Conflicting regulations on medicines and controlled drugs may expose pharmacists to criminal liability

© 2021 Royal Pharmaceutical Society. This is the accepted manuscript version of an article which has been published in final form at https://doi.org/10.1211/PJ.2021.1.71779Peer reviewe

The changing landscape of UK pharmacy law in the early 21st century and its effect on the moral agency of pharmacists

This thesis draws together a series of publications based on work carried out between 2008 and 2018, which examines various aspects of pharmacy regulation as it is reformed in response to changing perspectives on healthcare. The regulated activities of pharmacy include supply of medicines, handling of controlled substances, and maintenance of registration with the General Pharmaceutical Council. The legal underpinnings of each of these activities has undergone significant change in the last ten years. Failing to stay abreast of changes to pharmacy law, or to understanding how these changes affect their practice, can leave pharmacists open to criminal prosecution, civil actions, and fitness to practise proceedings. This regulatory environment can create the potential for moral distress to occur as practitioners are prevented from acting in congruence with their own moral agency. The submission includes thirteen pieces of work discussed under four headings: the three legally regulated activities mentioned above; and a fourth category dealing with moral considerations raised with respect to conscientious objection and moral distress. Initial analysis of the changing legal landscape identifies possible triggers for moral distress, which are subsequently factored into the development of a tool to measure this phenomenon in community pharmacists. The earlier publications included in this thesis have had a significant impact on several aspects of pharmacy regulation, while informing the direction of the later work, which seeks to provide an insight into the incidence of moral distress experienced by community pharmacists and provide researchers with a set of tools with which to extend the scope of the literature in this area

Doctor or drug dealer? International legal provisions for the legitimate handling of drugs of abuse

© The Author(s) 2020. The final, definitive version of this paper has been published in: Gallagher, C. T., Atik, S. K., Isse, L., & Mann, S. K. (2020). Doctor or drug dealer? International legal provisions for the legitimate handling of drugs of abuse. Drug Science, Policy and Law. by Sage Publications Ltd. All rights reserved. It is available at: https://doi.org/10.1177/2050324519900070In this paper, we compare how five jurisdictions (the USA; UK; Canada; New Zealand; and Australia) balance the disparate objectives of preventing the misuse of drugs to the detriment of society and allowing their legal for societally-beneficial purposes. The statutory law underpinning each country’s method of categorising drugs depict distinctive outlooks from the different jurisdictions, as each works towards these same goals. In examining how each country’s legislation deals with controlled substances, initial consideration will be given to whether drugs are categorised once only, or twice: once for dealing with their criminal misuse; and again for ensuring their safe medicinal use. In effectively dealing with criminal activities associated with drugs of abuse, Australia’s system of imposing penalties based on the quantity of a drug possessed, rather than on its grouping with other drugs of a broadly similar type offers the most flexibility. In terms of managing the legitimate use of such drugs, however, it is perhaps the least flexible of the four jurisdictions operating parallel systems of categorisation. The greatest level of flexibility is offered by Canada and the UK, which have functionally very similar protocols in this respect.Peer reviewedFinal Accepted Versio

Disciplinary Action Against UK Health Professionals for Sexual Misconduct: A Matter of Reputational Damage or Public Safety?

© 2021 Federation of State Medical Boards. All Rights Reserved.The regulation of health care professionals in the United Kingdom (UK) falls under the authority of one of nine General Councils, each of which has a statutory duty to ensure the fitness to practice of a subdivision of these professionals. Among the matters that may call fitness to practice into question are deviations from published standards of behavior, which include the maintenance of appropriate sexual boundaries by practitioners. The aim of this article is to examine how the common fitness-to-practice process utilized by General Councils deals with registered health care professionals who have exceeded these boundaries.Deductive thematic analysis was carried out on cases involving academic misconduct among registrants of the General Medical Council, General Dental Council, General Pharmaceutical Council, and Nursing and Midwifery Council, using themes derived from each council’s standards for registrants and guidance for disciplinary panel members.While each of these four cases involved some form of sexually motivated misconduct, the facts in each case were significantly different; however, not only was the outcome the same, but the rationale was similar in each instance. While the protection of the health, safety and well-being of the public may be considered in cases involving sexual misconduct, the need to maintain public and professional confidence in their respective professions is sufficient grounds alone to end the careers of health professionals who engage in sexual misconduct.Peer reviewedFinal Published versio

NMR Studies of Nucleic Acids as Drug Targets

Nogalamycin is a member of the anthracycline family of antitumour antibiotics. These are potent cytotoxic agents and are routinely used in cancer chemotherapy. Though nogalamycin is clinically insignificant, it does exhibit three distinct types of non-covalent binding to DNA. Since most other anthracyclines bind to DNA by only one or two of these mechanisms, nogalamycin is an excellent model with which to probe the interaction of this class of anti-tumour agents with DNA. Here, we investigate the binding orientation and stoichiometry of nogalamycin in adjacent TpG(CpA) (and CpG(CpG)) intercalation sites using a combination of NMR techniques and NOE-restrained molecular dynamics simulations. These methods are also employed to investigate the structure of GNA hairpin loops, which are considered to have important biological functions, and assess how their structure and stability are influenced by the introduction of nogalamycin at an adjacent site. The effect of nogalamycin on extrahelical thymine bases incorporated onto either face of the intercalation sites is also investigated in this context. Binding of quadruplex-specific antibodies to telomeric DNA in Stylonychia lemnae macronuclei has recently been detected using immunofluorescence, providing direct evidence for the formation of quadruplex DNA structures in vivo. Guanine-rich quadruplex structures have been extensively studied by NMR and x-ray crystallographic methods. Previous structural studies have failed to unambiguously resolve the conformation preferred by less-stable A-tetrads incorporated into DNA quadruplexes. Additionally, little effort has been made to address the exact number of ions bound to these adenine-containing structures. This forms the basis of our study into quadruplex DNA. Finally, we endeavour to investigate the extent of hydration of both duplex and quadruplex structures using rMD methods, and to comapre hydration patterns in the liquid- and solid-state

Measuring moral development in the pharmacy profession from undergraduate to established practitioner: a decadal longitudinal study

© 2023 The Author(s). Published by Oxford University Press on behalf of the Royal Pharmaceutical Society. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY), https://creativecommons.org/licenses/by/4.0/The aim of this study is to measure and evaluate the moral reasoning of undergraduate pharmacy students as they progress through a British university, and onward through the early years of their professional practice. This study utilizes version 2 of Rest's Defining Issues Test in a longitudinal design, evaluating a single cohort of future pharmacists, which started a 4-year Master of Pharmacy degree program in 2008-09, completed their preregistration training, and progressed through their early careers. The final dataset was collected in 2019. Both descriptive and inferential statistical analysis was subsequently carried out. The cohort experienced significant moral growth during the 4 years of their undergraduate degree, where they were exposed to an ethical education designed to engage students at the "plus one" level of moral reasoning. There is also evidence for work-based augmentation of moral development between graduation from university and qualification as pharmacists. The subjects underwent a marked increase in moral development as they progressed through their undergraduate studies, followed by another sizeable, though not statistically significant developmental progression during the preregistration year. The retrograde step in moral development observed between newly qualified level and established practitioner level requires further investigation: structured interviews with participants, which focus on changes to their experiences in practice and how these affected their moral agency are already underway.Peer reviewe

NMR Studies of Nucleic Acids as Drug Targets

Nogalamycin is a member of the anthracycline family of antitumour antibiotics. These are potent cytotoxic agents and are routinely used in cancer chemotherapy. Though nogalamycin is clinically insignificant, it does exhibit three distinct types of non-covalent binding to DNA. Since most other anthracyclines bind to DNA by only one or two of these mechanisms, nogalamycin is an excellent model with which to probe the interaction of this class of anti-tumour agents with DNA. Here, we investigate the binding orientation and stoichiometry of nogalamycin in adjacent TpG(CpA) (and CpG(CpG)) intercalation sites using a combination of NMR techniques and NOE-restrained molecular dynamics simulations. These methods are also employed to investigate the structure of GNA hairpin loops, which are considered to have important biological functions, and assess how their structure and stability are influenced by the introduction of nogalamycin at an adjacent site. The effect of nogalamycin on extrahelical thymine bases incorporated onto either face of the intercalation sites is also investigated in this context. Binding of quadruplex-specific antibodies to telomeric DNA in Stylonychia lemnae macronuclei has recently been detected using immunofluorescence, providing direct evidence for the formation of quadruplex DNA structures in vivo. Guanine-rich quadruplex structures have been extensively studied by NMR and x-ray crystallographic methods. Previous structural studies have failed to unambiguously resolve the conformation preferred by less-stable A-tetrads incorporated into DNA quadruplexes. Additionally, little effort has been made to address the exact number of ions bound to these adenine-containing structures. This forms the basis of our study into quadruplex DNA. Finally, we endeavour to investigate the extent of hydration of both duplex and quadruplex structures using rMD methods, and to comapre hydration patterns in the liquid- and solid-state

Fit to practise? Processes for dealing with misconduct among pharmacists in Australia, Canada, the UK and US

© 2018 Elsevier Inc.In many countries with legal systems based on English common law, pharmacy regulators have a responsibility to protect, promote and maintain the health and safety of patients. Where there is a potential risk to patient safety, or where the public's confidence in pharmacy could be adversely affected by the actions of a pharmacist, these regulators have a statutory duty to investigate concerns. The legal provisions underpinning each jurisdiction's disciplinary processes depict distinctive outlooks from the different authorities, as each works towards the same goal. Legal statues, regulations, rules, and guidance affecting the disciplinary process in Great Britain, Australia, New York and New Brunswick were collated, and the processes they describe were attached to a common process flow diagram for step-by-step evaluation of their respective legal provisions. The initial stages of the respective investigation process are broadly similar in all the jurisdictions examined; however, each process has subtle differences that afford some level of advantage or disadvantage over its comparators. Factors including: how matters of discipline are framed; the existence of a separate process for minor and uncontested violations; the ability to effect an interim suspension of a practitioner's license; threshold criteria for escalation of complaints; the membership of disciplinary panels; and the perceived independence of these panels all philosophically affect the public safety remit of each regulator. This work constitutes the first comparison of international regulatory frameworks for the profession of pharmacy. Of the four jurisdictions examined, Great Britain most clearly acts in the interest of the public and the profession – rather than the respondent pharmacist – at every step of its process.Peer reviewe

Anakinra for recalcitrant pyoderma gangrenosum

Pyoderma gangrenosum (PG) is an autoinflammatory neutrophilic dermatosis characterized by rapidly enlarging, painful ulcers. Anakinra is a recombinant interleukin-1 (IL-1) receptor antagonist that blocks the activity of IL-1α and IL-1β by competitively inhibiting IL-1 binding to the IL-1 type I receptor. We present a series of two patients with recalcitrant PG, who had limited therapeutic options due to multiple previous treatment failures and multiple co-morbidities, who obtained 100% healing with anakinra. Compared to conventional first-line therapies for PG, the safety profile of anakinra may be preferable for patients with multiple co-morbidities. Further research is needed to assess the safety and efficacy of anakinra for PG

Analytical and computational modelling for wave energy systems: the example of oscillating wave surge converters

The development of new wave energy converters has shed light on a number of unanswered questions in fluid mechanics, but has also identified a number of new issues of importance for their future deployment. The main concerns relevant to the practical use of wave energy converters are sustainabiliy, survivability, and maintainability. And of course, it is also necessary to maximize the capture per unit area of the structure as well as to minimize the cost. In this review, we consider some of the questions related to the topics of sustainability, survivability, and maintenance access, with respect to sea conditions, for generic wave energy converters with an emphasis on the oscillating wave surge converter (OWSC). New analytical models that have been developed are a topic of particular discussion. It is also shown how existing numerical models have been pushed to their limits to provide answers to open questions relating to the operation and characteristics of wave energy converters