ISSUES FOR CONSIDERATION IN REVIEW OF THE DRUGS POISONS AND CONTROLLED SUBSTANCES ACT 1996

Transcription

1 ISSUES FOR CONSIDERATION IN REVIEW OF THE DRUGS POISONS AND CONTROLLED SUBSTANCES ACT 1996 ADAVB Inc. SUBMISSION TO DEPARTMENT OF HUMAN SERVICES

2 ADAVB SUBMISSION TO DEPARTMENT OF HUMAN SERVICES ISSUES FOR CONSIDERATION IN REVIEW OF THE DRUGS POISONS AND CONTROLLED SUBSTANCES ACT INTRODUCTION As the professional association representing over 90% of Victoria s dentists, the Australian Dental Association Victorian Branch Inc. (ADAVB) is pleased to respond to the invitation from the Drugs and Poisons Unit, to offer comments on the review of the Drugs Poisons and Controlled Substances Act and Regulations. 2. SUMMARY OF RECOMMENDATIONS That the Drugs Poisons and Controlled Substances Regulations be amended as per the Medical Practice Board of Victoria s Guideline to prohibit the dispensing of medications for profit by registered health care providers other than pharmacists. That the Drugs Poisons and Controlled Substances Regulations be amended to extend the same guidance offered to medical practitioners under the MPBV s Guideline regarding such alternative therapies as herbal medicine, to all registered health care providers. That the Drugs Poisons and Controlled Substances Act and Regulations be amended to recognise that under a Dental Practice Board of Victoria Code of Practice, dental therapists and dental hygienists can administer local anaesthetic under the supervision of a dentist That the Drugs Poisons and Controlled Substances Regulations be amended to exempt dental local anaesthetic from secure storage requirements Page 1

3 3. KEY ISSUES 3.1 Prescribing and dispensing by registered persons To our knowledge, there are no policies or guidelines issued by the Dental Practice Board of Victoria dealing with prescribing and dispensing by dentists, though the ADAVB is encouraging the Board to do so. However the Medical Practitioners Board of Victoria has consulted with the Pharmacy Board, and issued the following Guideline that effectively prohibits the dispensing of drugs for profit. Supply of Medicines by Medical Practitioners The Board does not approve the routine stocking and dispensing of medicines and therapeutic goods for profit.* This policy is based upon the following considerations: The differentiation of responsibilities between pharmacists and medical practitioners who work collaboratively in the best interests of patients has evolved for very good reasons and should be maintained. The division between prescribing and dispensing responsibilities provides essential checks and balances to safeguard patients. The role of the pharmacists in this process of monitoring medications is recognised in laws and regulations regarding recordkeeping, labeling and dispensing. Adherence to the standards demanded by these regulations is closely monitored by inspectors of the Pharmacy Board. An additional benefit of the separation of responsibility for prescribing and dispensing is to reduce the risk that product sponsors might use incentives to directly enhance the use of their products. A further practical consideration is that doctors who dispense are likely to deny their patients access to the Pharmaceutical Benefits Scheme (as for example, through the maintenance of adequate records to monitor the safety net provisions). It is currently legal for medical practitioners to dispense medications in Victoria, subject to the same laws and regulations covering pharmacists (the Pharmacists Act 1974 and the Drugs, Poisons and Controlled Substances Act 1981). The dispensing of medications by doctors (other than in certain situations described below) is not subject to similar routine inspection and it is therefore not possible for either the Medical Practitioners Board of Victoria or the Pharmacy Board to ensure that the community is adequately safeguarded. For these reasons, the Medical Practitioners Board of Victoria advises that the practice of routinely dispensing medications or other therapeutic goods for profit is regarded as being professional conduct which is of a lesser standard than that which might reasonably be expected of a medical practitioner by his or her peers, and is likely to lead to the Board laying charges of unprofessional conduct. *This statement has been endorsed by the Pharmacy Board of Victoria. Page 2

4 This advice does not apply to: (a) the use of doctors emergency bag medications, (b) the provision of medications in unusual clinical situations, in remote areas or after hours i.e. whenever access to a pharmacy is likely to be difficult, and (c) the use of sample or starter packs of medications. Exceptions to the general prohibition on dispensing will usually be readily identified by medical practitioners, as they will be clearly in the best interests of patients and as the medications will not be provided for profit. In dispensing medications in such situations, medical practitioners are reminded that legal requirements for record keeping, labeling and dispensing must be met and that good medical practice always demands adequate counseling as to the use of these drugs, their side effects and potential interactions. As the professional expertise of the pharmacist is not available to the patient in these situations, the obligation on the medical practitioner to meet these legal and professional duties is increased. Source: Guide for Medical Practitioners, MPBV 1999, pp Some dentists report that they find their patients are more likely to comply with their prescriptions for pain relief and/or anti-biotic cover where they both prescribe and dispense as part of the treatment process. Experience indicates that scripts remain unfilled when the dentist merely prescribes and leaves the patient to attend a pharmacy at a later time. The most frequent circumstance where a dentist might provide schedule medicaments under Regulation 66 is in the use of strong pain relief medication after surgery; say an extraction. This is not necessarily dispensing for profit, as it will usually entail the dentist opening a package and providing medication for the patient to take during or immediately after the appointment. Further medication as required is often then given to the patient to take home and use as directed. The cost of this action is embedded in the fee for the surgery. RECOMMENDATION That the Drugs Poisons and Controlled Substances Regulations be amended as per the MPBV s Guideline to prohibit the dispensing of medications for profit by registered health care providers other than pharmacists. Page 3

5 3.2 Provision of herbal remedies by registered persons The ADAVB is aware that there are a number of dentists who offer holistic dentistry, homeopathic dentistry and other alternative therapies, and suggests that certain of these practitioners may require guidance with regard to potential risks to patient health and safety arising from provision of herbal remedies which could cause an adverse reaction when mixed with prescription medications being taken by the patient. The scenario which has been put to us, is that a registered dentist might for example undertake to remove and replace a patient s amalgam fillings with composite resin fillings, then proceed to offer them a shiatsu massage to cleanse their internal organs from the toxins they allege have been accumulating in the body, and as the patient prepares to leave, they might also then be offered various herbal remedies to further assist the cleansing of internal organs. The herbs involved may be harmless when taken by a generally healthy patient who is not taking any other medications, but contraindicated when certain patients are involved and they are on particular prescription drugs. The medical history taken by the dentist should reveal any medications being taken, but as the practise of herbal medicine in not a registered practice, and the dental treatment concluded at the point the composite fillings were completed, would the dentist be held liable for a professional misconduct in the event of an adverse reaction to the combination of herbs and scheduled drugs? The DPBV is only responsible for regulating the practice of dentistry, not the practice of herbal medicine. They have no guidelines or policies on this matter as yet, although they have been encouraged by the ADAVB to consider the development of an equivalent guideline to that offered by the Medical Practitioners Board of Victoria, which reads: Alternative or Complementary Medicines Doctors who practice or recommend alternative or complementary medicine have additional ethical responsibilities which include: Special care must be taken to inform patients when therapy is unproven and to fully inform patients of any risks associated with such therapy. Patients who are offered alternative remedies must not be denied access to standard proven therapies of a type which would be provided by medical peers. When alternative therapies pose risks of serious side effects, the patient should be advised to seek a second independent medical opinion. Doctors must not gain financial advantage by selling alternative therapeutic substances directly to patients. Source: Guide for Medical Practitioners, MPBV 1999, p.39 As the guidance offered by the Medical Practice Board would reasonably apply to all health practitioners recognised under the Drugs Poisons and Controlled Substances Act, we suggest that the regulations be amended to incorporate this guidance. Page 4

6 RECOMMENDATION That the Drugs Poisons and Controlled Substances Regulations be amended to extend the same guidance offered to medical practitioners under the MPBV s Guideline regarding such alternative therapies as herbal medicine, to all registered health care providers. 3.3 Inconsistency of Regulations and Code of Practice The DPBV s Code of Practice 002 Practice of Dentistry by Dental Hygienists and Dental Therapists, which became effective on 1 August 2002, appears to be inconsistent with requirements under the Drugs and Poisons Act and Regulations. The relevant sections read as follows: Part 1 This Code requires a team approach in the delivery of dental services, with a registered practising dentist or dentists adopting the role of clinical team leader(s) with overall responsibility for patient care. The dental therapist and dental hygienist work with the dentist(s) in a consultative and referral relationship to provide any or all of the following: preventive, periodontal, restorative and orthodontic dental services. A dental auxiliary may not engage in independent practice. Part 3 Dental hygienists and dental therapists may perform only those tasks for which they have been formally educated (in courses approved by the Board) within the following areas: Page 5 DENTAL THERAPISTS AND DENTAL HYGIENISTS - Oral examination including intra-oral radiography - Extra-oral dental radiography on the prescription of a dentist - Impression taking (for other than prosthodontic or prosthetic treatment) - Local anaesthesia for dental procedures - Application of therapeutic solutions to teeth, but not including insurgery bleaching of teeth - Orthodontic procedures under the supervision of a dentist, except for o Diagnosis and treatment planning for orthodontic treatment o Initial fixation of bands and brackets o Design of orthodontic appliances o Activation and adjustment of orthodontic appliances Source: DPBV Code of Practice for the practice of dentistry by dental hygienists and dental therapists,

7 In the DPBV Bulletin dated February 2003, an example was provided of a written agreement for a dental hygienist acceptable to the Board under its Code of Practice, and the following extract is relevant. There is no mention of either dental therapists or dental hygienists in the Drugs and Poisons Regulations, and so we would support their inclusion alongside dentists, not for prescribing rights and so on, but so that they are able to effectively and efficiently provide local anaesthetic to a patient without requiring a dentist to interrupt their treatment of another patient to strictly comply with the wording as currently framed. This is impractical and unnecessary, as many of these auxiliaries are effectively trained to administer local anaesthetic for dental treatment, and it is a helpful adjunct to their treatment relationship with patients, which remains subject to the dentist as clinical team leader having overall responsibility for patient care. Those who have not completed the required training would be required to do so before administering inferior dental blocks. Similar arrangements are provided for under equivalent draft Regulations and Codes proposed in Queensland and NSW (Refer extracts attached). RECOMMENDATION That the Drugs Poisons and Controlled Substances Act and Regulations be amended to recognise that under a Dental Practice Board of Victoria Code of Practice, dental therapists and dental hygienists can administer local anaesthetic under the supervision of a dentist 3.4 Locking away Dental Local Anaesthetic It is currently a requirement that a dentist lock local anaesthetics away in a secure storage facility when not actually using these substances. The ADAVB understands that medications that could be stolen for illegal drug manufacture or consumption are a risk that needs to be managed by requirements in the regulations. However there has never been any report of a person seeking to steal and make use of local anaesthetic in this way. Further, the unique cartridge packaging of dental local anaesthetic makes this highly unlikely. Page 6

8 It is an overly regulatory approach that allows a registered dentist to be unfairly prosecuted for a breach of the Act or Regulations for failing to lock away local anaesthetic. RECOMMENDATION That the Drugs Poisons and Controlled Substances Regulations be amended to exempt dental local anaesthetic from secure storage requirements Page 7

9 EXTRACT DENTAL BOARD OF QUEENSLAND DRAFT CODE OF PRACTICE Practice of Dentistry by Dental Hygienists and Dental Therapists General Functions The general functions of a Dental Therapist shall be: (i) dental examination and charting; (ii) dental radiography for usual dental examination; (iii) cleaning and polishing of teeth and restorations; (iv) removal of plaque and dental calculus; (v) topical application to the teeth of preventive agents; (vi) application and removal of rubber dam; (vii) administration of infiltration and inferior dental nerve block analgesia; (viii) preparation of cavities in deciduous and permanent teeth but excluding preparations involving pins and inlays; (ix) restoration of deciduous and permanent teeth with amalgam, cement or plastic materials; (x) emergency treatment of pulp exposures in permanent teeth; (xi) pulp therapy in vital deciduous teeth; (xii) forceps extraction of deciduous teeth under local analgesia; (xiii) emergency control of haemorrhage; (xiv) application of fissure sealants. Unless, the Board has made a determination otherwise under section 139A(2)(d)(ii) of the Act, a Dental Therapist may perform these functions only in the treatment of children 4 years of age or older who have not completed year 10 at school. The general functions of a Dental Hygienist shall be: (i) dental radiography for usual dental examination; (ii) application and removal of rubber dam; (iii) irrigation of the mouth and removal of sutures; (iv) topical application of solutions prescribed by a supervising registrant; (v) removal of dental cement; (vi) debridement to remove deposits from teeth; (vii) cleaning and polishing of teeth and restorations; (viii) removal of periodontal packs; (ix) band sizing; (x) placement and removal of archwire fixation; (xi) removal of archwires, bands and attachments; (xii) administration of infiltration and inferior dental nerve block analgesia; (xiii) application of fissure sealants; (xiv) measuring and recording signs of periodontal disease. A Dental Auxiliary Registrant shall not practise any of the functions of an auxiliary that are excluded by conditions on their registration imposed under section 133F of the Act. Page 8

10 EXTRACT Draft Dental Practice Regulation 2003 (NSW) under the Dental Practice Act Dental therapist activities section 19 For the purposes of section 19 (3) of the Act, the following activities, to the extent that the activities constitute restricted dental practices and involve dental treatment of preschool and school children, are prescribed for dental therapists as authorised activities: (a) dental examination, (b) the cleaning and polishing of teeth and restorations, (c) the topical application to teeth of sealants, medicaments and preventive coatings, (d) the removal of dental calculus not involving surgical techniques requiring incisions, (e) the application of topical anaesthetics, (f) the giving of supraperiosteal or mandibular nerve block injections of local anaesthetics not involving, in either case, any other regional, intra-osseous or intra-ligamental anaesthesia, (g) the extraction of deciduous or permanent teeth not involving either surgical techniques or incisions, (h) the pulp capping of deciduous or permanent teeth and the pulpotomy of deciduous teeth, (i) the restoration of deciduous or permanent teeth by the use of materials other than cast metals, gold foil or porcelain, (j) intra-oral radiography, (k) the taking of impressions, at the written request of a dentist, for use in study models, mouthguards and removable orthodontic appliances. Page 9

11 INFORMATION SUMMARY 2003/04 PURPOSES The objectives of the ADAVB are to promote the: improvement of the dental health of the public; art and science of dentistry; and highest standards of professional dental care MEMBERSHIP Approximately 2250 Dentists in private and public practice, and 4 th & 5 th year students 95% of registered private practitioners 10 suburban and 7 country groups MEMBER SERVICES & FUNCTIONS Continuing Education (including Professional Development Program) Dental health education programs (eg. Dental Awareness Month) Community Relations dispute resolution Code of Ethics (Conduct) Recent Graduate support Dental Assistant Training update seminars Member Service Plans (eg Professional Insurances; preferred suppliers) Industrial relations advice and representation Defence and legal support Advice on Practice Management Quality Assurance (including Doctors Health Advisory Service) Benevolent Fund Library and resource collection Political representation Representation to Government bodies Superannuation (Professional Provident Fund) Sports and social functions Publications Newsletter, Journal, Award details, Manuals etc. Home Page (find us at INFORMATION & DISPUTE RESOLUTION SERVICES The Branch provides information to the public on dental matters, and offers a conciliation service to assist patients to resolve disputes with member dentists. Information on treatments, facilities, dental issues and careers is available. PRESIDENT Dr Vlad Hardi Phone: CHIEF EXECUTIVE OFFICER Mr Garry Pearson MEdSt, HDT (SAC) AFAIM, MAICD Phone: AUSTRALIAN DENTAL ASSOCIATION VICTORIAN BRANCH INC. ABN Reg d Assoc. No.A E 49 MATHOURA ROAD (P.O.BOX 434) TOORAK 3142 TEL: (03) FAX: (03) adavbinfo@adavb.com.au