AHP prescribing in the UK and Australasia
Whilst formal prescribing by non-medically qualified allied health professionals is a new and fairly limited phenomenon in both the UK and Australasia, several of the smaller professions, most notably podiatrists and optometrists, have been accustomed to exercising legal rights to access, supply, administer and sell a restricted range of medicines over several decades [
28‐
38]. In other cases, such as physiotherapy and radiography, legal rights to the supply or administration of restricted category medicines have either been available only since 2005 (in the UK), or, in the case of Australian physiotherapy, not yet recognised [
39,
40]. Where rights do exist, the mode of use is often different, ranging from specialist practitioners working in fields such as musculo-skeletal care (in the case of physiotherapy) to more general use, as in the case of podiatry [
28,
41].
From a socio-historical viewpoint, since the 1960s, the emergence of supply and administration rights to certain restricted medicines, in the wake of changing legislation, might well be viewed as part of the broader 'professional project' of podiatrists, optometrists and others, and central to their desire to confirm professional autonomy and independence in practice [
33,
42]. Podiatry and optometry have, in the past, been distinguished from other allied health professions on the grounds of their independence from hospital practice, and thus relative freedom from immediate supervision by the medical profession [
14].
Radiography and physiotherapy, conversely, emerged more clearly as hospital employees working in direct support of the medical profession, on a daily basis [
14]. It is also clear that not all allied health professions are likely to become active prescribers, or aim to secure legal exemptions allowing limited access to medicines, possibly such as arts therapists.
In order to adequately understand the effect of managerialist health policy reforms on the transition in podiatric role boundaries, it is necessary to trace the chronological context of change. As a result, the context of podiatric prescribing must take into account the broader privileges associated with the legal right to access, administer, sell and supply specified medicines that are otherwise restricted (that is, those that fall within in the 'prescription only' and 'pharmacy only' categories of medicine in the UK and New Zealand, and those within the Schedule 3,4 and 8 categories in Australia), as well as the actual 'prescribing' mechanisms involved in 'supplementary' and 'independent' versions [
43], or the recent freedom granted in Victoria (Australia) to podiatrists under the Health Professions Registration Act of 2005.
In the UK, prior to the advent of supplementary prescribing or patient group directions podiatrists had 'accessed', 'supplied/sold' and 'administered' restricted category medicines through authority granted by statutory instruments. A statutory instrument is a form of 'delegated' legislation, allowing exemptions to be made to the provisions of established 'primary' legislation (in this case the Medicines Act of 1968), without the need to repeal the entire Act [
44]. Similarly, in Australia amendments to State or Territory legislation, such as the Health (Drugs & Poisons) Regulation 1996 (Queensland), grants the profession specific rights under the authorisation of the Health Minister.
Podiatry in the UK and Australasia
In both Australasia and the UK regulatory and legislative change has been gradual, but, as an AHP, podiatry is acknowledged as fully involved in the administration, access, supply, and prescription of prescription only and pharmacy medicines. Indeed, key shifts in the role and task domains within podiatry have evolved considerably over the years, and have been directly related to access to medicines.
In Britain, the immediate impact on podiatry of the Medicines Act (1968) was to undermine normative practices, such as drug preparation, and bar access to local anaesthetics [
28]. The potential consequences raised considerable anxiety across the profession [
34]. Prolonged and difficult lobbying, extending over a four year period, finally led to approval from the regulatory authority for the use of local 'analgesic' techniques, but still did not enable legislative access to the medicines [
28]. Access was not fully obtained until 1980, following an even longer period of lobbying [
74]. Protracted negotiations involving proposals and counter proposals were marked by arguments over dosages and concentrations of solutions, before agreement was finally reached [
28].
Acquisition of rights to local anaesthesia opened the door to the ongoing development of podiatric surgery, which would clearly have had difficulty continuing without access rights [
34]. Administration techniques were also rapidly expanded, from simple toe anaesthesia techniques, to full foot ankle block techniques, enabling more complex procedures to be undertaken. Indeed, most podiatric surgical procedures continue to employ local anaesthesia methods [
75].
The Thatcher Government, and the John Major administration that followed, signalled a major shift in healthcare policy, drawing on neo-liberal principles in introducing deregulation and competitive tendering for contracts in healthcare provision - a climate that engendered the prospect of further change in the medicines legislation [
47,
52]. The Society of Chiropodists canvassed its membership and collated evidence on the extent and scope of medicines usage, in a bid to construct a new, evidence-based, submission. The evidence, drawn from referral patterns, pointed to a need for access rights to certain oral antibiotic agents, notably erythromycin and flucloxacillin as well as a defined and limited range of other prescription only and pharmacy medicines [
76]. Even the regulatory body acknowledged the request as legitimate, based as it was on evidence drawn from the membership, noting that the referral patterns for those prescription only medicines sought (especially antibiotics) were 'regular'. An enhanced role for podiatrists in the field of medicines, as well as surgery, was further acknowledged by the Department of Health, in a joint NHS Chiropody Task Force publication of 1994 [
77]. Considerable emphasis was placed on the logic used to justify the proposed extensions, focusing on easing the patient pathway and reducing GP workload by preventing duplication of effort. In doing so, the submission adhered to the principles of the wider policy agenda, promoting a smooth, collaborative, inter-professional approach to patient care [
28]. In spite of the evidence and logic, the resulting exemption order reflected only limited success. Whilst access to several more prescription only and pharmacy medicines was granted, others, such as the antibiotics on the list, were denied [
78,
79].
The formalisation of patient group directions (which had been operating previously as group protocols) added another tier to the options available to podiatrists to access restricted category medicines. Podiatric surgeons probably benefited more than most in adopting this mechanism within the National Health Service, using it to gain access to a wide range of prescription only medicines beyond the scope of the existing exemptions, and thus further facilitating extensive foot surgical procedures. In addition, it continued to appeal to the modernisation agenda, establishing role flexibility and thus enabling greater access to medicines by patients [
80]. Podiatrists specialising in diabetes care or rheumatology were also increasingly able to access these mechanisms in order to ease patient throughput in complex multi-professional hospital clinics, reducing demand on hard pressed physicians and allowing the development of new skills, such as intra-articular injections. Patient group directions, were, however, locally devised and agreed, and were thus only possible to enact with the co-operation of those physicians willing to engage with the process, leading to disparities across the country. AHP prescribing was further acknowledged by the introduction of enabling legislation in the form of the Health and Social Care Act (2001), acting as primary legislation, and thus superceding key sections of the Medicines Act (1968) [
81].
Many physicians were highly supportive of expanding the role boundaries of allied health workers, including podiatrists, most notably within the diabetes fraternity. Some even suggested a role for podiatrists in the treatment and management of hypertension and insulin dose alteration [
82]. However, universal support is lacking, and the use of patient group directions is widely viewed as a measure likely to be replaced by a more robust system in due course, such as independent prescribing. In some measure this more robust process has already been established as 'supplementary prescribing', extended to physiotherapists, radiographers and podiatrists in April 2005 [
83]. However, it has received mixed responses from within the profession, being effective in multi-professional environments, but less effective in independent practice, especially in podiatric surgery, possibly accounting for the limited uptake [
84]. Indeed, by 2008 only 64 podiatrists had become supplementary prescribers [
85]. It is, in part, possible to account for this finding, as opportunities to undertake training in supplementary prescribing are 'rationed' by employers, who are required to fund places and provide mentorship.
AHP 'supplementary prescribing' also has the disadvantage that it is dependent upon co-operative physicians, who are essential as both mentors in training and as independent prescribers in practice. Without an authorised initial diagnosis and clinical management plan it is not possible to utilise a supplementary prescriber. Nevertheless, although it was originally envisaged that the supplementary prescribing role would consist of monitoring and adjusting existing prescriptions, in practice it has proved sufficiently flexible to enable the care of acute medical emergencies in patients with chronic illness (such as infected ischaemic ulcers in cases of diabetes) [
85].
In 2006 a new exemption list for podiatrists was introduced reflecting further the impact of health policy modernisation and the diminishing authority of medicine over prescribing. It included full access to the antimicrobials amoxicillin, flucloxacillin and erythromycin, without any specification on dosage or route of administration [
86]. It affords podiatrists in general practice the ability and scope to deploy antimicrobials to combat infections and to access adrenalin for use in emergency circumstances. Reflecting on the failure of repeated previous attempts to gain access to these medicines, the 2006 exemption particularly illustrates the new climate of change, and the growing acceptance of the reality of workforce redesign and role transfer in the sphere of medicines.
Most recently, in July 2009, the UK Department of Health published a report for the Chief Health Professions Officer, examining the case for extending prescribing and medicines supply mechanisms for the allied health professions [
85]. It concluded that there was a 'strong case for progression to independent prescribing for physiotherapists and podiatrists', and included key recommendations that further work be undertaken to establish independent prescribing for these two groups. Independent prescribing for podiatrists, whilst not directly comparable to medical or dental prescribing, is, seemingly, very much on the agenda. The change of climate is consistent with the need to develop a workforce capable of taking on new, expanded roles previously within the exclusive domain of medicine [
87,
88]. It is nevertheless intriguing to note that there remains an important distinction between independent prescribing for the AHPs, and medical (or dental) prescribing. Unlike the latter, the former does not include access to unlicensed medicines or controlled drugs (the equivalent of S8 in Australia). At face value this may seem relatively unimportant, yet podiatrists continue to use, very widely, at least one agent that until recently was regarded by the Medicines and Healthcare Products Regulatory Agency as an unlicensed medicine - specifically liquefied phenol, used in toenail ablation techniques. In July this year the Medicines and Healthcare Products Regulatory Agency published a statement asserting that, as it "does not have a primary mode of action which is pharmacological, metabolic or immunological it falls outside the definition of a medicinal product". As a result, providing the product is not marketed with medicinal claims, it is no longer subject to medicines legislation. In combination, these recent changes reflect the pace of the broader workforce trends towards redesign, role substitution and enhanced flexibility.
Like the UK, administration rights to local anaesthetic agents (Schedule 4 drugs) became the first marker of change for podiatry in Australia, facilitating the same advances in practice and similar challenges from the medical profession [
37]. Recent data shows that each State possesses similar access to a range of local anaesthesic agents, achieved over a comparable timeframe to that in the UK, where South Australia appears the most liberal, and (up until recently) Queensland the most restrictive [
89]. Although the schedules vary from state to state, only in South Australia, Western Australia and, more recently, Victoria and Queensland, are access, administration, supply or prescription rights to restricted or controlled medicines available (Schedule 4 or 8 medicines), though these are largely restricted to the relatively small workforce of qualified podiatric surgeons.
It is notable that since the original legislation, only South and Western Australia have seen subsequent additions and modifications. Furthermore, the Adverse Drug Reactions Advisory Committee has indicated that there is "no known pattern of adverse reactions relating to podiatric prescribing", although the Australian Medical Association in Victoria openly disputed this, indicating that "the suggestion that there has been no adverse side effects to medications prescribed by podiatrists reflects the hubris of many non-medical professions who seek prescribing rights..." [
90]. This criticism does raise the suggestion for the profession and its governing authorities to develop, or integrate into existing, adverse-event reporting pathways, and for public data to be collected on podiatric prescribing in Australia.
In Australia, access to medicines is governed by a 'drugs & poisons' authority in each State and Territory, although the actual 'scheduling' of medicines is a Commonwealth (Federal) responsibility, undertaken by the National Drugs & Poisons Schedule Committee (a branch of the Therapeutic Goods Administration and equivalent to the UK's Medicines and Healthcare Products Regulatory Agency) in combination with the Commonwealth Department of Health and Ageing [
37,
39]. Specific regulation on the mechanisms for the supply, administration or prescription of 'restricted and controlled' drugs is contained in a number of State & Territory 'drugs and poisons' legislation (for eg. Poisons Act 1933; Poisons and Drugs Act 1978; Drugs of Dependence Act (1989). Unlike the UK, there is no single over-arching medicines legislation, although currently plans to introduce a uniform scheduling of medicines to effect 'harmonisation' across Australia and New Zealand are underway [
91]. A new Medicines and Poisons Bill (2006) is currently under consultation, and will "not change non-medical prescribing rights" but will grant "consideration...to a proposal to grant ACT podiatrists limited prescribing rights" [
39].
In South Australia rights to a limited list of restricted medicines (other than local anaesthesia) were granted in 1989, and extended in 1996, largely limited to qualified podiatric surgeons. Similar changes were established in Western Australia in 1995, where podiatrists with a relevant Master's degree were able to apply to supply (but, importantly not prescribe) a narrow range of restricted drugs such as antibiotics and analgesics.
In Queensland, amendments to the Health (Drugs & Poisons) Regulation 1996 came in 2006 to allow recognised 'surgical podiatrists' (who hold Fellowship with the Australasian College of Podiatric Surgeons) to prescribe, supply or administer a limited formulary of Schedule 4 and one Schedule 8 drug. Importantly, Queensland then is the only Australian jurisdiction to allow authorised (surgical) podiatrists to prescribe a 'controlled' S8 drug of dependence (oxycodone), for managing postoperative pain. Additionally, the amendments allowed for general podiatrists to access adrenaline (in a pre-loaded device) for the emergency management of anaphylaxis, though curiously not for use in combination with local anaesthesia (as it is in several other Australian jurisdictions), unless the registrant was an endorsed 'surgical podiatrist'. Additional plain preparations of several other local anaesthetic agents were also made available for administration by general podiatry registrants.
It is in Victoria that the most recent, and advanced rights have been attained. Under the terms of the Health Professions Registration Act (2005) and the 2007 Regulation amendments to the Drugs, Poisons and Controlled Substances Act 1981, the Podiatrists' Registration Board had been given authority to determine which Schedule 2,3 and 4 medicines may be possessed, used, sold or supplied by its registrants following approval by the Health Minister. As a result, the Podiatrists' Board was empowered to create a subset of registrants known as 'authorised prescribers'. The Acts do not specify the particular form of undergraduate or postgraduate training, leaving these decisions to the Podiatrists Board, via advice from its own Prescribing Practice Advisory Committee and key stakeholders, and in consultation with the Minister. Most significantly, the Schedule 2, 3 and 4 drugs approved in Victoria are available for use by all suitably qualified podiatrists, and not just podiatric surgeons, as is predominantly the case elsewhere. Final approval of the initial formulary was given by the Health Minister in June 2009.
Under the current process of
National Registration & Accreditation, local state and territory health professional registration boards will be disbanded and replaced by national authorities. As such, the Podiatry Board of Australia was constituted in 2009, with the task of taking over the administration of registration and regulation of standards of practice for all Australian podiatrists in July 2010. Under the requirements of the
Health Practitioner Regulation (Administrative Arrangements) National Law Act 2008, the Board has already begun consultation on the mechanisms for the arguably overdue implementation of national standards for podiatric prescribing within Australia, to be submitted for approval by the Australian Health Workforce Ministerial Council [
92]. However, the move to any national prescribing standard will still be adversely affected by the jurisdiction inconsistencies of local drugs and poisons legislation in different states and territories, and a uniform approach will be a highly desirable long term solution to addressing this problem.
In 2005 a joint application was made by the Podiatrists Board of New Zealand and the New Zealand Society of Podiatrists to the New Prescribers Advisory Committee for podiatrists to be recognised as "designated prescribers," in the Regulations under the Medicines Act 1981[
73]. As part of this application, the proposed curriculum for New Zealand registrants wishing to potentially become a 'designated prescriber' was put forward from the Auckland University of Technology in the form of a Postgraduate Diploma of Health Science modelled on the nurse practitioner curriculum.
Under the terms of the Health Practitioners Competence Assurance Act 2003, the Podiatrists Board of New Zealand was granted the authority to determine Scopes of Practice for the profession. In doing so, it determined a new category of advanced scope practitioner known as a 'podiatric prescriber' [
73]. However, as at the end of 2007, the Podiatrists Board of New Zealand announced that NPAC had accepted its submission in principle, pending final modifications to the proposed monitoring processes and final list of medications, prior to activating the 'podiatric prescriber' category of registration [
93]. Table
1 summarises the varying and inconsistent nature of the various requirements for endorsed podiatric prescribers in Australasia.
Table 1
Summary of statutory requirements for drug prescribing by podiatrists in Australasia (as at 2009)
Victoria
| Recent undergraduate podiatry degree (2003 onwards from Latrobe University), with Board approved postgraduate pharmacology studies and clinical experience [interstate or less recent graduates are required to undertake additional core content studies and clinical experience] |
Least restrictive
|
New Zealand
| A postgraduate qualification as determined by the Podiatrists Registration Board of New Zealand, or equivalent overseas qualification | |
Western Australia
| Master's degree with advanced pharmacology core unit | |
South Australia
| Fellowship of the Australasian College of Podiatric Surgeons | |
Queensland
| Fellowship of the Australasian College of Podiatric Surgeons + additional Board requirements |
Most restrictive
|