Standing Prescription Order to Administer Travel Immunizations

Standing Prescription Order to Administer Travel Immunizations

(Pharmacy Name)

The subsequent list of immunizing pharmacists have completed all training requirements and updated certifications required by the Iowa Board of Pharmacy pertinent to vaccine administration in Iowa and are authorized on the basis of this protocol to deliver vaccines in Iowa under the medical direction of (supervising prescriber), (prescriber’s title) for (prescriber’s practice name).Please note that the qualified trained pharmacists listed below may delegate administration of a vaccine to another qualified and trained pharmacist or student pharmacist that assist our pharmacy in our immunization services.

Registered Pharmacists:

Last Name / First Name / License Number

Agreement Description:

To protect people from preventable infectious diseases that cause needless death and disease, the afore listed pharmacists may administer the following immunization(s) to eligible patients 18 years and older within the state of Iowa, according to indications and contraindications recommended in current guidelines from the Advisory Committee on Immunization Practices (ACIP) of the U.S. Centers for Disease Control & Prevention (CDC) and in accordance with product labeling. Further information on specific travel vaccinations for foreign countries can be found at . Other vaccines may be added to or deleted from this list by written supplementary instruction from the undersigned.

Hepatitis A
Twinrix (Hepatitis A & B)
Japanese Encephalitis
Polio
Rabies
Typhoid inactivated
Typhoid live oral
Yellow fever

Criteria:

Hepatitis A

Hepatitis A vaccination may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated.Pre-exposure prophylaxis is recommended for those traveling to or working in countries withintermediate to high rates of Hepatitis A infection. Pre-exposure prophylaxis is given as 2 doses, with the second dose at 6 to 12 months. A booster dose is administered based on the age at the time of the booster. Each dose is 0.5 mL for those whom are 18 years of age and 1.0 mL. For optimal protection, IG can be considered in addition to vaccine in older adults, immunocompromised persons, and persons with liver disease or other chronic medical conditions who are traveling to area within 2 weeks. Travelers who will be traveling for over 2 months should receive IG at 0.06 mL/kg, and repeated if travel period is over 5 months. Antibody response should be expected to last at least 4 years.

Contraindications/ Ineligible Patients for Hepatitis A Vaccine

Hypersensitivity to neomycin, alum, preservative 2-phenoxy ethanol (Havrix), or any components of the vaccine
Anaphylaxis to previous Hepatitis A vaccination
Deferred during moderate or severe acute illness until symptoms resolved
Latex rubber allergy (needle-less pre-filled syringe)

Precautions for Hepatitis A Vaccine

Pregnancy- although this is an inactivated virus and risk to fetus is expected to be low, risks of vaccination should be weighed against risk for hepatitis A
Concomitant use: rate of seroconversion for hepatitis A antibodies following first dose of VAQTA or concomitant administration of first dose of VAQTA with yellow fever and typhoid is similar, however titers for hepatitis A were reduced following concomitant administration. Following booster of VAQTA, titers were comparable.
Adults over 40 years of age and certain populations (American Indians, Alaskan Natives, and Hispanics) may benefit from pre-vaccination testing

Twinrix

Twinrix is a combination vaccine of Hepatitis A and Hepatitis B that may be given to all consenting individuals 18 years of age and above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of Hepatitis A and B infection. Twinrix is given as a 1.0mL IM vaccine into the deltoid muscle. In preparation for international travel, 3 doses should be given, with second dose 4 weeks following first dose and third dose at least 5 months after the second dose and 6 months after the first dose. If there is not adequate time to complete the 3 dose series, immunization should be given at least 4 weeks prior to expected exposure, allowing for 2 doses to be administered. The second and third doses are needed for long term protection. An alternative, accelerated schedule follows a second dose at least 7 days after first dose, a third dose at 21 to 30 days after the first dose, and the fourth and final dose at 12 months after the first dose.

Contraindications for Twinrix Vaccine

Hypersensitivity to the adjuvants aluminum phosphate, aluminum hydroxide, preservative 2-phenoxyethanol, neomycin, yeast, or other components of the vaccine
Moderate to severe acute illness, with or without fever
History of hypersensitivity to Twinrix, or monovalent hepatitits A or B vaccines

Precautions for Twinrix Vaccine

Pregnancy- risk of vaccine should be weighed against the risk for hepatitis
Pregnancy exposure registry: health care providers are encouraged to register pregnant women who receive Twinrix in the GSK vaccination pregnancy registry by calling 1-888-452-9622.
Latex- prefilled syringe tip caps and rubber plungers contain dry natural latex rubber

Japanese Encephalitis

Ixiaro, the Japanese encephalitis vaccine, may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of Japanese Encephalitis. Ixiaro is given as 2 doses of 0.5mL IM into the deltoid, at days 0 and 28. If series was given over 1 year ago, a booster dose may be given.

Contraindications for Ixiaro

Severe allergic reaction after a previous dose

Precautions for Ixiaro

Hypersensitivity to protamine sulfate
Immunocompetence: no safety in immunocompromised patients, may have diminished immune response to vaccine
No data regarding use concomitantly with immunosuppressive therapies
Pregnancy and lactation- use only if clearly needed
Pediatric and geriatric patients- no testing in those under 17 years of age and over 65 years of age
History of fainting with injections, a 15-minute observation period is recommended

Polio

The poliovirus vaccine may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of polio. Inactivated polio vaccine (IPV) is given to those over 19 as three doses of 0.5 mL SC or IM. The second dose is given 1 to 2 months following dose one and dose three is given 6 to 12 months after dose two. An accelerated schedule for high risk patients recommends administering the second dose 4 weeks following dose one and the third dose at 4 weeks following the second dose.

Contraindications for IPV

Serious allergic or anaphylactic reaction to a previous dose or its components, including formaldehyde, streptomycin, neomycin, or polymyxin B

Precautions for IPV

Vaccination should be deferred during moderate or severe illness, with or without fever, until symptoms have resolved
Pregnancy- if immediate protection against poliomyelitis is needed, you may administer IPV, otherwise vaccination should be avoided
Immune deficient persons may receive IPV vaccine, though due to immune status, only assume partial protection

Rabies

Rabies vaccines, IMOVAX and RabAvert, may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries in which they may come into contact with animals in which rabies is enzootic and immediate access to medical care may be limited. Rabies vaccines are given as 3 doses at 1.0mL IM into the deltoid. Doses are given at days 0, 7, and 21 or 28. A booster vaccine may be given if serologic testing proves an antibody titer is below the acceptable level.

Contraindications for Rabies vaccines

Situations such as developing febrile illness

Precautions for Rabies Vaccines

RabAvert is produced in chick embryo cell culture, thus those with a history of anaphylactic or other immediate reactions to egg ingestion should not be immunized with vaccine
When chlorquine phosphate was used routinely for malaria prophylaxis, it was discovered that the drug degreased antibody response to concomitant IMOVAX
Immune suppression treatment or immunosuppressive illnesses can interfere with development of active immunity
Pre-exposure vaccination not recommended during pregnancy, unless substantial risk

Typhoid inactivated

The typhoid inactivated vaccine, TyphimVi, may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of typhoid fever, especially those with prolonged exposure to contaminated food and drink. Vaccination should be given as a single dose of 0.5 mL IM, at least 2 weeks prior to exposure to Salmonella Typhi. Revaccination of travelers with a single dose every 2 years is recommended.

Contraindications for Typhoid vaccine

History of hypersensitivity to any component of this vaccine

Precautions for Typhoid vaccine

Acute infection or febrile illness may delay use
Only give to pregnant women if clearly needed, when possible delay vaccine until second or third trimester
There is no data on use of this product in nursing mothers for passive antibody transfer to infant

Typhoid live oral

The typhoid live oral vaccine, Vivotif, may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of typhoid fever caused by Salmonella Typhi, especially those with prolonged exposure to contaminated food and drink. Vaccination should be given as 4 doses, with one capsule given every 48 hours, at least 7 days prior to travel. All capsules must be taken within 10 days. A booster dose of 4 doses, with one taken every 48 hours, is recommended every 5 years.

Contraindications and Precautions for Typhoid Live Oral

Hypersensitivity to any component of the vaccine or enteric coated capsule
Do not give during acute febrile illness, postpone if persistent diarrhea or vomiting is occurring
Do not give to a person receiving sulfonamides or antibiotics, as they may inactivate the vaccine. If the patient is on ANY antibacterial agent, stop for 4 days then start the course of the vaccine. Restart antibiotic 4 days following completion of vaccine course
Mefloquine and atovaquone-proguanil at prophylactic doses may be given concurrently with live-attenuated typhoid live oral, however since the vaccine should be completed 7 days prior to traveling, there should be no concomitant administration in most travelers.
Should not be used by immune-compromised persons, including those known to be infected with human immunodeficiency virus. Vaccine should not be administered to these patients, regardless of benefits, instead use parenteral vaccine
Give to pregnant women only when clearly needed
If typhoid vaccine is warranted, it should not be delayed because of administration of viral vaccines.

Yellow fever

The yellow fever vaccine YF-VAX,may be given to all consenting individuals 18 years of ageand above in whom the vaccine is not contraindicated. Pre-exposure prophylaxis is recommended for those traveling to or working in countries with an intermediate to high rates of yellow fever infection. The vaccine should only be given to those individuals who are at risk of exposure to the virus or have proof of vaccination for country entry. In order to administer the vaccine, we must be in possession of the Yellow Fever Stamp and provide the patient with a completed, signed and validated International Certificate of Vaccination. The vaccine is given as a single dose at 0.5mL subcutaneously, and may be given simultaneously with all other vaccines. Revaccination may be required after 10 years.

Contraindications for Yellow Fever Vaccine

Have had a life threatening allergic reaction to eggs, chicken, gelatin, latex, or a previous yellow fever vaccine
Symptomatic HIV infection, or CD4-T lymphocyte values under 200/mm3
Have thymus disorder, associated with abnormal immune cell function- such as thymomas or myasthenia gravis
Primary immunodeficiencies
Malignant neoplasms
Transplantation
Immunosuppressive and immunomodulatory therapies
Contraindicated for those whose immunologic response is either suppressed or modulated by current or recent radiation therapy or drugs

Precautions for Yellow Fever Vaccine

Refer adults over 60 years of age to private provider before immunizing
Pregnant women and nursing mothers should avoid travel to yellow fever areas. If travel cannot be avoided, discuss vaccination with private provider before immunizing.
If travel is unavoidable for individuals over 60 years of age, the decision to vaccinated needs to be weighed against destination specific risk exposure. This is due to an increased risk of serious adverse events following this vaccination for individuals over 60 years of age
Asymptomatic HIV infection with moderate immune suppression, such as CD4-T lymphocyte values of 200-499/mm3

Documentation

In the course of providing vaccines, the pharmacist must maintain perpetual records of all vaccines administered. Before vaccine administration, vaccine candidates will be questioned regarding previous adverse events following vaccine administration, food or drug allergies, as well as questioned regarding appropriate vaccine contraindications and precautions. All vaccine candidates will be informed of the specific benefits and risks of the vaccine offered and will sign a consent form. All vaccine recipients will be observed for a suitable period of time after immunization for adverse events.

All vaccine recipients will be offered a written immunization record. The immunization will be reported to the physician issuing this written protocol and the patient’s primary care provider (if designated by the patient) by fax or mail. The immunization will also be reported to appropriate county or state immunization registries as made available.

Emergency Care

Emergency care will be given if needed using the Protocol for Allergic and Anaphylactic Reactions to Injectable/Intranasal Medications Administered by (pharmacy name)Pharmacists. The healthcare professional will maintain current certification in cardiopulmonary resuscitation. The emergency physician on call can be reached at pager number: ______ if needed.

Referrals

The healthcare professional will endeavor not to disrupt existing patient-physician relationships. The healthcare professional will refer patients needing medical consultation to a physician. The healthcare professional will make special efforts to identify susceptible people who have not previously been offered immunizations.

As the authorizing physician, I will review, on an annual basis, the activities of the health care professionals administering vaccines under this protocol. The authorization shall be valid until one year from the date indicated below, unless revoked in writing sooner or unless extended in writing.

The following (pharmacy name) pharmacists: Add Pharmacists names here……having completed the appropriate training for administration of vaccines and CPR certification as delegates for (supervising prescriber) according to and in compliance with the State of Iowa Board of Pharmacy may administer the medication(s) listed above on the premises of the (pharmacy name) and at other Iowa community locations and for a fee.

Prescriber Name: ______

NPI #: ______

DEA #: ______

Prescriber Signature:______

Date:______

Add address of supervising prescriber here

Local Telephone Number(s) for Consultations:

Pharmacist Signature:______

Pharmacist License #:______

Date:______

Protocol for Allergic and Anaphylactic Reactions to Injectable/ Intranasal Medications Administered by (pharmacy name) Pharmacists

If an allergic reaction to a medication occurs, the following standing orders will be used:

Procedures

Be prepared to call 911.
Take a thorough history for allergies and prior adverse events before any immunization.
Allow adequate physical space for fainting or collapse without injury and to lay patient flat on a hard surface in the event cardiopulmonary resuscitation (CPR) is needed.
Maintain current competency in immunization; observe all vaccine recipients for a suitable period of time after immunization; remind vaccine recipients to report any adverse events to you.

*If an allergic reaction is suspected, and the patient is fully alert and not in respiratory distress, do not hesitate to give diphenhydramine to the patient.

Supplies to Stock

(2) Epinephrine Auto-Injector devices, USP, (1:1000), 0.3 mg dose
Diphenhydramine hydrochloride liquid
Blood pressure measuring equipment

Recognition of Anaphylactic Reaction

Sudden onset of itching, redness, with or without hives, within several minutes after injecting vaccine. The symptoms may be localized or generalized.
Angioedema (swelling of the lips, face, throat), anxiety, difficulty swallowing, syncope, fall in blood pressure, light-headedness, paresthesia, flushing, sweating, palpitations
Bronchospasm, wheezing, tightness in chest, shock

Emergency Treatment

If suspect allergic response (i.e., welts, itching, hives, etc.) and in no respiratory distress give oral diphenhydramine1mg/kg body weight immediately, observe patient closely for 30 minutes, watching for generalized symptoms.
If symptoms are generalized, activate the emergency response system (9-1-1) and call the consulting physician for instructions. Another person should do this while the immunizer treats and observes the patient.
Administer epinephrine 0.3mg subcutaneously or intramuscularly. Site of administration can be the anterior thigh or deltoid area.
Monitor the patient closely until EMS arrives. Perform CPR and maintain airway, if necessary.
Keep patient in supine position unless he/she is having breathing difficulty. If breathing is difficult, patient’s head may be elevated, provided blood pressure is adequate to prevent loss of consciousness.
Monitor vital signs frequently
If EMS has not arrived and symptoms are still present, repeat dose of epinephrine every 15 minutes, depending on patient’s response.
Refer patient for medical evaluation, even if symptoms resolve completely. Symptoms may reoccur after epinephrine and diphenhydramine wear off, as much as 24 hours later. After the event is concluded complete a VAERS form.

*If physician direction is needed the on call provider can be reached at pager:______.

The following (pharmacy name) pharmacists:ADD PHARMACIST Name Herehaving completed the appropriate training for administration of vaccines and CPR certification as delegates for (supervising prescriber) according to and in compliance with the State of Iowa Board of Pharmacy, may administer the medication(s) listed above in the event of allergic and/or anaphylactic reaction.

Prescriber Name: ______

NPI #: ______

DEA #:______

Prescriber Signature:______