
maceration of the vaccination site secondary to fluid accumulation.
6. As an added precaution against spread of vaccinia virus, wear a
shirt with long sleeves to cover the vaccination site. This is
particularly important in situations of close physical contact such as
occurs in the household and health care setting. Long sleeves
should also be worn to bed to protect the site from scratching while
asleep.
7. Recently vaccinated healthcare workers should take great care
when in contact with patients, particularly those with
immunodeficiencies, until the scab has separated from the skin at
the vaccination site. As previously stated above in #4 of this
section, vaccinees MUST keep the vaccination site well covered
with gauze, a semi-permeable membrane, and a long sleeve shirt.
It is vitally important to maintain good hand-washing technique.
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8. Contaminated bandages should be placed in sealed plastic bags
before disposal in the trash. Wash hands immediately afterwards.
9. Keep a separate laundry hamper for clothing, towels, bedding, or
other items that may have come in direct contact with the
vaccination site or drainage from the site.
10. Wash clothing or any other materials that have come into contact
with the vaccination site using hot water with detergent and/or
bleach. Wash hands immediately afterwards.
11. When the scab falls off, throw it away in a sealed plastic bag.
Wash hands immediately afterwards.
D. Simultaneous administration with other vaccines:
1. Inactivated vaccines (e.g., Td, influenza vaccine, pneumococcal
vaccine): Vaccinia vaccine may be administered with any
inactivated vaccine to encourage appropriate receipt of all indicated
vaccines. Inactivated vaccines may be administered either
simultaneously or before or after the vaccinia vaccine.
2. Live virus vaccines (e.g., MMR)
With the exception of varicella vaccine, vaccinia vaccine may be
administered simultaneously with other live virus vaccines. To avoid
confusion in ascertaining which vaccine may have caused postvaccination skin lesions or other adverse events, and to facilitate
managing such events, varicella vaccine and vaccinia vaccine
should only be administered >28 days apart.
If other live virus vaccines are not given simultaneously with
vaccinia vaccine, then the second parenteral, live virus vaccine
should be administered at least 28 days after the first to avoid
interference with the replication of the second vaccine virus
E. Individuals with moderate to severe illness should defer vaccination until
their illness improves or resolves.
IV.
DOSAGE AND ADMINISTRATION
A. All persons who reconstitute vaccine and all vaccinators must be
vaccinated with vaccinia vaccine. Health care providers or vaccinators
who themselves have contraindications to vaccination should not handle
or administer the vaccine.
B. Read all directions completely (e.g., package insert) before beginning
reconstitution and administration.
C. Use protective gloves and aseptic technique when reconstituting and
administering the vaccine.
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D. Directions for Reconstitution of Dryvax® vaccine:
Note: The healthcare provider must have available a sterile 21 gauge or
smaller needle to release the vacuum in the vaccinia vial prior to adding
diluent. This needle must only be used to release the vacuum. The
needle to release the vacuum is NOT included in the kit.
1. Gloves must be worn during reconstitution.
2. Record date of reconstitution and batch number on vaccine vial
before reconstituting vaccine.
3. Lift up tab of aluminum seal on vaccine vial. DO NOT BREAK OFF
OR TEAR DOWN TAB.
4. Wipe off vial stopper with an alcohol sponge and ALLOW TO DRY.
5. Place vaccine vial upright in the vaccine stabilizer on a hard, flat
surface which has been covered with a barrier pad (e.g., Chux®) to
contain spills. Insert a sterile 21 gauge or smaller needle into the
rubber stopper to release the vacuum from the vaccine vial. Discard
the needle in biohazard sharps container.
6. To reduce viscosity of cold diluent, warm diluent-cartridge by
holding it in palm of hand for a minute or so.
7. Peel open the vented needle package (provided with the kit) and
aseptically remove the vented needle.
8. Remove rubber cover from end of the diluent syringe.
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9. With a twisting motion, aseptically attach the vented needle to the
hub of the diluent syringe.
10. Remove protective cover from the vented needle and expel the air
from the diluent syringe.
11. Aseptically insert the needle through the rubber stopper into the
vaccine vial up to the first hub.
12. Depress the plunger to ensure the entire volume of diluent is
delivered into the vial. Be aware that volume of diluent is only
0.25ml.
13. Withdraw diluent syringe/vented needle and discard in biohazard
sharps container.
14. Allow vaccine vial to stand undisturbed for 3 to 5 minutes. Then, if
necessary, swirl vial gently to effect complete reconstitution.
15. Wash hands immediately after reconstitution of vaccine.
16. When not in actual use, store reconstituted vaccine at 2° to 8°C
(36° to 46°F) The vaccine may be stored (under proper conditions)
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for no more than 90 days after reconstitution (FDA approved 2-122003). Do Not Freeze.
E. Site of Vaccination:
1. The skin over the insertion of the deltoid muscle or the posterior
aspect over the triceps muscle of the non-dominant arm is the
preferred site for smallpox vaccination.
2. NO skin preparation is needed.
3. If the skin is visibly contaminated, clean the area with soap and
water. Allow the site to dry completely before vaccination.
4. Alcohol should not be used as this can deactivate the vaccinia
virus.
5. Do not vaccinate over a scar, a tattoo, or a previous smallpox
vaccination scar.
F. Method of Vaccination:
1. Vaccinator must be vaccinated with vaccinia vaccine.
2. Gloves must be worn by vaccinator while giving vaccination.
3. Reconstituted vials should be inspected visually for particulate
matter and discoloration prior to administration. There is wide
variation in the color of reconstituted vaccine. It should not be used
if it turns BLACK. Any other color is acceptable.
4. Use 3 (three) insertions of the bifurcated needle for PRIMARY
VACCINATION.
5. Use 15 (fifteen) insertions of the bifurcated needle for
REVACCINATION.
A trace of blood should appear at the site of vaccination within 1520 seconds; if no trace of blood is visible, an additional 3 insertions
should be made using the same bifurcated needle without
reinserting the needle into the vaccine vial (for both primary and revaccination).
If no blood appears after the additional 3 punctures, do NOT give
additional insertions. Proceed with dressing site and site care
instructions as usual.
DO NOT, under any circumstances, re-inset needle into
vaccine vial after it has touched the skin.
6. Administration of Dryvax® vaccine:
a. First pull down the “tear off” tab from the aluminum seal of
the vaccine vial.
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b. Then remove rubber stopper from vaccine vial and
aseptically retain stopper (set aside inverted) for subsequent
reuse. Make certain that portions of the stopper which have
come in contact with vaccine do not come in contact with
vaccinator’s gloves, etc.
c. The skin over the insertion of the deltoid muscle or the
posterior aspect of the non-dominant arm over the triceps
muscle is the preferred site for smallpox vaccination. No
skin preparation is necessary. Do NOT use alcohol.
d. Tear off a packette containing a single, sterile bifurcated
vaccinating needle.
e. Peel back the packaging approximately halfway exposing
the butt-end of needle.
f. Hold butt-end of needle and gently pull bifurcated point end
free of packaging. The needle is sterile, so be careful not to
touch the bifurcated end.
g. Carefully dip bifurcated end of needle into vaccine. Visually
confirm that the needle picks up a drop of vaccine in the
space between the two tips.
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h. Deposit the drop of vaccine onto clean, DRY site previously
prepared for vaccination. Do NOT re-dip needle into
vaccine if needle has touched skin.
i. Place your free hand under the vaccinee’s arm and pull the
skin taut. (If vaccinee’s arm is large, vaccinator’s assistant
may need to place hands under vaccinee’s arm and pull skin
taut.)
j. Rest your wrist on the vaccine’s arm for stability and
accuracy. With the same needle, and using multiplepuncture technique, vaccinate through drop of vaccine to
penetrate the superficial layers of the skin. Holding the
bifurcated needle perpendicular to the skin, punctures are
made rapidly, within an area 5 millimeters in diameter, with
strokes vigorous enough to allow a trace of blood to appear
after 15-20 seconds.
Avoid inadvertent self-inoculation with the bifurcated needle.
k. Any remaining vaccine should be wiped off with gauze and
the gauze disposed of in a biohazard waste container.
l. Discard needle in a biohazard sharps container.
m. Vaccination site must now be covered with gauze dressing
and tape. Preferably, site will be dressed by vaccinator’s
assistant who is wearing gloves. Take care NOT to touch
dressing with gloves that were worn during vaccination, as
they may be contaminated with live vaccinia virus.
n. Care must also be taken to NOT touch objects (e.g.,
paperwork) with vaccinator’s gloves. Discard gloves,
disinfect hands with soap and water or alcohol-based hand
wash.
o. Complete paperwork. Re-glove for next vaccinee.
p. Repeat Steps c. through o. for each individual to be
vaccinated utilizing a new bifurcated needle for each
individual vaccinated.
q. If vaccine is to be stored for subsequent use, re-stopper the
vial with the rubber stopper and store vial at 2° to 8°C (36° to
46°F).
Proper care of the stopper during the clinic is imperative. If
the stopper comes into contact with reconstituted vaccine at
any time, remember that it has live vaccinia virus on it and
anything which touches it (e.g., gloves, inside of zip bag)
must not touch any other object.
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If stopper is no longer available, cover vial with clean tape or
parafilm and leave vial in vaccine stabilizer to prevent
spillage, again taking care that the tape or parafilm is
handled properly.
If smallpox vaccine vial is to be transported, follow directions
in Instructions for Transporting Smallpox Vaccine from a
Regional Storage Site (RSS) to an Immunization clinic Site
and Back (MDCH)
r. The vaccine may be stored (under proper conditions) for no
more than 90 days after reconstitution. (FDA approved 212-2003)
s. When needed next, wash hands, glove, remove vial from
cold storage, gently swirl suspension to ensure resuspension, and then carefully take off stopper-cap.
Remove gloves, wash hands, re-glove, and then proceed
with vaccinations.
t. Vaccinees who provide direct patient care should check and
assess their vaccination site daily, before assigned duties, to
ensure that the site is properly covered with gauze and semipermeable membrane. Vaccinees should wear a shirt that
covers the vaccination site.
V.
SITE CARE INSTRUCTIONS
A. Many site care instructions prevent the spread of vaccinia virus and are
listed previously in section III. Precautions, C. of this document. Please
also refer to that section.
B. Keep the vaccination site dry. Cover the vaccination site with a waterproof
bandage when bathing. Change gauze dressing if it gets wet.
C. Avoid hot tubs and swimming pools until the scab has fallen off.
D. Do not scratch or pick at the vaccination site or scab. Do not put salves,
creams, or ointments on the vaccination site. Do not apply heat or cold to
the vaccination site. Instead, consider using systemic antipruritics for
severe itching.
VI.
“TAKE” EVALUATION
A. “Take” is the term used to indicate successful smallpox vaccination.
B. Indication of a successful “take” includes:
1 Development of vesicular lesion at vaccination site in 3-4 days.
2 Development of pustular lesion at approximately Day 7.
3 Scab formation at approximately Day 14.
4 Scab falls off during the third week, leaving a small scar.
C. Vaccinees with REVACCINATION may have more rapid progression of
clinical response.
D. All vaccinees must have their vaccination site evaluated by a trained,
preferably vaccinated person 6-10 days after vaccination for evidence of a
“take.”
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E. If there is no evidence of a successful “take,” the individual should be
revaccinated, preferably using a different batch of vaccine. The procedure
for re-vaccination is the same as described in Section IV. Dosage and
Administration of this document.
VII.
ADDITIONAL INFORMATION
A. Be prepared at all times for allergic reactions. All staff administering
immunizations should be familiar with standing orders pertaining to
adverse reactions to immunizations.
B. TB skin tests should not be administered until 28 days after smallpox
vaccination.
C. Blood donation:
1. Donation by vaccines:
a. Vaccinees WITHOUT smallpox vaccine complications:
Donation by vaccinees without vaccine complications should
be deferred until after the vaccination scab has separated
spontaneously, or for 21 days post-vaccination, whichever is
the later date.
b. Vaccinees WITH smallpox vaccine complications:
Donation by vaccinees who have experienced complications
of vaccination should be deferred until 14 days after all
vaccine complications have completely resolved.
2. Donation by non-vaccinated persons who develop contact vaccinia:
a. Non-vaccinated persons WITH localized skin lesions and
WITHOUT any other symptoms or complications:
1) If localized skin lesion (scab) separated spontaneously,
and is no longer present, donation need not be deferred
based on the prior exposure to smallpox vaccine
recipient.
2) If scab was otherwise removed, donation should be
deferred for 3 months from the date when the donor had
contact with a vaccine recipient.
b. Non-vaccinated persons WITH vaccinia complications:
Donation should be deferred until 14 days after all vaccine
complications have completely resolved.
D. Always refer to and follow the additional information provided in the most
current product package insert.
E. Any clinician administering the smallpox vaccine must have been
vaccinated within the past 3 years and have received specific instruction
on the smallpox vaccine, vaccine administration, contraindications to
vaccination and reactions to the vaccine.
References:
1. Product Package Insert, Smallpox Vaccine, Dried, Calf Lymph Type, Dryvax,
Wyeth laboratories, inc., Marietta, PA., 11-6-2002.
2. Recommendations for Use of Smallpox Vaccine in a Pre-Event Smallpox
Vaccination Program: Supplemental Recommendations of the Advisory
Committee on Immunization Practices (ACIP) and the Healthcare Infection
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Control Practices Advisory Committee. February 26, 2003, Department of
Health and Human Services, CDC.
http://www.cdc.gov/mmwr/preview/mmwrhtml/m2d226.htm
3. Smallpox Pre-Vaccination Information Packet, January 23, 2003, Department of
Health and Human Services, CDC.
4. FDA Recommendations for Deferral of Donors and Quarantine and Retrieval of
Blood and Blood Products in recent Recipients of Smallpox Vaccine (Vaccinia
Virus) and Certain Contacts of Smallpox Vaccine Recipients. December 2002.
http://www.fda.gov/cber/gdlns/smpoxdefquar.pdf
5. CDC Smallpox Website: www.bt.cdc.gov/agent/smallpox
6. CDC Monkeypox Website: www.cdc.gov/ncidod/monkeypox
DISTRIBUTION
Immunization Manual
Smallpox Response Plan
Frederick A. Johansen, M.D., M.P.H.
Medical Director
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4-29-10
Date