Medicines Report: Review of the Medicines Lists

Transcription

Appendix 7
Medicines Report: Review of the Medicines Lists
September 2014
Contents
1
2
3
4
5
6
7
THE REVIEW PROCESS ................................................................................................................... 2
1.1
General principles of the review .......................................................................................... 2
TERMINOLOGY FOR PRESCRIBING REQUIREMENTS ........................................................................... 3
UNAPPROVED MEDICINES AND UNAPPROVED USES OF MEDICINES .................................................... 3
THE COMMUNITY NURSE PRESCRIPTION MEDICINES LIST .................................................................. 5
4.1
Medicines suggested to be removed or restricted by submitters ........................................ 5
4.2
Medicines suggested to be added by submitters ................................................................ 6
4.3
Other medicines removed from the list ............................................................................. 13
4.4
Medicines to be retained with conditions or in combinations ............................................ 13
4.5
Medicines to be removed from the prescription list ........................................................... 15
4.6
Medicines to be included on both the prescription and non-prescription lists .................. 22
THE SPECIALIST NURSE PRESCRIPTION MEDICINES LIST ................................................................. 22
5.1
General medicines ............................................................................................................ 23
5.2
Mental Health medicines ................................................................................................... 32
CONTROLLED DRUGS LIST ............................................................................................................ 54
6.1
Conditions for prescribing controlled drugs ....................................................................... 54
6.2
Council decisions controlled drugs.................................................................................... 56
SPECIALIST OPHTHALMOLOGY MEDICINES ..................................................................................... 62
List of Tables
Table 1: Community nurse list- Medicines suggested to be removed or modified by submitters
(Attachment 1)
Table 2: Community nurse list- Medicines suggested to be added by submitters
Table 3: Community nurse list- Other medicines removed
Table 4: Community nurse list- Other Medicines Modified
Table 5: Community nurse list- Other Medicines transferred to the non-prescription list
Table 6: Community nurse list- Other Medicines included on the prescription and non-prescription
lists
Table 7: Response to submitters suggestions for the Specialist Nurse prescription medicines list
(Attachment 2)
Table 8: Other general medicines to add, remove or restrict
Table 9: Review of antidepressants
Table 10: Review of antipsychotics
Table 11: Review of other common mental health medicines
Table 12: Review of addiction medicines
Table 13: Response to submitters’ feedback to remove or add Controlled Drugs
Table 14: Medicines submitters requested to be added for specialist ophthalmology services
68
7
13
14
16
22
84
24
37
44
50
52
57
63
1
1
The review process
The Council consulted on two prescription lists for “specialist nurse prescribing”. Both lists
have been reviewed according to the principles outlined below. This report covers “the
community nurse prescription medicines list”, and the “specialist nurse prescription
medicines list” divided into general medicines and mental health medicines. The list of
controlled drugs and a list of specialist ophthalmology medicines suggested by submitters
are also included.
1.1
General principles of the review
The following considerations have informed the review of the list.
1. Medicines and classes that are high risk or have complex diagnostic or close
monitoring requirements have in many cases been excluded.
2. Health Legal (Ministry of Health) have advised the Council that the list does not have
to conform exactly to the language of the Medicines Regulations. Community
pharmaceutical names, combinations and restrictions related to route, context and
collaboration are used to provide greater clarity about the specific form of the
medicine and the circumstances under which it can be prescribed.
3. PHARMAC restrictions have influenced the list. In some but not all cases medicines
that are not subsidised by PHARMAC have been removed. This is based on a
decision not to future proof the list as the Medicines Amendment Act 2013 has been
passed and lists will be published as Gazette notices rather than as part of the
regulation. This should enable them to be regularly updated. The Ministry of Health
has not been able to confirm this process yet.
4. Other PHARMAC mechanisms such as “specialist only” and “retail pharmacy
specialist” have led to some medicines being recommended to be removed.
PHARMAC have indicated that they would consider nurse prescribers being able to
repeat prescribe “Special Authority”1 medicines so some of these medicines have
been recommended to be included.
5. Best practice guidelines from the New Zealand Formulary, Nice (National Institute for
Health and Care Excellence) and BPAC (Best Practice Advisory Centre) have been
consulted and have influenced the list and informed the evidence.
6. Antibiotic resistance has been further considered. Antibiotic stewardship and best
practice guidelines have been followed and antibiotics have been removed if they
require a specialist recommendation. Further emphasis has been included in the
prescribing education programme standards.
7. Some unapproved medicines, that may be useful for patients, are not permitted to be
prescribed except by medical practitioners under section 29 of the Medicines Act and
1
Special Authority is an application process in which a prescriber requests government subsidy on a
Community Pharmaceutical for a particular person (http://www.health.govt.nz/new-zealand-healthsystem/claims-provider-payments-and-entitlements/special-authority)
2
have therefore been recommended to be removed (see section below for further
discussion).
8. Some medicines are restricted under section 23 of the Medicines Act or Regulation
22 of the Misuse of Drugs Act that require initiation by specialist doctors.
9. Some medicines were identified for unapproved uses or for unapproved patient
groups under section 25 of the Medicines Act. Unless there is clear evidence that
the medicine is widely used for this indication and its use is supported by evidence it
is not recommended to be included on the list.
10. The boundaries of the original proposal have been considered when reviewing the
list i.e. that this was a prescribing authority for nurses working in community and
ambulatory services not for inpatient ward or unit nurses.
11. Decisions about the scope of registered nurse prescribing have been made in
conjunction with the medicines review. Certain areas included in the initial proposal
or suggested by submitters are considered outside of scope because of diagnostic or
prescribing complexity. Examples of these areas are epilepsy, schizophrenia,
psychosis and bipolar.
2
Terminology for prescribing requirements
Various terminology has been used to indicate the prescribing requirements to be placed on
the list next to medicines to restrict the form or circumstances of prescribing some
medicines. These usually related to route of administration or the requirement that the nurse
does not initiate a medicine. The Ministry of Health has not been able to give any advice on
the wording to be used.
Rather than “do not initiate” or “repeat prescribe” which is used with another meaning in
general practice the Council has adopt the term “continuation prescribing”. A definition
adapted from the College of Registered Nurses of British Columbia is that: “The doctor or
nurse practitioner initiates the drug therapy and the registered nurse prescriber assumes
responsibility and authority for the continuation of the drug therapy, including ongoing
assessment and monitoring, re-ordering and/or making adjustments to the drug therapy, and
referral as needed.”
3
Unapproved medicines and unapproved uses of medicines
Medicines are approved for use in New Zealand by the Minister of Health on the advice of
Medsafe (Medicines and Medical devices safety authority). When a medicine is approved, it
is only approved for the specific indications, doses and routes of administration that were
applied for (Best Practice Journal, 2013)2. If an approved medicine is prescribed outside of
the approved indications, dose range or route of administration this is an unapproved use of
a medicine. This is permitted under section 25 of the Act and known as “off label” use. Many
medicines have not been approved for use in children because clinical trials have not been
2
Best Practice Journal. (2013). Upfront: Unapproved medicines and unapproved uses of medicines:
keeping prescribers and patients safe. Best Practice Journal. Issue 51
3
completed to demonstrate safety although they are often prescribed for them. Some
medicines are approved overseas for indications but have not been through an updating
approval process in NZ.
The term 'off label' refers to use of a medicine outside the specified indications or
intended purpose for example:




for an indication or intended use not mentioned in the data sheet or the package
label
in a different population to that intended (e.g., children or pregnant women)
at a different dose to that recommended
via a different route of administration
If the recommended use of a medicine changes with the result that a patient is now
taking the medicine 'off label' the patient should be informed. The patient and prescriber
will need to make a joint decision on treatment options. In New Zealand there is no legal
barrier to 'off label' medicine use providing that the Code of Health and Disability
Services Consumers’ Rights 1996 is followed.
http://www.medsafe.govt.nz/safety/EWS/q-and-a-hprofs.asp#off-labe
http://www.medsafe.govt.nz/profs/RIss/unapp.aspl
An unapproved medicine is a medicine for which consent has not been given by the Minister.
It can still be prescribed by a designated prescribers (under section 25) but only supplied by
a pharmacist when prescribed by a medical practitioner (under section 29). There is also a
requirement for the medical practitioner to get written informed consent. For this reason all
unapproved medicines have not been added to the list of medicines.
Medsafe provides advice to prescribers on how to safely comply with the Medicines Act
when prescribing approved medicines for unapproved indications (under section 25) and
also on complying with the Code of Health and Disability Consumers Rights. The prescriber
has an obligation to ensure the treatment, whether approved or unapproved, meets
appropriate ethical and professional standards. Consumers have the right to be fully
informed. Prescribers must decide whether the use of the medicine is legitimate (“supported
by evidence and considered appropriate”) and whether there are any safety concerns.
Unapproved medicines and unapproved indications have been identified where known.
Generally if a medicine is unapproved for an indication it has been removed. Where there is
considered to be enough evidence for the medicine to be legitimately prescribed for an
unapproved indication and it is part of usual practice, the medicine has been recommended
to be kept. However it does create some difficulties as the medicine in some cases is
being restricted to an unapproved use.
4
4
The community nurse prescription medicines list
The Council consulted on specialist nurse prescribers being able to access both the
“community nurse prescribing” and “specialist nurse prescribing” lists of medicines. The
community nurse prescribing medicines list was supported by half the submitters. Some of
the feedback on this list relates specifically to the community nurse prescribing proposal i.e.
the proposal that community nurse prescribers undertook a short course to prescribe all the
medicines on this list was not supported by half of the submitters. Many submitters
commented on the community list as being too extensive, not confined to minor ailments,
and there were too many medicines for the length of the course.
This review of the community list is for nurses who have experience in a specialty or
generalist area and a post graduate diploma in registered nurse prescribing. The concerns
raised by submitters that are relevant to this are: the inclusion of what were considered to
be inappropriate medicines, PHARMAC restrictions, the importance of subsidies,
incorporating best practice, concerns about antibiotics and clarifying the route of
administration and specifying repeat or collaborative prescribing.
The following advice and recommendations on the medicines have been developed for this
application and would not necessarily be the same for a community nurse prescribing
proposal.
4.1
Medicines suggested to be removed or restricted by submitters
Submitters identified specific medicines or classes of medicines they thought should be
removed. Many submitters did not give a specific rationale for their response on a particular
medicine. Where a specific rationale was given this has been included in Table 1
(Attachment 1). A list of submitters can be found in Appendix 12 of the application.
Anti-infectives
Some medicines that were recommended by submitters to be removed are antibiotics
(amoxicillin clavulanate, azithromycin, benazthine penicillin, cefaclor, ceftriaxone,
chloramphenicol, ciprofloxacin, clindamycin, mupirocin, natamycin, tobramycin, fusidic acid),
antivirals (acyclovir, valciclovir) and antifungals (amphotericin, bifonazole, fluconazole,
itraconazole, ketoconazole, terbinafine). Each of these medicines was considered
individually in relation to the specialist nurse areas of practice, antibiotic resistance and
PHARMAC restrictions. Some of these medicines were retained particularly because of the
significant role of nurses in sexual health in normally healthy people. Others have been
retained because of the potential for nurses to prescribe for common infections in primary
health including skin infections and sore throats and rheumatic fever prophylaxis. Some
medicines have been restricted to topical only because of safety and interaction concerns.
The postgraduate diploma in registered nurse prescribing will have a significant component
on common infections and antibiotic resistance. Some anti-infectives have been removed
because they are not available or not subsidised or fall into a non-prescription classification
when used topically.
5
Skin conditions
Several medicines were recommended to be removed by some submitters including
immunosuppresants (cyclosporin, methotrexate) folinic acid (methotrexate rescue therapy)
and anti-acne retinoids (trentinoin) and hormones, and corticosteroids (mometasone,
diflucortolone, clobestalol, hydrocortisone, methylprednisolone). These medicines have
either been removed from the list or specified as topical.
Local anaesthetics
All of these except lignocaine have either been removed or placed on the non-prescription
list. An ocular local anaesthetic has been restricted to ophthalmology specialist service use.
Migraine
Ergotamine and zolmitriptan have been removed for safety reasons.
Ingredients
Alcohol and camphorated oil have been removed.
See Attachment 1: Table 1: Community nurse list- Medicines suggested to be removed or
modified by submitters.
4.2
Medicines suggested to be added by submitters
Immunological products and vaccines
Submitters wanted medicines added to the list particularly medicines related to preventing
communicable diseases. This included childhood and other vaccines and immunoglobulins.
It is recommended that these two classes be added. Many primary care nurses become
authorised vaccinators early in their career. By the time they are specialist nurses it is
appropriate that they could prescribe vaccines rather than work under standing orders or by
delegation of the Medical Officer of Health. Although some of these medicines are not
subsidised they may be appropriate for nurses to prescribe in an occupational or travel
medicine context. Antimalarials were also suggested for prophylaxis for travel.
Most of the other suggestions were medicines that were already on one of the lists but not
identified by the common or brand name. See Table 2: Community nurse list- Medicines
suggested to be added by submitters.
6
Table 2: Community nurse list- Medicines suggested to be added by submitters
Medicine
Likely use
given
Submission
Reasons
Council decision
Rationale
Malarone
Anti malarial
92
Defence force use
Add
Not subsidised. For travellers to
overseas countries as
prophylaxis for malaria.
Particularly suitable for short
trips to highly chloro-quineresistant areas.
Mefloquine
Anti malarial
92
Defence force use
Add
Not subsidised. For travellers to
overseas countries as
prophylaxis for malaria.
Primaquine Phosphate
Anti malarial
92
Defence force use
Do not add
Unapproved medicine Section
29
Vaccines
Vaccine
1, 41, 58, 75, 111
Other vaccines that are not in the
Add class
childhood schedule, should also be
considered (not only cholera and
influenza), particularly for
authorised vaccinators (1).
The list prescription medicines does
not cover vaccines on the National
Immunisation Programme, other
funded vaccination programmes, all
other licenses vaccines and all
immunoglobulin products that may
be used to provide rapid immune
response after recent exposure to
the specific disease e.g. following
Adding a class will avoid
constantly changing the
schedule and enable nurses
who work with private patients
e.g. occupational health nurses
to prescribe. Becoming an
authorised vaccinator is often
an early step for primary health
nurses.
7
Medicine
Likely use
given
Submission
Reasons
Council decision
Rationale
Add
Not currently subsidised but
could be required in an
influenza epidemic. Safety
profile well established.
tetanus prone wounds, birth of baby
of Hepatitis B positive mother and
needs to be update to reflect this
(58).
Anthrax Vaccine (Section 29
Vaccines
unapproved), Cholera Vaccine,
Hepatitis A Vaccine, Hepatitis
B Vaccine, HPV, Influenza
Vaccine, Japanese
Encephalitis Vaccine (? Not
available), MMR Vaccine,
Meningococcal Vaccine,
Plague Vaccine (Section 29
unapproved), Pneumococcal
Vaccine, Polio Vaccine, Rabies
Immunoglobulin, Rabies
Vaccine, Tetanus-DiphtheriaAcellular Pertussis Vaccine,
Typhoid Vaccine, Varicella
Zoster Vaccine
92
Defence force
Oseltamivir
92
Defence force use
Prevention of
influenza
8
Medicine
Likely use
given
Submission
Reasons
Immunoglobulins
Immunisation or 58
prophylaxis
following
exposure
Add all immunoglobulins that may Add class
be used to provide rapid immune
response after recent exposure to
the specific disease. It can be
expected that they would prescribe
as appropriate for their specialty
(58)
Not subsidised but may be
used by Defence Force/paid by
patient.
Methoxyflurane
Inhalation
analgesic
92
Defence force use
Add
For emergency relief of pain by
self-administration in conscious
haemodynamically stable
patients with trauma and
associated pain, under
supervision of personnel trained
in its use and 2. For the relief of
pain in monitored conscious
patients who require analgesia
for surgical procedures such as
the change of dressings.
Entonox
Inhalation
Analgesic
74
Add
Nitrous oxide with oxygen
(Entonox) is indicated in adults
and children for analgesia.
Iodine
Unclear
98, 168, 179,1 87
Pre-pregnancy planning
Council decision
Rationale
Add to non
Multivitamin
prescription list (e.g.
Elevit with iodine)
9
Medicine
Likely use
given
Submission
Reasons
Oxygen
Anaphylaxis
41, 116, 141, 190
Anaphylaxis following immunisation Add
Not classified
Thiamine
Addictions
35, 76, 78, 158
addiction nurses
Move to non
prescription list
On specialist list
35, 61, 76, 78, 158
addictions nurses
Add to non
prescription list
92
Defence force
Already on list
Vitamins (multi)
Ava 30ED
Hormonal
contraceptive
ECP (Postinor 1)
Emergency
71, 155, 158, 156
contraceptive pill
Council decision
Many school nurses are currently
Already on list
ECP endorsed with NCNZ however
have difficulty obtaining the
medication. Being able to prescribe
ECP would overcome this issue.
Alternatively having access to
MPSO (155).
Rationale
Ethinyloestrdiol with
levonogestrol
Consider how this is listed as
not clear.
Would also like to see Postinor
included. This would be the most
frequently required medication for
nurses working within Secondary
Schools and is difficult to currently
access through other providers or
even via ECP endorsement due to
cost. Salbutamol is the other drug
we would like to see included
please (156)
10
Medicine
Likely use
given
Submission
Reasons
Council decision
Rationale
Azithromycin
Antibiotic
92
Defence force
Already on list
Azithromycin
Cotrimoxazole
Antibiotic
92
Defence force
Already on list
Trimethaprim and
sulfamethoxazole
Amoxiclav
Antibiotic
92
Defence force
Already on list
Amoxicillin and clavulanic acid
Hydrocortisone Butyrate
Skin conditions
92
Defence force
Hydrocortisone
already on list
Paramax
Analgesia
92
Defence force
On non prescription
list
Paracetamol and
metoclopramide
Pimfucort
Skin conditions
92
Defence force
Already on list
Hydrocortisone + neomycin,
natamycin
92
Defence force
Already on list
Hyoscine (scopoderm)
Scopolamine
Sodium Chloride solution
Dehydration,
wound care
92
Defence force
Add to non
prescription list
Non prescription medicine
Ultraproct
Haemorrhoids
92
Defence force
Already on list
Cinchocaine with fluocortolone
Adrenaline
Anaphylaxis
41, 116, 190
Required for potential anaphylaxis
administration of vaccines
Already on list
Already included for this
purpose
Bronchodilators
Asthma,
bronchospasm
85
No bronchodilators on the list
On Specialist list
although identified therapeutic area
Salbutamol
Asthma,
bronchospasm
41, 44, 75, 138, 155, Should be on community nurse list
156
Include individual inhalers
On Specialist list
11
Medicine
Likely use
given
Submission
Reasons
Council decision
Ear drops
Ear conditions
87
More ear drops
Some on prescription Add to non prescription
list
Sofradex
Ear conditions
92
Defence force
Already on list
Dexamethasone with
framycetin and gramicidin
Emla cream
Local
anaesthetic
74,
Debridement 74
Already on list
Non prescription non
subsidised list
Xylocaine
Biopseys
74
comment 74
Already on list
Lignocaine
Folic acid
Iron deficiency
98, 179, 187
Add… Folic acid… to the list in view Already on list
of the role of these nurses in health
promotion (98)
Move to non prescription list
Head lice treatment
Head lice
87
More head lice treatments
Premethrin only prescription
and subsidised
On prescription and
non prescription list
Rationale
12
4.3
Other medicines removed from the list
The Council removed seven other medicines from the list because they are not subsidised,
have PHARMAC restrictions, are of dubious value or will be included in the vaccines class.
See Table 3 below.
Table 3: Community nurse list- Other medicines removed
Medicine name
Type of medicine
amorolfine
Antifungal (nails)
Rationale
Partial subsidy only. More effective options that
require much less patient adherence & hence
more chance of success (amorolfine is a topical
lacquer that needs to be applied regularly for 6-12
months).
cholera vaccine
vaccine
Vaccines to be included as a class
idoxuridine
Anti-infective
General Sale, unsubsidised. Available in
combination with lidocaine & benzalkonium
chloride for herpes simplex. Dubious therapeutic
benefit compared with other products (e.g.
aciclovir, etc.).
influenza and
coryza vaccines
vaccine
Vaccines to be included as a class
ipecacuanha
expectorant
Very dubious therapeutic benefit. Not subsidised.
Classification depends on strength, indication, and
age of recipient. General Sale most common
classification.
mestranol
hormonal
contraceptive
Ingredient in Norinyl which is no longer available in
New Zealand.
vitamin supplement
No need for vitamin D. Cholecalciferol is
Prescription Medicine and the recommended form
of vitamin D for prevention of falls.
vitamin D
4.4
Medicines to be retained with conditions or in combinations
Fifteen medicines have been recommended to be retained on the list but to either have the
route or repeat prescribing specified or to have the particular combination specified. This
provides clarity about the exact form of the medicines and route it can be used e.g. ear
drops. Putting some hormonal contraceptives in combinations precludes the individual
medicines being prescribed for hormone replacement therapy.
13
Table 4: Community nurse list- Other Medicines modified
Type of
medicine
Rationale
Requirement
antiviral
Genital herpes can be difficult to
diagnose clinically as around 60% of
cases present with atypical symptoms
and 20% are asymptomatic (BPAC).
Aciclovir can be neurotoxic in renal
impairment e.g. In the elderly.
Herpes simplex (eye) Initiation and
monitoring requires specialist expertise.
Oral continuation
prescribing; not
intravenous; ocular forms
restricted to
ophthalmology specialist
nurses only
antipsoritic
Prescription Medicine, except if supplied
by Pharmacist as a continued supply.
Consider restricting nurse prescribing to
continuation, as is the case for
Pharmacists.
Continuation prescribing
clioquinol
antibacterial/
antifungal
Only subsidised in combination with
betamethasone (for skin) and
flumetasone (in ear drops).
List as an ingredient and
as betamethasone
valerate with clioquinol
and flumethasone pivalate
diclofenac
NSAID
Exclude ocular
Not ocular
erythromycin
antibacterial
Note that IV erythromycin is also fully
subsidised.
Oral only
ethinyloestradiol
hormonal
contraceptive
Hormone replacement therapy not within
scope. Therefore only in combination as
a contraceptive.
Only in combination as a
contraceptive. List with
deogestral ; with
levonorgestrel ; with
norethisterone; with
drospirenone; with
etonogestrel
flucloxacillin
antibacterial
Injection available
antibacterial
Dexamethasone and gramicidin are
Prescription Medicines and ingredients
in Sofradex. Consider listing framycetin
only as an ingredient.
Oral only
List as dexamethasone
with framycetin and
gramicidin and
Framycetin sulphate,
restrict to aural use only
antibacterial
Ingredient in Sofradex with framycetin;
note gramidicin in Viaderm, nystatin
(Nilstat), (Mycostatin)
List but also combinations
with framycetin and
nystatin and restrict to
skin and aural use.
Medicine name
aciclovir
calcipotriol
framycetin
gramicidin
14
Medicine name
Type of
medicine
medroxyprogester
one
hormonal
contraceptive
Rationale
Hormone Replacement Therapy (HRT)
outside of scope. Keep for contraceptive
purposes only.
antibacterial
Prescription Medicine, used as an
ingredient in multi-ingredient products
(including Viaderm KC cream).
Kenacomb
Several products with full or partial
subsidy.
Contraceptive use only
List as triamcinolone +
neomycin sulfate +
gramicidin + nystatin
(kenacomb); (viaderm);
hydrocortisone with
natamycin and neomycin
(Pimafucort cream),
dexamethasone +
neomycin sulfate +
polymyxin B sulfate skin
and aural only
antifungal
Prescription medicine only when NOT
used dermally, vaginally, or for oral
candidiasis. Used alone - topical only.
Used as an ingredient in multi-ingredient
products (including Viaderm KC cream
and Kenacomb ear drops). These are
Prescription Medicines. Keep on list for
multi-ingredient topical preparations
(and oral or vaginal candidiasis), which
will be Prescription Medicines (due to
other ingredients).
List nystatin (Nilstat),
(Mycostatin) but also list
combinations ViadermDermal and aural
neomycin
nystatin
4.5
Restriction
Medicines to be removed from the prescription list
Thirty three medicines have been identified as not being classified in the Medicines
Regulations as prescription medicines in the form that they would be “prescribed” by
registered nurses prescribers. Some of these medicines are also not subsidised. It is
recommended that they are transferred to the non-prescription list. See Table 5: Community
nurse list- Other Medicines transferred to the non-prescription list
15
Table 5: Community nurse list- Other Medicines transferred to the non-prescription list
Community prescription
Type of medicine
medicines for specialist nurse
prescribers
Likely use and NZ
Rationale
formulary indications
Council Decision
Aspirin
Mild to moderate pain;
pyrexia; prevention of
thrombotic
cardiovascular and
cerebrovascular
disease
Antiplatelet use is by far the most common. Antiplatelet
doses are General Sale, but prescription is required for
subsidy.
Non prescription list
Antiplatelet
Apart from a role in treating migraine (which may well be
superseded by the "triptans"), there is a minimal role for
aspirin as an analgesic either alone or in combination.
Safer alternatives (e.g. ibuprofen, paracetamol, etc.) are
preferred. Don't include higher strengths of aspirin on list.
Injectable aspirin in combination with other products isn't a
registered product and isn't subsidised. Don't include.
Non prescription, not
subsidised
Azelaic acid
Anti-acne
Acne
Uses are anti-acne, or mild to moderate rosacea, though
the product available in NZ is only indicated for acne. It is
not subsidised and is a Pharmacy-Only medicine.
Benzoyl peroxide
Anti-acne
Acne
Non Prescription,
All products with datasheets are for acne. Most products
available are 5% or less (General Sale), though some are in non subsidised
combination with other ingredients. One 10% product is
available, which is Pharmacy-Only. Not subsidised in
community.
Benzydamine
Local NSAID
Pharyngitis
Available as mouthwash, spray or lozenge. Effective for
mouth ulceration. Partial subsidy for mouthwash only,
which is Pharmacy-Only.
16
Type of medicine
prescribers
Likely use and NZ
Rationale
Council Decision
Chlorpheniramine
Antihistamine
Allergies and rhinitis
Ciclopirox
Antifungal
Clotrimazole
Antifungal
Fungal infections
Dexchlorpheniramine
Antihistamine
Allergic rhinitis; allergic As for chlorpheniramine, except age limit is 6 years old,
conjunctivitis; allergic
rather than 2 years old. Only tablet & syrup currently
skin conditions
available.
Dextromethorphan
Antitussive
Dry cough
Not subsidised
Non prescription not
subsidised
Diphenoxylate
Antidiarrhoeal
Adjunct to rehydration in
diarrhoea; control of
faecal consistency after
colostomy or ileostomy;
symptoms of ulcerative
colitis
Doxylamine
Antihistamine
Insomnia (short-term
use)
Sedating antihistamine used in cough/cold remedies
(Pharmacy-Only) or in combination with paracetamol &
subsidised
Only a Prescription Medicine if not oral (no non-oral
products registered at this time) or if prescribed for under 2
year olds (not recommended), or if used for anxiety or
insomnia in quantities larger than 10 dosage units. Hence,
minimal (if any) role as a Prescription Medicine. All oral
sedating antihistamines classified similarly, so only
injectable sedating antihistamines (e.g. promethazine inj.)
could be included.
Prescription- except for external use
Prescription medicine only when used internally - a useful
product for nurse prescribers.
17
Type of medicine
prescribers
Likely use and NZ
Rationale
Council Decision
codeine for relief of tension-type pain (Restricted Medicine).
Dubious therapeutic usefulness, especially for insomnia
(Restricted Medicine). Not subsidised.
Econazole
Antifungal
Fungal skin infections
Vaginal products are Restricted Medicines. Other topical
preparations are either Pharmacy-Only or General Sale.
Foaming solution & cream partially subsidised.
Topical (Pharmacy-Only) or injectable (Prescription
Medicine) NSAID. Topical gel possibly available in NZ but
not subsidised.
subsidised (external
use)
Etofenamate
NSAID
Musculoskeletal pain
and inflammation
Fexofenadine
Antihistamine
Allergic rhinitis; urticaria Prescription Medicine only if non-oral & no non-oral
products registered in NZ.
Fluorides
Mineral supplement
Prevention of dental
caries
Prescription Medicine only in high strengths. Limited
therapeutic value? Toothpaste more effective?
Guaiphenesin
Mucolytic
Symptomatic relief of
deep chesty coughs;
expectorant for
productive cough
Dubious therapeutic benefit (though a good emetic!). Not
subsidised. Pack size is a major determinant of
classification - pack size not important if prescribed.
Potential for inappropriate/unproven use (fibromyalgia).
General sales
Hypromellose
Ocular lubricant
Dry eye
Ocular lubricant is General Sale (partially subsidised. Also
when in combination with dextran 70 is General Sale and
partially subsidised. No other combinations available or
subsidised.
18
Type of medicine
prescribers
Likely use and NZ
Rationale
Council Decision
Would only be used as an ingredient if special eyedrops are
required to be manufactured, which is unlikely in community
pharmacy given sterility requirements. So no need to
include just as an ingredient.
Iron
Iron supplement
Iron deficiency anaemia Injection is Prescription Medicine, oral iron is PharmacyOnly (or General Sale if lower strength & smaller pack
sizes, which are less helpful for the management of iron
deficiency anaemia).
(oral)
Ferrous sulfate and ferrous fumarate currently fully
subsidised. Iron polymaltose injection full subsidised.
Useful therapeutic benefit, but very toxic in overdose.
Ketotifen
Antihistamine
Seasonal allergic
conjunctivitis
Only eye drop products registered - Pharmacy-Only. Not
subsidised.
subsidised
Levocabastine
Antihistamine
Allergic conjunctivitis
Pharmacy-Only. Partial subsidy. Fully subsidised
alternative is currently naphazoline.
Lodoxamide
Mast cell stabilizer
Allergic conjunctivitis
Only eye drops registered for use in NZ, so not Prescription Non prescription
medicines
Medicine.
Meclozine
Antihistamine
Nausea and vomiting
Smaller pack sizes for motion sickness Pharmacy-Only.
subsidised list
Smaller pack sizes for anxiety or insomnia Restricted
Medicine. Doubtful whether larger pack sizes are available
as most use is over the counter sales for motion sickness.
19
Type of medicine
prescribers
Likely use and NZ
Rationale
Council Decision
Not subsidised. Cyclizine fully subsidised alternative. Make
sure cyclizine is on list.
Non prescription on
subsidised
Mepyramine
Antihistamine
Symptomatic relief of
insect stings and bites,
and nettle rash
Only available as cream - General Sale. Not subsidised.
Better alternatives (e.g. 1% hydrocortisone cream).
Miconazole
Antifungal
Fungal skin infections;
vulvovaginal
candidiasis; oral and
intestinal candidiasis
Useful antifungal, though not all products fully subsidised.
Possibly superseded by fluconazole. Topical products are
not Prescription Medicines - have lower classifications. Oral
gel may be useful in geriatrics &/or palliative care, though
has potential for numerous interactions via cytochrome
P450.
Nicotine
Substance
dependence
Aid in smoking
Prescription Medicine only when not used for smoking
cessation, smoking
cessation or if used nasally. Gum & patches are General
reduction, or temporary Sale.
abstinence
Paracetamol
Analgesic
Mild to moderate pain;
pyrexia with discomfort;
post-immunisation
pyrexia with discomfort
in infants
Permethrin
Paraciticidal
Scabies; crab lice
Propamidine
Antibacterial
Superficial bacterial eye
20
Type of medicine
prescribers
Likely use and NZ
Rationale
Council Decision
infections
Pyridoxine
Vitamin supplement Prevention and
treatment of pyridoxine
deficiency; sideroblastic
anaemia;
homocystinuria; primary
hyperoxaluria; isoniazidinduced neuropathy
[unapproved]
Silver sulphadiazine
Antibacterial
Prophylaxis and
treatment of infection in
burn wounds and other
wounds (including
pressure sores and leg
ulcers)
Zinc
Barrier/mineral
supplement
Skin barrier protection/
supplement for zinc
losing conditions
Oral capsules are Prescription Medicine if not in a pack
designed for over-the-counter sale (e.g. dispensary pack) & (external use)
are fully subsidised. Should be considered to be a
Prescription medicine as far as Designated Nurse
Prescribers are concerned.
Topical zinc barrier creams are General Sale may have a
role in ostomy care or paediatrics. Only zinc & castor oil
fully subsidised at this time.
21
4.6
Medicines to be included on both the prescription and non-prescription
lists
Twelve medicines appear on both the prescription and non-prescription lists in different
forms. See Table 6. Note that non subsidised non-prescription forms of some medicines
have been removed from the lists altogether, see Appendix 9. If these were subsidised the
Council would include them on the list.
Table 6: Community nurse list- Other Medicines included on the prescription
and non-prescription lists
Medicine name
Type of medicine
Non-prescription form
aciclovir
antiviral
cinchocaine
local anaesthetic
diclofenac
NSAID
topical (not subsidised)
when combined with hydrocortisone
(e.g. Proctasedyl®) and prescribed
in quantities ≤35g or 12
suppositories,
Gel, spray and some oral forms (not
subsidised)
fluticasone
corticosteroid
nasal spray
hyoscine
ibuprofen
patch
gel (not subsidised)
ipratropium
Antiemetic
NSAID
anticholinergic
bronchodilator
lignocaine
local anaesthetic
cream (in combination)
metoclopramide
antiemetic
with paracetamol
nystatin
antifungal
cream
sodium cromoglycate
cromoglycate
nasal spray (not subsidised)
triamcinolone
corticosteroid
nasal spray (not subsidised)
nasal spray
Medicine added
Betamethasone was added as a common corticosteroid left off the list.
5
The specialist nurse prescription medicines list
The specialist nurse prescribing list was supported by 62.3% of submitters. Most submitters
agreed that the list reflected the range of medicines that specialist nurses with prescribing
rights will need to access. Some submitters were concerned that the list was too extensive,
should be restricted to specialty areas or some medicines should only be repeat prescribed.
22
Submitters identified specific medicines or classes of medicines they thought should be
removed or added to the specialist nurse prescribing list.
5.1
General medicines
Many medicines were recommended to be removed or restricted by submitters. In many
cases the medicines have been removed. A few cardiac medicines have been retained as
“continuation prescribing only” to allow specialist nurses to repeat prescribe and titrate doses
but not to initiate a prescription as the diagnosis is complex e.g. heart failure.
A few submitters requested unspecified medicines be added to the list for palliative care
purposes (140, 9, 124, 153). A small number of medicines used in palliative care have not
been added to the list (ketamine, midazolam, phenobarbitone, quetiapine, valproate) as they
have been excluded for other reasons or they are unapproved medicines or unapproved
uses but many are on the list (diclonafac, fentanyl, lorazepam, ranitidine, antiemetics,
laxatives, opioid analgesics).
The following table contain a response to the submitter comments to add, restrict or
removed medicines from the list. See Attachment 2: Table 7: Response to submitters
suggestions for the Specialist Nurse prescription medicines list
A second table contains other medicines identified in the general review of the list to add,
restrict or removed. See Table 8: Other general medicines to add, remove or restrict
23
Table 8: Other general medicines to add, remove or restrict
Classification
Drug
Indications
Council decision
Evidence
NSAIDs
Celecoxib
Pain relief in osteoarthritis
and soft-tissue disorders
Do not add.
Choice differences in anti-inflammatory activity
between NSAIDs are small, but there is
considerable variation in individual response and
tolerance to these drugs. About 60% of patients
will respond to any NSAID; of the others, those
who do not respond to one may well respond to
another.
Etoricoxib
Not subsidised in the community.
Listed HML under Non-Steroidal AntiInflammatory Drugs. Restricted- For
preoperative and/or postoperative use
for a total of up to 8 days’ use.
Pain relief starts soon after taking the first dose
and a full analgesic effect should normally be
obtained within a week, whereas an antiinflammatory effect may not be achieved (or
may not be clinically assessable) for up to 3
weeks. If appropriate responses are not
obtained within these times, another NSAID
should be tried. NSAIDs reduce the production
of prostaglandins by inhibiting the enzyme cyclooxygenase. They vary in their selectivity for
inhibiting different types of cyclo-oxygenase;
selective inhibition of cyclo-oxygenase-2 is
associated with less gastro-intestinal
intolerance.
Several other factors also influence susceptibility
to gastro-intestinal effects, and a NSAID should
be chosen on the basis of the incidence of
gastro-intestinal and other adverse effects.
Educational preparation in prescribing for
NSAIDs must be included in the educational
preparation of nurses including risk associated
24
Classification
Drug
Indications
Council decision
Evidence
with gastro-intestinal bleeding and
nephrotoxicity.
Meloxicam
Pain and inflammation in
rheumatoid arthritis and
osteoarthritis
Remove from the list
Special authority
The decision to prescribe a selective COX-2
inhibitor should only be made after assessment
of the individual patient's overall risk for
developing severe adverse events e.g. history of
cardiovascular, renal, or gastrointestinal
disease, and after use of alternative therapies
such as non-pharmacological interventions and
simple analgesic therapy where these have
been found to lack analgesic efficacy or to have
unacceptable adverse effects. Use of COX-2
inhibitors (of which meloxicam is one) has been
associated with an increased risk of
cardiovascular adverse events (myocardial
infarction and stroke). This association has been
demonstrated with agents of the Coxib class.
Prescribers should inform the individual patient
of the (possible or potential) increased risks
when prescribing meloxicam tablets for patients
at high risk of cardiovascular adverse events
(including patients with diabetes, ischaemic
heart disease, cardiac failure, hyperlipidaemia,
hypertension or smokers). Medsafe Datasheet
Muscle relaxant
Baclofen
Chronic severe spasticity
resulting from disorders
such as multiple sclerosis
or spinal cord trauma or
diseases; muscle spasm
Screening and titration required
Baclofen inhibits transmission at spinal level and
also depresses the central nervous system. The
dose should be increased slowly to avoid the
major adverse effects of sedation and muscular
hypotonia (other adverse events are
25
Classification
Drug
Indications
Council decision
of cerebral origin
Evidence
uncommon).
The underlying cause of spasticity should be
treated and any aggravating factors (e.g.
pressure sores, infection) remedied. Skeletal
muscle relaxants are effective in most forms of
spasticity except the rare alpha variety. The
major disadvantage of treatment with these
drugs is that reduction in muscle tone can cause
a loss of splinting action of the spastic leg and
trunk muscles and sometimes lead to an
increase in disability.
Antimuscarinic
Benzatropine
Parkinsonism; druginduced extrapyramidal
disorders (except tardive
dyskinesia); acute dystonic
reactions
Remove from list
Outside of scope, close monitoring
required.
Antimuscarinic drugs exert their antiparkinsonian
action by reducing the effects of the relative
central cholinergic excess that occurs as a result
of dopamine deficiency. Antimuscarinic drugs
can be useful in drug-induced parkinsonism, but
they are generally not used in idiopathic
Parkinson's disease because they are less
effective than dopaminergic drugs and they are
associated with cognitive impairment.
The antimuscarinic drugs benztropine,
orphenadrine, and procyclidine, reduce the
symptoms of parkinsonism induced by
antipsychotic drugs, but there is no justification
for giving them routinely in the absence of
parkinsonian adverse effects. Tardive dyskinesia
is not improved by antimuscarinic drugs and
may be made worse.
In idiopathic Parkinson's disease, antimuscarinic
26
Classification
Drug
Indications
Council decision
Evidence
drugs reduce tremor and rigidity but they have
little effect on bradykinesia. They may be useful
in reducing sialorrhoea.
Antihistamine
Brompheniramin
Antagonists for
central and
respiratory
depression
Flumazenil
Move to non-prescription list
Reversal of sedative
effects of benzodiazepines
in anaesthetic, intensive
care, and clinical
procedures; overdosage
with benzodiazepines
Methylsalicylate
Rubefacient
Salbutamol
Andrenoreceptor angonist
Add a restriction
Indications outside of scope
There are no important differences between the
antimuscarinic drugs, but some patients tolerate
one better than another.
Short term management of anxiety or insomnia.
Should only be administered by, or under the
direct supervision of, personnel experienced in
their use.
Flumazenil is a benzodiazepine antagonist for
the reversal of the central sedative effects of
benzodiazepines after anaesthetic and similar
procedures. Flumazenil has a shorter half-life
and duration of action than diazepam or
midazolam so patients may become resedated.
Benzodiazepine
antagonist
Not injection
Wouldn't normally expect this to be prescribed.
Usually people are advised or know to purchase
Deep Heat (or similar). A salicylate, so related
to aspirin & can have similar effects, but only
really used in combination topically to warm and
provide some anti-inflammatory impact.
However, topical anti-inflammatories (e.g.
diclofenac gel/cream, etc) may be more
appropriate to prescribe.

Severe acute asthma
Regard each emergency consultation as being
27
Classification
Drug
Indications
Council decision
Evidence
Emergency indications outside scope
for severe acute asthma until shown otherwise.
Start treatment and send immediately to hospital
Consider intravenous salbutamol, aminophylline,
or magnesium sulfate only after consultation
with senior medical staff.
Oestradiol
oestriol
Hormone replacement
therapy
NP or medical practitioner prescribing.
Extensive Counselling required
regarding the increased risks of some
cancers and other adverse effects.
HRT increases the risk of venous
thromboembolism, stroke, endometrial cancer
(reduced by a progestogen), breast cancer, and
ovarian cancer; there is an increased risk of
coronary heart disease in women who start
combined HRT more than 10 years after
menopause. For details of these risks see HRT
Risk table.
The minimum effective dose of HRT should be
used for the shortest duration. Treatment should
be reviewed at least annually and for
osteoporosis alternative treatments considered
(section 6.6). HRT does not prevent coronary
heart disease or protect against a decline in
cognitive function and it should not be
prescribed for these purposes. Experience of
treating women over 65 years with HRT is
limited.
Heparins
Include heparinised saline
Some indications for low molecular
A range of strengths of unfractionated heparin
injection are fully subsidised without
prescription. Heparinised saline is fully
subsidised without restriction.
Low molecular weight heparin (dalteparin or
28
Classification
Drug
Indications
Council decision
Evidence
heparins special authority may be
within scope.
enoxaparin) require a Special Authority for
subsidy. Special Authority may be applied for by
any relevant practitioner - includes a nurse
prescriber working in the appropriate field.
PHARMAC SPECIAL AUTHORITY
Venous thromboembolism other than in
pregnancy or malignancy
For the short-term treatment of venous
thromboembolism prior to establishing a
therapeutic INR with oral anti-coagulant
treatment
For the prophylaxis and treatment of venous
thromboembolism in high risk surgery.
To enable cessation/re-establishment of existing
oral anticoagulant treatment pre/post surgery
For the prophylaxis and treatment of venous
thromboembolism in Acute Coronary Syndrome
surgical intervention.
To be used in association with cardioversion of
atrial fibrillation.
Cromogliate
Sodium
cromoglycate
Prophylaxis of allergic
rhinitis
Move to non-prescription list
Pharmacy only medicine
Antibiotics
Benzylpenicillin
sodium (Penicillin
Throat infections; otitis
media; endocarditis;
Add to the list
Benzylpenicillin sodium (Penicillin G) remains an
important and useful antibiotic but is inactivated
29
Classification
Drug
Indications
G)
meningococcal disease;
pneumonia; cellulitis
Phenoxymethylpe
nicillin
Oral infections; tonsillitis;
otitis media; erysipelas;
cellulitis; group A
streptococcal infection;
rheumatic fever and
pneumococcal infection
prophylaxis
Add to the list
Upper respiratory tract
infections; lower
respiratory tract infections;
dental infections; skin
infections; urethritis (nongonococcal)
Add to the list
(Penicillin V)
Roxithromycin
Council decision
Evidence
by bacterial beta-lactamases. It is effective for
many streptococcal (including pneumococcal),
gonococcal, and meningococcal infections.
Benzylpenicillin is inactivated by gastric acid and
absorption from the gut is low; therefore it is best
given by injection.
Phenoxymethylpenicillin (Penicillin V) has a
similar antibacterial spectrum to benzylpenicillin,
but is less active. It is gastric acid-stable, so is
suitable for oral administration. It should not be
used for serious infections because absorption
can be unpredictable and plasma concentrations
variable. It is indicated principally for respiratorytract infections in children, for streptococcal
tonsillitis, and for continuing treatment after one
or more injections of benzylpenicillin when
clinical response has begun. It should not be
used for meningococcal or gonococcal
infections. Phenoxymethylpenicillin is used for
prophylaxis against streptococcal infections
following rheumatic fever (second line) and
against pneumococcal infections following
splenectomy or in sickle-cell disease.
Macrolides are an alternative to
penicillin sensitive patients.
Erythromycin and azithromycin
already on the list.
Many conditions that are managed by
30
Classification
Drug
Indications
Council decision
Evidence
specialist nurses will require an
alternative to penicillins.
Cefazolin
Respiratory tract infection;
genitourinary tract
infection; skin and softtissue infection; biliary
tract infection; bone and
joint infection;
septicaemia; endocarditis;
perioperative prophylaxis
Add to the list
“First generation” cephalosporin. It has good
activity against a wide spectrum of Gram
positive bacteria, modest activity against gram
negative bacteria.
PHARMAC Subsidy by endorsement- dialysis or
cellulitis in accordance with DHB approved
protocol.
Injectable only.
Cefalexin
Infections due to sensitive
Gram-positive and Gramnegative bacteria
Add to the list
The orally active ‘first generation’ cephalosporin
cefalexin, and the ‘second generation’
cephalosporin, cefaclor, have a similar
antimicrobial spectrum. They are useful for
urinary-tract infections which do not respond to
other drugs or which occur in pregnancy,
respiratory-tract infections, otitis media, sinusitis,
and skin and soft-tissue infections. Cefaclor has
good activity against H. influenzae, but it is
associated with protracted skin reactions
especially in children.
31
5.2
Mental Health medicines
Submitters that commented on specialist nurse prescribing for mental health conditions
recommended that the nurse should not initiate medicines but could repeat prescribe
(continue), or were better to work in a model of collaborative prescribing i.e. discussion
between the nurse and the psychiatrist before a medicine was initiated. Only one submitter
thought specialist nurses should be able to initiate mental health medicines.
I agree that antipsychotic medicines should only be repeat prescriptions, not initiated by the
nurse. However a psychiatric nurse may be working in a collaborative role with the mental
health team and take direction from the psychiatrist to write the said prescription. (3, The
Pharmacy Defence Association of New Zealand (Inc.))
I think antipsychotic medication started by a doctor or psychiatrist could perhaps be repeated
on one occasion by the nurse and the next time be represcribed by the doctor or psychiatrist
(25, Individual Nurse)
Prescribing anti depressant for first time- collaborative approach would be advisable (46,
Individual Nurse)
Provided an agreed monitoring plan was put into place with the primary medical practitioner
(86,CAPA- Clinical Advisory Pharmacists ).
A secondary or specialist level mental health patients have a complex presentation.
Diagnosis of mental health conditions/disorders and physical symptoms should remain the
responsibility of the specialist doctor. A relatively short period of additional training would not
necessarily provide nurses with sufficient knowledge to be aware of what could be missed.
Psychiatry may benefit from highly trained and experienced specialist nurses who could
prescribe and monitor some of the long term medications. However, a specialist nurse
should not be initiating new prescriptions. A particularly useful contribution of a specialist
nurse prescriber would be repeat prescriptions of well-established medications. This could
include drugs such as clozapine and methylphenidate that require monthly repeat
prescriptions. Drugs such as clozapine would fit well into specialist nurse prescribing of
established medications, as nurses have particular expertise around following protocols and
generally carry out all required checks and monitoring to a high standard. (143, The Royal
Australian & New Zealand College of Psychiatrists).
Mental Health is an area where initiation of medicines is fraught and the group would
suggest specialist nurse prescribers should not initiate but could repeat prescribe if a patient
is stable. The decision on whether a patient is stable, unless made by a multidisciplinary
team, would need to be based on a documented process. (148 Medication Safety Expert
Advisory Group (MSEAG), Health Quality & Safety Commission).
32
Should be able to initiate
I disagree that specialist nurse prescribers working in a mental health setting cannot initiate
prescriptions for anti-psychotics. I, and many colleagues, engage in de facto prescribing on
occasion and this is often used for out of hours services. Many mental health services
provide 24 hour face to face services with doctors on call. Waiting for a doctor to see the
service user after a comprehensive nursing assessment can cause the service user
unnecessary distress which could be lessened if a specialist nurse prescribers were able to
prescribe (initially and subsequently) common used medications used within their field of
practice (64, Individual nurse).
Submitters also emphasised that these medicines should only be prescribed by nurses who
were specialised in mental health. Submitters also expressed concerns about some of the
medicines included on the list (first generation antipsychotics and tricyclic antidepressants)
and suggested some common mental health medicines that have not been included e.g.
lithium and sodium valproate and some addictions medicines.
We do not think antidepressant medication should be prescribed by either nurses or GPs
who do not have some postgraduate training in mental health care (14, Womens health
action)
We have concerns re nurses prescribing repeat medications outside defined scope of
practice. For example mental health meds if you are a specialist cardiac nurse (47, Café
Incorporated (known as Café for Youth Health)
For example, the consultation states “Medicines for some common mental health conditions
have been included as 50 to 70% of mental health disorders are managed by general
practice. Demand is expected to double by 2020.” The Society believes that this is an area
of clinical practice requiring specialist knowledge and disagrees with their inclusion for
prescribing (178, Pharmaceutical Society of New Zealand).
5.2.1
Antipsychotics
The Council consulted on a number of antidepressant and antipsychotic medicines3.
General guidance for use of antipsychotics (New Zealand Formulary, July 2014)4
1. Pharmacological treatment should always be used in conjunction with
comprehensive psychosocial interventions, and treatment should be a multidisciplinary approach.
2. Atypical antipsychotics are now considered to be first, second and third-line
treatment in newly diagnosed patients
3
Other medicines used in mental health that have a sedative or anxiolytic effect including
benzodiazepines (alprazolam, diazepam, oxazepam, nitrazepam, temazepam) and buspirone are
also on the list. The benzodiazepines will be discussed under the Controlled drug report.
4
New Zealand Formulary. (July 2014). 4.2 Drugs used in psychoses and related disorders. New
Zealand Formulary, 2014.
URL: http://nzf.org.nz/nzf_2096.html
33
3. Clozapine is indicated for treatment resistance, and should be considered following
unsuccessful trials of 2 alternative antipsychotics.
4. Antipsychotics should be used with caution in elderly patients and only used for
severe distressing symptoms, and risk and benefits must be considered.
5. It is important to regularly monitor the patient for medium to long-term adverse
effects such as diabetes, weight gain, extra-pyramidal effects or blood dyscrasias
associated with many antipsychotic medications
6. Combination treatment of 2 or more antipsychotics is not recommended unless
switching between 2 medications.
7. Unapproved indications include autism, insomnia, anxiety, and post traumatic
stress disorder (PTSD). Careful consideration of risks and benefits must be
taken, the patient must be fully informed and the treatment plan documented in
the patient’s notes. (Note some of these drugs are used in dementia also an
unapproved use)5.
Both the typical and atypical antipsychotics are high risk medicines and have potential for
serious side effects (see the Table on page 37). Antipsychotics have traditionally been
initiated by psychiatrists. General practitioners may continue prescribe or are advised to
discuss the treatment plan with a psychiatrist before prescribing (Best Practice Journal,
2011)6. Atypical antipsychotics have mostly replaced the older antipsychotics for treating
schizophrenia, bipolar disorder, and other severe mental illness because of their many
advantages.
There is little meaningful difference in efficacy between each of the antipsychotic
drugs (other than clozapine), and response and tolerability to each antipsychotic drug
varies. There is no first-line antipsychotic drug, which is suitable for all patients.
Choice of antipsychotic medication is influenced by the patient’s medication history,
the degree of sedation required (although tolerance to this usually develops), and
consideration of individual patient factors such as risk of extrapyramidal adverse
effects, weight gain, impaired glucose tolerance, QT-interval prolongation, or the
presence of negative symptoms.
(New Zealand Formulary, July 2014)7.
Clozapine was suggested as possibly being appropriate as a medicine to be repeat
prescribed by specialist mental health nurses but it has significant adverse effects and is
restricted by the Minister of Health to be prescribed by specified medical practitioners only.
(See Table on page 37). The other atypical antipsychotics also have potential for adverse
effects but not the same monitoring requirements.
5.2.2
Antidepressants
First line treatment for moderate depression is a Selective Serotonin reuptake inhibitor
(SSRI) or psychological therapy.
5
There is much criticism of the use of antipsychotic medicines in dementia, for which there is
extremely limited evidence of benefit.
Jackson, G., Gerard, C., Minko, N., & Parsotam, N. (2014). Variation in benzodiazepine and
antipsychotic use in people aged 65 and over in New Zealand. The New Zealand Medical Journal.
Vol. 127, No. 1396.
6
Best Practice Journal. (2011). Prescribing atypical antipsychotics in general practice. Best Practice
Journal. Issue 40.
7
New Zealand Formulary. (July 2014). 4.2.1 Antipsychotic drugs. New Zealand Formulary, 2014.
34
SSRIs are better tolerated and are safer in overdose than other classes of
antidepressants and should be considered first-line for treating moderate to severe
depression. SSRIs are less likely to cause orthostatic hypotension, and other
cardiovascular adverse effects, so are the first line choice in patients with cardiac
disorders. In patients with unstable angina or who have had a recent myocardial
infarction, sertraline has been shown to be safe.
Tricyclic antidepressants may be particularly helpful for patients with melancholic
depression, or for patients who have found them effective in the past. Tricyclic
antidepressants have similar efficacy to SSRIs but are more likely to be discontinued
because of adverse effects; toxicity in overdosage is also a problem.
SNRIs are of intermediate toxicity, greater than SSRIs but less than TCAs.
Irreversible MAOIs (phenelzine and tranylcypromine) have dangerous interactions
with some foods and drugs, and should only be prescribed by specialists familiar with
their use. Moclobemide is a reversible monoamine oxidase inhibitor (RIMA) and may
interact with food or drugs but to a lesser extent, and does not usually require
specialist supervision.
Combined use of antidepressants with antipsychotics under the supervision of a
psychiatrist may be necessary for patients who have depression with psychotic
symptoms. (NZ Formulary, July 2014)8.
The most serious adverse event associated with SSRIs is serotonin syndrome and most
nurses trained in Mental Health would be familiar with this condition.
Serotonin syndrome (or serotonin toxicity) is a potentially life threatening adverse
reaction that results from excess serotonergic activity at central nervous system and
peripheral serotonin receptors. It can develop from excessive doses of a single
serotonergic drug but more commonly occurs when combinations of serotonergic
medicines are used together, particularly when these drugs act to increase serotonin
via different mechanisms. Examples of drugs that can cause serotonin syndrome
include antidepressants (especially SSRIs and clomipramine), lithium, St John’s wort,
pethidine, tramadol, dextromethorphan (an over-the-counter cough suppressant),
and linezolid. Serotonin syndrome can arise when switching between
antidepressants without an adequate “washout” period (New Zealand Formulary, July
2014)9.
Best practice is to sequentially trial two SSRIs before trialling another type of
antidepressants. It would be appropriate to have specialist involvement if other
antidepressants were to be prescribed.
The ability to prescribe SSRIs may be useful for some nurses working with patients with long
term conditions who often suffer from severe anxiety and depression that impact on their
physical illness, in addition to specialist mental health nurses.
Already on the list are citalopram, fluoxetine, sertraline and paroxetine. It is recommended
that two other SSRIs (escitalopram and fluvoxamine) are added to the list.
8
New Zealand Formulary. (July 2014). 4.3 Antidepressant drugs. New Zealand Formulary, 2014.
9
New Zealand Formulary, (July 2014). 4.3.3 Selective serotonin re-uptake inhibitors. New Zealand
Formulary, 2014.
URL: http://nzf.org.nz/nzf_2287.html?searchterm=Serotonin%20syndrome
35
5.2.3
Other common mental health and addictions medicines
Submitters suggested that specialist nurses be able to repeat prescribe some other common
mental health medicines. These include sodium valproate and lithium that are used for
bipolar prophylaxis. Methylphenidate for ADHD was also suggested by the Royal College of
Psychiatrists. It is a restricted medicine (by the Minister of Health) to be prescribed by
specified medical practitioners only. A number of medicines that are used for treatment of
addiction (some of which are controlled drugs) were recommended to be added to the list.
This included burenorphine which is used in combination with naloxone in opioid
substitution. By itself, buprenorphine can be prescribed as a partial agonist opioid analgesic.
At present only appropriately authorised medical practitioners can prescribe opioid
substitution therapy. Future amendments to the Misuse of Drugs Act are planned that could
see this prescribing permitted for approved nurse practitioners and registered nurse
prescribers. The list of controlled drugs should be future proofed as it is regulated under the
Misuse of Drugs Act regulations and will not be able to be regularly updated through
Gazette notices in the way the prescription list can be.
More detailed information on each of the medicines and recommendations are included in
the table below. Benzodiazepines (also used in mental health for anxiety and addictions)
are also discussed in the Controlled drug list section.
5.2.4
Off label prescribing for neuropathic pain
There are 2 medicines on the list that are recommended to be removed for mental health
prescribing but are used off label for neuropathic pain. They are amitriptyline and
nortriptyline. They are discussed in the table below.
http://www.bpac.org.nz/BPJ/2008/September/docs/bpj16_neuropathic_pain_pages_1315.pdf
36
Table 9: Review of antidepressants
Comments from submitters
The list of drugs for Specialist Nurse prescribing has a proliferation of Tri-cyclic anti-depressants, which harbour safety issues (76, Te Ao
Maramatanga, New Zealand College of Mental Health Nurses).
Tricyclic antidepressants: Exclude (except for amitriptyline and nortriptyline for neuropathic pain). Dothiepin, Doxepin, Imipramine, Maprotiline
(tetracyclic) are no longer considered appropriate antidepressants due to their side effect profile particularly maprotiline.
Mianserin –Exclude. Antidepressant only indicated in very specific circumstances due to serious side effect of agranulocytosis. Special
Authority required.
Mirtazapine – Exclude due to the severity of the medical indication (severe major depressive disorder, refractory to at least two other
antidepressants). Special Authority required.
Moclobemide – Exclude. Selective monoamine oxidase inhibitor antidepressant not routinely used first or second-line, would require
assessment by a medical practitioner (86, CAPA- Clinical Advisory Pharmacists).
Class
SSRIs
Drug
Council decision
Keep SSRIs on the list for specialist
nurses working in mental health
teams. May be appropriate for
specialist nurses working in
multidisciplinary long term condition
teams, e.g. pain, diabetes, as about
30% of people with a long term
conditions are estimated to have
anxiety and/or depression which
impacts on their ability to self-care
and can lead to exacerbation of their
10
physical illness (Naylor et al, 2012)
There are numerous factors that
need to be taken into consideration
Evidence
Update: QT Prolongation with
Antidepressants Prescriber Update
34(4): 44 December 2013


QT prolongation appears to be a
class effect for all selective
serotonin reuptake inhibitors
(SSRIs) and tricyclic
antidepressants (TCAs), and
also occurs with venlafaxine.
The potential for QT prolongation
to occur should be considered as
part of the risk benefit
assessment prior to prescribing
Considerations
Antidepressant drugs are effective for
treating moderate to severe depression
associated with psychomotor and
physiological changes such as loss of
appetite and sleep disturbance;
improvement in sleep is usually the first
benefit of therapy. Ideally, patients with
moderate to severe depression should
be treated with psychological therapy in
addition to drug therapy.
Antidepressant drugs are also effective
for dysthymia (lower grade chronic
depression (typically of at least 2 years
duration)).
10
Naylor, C., Parsonage, M., McDaid, D., Knapp, M., Fossey, M., Gelea, A. (2012). Long term conditions and mental health : the cost of co-morbidity. The
Kings Fund and Centre for Mental Health, 2012.
37
Class
Drug
Council decision
when prescribing SSRIs. The NZ
Formulary has provided extensive
resources and advice for prescribers
of this class.
Specialist nurses in mental health are
likely to manage conditions
sometimes on their own or with
medical practitioners in the clinical
setting when prescribing for mental
health conditions.
citalopram
fluoxetine
paroxetine
Evidence
an antidepressant.
 There are no high quality data
comparing the risk of QT
prolongation between different
antidepressants (other than
citalopram and escitalopram).
 If QT prolongation or
symptomatic arrhythmia occurs
during antidepressant treatment,
specialist medical advice should
be sought.
Keeping SSRIs on the list is
important both for autonomous
practice of Specialist nurses in a
mental health setting and for shortterm use in cases or anxiety related
disorders.
Serotonin syndrome/toxicity reminder
NOTE: Preparation for all nurses who
intend to prescribe mental health
medicines will require solid
educational preparation in mental
health pharmacology added to a
postgraduate course on
Pharmacology and Therapeutics.
Serotonin syndrome, more correctly
termed serotonin toxicity, is a set of
predictable type A dose dependent
adverse reactions caused by
increased intra-synaptic/extracellular
serotonin.
Working collaboratively and as team
is a common practice in Mental
Health settings.
Indication depression.
Indications depression;
Indications depression; generalised
anxiety disorder
Paroxetine has a short half-life and
are associated with a higher risk of
discontinuation symptoms.
Website: December 2010
Prescriber Update 2010; 31(4):30-31
Since serotonin toxicity can be fatal
after a single dose of an
inappropriate medicine (or
combination) it is vitally important to
be familiar with both the causal
agents and signs and symptoms.
Considerations
Antidepressant drugs should not be used
routinely in mild depression, and
psychological therapy should be
considered initially; however, a trial of
antidepressant therapy may be
considered in cases refractory to
psychological treatments or in those
associated with psychosocial or medical
problems.
Drug treatment of mild depression
may also be considered in patients
with a history of moderate or severe
depression.
There is little to choose between the
different classes of antidepressant drugs
in terms of efficacy, so choice should be
based on the individual patient's
requirements, including the presence of
concomitant disease, existing therapy,
suicide risk, and previous response to
antidepressant therapy. There may be
an interval of 2 weeks or more before the
antidepressant action takes place.
During the first few weeks of treatment,
there is an increased potential for
agitation, anxiety, and suicidal ideation.
SSRIs are better tolerated and are
safer in overdose than other classes
of antidepressants and should be
considered first-line for treating
moderate to severe depression. SSRIs
are less likely to cause orthostatic
hypotension, and other cardiovascular
38
Class
Drug
sertaline
Council decision
Indications depression; social anxiety
disorder; premenstrual dysphoric
disorder.
Evidence
escitalopram
Add to the list
Escitalopram is associated with an
increased risk of QT prolongation at
supratherapeutic doses.Medsafe
Indications: depression; social
anxiety; generalised anxiety.
fluvoxamine
Considerations
adverse effects, so are the first line
choice in patients with cardiac disorders.
In patients with unstable angina or who
have had a recent myocardial infarction,
sertraline has been shown to be safe.
Source: NZ Formulary
http://www.saferx.co.nz/full/citalopram_e
scitalopram.pdf
waitemata info sheet
Add to the list
Indications depression.
Tricyclic
antidepressa
nt
amitriptyline
Keep for pain management only
Tricyclic antidepressants are not first
line treatment for depression and
greater potential for adverse effects.
Indications depression; neuropathic
pain [unapproved] ; migraine
prophylaxis [unapproved]
The use of amitriptyline and
nortriptyline in neuropathic pain is a
legitimate use, well recognised and
with reasonable evidential basis –
see Cochrane Database of
Systematic Reviews.
Both amitriptyline and nortriptyline
may also be useful in smoking
cessation. Lower doses are used for
pain management. Dose could be
restricted as lower doses used for
pain (10 mg then uptitrate to 75 mg
max) than for depression (75 mg
Elderly patients are particularly
susceptible to many of the adverse
effects of tricyclic antidepressants;
low initial doses should be used with
slow titration to an effective dose.
Patients should be closely monitored,
particularly for psychiatric and
cardiac adverse effects.
Overdosage: Limited quantities of
tricyclic antidepressants should be
prescribed and/or dispensed at any
one time because their
cardiovascular and epileptogenic
effects are dangerous in overdosage.
In particular, overdosage with
dosulepin (dothiepin) and
amitriptyline is associated with a
relatively high rate of fatality.
Clomipramine -Adverse effects high
rate of fatality in overdose—see
notes; antimuscarinic effects
(including dry mouth, blurred vision,
constipation, urinary retention)
There is little to choose between the
different classes of antidepressant drugs
in terms of efficacy, so choice should be
based on the individual patient's
requirements, including the presence of
concomitant disease, existing therapy,
suicide risk, and previous response to
antidepressant therapy. There may be
an interval of 2 weeks or more before the
antidepressant action takes place.
During the first few weeks of treatment,
there is an increased potential for
agitation, anxiety, and suicidal ideation.
Cautions Tricyclic and related
antidepressant drugs should be used
with caution in patients with
cardiovascular disease because of the
risk of arrhythmias. Care is also needed
in patients with epilepsy and diabetes.
Tricyclic antidepressant drugs have
antimuscarinic activity, and therefore
caution is needed in patients with
prostatic hypertrophy, chronic
39
Class
Drug
clomipramine
doxepin
dothiepin
Imipramine
Council decision
starting dose).
Dosing consideration and further
diagnostic assessments are essential
skills needed before Tricylic related
anti-depressants are introduced.
Dosing considerations are
fundamental as this drug has
numerous fatal adverse effects.
Remove from the list due to its
adverse effect profile.
Overdosage Limited quantities of
prescribed at any one time because
their cardiovascular and
epileptogenic effects are dangerous
in overdosage. In particular,
overdosage with dosulepin
(dothiepin) and amitriptyline is
associated with a relatively high rate
of fatality.
adverse effect profile.
Evidence
anxiety, dizziness, agitation,
confusion, diarrhoea, sleep
disturbances, irritability,
paraesthesia, drowsiness, sexual
dysfunction, yawning, changes in
blood sugar, increased appetite,
weight gain or loss, anorexia,
postural hypotension, flushing,
nausea, vomiting, taste disturbance,
tinnitus, rash, urticaria, pruritus,
photosensitivity, alopecia, sweating
Imipramine is well established, but
has more marked antimuscarinic
adverse effects than other tricyclic
and related antidepressants.
Considerations
constipation, increased intra-ocular
pressure, urinary retention, or those with
a susceptibility to angle-closure
glaucoma.
Tricyclic and related antidepressant
drugs should be used with caution in
patients with a significant risk of suicide,
or a history of psychosis or bipolar
disorder, because antidepressant
therapy may aggravate these conditions;
treatment should be stopped if the
patient enters a manic phase.
See note below.
in overdosage. In particular,
overdosage with dosulepin
(dothiepin) and amitriptyline is
associated with a relatively high rate
of fatality.
40
Class
Drug
Council decision
adverse effect profile
Evidence
Considerations
in overdosage.
nortriptyline
Tricyclic
related antidepressants
maprotiline
Keep on the list for pain
management and smoking
cessation only
Indications depression; neuropathic
pain [unapproved]; aid in smoking
cessation
Dosing consideration and further
diagnostic assessments are essential
skills needed before Tricylic related
anti-depressants are introduced.
Dosing considerations are
fundamental as this drug has
numerous fatal adverse effects.
mianserin
See comments for amitriptyline –
nortriptyline is an active metabolite of
amitriptyline. Suggest remove
depression as an indication, but keep
neuropathic pain and possibly add
smoking cessation.
Failure to respond to initial treatment
with an SSRI may require an
increase in the dose, or switching to
a different SSRI, SNRI, TCA or other
antidepressant.
Tricyclic antidepressants may be
particularly helpful for patients with
melancholic depression, or for patients
who have found them effective in the
past. Tricyclic antidepressants have
similar efficacy to SSRIs but are more
likely to be discontinued because of
adverse effects; toxicity in overdosage is
also a problem.
Note: May cause fewer
antimuscarinic and cardiovascular
adverse effects than tricyclics but
generally more sedating. Greater
potential for toxicity in overdose than
SSRIs. Also, risk of blood dyscrasias
greater than other tricyclic agents.
41
Class
Other antidepressant
group
Drug
mirtazapine
Council decision
Remove from list.
Reversible
monoamineoxidase
inhibitors
moclobemide
Not considered first line choice.
Therefore patients would already be
on one or several anti-depressant
drug. More complicated depressive
conditions are better managed by
Consultants.
Evidence
Tricyclic antidepressants and
venlafaxine should be considered for
more severe forms of depression.
Third line choices include
moclobemide, mirtazapine, or one of
the irreversible MAOIs, and these
patients should be referred to
specialist mental health services.
Indication for this drug:
Moclobemide is indicated for
depressive syndromes and social
phobia. Conditions not commonly
manage by specialist nurses.
venlafaxine
Do not add to list
Indications:
depression; generalised anxiety
disorder; social anxiety disorder;
panic disorder.
Not suitable for specialist nurse
prescribing, lack of evidence and not
first line drug of choice. Also dose
dependent effects – i.e. different
effects at different doses & would
take medical specialist to optimise its
use.
Considerations
Mirtazapine is a presynaptic alpha2adrenoceptor antagonist, increases
central noradrenergic and serotonergic
neurotransmission. It has few
antimuscarinic effects, but its
histaminergic effect causes sedation
during initial treatment.
Moclobemide should not be given with
another antidepressant. Owing to its
short duration of action no treatment-free
period is required after it has been
stopped but it should not be started until
at least a week after a tricyclic or related
antidepressant or an SSRI or related
antidepressant has been stopped (at
least 5 weeks in the case of fluoxetine),
or for at least a week after an MAOI has
been stopped.
Venlafaxine is a serotonin and
noradrenaline re-uptake inhibitor; it lacks
the sedative and antimuscarinic effects
of the tricyclic antidepressants. There is
limited evidence of venlafaxine having
greater efficacy in treatment resistant
depression particularly at higher doses.
Venlafaxine is associated with a high risk
of withdrawal effects.
•QT prolongation appears to be a class
effect for all selective serotonin reuptake
inhibitors (SSRIs) and tricyclic
antidepressants (TCAs), and also occurs
with venlafaxine.
•The potential for QT prolongation to
occur should be considered as part of
the risk benefit assessment prior to
prescribing an antidepressant.
All antidepressants on the market are
42
Class
Drug
Council decision
Evidence
Considerations
potentially effective. Usually, 2-6 weeks
at a therapeutic-dose level are needed to
observe a clinical response. The choice
of medication should be guided by
anticipated safety and tolerability, which
aid in compliance.
NOTE: Antidepressant discontinuation syndrome may occur within 5 days of stopping treatment with antidepressant drugs; symptoms are
usually mild and self-limiting (lasting for 1–2 weeks), but in some cases may be severe.
General guidance only for switching between antidepressants. It is important to be aware that differing recommendations exist between
publications and caution is required when switching between antidepressants due to the risk of serotonin syndrome or, in the case of
monoamine oxidase inhibitors (MAOIs), hypertensive crisis.
43
Table 10: Review of antipsychotics
On the list provided there are a number of Typical Antipsychotics that are no longer in common use. They should not be on the list (43, Denise
Black & the Mental Health Senior Nurse Group).
Some hardly used typical anti-psychotics are listed where as frequently used, almost first line treatments, such as risperidone is not included.
Risperidone tablets do not need special authority (although the oral dispersible wafers and Consta IMI does). Should most medications
commonly used be included (if no special authority is required) (64, individual nurse).
The list contains a lot of First Generation anti-psychotics, and although the evidence is that they are equally efficacious as their second
generation cousins (Olanzapine, Risperdione etc), they require careful prescribing and dose management, along with the management of the
side-effects (76, Te Ao Maramatanga, New Zealand College of Mental Health Nurses).
Council is concerned about the inclusion of some medicines that we believe should only be initiated or repeat prescribed by a medical
practitioner. GPs do not initiate some of these medicines so it is of concern to see them included here….many of the medicines listed are not
appropriate for nurses to access….. antipsychotics (85, Pharmacy Council of New Zealand).
Antipsychotics: Chlorpromazine, Flupenthixol, Fluphenazine, Olanzapine ,Pipothiazine, Zuclopenthixol. These medicines would not be
appropriate for a non-medical prescriber to initiate due to the complexity of the medical condition (schizophrenia) and its treatment, but would
probably be suitable for inclusion on a list of medicines for repeat prescribing (86, CAPA- Clinical Advisory Pharmacists).
I notice that there are a number of depot antipsychotics on the list. Presumably prescribing nurses would not normally initiate IMI treatment,
especially some of the older meds? (154, Individual nurse).
There are a few items that we have concerns with: e.g. Olanzapine (181, PHARMAC).
The Guild agrees that antipsychotic treatment should not be initiated by specialist nurse prescribers, but that they could safely prescribe
repeats once the patient is stable and adherent (60, Pharmacy Guild of New Zealand).
44
Class
Thioxanthenes
Drug
flupenthixol
Council decision
Further diagnostic assessments
are essential skills needed before
prescribing.
Typical
antipsychotic
fluphenazine
prescribing.
First generation
Group 3
Indications maintenance in
schizophrenia and other
psychoses.
DEPOT Injection
pipothiazine
Evidence
Before initiating antipsychotic drugs,
an ECG may be required, particularly
if physical examination identifies
cardiovascular risk factors, or if there
is a personal history of
cardiovascular disease. A number of
antipsychotics can cause
prolongation of the QT-interval; those
with a moderate to high effect include
amisulpride, chlorpromazine,
haloperidol, quetiapine.
Dosage Individual responses to
antipsychotic drugs are very variable
and to achieve optimum effect,
dosage and dosage interval must be
titrated according to the patient's
response
First-generation typical
antipsychotic
Group 3: fluphenazine and
trifluoperazine, generally
characterised by fewer sedative and
antimuscarinic effects, but more
pronounced extrapyramidal adverse
effects than groups 1 and 2.
Considerations
Thioxanthenes (flupentixol and
zuclopenthixol) have moderate sedative,
antimuscarinic, and extrapyramidal effects.
Long-acting depot injections are used for
maintenance therapy especially when
compliance with oral treatment is unreliable.
However, depot injections of conventional
antipsychotics may give rise to a higher
incidence of extrapyramidal reactions than
oral preparations, although extrapyramidal
reactions occur less frequently with secondgeneration antipsychotic depot preparations,
such as risperidone and olanzapine
embonate.
prescribing.
zuclopenthixol
psychoses.
DEPOT Injection.
45
Class
Drug
Council decision
Evidence
Considerations
First-generation typical antipsychotic
Antipsychotic drugs have been associated
with cardiovascular adverse effects such as
tachycardia, arrhythmias and hypotension.
QT-interval prolongation is a particular
concern with pimozide [section 29,
unapproved medicine], ziprasidone, and
haloperidol.
prescribing.
haloperidol
psychoses.
DEPOT Injection.
Not for prescribing in mental
health but retain for palliative
care
prescribing
Atypical
Antipsychotic
olanzepine
Indications schizophrenia and
other psychoses; mania; shortterm adjunctive management of
psychomotor agitation,
excitement, and violent or
dangerously impulsive behaviour.
Intractable hiccup (unapproved).
prescribing.
related psychoses; mania;
preventing recurrence in bipolar
disorder; monotherapy for mania;
control of agitation and disturbed
behaviour in schizophrenia and
related psychoses or mania.
Unapproved use in palliative care for
hiccups (s.c. injection).
Haloperidol’s use in palliative care
will be associated with and as per
clear best-practice guidance and so
it’s inclusion for Specialist palliative
care nurses for specific indications
would be appropriate.
Atypical antipsychotics have mostly
replaced the older antipsychotics for
treating schizophrenia, bipolar
disorder, and other severe mental
illness because of their many
advantages.
Second generation antipsychotic
drugs:
There are eight drugs listed under
the NZ Formulary, only one listed
under the Specialist nurse list.
Second generation antipsychotic drugs
should be prescribed if extrapyramidal
adverse effects are a particular concern. Of
these, aripiprazole, clozapine, olanzapine,
and quetiapine are least likely to cause
extrapyramidal effects. Although amisulpride
is a dopamine-receptor antagonist,
extrapyramidal effects are less common than
with the first-generation antipsychotic drugs
because amisulpride selectively blocks
mesolimbic dopamine receptors, and
extrapyramidal symptoms are caused by
blockade of the striatal dopamine pathway.
Significant risk of metabolic
46
Class
Drug
Council decision
quetiapine
Do not add to the list
Evidence
Considerations
effects/hyperglyacaemia/diabetes.
Quetiapine is an agent that is abused – it has
a “street” value.
Aripiprazole is a dopamine D2 partial
agonist with weak 5-HT1a partial
agonism and 5-HT2A receptor
antagonism. Aripiprazole can cause
nausea and, unlike other
antipsychotic drugs, lowers prolactin.
Subsidy only applies with a Special Authority
that relies on a medicine that is not on the list
has being tried and found not suitable. This
is likely to be a significant barrier to its use,
especially if Specialist nurses cannot apply
for a Special Authority.
Aripiprazole has negligible effect on
the QT-interval and less likely to
cause metabolic effects.
Adverse reaction identified
through IMMP monitoring (Source
Medsafe)
All of the atypical antipsychotics
currently available in New Zealand
(i.e. clozapine, olanzapine,
quetiapine and risperidone) are
monitored in the Intensive Medicines
Monitoring Programme (IMMP).
From the 572 case reports analysed,
hypertension has been identified as
a possible adverse reaction. Routine
screening of the data revealed this
Indications: acute and chronic psychoses;
mania; short-term treatment (up to 6 weeks)
of persistent aggression in patients with
moderate to severe Alzheimer's dementia
unresponsive to non-pharmacological
interventions and when there is a risk of harm
to self or others; short-term treatment (up to 6
weeks) of persistent aggression in conduct
disorder (under specialist supervision);
behaviour disturbance in autism.
prescribing.
aripiprazole
related psychoses; mania;
preventing recurrence in bipolar
disorder; monotherapy for mania;
control of agitation and disturbed
behaviour in schizophrenia and
related psychoses or mania.
Do not add to the list.
Indications schizophrenia;
treatment and recurrence
prevention of mania (with or
without depressive or psychotic
features).
risperidone
Do not add to list.
prescribing.
Risk: benefit ratio important to determine
prior to prescribing, especially in older
47
Class
Drug
Council decision
Second
generation
antipsychotic
clozapine
Do not add because of safety,
legal and monitoring
requirements.
Submitted to be added by the
Royal College of Psychiatrist for
repeat prescribing.
Clozapine is an atypical
antipsychotic. This has been
covered it in a separate SafeRx®
bulletin because of its specific
adverse reaction
profile and the higher risks
associated with its use
(\http://www.saferx.co.nz/).
Evidence
unexpected association.
Hypotension with atypical
antipsychotics is a known effect and
for all four medicines a total of 19
reports of hypotension, or symptoms
suggesting hypotension (e.g.
faintness) have been received. In
comparison, 13 reports of
hypertension have been received; 10
with clozapine, two with risperidone
and one with quetiapine. At this
stage of monitoring more data have
been collected for clozapine and so
the actual numbers of reports of
hypertension are not a guide to
comparative risk. The two most
severe cases occurred with
risperidone.
Clozapine is a restricted medicine:
Medsafe website 3 March 2014.
Prescribing of clozapine is subject to
restrictions:
The medicine may only be prescribed
by psychiatrists, medical practitioners
employed as registrars in the branch
of psychiatry who are under the
supervision of the persons referred to
above, Medical officers who are in
the employment of a district health
board, and are under the supervision
of psychiatrists and general
practitioners who must be continuing
the prescribing of clozapine for a
specific patient whose illness is wellcontrolled in collaboration, or
following consultation, with a
Considerations
people.
The reason is as highlighted in the
MEDSAFE report:
It causes agranulocytosis in up to 1% of
patients and regular monitoring of neutrophil
counts is mandatory throughout treatment. In
New Zealand one death from agranulocytosis
has been reported to the IMMP. In contrast,
four deaths from complications of severe
constipation have been reported. This article
reminds health professionals that the
gastrointestinal effects of clozapine are
potentially serious. Awareness of this issue
may prevent life-threatening complications.
Clozapine-induced constipation may be fatal.
Constipation is often regarded as a frequent,
minor side effect of clozapine. However,
review of New Zealand reports received by
the IMMP shows that clozapine-induced
48
Class
Drug
Council decision
Evidence
Community Mental Health Team.
Persons prescribing the medicine
must comply with appropriate local
treatment guidelines.
The medicine must be dispensed in
accordance with appropriate local
dispensing guidelines.
Sale or marketing of this medicine
may only occur if:
The sponsor has an appropriate
blood monitoring and patient record
database in place.
Considerations
constipation may be associated with serious
effects such as intestinal obstruction, bowel
perforation and toxic megacolon. The four
deaths reported to IMMP demonstrate that
these effects can be fatal.
Clozapine affects motility throughout the gut
In addition to reports of constipation
associated with clozapine, IMMP has
received three reports of paralytic ileus and a
further three reports of oesophageal
dysmotility. These case reports suggest that
clozapine may reduce gastrointestinal (GI)
motility throughout the gut, resulting in
complications higher in the GI tract.
49
Table 11: Review of other common mental health medicines
Common mental health medicines were supported to be on the list (73, Bay of Plenty District Health Board).
International best practice prescribing guidelines should be sought to finalise this list, especially as those drugs requiring Special authority are not
present (76, Te Ao Maramatange, New Zealand College of Mental Health Nurses).
Include more recent antidepressant medication options (84, Individual Nurse).
Valproic acid – listed for neuropathic pain. Not licensed for neuropathic pain and no evidence of benefit for this indication. Licensed for epilepsy and
bipolar disorder. More commonly known as sodium valproate. May be appropriate for repeat prescribing but not initiation of treatment due to severity of
medical conditions (epilepsy, bipolar disorder) (86, CAPA-Clinical Advisory Pharmacists).
Omissions for commonly used psychiatric meds include risperidone, quetiapine, aripiprazole, lithium, sodium valproate (154, Individual Nurse).
Class
Others
Drug
Lithium
Council decision
Do not add to list
Further diagnostic assessments are
essential skills needed before
prescribing.
Toxicity profile is high.
Lithium has a narrow therapeutic
range and monitoring of serumlithium concentrations is necessary.
Samples should be taken 12 hours
after the dose. The usual range for
maintenance is 0.4–0.8 mmol/litre
and for acute episodes of mania,
Evidence
Most cases of lithium intoxication
occur as a complication of long-term
therapy and are caused by reduced
excretion of the drug because of a
variety of factors including
dehydration, deterioration of renal
function, infections, and coadministration of diuretics or NSAIDs
(or other drugs that interact). Acute
deliberate overdoses may also occur
with delayed onset of symptoms (12
hours or more) owing to slow entry of
lithium into the tissues and continuing
absorption from modified-release
formulations.
Considerations
Lithium salts are used in the prophylaxis and
treatment of mania, in the prophylaxis of
bipolar disorder (manic-depressive disorder),
as concomitant therapy with antidepressant
medication in patients who have had an
incomplete response to treatment for acute
depression in bipolar disorder, and in the
prophylaxis of recurrent depression (unipolar
illness or unipolar depression). Lithium is also
used to augment other antidepressants in
patients with treatment-resistant depression
[unapproved indication] (section 4.3). The
decision to give prophylactic lithium requires
specialist advice, and must be based on
careful consideration of the likelihood of
50
Class
Drug
valproate
sodium
(Epilim)
Listed as
valproic acid
CNS
Stimulant
methylphenidat
e
hydrochloride
Council decision
0.8–1.2 mmol/litre. It is important to
determine the optimum range for
each individual patient.
Do not keep for bipolar or epilepsy
Evidence
Potential for toxicity. Requires regular
monitoring.
Note not approved for use for
neuropathic pain. Evidence not
strong for use and third line choice.
Note supported by Royal College of
Psychiatrists (see above).
Note: Prescribing is restricted to
specified Medical practitioners.
Listed in Misuse of Drugs
Regulations on the “designated
prescriber nurses” (previous nurse
practitioner) list but this is over ruled
by the MOH restrictions.
It was not included in Council’s
registered nurse controlled drug
consultation.
May only be prescribed by: Medical
practitioners with a vocational scope
of practice of Paediatrics or
Psychiatry, for the treatment of
Attention Deficit and Hyperactivity
Disorder (ADHD), or Medical
practitioners with a vocational scope
of practice of Internal Medicine, for
the treatment of narcolepsy, or
Medical practitioners with a
vocational scope of Palliative
Medicine, for use in palliative care
treatment. Any other medical
practitioner when acting on the
written recommendation of one of the
vocationally registered medical
practitioners described above, for the
conditions specified. This is a legal
requirement of regulation 22 of the
Misuse of Drugs Regulations and the
delegated direction of the Minister of
Health for this controlled drug. See
www.medsafe.govt.nz/profs/RIss/rest
rict.asp.
Considerations
recurrence in the individual patient, and the
benefit of treatment weighed against the
risks.
Indications epilepsy; treatment and
recurrence prevention of mania in bipolar
disorder; migraine prophylaxis [unapproved].
Class B2 controlled drugs.
Drug treatment of ADHD should be part of a
comprehensive treatment programme. The
choice of medication should take into
consideration co-morbid conditions (such as
tic disorders, Tourette syndrome, and
epilepsy), the adverse effect profile, potential
for drug misuse, and preferences of the
patient and carers. Methylphenidate and
atomoxetine are used for the management of
ADHD.
51
Table 12: Review of addiction medicines
We do not believe specialist nurses should initiate all medicines but could repeat prescribe some medications. For example addiction specialist nurses
prescribers should not initiate but could repeat prescribe anti craving medications (Naltrexone and Disulfiram), alcohol withdrawal management rimes
(Diazepam, Oxazepam), and anti psychotic agents. Opioid Substitution treatment (methadone and Suboxone) should also be repeat prescribed once
the barriers resulting from the current Misuse of Drugs Act are addressed (35, Drug and Alcohol Nurses of Australasia).
We would strongly support the Council considering medicines that specialist nurses could safely repeat prescribe within the specialty services of
mental health and addiction. Such medicines should include consideration of antipsychotic medicines, anticraving medications such as naltrexone for
alcohol dependence as well as disulfiram for alcohol dependence; medicines for alcohol withdrawal and medicines for opioid substitution treatment
particularly buprenorphine (eg. In combination with naloxone) and methadone. We are aware that the barriers to nurse practitioner prescribing for drug
dependence inherent in the Misuse of Drugs Act is being addressed following the barriers again being raised. (76, Te Ao Maramatanga, New
ZealandCollege of Mental Health Nurses).
Other submitters supported drugs for Addictions to be added to the list (78, 83, 158).
Class
Hypnotics
Drug
diazepam,
oxazepam
benzodiazepi
nes
Opioid
antagonist
Council decision
Keep for repeat prescribing
Note these drugs are also discussed
under controlled drug list.
Naltrexone
Keep for repeat prescribing by
nurses in specialist addiction teams
Evidence
Risk of dependence is high for
these drugs.
Considerations
Hypnotics: benzodiazepines (alprazolam,
diazepam, lorazepam,nitrazepam,temazepam
Diazepam is used to produce mild sedation with
amnesia. It is a long-acting drug with active
metabolites and a second period of drowsiness
can occur several hours after its administration.
Benzodiazepines are indicated for the short-term
relief of severe anxiety; long-term use should be
avoided (see section 4.1). Diazepam and
alprazolam have a sustained action. Shorteracting compounds such as lorazepam and
oxazepam may be preferred in patients with
hepatic impairment but they carry a greater risk of
withdrawal symptoms.
Naltrexone is an opioid-receptor antagonist, but is
useful as an adjunct in the treatment of alcohol
dependence after a successful withdrawal.
Treatment should be initiated by a specialist and
52
Class
Opioid
substitution
treatment
Drug
Council decision
Evidence
disulfiram
(Antabuse)
Keep for repeat prescribing by
nurses in specialist addiction teams
Methadone/sub
oxone
(buprenorphine
+naloxone)
Before initiating disulfiram,
prescribers should evaluate the
patient’s suitability for treatment,
because some patient factors, for
example memory impairment or
social circumstances, make
compliance to treatment or
abstinence from alcohol difficult.
During treatment with disulfiram,
patients should be monitored,
including review of LFTs at least
every 2 weeks for the first 2 months,
then each month for the following 4
months, and at least every 6 months.
The prescriber should monitor for
signs of toxicity, and the patient
should be told to be aware of warning
signs of toxicity on initiation and
during titration. The risk of death is
highest in the first 2 weeks of
methadone initiation: this should be
undertaken in a closely supervised
setting.
Note a change would need to be
made to the Misuse of Drugs Act.
The controlled drug lists cannot
be updated through a Gazette
notice so future proofing is
required.
It is anticipated that specialist
addiction registered nurse
prescribers (and nurse practitioners)
would also be appropriately
authorised under the Misuse of
Drugs Act as are specified medical
practitioners.
Note these drugs are also discussed
under controlled drug list.
Naloxone is already on the list.
Considerations
continued under specialist supervision.
Treatment should be reviewed monthly for the first
6 months, and then at reduced intervals;
naltrexone should be stopped if drinking continues
for 4–6 weeks after starting treatment.
Disulfiram is used as an adjunct in the treatment of
alcohol dependence (under specialist supervision).
It gives rise to an extremely unpleasant systemic
reaction after the ingestion of even a small amount
of alcohol because it causes accumulation of
acetaldehyde in the body; it is only effective if
taken daily. Symptoms can occur within 10
minutes of ingesting alcohol and include flushing
of the face, throbbing headache, palpitation,
tachycardia, nausea, vomiting, and, with large
doses of alcohol, arrhythmias, hypotension, and
collapse; these reactions can last several hours.
Buprenorphine is a Class C4 controlled drug
Methadone is a Class B3 controlled drug
Methadone and buprenorphine with naloxone are
used as substitution therapy in opioid
dependence. Substitute medication should be
commenced with a short period of stabilisation,
followed by either maintenance treatment or a
withdrawal regimen. Maintenance treatment
enables patients to achieve stability, reduces drug
use and crime, and improves health; it should be
regularly reviewed to ensure the patient continues
to derive benefit.
53
6
Controlled drugs list
There was strong support from submitters for the list of 15 controlled drugs proposed by the
Council (81.8%). This report responds to the feedback from submitters that concerned the
list of drugs but also other restrictions around how they are prescribed.
There was support for nurses to be able to prescribe controlled drugs in palliative care (20,
53, 83, 98, 111, 128, 129, 140, 147, 164, 171) including end stage COPD and heart failure
(6). Pain management was also identified as an appropriate specialty (53, 98, 111, 128,
129, 140). For mental health there was support for prescribing of some benzodiazepine
drugs including clonazepam (43, 64, 154) and opioid substitutes (76).
Some submitters were cautious in their agreement believing it would depend on the specialty
or ‘scope’ of the nurse (25, 38, 47, 52, 96, 125, 140, 179, 187), to restrict this to specialty
areas (128, 129, 140, 147, 158) or to repeat prescribing (147) or have an additional
authorisation (93, 143).
I do not agree that the specialist nurse should have prescribing rights of controlled drugs. If
the patient needed controlled drugs their condition should be reviewed by a medical
practitioner or a nurse practitioner. However if a palliative specialist nurse has authority to
prescribe limited controlled drugs I do not see that as a problem as long as it was written into
their scope of practice (20, Individual Nurse).
These drugs are controlled because they are dangerous- to the consumer, the public, and
the prescriber. We support the initiation of prescription of these drugs by the specialist Pain
Nurses, but only as part of a therapeutic team (186, New Zealand Society of Anaesthetists).
Commencing a medication would have to be related to the context setting e.g. a Nurse
Specialist working in a clinical setting that manages a methadone programme could
prescribe/re-prescribe methadone not an RN in a GP practice; or morphine is the domain of
the Palliative Care Nurse Specialist. Clarity needed around the clinical context. (147, Rural
Canterbury Primary Health Organisation).
For Mental Health Specialist nurse prescribers they should not be able to prescribe the
following Alprazolam, Codeine, Dihydrocodeine, Fentanyl, Lormetazepam, Methadone,
Morphine, Oxycodone (43, Group of Nurses, DHB).
Others said it was too inclusive of opiates and benzodiazepines (31, 74, 86).
6.1
Conditions for prescribing controlled drugs
Designated nurse prescribers are restricted to prescribing controlled drugs only for patients
under their care, only in an emergency and only a three day supply (Misuse of Drugs
Regulations 1977 section 21(4B)).
The Council asked if these conditions were too restrictive. A majority of submitters (56.1%)
agreed that specialist nurse prescribers should be able to prescribe controlled drugs for a
period longer than three days. Many submitters indicated that a longer timeframe would be
54
appropriate as three days was not always long enough to cover periods when authorised
prescribers were not available or easily accessible to the patient e.g. in palliative care (79,
91, 99, 121, 123, 138, 140, 147, 151, 158, 166, 184, 190), pain management (38, 91), rural
(99, 116, 147, 158), and for patients with chronic long term conditions (77, 110, 123, 167).
The list of medications is appropriate, however the restrictions on prescribing them is
prohibitive. For patients who have been prescribed a controlled drug for ongoing
management of a chronic condition (e.g. low dose morphine elixir for shortness of breath) it
would be appropriate for an appropriately trained nurse prescriber to provide repeat
prescriptions, and titrate doses (13, Group of Nurses, DHB CNS).

Palliative care or remote settings will be limited by this restriction. Suggest that it may
be an idea for employers to consider this in a hospital setting but why only controlled drugs –
these are not the most dangerous and I don’t think there is any evidence to suggest nurses
would be more prone to misuse than any other prescriber and therefore should not be
specifically restricted

Palliative care or areas in the rural sector where GP oversight is variable depending on
availability and healthcare is provided mainly by RNs. Good to have flexibility
(158, Canterbury Regional Directors of Nursing and Canterbury Postgraduate Nursing
Education).
A longer timeframe was suggested by some submitters. These included five days (57, 117),
seven days or one week (5, 124, 140, 153, 64), nine days or three x three - day supplies (84)
or two weeks (33, 154). One suggested up to 30 days (85) and some suggested it should be
longer in palliative care (28, 59, 75, 80). One submitter advocated no restriction (175)
although medical practitioners have restrictions on the length of supply they are legally able
to prescribe.
Patient assessment and need should be the primary impetus for the prescription of
controlled drugs. Stipulating a defined time duration may be limiting in some circumstances
of addressing patient need (53, Nursing and Midwifery Board of Ireland).
Those who disagreed with a change to the three day restriction included some who
commented that a doctor should be involved after three days (3, 4, 40, 63, 66, 82, 106, 112,
133, 142, 146, 169, 150, 178).
Patients should be going to their GP for longer term prescriptions for controlled drugs (82,
College of Emergency Nurses New Zealand - NZNO).
All controlled drugs should be strictly monitored by doctors and/or nurses and if a patient
requires it longer it should be a professional decision between doctor and nurse (4,
Individual Nurse).
Some were concerned about drug seekers (14, 60, 114,). Others were concerned about
benzodiazepines and nurses being exposed to drug seekers (14, 39, 60, 114, 140, 170, 178,
181) or potential for mis-prescribing (85). The emergency condition was seen by one as a
reason to restrict the list further (176).
55
We are not supportive of this proposal, from a safety perspective (again, noting the
limitations of our expertise with respect to safety and clinical practice). These are medicines
with high ‘addictive’ properties, and also, in some cases, should not be for long-term use.
So we are of the view that keeping the 3 days limit appears to be appropriate (181,
PHARMAC).
While we agree with nurse prescribing of opioid analgesia in an emergency for no longer
than 3 days we do not agree with extending this period or with nurse prescription of
benzodiazepines in any circumstances.
We also note both of these types of these medications have been found to be highly
addictive and GPs have complained about being put under extreme pressure to prescribe
them at times. It would be important to have some mechanisms to protect both consumers
and specialist nurses from any misuse of these medications especially when they may be
prescribed in the context of home based visits (14, Women's Health Action).
Issues surrounding prescription of controlled drugs are well-documented. It may well be
appropriate for nurses to prescribe opioids in rural areas and/or in palliative care practice;
however the Nursing Council must ensure that nurses have adequate training and support to
recognise and appropriately deal with drug seeking behaviours and diversion of such
medicines. It is critical that health professionals’ personal safety is protected (114, New
Zealand National Committee of the Australian & New Zealand College of Anaesthetists
(ANZCA)).
Only in an emergency. I do not believe the following medicines are required in an
emergency: Alprazolam, lormetazepam, nitrazepam, oxazepam, temazepam, triazolam,
zopiclone (176, Individual Pharmacist).
6.2
Council decisions controlled drugs
1. The controlled drugs included in the consultation remain on the list except oxycodone
but some medicines are restricted by specialty or indication.
2. Clonazepam and buprenorphine are added to the list. Please note that clonazepam
is not for the approved use (epilepsy) but for an unapproved (section 25) use (panic
disorders).
3. Pethidine and methylphenidate are not added to the list.
4. The Council submit to the Ministry of Health that the restrictions for designated nurse
prescribers under the Misuse of Drugs Act 1975 are changed to requirement to be
working in a collaborative prescribing team, and limited to a 7 day supply after which
there must be consultation with an authorised prescriber.
5. The education programme for nurse prescribers will include specific content on the
prescribing of benzodiazepines and opioids and recognising and managing drug
seeking behaviour.
56
Table 13: Response to submitters’ feedback to remove or add controlled drugs
Classification
Hypnotics
benzodiazepine
Drug
lormetazepam
temazepam
triazolam
nitrazepam
alprazolam
lorazepam
clonazepam
diazepam,
oxazepam
Submissions
Council decision
Suggest reduce number of
benzodiazepines availablhe (86,
CAPA- Clinical Advisory Pharmacists
Association). Benzodiazepines, along
with opioids are the most commonly
misused prescription drugs in New
Zealand. Misuse frequently occurs
when multiple drugs are misused,
with the highest correlation between
concurrent addiction to opioids and
alcohol. Some benzodiazepines
have limited licensed use in New
Zealand and it is debatable if they
should be on the list at all. If
benzodiazepines remain on the list,
they should be limited to a 30 day
supply only (85, Pharmacy Council).
Keep on the list
I believe that Clonazepam should be
added to the proposed specialist
nurse – controlled drug list (pg. 44)
as this is regularly used in mental
health settings (64, Individual Nurse).
(43, 154).
Add to the list for
anxiety and panic
disorder
Remove Diazepam from the list for
all (43, Group of Nurses, DHB).
Evidence
Benzodiazepines used as hypnotics include nitrazepam
and diazepam which have a prolonged action and may
give rise to residual effects on the following day; repeated
doses tend to be cumulative.
Lormetazepam and
temazepam act for a shorter time and they have little or no
hangover effect. Withdrawal phenomena are more
common with the short-acting benzodiazepines.
Benzodiazepines are indicated for the short-term relief of
severe anxiety; long-term use should be avoided
Diazepam and alprazolam have a sustained action.
Shorter-acting compounds such as lorazepam and
oxazepam may be preferred in patients with hepatic
impairment but they carry a greater risk of withdrawal
symptoms.
Note section 25
indication only.
Keep on the list for
continuation
In panic disorders (with or without agoraphobia) resistant
to antidepressant therapy a benzodiazepine (such as
lorazepam 3–5 mg daily) or clonazepam 1–2 mg daily
[both unapproved indications] may be used; alternatively, a
benzodiazepine may be used as short-term adjunctive
therapy at the start of antidepressant treatment to prevent
the initial worsening of symptoms.
Clonazepam is unapproved for anxiety and panic attack
and only approved for seizures and epilepsy.
Evidence for Section 25 use
Curr Drug Targets. 2013 Mar;14(3):353-64.
Clonazepam for the treatment of panic
disorder.
1
Nardi AE , Machado S, Almada LF, Paes F, Silva AC,
Marques RJ, Amrein R, Freire RC, Martin-Santos R, Cosci
F, Hallak JE, Crippa JA, Arias-Carrión O
Diazepam is used to produce mild sedation with amnesia.
It is a long-acting drug with active metabolites and a
57
Classification
Drug
(Alcohol
withdrawal
Benzodiazepine
s)
Opioid analgesic
pethidine
Submissions
Council decision
Evidence
For example addiction specialist
nurses prescribers should not initiate
but could repeat prescribe anti
craving medications (Naltrexone and
Disulfiram), alcohol withdrawal
management rimes (Diazepam,
Oxazepam), and anti-psychotic
agents (35, Drug and Alcohol Nurses
of Australasia).
Other submitters supported drugs for
Addictions to be added to the list.
(76, 78, 83, 158)
No rational given (92, Defence
Force)
prescribing by nurses
in specialist addiction
teams
second period of drowsiness can occur several hours after
its administration.
Benzodiazepines are indicated for the short-term relief of
severe anxiety; long-term use should be avoided (see
section 4.1). Diazepam and alprazolam have a sustained
action. Shorter-acting compounds such as lorazepam and
oxazepam may be preferred in patients with hepatic
impairment but they carry a greater risk of withdrawal
symptoms.
Pethidine produces prompt but short-lasting analgesia; it is
less constipating than morphine, but even in high doses is
a less potent analgesic. It is not suitable for severe
continuing pain as it is a long-acting metabolite may
accumulate and cause toxicity with ongoing dosing,
especially in renal impairment.
No indication for nurse
prescribers in NZ
oxycodone
Oxycodone has high abuse potential
as it is a potent opioid that is easily
extracted from the long-acting tablet
formulation for IV use. These tablets
can be crushed, dissolved and
injected, unlike other drugs that might
need chemical manipulation before
use. Oxycodone has no clinical
advantage over other opioid
analgesics and, as recommended by
bpacnz (Best Practice June 2011)
should only be used if morphine is
not tolerated or not suitable. Council
because of potential for
dependence and drug
seeking
It is used for analgesia in labour; however, other opioids,
such as morphine are often preferred for obstetric pain
(NZF)
Oxycodone has an efficacy and adverse effect profile
similar to that of morphine. It is an alternative to morphine
in the treatment of severe pain if morphine is not effective
or not tolerated (NZF).
Oxycodone is much (40x) more potent than morphine and
more likely to cause dependence. There is good reason to
restrict access, and not much reason to widen access to
this medicine, on both safety and efficacy. grounds.
http://www.bpac.org.nz/BPJ/2012/may/oxycodone.aspx
http://www.bpac.org.nz/BPJ/2014/June/upfront.aspx
58
Classification
Opioid analgesic
and opioid
substitute
Drug
methadone
Submissions
therefore believes serious
consideration should be given to
restricting oxycodone to medical
practitioners only (85, Pharmacy
Council of New Zealand).
The College’s addiction medicine
physicians note that, specific to the
practice of addiction medicine in New
Zealand:
There is an additional safeguard
under the Misuse of Drugs Act 1975,
section 24, in relation to prescribing
for dependency: if the prescribing
happens outside of a gazetted (i.e.
specialist) addiction service, there
must be a specialist letter of authority
to the prescriber from the service
including details of the prescribing
parameters. In this way, it can be
expected that all controlled drug
prescribing in addiction would be
overseen by a medical practitioner,
either because the nurse prescriber
works in the specialist service, or is
authorised by that service.
At the time of this submission, the
Misuse of Drugs Act limits controlled
drug prescribing to medical
practitioners only. It is understood
that an amendment to this limitation
has been proposed to allow for nurse
prescribing. This submission allows
for the possibility that this
amendment will proceed (189, The
Council decision
Evidence
Keep as an analgesic
in palliative care
Methadone is less sedating than morphine and acts for
longer periods. Methadone may be used instead of
morphine in the occasional patient who experiences
excitation (or exacerbation of pain) with morphine.
Methadone requires careful dose titration and should only
be used by those experienced in its use (NZF).
Keep on the list for
continuation
teams
Note a change would
need to be made to the
Misuse of Drugs Act.
The controlled drug lists
cannot be updated
through a Gazette notice
so future proofing is
required.
It is anticipated that
specialist addiction
registered nurse
prescribers (and nurse
practitioners) would also
be appropriately
authorised under the
Misuse of Drugs Act as
are specified medical
practitioners.
59
Classification
Opioid/opioid
substitution
treatment
Drug
buprenorphine
Submissions
Royal Australasian College of
Physicians).
Opioid Substitution treatment
(methadone and Suboxone) should
also be repeat prescribed once the
barriers resulting from the current
Misuse of Drugs Act are addressed
(35, Drug and Alcohol Nurses of
Australasia).
Council decision
Evidence
Add buprenorphine
with naloxone for
continuation
teams
Buprenorphine is a Class C4 controlled drug.
Keep buprenorphine
(transdermal only)
Note a change would
need to be made to the
Misuse of Drugs Act.
The controlled drug lists
cannot be updated
through a Gazette notice
so future proofing is
required.
CNS Stimulant
methylphenidat
e
hydrochloride
Note supported by Royal College of
Psychiatrists (see Mental; Health
Drug report).
It is anticipated that
specialist addiction
registered nurse
prescribers (and nurse
practitioners) would also
be appropriately
authorised under the
Misuse of Drugs Act as
are specified medical
practitioners.
Naloxone is already on
the list (combination
Suboxone).
Diagnostic complexity
Methadone is a Class B3 controlled drug.
Methadone and buprenorphine with naloxone are used as
substitution therapy in opioid dependence. Substitute
medication should be commenced with a short period of
stabilisation, followed by either maintenance treatment or
a withdrawal regimen. Maintenance treatment enables
patients to achieve stability, reduces drug use and crime,
and improves health; it should be regularly reviewed to
ensure the patient continues to derive benefit.
The prescriber should monitor for signs of toxicity, and the
patient should be told to be aware of warning signs of
toxicity on initiation and during titration. The risk of death is
highest in the first 2 weeks of methadone initiation: this
should be undertaken in a closely supervised setting
Note can also be prescribed for pain as a transdermal
patch or an injection.
Class B2 controlled drug.
Drug treatment of Attention Deficit and Hyperactivity
60
Classification
Drug
Submissions
Note: Prescribing is restricted to
specified Medical practitioners at
present.
Council decision
Evidence
and drug seeking.
Disorder (ADHD) should be part of a comprehensive
treatment programme. The choice of medication should
take into consideration co-morbid conditions (such as tic
disorders, Tourette syndrome, and epilepsy), the adverse
effect profile, potential for drug misuse, and preferences of
the patient and carers. Methylphenidate and atomoxetine
are used for the management of ADHD.
May only be prescribed by: Medical practitioners with a
vocational scope of practice of Paediatrics or Psychiatry,
for the treatment of Attention Deficit and Hyperactivity
Disorder (ADHD), or Medical practitioners with a
vocational scope of practice of Internal Medicine, for the
treatment of narcolepsy, or Medical practitioners with a
vocational scope of Palliative Medicine, for use in palliative
care treatment. Any other medical practitioner when acting
on the written recommendation of one of the vocationally
registered medical practitioners described above, for the
conditions specified. This is a legal requirement of
regulation 22 of the Misuse of Drugs Regulations and the
delegated direction of the Minister of Health for this
controlled drug. See
www.medsafe.govt.nz/profs/RIss/restrict.asp.
61
7
Specialist ophthalmology medicines
The Council received a number of submissions (113, 133, 142, 146, 160, 169) requesting
ophthalmology medicines be added to the list. Although this was not an area identified for
nurse prescribing in the consultation document these submissions have been reviewed. This
quote represents the comments made by these submitters.
Ophthalmology is a small area of practice for nursing in New Zealand but there are
many nurses within the speciality who meet the criteria outlined for the specialist
nurse prescriber. We have consulted and developed a list of ophthalmic medications
that we wish to submit for consideration to be added to the current list as per the
consultation document. This list has been developed in consultation with an
Ophthalmic NP and several nurses who are currently appointed as Nurse Specialists
and Charge Nurses within Ophthalmology from several District Health Boards as well
as Professor Charles McGhee, Professor of Ophthalmology, Faculty of Medical and
Health Sciences, University of Auckland Ophthalmic nurses group from several
DHBs and Professor Charles McGhee (146).
The demand for eye health services is expected to double between 2010 and 2020
according to a 2010 Eye Health Workforce Service Review by Health Workforce New
Zealand http://www.health.govt.nz/system/files/documents/pages/eye-health-review-may2011.pdf.
“The role of nurses in eye health care in New Zealand varies from providing technical
assistance to ophthalmologists through to running nurse led clinics and performing certain
treatments in hospitals.” according to a Health Workforce New Zealand Report on the Eye
Health Workforce (HWNZ, 2010, p.14). Some nurses undertake an expanded role which
includes injecting local anaesthesia into the eye (sub tendons block) prior to surgery when
anaesthetists are unavailable and some minor surgery (meibomian cysts and other minor lid
lesions). Other potential activities that could involve prescribing mentioned in this report
were:
 Glaucoma – some FSA (first specialist appointment) patients, could provide follow-up
and have collaborative models in place
 Diabetes – undertake primary and secondary screener’s roles.
 Uveitis – relieves the workload from acute eye services, provides patients with continuity
of care and care is collaborative with ophthalmologists
 Acute eye services – provide triage, diagnosis and treatment to some acute
presentations to eye departments. This could be achieved in NZ with more NP
appointments in larger metropolitan areas.
A few of the medicines suggested are suitable for the general prescribing list or are nonprescription medicines. Others require suitable diagnostic equipment and collaboration with
an ophthalmologist or an ophthalmologist to diagnose and make the initial prescribing
decision. Some of these medicines are only subsidised in District Health Boards (hospitals).
The list of medicines proposed by the submitters is reviewed on the following table.
62
Table 14: Medicines submitters requested to be added for specialist ophthalmology services
Class
Antimuscarinics
Medicine
tropicamide 0.5%,
1%,
Antimuscarinics
phenylephrine 2.5%,
Eye drops
Antimuscarinics
cyclopentolate 0.5%
& 1.0%,
Eye drops
Antimuscarinics
atropine 1%
Eye drops
Local Anaesthetics
benoxinate
hydrochloride
Eye drops
Local Anaesthetics
Local Anaesthetics
Local Anaesthetics
(Oxybuprocaine
0.4%)
Proxymetacaine
hydrochloride
(0.5%)(Alcaine)
Tetracaine
hydrochloride (0.5%,
1%)
(Amethocaine
hydrochloride)
lignocaine 1% & 2%
Formulation
Eye drops
Council decision
Add to the list for specialist nurses practising in Ophthalmology specialist teams
Antimuscarinics dilate the pupil and paralyse the ciliary muscle; they vary in potency and duration
of action
Antimuscarinic - Short-acting, relatively weak mydriatics, last 4 to 6 hours to facilitate the
examination of the fundus of the eye.
Add to the non-prescription list for specialist nurses practising in Ophthalmology specialist
teams
Not subsidised in the community
Sympathomemetic - Phenylephrine is used for mydriasis in diagnostic or therapeutic procedures;
mydriasis occurs within 60–90 minutes and lasts up to 5–7 hours. Phenylephrine 10% drops are
contra-indicated in children and the elderly owing to the risk of systemic effects. Doses above
2.5% are not necessary to perform procedure and care is needed with children and elderly.
Add to the non-prescription list for specialist nurses practising in Ophthalmology specialist
teams but not to be initiated independently due to longer duration of action
Antimuscarinic. This has a much longer duration of action which is 24 hours. Cyclopentolate 1%
(action up to 24 hours)
Atropine (action up to 7 days) are preferable for producing cycloplegia for refraction in young
children.
Adult 1 drop in the eyes(s) according to procedure; tonometry 1 drop; fitting contact lenses 2 drops
at an interval of 90 seconds; corneal foreign body removal.
Eye drops
Eye drops
Injection
Add to the prescription list for specialist nurses practising in Ophthalmology specialist
teams
Ophthalmology use is prescription.
Prescription- for injection except when used as a local anaesthetic in practice by a nurse whose
63
Class
Local Anaesthetics
Sympathomimetics
Local Anaesthetics
Staining
Staining
Ocular lubricants
Preparations for tear
deficiency
Ocular lubricants
Ocular lubricants
Medicine
Bupivacaine
(Marcaine)
adrenaline
ropivacaine
Fluorescein sodium
0.6 -1mg
fluorescein with local
anaesthetic –
Pharmacy only
Lissamine green
Poly tear - dextran +
hypromellose
Refresh- polyvinyl
alcohol 1.4 to 3%
Systane-propylene
glycol 0.6%
Visco tears
Formulation
Injection
Injection
injection
Eye drops
Ophthalmic
strips 1.5 mg
Eye drops
Eye drops
Eye drops
Council decision
scope of practice permits the performance of general nursing; for ophthalmic use except when
used in practice by an optometrist registered with the Optometrists and Dispensing Opticians
Board
(Classification in Medicines Regulations)
Used for surgical anaesthesia, pain management.
Not indicated for use in ophthalmology.
The drugs in section 15.2 (local anaesthetics) should only be administered by, or under the direct
supervision of, personnel experienced in their use, with adequate training in anaesthesia and
airway management, and should not be administered parenterally unless adequate resuscitation
11
equipment is available (New Zealand Formulary, July 2014) .
Keep on the non-prescription list for specialist nurses practising in Ophthalmology
specialist teams.
Indications Ophthalmic diagnostic examination and detection of lesions and foreign bodies.
Add to the non-prescription non-subsidised list for specialist nurses practising in
Ophthalmology specialist teams
Hospital medicines only.
Keep on non-prescription list
Indications: Dry eyes
List on non-prescription list.
Indications: Dry eyes
Add to non-prescription list. For continuation of prescribing once diagnosis made and
special authority obtained.
Special Authority- Retail pharmacy PHARMAC as of the 1 August 2013
Uses: For the temporary relief of burning and irritation due to dryness of the eye.
Funding pre-requisites:
 Confirmed diagnosis by slit lamp of severe secretory dry eye, and
 Patient is using eye drops more than four times daily on a regular basis, or
 Patient has had a confirmed allergic reaction to preservative in eye drop
Add to non-prescription list. For continuation of prescribing once diagnosis made and
special authority obtained.
11
New Zealand Formulary. (July 2014). 15.2 Local Anaesthesia. New Zealand Formulary, 2014.
64
Class
Other eye preparations
Ocular lubricants
Ocular lubricants
Antibiotics
Antibiotics
Medicine
carbomer
(Refresh Night
time)paraffin liquid
0.425 mL/g + paraffin
soft white 573 mg/g
Optive - carmellose
sodium 0.5 to 0.9%
Blink - macrogol-400
(polyethylene glycol
400) (PEG 400)
Chloramphenicol
0.5%, 1%
Fucithalmic- fusidic
acid 1%
Formulation
Eye Drop
Eye drops
Eye drops
Drops &
Ointment
Ointment
Corticosteroids (with
antibacterials)
Corticosteroids
Maxitrol dexamethasone +
neomycin sulfate +
polymyxin B sulphate
fluorometholone
Eye
drops/ointment
Eye drops
Council decision
Special Authority- Retail pharmacy
Uses: For the temporary relief of burning and irritation due to dryness of the eye.
Funding pre-requisites:
 Confirmed diagnosis by slit lamp of severe secretory dry eye, and
 Patient is using eye drops more than four times daily on a regular basis, or
 Patient has had a confirmed allergic reaction to preservative in eye drop
Add to non-prescription list
Indication: Temporary relief for dry eyes
Add to non-prescription list not subsidised
Indication: Dry eyes
Keep on non-prescription list and add eye use.
Indication: Dry eyes
Keep on the list
Indications: superficial bacterial eye infection
Indications: superficial staphylococcal bacterial eye infection
Recommend restrict to ophthalmology as second line agent. Most useful against staphylococcal
infections (including MRSA), whereas chloramphenicol is broader spectrum.
CNS with ophthalmology scopes of practice do sub tenons blocks for cataract as well as
meibomian cyst excision. These procedures have been considered as expanded practice roles,
hence the need for antibiotic/steroid drugs
Please note: All drugs in this group are for ongoing/continued treatment not to initiate– as per
Consultation with Ophthalmologists (Carol Slight NP Ophthalmology).
Post-operative short term use
Add to the list for specialist nurses practising in Ophthalmology specialist teams –
Indications: ocular inflammation when concurrent use of an antimicrobial indicated (short-term)
Indications: local treatment of inflammation of the palpebral and bulbar conjunctiva, cornea, and
anterior segment of the globe (short-term)
65
Class
Corticosteroids
Corticosteroids
Corticosteroids
Treatment of
glaucoma – Betablockers compound
preparations
Treatment of
glaucoma – Carbonic
anhydrase inhibitors
Treatment of
preparations
Treatment of
glaucoma – Carbonic
anhydrase inhibitors
Medicine
Pred-forte –
Prednisolone acetate
0.12 to 1%
Pred-mild –
Prednisolone 0.12 to
1%
Maxidex –
dexamethasone
0.1%
Cosopt- dorzolamide
+ timolol 2%
Formulation
Eye drops
Eye drops
Eye
drops/ointment
Eye drop
Council decision
Indications: local treatment of inflammation (short-term).
Indications local treatment of inflammation (short-term)
Indications: local treatment of inflammation (short-term)
Indications: Raised intra-ocular pressure in open-angle glaucoma and ocular hypertension not
adequately responding to beta blocker monotherapy
Indications: raised intra-ocular pressure in open-angle glaucoma or ocular hypertension
Indications: raised intra-ocular pressure in open-angle glaucoma; ocular hypertension
Brinzolamide – 1%
Eye drops
Brimonidine tartate
0.15- 2%
Eye drops
Dorzolamide
Eye drops
Indications: raised intra-ocular pressure in open-angle glaucoma; ocular hypertension; adjunctive
therapy with ophthalmic beta-blocker
Treatment of
preparations
Treatment of
glaucoma - Miotics
Combigan brimonidine + timolol
0.2%
Eye drops
pilocarpine 1% & 2%
Eye drops
Treatment of
glaucoma – Betablockers
Treatment of
glaucoma –
timolol 0.25% &
0.5%,
Eye drops
Latanoprost 0.005%
Eye drops
Add to the list for specialist nurses practising in Ophthalmology specialist teams Continuation prescribing
Indications: raised intra-ocular pressure in open-angle glaucoma and for ocular hypertension not
adequately responding to monotherapy
Indications: miotic for reversing the action of weaker mydriatics; emergency treatment of glaucoma
Indications: raised intra-ocular pressure; adjunctive treatment in paediatric glaucoma
66
Class
Prostaglandin
analogues
Treatment of
glaucoma –
Prostaglandin
analogues
Treatment of
glaucoma –
Prostaglandin
analogues
Antivirals
Medicine
Formulation
Council decision
Indications: Used to reduce intra-ocular pressure in ocular hypertension or open-angle glaucoma.
Travoprost 0.004%
Eye drops
Add to the list for specialist nurses practising in Ophthalmology specialist teams Continuation prescribing
Bimatoprost 0.03%
Eye drops
Aciclovir
Tablets and
eye ointment
Analgesia
Paracetamol
Tablets
Non-steroidal antiinflamatory
Carbonic anhydrase
inhibitors
Ibuprofen
Tablets
Acetazolamide
Diamox
Oral only
Add for specialist nurses practising in Ophthalmology specialist teams- Continuation
prescribing
Ophthalmologist to diagnose herpes simplex keratitis
Repeat prescribing with tablets on specialist nurse community list
Already on non-prescription list
General sales Pharmacy Only medicine
Already on the prescription list
Do not to add to the list
Indication chronic angle closure glaucoma or secondary glaucoma
67
Attachment 1: Table 1: Community nurse list- Medicines suggested to be removed or modified (Submitters)
Medicine
Likely use
Adapalene
Anti acne
Adrenaline
Alcohol
Amethocaine
Amoxy clavulanic
acid
Submission made that
medicine be removed
(or conditions specified)
from the list
177
Reason given by
submitter to remove or
include a condition
Council decisions
Rationale
Retinoid
Keep
Anaphylaxis
20, 21 (Emergency only
178)
Emergency drug outside
scope (20, 21)
Keep
Ingredient,
disinfectant,
antiseptic
Venepuncture,
local anaesthetic
178 (topical only)
Not generally dispensed
to patients on a
prescription
Ocular anaesthetic
Remove
Useful in the treatment of Acne
Vulgaris which is a condition
commonly encountered by nurse
specialist in specialist areas.
Adapalene is a third generation
retinoid with minimal side effects.
Adapalene has become widely used
because of its comparable efficacy
and favourable tolerability profile
when compared with other topical
retinoids.
Specify treatment of acute
anaphylaxis only and only IM
(intramuscular) route.
Not necessary as an ingredient.
Infection
150, 107
85, 178
Broad spectrum antibiotic
when prescribed
inappropriately could
potentially affect
resistance pattern locally
(107), The list should not
include any antibiotic or
class of antibiotic with
resistance problems
(150).
Keep eye drops
ophthalmology only.
Include in nonprescription non
subsidised list (topical).
Keep
Specify topical Gel, not prescription
and not subsidised.
Specify oral only; - Indicated for
animal bites and in certain infections
(where amoxicillin alone not
appropriate) including respiratorytract infections.
68
Medicine
Likely use
medicine be removed
from the list
153, 177, 179 (Specify
route 86)
Reason given by
include a condition
Amphotericin
Antifungal
Atropine
Anti-diarrhoeal
20, 21, 178
Emergency drug outside
scope (20, 21).
Azithromycin
Uncomplicated
gonorrhoea and
chlamydia
179
Benzocaine
Symptomatic
treatment of
irritated or inflamed
mucous
membranes of the
mouth and pharynx
Group A
streptococcal
upper respiratory
tract infection;
syphilis; rheumatic
fever prophylaxis
Antifungal
178
Only available combined
with tetracaine and
indicated for topical
anaesthetic for dental
procedures.
Move to nonprescription list
(Specify oral)
178
Only available in IM for
specific serious infections.
Keep
Nurses in primary care ideally
positioned to manage populations at
risk of rheumatic fever.
Remove
PTAC (Pharmacology and
Therapeutics Advisory Committee,
PHARMAC) subcommittee noted that
bifonazole 1% cream is not in wide
use in DHB hospitals and is not
subsidised in the Pharmaceutical
Schedule. The Subcommittee
recommended that it not be included
in a national PML (Preferred
Benzathine
penicillin
Bifonazole
86 (not subsidised)
Council decisions
Rationale
Remove
Amphotericin B is reserved for more
serious forms of fungal disease and
is not first line drug for oral
candidiasis.
Ingredient in diastop; non
prescription, not subsidised.
Move to nonprescription list non
subsidised list
Keep
Azithromycin is indicated for
uncomplicated gonorrhoea;
uncomplicated genital chlamydial
infections; these are conditions that
are commonly managed by nurses.
Oral and topical items are not
prescription.
69
Medicine
Likely use
medicine be removed
from the list
Reason given by
include a condition
Council decisions
Rationale
Medicines List).
Budesonide
Prophylaxis of
asthma, allergic
rhinitis, asthma
60 special authority
Calcitrol
Vitamin D3
metabolite
86
Calcitrol would not be first
or second line choice
apart from very specific
prescribing indications
including patients with
chronic renal failure.
Camphorated oil
Ingredient
3, 107, 174, 178
Cefaclor
Urinary-tract
infections which do
not respond to
other drugs,
respiratory-tract
infections, otitis
media, sinusitis,
and skin and soft-
107
Can be very toxic to
young children- is it still
used. Delete (3).
Unlikely clinical need
(178).
Broad spectrum antibiotic
when prescribed
inappropriately could
potentially affect
resistance pattern locally
(107).
Keep; Include nasal
spray on nonprescription list
(Specify inhaled)
Remove
Remove
Keep
Conditions and management
common for nurses in expanded
roles.
Postmenopausal osteoporosis; renal
osteodystrophy; secondary
hyperparathyroidism in moderate to
severe chronic renal failure;
hypoparathyroidism; vitamin Ddependent and hypophosphatemia
vitamin D-resistant rickets;
prevention of corticosteroid induced
osteoporosis. Conditions listed not
likely to be manage by nurses in
extended and expanded roles.
Not needed as ingredient.
Use in paediatrics and patients
allergic to penicillin.
70
Medicine
Likely use
medicine be removed
from the list
Reason given by
include a condition
Council decisions
Rationale
Although there is risk of antibiotic
resistance and DILI this is the firstline drug of choice for gonorrhoea
and pelvic inflammatory disease.
These are conditions often managed
by nurses.
Chloramphenicol or neomycin eye
drops are used to treat mild
conjunctivitis.
Aspirin and chloroform topical
treatment for shingles not best
practice.
tissue infections.
Ceftriaxone
Gonorrhoea and
pelvic inflammatory
disease;
13, 60, 179, 178
A 3rd generation antibiotic
and would rarely be given
as a repeat prescription.
Keep
Chloramphenicol
Bacterial
conjunctivitis
153, 177, (topical
86,150,178)
Second line systemic
antibiotic (177).
Keep; Specify Ocular
only
Chloroform
Herpes
61, 86, 114, 115, 173,
174, 176, 186, 188, 178
Cimetidine
H2 antagonist;
reflux
oesophagitis; other
conditions where
gastric acid
reduction is
3, 85, 86,178
The only therapeutic use
for this would be aspirin in
chloroform for herpes. No
longer considered best
practice (86, 178).
Outdated (114).
Dangerous (115).
Perplexed and concerned
(173).
This drug has not been
used for 40 to 50 years
and is probably no longer
available (186).
Should be excluded. It is
no longer considered an
appropriate H2 antagonist
for use in gastrointestinal
reflux. It is a potent
CYP450 3A4 inhibitor and
Remove
Potential to interact with many
commonly used medicines.
Superseded by omeprazole and
other H2-RAs as a therapy for GORD
and other GI conditions.
71
Medicine
Likely use
medicine be removed
from the list
beneficial
Ciprofloxacin
Antibiotic
31, 60, 86, 177, 179,
(Specialist only 178)
Reason given by
include a condition
has the potential to
interact with a large
number of commonly
used medicines with
clinically significant
consequences. There are
several far more
appropriate alternatives
for the treatment of GORD
and it is completely
unnecessary to include
this as an option (86).
Not first line treatment
(60).
It is not usually indicated
for minor infections and
not considered a good
choice for most skin
infections. Ciprofloxacin is
one of the only oral
antibiotics active against
Pseudomonas so
considering issues of
antimicrobial resistance, it
is not appropriate to
increase its availability for
prescribing. We already
have bacterial resistance
problems and
ciprofloxacin is already
restricted in some hospital
guidelines (86).
Council decisions
Rationale
Remove
Ciprofloxacin is not first line antibiotic
for eye infection and STD (Sexually
Transmitted Disease), it is for
Salmonella enterocolitis (condition
which specialist nurses do not
commonly manage). It is only one of
the alternate drugs of choice for
gonorrhoea and acute pyelonephritis.
72
Medicine
Likely use
medicine be removed
from the list
177, (86, 107 specify
route), (60, 181 specialist
only)
Reason given by
include a condition
Council decisions
Rationale
Clindamycin
Acne
Second line systemic
antibiotic (177).
Remove
Topical solution not subsidised. Oral
Retail pharmacy specialist.
Clobetasol
Corticosteroid
177
Potent topical steroid.
Keep and nonprescription not
subsidised
Psoriasis
3, 31, 86, 97, 100, 107,
115, 127, 150, 153, 166,
174, 176, 177, 190, 178
Should only be permitted
to write a repeat
prescription (3).
Cyclosporin is a complex
and potentially toxic
medicine which many
GPs would feel
uncomfortable initiating. It
is also well-known to have
many clinically significant
drug interactions. If the
patient’s psoriasis is
severe enough to warrant
the initiation of
cyclosporin, it should be
assessed by a medical
professional (86).
Potentially serious side
effects (177, 107).
Remove
Short-term treatment only of severe
resistant inflammatory skin disorders
such as recalcitrant eczemas
unresponsive to less potent
corticosteroids; psoriasis. May be
conditions managed by specialist
nurses. Clobetasone butyrate
(0.05%) Eumovate cream.
Very high potential for adverse
effects and renal effects.
Cyclosporin
73
Medicine
Likely use
medicine be removed
from the list
177, 178 (combination
contraceptive only), 181
(specialist only).
Reason given by
include a condition
Council decisions
Rationale
Cyprotene
Acne
Potentially serious
adverse effects (177).
Remove
Prophylaxis and
treatment of
constipation in
terminally ill
patients
Relief of allergic
rhinitis; chronic
idiopathic urticaria
Corticosteroid - ear
drops/eye drops
86, 174 (specify palliative
care 178).
Restricted to terminally ill
patients only (86, 174).
Keep
(Specify palliative care
only)
Cyproterone acetate with
ethinyloestradiol is indicated for use
in women with severe acne that has
not responded to oral antibacterials
and for moderately severe hirsutism;
it should not be used solely for
contraception. It is contra-indicated in
those with a personal or close family
history of venous thromboembolism.
Women with severe acne or
hirsutism may have an inherently
increased risk of cardiovascular
disease.
Indications prophylaxis and treatment
of constipation in terminally ill
patients; Condition that is commonly
managed by specialist nurses in
palliative care settings.
Not prescription and not subsidised
Dantron
Diflucortolone
Corticosteroid
60 (not subsidised), 177.
Diphemanil
Antiperspirant
60 (not subsidised) .
Ergotamine
Migraine
61, 37, 174, 188
Desloratadine
Dexametasone
179 (not subsidised)
Remove
60 (specialist only), 168
Keep
(Specify Only in
combination; aural)
Adverse effects of corticosteroids are
numerous and this drug is often use
long-term. Tablets Retail pharmacy
specialist.
Remove
Not subsidised by PHARMAC.
Remove
Remove
The value of ergotamine for migraine
is limited by difficulties in absorption
and by its adverse effects,
particularly nausea, vomiting,
abdominal pain, and muscular
potent topical
corticosteroid 177
Toxic potential drug
interaction (174).
74
Medicine
Likely use
medicine be removed
from the list
Reason given by
include a condition
Council decisions
Rationale
cramps; it is best avoided.
Remove
Superseded by omeprazole. Not
subsidised by PHARMAC.
Too extensive and
inappropriate.
Move to nonprescription list.
(Topical only).
179
Not in Pharmaceutical
schedule.
Keep
Fluconazole and ketoconazole
strongly inhibit the CYP P450
enzyme system in the liver and are
associated with many drug-drug
interaction, therefore only the topical
has been recommended as a
formulary. Only capsules Retail
pharmacy specialist or endorsement.
Inflammation with secondary
infection in otitis external.
Haemorrhoids
150
Keep
Haemorrhoids; superficial anal
fissures. Conditions commonly
manage by specialist nurses.
Ophthalmic
diagnostic
examination and
detection of lesions
and foreign bodies.
3, 71
Not appropriate for nurse
to prescribe for severe
inflammatory skin
disorders unless
specialised in
dermatology.
Should only be prescribed
by the DR or
ophthalmologist not the
nurse (3).
In combination with
lidocaine.
Ophthalmology only
Growing specialist nurse role within
ophthalmology clinics. Work in
collaboration with a medical
specialist. Must have availability and
ability to use specialist equipment
e.g. slit lamp examination. Must have
appropriate fluorescein with local
anaesthetic – Pharmacy ONLY.
Famotidine
H2 agonist
86 (not available)
Fluconazole
Antifungal.
treatment of
vaginal candidiasis
179
Flumetasone
Corticosteroid
eardrops
Fluocortolone
Fluorescein
75
Medicine
Likely use
Folinic acid
Prevention of
methotrexateinduced adverse
effects; suspected
methotrexate
overdose; adjunct
to fluorouracil in
colorectal cancer.
Skin infections
Fusidic acid
medicine be removed
from the list
3, 86, 178
Reason given by
include a condition
Council decisions
Rationale
This is methotrexate
rescue therapy, should
only be prescribed by the
DR (3).
Remove
Not conditions managed by nurses.
86, 107 (specify route)
Should be restricted to
topical only. GPs require a
specialist
recommendation to
prescribe oral fusidic acid.
Again there are issues
with bacterial resistance
and oral fusidic acid
should always be used in
combination with another
antistaphylococcal
antibiotic (86).
The mode of delivery is
not stated which may
influence the safety profile
(41).
Keep
(Specify Topical only)
Hydrocortisone
Mild inflammatory
skin disorders
41 (specify route)
Imiquimod
Genital warts
86, 178 (special authority)
Itraconazole
Antifungal
86, 97, 177, 178 (86, 181
specialist only)
Specialist use. Significant
interactions (178).
Keep
Remove
Special authority. Not for repeat
prescribing.
Remove
See Fluconazole Retail pharmacy
only.
76
Medicine
Likely use
Ketoconazole
Antifungal; skin
infections, dandruff
Methotrexate
Psoriasis,
antineoplastic
medicine be removed
from the list
(60, 86 specialist only),
86, 177, 178
3, 28, 31, 41, 56, 57, 60,
86, 88, 91, 97, 100, 107,
110, 115, 122, 127, 150,
153, 158,166,173,174,
175, 176, 177, 181,186,
190, 178 (60,181
specialist only)
Reason given by
include a condition
Council decisions
Specialist use. Significant
interactions (178).
Itraconazole and
ketoconazole – should be
excluded. Both are
medicines that GPs
require a specialist
recommendation to
prescribe. Both are potent
cytochrome P450 3A4
inhibitors and have the
potential to interact with a
large number of
commonly used
medicines with clinically
significant consequences,
notably with the widely
used statins causing
potentially fatal
rhabdomyolysis (86).
Should only be prescribed
by the Dr as too many
incorrect prescribing
errors already occur as
daily instead of weekly
and lead to major harm
and/or death (3). It is a
cytotoxic drug and potent
immunosuppressant.
According to the UK
National Patient Safety
Agency, “Oral
methotrexate is
associated with a high
rate of adverse incidents
(Topical only)
Remove
Rationale
High risk of severe toxicity.
77
Medicine
Likely use
medicine be removed
from the list
Reason given by
include a condition
Council decisions
Rationale
and deaths in the NHS
and worldwide”. It has
caused 25 fatalities in the
UK alone. It may have
been included on the
proposed list for the
treatment of psoriasis. If
the patient’s psoriasis is
severe enough to warrant
the initiation of
methotrexate, it should be
assessed by a medical
professional (86).
Of particular concern was
the inclusion of
methotrexate, a medicine
considered ‘high-risk’
internationally due to
patient harm and death
from prescribing,
dispensing and
administration errors. The
Health Quality and Safety
Commission NZ have
recently published a
Medication Alert to
highlight the key issues.
http://www.hqsc.govt.nz/a
ssets/MedicationSafety/Alerts-PR/Oralmethotrexate-Alertfinal.pdf (173).
78
Medicine
Likely use
medicine be removed
from the list
86, 97, 177, 100, (60,86,
181 specialist only)
Methylprednisolone
Eczema
Minoxidil
Hair growth
promoter
122, 86, 178 (not
subsidised)
Mometasone
Corticosteroid
177
Mupirocin
Bacterial skin
infections
86, 107
Reason given by
include a condition
Council decisions
It is unclear which minor
ailment this corticosteroid
would be indicated for
(86). Requires close
supervision (100).
Potent topical steroids
(177).
Keep
Rationale
Remove
Not subsidised by PHARMAC
Potent topical steroid
(177).
Keep
This should be restricted
to very specific indications
because of antimicrobial
resistance patterns (86);
Topical antibiotics such as
fusidic acid and mupiricin
have been limited in the
past due to emerging
patterns in resistance. If
these were to be on the
list it would be important
to ensure adequate
training around this
occurred with all
prescribers (107).
Keep
(Topical only)
Mometasone is a potent topical
corticosteroid formulation which is
100–150 times as potent as
hydrocortisone.
Mupirocin is not related to any other
antibacterial in use; it is effective for
skin infections, particularly those due
to Gram-positive organisms but it is
not indicated for pseudomonal
infection. Although Staphylococcus
aureus strains with low-level
resistance to mupirocin are
emerging, it is generally useful in
infections resistant to other
antibacterials. In the community,
acute impetigo on small areas of the
skin may be treated by short-term
topical application of fusidic acid or
mupirocin. If the impetigo is
extensive or longstanding, an oral
antibacterial such as flucloxacillin (or
suitable alternative in penicillinallergy) should be used BPAC.
79
Medicine
Likely use
Natamycin
Short-term
treatment of
superficial
corticosteroid
sensitive
dermatoses
complicated by
secondary
bacterial or
candidal infection
Proton pump
inhibitor
Omeprazole
medicine be removed
from the list
115, 176
Reason given by
include a condition
Council decisions
Rationale
Dangerous (115)
Keep
(Topical only)
List as combination. Ingredient in
Pimafucort cream. Low potency.
97
Not commonly used
medicines, require
specialist knowledge.
Keep
Not commonly used
medicines, require
specialist knowledge (97).
Not generally available on
its own (179).
Keep
Only Pharmacy-Only when sold in
manufacturer's original pack
designed for over the counter sales.
Otherwise Prescription Medicine, so
consider it a Prescription Medicine as
far as Designated Nurse Prescribers
are concerned. Fully subsidised.
As per omeprazole. Possibly fewer
interactions compared with
omeprazole.
For topical use in eczema
and dermatitis only
Pantoprazole
Proton pump
inhibitor
97
Penciclovir
antiviral
179
Phenol
Haemorrhoid
sclerosant
178 (topical)
Phenylephrine
Decongestant
186, 122 (not subsidised)
Podophyllotoxin
Warts
177
Remove
Items that are
contraindicated in
pregnancy, such as
podophyllum,
podophyllotoxin, and
Keep
Sclerosing not in scope of practice,
Phenol ingredient in egopsoryl TAgeneral sales. Partial subsidy. Stable
to moderate psoriasis.
Podophyllotoxin is fully subsidised.
Podophyllotoxin is a Prescription
medicine when used to treat anogenital warts, but a Restricted or
Pharmacy-Only Medicine in weaker
80
Medicine
Likely use
medicine be removed
from the list
Reason given by
include a condition
Council decisions
retinoids (177).
Items that are
contraindicated in
pregnancy, such as
podophyllum,
retinoids Insert (177).
Move to nonprescription not
subsidised list
podophyllum
Warts
177
Prilocaine
Local anaesthetic
178 (specify topical)
Terbinafine
antifungal
97, 177
Not oral antifungal agents
(177).
Keep and add to nonprescription list
Tobramycin
Mild to superficial
bacterial eye
infection
74, 97, 115, 174, 176
(specify route 86, 91, 178)
Not commonly used
medicines, require
Many of the medicines
have narrow therapeutic
indexes and can be
associated with
considerable toxicity,
potential for drug
interactions and are
difficult for GPs and even
specialists to manage.
Some examples are
methotrexate, tobramycin,
cyclosporin, tretinoin,
vitamin A supplement and
ergotamine (174).
Should be restricted to
Keep, ocular only
Rationale
concentrations and when used to
treat warts other than ano-genital
warts.
Move to Nonprescription list (Emla
cream)
Non-prescription Terbinafine is the
drug of choice for fungal nail
infections.
81
Medicine
Likely use
medicine be removed
from the list
Tretinoin
Acne
115, 174, 176, 177, (86
topical only) (181,
specialist only)
Trimeprazine
Antihistamine,
urticaria and
pruritus
86
Valaciclovir
Antiviral
60, 97 (60, 181 special
authority)
Reason given by
include a condition
topical only. Nebulised
and IV tobramycin should
only be initiated by a
medical specialist (86).
Items that are
contraindicated in
pregnancy, such as
podophyllum,
retinoids (177).
Should be excluded. This
is not an appropriate
choice of antihistamine as
it is highly sedating and
there are several far more
reasonable alternatives. It
is occasionally used as a
sedative for children but
this is effectively chemical
restraint and is an
inappropriate and highly
controversial use (86).
Not commonly used
medicines, require
Council decisions
Rationale
Keep, topical only
Move to nonprescription list.
Specify not in
combination and for
allergy only.
Antihistamine (also available as a
non prescription medicine).
Keep
Specify repeat prescribing only.
Special authority.
82
Medicine
Likely use
Vitamin a
Vitamin A
deficiency
Zolmitriptan
migraine
medicine be removed
from the list
115, 174, 176
115, 176
Reason given by
include a condition
Council decisions
Rationale
Many of the medicines
have narrow therapeutic
indexes and can be
associated with
considerable toxicity,
potential for drug
interactions and are
difficult for GPs and even
specialists to manage.
Some examples are
methotrexate, tobramycin,
cyclosporin, tretinoin,
vitamin A supplement and
ergotamine (174).
Dangerous (115)
Remove
High toxicity profile. Diagnosis of
VITAMIN A deficiency is essential.
Not common condition for specialist
nurse expanded role.
Keep, nasal spray
only.
High toxicity profile.
83
Attachment 2: Table 7: Response to submitters suggestions for the Specialist Nurse prescription medicines list
Medicine
Classification
Sub-classification
and Individual
Medicine
ACEIs
Submitters Recommendation
Council decision
Evidence
No longer considered an appropriate
ACEI, not in line with current best
practice recommendations. Mainly
used by specialist paediatricians
(86).
Remove from list – no longer
funded by PHARMAC
PHARMAC Notification website
captopril
There are other ACEIs listed under
the NZ Formulary that are on in the
specialist nurses list: cilazapril,
enalapril, lisinopril, peridopril,
quinalapril and trandopril.
Anti
hypertensives
Beta-blockers
Two submitters suggested specialist
nurse prescribers do not initiate
betablockers.
Betablockers require special
consideration and I do not think they
are appropriate for specialist nurses
to initiate (174).
In diabetes scenario being able to
repeat prescribe allopurinol,
colchicine, digoxin, frusemide, ISMN,
beta-blockers etc would be good
examples while perhaps not suitable
to initiate (129).
Anti arrhythmic, i.e. Amiodarone and
Beta-blockers listed on the Specialist
Nurses List: Atenolol, Bisoprolol,
Celiprolol, Carvedilol, Metoprolol,
Labetalol, Metoprolol, Nadolol.
Beta-blockers usually not considered
first line treatment for hypertension
however, beta-blocker are considered
if ACEIs inhibitors or Angiotensin
receptor blocker is not tolerated. They
also have other uses including heart
failure and angina.
Therefore keep atenolol, metoprolol,
labetalol, nadolol
Atenolol is on the list for the treatment
Captopril tablets discontinued –
transition advice to another ACE inhibitor
http://www.pharmac.health.nz/news/notifi
cation-2013-12-09-captopril/
9 December 2013 (note oral liquid for
under 12 year olds Specialist
paediatrician medicine).
Labetalol, celiprolol, and carvedilol are
beta-blockers that have, in addition, an
arteriolar vasodilating action, by diverse
mechanisms, and thus lower peripheral
resistance. There is no evidence that
these drugs have important advantages
over other beta-blockers in the treatment
of hypertension.
Atenolol, bisoprolol, and metoprolol have
less effect on the beta2 (bronchial)
receptors and are, therefore, relatively
cardioselective, but they are not
cardiospecific. They have a lesser effect
on airways resistance but are not free of
this adverse effect.
84
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Sotalol for these medicine to be
safely prescribe access to laboratory
test, radiology and ECGs must be
easily & regularly accessible for on
going monitoring of patients
response to these treatments (57).
of hypertension only. In terms of its
effects on the beta 2 receptor, choice
between atenolol and metoprolol
should be provided.
NZ Formulary advices:
184 and 111 Sotalol remove (no
rationale given).
Important to take note that metoprolol
is both (succinate and tartate not well
defined in the list).
Extreme care should be taken to avoid
confusion between oral immediate
release metoprolol and oral modified
release metoprolol. Taking crushed
oral modified release tablets could lead
to the rapid release and absorption of
a potentially toxic dose.
Remove from the list: sotalol
Bisoprolol, celiprolol, carvedilol are
used for more specialist prescribing
(heart failure) Keep for repeat
prescribing.
Drug treatment of hypertension may be
affected by the patient's age and ethnic
background. An ACE inhibitor or an
angiotensin-II receptor antagonist may
be the most appropriate initial drug in
younger Caucasians; however a betablocker may be considered if an ACE
inhibitor or an angiotensin-II receptor
antagonist is not tolerated or is contraindicated (see also Hypertension in
Pregnancy).
Use of the New Zealand Primary Care
Handbook must be referred to when
choosing first-line drugs for
hypertension. This aspect is always
considered in the educational
preparation or nurses for prescribing.
These drugs are not first-line drugs for
uncomplicated hypertension. Nurses in
primary care will have other options.
Other specialist nurse groups however,
e.g. heart failure nurses may be
considered for the above if working
85
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
closely with Medical Specialist or NP.
Calcium blockers
isradipine
Should only be initiating commonly
used drugs i.e. first and second line
medicines (115,174, 176).
Several calcium blockers are already
in the Specialist nurses list:
amlodipine, diltiazem hydrochloride,
felodipine.
These drugs are all indicated for
treatment for uncomplicated
hypertension and angina. Area of
prescribing is suitable for nurses in
primary care and other speciality areas.
Individualized dosing of Dynacirc SRO is
recommended for elderly patients and
patients with hepatic impairment. A
cautious dosing regimen is
recommended for patients with renal
impairment or chronic heart failure.
Dosing consideration for this drug
require extensive knowledge of
pharmacotherapeutic considerations
best suited for nurse practitioner
prescribing.
Caution should be exercised when
treating patients with confirmed or
strongly suspected sick sinus syndrome
who are not fitted with a pacemaker.
nifedipine
verapamil
Mainly restricted to use in pregnancy
only, should not be routinely used as
an antihypertensive or antianginal in
other patients (86).
No longer considered an appropriate
antihypertensive or antianginal, use
is primarily limited to cardiac
arrhythmias in which case those
best suited for NP prescribing
Short-acting formulations of nifedipine
are not recommended for angina or longterm management of hypertension; their
use may be associated with large
variations in blood pressure and reflex
tachycardia.
Verapamil is used for the treatment of
angina, hypertension and arrhythmias. It
is a highly negatively inotropic calciumchannel blocker and it reduces cardiac
86
Medicine
Classification
Others placed in
this category of
antihypertensives
Sub-classification
and Individual
Medicine
midodrine
Treatment for
diabetic neuropathy
Vasodilator
antihypertensive
drugs
Council decision
Evidence
comments apply (86) (see
antiarrhythmics).
best suited for NP prescribing.
output, slows the heart rate, and may
impair atrioventricular conduction. It may
precipitate heart failure, exacerbate
conduction disorders, and cause
hypotension at high doses and should
not be used with beta-blockers.
Exclude due to complexity of medical
indication. Specialist assessment
usually sought. Special Authority
required (86) (115, 176).
Indications neuropathic postural
hypotension when response to other
therapy inadequate; hypotension
secondary to medical conditions (e.g.
diabetes, Parkinson’s disease).
Very specific indications and usually
only initiated by a cardiologist, not
funded on the Pharmac Schedule
(86).
Remove (115,176,174)
This is not used for hypertension but
for hypotension and is a specialist only
drug. Special authority for subsidy.
prescribing. Section 29 unapproved
medicine. Special authority for
subsidy.
hydralazine
NOTE: No drugs listed in this group is
available for specialist nurse
prescribing after these two drugs are
remove from the list.
nitroprusside sodium
Sodium nitroprusside is a
vasodilator/antihypertensive. In
common with many of those listed,
this drug is potentially extremely
prescribing.
Hydralazine is given by mouth [section
29, unapproved medicine] as an adjunct
to other antihypertensives for the
treatment of resistant hypertension but is
rarely used; when used alone it causes
tachycardia and fluid retention. The
incidence of adverse effects is lower if
the dose is kept below 100 mg daily, but
systemic lupus erythematosus should be
suspected if there is unexplained weight
loss, arthritis, or any other unexplained ill
health.
Sodium nitroprusside is given by
intravenous infusion to control severe
hypertensive emergencies when
parenteral treatment is necessary.
87
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Keep on the list for repeat
prescribing only as these are the only
two centrally acting antihypertensive
drugs available and on the list.
Central alpha agonists lower blood
pressure by stimulating alpha-receptors
in the brain which open peripheral
arteries easing blood flow. Central alpha
agonists, such as clonidine, are usually
prescribed when all other antihypertensive medications have failed.
For treating hypertension, these drugs
are usually administered in combination
with a diuretic.
dangerous, and should not be used
without careful consideration and
very careful monitoring. It is not used
outside an operating theatre or
intensive care unit (186).
Due to safety reasons I do not think
the following list of medicines should
be able to be initiated by a specailist
nurse prescriber: (115, 176).
Centrally –acting
antihypertensive
drugs
clonidine
Remove (115, 176, 174)
No longer used as an
antihypertensive, used in patch form
as an adjunct in chronic pain (86).
Other groups of specialist nurses may
require these drugs for other purposes.
Recommended that specialist nurses
work closely with medical practitioners
in prescribing these drugs.
Clonidine has the disadvantage that
sudden withdrawal of treatment may
cause severe rebound hypertension.
Clonidine is also prescribe for the other
following conditions:


High blood pressure
Hot flashes
88
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence




methyldopa
Should be restricted to use in
pregnancy only (86).
Alcohol or drug withdrawal
Attention-deficit/hyperactivity
disorder (ADHD)
Tourette syndrome
And in analgesia (unapproved)
prescribing as these are the only two
centrally acting antihypertensive drugs
available and on the list.
Other groups of specialist nurses may
require these drugs for other purposes.
Recommended that specialist nurses
work closely with medical practitioners
in prescribing these drugs.
Loop diuretics
Diuretics
furosemide
to initiate (129).
Keep on the list (not injection)
Other loop diuretic is already on the list
(bumetanide). Furosemide and
bumetanide have similar activity (NZ
Formulary).
Other groups of specialist nurses (e.g.
heart failure nurses) may require these
drugs for other purposes. Nurses
working in these specialty area have
always worked closely with medical
specialist.
Loop diuretics are used in pulmonary
oedema due to left ventricular failure;
intravenous administration produces
relief of breathlessness and reduces preload sooner than would be expected
from the time of onset of diuresis. Loop
diuretics are also used in patients with
chronic heart failure.
89
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Thiazide related
diuretic
used drugs i.e. .first and second line
medicines (115, 176).
There are already two thiazide related
diuretics on the list for Specialist nurses:
chlorthalidone
prescribing.
Chlortalidone, a thiazide-related
compound, has a longer duration of
action than the thiazides.
Bendroflumethiazide (bendrofluazide) is
widely used for mild or moderate heart
failure and for hypertension- alone in the
treatment of mild hypertension or with
other drugs in more severe
hypertension.
Indapamide is chemically related to
chlortalidone. It is claimed to lower blood
pressure with less metabolic
disturbance, particularly less aggravation
of diabetes mellitus.
Diabetes agents
Other antidiabetic
drug
Will be adequately trained and will be
working in collaboration with the MDT
Other antidiabetic agents available on
the specialist nurse list with better
efficacy profile.
Acarbose
Pioglitazone
Not commonly prescribed. Some
Acarbose, an inhibitor of intestinal alpha
glucosidases, delays the digestion and
absorption of starch and sucrose; it has
a small but significant effect in lowering
blood glucose. Use of acarbose is
usually reserved for when other oral
hypoglycaemics are not tolerated or are
contra-indicated. Postprandial
hyperglycaemia in type 1 diabetes can
be reduced by acarbose, but it has been
seldom used for this purpose.
Medsafe advice pioglitazone:
cardiovascular safety. Incidence of heart
failure is increased when pioglitazone is
90
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
(111).
cardiovascular risks identified.
combined with insulin especially in
patients with predisposing factors.
Before initiating treatment with
pioglitazone, patients should be
assessed for risk factors of bladder
cancer (including age, smoking status,
exposure to certain occupational or
chemotherapy agents, or previous
radiation therapy to the pelvic region)
and any macroscopic haematuria should
be investigated. The safety and efficacy
of pioglitazone should be reviewed after
3–6 months and pioglitazone should be
stopped in patients who do not respond
adequately to treatment.
Lipid regulating
drugs
Ezetimibe
Will be adequately trained and will be
working in collaboration with the MDT
(111).
Other lipid regulating drugs are on the
Specialist nurses list such as: Statins
(atorvastatin, pravastatin and
simvastatin).
Ezetimibe and pancreatitis - emerging
evidence
Website: Feb 2009Prescriber Update
2009;30(1):1 Prescribers are reminded
that medicines are a common, but under
recognised, cause of acute pancreatitis.
Medicines frequently implicated include
anti-HIV agents, statins, tetracyclines,
and valproate. There is emerging
evidence that ezetimibe, with or without
a statin, can also cause pancreatitis.
Reports in the CARM database indicate
91
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
that there are proportionately more
reports of pancreatitis with ezetimibe
than with statins.
Bile acid
sequestrants
Colestipol and
colestyramine
These have numerous drug
interactions due to their potential to
bind to and inactivate many other
medicines. It is very uncommon to
use these medicines to reduce lipids.
If a patient’s lipids are at the stage of
requiring either of these medicines,
they should be assessed by a
medical practitioner (86).
Keep on the list
NZ Formulary advise:
These are the only two bile
sequestrants available in NZ. Only one
submitter supported its removal with
no rationale.
Before instituting therapy with Colestid, a
vigorous attempt should be made to
control serum cholesterol by an
appropriate dietary regimen and weight
reduction; any underlying disorder that
may contribute to the
hypercholesterolaemia such as
hypothyroidism, diabetes mellitus
especially poorly controlled cases,
nephrotic syndrome, dysproteinaemias,
other drug therapy, alcoholism and
obstructive liver disease should be
looked for and specifically treated. The
patient’s current medications should be
reviewed for their potential to increase
serum LDL-cholesterol or total
cholesterol.
Decision was based on the idea that
specialist nurses likely to prescribe this
drug works in specialist area of
practice (e.g. Diabetes, Liver) and
would already be working closely with
a medical practitioner.
Effect on Vitamin Absorption
Because it sequesters bile acids,
Colestid may interfere with normal fat
absorption and thus may prevent
absorption of folic acid and fat soluble
vitamins such as A, D, E and K. A study
92
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
done in humans found only one patient
in whom a prolonged prothrombin time
was noted. Most studies did not show a
decrease in vitamin A, D or E levels
during the administration of COLESTID.
Nicotinic Acid group
medicines (115, 176). (174).
Acipimox and
nicotinic acid
Fibrates
Gemfibrozil
Not commonly used. Not suitable for
specialist nurse prescribing. More
suitable for NP prescribing. In the list
choices for prescribing in
hypercholesterolemia is Statins and if
contraindicated with be Bile Acid
Sequestrants.
Not first line except for patients who
cannot tolerate statins. More suitable
for NP prescribing. Bezafibrate is
already listed under the Specialist
nurse list.
Fibrates are first-line therapy only in
those whose serum-triglyceride
concentration is greater than 10
mmol/litre or in those who cannot
tolerate a statin.
Gemfibrozil however have high
The value of nicotinic acid is limited by
its adverse effects, especially
vasodilatation. Acipimox seems to have
fewer adverse effects than nicotinic acid
but may be less effective in its lipidregulating capabilities.
Bezafibrate, and gemfibrozil act mainly
by decreasing serum triglycerides; they
have variable effects on LDL-cholesterol.
Although a fibrate can reduce the risk of
coronary heart disease events in those
with low HDL-cholesterol or with raised
triglycerides, a statin should be used
first. Fibrates can cause a myositis-like
syndrome, especially if renal function is
impaired. Also, combination of a fibrate
with a statin increases the risk of muscle
effects (especially rhabdomyolysis) and
should be used with caution (see muscle
effects) and monitoring of liver function
93
Medicine
Classification
Hyperuricaemic
agents
Sub-classification
and Individual
Medicine
allopurinol
to initiate (129).
Council decision
Evidence
interactive properties with statins.
Statins are already available on the
specialist nurses list. Minimising
potential for drug interactions would
justify limiting use of this drug for
medical specialist or NP prescribing.
and creatine kinase should be
considered; gemfibrozil and statins
should not be used concomitantly.
Keep on the list
Azathioprine-Allopurinol Interaction:
Danger! Website: December 1998
Prescriber Update No.17:16-17 Medsafe
Editorial Team Allopurinol and
azathioprine should not be co-prescribed
unless the combination cannot be
avoided. Allopurinol interferes with the
metabolism of azathioprine, increasing
plasma levels of 6-mercaptopurine which
may result in potentially fatal blood
dyscrasias. Concomitant use requires
special precautions: the dose of
azathioprine should be reduced to 25%
of the recommended dose and the
patient’s blood count should be
monitored assiduously.
There are only two drugs for gout
treatment in the list – allopurinol and
probenecid.
Gout is a common condition that is
managed by primary care nurses.
Educational preparation will need to
include Safe Prescribing
considerations (NZ Formulary).
colchicine
Particularly hazardous medicines
such as amiodarone, azathioprine,
colchicine, etc should not be included
(150).
(129 see above)
NSAIDs are better drug of choice.
High adverse effect and drug
interaction profile.
Colchicine Toxicity Prompts Dosage
Change
Website: December 1998
Prescriber Update No.17:9-11
94
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Medsafe Editorial Team
Colchicine: Lower doses for greater
safety
Website: November 2005
Prescriber Update 2005;26(2):26-27
Medsafe Pharmacovigilance Team
Colchicine: Beware of toxicity and
interactions
Website: March 2011
Prescriber Update 2010; 32(1):2
Corticosteroids
Prednisolone
(repeat only 177)
NZ Formulary advises:
Indications not commonly managed by
nurse specialists
Prednisolone tablets [tablets section 29,
unapproved medicine]
Tablet form unapproved medicine (sec
29).
Note eye drop ophthalmology only
Note oral liquid is approved. Investigate
use in children.
Anticoagulant
Heparin antidote
Protamine
Remove (3). No rationale given
specialist nurses.
Protamine sulfate [section 29,
unapproved medicine] is used to treat
over dosage of unfractionated or low
molecular weight heparin.
Unapproved medicine ( section 29).
95
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Dabigatran
We have concerns with many
medicines here including those
restricted to certain areas e.g.
adenosine in ICU as well as those
initiated by consultants specialising in
certain areas e.g. dabigatran (127).
High Risk drug especially for high risk
patients.
Clinical nurse specialist.
Note: This leaves specialist nurses
only one drug of this class to keep:
warfarin.
(Remove 31,181, 3, 127, 86) (Repeat
only 85,107, 115, 174, 176)
Rivaroxaban
Anticoagulants?: Dabigatran,
Unfractionated Heparin,
Rivaroxaban, Warfarin Exclude with
possible exception of warfarin (86).
31, (repeat only 85, 107, 115, 174,
176)
Note: This leaves specialist nurses
only one drug of this class to keep:
warfarin
Clinical nurse specialist
Indications prevention of stroke and
systemic embolism in patients with nonvalvular atrial fibrillation and with at least
one of the following risk factors: previous
stroke, transient ischaemic attack, or
systemic embolism, left ventricular
ejection fraction <40%, symptomatic
heart failure, age ≥75 years (age ≥65
years in patients with diabetes, coronary
artery disease, or hypertension);
prophylaxis of venous thromboembolism
following total hip replacement or total
knee replacement surgery.
Indications prophylaxis of venous
thromboembolism following elective hip
or knee replacement surgery;
prophylaxis of stroke and systemic
embolism in patients with non-vascular
atrial fibrillation and with at least one of
the following risk factors: congestive
heart failure, hypertension, age ≥ 75
years, diabetes mellitus, prior stroke or
transient ischaemic attack; treatment of
deep-vein thrombosis; prophylaxis of
recurrent deep-vein thrombosis and
96
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
pulmonary embolism.
Warfarin
Antiplatelet
Clopidogrel
(Remove 31). (repeat only 85, 107,
115, 116, 166, 174, 176, 190)
Keep on list
(See above 86).
Most specialist nurse prescribing this
drug would be working closely with
Medical doctors and pharmacists.
Far too inclusive (31).
specialist nurses. Cardiac nurses
prescribing this drug should be NP
prepared or working closely with
Medical Specialist
One other antiplatelet drug is available
on the list: dipyridamole.
Warfarin is a drug with a narrow
therapeutic index. INR is available to
help ensure safe prescribing for this
drug.
Clopidogrel is an alternative to aspirin (if
contra-indicated or not tolerated) for the
prevention of atherothrombotic events in
patients with a history of symptomatic
ischaemic disease. Clopidogrel, in
combination with low-dose aspirin, is
also indicated for acute coronary
syndromes, is given for 12 months.
There is currently no evidence to support
continuing clopidogrel treatment for
longer than 12 months but treatment with
aspirin alone should be continued.
Use of clopidogrel with aspirin increases
the risk of bleeding. Clopidogrel
monotherapy may be an alternative
when aspirin is contra-indicated, for
example in those with aspirin
hypersensitivity, or when aspirin is not
tolerated despite the addition of a proton
pump inhibitor (see also New Zealand
97
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Primary Care Handbook 2012).
Erectile
dysfunction
Papaverine
medicines (115,176).
NZ Formulary source:
Clinical nurse specialist.
Pharmacy only drug except for injection
Note: No medicine under this
classification is on the list.
Hypoglycaemic
drugs
Sulphonylurea
Gliblenclamide
Prostaglandin
and Oxytoxics
Oxytocin
Oral hypoglycaemic no longer
recommended for routine use in
diabetes due to long half-life and
increased risk of hypoglycaemia
especially in the elderly (86) ,(111)
Many of the medicines listed are not
appropriate for nurses to access, for
example …labour induction agents.
(85) (115).
This drug can have a high-risk profile
Other drugs of this class is available
with a shorter half-life and more
suitable for prescribing in elderly
patients.
specialist nurse. Midwifery use.
Several sulfonylureas are available and
choice is determined by adverse effects
and the duration of action as well as the
patient's age and renal function.
Gliclazide and glipizide are short acting
sulfonylureas and should generally be
used over the longer acting
glibenclamide, especially in elderly
patients, as it is associated with a
greater risk of hypoglycaemia.
Indications induction or enhancement of
labour; caesarean section; prevention
and treatment of postpartum
haemorrhage; incomplete, inevitable, or
missed miscarriage in early pregnancy.
Question oxytocin for the use of
labour induction being part of the
scope of practice of an RN
regardless of their level of advanced
98
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Keep on the list
Melatonin prolonged release 2mg
(CIRCADIN) has proven benefit in
facilitating onset of sleep, improving
sleep quality, next day alertness and
quality of life in people aged 55 years
and over, with primary insomnia. With a
low risk of side effects, lack of
dependence and lack of abuse, this
medicine has a favourable risk-benefit
profile for non-prescription supply.
practice development (187).
Oxytocin for labour induction. Labour
induction is outside of the scope of
practice of a nurse as the indication
for induction is a medical decision
following consultation and
assessment. Further monitoring and
assessment of the woman who is
being induced is within the scope of
practice of a midwife and not the
nurse.
There is no benefit to the consumer if
nurses were given access to oxytocin
(188).
Hypnotics/anxioly
tics
Hypnotic
Repeat only (3)
Under hypnotics other classes of drugs
has been listed e.g. benzodiazepines
and zopiclone.
Melatonin
The drugs above have a high
dependency profile. However, not for
melatonin.
Anxiolytics
Not first-line anxiolytic, Special
Authority required (86). There would
not be the need to initiate any
Keep on the list
This drug is used in managing anxiety
The dependence and abuse potential of
buspirone is low; it is indicated for the
short-term treatment of anxiety
99
Medicine
Classification
Sub-classification
and Individual
Medicine
Buspirone
Positive
inonotropic drugs
Cardiac glycosides
Digoxin
Council decision
Evidence
antiarrythmic, anxiolytic,
antipsychotic, anticoagulant, positive
inotrope, antidepressant without
collaboration with a doctor. For this
reason I think these medications
should be removed (107).
(short term)
disorders.
There would not be the need to
initiate any antiarrythmic, anxiolytic,
antipsychotic, anticoagulant, positive
inotrope, antidepressant without
collaboration with a doctor. For this
reason I think these medications
should be removed (107).
Repeat only, (not injection)
Digoxin has a long half-life and
maintenance doses need to be given
only once daily (although higher doses
may be divided to avoid nausea); renal
function is the most important
determinant of digoxin dosage.
Unwanted effects depend both on the
concentration of digoxin in the plasma
and on the sensitivity of the conducting
system or of the myocardium, which is
often increased in heart disease. It can
sometimes be difficult to distinguish
between toxic effects and clinical
deterioration because symptoms of both
are similar.
to initiate (129.)
Examples (of repeat prescribing) in
primary care could include digoxin,
antipsychotic medications (179).
This drug has a narrow margin of
safety and the indications for the use
of this drug is not suitable for specialist
nurse prescribers but for NPs.
May be acceptable for a repeat
prescribing if nurses are working
closely with NP or Medical Specialist.
There are many medications that are
not initiated by GPs but they do
repeat prescribe on the instruction of
a specialist. The same situation
should apply to nurse
100
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
prescribing…Digoxin, antipsychotic
medications (187). (repeat only 98)
Drugs for pain
Gabapentin
(repeat only 3)
Keep on the list for neuropathic
pain
There are other indications for this
drug e.g. seizures. However, this
report is only responding to its use in
neuropathic pain. Unapproved for
migraine.
Use in conditions commonly managed
by some specialist nurses (pain).
Note: Subsidy only available for the
treatment of epilepsy or neuropathic
pain after other agents have been tried
but have been found to be
unacceptable. A Subsidy requires
Special Authority which must be
applied for by a relevant "practitioner".
PHARMAC define a "practitioner" as
meaning, "...a Doctor, a Dentist, a
Dietitian, a Midwife, a Nurse
Prescriber, an Optometrist, or a
Pharmacist Prescriber.
Anticonvulsants
Phenytoin
Antiepileptic with complex
pharmacokinetics, difficult dose
titration, risk of toxicity within usual
Indications all forms of epilepsy except
Phenytoin is effective for tonic-clonic and
focal seizures. It has a narrow
therapeutic index and the relationship
101
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
dose range and serious side effects
(86).
absence seizures; status epilepticus;
prevention of seizures following
neurosurgery. Specialist nurses not
fully trained in diagnosis of these
conditions.
between dose and plasma-drug
concentration is non-linear; small dosage
increases in some patients may produce
large increases in plasma concentration
with acute toxic adverse effects.
Similarly, a few missed doses or a small
change in drug absorption may result in
a marked change in plasma-drug
concentration. Monitoring of plasma-drug
concentration improves dosage
adjustment.
(Remove 115, 174, 176).
Muscle relaxants
Dantrolene sodium
medicines (115,176) (174).
Remove from list due to its
hepatotoxic profile and long term
use.
Cautions impaired cardiac and
pulmonary function; therapeutic effect
may take a few weeks to develop—
Hepatotoxicity. Potentially lifethreatening hepatotoxicity reported.
Rheumatoid
agent/
Penicillamine
Disease-modifying agents for use in
rheumatoid arthritis: Azathioprine,
Hydroxychloroquine, Leflunomide,
Penicillamine. Specialist
rheumatology medicines with serious
side effect profiles. Appropriate to
repeat prescribe, not initiate (86).
Penicillamine has a similar action to
gold. More patients are able to continue
treatment than with gold but adverse
effects are common. It is now seldom
used in the treatment of rheumatoid
arthritis.
Remove from the list for this
purpose by keep as an antimalarial
arthritis agent
Use as anti-malarial
as well as for
Rheumatoid arthritis
Medical specialist initiation and on
going management.
Adverse effects and toxicity related
effects are important considerations and
also in relation to dosing parameters.
Rheumatoid arthritis is a condition that
is commonly managed by specialist
102
Medicine
Classification
Sub-classification
and Individual
Medicine
hydroxychloroquine
Council decision
(Repeat 40).
nurses however, establishing
diagnosis will require a good depth of
diagnosis to rule out other conditions.
Keep in the list for repeat
prescribing in rheumatology
Aminosalicylates
Evidence
Sulfasalazine has a beneficial effect in
suppressing the inflammatory activity of
rheumatoid arthritis.
Specialist nurses prescribing this
should work closely with medical
prescribers.
Sulfasalazine
Antimuscarinic
drug
Procyclidine
This is an anticholinergic used in
Parkinson’s disease, it is not an
antiemetic. Did Nursing Council
intend this to be
prochlorperazine?(86)
This drug is use in parkinsonism; druginduced extrapyramidal symptoms not as
an anti-emetic as per summary.
Anti-histamine
Sedating group
This is not an appropriate choice of
antihistamine as it is highly sedating
and there are several far more
reasonable alternatives. It is
occasionally used as a sedative for
children but this is effectively
chemical restraint and is an
inappropriate and highly controversial
use (86).
Remove from the prescription list
Restricted and Pharmacy only drug as
per NZ Formulary. See comments on
community list report.
Many of the IV preparations are
inappropriate e.g. aminophylline (86).
This drug has narrow margin of safety
Trimeprazine
Anti-asthma drug
Aminophylline
This is an injectable compound and
103
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
given intravenously.
More suitable for NP and medical
specialist prescribing.
Theophylline
(Repeat only 26).
Not commonly used. More suitable for
NP and medical prescribing.
Immunosuppressants
Azathioprine
Indications for the use of the drug are
conditions not commonly manage by
specialist nurses.
Monitor TDM monitoring plasmatheophylline concentration for optimum
response- narrow margin between
therapeutic and toxic dose.
Different formulations may vary in
bioavailability (caution in transplant
patients).
PHARMAC restriction: Retail Pharmacy
Specialist
A patient cannot receive a funded
prescription for this without specialist
endorsement. We would expect that
the same requirement would exist for
nurse prescribers (194).
(Remove 31, 150,41,194,54,62, 178).
(Repeat only 40, 115, 174, 176, 184).
Leflunomide
See above (86).
This drug is a lot more toxic than
azathioprine.
Leflunomide acts on the immune system
as a disease-modifying antirheumatic
drug. Its therapeutic effect starts after 4–
6 weeks and improvement may continue
104
Medicine
Classification
Anti-bacterial
Sub-classification
and Individual
Medicine
Cephalosporins
Cefuroxime
Cephalexin
Two submitters cautioned prescribing
of antibiotics by nurses (69, 194).
The College has concerns that
extending prescribing rights to nurses
could accelerate the prescribing of
antibiotics when they are not
necessary to treat an infection. Overprescribing, that is prescribing
antibiotics when they are not
necessary to treat the infection, has
Council decision
Evidence
Rationale: Outside specialist nurse
scope of practice.
for a further 4–6 months. Leflunomide,
which is similar in efficacy to
sulfasalazine and methotrexate, may be
chosen when these drugs cannot be
used. It may also be combined with
methotrexate if the response to either
drug alone is insufficient. The active
metabolite of leflunomide persists for a
long period; active procedures to wash
the drug out are required in case of
serious adverse effects, or before
starting treatment with another diseasemodifying antirheumatic drug, or, in men
or women, before conception. Adverse
effects of leflunomide include bonemarrow toxicity; its immunosuppressive
effects increase the risk of infection and
malignancy (NZ Formulary).
Keep both cephalosporins in the list
All prescribers must refer to BPAC or
other suitable antibiotic guideline (e.g.
local guidelines based on local
resistance patterns and antibiotic
stewardship protocols) for conditions
and first-line antibiotic use.
Cefuroxime is a ‘second generation’
cephalosporin that is less susceptible
than the earlier cephalosporins to
inactivation by beta-lactamases. It is,
therefore, active against certain bacteria
which are resistant to the other drugs
and has greater activity against
Haemophilus influenzae.
Recommendation to add more drugs in
the cephalosporin class. This gives
specialists nurses more flexibility in
Cephalosporins are broad spectrum in
105
Medicine
Classification
Sub-classification
and Individual
Medicine
Cefoxitin
Council decision
Evidence
been a factor worldwide in the
development and spread of antibiotic
resistant bacteria and is increasing
global concern.
prescribing antibiotics. Same
considerations apply and that is
educational preparation of all
prescribers when prescribing
antibiotics.
activity and may increase likelihood of
emergence of resistance. However,
Specialist nurses must be given the
options of different groups of antibiotics.
Preventing over-use of antibiotics in
the community is important in slowing
the development and spread of
antibiotic resistant bacteria. The
Ministry of Health, the College, health
care networks, PHARMAC, the New
Zealand Medical Association and
other groups contribute to raise
awareness amongst GPs and other
prescribers to limit antibiotic use. The
College is concerned that these
benefits could be lost and that New
Zealand could more quickly towards
the situation experienced in other
countries where resistance patterns
make treating infections more difficult
(194).
Add - No rationale given (92)
Do not add
Not first line for common infections.
Not subsidised. On Hospital Medicines
List only.
Macrolide
See above
Keep on the list and add
roxithromycin
Antibiotic-associated DILI (Druginduced-liver disease
Note significant PHARMAC funding
Antibiotics are a common cause of DILI,
106
Medicine
Classification
Sub-classification
and Individual
Medicine
Clarithromycin
(add roxithromycin)
Council decision
Evidence
barrier to more than 500mg. Special
authority respiratory specialist,
infectious disease specialist or
paediatrician.
probably because of the high rate of
exposure in the community. Most cases
are idiosyncratic and are therefore rare,
unpredictable (from the pharmacology of
the antibiotic) and largely doseindependent.
Macrolides are an alternative to
penicillin sensitive patients.
Erythromcin and azithromycin already
on the list.
Many conditions that are managed by
specialist nurses will require an
alternative to penicillins.
Keep on the list
Penicillins
procaine penicillin
See above.
Common conditions managed by
specialist nurses.
Indications group A streptococcal
upper respiratory tract infections; skin
and skin structure infections; rheumatic
fever; scarlet fever; pneumococcal
upper respiratory tract infections;
gonorrhoea; syphilis.
Education of antibiotics and antibiotic
resistance should be strongly promoted
in the educational preparation of
specialist nurse prescribers.
DILI and neprotoxicity adverse effects is
a considerations when prescribing
antibiotics.
(These groups were also suggested in
the Submitters to add to the specialist
nurse list and are on the community
nurse list)
amoxicillin
amoxicilllin + clavulanic acid
flucloxacillin
Most staphylococci are now resistant to
benzylpenicillin because they produce
penicillinases. Flucloxacillin is a more
suitable drug for these micro-organisms.
107
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Note: warning on hepatic disorders.
Anti-tuberculosis
69, 86, 194 (repeat only 184)
prescribing only
PHARMAC restriction
rifampicin
For confirmed recurrent
Staphylococcus aureus infection in
combination with other effective antistaphylococcal antimicrobial based on
susceptibilities and the prescription is
endorsed accordingly; can be waived
by endorsement - Retail pharmacy Specialist. Specialist must be an
internal medicine physician, clinical
microbiologist, dermatologist,
paediatrician, or public health
physician.
Anti-arrythmic
drugs
Adenosine
It would be extremely imprudent for a
nurse to diagnose an SVT, prescribe
and administer adenosine in the
absence of a properly trained ED
physician. However, remote there is
the possibility the patient will have an
unrecognised accessory pathway or
have their VT misdiagnosed as wide
complex SVT while under pressure
and working at the edge of their
scope; he consequences of which
Numerous submitters suggested
Indication for use of drug not
commonly associated with specialist
nurses whose area of specialty of
cardiac will work closely with Medical
prescribers in conditions related to
supraventricular tachycardia as this is
Conditions likely to be manage by
specialist nurses in primary care,
respiratory and public health teams
needing Rifampicin:

Tuberculosis

Prophylaxis of meningococcal
meningitis and Haemophilus
influenzae (type b) infection

Recurrent staphylococcal skin
infections
Adenosine is usually the treatment of
choice for terminating acute
presentations with paroxysmal
supraventricular tachycardia. As it has a
very short duration of action (half-life
only about 8 to 10 seconds).
108
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
would be catastrophic (85).
an emergency situation.
Evidence
57, 127, 128, 186 (repeat only 31,
76, 86, 107, 115, 174, 176, 178)
Amiodarone
These medicines would not be
appropriate for a non-medical
prescriber to initiate due to the
complexity of the medical condition
(arrhythmias) and its treatment but
would be suitable for inclusion on a
list of medicines for repeat
prescribing. There are a number of
issues with these drugs that require
medical assessment (diagnosis) such
as syncope, rhythms etc. It is a very
complex treatment area with many
potential ADRs and drug interactions
e.g. amiodarone.(86) There are
medicines on this list that are
classified as “Retail Pharmacy –
Specialist” that the Guild believes
should not be initiated by a specialist
nurse prescriber (e.g. amiodarone,
flecainide).(60) Anti arrhythmic, i.e.
Amiodarone and Sotalol for these
medicine to be safely prescribe
access to laboratory test, radiology
and ECGs must be easily & regularly
accessible for on going monitoring of
nurses. Nurses whose area of
specialty of cardiac will work closely
with Medical prescribers in conditions
related to supraventricular tachycardia
as this is an emergency situation.
Amiodarone is used in the treatment of
arrhythmias, particularly when other
drugs are ineffective or contra-indicated.
It can be used for paroxysmal
supraventricular, nodal and ventricular
tachycardias, atrial fibrillation and flutter,
and ventricular fibrillation. It can also be
used for tachyarrhythmias associated
with Wolff-Parkinson-White syndrome. It
should be initiated only under hospital or
specialist supervision.
This drug has a long half life extending
to several weeks) and only needs to be
given once daily (but high doses can
cause nausea unless divided). Many
weeks or months may be required to
achieve steady-state plasmaamiodarone concentration; this is
particularly important when drug
interactions are likely. Therefore
knowledge base required of prescriber
can be challenging.
109
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
prescribing only as this the only drug
that is listed under this class and group
that has the least adverse effect and
toxicity profile.
Prevention and treatment of lifethreatening ventricular and
supraventricular arrhythmias, including
after myocardial infarction; maintenance
of sinus rhythm after cardioversion.
patients response to these
treatments (57).Concern was
expressed regards initiating (or
ceasing) medications such as
Amiodarone is quite different to
represcribing/monitoring. Such
medicines with high potential for
harm need to be removed (41).
There are a lot of medications on
there that should only be initiated
with direct instruction from a medical
specialist. For example, a specialist
nurse may consider a patient needs
amiodarone, but clear discussion and
clarity about the prescription would
need to be agreed to by the
cardiologist and then the nurse could
prescribe it (110).
(Remove 85, 41, 184,). (Repeat only
96, 107, 115,150, 174, 176, 178).
Disopyramide
We would not be comfortable in RN
Prescribers initiating some of the
medications listed e.g. antiarrhythmic medications (57). 85
(repeat only 86, 107, 115, 174, 176,
178).
Specialist nurses prescribing this drug
should work closely with Medical
110
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
Practitioners under a collaborative
prescribing framework
flecainide
Propafenone
There are medicines on this list that
are classified as “Retail Pharmacy –
Specialist” that the Guild believes
should not be initiated by a specialist
nurse prescriber (e.g. amiodarone,
flecainide) (60). (Remove 85, 57,
60,111,184). (Repeat only 86, 96,
107, 115, 174, 176, 178)
85, 57 (repeat only 86, 107, 115,
174, 176, 178).
nurses.
nurses.
Anti-muscarininc
bronchodilators
Tiotropium
We are concerned about the
absence of long-acting
anticholinergics (tiotropium). We
presume that combination inhalers
(Seretide, Vannair and Symbicort)
can be prescribed as the products in
Add to the list
Formulation: Inhalation
Indications maintenance treatment of
chronic obstructive pulmonary disease.
Flecainide belongs to the same general
class as lidocaine (lignocaine). It may be
indicated for junctional re-entry
tachycardias and for paroxysmal atrial
fibrillation. However, it can precipitate
serious arrhythmias in a small minority of
patients (including those with otherwise
normal hearts). Use should be avoided
in patients with impaired cardiac function
or coronary heart disease unless
recommended by a specialist.
Propafenone is used for the prophylaxis
and treatment of ventricular arrhythmias
and also for some supraventricular
arrhythmias. It has complex mechanisms
of action, including weak beta-blocking
activity (therefore caution is needed in
obstructive airways disease—contraindicated if severe).
Tiotropium, a long-acting antimuscarinic
bronchodilator, is effective for the
management of chronic obstructive
pulmonary disease; it is not suitable for
the relief of acute bronchospasm.
111
Medicine
Classification
Erythropoietins
Sub-classification
and Individual
Medicine
Epoetins alfa and
beta?
Council decision
the combination inhalers are listed
separately. We also presume that
specialist nurse prescribers will be
able to apply for Special Authority
numbers for these medications (13).
PHARMAC Special authority required.
In our area there are renal specific
medications, e.g. Which may need to
be added. Has council considered
adding in specialty specific classes of
medications e.g. Erythropoietin, iron?
(54).
Add both for repeat prescribing
Alfa:
Indications for use is commonly
manage by renal and oncology nurses.
Indications symptomatic anaemia
associated with chronic renal failure in
patients on haemodialysis; symptomatic
anaemia associated with chronic renal
failure in adults on peritoneal dialysis;
severe symptomatic anaemia of renal
origin in adults with renal insufficiency
not yet on dialysis; symptomatic
anaemia in adults receiving cancer
chemotherapy.
Erythropoietins
Epoetins alfa and beta (recombinant
human erythropoietins) are used to
treat symptomatic anaemia associated
with erythropoietin deficiency in
chronic renal failure and to increase
the yield of autologous blood in normal
individuals. Epoetin beta is also used
for the prevention of anaemia in
preterm neonates of low birth-weight;
only unpreserved formulations should
be used in neonates because other
preparations may contain benzyl
alcohol.
Evidence
Beta:
Indications symptomatic anaemia
associated with chronic renal failure;
prevention of anaemia of prematurity in
neonates with birth-weight of 0.75–1.5
kg and gestational age of less than 34
weeks; symptomatic anaemia in adults
with non-myeloid malignancies; to
increase yield of autologous blood (to
avoid homologous blood) in predonation.
112
Medicine
Classification
Antiprogestogeni
c steroid
Sub-classification
and Individual
Medicine
Council decision
Evidence
Mifepristone
ALRANZ would like to see the
inclussion of Mifegyne and
Misoprostol. These medications are
used in medical terminations. As the
law stands women are already
seeing two medical doctors and there
may appear little to be gained by
nurses being able to prescribe these
medications. However, we believe it
would be adventagous to include
these medications to future proof
possible changes to the laws
governing abortion (172).
Indications - medical termination of intrauterine pregnancy (followed by a
prostaglandin); cervical ripening before
surgical termination of pregnancy; labour
induction in fetal death in utero.
As above
Add to the list
Synthetic
prostaglandin
analogue
Misoprostol
Thiazides and
related diuretics
Metolazone
Outside of scope according to present
legislation for abortion.
Indications not diagnosed and manage
by specialist nurses.
Section 29 use of medicine if used in
medical abortion. Indicated for gastric
ulcer prophylaxis.
From my own practice of managing
heart failure patients we would also
ask for Metolazone (a thiazide used
for persistent oedema and end stage
heart failure) 175.
Not able to be prescribed by
designated prescribers. Section 29,
unapproved medicine.
PHARMAC Special authority
Misoprostol has antisecretory and
protective properties, promoting healing
of gastric and duodenal ulcers. It can
prevent NSAID-associated ulcers, its use
being most appropriate for the frail or
very elderly from whom NSAIDs cannot
be withdrawn.
Indication: oedema. Metolazone
[section 29, unapproved medicine] is
particularly effective when combined with
a loop diuretic (even in renal failure);
profound diuresis can occur and the
patient should therefore be monitored
carefully. It may however be of benefit in
113
Medicine
Classification
Sub-classification
and Individual
Medicine
Council decision
Evidence
patients with resistant heart failure.
Long acting beta
2 agonists
Chronic asthma
Formoterol
(eformoterol)
We presume that combination
inhalers (Seretide, Vannair and
Symbicort) can be prescribed as the
products in the combination inhalers
are listed separately. We also
presume that specialist nurse
prescribers will be able to apply for
Special Authority numbers for these
medications (13).
Add to the list, (inhaled route)
Continuation of prescribing in close
collaboration with medical practitioner.
Asthma maintenance therapy; asthma
maintenance and reliever therapy;
chronic obstructive pulmonary disease.
PHARMAC restriction: Special authority.
114

Medicines Report: Review of the Medicines Lists

Transcription

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