Regulatory Impact Statement Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments 2004)
Regulatory Impact Statement Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 Summary Section 1 Objective of the proposed regulations The primary objective of the proposed regulations will provide for the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by nurse practitioners. Other amendments are to provide an update to various references in the Principal Regulations by amending reference to the terms Chief General Manager to read that of Secretary and replacing the term veterinary surgeons with veterinary practitioners. Section 2 Assessment and nature and extent of the problem A nurse practitioner is a registered nurse educated for advanced and extended practice whose registration is endorsed pursuant to Section 8B of the Nurses Act, 1993. Authority to obtain and possess to use, sell and supply Schedule 2, 3, 4 and 8 poisons is limited to persons authorised under Section 13 of the Drugs, Poisons and Controlled Substances Act, 1981 (the Principal Act ). Authorised persons include medical practitioners and dentists (for human use) and veterinary practitioners (for animal use). Authorised optometrists can prescribe a limited number of topical Schedule 4 poisons for diagnostic and therapeutic use (limited to the list of poisons approved by the Minister). The obtaining, possession, use, sale or supply of Scheduled poisons contrary to the lawful practice of a medical practitioner, dentist, veterinary surgeon or authorised optometrist respectively constitutes a breach or breaches of the Principal Act and the Drugs Poisons and Controlled Substances Regulations, 1995 (the Principal Regulations ) with penalties applying. The introduction of nurse practitioners as authorised persons requires similar regulations to facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of Schedule 2, 3, 4 & 8 poisons. The poisons applicable to each category of nurse practitioner are identified in the lists contained in the proposed regulations. This will result in nurse practitioners being regulated in a similar way to which other authorised persons are regulated. 2
The secondary amendments are proposed to solely update the above mentioned in the principal Regulations. Section 3 Explanation of the proposed regulations The proposed regulations amend the Principal Regulations to ensure that nurse practitioners obtaining, possessing, using, selling and supplying those Schedule 2, 3, 4 and 8 poisons contained within the list relevant to their category of endorsement do so within the confines of their lawful practice as a nurse practitioner. The proposed regulations place the same requirements on authorised nurse practitioners as are placed on other authorised persons (i.e. medical practitioners, pharmacists, veterinary practitioners and dentists) by the Principal Regulations. The amendment of the terms by deleting all reference to Chief General Manager and replacing with Secretary and deleting reference to veterinary surgeon and replacing it with veterinary practitioner will have no impact upon the substance of the Principal Regulations. Section 4 Costs and benefits of the proposed legislation The proposed regulations will give effect to nurse practitioner policy whereby it will allow nurse practitioners to perform their role as intended. The amendments will allow nurse practitioners to treat those conditions they have been specifically trained to diagnose and treat. There are a number of costs involved with the implementation of the regulations. These costs apply to the nurse practitioners, government, patients and medical practitioners. Some costs involve a net cost from implementing the regulations, others involve transfers between groups. The main benefits of these regulations include minimising the risks that therapeutic substances are used for non-therapeutic purposes, illegally diverted, prescribed inappropriately, or Schedule 2, 3, 4 and 8 poisons are consumed unnecessarily. The benefits also include ensuring consistency with the requirements placed on other authorised persons (medical practitioners, pharmacists, veterinary practitioners, dentists and authorised optometrists) so that the system for prescribing drugs by nurse practitioners is clear, transparent, enforceable and easily understood by patients. Section 5 Comparison of costs and benefits There are no onerous cost implications associated with the updating of the abovementioned references. The effect of the proposed regulations will be to improve economic efficiency by providing greater opportunity for suitably trained and experienced nurse practitioners to prescribe and supply Schedule 2, 3, 4 and 8 poisons for the wider treatment of patients. The proposed regulations also provide patients a choice of health practitioners from whom treatment for relevant conditions can be sought. The costs associated with controlling the use and supply of drugs and establishing and complying with a consistent process are minimal. There may be some additional costs to nurse practitioners associated with storing drugs and keeping records, and additional costs to government from monitoring compliance by nurse practitioners and responding to queries from pharmacists (e.g. re prescriptions). These costs, 3
however, are expected to be relatively low and much less than the benefits associated with the regulations. The costs associated with specifying the list of drugs are higher, and involve direct costs to government and the nursing industry. They include costs to the Department relate to compliance monitoring, updated guidelines and preparing the proposed list of Schedule 3, 4 and 8 for the various categories of nurse practitioner including costs associated with convening, and then placing the list before, the Poisons Advisory Committee for their recommendation to the Minister. These costs are significant but not excessively large. The benefits of specifying the list of drugs, however, are quite large, as limiting the list reduces the risk of abuse and the inappropriate use of drugs. On balance the benefits outweigh the costs. Section 6 Assessing the costs and benefits of practical alternatives The proposed regulations are required to facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by nurse practitioners in a similar way to which other authorised persons are covered. Whilst alternatives are considered, the most practical and logical way to implement the required changes and to give effect to the amendments to the provisions of the Nurses (Amendment) Act 2000 and the policy associated with nurse practitioner prescribing is to amend the Drugs, Poisons and Controlled Substances Regulations 1995. Section 7 Net benefits of regulation vs alternatives Amending the current regulations is preferable to the option of making separate regulations specifically for nurse practitioners. The making of separate regulations could increase the potential for inconsistency between the legislation relating to nurse practitioners and to other authorised persons. There are no genuine alternatives to amending the Principal Regulations Section 8 National Competition Policy While there are restrictions on competition contained in the primary legislation and other parts of the regulations these specific regulatory amendments are part of a total package of reform that is procompetitive. It increases the types of health care professionals that are authorised to obtain, use, sell and supply certain drugs. Section 9 Conclusion To facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by nurse practitioners it is necessary to institute appropriate regulations to both prescribe the list of poisons available to each category of nurse practitioner and to define what constitutes lawful practice within their profession. Section 10 Consultation Extensive consultation with key stakeholders was undertaken prior to the amendments to the Nurses Act, 1993 in 2000 that provided for the endorsement of a 4
nurse s registration as a nurse practitioner. The Poisons Advisory Committee - (PAC) has been continually consulted, as required by the Minister, to ensure the processes associated with the endorsement of candidates and the range of drugs, poisons and controlled substances to be approved by the Minister for each category of practice are satisfactory and appropriate. The updating of the aforesaid references will provide for consistency in the description of those references as they appear in other statutory instruments. 5
Summary...2 Section 1. Objective of the proposed regulations...7 Section 2. Nature and Extent of the Problem...8 Section 3. Explanation of proposed regulations... 11 Section 4. Cost and Benefits of the proposed legislation... 17 Section 5. Comparison of costs and benefits... 23 Section 6. Assessing the costs and benefits of practical alternatives... 24 Section 7. Net benefits of regulation vs alternatives... 25 Section 8 National Competition Policy... 26 Section 9 Conclusion... 28 Section 10 Consultation... 29 Appendix 1... 30 Appendix 2... 31 6
Regulatory Impact Statement Drugs, Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 Section 1. Objective of the proposed regulations The objectives of the regulations are to respond to industry trends and changes in the demand for health services by: Enhancing the efficiency with which health resources are used Providing improved career development through training and employment opportunities for Divisions 1, 3 and 4 nurses; and Providing nurse practitioner access to similar privileges to obtain, use, sell or supply S2, 3,4 and 8 poisons applicable to their category of practice on a similar basis to other persons authorized under s13 of the Principal Act. Prescribing lists of Schedule 2, 3, 4 and 8 poisons for particular categories of nurse practitioner are able to obtain, possess, use, sell or supply; and Defining the limits of lawful practice of the profession of nurse practitioner to be similar to that of other persons authorized under S13 of the Drugs, Poisons and Controlled Substances Act 1981 (the Principal Act) by providing for penalties for non-compliance. 7
Section 2. Nature and Extent of the Problem Section 8B of the Nurses Act 1993, which came into effect on 5 December 2000, provides that the Nurses Board of Victoria may endorse the registration of a nurse to that of nurse practitioner. This endorsement will be made when that nurse has satisfactorily completed a course of study and undertaken clinical experience, which, in the opinion of the Board, qualifies the nurse to the level of nurse practitioner. Amendments made to the Principal Act, by the Nurses (Amendment) Act, provided for the inclusion of nurse practitioners in the cohort of persons authorized under section 13 of the Principal Act who are authorized to obtain, possess, use, sell or supply Schedule 2, 3, 4 and 8 poisons. It is not possible to estimate how many nurse practitioners there will be in Victoria. Other Australian states can be used as a guide since November 2000 there have been 35 nurse practitioners authorised in New South Wales, five in South Australia, and in Western Australia. Given these numbers it is not expected that the numbers in Victoria will be high. The Schedules provide the basis for the major legislative control on the level of access and the manner in which drugs and poisons must be supplied. These restrictions impact on both providers and consumers. The restrictions that are based on the Schedule, in which a substance is included, generally specify who may sell or supply, who may have access and the amount and form of goods that can be supplied. The controls imposed by drugs, poisons and controlled substances legislation flows from the Schedule in which a substance is included. The categories of the schedule that is applicable in this instance are those that relate to medicines (Schedule 2, 3, 4 and 8). Scheduling seeks to ensure, amongst other things, that the use of these products is supported by adequate information to enable consumers to use medicines safely and effectively. Currently this information can be provided by: Health professionals, especially medical practitioners the time of consultation and pharmacists at the time of supply; and Written information, including product labeling and consumer medicine information. The amendments to the Principal Act provide for the prescribing of lists of Schedule 2, 3, 4 or 8 poisons different categories of nurse practitioners which, will be able to obtain and have in their possession and to use, sell or supply in the lawful practice of their profession. The proposed regulations contain those lists with other provisions containing the parameters for establishing what will constitute the lawful practice of nurse practitioners with respect to obtaining, possessing, using, selling and supplying those Schedule 2, 3, 4 and 8 poisons identified in the lists against each category. The proposed regulations are therefore required to identify for nurse practitioners, and depending upon their category of practice, those drugs, poisons and controlled substances they will be able to obtain, possess, use, sell or supply (including prescribe) for therapeutic purposes. 8
The lists will also identify for other health professionals, particularly pharmacists who are most likely to supply the poison on presentation of a nurse practitioner s prescription, those poisons the nurse practitioner can utilise in the lawful practice of their profession. Nurses who have not undergone the additional training to become nurse practitioners and whose registration has not been endorsed would only be allowed to possess and administer those Schedule 2, 3, 4 and 8 poisons as currently permitted by the Principal Act and the Principal Regulations. It is commonly accepted that the majority of patients do not have the skills or information necessary to make an independent fully informed choice about the type of medication most suited to their medical condition. In addition, at the time many patients are in need of medication, their illness will often reduce further their ability to make informed choices. Consequently, patients rely heavily on the skills and expertise of health care professionals and will not be able to judge for themselves whether their medication is the most appropriate course of treatment. The cost to patients of inappropriately prescribed medication can be very high. Mistakes can cause an illness to become worse, create other health problems or even cause death. Problems with medications lead to two or three percent of all hospital admissions 1. These admissions are associated with both overuse and under use of medications and many of these problems are preventable 2. The risks to patients, and the subsequent need to manage the process for obtaining, using, selling and supplying drugs, has been recognised for other medical practitioners that are authorised to obtain, use, sell or supply drugs. The controls include provisions that enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, and in the case of optometrists and veterinary practitioners restrict the range of drugs they have access to. An additional problem would emerge if a different process were adopted for nurse practitioners. The system would become less predictable. There would be an increase in the cost of ensuring that health professionals as well as consumers understand a different system, this would involve an extensive education and advertising program In addition to this in the current system the pharmacist provides an additional line of protection and information to patients. Without a consistent approach it could not be guaranteed that the pharmacists would get clear unambiguous information upon which they can fill prescriptions and provide advice to patients. Also, pharmacists could not ensure that the drugs prescribed by nurse practitioners are utilised in the lawful practice of their profession. Finally, without the regulation it would be considerably more difficult to track the supply of drugs and identify any cases of illegal use or supply. 1 Australian Safety and Quality in Health Care. Safety and Quality Council. Second National Report on Patient Safety, Improving Medication Safety. Canberra 2002 2 Roughhead, L & Semple, S. Building a safer system for Australian healthcare: essential role of clinical pharmacy services. Journal of pharmacy practice & research. 9
The secondary amendments are proposed solely to update the aforesaid terms of Chief General Manager and veterinary surgeons as they currently appear in the Principal Regulations. 10
Section 3. Explanation of proposed regulations i) Authorising power and the relevant Act The regulations are made under sections 129, 132 and 132B of the Principal Act. The new regulations update the Principal Regulations. ii) Form and incidence of the proposed regulations The Principal Regulations are more performance oriented than the previous prescriptive and detailed legislation. These regulations are complementary to professional standards, and aim to ensure a consistency of approach by the various professions and others who handle drugs and poisons, together with proper accountability over substances that have a significant potential to cause harm if misused or abused. The proposed regulations amend the Principal Regulations to facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by nurse practitioners in a similar way to which other authorised persons are covered. The proposed regulations will therefore allow a nurse practitioner to obtain, possess, use, sell and supply Schedule 2, 3, 4 and 8 poisons prescribed in the list relating to the particular category of nurse practitioner for the treatment of conditions associated with that category. Nurse practitioners are not allowed to treat conditions that are outside the scope of their endorsed category of practice (expertise). This is consistent with current provisions within the Principal Regulations relating to the obtaining, possessing, using, selling or supplying Schedule 2, 3, 4 and 8 poisons by medical practitioners, dentists, veterinary practitioners and authorised optometrists: a medical practitioner is restricted to the medical treatment of a person under his or her care; a dentist to the dental treatment of a person under his or her care; a veterinary surgeon to the treatment of an animal under his or her care and an optometrist treating patients under their care with those preparations prescribed in the list of poisons approved by the Minister. The proposed regulations will amend the Principal Regulations in the following manner: Regulation 4 of the proposed regulations will amend the Principal inserting a new Part 1A therein establishing the framework for the development of the lists of poisons in Schedules 2, 3, 4 and 8 able to be obtained, possessed, used, sold or supplied by a nurse practitioner. This amendment also provides for the insertion of those lists, in the form of Schedules, within the Principal Regulations. Regulation 5 of the proposed regulations will amend Regulation 5 of the Principal allowing possession by persons who have been legally supplied by a nurse practitioner Schedule 4 and/or 8 poisons from the list of poisons contained within the proposed Schedules to the regulations. Regulation 6 of the proposed regulations will amend the Principal 11
inserting a new Regulation 7A which will have the effect of requiring a nurse practitioner to ensure a therapeutic need prior to administering, prescribing, selling or supplying a drug of dependence or a Schedule 4 or Schedule 8 poison and to establish the identity of a person before prescribing a Schedule 8 poison. This is consistent with the requirements for medical practitioners, dentists, veterinary practitioners (formerly referred to as veterinary surgeons) and authorised optometrists, and aims to ensure that poisons are prescribed in such a way that the person for whom they are prescribed is not harmed, and that the poisons are not prescribed or supplied for abuse or misuse. Regulation 7 of the proposed regulations will amend Regulation 9 of the Principal removing the requirement for a pharmacist to determine a patient s identity and a therapeutic need prior to supplying a drug of dependence when that poison has been prescribed by a nurse practitioner. This is consistent with the requirements for medical practitioners, dentists, veterinary practitioners and authorised optometrists. Regulation 9 of the Principal Regulations refers only to Schedule 4 and 8 poisons. Regulation 8 of the proposed regulations will amend Regulation 11 of the Principal requiring that a nurse practitioner notify the Secretary (formerly referred to as the Chief General Manager) of the Department and the police of any person obtaining drugs by means of false pretence. Medical practitioners, pharmacists, veterinary practitioners and dentists must currently meet this requirement. Regulation 9 of the proposed regulations will amend Regulation 12 of the Principal allowing a pharmacist to sell or supply a Schedule 2, 3, 4 and 8 poison on the written authorisation of a nurse practitioner in addition to the written authorisation of a medical practitioner, veterinary practitioner, dentist or authorised optometrist. Regulation 10 of the proposed regulations will amend Regulation 14 of the Principal providing that a pharmacist may supply a Schedule 4 poison on a prescription written by a nurse practitioner registered in a State or Territory of the Commonwealth other than Victoria, as a person legally permitted to practise as a nurse practitioner and authorised in that State or Territory to prescribe Schedule 4 poisons. This is consistent with current regulations relating to the obtaining, possessing, using, selling or supplying Schedule 4 poisons by medical practitioners, veterinary practitioners and dentists. Regulation 11 of the proposed regulations will amend Regulation 18 of the Principal providing for consistency with current regulations relating to the authorising of administering, supplying or prescribing amphetamine, dexamphetamine, dextromoramide, methadone, methylamphetamine or methylphenidate by medical practitioners. This amendment is being proposed so as to prevent the improper use of these poisons. Under the proposed amendment a nurse practitioner must not administer, supply or prescribe any one or more of those substances where the nurse practitioner is required to hold a permit 12
under section 34 (1) of the Principal Act unless that nurse practitioner has a permit issued by the Department of Human Services authorising that nurse practitioner to administer, supply or prescribe one or more of those substances. Regulation 12 of the proposed regulations will amend Regulation 21 of the Principal providing that a person who in the previous 8 weeks has been treated with a drug of dependence must not, without disclosing that fact at the time, procure or attempt to procure from a nurse practitioner the same or similar drug of dependence or a drug of dependence for the same or similar purpose. This is consistent with current regulations with respect to medical practitioners, veterinary practitioners and dentists. Regulation 13 of the proposed regulations will amend Regulation 22 of the Principal allowing a nurse practitioner to write a prescription for a Schedule 4 and/or 8 poison, but only for the person named on that prescription. A nurse practitioner is only authorised with respect to specified Schedule 4 and 8 poisons prescribed in the list contained within the proposed Schedules. Nurse practitioners will not be allowed to write a prescription for any other Schedule 4 and 8 poisons. Prescriptions written by a nurse practitioner must comply with the same requirements as prescriptions written by a medical practitioner, dentist, veterinary surgeon or authorised optometrists. Regulation 14 of the proposed regulations will amend Regulation 23 of the Principal providing for the style and required particulars a nurse practitioner must comply with when writing prescriptions. This is consistent with current regulations with respect to medical practitioners, veterinary practitioners and dentists. Regulation 15 of the proposed regulations will amend Regulation 24 of the Principal providing for a nurse practitioner to issue oral instructions to a pharmacist to supply a Schedule 4 or 8 poison from those poisons prescribed in the list of poisons relevant to that category of nurse practitioner if in the opinion of the nurse practitioner an emergency exists. The nurse practitioner must, as soon as practicable, write a prescription indicating that it is confirmation of the oral instructions and deliver and forward this prescription to the pharmacist dispensing the poison. This proposed amendment is consistent with regulations relating to medical practitioners, veterinary practitioners and dentists. Regulation 16 of the proposed regulations will amend Regulation 26 of the Principal providing that labels of Schedule 4 and 8 poisons supplied by, or on the prescription of, a nurse practitioner must comply with the same requirements as labels of poisons supplied by, or on the prescription of, a medical practitioner, dentist, veterinary practitioner or authorised optometrist. Regulation 17 of the proposed regulations will amend Regulation 30 of the Principal 13
providing that prescriptions written by a nurse practitioner must be retained for a period of 3 years from the date of last supply by the person who supplies a Schedule 8 poison. This amendment is consistent with regulations relating to medical practitioners, veterinary practitioners and dentists. Regulation 18 of the proposed regulations will amend Regulation 39 of the Principal providing that a nurse practitioner must keep records of all transactions relating to Schedule 4 and 8 poisons. This amendment is consistent with requirements imposed upon other authorized persons. Regulation 19 of the proposed regulations will amend Regulation 46 of the Principal providing that the requirements with respect to the authorisation of administration of a Schedule 4 or 8 poison by a nurse practitioner are consistent with those imposed upon other authorised persons. Regulation 20 of the proposed regulations will amend Regulation 47 of the Principal providing that a person will be able to self-administer a Schedule 4 or 8 poison prescribed by a nurse practitioner. Currently, a patient is allowed to self-administer a poison prescribed only by a medical practitioner, dentist or authorised optometrist. Self-prescribing by a nurse practitioner will also be illegal. This amendment is consistent with restrictions currently placed upon other authorised persons. Regulation 21 of the proposed regulations will amend Regulation 50 of the Principal including nurse practitioners as a person authorised under Regulation 50 to destroy or to witness the destruction of, a Schedule 8 poison. This will then provide consistency with other persons authorised to do the same acts. Regulation 22 of the proposed regulations will amend the Principal inserting a new Regulation 58A into the Principal Regulations which will require that a nurse practitioner must determine that a therapeutic needs exists prior to any Schedule 3 poison being administered, prescribed, sold or supplied to a person. This amendment is consistent with regulations relating to medical practitioners, veterinary practitioners, dentists and pharmacists (Regulations 58, 59, 60 and 61 of the Principal Regulations refer respectively). Regulation 23 of the proposed regulations will amend Regulation 61 of the Principal not requiring that a pharmacist ensure that a therapeutic need exists for a Schedule 3 poison where the supply of that poison has been prescribed by a nurse practitioner. This amendment is consistent with regulations relating to supply by a pharmacist pursuant to a prescription by a medical practitioner, veterinary practitioner or dentist. Regulation 24 of the proposed regulations will amend Regulation 63 of the Principal requiring that where a Schedule 3 poison is sold or supplied by a pharmacist pursuant to a prescription by a nurse practitioner, the pharmacist need not 14
comply with the requirements of sub-regulation 63 (1). This proposed regulation will bring the supply by a pharmacist on a prescription from nurse practitioners into line with other authorised persons. Regulation 25 of the proposed regulations will amend Regulation 66 of the Principal allowing a nurse practitioner, in the course of the lawful practice of his/her profession, to sell or supply a poison or controlled substance in an opened pack. This amendment is consistent with regulations relating to medical practitioners, veterinary practitioners, pharmacists and dentists. Regulation 26 of the proposed regulations will amend Schedule 2 of the Principal providing for amendment of prescribed forms to include nurse practitioners. These forms relate to Notification of Drug Dependent Person (DP1), Treatment with Schedule 8 Poisons (DP2- Part A only) and Permit to Administer, Prescribe or Supply a Schedule 8 Poison (DP3). This amendment is consistent with the requirement placed on medical practitioners. Regulation 27 of the proposed regulations will amend the Principal inserting a new Schedule 3 into the Principal Regulations. This new Schedule will contain the list of Schedule 2, 3, 4 and 8 poisons each category of nurse practitioner is able to obtain, possess, use, sell or supply. An effect of the proposed amendments to the Principal Regulations is that pharmacists will be allowed to dispense prescriptions written by nurse practitioners in addition to prescriptions written by medical practitioners, dentists, veterinary practitioners or authorised optometrists. However, a nurse practitioner may directly supply a Schedule 2, 3, 4 or 8 poison to patients. This is also the case where poisons or controlled substances are supplied directly by medical practitioners, dentists, veterinary practitioners and authorised optometrists. A consequence of nurse practitioners being granted authority to obtain, possess, use, sell and supply Schedule 2, 3, 4 and 8 poisons will be that some patients will not then need to consult a medical practitioner for treatment after having been examined, diagnosed and provided with a Scheduled poison by the nurse practitioner treating them. Patients may save time and money if they do not need to be referred to a medical practitioner for an appointment as some conditions could be diagnosed and treated while the patient is being examined by the nurse practitioner. However, unless nurse practitioners gain Pharmaceutical Benefits Scheme (PBS) prescribing rights their patients would have to pay the full price of drugs prescribed by them. iii) Proposed or existing enforcement regime The Drugs and Poisons Unit, Drugs Policy enforce the Principal Regulations and Services Branch located within the Rural and Regional Health and Aged Care Services Division of the Department of Human Services. Department field officers inspect "authorised persons" (medical practitioners, pharmacists, veterinary practitioners and dentists) and licence and permit holders for compliance with the legislation. The Department also cooperates with professional and industry organisations ensuring compliance. Areas addressed during monitoring of authorised persons and licence and permit holders include security of storage, maintenance of records, procedures 15
involved in administration, prescription, sale and supply, and adequate reconciliation to demonstrate that drugs and poisons are not diverted from their intended purpose. The proposed regulations place the same requirements and penalties on nurse practitioners as are placed on other authorised persons (medical practitioners, pharmacists, veterinary practitioners, dentists and authorised optometrists). Proposed Regulation 7A is the only new regulation to list a specific penalty; this penalty is consistent with penalties in the Principal Regulations for the same offence when committed by other authorised persons (Regulations 7, 8, 8A, 9 and 10 refer). Offences committed against the Regulations by persons authorised under Section 13 of the Principal Act are indictable offences. Penalties for non-compliance range between 50 to 100 penalty units ($5,000 to $10,000). In addition, offences against the Principal Act or Principal Regulations may constitute unprofessional conduct, with offenders being subject to disciplinary action by the professional registration boards. Regulations relating to obtaining, possessing, using, selling or supplying of Schedule 2, 3, 4 and 8 poisons by nurse practitioners will be enforced by the Department in the same manner as the corresponding regulations covering other authorised persons are enforced. It is anticipated that enforcement would be carried out in conjunction with the Nurses Board of Victoria. The amendment of the terms by deleting all reference to Chief General Manager and replacing with Secretary and deleting reference to veterinary surgeon and replacing it with veterinary practitioner will have no impact upon the substance of the Principal Regulations. 16
Section 4. Cost and Benefits of the proposed legislation Benefits of proposed regulations The proposed regulations will give effect to nurse practitioner policy whereby it will allow nurse practitioners to perform their role as intended. The amendments will allow nurse practitioners to treat those conditions they have been specifically trained to diagnose and treat. The regulations will therefore increase the scope of services a nurse practitioner can offer and provide a wider range of treatment options for the public than previously available. In areas of Victoria where access to health services is limited there is an opportunity for patients to have more timely and effective health care, for example in a maternal and child health setting in a rural area of the state the nurse practitioner will see a sick baby and following a thorough assessment diagnoses a chest infection. The nurse practitioner can then prescribe an appropriate antibiotic from their formulary for the treatment of the baby. If the nurse practitioner is unable to prescribe the parent will need to take the child to see the medical practitioner who may be up to an hours drive away and will wait up to two hours to see the medical practitioner. In all areas of Victoria it gives employers increased flexibility in relation to their workforce options. Where nurse practitioners treat conditions themselves, the need for referral to a medical practitioner will be decreased. This will benefit the patient, as the nurse practitioner would have specialised knowledge and experience in a specific area relative to their endorsement. It will save patients the time and expense of a separate medical practitioner's appointment. If the nurse practitioner were unable to prescribe it would be necessary for the patient to go to the doctor as well for a prescription. This involves extra time spent by the patient seeing another health professional. Benefits of controlling the use and supply of drugs A number of the provisions aim to help prevent use of therapeutic substances for non-therapeutic purposes, illegal diversion and to reduce unnecessary consumption of Schedule 2, 3, 4 and 8 poisons. The requirement for a nurse practitioner to "take all reasonable steps to ensure a therapeutic need exists for that poison" is consistent with requirements for other authorised persons. Requirements for locked storage of Schedule 4 and 8 poisons (cupboards, refrigerators and safes) and recording of use and supply to a patient are consistent with the current requirements for Schedule 4 and 8 poisons, and apply to all authorised persons. As with all other authorised persons the nurse practitioner must undertake a thorough assessment of the patient and determine the most appropriate therapeutic management for the patient, this reduces the risk of patients being prescribed unnecessary medication ensuring they are not harmed and that the poisons are not prescribed or supplied for abuse or misuse. Benefits of Consistency The requirements for nurse practitioner prescribing concerning style of prescriptions and labeling are consistent with those of other authorised persons. This ensures that an appropriate quality of service to consumers is maintained. If the process for 17
prescribing by nurse practitioners was different from other authorised persons there would be an increased risk of confusion among patients regarding their medications. The benefits of specifying requirements for prescriptions and labeling are that prescriptions should include all information needed by the pharmacist to supply substances safely and all the labeling instructions/directions for use by patients. The pharmacist should not have to contact the nurse practitioner for this information, while labels should include directions for use to assist the patient in the safe use of the product. A different process for nurse practitioners has the potential to increase dispensing errors, as pharmacists would have to manage two different dispensing processes. Benefits of specifying the list of drugs Nurse practitioners are mandated to have a list of medications related to their category of practice pursuant to the Drugs Poisons and Controlled Substances Act 1981 Section 132 The Governor in Council may make regulations for or with respect to- (g) "prescribing the Schedule 2, 3, 4 or 8 poisons that a nurse practitioner or category of nurse practitioner is authorised to obtain and have in his or her possession and to use, sell or supply." Each nurse practitioner must develop clinical practice guidelines related to their specific category of practice to be endorsed by the Nurses Board of Victoria. These clinical practice guidelines must include the formulary of drugs that the nurse practitioner intends to use for the therapeutic management of patients. The nurse practitioner consults a multidisciplinary team that includes nurses, doctors, allied health professionals and pharmacists who have expertise in the category in which the nurse practitioner is applying for endorsement when developing their guidelines. The guidelines are based upon the best available evidence and as such the medications included in the formulary are the most appropriate treatment option for the specific patient group. This approach ensures that the nurse practitioner can only prescribe drugs within their specific area of practice and does not require them to make decisions about drugs that are outside their scope of practice. It reduces the risk of abuse by limiting the list to include only drugs that nurse practitioners will need to use in the course of their work. Costs of the proposed regulations There are a number of costs involved with the implementation of the regulations. These costs apply to the nurse practitioners, government, patients and medical practitioners. Some costs involve a net cost from implementing the regulations, others involve transfers between groups. Nurse practitioners do not currently have Pharmaceutical Benefits Scheme (PBS) prescribing rights with the result that where a nurse practitioner prescribes a Schedule 4 or 8 poisons the cost of that poison will not be subsidised under the PBS. In some cases, this results in an increased cost to the patient, as they will have to pay full price for medications prescribed by a nurse practitioner. As the table below shows, the price variance between the prescribing of poisons from the list applicable to the various category of nurse practitioner is negligible when the same poisons are prescribed by a medical practitioner. 18
LIST OF POISONS Category of Practice Wound Management Schedule 2 MP NP Schedule 3 MP NP Schedule 4 MP NP Schedule 8 MP NP Codeine $5.95 $5.95 Clotrimazole $4.95 $4.95 Amoxycillin $13.55 $13.55 Morphine $18.70 $18.70 Lignocaine $8.95 $8.95 Codeine $5.95 $5.95 Betamethasone $11.55 $11.55 Oxycodone $18.10 $18.10 Paracetamol $3.00 $3.00 Iron $8.15 $8.15 compounds Miconazole $4.95 $4.95 Cephalexin $13.05 $13.05 Ciprofloxacin $16.90 $16.90 Clavulanic acid $18.05 $18.05 Clindamycin $23.10 $23.10 Dicloxacillin $16.00 $16.00 Doxycycline $12.10 $12.10 Flucloxacillin $16.00 $16.00 Lignocaine $19.20 $19.20 Methylprednisolone $15.05 $15.05 Metronidazole $11.30 $11.30 Mupirocin $20.95 $20.95 Sulfamethizole $13.30 $13.30 Terbinafine $16.95 $16.95 Tramadol $13.65 $13.65 Triamcinolone $17.95 $17.95
Category of Practice Young People s Health Schedule 3 MP NP Schedule 4 MP NP Levonorgestrel $29.90 $29.90 Azithromycin $23.70 $24.95 Salbutamol $10.00 $10.00 Ethinyloestradiol $19.25 $19.25 Hepatitis B Vaccine $24.70 $24.70 Levonorgestrel $19.10 $19.10 Medroxyprogesterone $17.70 $17.70 Salbutamol $23.70 $24.65 Category of Practice Intensive Care Unit Liaison Schedule 3 MP NP Schedule 4 MP NP Adrenaline $14.10 $14.10 Digoxin $13.15 $13.15 Dobutamine $47.95 $47.95 Dopamine $35.75 $35.75 Frusemide $15.30 $15.30 Note/Key:MP Medical Practitioners NP Nurses Practitioners 20
Costs of controlling the use and supply of drugs The provisions applying to nurse practitioners which relate to taking "all reasonable steps to ensure a therapeutic need exists for that poison", storage and records will have some costs. As nurse practitioners are nurses that are currently allowed to administer Schedule 4 and 8 poisons under the direction and authority of a medical practitioner so suitable storage facilities would normally be in place. The requirements relating to storage and records are consistent with current requirements, there may be some additional costs to nurse practitioners, depending on the quantities of drugs stored and used. This cost would be small as it is expected that the nurse practitioner s formularies will not be extensive. Further, nurses are already required to keep records in compliance with Drugs, Poisons and Controlled Substances legislation. So any additional costs of record keeping would also be minor. In other cases, such as the requirement to undertake an assessment of therapeutic need, for example, these activities are already undertaken by the doctor who currently prescribes the medication. Those aspects of the regulations which transfer functions from doctors to nurse practitioners do to not impose any additional costs. The costs of consistency Compliance with the legislation by authorised nurse practitioners will be monitored in the same way as compliance by other authorised persons is monitored. It is anticipated that enforcement would be in conjunction with the Nurses Board. Costs to the Department include costs relating to: monitoring compliance of nurse practitioners, responding to queries from pharmacists (e.g. re prescriptions), and; providing advice on the list of poisons in the making of the regulations. It is difficult to determine the costs of the above as it is unknown how many nurse practitioners there will be in Victoria in the future. Although it is assumed that the costs will not be onerous. The costs of specifying the list of drugs The costs of establishing and subsequently amending the list are mostly time and personnel costs related to the following: developing Clinical Practice Guidelines, including the formulary, this can take up to two years. This process involves the nurse practitioner candidate and a multidisciplinary team, including nurses, doctors, allied health and pharmacists. meeting of the Nurses Board of Victoria, who assess the guidelines and the proposed formulary and approves them. The Nurses Board meets monthly and the Nurse Practitioner Advisory Committee meets every 2 nd month. The process takes between four and six months. As the Nurses Board of Victoria is industry funded there will be no additional direct costs to the consumer. As new medications come on to the market that the nurse practitioner needs to add to his/her formulary, the nurse practitioner will need to apply to have their formulary
amended. This process is currently undertaken by optometrists when they need to amend their formulary and this ordinarily takes no longer than four months. It is expected that this process will occur annually. The cost of this will be similar to the above. It is not possible to quantify these costs. If amendments are to be made the submission would come from the Nurses Board of Victoria as the governing professional body. There are no onerous cost implications associated with the updating of the abovementioned references to the terms Chief General Manager and veterinary surgeon. 22
Section 5. Comparison of costs and benefits The proposed regulations give effect to the legislation which allow nurse practitioners to prescribe certain Schedule 2, 3, 4 and 8 poisons for the treatment of conditions relevant to their endorsed category of practice. The legislation allows suitably trained and experienced nurse practitioners to diagnose and treat conditions directly within the scope of their category of endorsement and will decrease the need for nurse practitioners to refer patients to a medical practitioner for treatment of these conditions. The effect of the proposed regulations will be to improve economic efficiency by providing greater opportunity for suitably trained and experienced nurse practitioners to prescribe and supply Schedule 2, 3, 4 and 8 poisons for the wider treatment of patients. The proposed regulations also provide patients a choice of health practitioners from whom treatment for relevant conditions can be sought. The costs associated with controlling the use and supply of drugs and establishing and complying with a consistent process are minimal. There may be some additional costs to nurse practitioners associated with storing drugs and keeping records, and additional costs to government from monitoring compliance by nurse practitioners and responding to queries from pharmacists (e.g. re prescriptions). These costs, however, are expected to be relatively low and much less than the benefits associated with the regulations. The main benefits of these regulations include minimising the risks that therapeutic substances are used for non-therapeutic purposes, illegally diverted, prescribed inappropriately, or Schedule 2, 3, 4 and 8 poisons are consumed unnecessarily. The benefits also include ensuring consistency with the requirements placed on other authorised persons (medical practitioners, pharmacists, veterinary practitioners, dentists and authorised optometrists) so that the system for prescribing drugs by nurse practitioners is clear, transparent, enforceable and easily understood by patients. The costs associated with specifying the list of drugs are higher, and involve direct costs to government and the nursing industry. They include costs to the Department relate to compliance monitoring, updated guidelines and preparing the proposed list of Schedule 3, 4 and 8 for the various categories of nurse practitioner including costs associated with convening, and then placing the list before, the Poisons Advisory Committee for their recommendation to the Minister. These costs are significant but not excessively large. The benefits of specifying the list of drugs, however, are quite large. Listing ensures that the nurse practitioner can only prescribe drugs within their specific area of practice and does not require them to make decisions about drugs that are outside their scope of practice. It reduces the risk of abuse by limiting the list to include only drugs that nurse practitioners will need to use in the course of their work. On balance these benefits outweigh the costs. 23
Section 6. Assessing the costs and benefits of practical alternatives There are no viable alternatives to the implementation of the proposed regulations to give effect to the policy underpinning nurse practitioner endorsement. The following range of common options are not viable alternatives in that: i) if nothing is done it would remain illegal for a patient to possess a Schedule 2, 3, 4 and 8 poison supplied by a nurse practitioner, illegal for a pharmacist to sell or supply a Schedule 4 or Schedule 8 poison on the authorisation of a nurse practitioner, illegal for a nurse practitioner to write a prescription for a Schedule 4 or 8 poison, and there would be no requirements for nurse practitioners relating to prescriptions, labelling, etc.; all would be inconsistent with current burdens placed upon other authorised persons. ii) iii) iv) if separate regulations under the Nurses Act, 1993 were to be implemented rather than incorporate the regulations into the Drugs, Poisons and Controlled Substances Regulations 1995, it would be difficult to keep regulations covering nurse practitioners consistent with the regulations for other authorised persons (e.g. with respect to storage, records, prescription formats, labelling, enforcement, penalties). In the interests of consistency with the current regulations applying to other health professionals for the same functions, it is logical and efficient to extend the coverage of the existing regulations. if self regulation by the Nurses Board, or by the nurse practitioners themselves were allowed nurse practitioner professional bodies to formulate their own standards of practice relating to use and dispensing of Schedule 4 or 8 poisons, education requirements and lists of drugs could lead to inconsistent requirements for different professions with the potential for confusion among consumers. It is important that the standards expected of all health professionals with respect to prescribing, supply and administration of poisons are consistent so as to ensure that members of the community are not put at risk by gaining unauthorised access to potentially harmful substances. This option would still require some changes to the current Drugs, Poisons and Controlled Substances Regulations 1995, otherwise it would be illegal for a patient to possess a Schedule 4 or 8 poison supplied by a nurse practitioner, for a pharmacist to sell or supply a Schedule 4 or 8 poison on the authorisation of a nurse practitioner and for a nurse practitioner to write a prescription or supply for a Schedule 4 or 8 poison. If there was no limit to the list of medications from which nurse practitioners could prescribe there is a risk that they would be prescribing from outside their area of clinical expertise. This increases the risk to patients in that they might not be prescribed the most appropriate medications, this could result in other health problems, a worsening of their current condition and a need for hospitalisation. Alternatively if the list from which the nurse practitioner was severely restricted then the patients will not be prescribed the most effective medications. Hence to put into effect the underpinning policy with respect to nurse practitioners, then the proposed regulations present the only viable and defensible means. 24
Section 7. Net benefits of regulation vs alternatives The proposed regulations are necessary to give effect to the Nurses (Amendment) Act 2000 and the amendments to the Drugs, Poisons and Controlled Substances Act 1981 which provide for nurse practitioners whose registration is endorsed to obtain and possess, use, sell or supply those Schedule 2, 3, 4 and 8 poisons prescribed in the list of poisons relevant to that category of nurse practitioner practice. Under the current Drugs, Poisons and Controlled Substances Regulations 1995 it is illegal for a patient to possess a Schedule 4 or 8 poison supplied by a nurse practitioner, for a nurse practitioner to write a prescription for a Schedule 4 or 8 poison, or for a pharmacist to dispense a prescription written by a nurse practitioner for a Schedule 4 or 8 poison. The proposed regulations amend the Drugs, Poisons and Controlled Substances Regulations 1995 to allow nurse practitioners to possess, use, sell and supply certain Schedule 2, 3, 4 and 8 poisons for conditions they have been trained to diagnose and treat while preventing use or prescription of substances for which they are not trained. Nurses who have not undergone additional training remain able to possess and use Schedule 2, 3, 4 and 8 poisons either under the supervision of a registered medical practitioner or dentist (for authorised optometrists those Schedule 4 poisons approved by the Minister). The legislation is consistent with legislative requirements for other authorised persons (medical practitioners, pharmacists, veterinary practitioners and dentists and authorised optometrists). Amending the current regulations is preferable to the option of making separate regulations specifically for nurse practitioners. The making of separate regulations could increase the potential for inconsistency between the legislation relating to nurse practitioners and to other authorised persons. Self-regulation increases the likelihood of inconsistent requirements for nurse practitioners compared with those for other authorised persons resulting in the potential for the creating of a precedent for deregulation of other professional and industry groups and further inconsistencies. Legislative change would be required to allow self-regulation. Not limiting the list of medications from which nurse practitioners gives rise to the potential problem of nurse practitioners prescribing from outside their area of expertise. This may increase the risk of patients receiving medications that are not the most appropriate to treat their illness 25
Section 8 National Competition Policy The current drugs, poisons and controlled substances legislation imposes considerable barriers to competition both in terms of who can participate in the market (market access) and also in the manner in which they can participate (business conduct). Market Access The market access controls limit who can participate in the market by: Restricting consumer access to certain substances (i.e. the need to obtain a prescription from an authorized prescriber). Placing barriers on access to the market, (i.e. only those who hold specified qualifications). The current legislation prevents anyone, other than a pharmacist, doctor, veterinarian or a licensed poison seller, from entering the market. By reducing competition from others, these restrictions can be expected to add to costs. These costs are likely to be passed onto the consumer by increasing costs of obtaining the product (i.e. through the need to attend a pharmacy and/or doctor) and to government costs where health practitioners visits are subsidized. They also limit consumer access, making it more difficult and more costly (in time, convenience and money) for consumers to obtain products containing scheduled substances. Business Conduct Drugs poisons and controlled substances legislation also imposes a number of controls on the business conduct of those who enter the market. As described above, these controls cover such matters as advertising, labeling and packaging as well as manufacturing, storing and handling products. For some substances there are also requirements for recording and reporting. These restrictions are a significant impediment to competition. While there are restrictions on competition contained in the primary legislation and other parts of the regulations these specific regulatory amendments are part of a total package of reform that is procompetitive. It increases the types of health care professionals that are authorised to obtain, use, sell and supply certain drugs. The specific regulatory amendments are targeted primarily at two issues. 1. ensuring consistency in approach in regulating the sale, supply, prescribing, administration, dispensing and use of drugs by nurse practitioners; and 2. specifying the drugs that specific categories of nurse practitioners are authorised to obtain and have in their possession and to use, sell or supply. The first of these issues does not involve any significant restrictions on competition. These amendments simply require nurse practitioners to follow the same processes as all other authorised health care professionals. 26
The second issue, however, does potentially involve a restriction on competition. Schedule 3 constrains the range of drugs nurse practitioners can prescribe. This potentially reduces the scope for nurse practitioners to compete with medical practitioners. As previously noted this restriction is in the public interest to ensure patient and community safety. The discussion on alternatives approaches also demonstrates that the objectives of this policy cannot be achieved without restricting competition. 27
Section 9 Conclusion To facilitate and enhance the orderly sale, supply, prescribing, administration, dispensing and use of drugs, poisons and controlled substances by nurse practitioners it is necessary to institute appropriate regulations to both prescribe the list of poisons available to each category of nurse practitioner and to define what constitutes lawful practice within their profession. The most practical and logical way to implement the required change and to give effect to the amendments to the provisions of the Nurses (Amendment) Act 2000 and the policy associated with nurse practitioner prescribing is to amend the Drugs, Poisons and Controlled Substances Regulations 1995. The consequence of amending these regulations will result in consistency in approach to monitoring health professionals such as medical practitioners, dentists, veterinary practitioners and authorised optometrists in respect to obtaining, possessing, using, selling and supplying of scheduled poisons. The updating of the above mentioned references will provide for consistency in the description of those references as they appear in other statutory instruments. 28
Section 10 Consultation Extensive consultation with key stakeholders was undertaken prior to the amendments to the Nurses (Amendment) Act, 2000, which provided for the endorsement of a nurse s registration as a nurse practitioner. The list of stakeholders consulted is detailed in `Appendix 2. The Poisons Advisory Committee - (PAC) has been continually consulted, as required by the Minister, to ensure the processes associated with the endorsement of candidates and that the range of poisons to be approved by the Minister for each category of practice, are satisfactory and appropriate. 29
Appendix 1 Drugs Poisons and Controlled Substances (Nurse Practitioner and Miscellaneous Amendments) Regulations 2004 Please see attachment 1 30
Appendix 2 STAKEHOLDERS CONSULTED Community organisations contacted for focus group discussion conducted July 1999: Health centres Koorie Unit, Department of Human Services Victorian Aboriginal Community Health Organisation Country Women s Association ORANA Family Services Maternity Coalition Carer s Association Australian Greek Welfare CO-AS-IT, Italian Welfare Organisation Foundation for Spanish-speaking Older People Inc. Inner South Community Health Services Darebin Community Health Services Moreland Community Health Services Broadmeadows Community Health Douta Galla Community Health Victorian Mental Illness Awareness group Progress Association, Northcote and Broadmeadows Australian Complementary Health Association Carer s Links North Association for Children with a Disability Nurse Practitioner Implementation Steering Committee, established in 2000, consulted with: Nurses Board Victoria Australian Nursing Federation Health and Community Sector Union Deans of Nursing Royal College of Nursing Australia Royal Australia College of General Practitioners Australian Medical Association Pharmacy Board of Victoria Victorian Hospitals Association Consultation forums held throughout Victoria in October 2000 with over 200 people attending. Participants included: nurses, allied health professionals, radiologists, medical practitioners, pharmacists; and, other interested parties. 31