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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. Non prescription list 16 Community prescription Type of medicine medicines for specialist nurse prescribers Likely use and NZ Rationale formulary indications 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. Non prescription list 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 & Non prescription non subsidised Non prescription list 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 Non prescription list Prescription medicine only when used internally - a useful product for nurse prescribers. Non prescription list 17 Community prescription Type of medicine medicines for specialist nurse prescribers Likely use and NZ Rationale formulary indications 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. Non prescription list Foaming solution & cream partially subsidised. Topical (Pharmacy-Only) or injectable (Prescription Medicine) NSAID. Topical gel possibly available in NZ but not subsidised. Non prescription not 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. Non prescription list Fluorides Mineral supplement Prevention of dental caries Prescription Medicine only in high strengths. Limited therapeutic value? Toothpaste more effective? Non prescription list 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. Non prescription list 18 Community prescription Type of medicine medicines for specialist nurse prescribers Likely use and NZ Rationale formulary indications 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). Non prescription list (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. Non prescription not subsidised Levocabastine Antihistamine Allergic conjunctivitis Pharmacy-Only. Partial subsidy. Fully subsidised alternative is currently naphazoline. Non prescription list 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 Non prescription non 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 Community prescription Type of medicine medicines for specialist nurse prescribers Likely use and NZ Rationale formulary indications 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 Non prescription list 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 Non prescription list Paracetamol Analgesic Mild to moderate pain; pyrexia with discomfort; post-immunisation pyrexia with discomfort in infants Non prescription list Permethrin Paraciticidal Scabies; crab lice Non prescription list Propamidine Antibacterial Superficial bacterial eye Non prescription list 20 Community prescription Type of medicine medicines for specialist nurse prescribers Likely use and NZ Rationale formulary indications Council Decision infections Pyridoxine Vitamin supplement Prevention and treatment of pyridoxine deficiency; sideroblastic anaemia; homocystinuria; primary hyperoxaluria; isoniazidinduced neuropathy [unapproved] Non prescription list Silver sulphadiazine Antibacterial Prophylaxis and treatment of infection in burn wounds and other wounds (including pressure sores and leg ulcers) Non prescription list Zinc Barrier/mineral supplement Skin barrier protection/ supplement for zinc losing conditions Non prescription list 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 Remove from the list 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 Remove from the list Methylsalicylate Rubefacient Remove from the list 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 Remove from the list 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. URL: http://nzf.org.nz/nzf_2098.html 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. URL: http://nzf.org.nz/nzf_2225.html 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). Remove from the list 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 tricyclic antidepressants should be 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. Remove from the list due to its 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. Overdosage Limited quantities of tricyclic antidepressants should be 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. Remove from the list due to its 40 Class Drug Council decision adverse effect profile Evidence Considerations Overdosage Limited quantities of tricyclic antidepressants should be prescribed at any one time because their cardiovascular and epileptogenic effects are dangerous 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 Remove from the list 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. Remove from the list 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 Comments from submitters 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 Remove from the list Further diagnostic assessments are essential skills needed before prescribing. Typical antipsychotic fluphenazine Remove from the list Further diagnostic assessments are essential skills needed before 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. Remove from the list Further diagnostic assessments are essential skills needed before prescribing. zuclopenthixol Indications maintenance in schizophrenia and other psychoses. DEPOT Injection. Remove from the list 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. Further diagnostic assessments are essential skills needed before prescribing. haloperidol Indications maintenance in schizophrenia and other psychoses. DEPOT Injection. Not for prescribing in mental health but retain for palliative care Further diagnostic assessments are essential skills needed before 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). Remove from the list Further diagnostic assessments are essential skills needed before prescribing. Indications schizophrenia and 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. Further diagnostic assessments are essential skills needed before prescribing. aripiprazole Indications schizophrenia and 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. Further diagnostic assessments are essential skills needed before 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 Comments from submitters 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. Do not add to the list 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 Comments from submitters 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) Keep for repeat prescribing 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. Do not add to the list 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 Remove from the list 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 prescribing by nurses in specialist addiction 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 prescribing by nurses in specialist addiction 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). Do not add to the list. 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) Add to the list for specialist nurses practising in Ophthalmology specialist teams Atropine (action up to 7 days) are preferable for producing cycloplegia for refraction in young children. Add to the list for specialist nurses practising in Ophthalmology specialist teams 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. Not subsidised in the community Eye drops Add to the list for specialist nurses practising in Ophthalmology specialist teams Not subsidised in the community Eye drops Add to the list for specialist nurses practising in Ophthalmology specialist teams Not subsidised in the community 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) Do not add to the list. 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. URL: http://nzf.org.nz/nzf_7022.html 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 Not subsidised in the community Keep on non-prescription list and add eye use. Indication: Dry eyes Keep on the list Indications: superficial bacterial eye infection Add to the list for specialist nurses practising in Ophthalmology specialist teams 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 – Continuation prescribing Indications: ocular inflammation when concurrent use of an antimicrobial indicated (short-term) Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing 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 glaucoma – Betablockers compound 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 Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: local treatment of inflammation (short-term). Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications local treatment of inflammation (short-term) Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: local treatment of inflammation (short-term) Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: Raised intra-ocular pressure in open-angle glaucoma and ocular hypertension not adequately responding to beta blocker monotherapy Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: raised intra-ocular pressure in open-angle glaucoma or ocular hypertension Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing 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 Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: raised intra-ocular pressure in open-angle glaucoma; ocular hypertension; adjunctive therapy with ophthalmic beta-blocker Treatment of glaucoma – Betablockers compound 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 Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: miotic for reversing the action of weaker mydriatics; emergency treatment of glaucoma Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: raised intra-ocular pressure; adjunctive treatment in paediatric glaucoma Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing 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 Indications: Used to reduce intra-ocular pressure in ocular hypertension or open-angle glaucoma. Bimatoprost 0.03% Eye drops Add to the list for specialist nurses practising in Ophthalmology specialist teams – Continuation prescribing Indications: Used to reduce intra-ocular pressure in ocular hypertension or open-angle glaucoma. 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 Submission made that medicine be removed (or conditions specified) from the list 153, 177, 179 (Specify route 86) Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) from the list Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) from the list Reason given by submitter to remove or 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 Move to nonprescription list 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 Submission made that medicine be removed (or conditions specified) from the list beneficial Ciprofloxacin Antibiotic 31, 60, 86, 177, 179, (Specialist only 178) Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) from the list 177, (86, 107 specify route), (60, 181 specialist only) Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) from the list 177, 178 (combination contraceptive only), 181 (specialist only). Reason given by submitter to remove or 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 Not subsidised by PHARMAC. 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 Submission made that medicine be removed (or conditions specified) from the list Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) from the list 3, 86, 178 Reason given by submitter to remove or 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 (Specify Topical only) 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 Submission made that medicine be removed (or conditions specified) 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 submitter to remove or 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 Move to nonprescription list (Topical only) Remove Rationale High risk of severe toxicity. 77 Medicine Likely use Submission made that medicine be removed (or conditions specified) from the list Reason given by submitter to remove or 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 Submission made that medicine be removed (or conditions specified) 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 submitter to remove or 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 (Specify Topical only) 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 Submission made that medicine be removed (or conditions specified) from the list 115, 176 Reason given by submitter to remove or 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. Not subsidised by PHARMAC. For topical use in eczema and dermatitis only Move to nonprescription list Pantoprazole Proton pump inhibitor 97 Penciclovir antiviral 179 Phenol Haemorrhoid sclerosant 178 (topical) Phenylephrine Decongestant 186, 122 (not subsidised) Podophyllotoxin Warts 177 Remove Move to nonprescription list 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. Not subsidised by PHARMAC. 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 Submission made that medicine be removed (or conditions specified) from the list Reason given by submitter to remove or include a condition Council decisions retinoids (177). Items that are contraindicated in pregnancy, such as podophyllum, podophyllotoxin, and 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 (Specify Topical only) Tobramycin Mild to superficial bacterial eye infection 74, 97, 115, 174, 176 (specify route 86, 91, 178) Not commonly used medicines, require specialist knowledge (97). 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. Not subsidised by PHARMAC. Move to Nonprescription list (Emla cream) Non-prescription Terbinafine is the drug of choice for fungal nail infections. 81 Medicine Likely use Submission made that medicine be removed (or conditions specified) 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 submitter to remove or 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, podophyllotoxin, and 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 specialist knowledge (97). 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 Submission made that medicine be removed (or conditions specified) from the list 115, 174, 176 115, 176 Reason given by submitter to remove or 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 Submitters Recommendation 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 Submitters Recommendation 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. Remove from the list 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). Remove from the list No longer considered an appropriate antihypertensive or antianginal, use is primarily limited to cardiac arrhythmias in which case those Remove from the list Dosing consideration for this drug require extensive knowledge of pharmacotherapeutic considerations best suited for NP prescribing Dosing consideration for this drug require extensive knowledge of 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 Submitters Recommendation Council decision Evidence comments apply (86) (see antiarrhythmics). pharmacotherapeutic considerations 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). Remove from the list 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 from the list Remove (115,176,174) This is not used for hypertension but for hypotension and is a specialist only drug. Special authority for subsidy. Not suitable for specialist nurse 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 Remove from the list Not suitable for specialist nurse 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 Submitters Recommendation 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 Submitters Recommendation 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) Keep on the list for repeat 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 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). 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 Submitters Recommendation Council decision Evidence Thiazide related diuretic Should only be initiating commonly used drugs i.e. .first and second line medicines (115, 176). Remove from the list There are already two thiazide related diuretics on the list for Specialist nurses: chlorthalidone Not suitable for specialist nurse 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 Should only be initiating commonly used drugs i.e. first and second line medicines (115, 176). Remove from the list Will be adequately trained and will be working in collaboration with the MDT Remove from the list 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 Submitters Recommendation 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). Keep for repeat prescribing 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 Submitters Recommendation 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 Submitters Recommendation 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 Should only be initiating commonly used drugs i.e. first and second line medicines (115, 176). Remove from the list Should only be initiating commonly used drugs i.e. first and second line medicines (115, 176). (174). Remove from the list 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 Submitters Recommendation 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). 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). Remove from the list (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 Submitters Recommendation 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) Remove from the list 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 Remove from the list Indications not commonly managed by 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 Submitters Recommendation 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). Remove from the list High Risk drug especially for high risk patients. Indications not commonly managed by 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). Remove from the list 31, (repeat only 85, 107, 115, 174, 176) Note: This leaves specialist nurses only one drug of this class to keep: warfarin Indications not commonly managed by 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 Submitters Recommendation 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). Remove from the list Indications not commonly managed by 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 Submitters Recommendation Council decision Evidence Primary Care Handbook 2012). Erectile dysfunction Papaverine Should only be initiating commonly used drugs i.e. first and second line medicines (115,176). Remove from the list NZ Formulary source: Indications not commonly managed by 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) Remove from the list Many of the medicines listed are not appropriate for nurses to access, for example …labour induction agents. (85) (115). Remove from the list 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. Indications not commonly managed by 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 Submitters Recommendation 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 Submitters Recommendation 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. 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.) 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 Submitters Recommendation 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 Remove from the list 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 Submitters Recommendation 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 Should only be initiating commonly used drugs i.e. first and second line 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). Remove from the list 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. Disease-modifying agents for use in rheumatoid arthritis: Azathioprine, Hydroxychloroquine, Leflunomide, Penicillamine. Specialist 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 Submitters Recommendation Council decision rheumatology medicines with serious side effect profiles. Appropriate to repeat prescribe, not initiate (86). (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) Remove from the list 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). Remove from the list 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 Submitters Recommendation Council decision Evidence given intravenously. More suitable for NP and medical specialist prescribing. Theophylline (Repeat only 26). Remove from the list Not commonly used. More suitable for NP and medical prescribing. Immunosuppressants Azathioprine 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). Remove from the list 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). Remove from the list 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 Submitters Recommendation 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 Submitters Recommendation 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 Two submitters cautioned prescribing of antibiotics by nurses (69, 194). 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 Submitters Recommendation 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 Two submitters cautioned prescribing of antibiotics by nurses (69, 194). 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 Submitters Recommendation Council decision Evidence Note: warning on hepatic disorders. Anti-tuberculosis 69, 86, 194 (repeat only 184) Keep on the list for repeat 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 Remove from the list Numerous submitters suggested remove from the list. 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 Submitters Recommendation 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 Remove from the list Numerous submitters suggested remove from the list. Indication for use of drug not commonly associated with specialist 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 Submitters Recommendation Council decision Evidence Keep on the list for repeat 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 Submitters Recommendation 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) Remove from the list 85, 57 (repeat only 86, 107, 115, 174, 176, 178). Remove from the list Numerous submitters suggested remove from the list. Indication for use of drug not commonly associated with specialist nurses. Numerous submitters suggested Remove from the list Indication for use of drug not commonly associated with specialist 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? Submitters Recommendation 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 Submitters Recommendation 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). Do not add to the list 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. Do not add to the list 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 Submitters Recommendation 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