Consideration of the novel psychoactive substances (‘legal highs’)

Original report can be found at: http://www.homeoffice.gov.uk/ Crown Copyright, the Advisory Council/ The Home Office. This work is published under an open government license.The Advisory Council on the Misuse of Drugs (ACMD) committed to providing the Government with advice on novel psychoactive substances (often colloquially termed „legal highs‟). This is a relatively recent phenomenon, exemplified by the drug known as mephedrone. The actions by the ACMD and subsequently by the Government on this drug have gone some way to reducing the potential harms caused by this substance. However, there is more that can be done. The advent of novel psychoactive substances has changed the face of the drug scene remarkably and with rapidity. The range of substances now available, their lack of consistency and the potential harms users are exposed to are now complex and multi-faceted. In light of this we have pleasure in enclosing the Council‟s report. This report provides advice on high level issues that ACMD believe the Government should give careful consideration to in addressing legally available psychoactive substances. The report does not purport to provide a single solution to the problem, but rather a number of practicable options that, in combination, seek to tackle the on-going sale, supply and consequential harms. It is important that the Government recognises that each and every department, that has a locus of responsibility in drug issues should both take personal ownership and share collective responsibility of the recommendations in this report. Tackling the issues that are raised by novel psychoactive substances requires a co-ordination of efforts that can only be realised by a strategic and co-operative approach. The ACMD has identified lead departments for each of the recommendations that should assist and guide the Government in this aim. The ACMD provides key recommendations in this report on legislation, public health, education and research. The key legislative measures are primarily concerned with tightening the enforcement of existing legislation and moving the responsibility for the supply of novel psychoactive substances to the vendors, such that the burden of proof falls to them. The ACMD believe it is for vendors to prove that such substances are neither analogues of current medicines nor products harmful to consumers in their intended form. The ACMD also makes key recommendations around public awareness from local to international initiatives.Final Published versio

Towards a safer drug policy: challenges and opportunities arising from ‘legal highs’.

The All-Party Parliamentary Group for Drug Policy Reform launches the Report of its Inquiry into New Psychoactive Substances ('legal highs') on the 14th January 2013. The Inquiry began in 2011 and was initiated in response to the rapid development of new and unknown psychoactive substances and to examine whether alternative forms of regulation could prove more effective in minimising the potential harms of such substances than the current system of drug control. The Group has received evidence from the Chairman of the Advisory Council for the Misuse of Drugs, Association of Chief Police Officers, the Home Office, The Trading Standards Institute, the Independent Scientific Committee on Drugs – in all, 31 government departments, organisations and experts. It has also examined in detail initiatives from abroad which seek to regulate new substances particular the system of regulation for 'low risk' substances being planned in New Zealand. The Report recommends that there is a system of regulated supply of those new drugs which are the least harmful and further recomments the decriminalising the possession and use of all drugs. The report concludes that a review of the Misuse of Drugs Act 1971 is now necessary. The Report also recommends that politics be taken out of decisions on the classification of drugs, as it has been with respect to the setting of interest rates by the Monetary Policy Committee, and in determining which pharmaceutical drugs may be provided through the NHS. All these issues involve scientific judgements and are too sensitive for politicians to handle directly

Managing chemotherapy risks : Learning from medication errors and developing a national knowledge source for chemotherapy regimens

The basics in cancer treatment are surgery, radiation therapy, and treatment with cancer drugs, often combined. Chemotherapy regimens that define the drugs used, the dosage, the frequency and duration of drug administration, have been developed and used for different cancer diagnoses. Several healthcare professionals are involved in the treatment: the physician prescribing the drugs, the pharmacist preparing or dispensing the drugs, and finally, the nurse or the patient administering the drugs. Chemotherapy errors that can occur during the treatment represent potential risks for severe patient harm. The aims of this PhD thesis were to increase knowledge about serious medication errors (MEs) in chemotherapy and to develop, implement, and evaluate a national knowledge source for chemotherapy regimens (an e-library) that can support healthcare professionals and mitigate patient safety risks.The characteristics of MEs with parenteral cytotoxic drugs were identified in a retrospective qualitative analysis of 60 cases reported to the Swedish national incident reporting systems 1996-2008. The drugs most involved were fluorouracil, carboplatin, and cytarabine. The largest ME categories included too high doses originating from prescribing, and the wrong drug used during preparation or prescription. Twenty-five of the 60 MEs occurred when physicians were prescribing. Another 25 occurred within the pharmacies. The remaining 10 MEs occurred when the nurses prepared or administered the drug. All the drugs with MEs that occurred during prescription were delivered to the patients. The consequences were especially severe in these cases, including death and harm to the patients. The general failure types (GFTs) and active failures were identified in the 60 cases to better understand why these errors happened. The most frequently encountered GFTs were in Defences (e.g., missed double checking of the patient’s or the drug’s identity) and Procedures (e.g., routines that were lacking or insufficient). Working conditions were a common denominator, often underlying the MEs. Examples were high workloads, and low staffing.A national e-library for chemotherapy regimens with standardised nomenclature and content was developed in close co-operation with healthcare professionals in an iterative process within the Swedish Regional Cancer Centres. The national e-library is a knowledge source containing updated regimens and other supportive information based on the latest evidence, available at: https://kunskapsbanken.cancercentrum.se. To ensure that the design and content complied with the users’ needs, the usage and usability of the national e-library were evaluated using mixed methods. Statistics from the website show an average of just over 2,500 visits and 870 unique visitors per month. The web survey, with 292 answers, showed that the visitors were mainly physicians and nurses. Almost 80% searched for regimens, and 90% found what they were looking for and were satisfied with their visit. An expert evaluation showed that the e-library follows many existing design principles. Qualitative interviews with 4 nurses, 3 physicians, and 3 pharmacists revealed various ways to use the information in the regimens. Users have different needs depending on their profession and their workplace, and the e-library can support these different needs. The national e-library was used in the intended way, and the users were able to interact without any problems. The research in this thesis shows that it is of utmost importance to minimise the potential for errors in the prescribing stage and that a common denominator behind the errors often was working conditions. Today’s Swedish national e-library for chemotherapy regimens contains information based on the latest evidence, is embedded in a national quality system, and contributes to organisational and national learning, ultimately supporting healthcare professionals in managing chemotherapy risks

An investigation of the influence of a European formulary on general practitioner prescribing as part of an educational intervention

PhD ThesisThis thesis has addressedth e issue of primary care prescribing in different European countries. The first hypothesis investigated was: that the planned implementation of a multinational consensus-basedE uropean Formulary in primary care will result in more rational prescribing. A controlled trial involved 235 GPs from eight European countries with half the GPs participating in an educational intervention. This comprised dissemination of the Formulary and discussion of antibiotic and NSAID prescribing. Details of 101,544 doctor-patient consultations were collated and prescribing was compared and contrasted, before (Phase 1) and after the intervention (Phase 11), using performance indicators. This included measurement of the prescribing concordance with drugs recommended in the Formulary which increased by 2.9% (SEM 0.7) between Phases I to 11 in the intervention group and decreased by 1.3% (SEM 0.6) in the control group. This difference was found to be highly significant (p <0.001). Although some changes in clinical practice occurred, more notable differences were found in prescribing patterns between countries. A second hypothesis followed: that identification of the main influences on the participating GPs'prescribing will assist in the explanation of the varying effects of the Formulary in the different countries. A two-stage Delphi questionnaire study asked the GPs to identify the factors which they perceived to influence their prescribing and to rate their importance. The most important influences were drug related characteristics in six countries, followed by education/information and then patient factors. Pharmaceutical industrial factors were considered the least important influence in six countries, which followed regulatory factors in five countries. More influential factors appeared to be in the GPs' control, rather than ones imposed by national health care systems, regulation and government. The results show that the extent of Formulary adoption varied in different European countries. There remains a continuing place for the promotion of rational prescribing principally through education and information, including prescribing guidelines. Future initiatives may be more appropriate within countries but require adequate and sustained professional and government support

The impact of a ward pharmacist in a surgical ward of a private hospital in the Eastern Cape

Medication errors are becoming problematic in both hospital and outpatient settings worldwide. Inappropriate use of medication can cause harm to the patient and maintaining high levels of quality patient care is essential to protect all patients. Clinical pharmacy practice contributes to improved patient care by optimising medication therapy; and promoting health, wellness and disease prevention. The involvement of a pharmacist at a ward level has been shown to improve patient care; reduce mortality and morbidity rates; decrease healthcare costs; minimise medication errors; and improve outcomes of drug therapy. However, clinical pharmacy is a fairly new practice in South Africa and there are limited studies available. This study aimed to evaluate the perceived benefits of a ward-based pharmacist on the provision of pharmaceutical care to patients in a hospital setting and to consequently implement a ward-based pharmacy service. The objectives of the study were: (1) to assess, via a questionnaire, the perceptions and attitudes of medical practitioners and nurses to ward-based pharmacy prior to and after implementation of a ward-based pharmacy service, (2) to implement a ward-based pharmacy service in a selected hospital ward; (3) to document and analyse the nature of the work and activities that a ward pharmacist undertakes, and (4) to document and analyse the frequency and nature of ward pharmacist interventions. The study was conducted in a surgical ward of a private hospital in the Eastern Cape. The study design was an intervention study, using a mixed-methods design, with a convergent approach. A convenience sample of 106 patients was obtained over the eight week study period. Participation was voluntary and confidentiality was maintained at all times. Four data collection tools were used during the study and a pilot study was conducted to ensure their validity and reliability. The quantitative data was analysed statistically while the qualitative questions were analysed through coding the various responses. The results of the study showed that medical practitioners and nurses of a surgical ward had a positive attitude towards ward pharmacy both prior to and after the implementation of a ward pharmacy service. There were ward pharmacist interventions made in 50% (n=106) of the patients who participated in the study. A large percentage (57%; 50; n=87) of the ward pharmacist interventions were pharmacist-initiated interventions to optimise patient care while prescribing errors (51%; 19; n=37) were the most commonly occurring medication error. The majority of the medication items involved in the interventions (34%; 34; n=101) were related to the anti-microbial medication class. Overall, there was a 73% (36; n=49) acceptance rate of the ward pharmacist interventions that were made to both the medical practitioners and nurses. There were a number of factors that had a significant relationship with a ward pharmacist intervention being required which included: (1) number of medication items (p=0.001; Chi² test; p<0.0005 Student’s t-test), (2) length of hospital stay (p<0.0005; Chi² test), (3) presence of one or more chronic disease states (p=0.003; Chi² test) and (4) presence of one or more allergies (p=0.028; Chi² test). The ward pharmacist interventions were shown to be of clinical significance and to have a positive impact on the patients concerned. It can be concluded that the ward pharmacy service was beneficial to the patients, medical practitioners and nursing staff

“Gear is the Next Weed”:A Qualitative Exploration of the Beliefs, Attitudes and Behaviours of Performance and Image Enhancing Drug Using Subcultures in the South-West of England

Performance-enhancing drugs until relatively recently have been seen to be the preserve of sport-focussed athletes, but in recent years there has been an apparent increase in use amongst the general population, with individuals now using PIEDs not only to increase athletic prowess, but for image-conscious reasons entirely divorced from such ‘competitive’ notions. This research explores the different types of PIED user training in gym environments today, identifying differences in ‘ethnopharmacologies’ between these groups, allowing them to be categorised by their beliefs, attitudes, and patterns of use, based on qualitative data gathered ‘in the field’ from a total of 27 respondents, including 14 in-depth interviews. This exploration further evidences the extent to which a ‘normalisation’ of PIED use is occurring.Results suggest PIED users can be split into three categories, ‘sport-oriented’, ‘image-oriented’ and ‘hedonic’, with sport-oriented users conducting the most research, and having the most rigid cultural ‘disciplines’, and ‘hedonic’ users the least. This is evidenced through exploration of participants’ ‘decision to begin using’, their processes of ‘learning to use’ and their ‘longer term use’ of PIEDs, all of which suggest that patterns of use exist on a spectrum, from informed and cautious use employed by the most serious sport-focussed PIED users, to high-risk, high time-preference use associated with ‘hedonic’ users. This divergence in ethnopharmacologies and behaviours between groups evidences the need for such a categorisation of users in future research and policy, particularly for harm-minimisation purposes, as well as offering in-depth qualitative contributions to findings reported in recent longitudinal studies. Further, these elements of use evidence an increasing normalisation of PIEDs, which appears to have been largely achieved, excepting a perception of ‘stigmatisation’ still faced by users, principally stemming from media portrayals of ‘roid rage’. This limitation to cultural acceptance is therefore addressed, with evidence suggesting ‘roid rage’ is a ‘myth’, and further that this stigmatisation is likely to decline as knowledge is transferred from using populations to their non-using peers, indicating ‘normalisation’ is occurring.<br/

Rationalising health care provision under market incentives: experimental evidence from south Africa

Unnecessary medical treatments place a significant burden on health systems striving for universal health coverage (UHC). This thesis studies inappropriate treatment incentives in the private sector in South Africa, where plans to implement a national health insurance system (NHI) foresee the contracting of private physicians to deliver publicly-funded health care. Private providers are increasingly recognized as necessary partners for UHC success in many low-and-middle-income countries (LMIC). However, aligning the incentives of these actors with UHC and public health goals requires a better understanding of incentive effects in these settings. I conduct two field experiments with incognito standardized patients (SPs), to both evaluate appropriate care provision and experimentally vary the treatment incentives facing private physicians. First, I run a within-subject experiment with 89 private primary care physicians (GPs) in Johannesburg, to investigate the causal impact of improving patients’ financial protection (insurance cover) on physicians’ quality of care delivery. The results suggest that more insured patients receive a higher level of visible clinical effort, but a lower level of technical care quality – including a higher likelihood of inappropriate antibiotic treatment. Second, I use data from the same experiment to evaluate the impact of patient insurance on the quantity and costs of care. I find that more insured patients are more likely to receive unnecessary diagnostic tests and treatment procedures, and receive more and more expensive branded drugs, resulting in significantly higher care costs. The results on antibiotic treatment and drug treatment quantity and costs occurred despite the absence of any financial incentives attached to drug prescribing for GPs, which suggests the presence of alternative motives for physicians’ treatment decisions that might vary with patient insurance – including intrinsic or altruistic motives. Third, I explore the scope for leveraging such intrinsic motivations to improve physicians’ treatment choices. I conduct a randomized (between-subject) experiment with 80 GPs, to evaluate the impact of intrinsic, informational incentives from private performance audit and feedback (A&F) on physicians’ antibiotic treatment choices and care costs. The findings suggest that private A&F can significantly reduce the likelihood of inappropriate antibiotic treatment for common viral infections that present in primary care, without simultaneously reducing appropriate antibiotic use for bacterial infections or increasing other inappropriate drug treatments. However, improved performance on antibiotic use does not coincide with significantly lower treatment costs or any improvements in measured diagnostic effort or accuracy. There is indicative evidence that prescribing norms and perceived patient expectations may play an important role in mediating private physicians’ treatment choices in all three empirical chapters

Exploring the Experiences of Receiving the Label ‘Treatment Resistant’ for People with a Diagnosis of Schizophrenia

There is a wealth of research which focuses on the impact a diagnosis of schizophrenia or schizoaffective disorder can have on people’s lives. Less common is research which explores how the additional label of treatment resistant has affected this cohort of people. Previous literature is overwhelmingly quantitative and indicates the label is synonymous with a biogenetic approach to causality and treatment, with little hope given for recovery. The aim of the current study was to explore the experiences of those who have been diagnosed with schizophrenia and schizoaffective disorder and received the label of treatment resistant. Participant perspectives on the explanations for them receiving the label were sought, along with the effects it had on treatment, their perspectives and the perspectives of others. The study utilised a qualitative design and conducted semi-structured interviews with seven participants, six of whom had a diagnosis of schizophrenia and one of whom had a diagnosis of schizoaffective disorder. The resulting data was analysed using Thematic Analysis. Six themes were constructed: ‘Effects of a psychosis diagnosis’, ‘Antipsychotic medication in the treatment resistant context’, ‘Explanatory models of distress and treatment resistance’, ‘Effects of the treatment resistant label on service user’s perceptions’, ‘Effects of the treatment resistant label on others’ and ‘Sources of meaning and support’. The study found that the treatment resistant label can have a damaging effect on those who receive it, particularly in the context of participants’ pre-existing psychosis diagnosis which is already highly stigmatised. The label was reported to be associated with reduced hope for recovery from both mental health staff and participants themselves, underpinned by ideas around personal responsibility and chronicity. The treatment resistant label was linked to severe medication side effects and shaped which treatment was offered, or not, to participants. Implications of the study are considered at policy, research, practitioner and service user level