Simplifying the legal management of controlled drugs as medicines in the UK

Gallagher, Cathal T.

doi:10.1093/ijpp/riab061

Cited by 3 publications

(13 citation statements)

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“…The fundamental barrier to the implementation of this particular SP-led prescribing model of care was the complexity of medicines management cycle including definitions and procedures relating to 'prescribing', 'administration' and 'supply' functions. These complications particularly in relation to the complexity of legislation and policy as it relates to non-medical prescribing is well documented in the literature (Gallagher, 2021a(Gallagher, , 2021bGraham-Clarke et al, 2019). For both medications being considered in the model, different issues impacted implementation.…”

Section: Discussionmentioning

confidence: 99%

Speech pathology prescribing in the outpatient setting: A review of requirements, considerations and barriers

Schwarz

Ward

Seabrook

et al. 2022

Intl J Lang & Comm Disor

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Background: As health systems face increasing demands, non-medical prescribing is a workforce redesign strategy adopted within some services. Despite successful implementation in other professional groups, non-medical prescribing within speech pathology (SP) has not yet been described. Aims: To provide a descriptive account of the development and planned implementation of two SP prescribing models. Methods & Procedures:The evolution of two SP-led prescribing models, including relevant training and credentialing, for use of (1) nystatin oral drops (100,000 units/mL); and (2) lidocaine (lignocaine) and phenylephrine nasal spray (5 mg/500 µg/spray), in the outpatient setting is detailed. Challenges to implementation are outlined. Main Contribution: The development of relevant governance structures, a research evidenced-based project evaluation framework, and an overview of training pathways and credentialing was successfully completed. However, implementation of the models was unable to be achieved. A thorough review of the requirements and a discussion of contextual considerations that had a negative influence on the implementation of SP-led prescribing within this specific service context is provided. Conclusions & Implications:The successful implementation of SP-led prescribing is complex and highly context dependent. This work offers a discussion 1194

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Section: Discussionmentioning

confidence: 99%

Speech pathology prescribing in the outpatient setting: A review of requirements, considerations and barriers

Schwarz

Ward

Seabrook

et al. 2022

Intl J Lang & Comm Disor

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“…Far from enabling the delivery of seamless care, independent prescribing appears to maintain limits to practice that constrain the scope of the profession [ 29 , 30 ]. This is manifest in two exemplars which have necessitated further submissions to the Commission on Human Medicines (an advisory, non-departmental body sponsored by the Department of Health and Social Care) and the Advisory Council on the Misuse of Drugs (sponsored by the Home Office) over the last year (2021).…”

Section: Main Textmentioning

confidence: 99%

“…Such a serious assertion demands attention, and on closer inspection accounts in part for the problems which have recently beset podiatry. The disjunction between the MDRs and the HMRs affected the paramedic profession in 2018, as the HMRs were amended to allow paramedic independent prescribing, but, crucially, no corresponding amendment was made to the MDRs [ 29 , 30 ]. However, the key to the problem, for Gallagher, is the fact that the Misuse of Drugs Act (1971) “prohibits possession, production, supply, import and export of CDs…as allowed by regulations”, but, crucially, does “not prohibit the act of prescribing CDs” [ 29 , 30 ].…”

Section: Main Textmentioning

confidence: 99%

“…The disjunction between the MDRs and the HMRs affected the paramedic profession in 2018, as the HMRs were amended to allow paramedic independent prescribing, but, crucially, no corresponding amendment was made to the MDRs [ 29 , 30 ]. However, the key to the problem, for Gallagher, is the fact that the Misuse of Drugs Act (1971) “prohibits possession, production, supply, import and export of CDs…as allowed by regulations”, but, crucially, does “not prohibit the act of prescribing CDs” [ 29 , 30 ]. No restriction was placed on doctors or dentists, yet the advent of nurse and pharmacy independent prescribing saw the introduction of a new amendment to the MDRs – regulation 6B – which gave “authority” for these groups to prescribe CDs, when it was not actually required.…”

Section: Main Textmentioning

confidence: 99%

“…No restriction was placed on doctors or dentists, yet the advent of nurse and pharmacy independent prescribing saw the introduction of a new amendment to the MDRs – regulation 6B – which gave “authority” for these groups to prescribe CDs, when it was not actually required. Subsequently, when physiotherapy and podiatry were granted independent prescribing, another “authority” was granted in the MDRs – regulation 6 C – which is also deemed unnecessary [ 29 , 30 ]. For podiatry, however, there were even further implications, which were not revealed in Gallagher’s work, but which came to light in late 2019, uncovered by the authors of this paper.…”

Section: Main Textmentioning

confidence: 99%

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A decade of independent prescribing in the UK: a review of progress

Fitzpatrick

Borthwick

2022

Journal of Foot and Ankle Research

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Background 2022 marks a decade since the profession of podiatry secured independent prescribing rights in the UK. Widely viewed as a significant milestone, its advent appeared to herald a new age of practice, with increased autonomy, a broader scope of practice and improved patient care. Access to any medicine within the British National Formulary (with a few notable exceptions) seemed to signal an end to the perennial difficulties and frequent disappointments in obtaining ease of access to medicines necessary for effective practice. Main body Recent attempts to expand the scope of prescribing practice to include access to a broader range of controlled drugs (CDs) have led to unanticipated complications which may even threaten existing rights. These issues highlight the limitations of current independent prescribing and the continuing inability of podiatrists to access certain key medicines, primarily controlled drugs. Reliance on specified ‘lists’ of approved medicines, whether a controlled drug list for prescribers or the use of statutory exemptions by non-prescriber podiatrists, remain inflexible and difficult to change. The data underpinning much of this paper is derived from the work undertaken by the authors as representatives of podiatry on NHS England’s Chief Professions’ Officers’ Medicines project, in particular involving submissions to the Commission on Human Medicines and the Advisory Council on the Misuse of Medicines, spanning the years 2017–2021. It describes a complex process, and highlights a misalignment between two legislative frameworks that threaten to unravel existing rights. Short conclusion Ongoing difficulties relating to controlled drugs illustrate the problematic nature of current supply, administration and prescribing rights in podiatry. Efforts to keep pace with periodic legal reclassifications of medicines are constrained by limited and inflexible legal mechanisms, and formal approval for extended access via prescribing remains unpredictable and complex. For prescriber and non-prescriber1 (1Non- prescriber podiatrists are those who are neither supplementary or independent prescribers, but do enjoy existing administration and supply rights to certain medicines.) podiatrists alike, the profession of podiatry faces a new challenge to its ability to access medicines, and to realise its full clinical potential.

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The Misuse of Drugs Regulations 2001: A case study in poor legislative drafting

Gallagher

2022

Drug Science, Policy and Law

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The Misuse of Drugs Regulations 2001 (MDRs) create exemptions to the offences of possession, production, supply, and administration of controlled drugs (CDs), which are necessary to allow healthcare professionals to treat patients without rendering themselves liable to prosecution for various offences under the Misuse of Drugs Act 1971. As the scope of healthcare in the UK grows to include extended roles for an increasing number of professions, so must the law be amended to allow for these. The MDRs were poorly drafted in their original form, and this has been compounded by twenty years of equally poor amendments, leading to a degree of inaccuracy and ambiguity that is no longer acceptable. These regulations both lack internal consistency, and fail to align with the Human Medicines Regulations, such that neither healthcare professionals, their regulators, nor their representative bodies agree on either the spirit or letter of the law. There are fewer than 30 active regulations in the MDRs, of which more than half contain ambiguities originating from poor drafting. While these could be clarified by a further series of amendments, the time is right to learn from previous mistakes and start over afresh.

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Simplifying the legal management of controlled drugs as medicines in the UK

Cited by 3 publications

References 2 publications

Speech pathology prescribing in the outpatient setting: A review of requirements, considerations and barriers

Speech pathology prescribing in the outpatient setting: A review of requirements, considerations and barriers

A decade of independent prescribing in the UK: a review of progress

The Misuse of Drugs Regulations 2001: A case study in poor legislative drafting

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