Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Nurse Practitioner Clinical Protocol Amendment
For
Haematology
Prepared by
Christina Crosbie RN, BSc, MN (NP)
August 2014
Sir Charles Gairdner Hospital
North Metropolitan Health Service
Author: Christina Crosbie
Version 1.2
Effective: August 2014 – Review: 2017
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Contents
Clinical Protocol Amendment Panel....................................................................................... 3
1. Introduction ...................................................................................................................... 4
2. Patient Group – No change. ............................................................................................. 4
3. Provision of Care – No Change ........................................................................................ 4
4. Diagnostic Tests and Investigations – No Change ............................................................ 4
5. Medications ...................................................................................................................... 4
6. Collaboration and Referral – No change. .......................................................................... 4
7. Accountability and Professionalism – No change. ............................................................ 4
8. Clinical Protocol................................................................................................................ 4
9. Medication Formulary ....................................................................................................... 7
Formulary Monograph ....................................................................................................... 8
Appendix 1 ...........................................................................................................................31
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Clinical Protocol Amendment Panel
Name:
Position
Professional Qualifications:
Organisation:
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Author: Christina Crosbie
V1.2
Date:
Date:
Date:
Date:
Date:
Date:
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
1. Introduction
The previous versions of this Clinical Protocol (V1 and V1.1) continue to be current and
relevant. This amendment includes additions to the scope of practice and care provided to
patients within haematology at Sir Charles Gairdner Hospital.
2. Patient Group – No change.
3. Provision of Care – No Change
4. Diagnostic Tests and Investigations – No Change
5. Medications
Addition to Clinical Protocol
Introduction of Vaccination program for stem cell transplant patients.
Studies have shown that the levels of antibodies to diseases that can be prevented by
vaccination decrease during the first few years after a stem cell or bone marrow transplant.
The immunities acquired by the patient prior to the transplant are generally lost. This can
occur after both allogeneic and autologous stem cell transplantation. Transplant patients are
at a higher risk of infection until their immune systems become stronger. Vaccination can
protect the post-transplant patient from infections such as childhood diseases, influenza and
pneumococcal pneumonia. A copy of the newly introduced post transplant vaccination
protocol is included in Appendix 1. The prescribing and administration of vaccines will be
carried out by the Nurse Practitioner in Haematology and all vaccines are listed within the
formulary.
Other additions (listed in Formulary Section 9)
Tranexamic Acid
Norethisterone
Voriconazole
Posaconazole
Within the formulary section will be a description for use in practice.
6. Collaboration and Referral – No change.
7. Accountability and Professionalism – No change.
8. Clinical Protocol
Additions to the clinical protocol are detailed within this section.
Addition
Decision making for insertion/removal of Vascular Access Devices
The addition to the scope of practice within the NP role is to make the independent and/or
collaborative decision to insert and/or remove central venous access devices. Central
venous access devices (CVAD’s) include Central Venous Catheters (CVC), Peripherally
Inserted Central Catheters (PICC), VASCATH’s. These devices are inserted to assist with
the administration of chemotherapy, emergency venous access after treatment, stem cell
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
collection procedure, administration of blood products and administration of intravenous
antibiotics etc. The insertion and removal of an access device is decided upon on an
individual patient basis, this decision can also be in collaboration with the patients treating
consultant if any doubt arises.
Vascular
Access Device
Central Venous
Catheter
Decision
Insertion
Prior to chemotherapy
treatment
Prior to Stem Cell
Transplant
As directed by any
haematology
consultant or registrar
Peripherally
Inserted Central
Catheter
Non-tunnelled
large bore,
central venous
catheters
(VASCATH)
Prior to chemotherapy
treatment
Removal
• Chemotherapy treatment completion and
platelet count of approximately
≥30x10*9/L
• Thrombosis and in consultation with the
patients treating haematology
consultant
• Transplant recovery and platelet count of
approximately ≥30x10*9/L
• Thrombosis and in consultation with the
patients treating haematology
consultant
• As directed by any haematology consultant
or registrar
• Thrombosis and in consultation with the
patients treating haematology
consultant
• Chemotherapy treatment completion
• Thrombosis and in consultation with the
patients treating haematology
consultant
Prior to Stem Cell
Transplant
•
•
Transplant recovery
Thrombosis and in consultation with the
patients treating haematology
consultant
As directed by any
haematology
consultant or registrar
•
Prior to Stem Cell
Collection (If patient
has poor venous
access for procedure)
•
•
As directed by any haematology consultant
or registrar
Thrombosis and in consultation with the
patients treating haematology
consultant
After Stem Cell Collection
As directed by the haematology medical
team
Platelet count of approximately ≥30x10*9/L
Author: Christina Crosbie
V1.2
•
•
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Hydration for Haematology Patients
Dehydration is a common side effect after chemotherapy/stem cell transplant and
Intravenous Hydration (IVH) can be required at this time. Dehydration can be due to a
number of factors. These factors can include reduced fluid intake, vomiting, diarrhoea and
use of antihypertensive medication. This can result in patients experiencing varying
symptoms and include hypotension, postural hypotension, increased nausea and altered
renal function.
Each patient will be assessed for IVH on presentation of a documented hypotension and/or
symptoms of dehydration.
Decision on volume and rate is decided upon on an individual patient basis and in
collaboration with medical staff where required. Initial hydration solution will be Normal
Saline 0.9% and further hydration will be decided after collaboration with the medical team.
Intravenous Hydration (IVH)
Decrease in oral fluid intake after
Reason for
chemotherapy and/or stem cell
commencing IV transplant
hydration
Decrease in renal function
Hypotension due to vomiting and/or
diarrhoea post chemotherapy/stem
cell transplant.
Hypotension after chemotherapy
and/or stem cell transplant while
taking antihypertensive medication
As directed by any haematology
consultant or registrar
Post lumbar Puncture (LP)
headache
Author: Christina Crosbie
V1.2
Effective:
Documented hypotension and/or
symptoms
Intake less than 1 litre in 24 hrs
Slow IVH
IVH administered after
consultation with haematology
consultant or registrar
Hypotension recorded and/or
vomiting and diarrhoea. IVH
given alongside anti-emetics
Documented hypotension and/or
symptoms
IVH to restore blood pressure
and withhold anti-hypertensive
medication if required
As discussed and documented
IVH alongside regular analgesia
medication intervention and
admission for post LP headache
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
9. Medication Formulary
Additions – Additional vaccinations and mediations added to the existing formulary.
The following Medications are additions to V1 and V1.1. The following list contains details of
the additions of medications and is endorsed by the Oncology Pharmacist within the Medical
Specialties Division (previously Cancer Division) of Sir Charles Gairdner Hospital.
Drug
Vaccinations
Prevenar 13
(13vPCV)
Pneumovax
(23vPPV)
Route
Intramuscular
Subcutaneous
Intramuscular
Hiberix (Hib)
Intramuscular
Ipol (IPV)
Subcutaneous
Boostrix (dTpa)
Intramuscular
ADT (dT)
Intramuscular
H-B-Vax II 40 mcg
- (dialysis
formulation)
Fluvax
(Inactivated)
Priorix (MMR) Live
vaccine
Varivax (Varicella)
Intramuscular
Menactra
(Meningococcal)
Gardasil (HPV
Intramuscular
Intramuscular
Subcutaneous
Intramuscular
Subcutaneous
Intramuscular
Other Medications
Tranexamic Acid
Oral
Norethisterone
Oral
Voriconazole
Posaconazole
Oral
Oral
Author: Christina Crosbie
V1.2
Section
Dose Range
Poisons
Schedule
0.5 mL prefilled
syringe
0.5 mL prefilled
syringe
S4
VaccinesImmunology
VaccinesImmunology
VaccinesImmunology
VaccinesImmunology
VaccinesImmunology
0.5 mL
S4
0.5 mL
S4
0.5 mL
S4
0.5 mL
S4
40 mcg/1mL
S4
VaccinesImmunology
or VaccinesImmunology
VaccinesImmunology
VaccinesImmunology
VaccinesImmunology
0.5mL
S4
0.5 mL
S4
0.5 mL
S4
0.5 mL
S4
0.5 mL
S4
500-1000mg
one - three
times daily
S3
(36
tabs)
S4
(all
others
S4
VaccinesImmunology
or VaccinesImmunology
Haemostatic
agents
Cardiovascular
System
Contraceptive
Agents
Antifungal agent
Antifungal agent
Effective:
5-10mg one three times daily
50-200mg
200-400mg
S4
S4
S4
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccination – Streptococcus pneumoniae
Drug generic name: 13vPCV (Prevenar 13)
Poisons schedule: S4
Dosage range: 0.5ml prefilled syringe
Route: Intra-muscular – as per manufacturer recommendation on administration
Frequency of administration: As per vaccination protocol (Appendix 1)
Duration of order: Once
Actions: The protection afforded by Prevenar 13 vaccination is mediated by the induction of
antibodies against the pneumococcal capsular serotypes in the vaccine.
B-cells produce antibodies in response to antigenic stimulation via T-dependent and Tindependent mechanisms. The immune response to most antigens is T-dependent and
involves the collaboration of CD4+ T-cells and B-cells, recognizing the antigen in a linked
fashion. CD4+ T-cells (T-helper cells) provide signals to B-cells directly through cell surface
protein interactions, and indirectly through the release of cytokines. These signals result in
proliferation and differentiation of the B-cells, and production of high affinity antibodies. CD4+
T-cell signaling is a requisite for the generation of long lived B-cells called plasma cells,
which continuously produce antibodies of several isotypes (with an IgG component) and
memory B-cells that rapidly mobilize and secrete antibodies upon re-exposure to the same
antigen. Bacterial capsular polysaccharides (PSs), while varied in chemical structure, share
the common immunological property of being largely T-independent antigens. In the absence
of T-cell help, PS stimulated B-cells predominantly produce IgM antibodies; there is generally
no affinity maturation of the antibodies, and no memory B-cells are generated. As vaccines,
PSs are associated with poor or absent immunogenicity in infants less than 24 months of age
and failure to induce immunological memory at any age. Conjugation of PSs to a protein
carrier overcomes the T-cell independent nature of PS antigens. Protein carrier specific Tcells provide the signals needed for maturation of the B-cell response and generation of Bcell memory. Conversion of Streptococcus pneumoniae PSs to a T-cell dependent antigen by
covalent coupling to the immunogenic protein carrier CRM197 enhances the antibody
response and induces immune memory. This has been demonstrated to elicit booster
responses on re-exposure in infants and young children to pneumococcal polysaccharides.
Indications for use: Active immunisation for the prevention of disease caused by
Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F
(including invasive disease, pneumonia and acute otitis media) in infants and children from 6
weeks up to 17 years of age. Active immunisation for the prevention of pneumococcal
disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C,
19A, 19F and 23F in adults aged 50 years and older.
Contraindications for use: Hypersensitivity to the active substances or to any of the
excipients, or to diphtheria toxoid. Allergic reaction or anaphylactic reaction following prior
administration of Prevenar.
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Adverse effects
Very common: fever, any injection site erythema, induration/swelling or pain/tenderness;
injection site erythema or induration/swelling 2.5-7.0 cm (after toddler dose and in older
children [age 2 to 5 years]).
Common: fever greater than 39deg. C, injection site erythema or induration/swelling 2.5-7.0
cm (after infant series); injection site pain/tenderness interfering with movement.
Uncommon: injection site induration/swelling or erythema greater than 7.0 cm.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccination - Pneumococcal
Drug generic name: 23vPPV (Pneumovax 23)
Poisons schedule: S4
Dosage range: single dose of Pneumovax 23 0.5 mL
Route: Subcutaneous or intramuscular as per manufacturer recommendation on
administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions:
Indications for use: Pneumovax is indicated for immunisation of individuals in the following
situations.
• All individuals over the age of 65 years.
• Individuals with asplenia, either functional or anatomical, including sickle cell disease,
in persons more than 2 years of age; where possible the vaccine should be given at
least 14 days before splenectomy.
• Immunocompromised patients at increased risk of pneumococcal disease (e.g.
patients with HIV infection before the development of AIDS, nephrotic syndrome,
multiple myeloma, lymphoma, Hodgkin's disease and organ transplantation).
• Aboriginal and Torres Strait Islander people over 50 years of age.
Immunocompetent persons at increased risk of complications from pneumococcal
disease because of chronic illness (e.g. chronic cardiac, renal or pulmonary disease,
diabetes mellitus, alcoholism and cirrhosis).
• Patients with cerebrospinal fluid leaks.
Contraindications for use: Hypersensitivity to any component of the vaccine.
Adverse effects - Intradermal administration may cause severe local reactions
Common – fever (less than or equal to 38.8deg. C), injection site reactions including
soreness, erythema, warmth, swelling and local induration.
Rare – Cellulitis like reaction at injection site.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccination - Haemophilus influenzae type b capsular polysaccharide.
Drug generic name: Hib (Hiberix)
Poisons schedule: S4
Dosage range: single dose of 0.5 mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Induce anti-PRP antibodies above the level known to be protective against invasive
disease due to Haemophilus influenzae type b. An anti-PRP antibody titre greater than or
equal to 0.15 microgram/mL correlates with immediate protection against Hib infection and
greater than or equal to 1.0 microgram/mL correlates with long-term protection.
Indications for use: Active immunisation against Haemophilus influenzae type b infection in
children aged from two months to five years.
Contraindications for use: Known hypersensitivity to any component of the vaccine, or
subjects having shown signs of hypersensitivity after previous administration of Hib vaccines.
As for any vaccine, Hiberix should not be administered to subjects suffering from acute
severe febrile illness. However, the presence of minor infection does not contraindicate
vaccination.
Adverse effects
Very Common – Fever, erythematous rash, injection site reaction, redness, pain and
swelling at injection site.
Common – Loss of appetite, vomiting, diarrhoea, conjunctivitis, otitis media, rhinitis,
coughing, respiratory disorder, upper respiratory tract infection and bronchitis,
Uncommon - Sweating increased, purpura and abdominal pain.
Rare – Loss of appetite, vomiting, diarrhoea. Uncommon: spastic paralysis, insomnia,
emotional lability, restlessness and unusual crying
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccination - Poliomyelitis
Drug generic name: IPV (Ipol)
Poisons schedule: S4
Dosage range: Single Dose 0.5 m/L
Route: Subcutaneous - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions:
Indications for use: Ipol is indicated for active immunisation of infants, children and adults
for the prevention of poliomyelitis. Recommendations for the use of live and inactivated
poliovirus vaccines are described in the national immunisation guidelines.
1. General recommendations.
It is recommended that all infants, unimmunised children and adolescents not previously
immunised be vaccinated routinely against paralytic poliomyelitis. Ipol should be offered to
patients who have refused OPV, or in whom OPV is contraindicated.
2. Ipol is also indicated for: the primary vaccination of immunocompromised individuals of all
ages (see Precautions), and household contacts of such individuals (when vaccination is
indicated); unvaccinated or inadequately vaccinated* adults, particularly if at increased risk
of exposure to live poliovirus, including: travellers to areas or countries where poliomyelitis is
epidemic or endemic;
laboratory workers handling specimens which may contain
polioviruses; healthcare workers in close contact with patients who may be excreting
polioviruses.
Contraindications for use: Known systemic hypersensitivity to any component of Ipol or
serious reaction after previous administration of the vaccine or vaccine containing the same
substances. Vaccination should be postponed in cases of febrile or acute disease.
Adverse effects
Common – local reactions at injection site and fever
Very rare – lymphadenopathy, injection site oedema, injection site pain, injection site rash or
injection site mass within 48 hours
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Diptheria, Tetanus, Pertussis
Drug generic name: dTPA (boostrix)
Poisons schedule: S4
Dosage range: 0.5 mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Boostrix (dTpa vaccine) induces antibodies against all vaccine components.
Indications for use: Booster vaccination against diphtheria, tetanus and pertussis of
individuals aged ten years and older.
Contraindications for use: Boostrix should not be administered to subjects with known
hypersensitivity to any component of the vaccine, or to subjects having shown signs of
hypersensitivity after previous administration of diphtheria, tetanus or pertussis vaccines.
As with other vaccines, the administration of Boostrix should be postponed in subjects
suffering from acute severe febrile illness. The presence of a minor infection, however, is not
a contraindication.
Boostrix is contraindicated if the subject has experienced an encephalopathy of unknown
aetiology, occurring within seven days following previous vaccination with pertussis
containing vaccine. In these circumstances, pertussis vaccination should be discontinued
and the vaccination course should be continued with diphtheria and tetanus vaccines.
Boostrix should not be administered to subjects who have experienced transient
thrombocytopenia or neurological complications following an earlier immunisation against
diphtheria and/or tetanus.
Adverse effects
Common – crying, irritability, drowsiness, limb swelling in children,
Vaccines containing polio antigen: vomiting, diarrhoea, loss of appetite
Infrequent - lethargy, myalgia, malaise
Rare – Urticaria, peripheral neuropathy, encephalopathy, seizure, limb swelling (adults),
hypotonic-hyporesponsive episodes.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Diptheria/Tetanus
Drug generic name: dT (ADT)
Poisons schedule: S4
Dosage range: 0.5 mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Following intramuscular injection, ADT Booster stimulates the immune system with
the effect that antibodies are formed that protect against the diseases caused by exposure to
Corynebacterium diphtheriae and Clostridium tetani. Protection against diphtheria and
tetanus can be expected to last for up to ten years.
Indications for use: Vaccination of children (greater than or equal to 5 years of age) and
adults who have previously received at least three doses of a vaccine for primary
immunisation against diphtheria and tetanus. ADT Booster is not intended for primary
immunisation against diphtheria and tetanus.
Contraindications for use: ADT Booster should not be administered to subjects who have
previously experienced a serious reaction (e.g. anaphylaxis) to this vaccine or who are
known to be hypersensitive to any of the vaccine components.
Adverse effects:
Common – Malaise, fever greater than or equal to 38deg. C, redness/ swelling at the
injection site. Uncommon: redness/ swelling greater than or equal to 6 cm at the injection
site. Rare: high fever > 40deg. C, granuloma or sterile abscess at the injection site.
Infrequent – Eczema, dermatitis.
Rare – Anaphylactic reactions, urticarial reactions.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Hepatitis B
Drug generic name: H-B-Vax II 40mcg – (Dialysis formulation)
Poisons schedule: S4
Dosage range: 40mcg
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Clinical studies have established that H-B-Vax II, when injected into the deltoid
muscle, induced protective levels of antibody (defined as greater than or equal to 10 mIU/mL
anti-HBs) in 96% of 1,213 healthy adults who received the recommended three dose
regimen.
Indications for use: -B-Vax II is indicated for immunisation against infection caused by all
known subtypes of hepatitis B virus. Adolescent vaccination is not necessary for children
who have received a primary course of hepatitis B vaccine. Vaccination is recommended in
adults who are at substantial risk of hepatitis B virus infection and have been demonstrated
or judged to be susceptible. Vaccination of individuals who have antibodies against hepatitis
B virus from a previous infection is not necessary.
Contraindications for use: Hypersensitivity to any component of the vaccine.
Hypersensitivity to yeast (Saccharomyces cerevisiae). Patients who develop symptoms
suggestive of hypersensitivity after an injection should not receive further injections of H-BVax II.
Adverse effects
Common – transient injection site reactions (pain, redness, itching, swelling or burning,
small hard lump that may persist for some weeks), transient fever, fainting (more common in
adolescents).
Rare – malaise, myalgia, arthralgia, lymphadenopathy, peripheral neuropathy, delayed
hypersensitivity reactions.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations - Influenza A&B
Drug generic name: Fluvax
Poisons schedule: S4
Dosage range: 0.5mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Induce antibodies to the viral surface glycoproteins, haemagglutinin and
neuraminidase. These antibodies are important in the prevention of natural infection.
Seroprotection is generally obtained within 2 to 3 weeks. The duration of post vaccination
immunity to homologous strains or to strains closely related to the vaccine strains varies, but
is usually 6 to 12 months.
Indications for use: For the prevention of influenza caused by influenza virus types A and
B.
Contraindications for use: Fluvax vaccine must not be used in children under 5 years.
Anaphylactic hypersensitivity to previous influenza vaccination or to eggs, neomycin,
polymyxin B sulfate or any of the constituents or trace residues of this vaccine.
Immunisation must be postponed in people who have febrile illness or acute infection.
Adverse effects:
Common – Fever, malaise, myalgia, headache (these reactions may last 1–2 days).
Infrequent - Transient injection site reactions (pain, redness, itching, swelling or burning,
small hard lump that may persist for some weeks), transient fever, fainting (more common in
adolescents).
Rare – Allergic reactions (hives, angioedema, asthma, anaphylaxis).
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Measles,Mumps and Rubella (MMR)
Drug generic name: Priorix (Live Vaccine)
Poisons schedule: S4
Dosage range: 0.5mL
Route: Subcutaneous/intramuscular - as per manufacturer recommendation on
administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions:
Indications for use: Prevention of measles, mumps and rubella, Immunosuppression.
Children with history of seizures—may require treatment to reduce fever 5–12 days after
vaccination, see Paracetamol.
Untreated TB—MMR vaccination may theoretically exacerbate the condition; vaccinate when
TB is being treated.
Treatment with immunoglobulins, other blood products (excluding washed red blood cells)—
may interfere with the immune response; see the latest Australian Immunisation Handbook
for the recommended interval before giving MMR vaccine (varies depending on blood
product and its dosage; may be up to 11 months). If immunoglobulin or blood products are
given within 3 weeks after an MMR vaccine, test for immunity after 6 months or revaccinate
after recommended interval.
Contraindications for use: History of anaphylaxis Treatment with immunoglobulins—may
interfere with the immune response to some live virus vaccines; seek specialist advice.
Adverse effects
Common – Headache, fever (usually 5–12 days after vaccination, lasting 2–3 days); arthritis
and arthralgia (in women), sore throat, lymphadenopathy and rash may occur 1–3 weeks
after vaccination and are usually transient
Infrequent - Febrile seizures, parotid swelling; arthritis and arthralgia (in children) may occur
1–3 weeks after vaccination and are usually transient.
Rare – Allergic reactions including anaphylaxis
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Varicella Zoster Virus
Drug generic name: Varivax
Poisons schedule: S4
Dosage range: 0.5 mL
Route: Subcutaneous - as per manufacturer recommendation on administration
Frequency of administration: Once
Duration of order: As per vaccination protocol (Appendix 1)
Actions:
Indications for use: Varicella vaccine: Prevention of varicella (chickenpox).
Zoster vaccine: Prevention of herpes zoster (shingles) in people >50 years, and reduction of
zoster-associated pain in people >60 years
Contraindications for use:
•
•
•
•
•
•
•
•
•
•
A history of hypersensitivity to any component of the vaccine, including
gelatin.
A history of anaphylactoid reaction to neomycin (each dose of reconstituted
vaccine contains trace quantities of neomycin).
Individuals with blood dyscrasias, leukaemia, lymphomas of any type, or other
malignant neoplasms affecting the bone marrow or lymphatic systems.
Individuals receiving immunosuppressive therapy. Individuals who are on
immunosuppressant drugs are more susceptible to infections than healthy
individuals.
Vaccination with live attenuated varicella vaccine can result in a more
extensive vaccine associated rash or disseminated disease in individuals on
immunosuppressant doses of corticosteroids.
Individuals with primary and acquired immunodeficiency states, including
those who are immunosuppressed in association with AIDS or other clinical
manifestations of infection with human immunodeficiency virus; cellular
immune
deficiencies;
and
hypogammaglobulinaemic
and
dysgammaglobulinaemic states.
A family history of congenital or hereditary immunodeficiency, unless the
immune competence of the potential vaccine recipient is demonstrated.
Active untreated tuberculosis.
Any febrile respiratory illness or other active febrile infection.
Pregnancy; the possible effects of the vaccine on fetal development are
unknown at this time. However, wild-type varicella is known to sometimes
cause fetal harm. If vaccination of postpubertal females is undertaken,
pregnancy should be avoided for three months following vaccination.
Adverse effects:
Common – Transient injection site reactions (pain, redness, itching, swelling or burning,
small hard lump that may persist for some weeks), transient fever, fainting (more common in
adolescents).
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Varicella vaccines: Mild papular-vesicular rash (usually within 5–26 days),
Zoster vaccine: headache, haematoma.
Rare – Allergic reactions including anaphylaxis.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Meningococcal
Drug generic name: Menactra (Meningococcal)
Poisons schedule: S4
Dosage range: 0.5 mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: once
Duration of order: As per vaccination protocol (Appendix 1)
Actions: The presence of bactericidal anticapsular meningococcal antibodies has been
associated with protection from invasive meningococcal disease. Menactra vaccine induces
the production of bactericidal antibodies specific to the capsular polysaccharides of
serogroups A, C, Y and W-135.
Indications for use:
• Menactra vaccine is indicated for active immunisation of individuals 2 through 55
years of age for the prevention of invasive meningococcal disease caused by N.
meningitidis serogroups A, C, Y and W-135.
• Menactra vaccine is not indicated for the prevention of meningitis caused by other
microorganisms or for the prevention of invasive meningococcal disease caused by
N. meningitidis serogroup B.
• Menactra vaccine is not indicated for treatment of meningococcal infections.
• Menactra vaccine is not indicated for immunisation against diphtheria.
Contraindications for use:
• Known hypersensitivity to any component of Menactra vaccine including diphtheria
toxoid, or a life threatening reaction after previous administration of a vaccine
containing similar components, are contraindications to vaccine administration.
• Known history of Guillain-Barre syndrome (see Precautions section) is a
contraindication to vaccine administration.
• Vaccination must be postponed in case of febrile or acute disease. However a minor
febrile or nonfebrile illness, such as mild upper respiratory infection, is not usually a
reason to postpone immunisation.
Adverse effects
Common - Headache, irritability, malaise, GI symptoms (eg nausea), loss of appetite, rash.
Bexsero®: fever (70–80%), vomiting, diarrhoea (in infants); myalgia, arthralgia (in
adolescents).
infrequent - Transient injection site reactions (pain, redness, itching, swelling or burning,
small hard lump that may persist for some weeks), transient fever, fainting (more common in
adolescents).
Rare - Allergic reactions including anaphylaxis.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Vaccinations – Human Papillomavirus (HPV)
Drug generic name: Human Papillomavirus Vaccination - Gardasil
Poisons schedule: S4
Dosage range: 0.5 mL
Route: Intramuscular - as per manufacturer recommendation on administration
Frequency of administration: 3 doses – second dose two months after first dose, third
dose six months after the first dose.
Duration of order: As per vaccination protocol (Appendix 1)
Actions: Gardasil contains HPV 6, 11, 16 and 18 L1 VLPs. Each VLP is composed of a
unique recombinant L1 major capsid protein for the respective HPV type. Because the viruslike particles contain no viral DNA, they cannot infect cells or reproduce. Preclinical data
suggest that the efficacy of L1 VLP vaccines is mediated by the development of humoral
immune responses. Induction of antipapillomavirus antibodies with L1 VLP vaccines resulted
in protection against infection. Administration of serum from vaccinated to unvaccinated
animals resulted in the transfer of protection against HPV to the unvaccinated animals. The
induction of a strong anamnestic (immune memory) response has been further demonstrated
in clinical trials.
Indications for use: Prevention of cervical, vulvar, vaginal, anal cancer, precancerous or
dysplastic lesions, genital warts, infection caused by HPV types 6, 11, 16, 18 in females 945.
Contraindications for use: Hypersensitivity to the active substances or to any of the
excipients of the vaccine (see Excipients). Individuals who develop symptoms indicative of
hypersensitivity after receiving a dose of Gardasil should not receive further doses of
Gardasil.
Practice Point - observe for 15 minutes post vaccination
Adverse effects:
Common - Transient injection site reactions (pain, redness, itching, swelling or burning,
small hard lump that may persist for some weeks), transient fever, fainting (more common in
adolescents).
Rare - Allergic reactions including anaphylaxis.
Indications for use in practice: Use in conjunction with the vaccinations protocol
described in Appendix 1
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Drug generic name: Tranexamic Acid
Poisons schedule: S3 for 36 (blister pack) tablets/S4 for all other presentations
Dosage range: 500-1000mg up to three times daily
Route: Oral
Frequency of administration: from 1-3 times daily
Duration of order: 30 days
Actions: Tranexamic acid is a competitive inhibitor of plasminogen activation and at much
higher concentrations a non-competitive inhibitor of plasmin, thus implying that tranexamic
acid interferes with the fibrinolytic process in the same way as aminocaproic acid.
Indications for use: Short-term use in the treatment of hyphaemia and in patients with
established coagulopathies who are undergoing minor surgery and menorrhagia.
Contraindications for use: Patients with a history or risk of thrombosis should not be given
tranexamic acid, unless at the same time it is possible to give treatment with anticoagulants.
Active thromboembolic disease such as deep vein thrombosis (DVT), pulmonary embolism
and cerebral thrombosis. The preparation should not be given to patients with acquired
disturbances of colour vision. If disturbances of colour vision arise during the course of
treatment, the administration of the preparation should be discontinued.
Patients with subarachnoid haemorrhage should not be given tranexamic acid as anecdotal
experience indicates that cerebral oedema and cerebral infarction may be caused in such
cases. Hypersensitivity to tranexamic acid or any of its excipients.
Adverse effects
Common - Nausea, vomiting, diarrhoea.
Rare - Thrombosis, visual disturbances including transient disturbance of colour vision.
Allergic skin reactions.
Indications for use in practice: Prescribed only after consultation with the patients
treating consultant haematologist. Patients with end stage haematological
malignancy experiencing bleeding with an acceptable platelet count of more than
10x10*9/L. Not for patients who have a clotting disorder or receiving anti-coagulation
therapy unless directed by the patients treating haematologist.
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date: _______________________
Formulary Monograph
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Drug generic name: Norethisterone
Poisons schedule: S4
Dosage range: 5-10mg
Route: Oral
Frequency of administration: 1 or 2 tablets, 1-3 times daily
Duration of order: 30 days
Actions: Norethisterone is a progestogen with negligible androgenic effects. Complete
transformation of the endometrium from a proliferative to a secretory state was achieved in
oestrogen primed castrated or climacteric women who were administered oral doses of
norethisterone 100-150 mg/cycle. The progestogenic effects of norethisterone on the
endometrium is the basis of the treatment of dysfunctional bleeding, primary and secondary
amenorrhoea and endometriosis with Primolut N.Gonadotropin secretion inhibition and
anovulation can be achieved with a daily intake of norethisterone 0.5 mg. Positive effects of
Primolut N on premenstrual symptoms can be traced back to suppression of ovarian
function. Due to the stabilising effects of norethisterone on the endometrium, administration
of Primolut N can be used to shift the timing of menstruation. Like progesterone,
norethisterone is thermogenic and alters the basal body temperature.
Indications for use: Dysfunctional bleeding; primary, sec amenorrhoea; premenstrual
syndrome; delay menstruation; endometriosis; oestrogen replacement therapy (adjunct).
Contraindications for use: Presence or history of thrombosis, thromboembolism (e.g. DVT,
PE, MI), CVA; thrombosis prodromi (e.g. TIA, angina); history of migraine with focal
neurological symptoms; severe hepatic dysfunction (or history) with abnormal Liver function
tests; liver tumour (including history); diabetes with vascular involvement; known, suspected
sex hormone dependent malignancy; Dubin-Johnson, Rotor syndrome; missed abortion;
undiagnosed genitourinary bleeding, breast disease; pregnancy (including suspected),
lactation.
Adverse effects
Caution in patients with a history of depression, diabetes, Fluid retention
Contraception: reversible ovarian cysts.
Common - menstrual irregularity, prolonged bleeding, spotting, amenorrhoea, breast
tenderness, depression, acne.
Infrequent – nausea, vomiting, headache, dizziness, lethargy.
Rare - cholestatic jaundice, decreased libido, androgenic effects (hirsutism, greasy hair),
anaphylactic reaction.
Indications for use in practice: Prescribed only after consultation with the patients
treating consultant haematologist. To delay menstruation during the course of
chemotherapy treatment and/or stem cell transplantation until bone marrow recovery
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date:
Author: Christina Crosbie
V1.2
Effective:
______________________
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Drug generic name: Voriconazole
Poisons schedule: S4
Dosage range: 50-200mg twice daily
Route: Oral - Take either 1 hour before or 1 hour after food.
Frequency of administration: As directed by the medical team
Duration of order: As directed by the medical team
Actions: Voriconazole is a triazole antifungal agent. Voriconazole's primary mode of action
is the inhibition of fungal cytochrome P450 mediated 14 alpha-sterol demethylation, an
essential step in ergosterol biosynthesis. Voriconazole is more selective than some other
azole drugs for fungal as opposed to various mammalian cytochrome P450 enzyme systems.
The subsequent loss of normal sterols correlates with the accumulation of 14 alpha-methyl
sterols in fungi and may be responsible for its fungistatic/ fungicidal activity.
Indications for use: For treatment of the following fungal infections. Invasive aspergillosis.
Serious Candida infections (including Candida krusei), including oesophageal and systemic
Candida infections (hepatosplenic candidiasis, disseminated candidiasis, candidaemia).
Serious fungal infections caused by Scedosporium sp. and Fusarium sp. Other serious
fungal infections, in patients intolerant of, or refractory to, other therapy. Prophylaxis in
patients who are at high risk of developing invasive fungal infections. The indication is based
on studies including patients undergoing haematopoietic stem cell transplantation.
Contraindications for use:
• Known hypersensitivity to voriconazole or to any of the excipients. Coadministration
of the CYP3A4 substrates pimozide or quinidine with voriconazole is contraindicated
since increased plasma concentrations of these medicinal products can lead to QTc
prolongation and rare occurrences of torsades de pointes.
• Coadministration of voriconazole with rifabutin, rifampicin, carbamazepine and long
acting barbiturates (e.g. phenobarbitone) is contraindicated since these medicinal
products are likely to decrease plasma voriconazole concentrations significantly.
• Coadministration with efavirenz at a dose of 400 mg once daily or above is
contraindicated because efavirenz significantly decreases plasma voriconazole
concentrations in healthy subjects at this dose.
• Coadministration of voriconazole with high dose ritonavir (400 mg and above twice
daily) is contraindicated because ritonavir significantly decreased plasma
voriconazole concentrations in healthy subjects at this dose.
• Coadministration of ergot alkaloids (ergotamine, dihydroergotamine), which are
CYP3A4 substrates, is contraindicated since increased plasma concentrations of
these medicinal products can lead to ergotism.
• Coadministration of voriconazole and sirolimus is contraindicated, since voriconazole
is likely to increase plasma concentrations of sirolimus.
• Coadministration of voriconazole with St John's Wort is contraindicated.
Adverse effects:
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Common – Sinusitis, thrombocytopenia, anaemia, leukopenia, pancytopenia, hypokalaemia,
hypoglycaemia, hallucinations, confusion, depression, anxiety, agitation, headache,
dizzyness, tremor, paraesthesia, rash, face oedema, maculopapular rash, back pain,
elevated liver function, increased creatinine, acute kidney failure, fever.
Infrequent – Lymphadenopathy, agranulocytosis, eosinophilia, disseminated intravascular
coagulation, marrow depression, allergic reaction, anaphylactiod reaction, adrenal cortex
insufficiency, hypercholesterolaemia, chills.
Rare – Hyperthyroidism, hypothyroidism, Guillain-Barre syndrome, insomnia, angioedema.
Indications for use in practice: Initial prescription will be at the instruction of the
patients treating consultant and Infectious Diseases (ID). Subsequent prescriptions
will be for repeat prescriptions only and only after discussion with the patients treating
consultant haematologist and or ID.
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date:
Author: Christina Crosbie
V1.2
Effective:
______________________
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Formulary Monograph
Drug generic name: Posaconazole
Poisons schedule: S4
Dosage range: 200-400mg: as directed by the medical team
Route: Oral
Frequency of administration: As directed by the medical team
Duration of order: As directed by the medical team
Actions: Posaconazole is a triazole antifungal agent. It is an inhibitor of the enzyme
lanosterol 14alpha-demethylase, which catalyses an essential step in ergosterol
biosynthesis. Ergosterol depletion, coupled with the accumulation of methylated sterol
precursors, is thought to impair membrane integrity and the function of some membrane
associated proteins. This results in the inhibition of cell growth and/or cell death.
Indications for use:
• For use in the treatment of the following invasive fungal infections in patients 13 years
of age or older.
• Invasive aspergillosis in patients intolerant of, or with disease that is refractory to,
alternative therapy.
• Fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis and mycetoma
in patients intolerant of, or with disease that is refractory to, alternative therapy.
Noxafil is also indicated for the following:
•
•
Treatment of oropharyngeal candidiasis in immunocompromised adults, including
patients with disease that is refractory to itraconazole and fluconazole.
Prophylaxis of invasive fungal infections among patients 13 years of age and older,
who are at high risk of developing these infections, such as patients with prolonged
neutropenia or haemopoietic stem cell transplant (HSCT) recipients.
Contraindications for use:
• Noxafil is contraindicated in patients with known hypersensitivity to posaconazole or
to any of the excipients.
• Coadministration
of
posaconazole
and
ergot
alkaloids
(ergotamine,
dihydroergotamine) is contraindicated as posaconazole may increase the plasma
concentration of ergot alkaloids, which may lead to ergotism (see Interactions with
Other Medicines).
• Coadministration with the HMG-CoA reductase inhibitors that are primarily
metabolised through CYP3A4 is contraindicated since increased plasma
concentration of these drugs can lead to rhabdomyolysis.
• Although not studied in vitro or in vivo, coadministration of posaconazole and certain
drugs metabolised through the CYP3A4 system (terfenadine, astemizole, cisapride,
pimozide and quinidine) may result in increased plasma concentrations of those
drugs, leading to potentially serious and/or life threatening adverse events, such as
QT prolongation and rare occurrences of torsades de pointes (see Interactions with
Other Medicines).
Author: Christina Crosbie
V1.2
Effective:
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Adverse effects:
Common – Neutropenia, fever, rash, headache, dizziness nausea, vomiting, abdominal
pain, diarrhoea, elevated liver enzymes.
Infrequent – Hypokalaemia, respiratory insufficiency, oedema constipation.
Rare – adrenal insufficiency, tongue or facial oedema, thrombocytopenia, other blood
dyscrasias, serious hepatotoxicity including hepatic failure, anaphylactic/anaphylactoid
reactions, alopecia (especially with prolonged courses), peripheral neuropathy (more
common with long-term use).
Indications for use in practice: Initial prescription will be at the instruction of the
patients treating consultant and Infectious Diseases (ID). Subsequent prescriptions
will be for repeat prescriptions only and only after discussion with the patients treating
consultant haematologist and/or ID..
Endorsed By: ____________________________________________________
Date: ________________________
Effective Date: _______________________
Review Date:
Author: Christina Crosbie
V1.2
Effective:
______________________
Christina Crosbie – Sir Charles Gairdner Hospital – Nurse Practitioner Haematology Clinical
Protocol Amendment
Appendix 1
Author: Christina Crosbie
V1.2
Effective:
Author: Christina Crosbie
Version 1.2
Effective: August 2014 – Review: 2017
Author: Christina Crosbie
V1.2
Effective:
Author: Christina Crosbie
V1.2
Effective:
Author: Christina Crosbie
V1.2
Effective: