bluuebunny/crossref_metadata_2025 huggingface dataset:
Presence of Striatal Amyloid Plaques in Parkinson's Disease Dementia Predicts Concomitant Alzheimer's Disease: Usefulness for Amyloid Imaging
Authors: Dugger Brittany N. , Serrano Geidy E. , Sue Lucia I. , Walker Douglas G. , Adler Charles H. , Shill Holly A. , Sabbagh Marwan N. , Caviness John N. , Hidalgo Jose , Saxon-LaBelle Megan , Chiarolanza Glenn , Mariner Monica , Henry-Watson Jonette , Beach Thomas G. ,   The Arizona Parkinson's Disease Consortium
Published: December 2019

Dementia is a frequent complication of Parkinson's disease (PD). About half of PD dementia (PDD) is hypothesized to be due to progression of the underlying Lewy body pathology into limbic regions and the cerebral cortex while the other half is thought to be due to coexistent Alzheimer's disease (AD). Clinically, however, these are indistinguishable. The spread of amyloid plaques to the striatum has been reported to be a sensitive and specific indicator of dementia due to AD. The purpose of the present study was to determine if the presence of striatal plaques might also be a useful indicator of the presence of diagnostic levels of AD pathology within PD subjects. We analyzed neuropathologically-confirmed cases of PD without dementia (PDND, N = 31), PDD without AD (PDD, N = 31) and PD with dementia meeting clinicopathological criteria for AD (PDAD, N = 40). The minimum diagnostic criterion for AD was defined as including a clinical history of dementia, moderate or frequent CERAD cortical neuritic plaque density and Braak neurofibrillary stage III-VI. Striatal amyloid plaque densities were determined using Campbell-Switzer and Thioflavine S stains. Striatal plaque densities were significantly higher in PDAD compared to PDD (p < 0.001). The presence of striatal plaques was approximately 80% sensitive and 80% specific for predicting AD. In comparison, the presence of cerebral cortex plaques alone was highly sensitive (100%) but had poor specificity (48% to 55%). The results suggest that striatal amyloid imaging may be clinically useful for making the distinction between PDD and PDAD.
Levodopa-Induced-Dyskinesias Clinical Features, Incidence, Risk Factors, Management and Impact on Quality of Life
Authors: Manson Alice , Stirpe Paola , Schrag Anette
Published: December 2019

Levodopa-induced dyskinesias (LID) belong to the most common dose-limiting adverse effects of levodopa therapy. “Peak-dose” LID occur with the maximum effect of medication, ‘diphasic dyskinesias’ have a “beginning- and end-of-dose” pattern, and the, “off-period dyskinesia” occur during off-periods, most frequently in the early mornings and are typically dystonic in nature. The majority of patients will have developed dyskinesias after 10 years of treatment, and about 40–50% after 5 years. Occurrence of LID appears to be related to dose and duration of treatment with levodopa and severity and duration of disease. In addition, patients with younger age of onset have been reported to have an earlier onset and higher rate of LID. The important aetiological role of non-physiological pulsatile stimulation of dopaminergic receptors is increasingly recognized and more continuous dopaminergic stimulation with the longer acting dopamine agonists has been shown to reduce and delay the onset of dyskinesias. LID may not have a significant effect on quality of life in patients with early disease or in very advanced disease stages. when often other problems arise, but in other patients they may be severely disabling. Treatment strategies to overcome LID include adjustment of timing, type and amount of dopaminergic medication, treatment with amantadine and, in treatment resistant cases, stereotactic surgery involving deep brain stimulation or lesioning procedures. A number of other pharmacological options are also being explored. Several methods for the assessment of LID are available to attempt accurate assessment of efficacy, although all of these have limitations, and further evidence on their utility if needed.
New onset alcohol dependence linked to treatment with selective serotonin reuptake inhibitors
Authors: Atigari Onome V. , Kelly Anne-Marie , Jabeen Qamar , Healy David
Published: December 2019

BACKGROUND: Genetic and environmental factors influence the development of alcohol dependence and alcohol dependence increases the risk of developing Major Depressive Disorder-MDD (vice versa). Amongst antidepressants, the selective serotonin reuptake inhibitors (SSRIs) are likely the most frequently prescribed for MDD. However, findings on the role of SSRIs in alleviating alcoholism are conflicting. CASE DESCRIPTION: A review of the literature is highlighted with a case of middle-aged lady with new onset alcohol dependence syndrome after commencement of SSRI, which resolved following discontinuation of the SSRIs and the introduction of Mirtazapine. DISCUSSION: The serotonin transporter gene has been linked to excessive drinking, early-onset problem drinking, alcohol dependence, anxiety and impulsiveness. While the evidence for antidepressant use appears consistent in alleviating depressive symptoms in patients with comorbid alcohol dependence and depression, some groups of patients may show an increase in alcohol consumption. Alternatively, there are a series of studies suggesting that antagonism of S-3 receptors can lead to diminished cravings for alcohol. This case highlights the need for further research into the effects of SSRIs on alcohol consumption in those with and without previous alcohol dependence syndromes. It also indicates a need to monitor changes in alcohol consumption and behaviour while on SSRIs.
Sharps injuries among health care workers in Cairo University Hospitals
Authors: Zawilla N.H. , Ahmed D.
Published: December 2019

BACKGROUND: Health care workers (HCWs) are exposed to blood borne pathogens, through job-related risk factors like sharps injuries (SIs). Sharps injuries can be prevented by safer devices and through education and training of universal precautions and safe work practices. OBJECTIVES: The present study aims to examine the current situation of infection control at Cairo University Hospitals in Egypt, through studying SIs among health care workers and evaluating the preventive measures. SUBJECTS AND METHODS: The first part of this study was cross-sectional in design. A self-administered Arabic questionnaire was designed for this study based on EPINet (Exposure Prevention Information Network) Needle Stick and Sharps injuries reporting Sheet. The second part of the study was an interventional design to evaluate the effectiveness of preventive measures which were introduced since the beginning of 2011. RESULTS: Forty percent of the participants (416/1036) reported at least one sharps injury in the preceding year (2010), of which more than 70% (293/416) experienced more than one injury. 88.9% (370/416, p < 0.001) of HCWs did not report their injury. Following intervention measures injury rates were significantly reduced from 36.9/100 person in 2010 in the intensive care units, to 12.4/100 person during 2011, (X2 = 21.419 and P value < 0.001). CONCLUSION: There is a high occurrence of sharps injuries in Cairo University Hospitals. Implementation of safety devices and adequate training will lead to reduction of SIs among HCWs.
Data based medicine and clinical judgement
Authors: Healy David , Mangin Derelie , Antonuccio David
Published: December 2019

Randomized controlled trials (RCTs) are a useful tool to check the effectiveness of drugs but have come to shape the culture of medicine in a manner that increasingly compromises medical care. Dependence on RCT evidence is compromised by the well-known problems stemming non-publication of trials, lack of access to trial data, ghostwriting of those trials that are published and a variety of coding and other strategies to hide harms. But what is less appreciated is that whenever a drug and an illness can produce the same benefit or harm that the outcomes of RCTs can be profoundly misleading. This article gives examples of how RCTs can produce the wrong answer.
Dependence and withdrawal reactions to benzodiazepines and selective serotonin reuptake inhibitors. How did the health authorities react?
Authors: Nielsen Margrethe , Hansen Ebba Holme , Gøtzsche Peter C.
Published: December 2019

AIM: Our objective was to explore communications from drug agencies about benzodiazepine dependence and selective serotonin reuptake inhibitors (SSRIs) withdrawal reactions over time. METHODS: Documentary study. We searched the web-sites of the European Medicines Agency and the drug agencies in USA, UK, and Denmark for documents mentioning benzodiazepines or SSRIs. We supplemented with other relevant literature that could contribute to our study. The searches were performed in 2009 in PubMed, Google, BMJ and JAMA. RESULTS: It took many years before the drug regulators acknowledged benzodiazepine dependence and SSRI withdrawal reactions and before the prescribers and the public were informed. Drug regulators relied mainly on the definitions of dependence and withdrawal reactions from the diagnostic psychiatric manuals, which contributed to the idea that SSRIs do not cause dependence, although it is difficult for many patients to stop treatment. In the perspective of a precautionary principle, drug agencies have failed to acknowledge that SSRIs can cause dependence and have minimised the problem with regard to its frequency and severity. In the perspective of a risk management principle, the drug agencies have reacted in concordance with the slowly growing knowledge of adverse drug reactions and have sharpened the information to the prescribers and the public over time. However, solely relying on spontaneous reporting of adverse effects leads to underestimation and delayed information about the problems. CONCLUSION: Given the experience with the benzodiazepines, we believe the regulatory bodies should have required studies from the manufacturers that could have elucidated the dependence potential of the SSRIs before marketing authorization was granted.
An observational study to compare the contents and quality of information furnished in CDSCO ADR reporting form, yellow card, medwatch and blue form by the healthcare professionals
Authors: Rehan Harmeet S. , Chopra Deepti , Holani Sonika Newar , Mishra Ritu
Published: December 2019

BACKGROUND: Spontaneous adverse drug reaction (ADR) reporting form is a vital tool for collecting information about ADRs, which helps in establishing the causal assessment and generating a signal. This is feasible if quality information is translated into the reporting form by health care professional (HCPs). Hence, present study was carried out to compare efficiency of HCPs in translating suspected ADR information in the spontaneous reporting forms and to compare the ADR reporting forms of different countries and their duration of training in pharmacovigilance. METHODS: In a cross-sectional study, 50 doctors, 50 Nurses and 50 Pharmacists were asked to fill different reporting forms (CDSCO form, Medwatch, Yellow card and the Blue form) using different simulated ADR case reports. Filled forms were analysed for their contents, information captured and time taken to fill these forms. They were also asked about their training and exposure to pharmacovigilance related activities. RESULTS: All the spontaneous ADR reporting forms had 24–26 data elements to furnish information. Information regarding dechallenge was lacking in the Yellow card and Blue form. Blue form also lacked the information on rechallenge. Overall nurses took longer time to fill all the ADR reporting forms as compared to the doctors and pharmacists. Majority of HCPs missed to fill reporter's information in all the forms. CONCLUSION: Study suggested that the quality of information translated by the HCPs needs improvement for which they should be sensitized periodically on the basic elements of pharmacovigilance.
Information on adverse events in randomised clinical trials assessing drug interventions published in four medical journals with high impact factors
Authors: Maggi Cátia Bauer , Griebeler Isabel Heinzmann , Dal Pizzol Tatiane da Silva
Published: December 2019

BACKGROUND: The impact of the extension of the Consolidated Standards of Reporting Trials (CONSORT) statement, which was published in 2004 and aimed to improve the quality of the safety information presented in clinical trials, remains uncertain. OBJECTIVE: To assess the incorporation of the CONSORT statement extension's recommendations in randomised clinical trials (RCTs) evaluating drug therapies published in high-impact medical journals. METHODS: Using Medline, 122 RCTs published in 2009 were selected from BMJ, JAMA, Lancet, and NEJM. A structured form was used to identify the harms information reported in the RCTs, following the recommendations of the CONSORT statement extension. RESULTS: The most frequently met CONSORT recommendation was the mention of harms in the title or abstract of the paper (72.1% of the papers analysed); the least-met recommendation was the reporting of how the harms information was collected (10.7%). The studies that focused on harms presented better information on safety, but only 10.8% met all recommendations in the CONSORT statement. CONCLUSION: The adverse event information was insufficient for the RCTs published in four high-impact medical journals five years after the publication of the extension of the CONSORT statement.
Medication safety activities of hospital pharmacists in Ghana; challenges and perceived impact on patient care
Authors: Acheampong Franklin , Bruce Elizabeth , Anto Berko Panyin
Published: December 2019

BACKGROUND: Pharmacists by their training have the competences and skills to promote safe use of medicines which is an essential component of patient safety. This study explored the perceptions of hospital pharmacists' role in medication safety in Ghana, identified their attendant challenges and ways of enhancing such roles in the future. METHOD: A self-administered questionnaire was delivered to 200 pharmacists selected conveniently from the 10 regions of Ghana. Questions in the questionnaire were based on a systematic literature review that had catalogued and summarised all the activities of hospital pharmacists related to medication safety. RESULTS: A total of 176 (88% response rate) questionnaires were completed and returned. Almost all pharmacists (97.7%) believed that they were involved in medication safety activities in their daily routine. The frequently performed activities were counselling of out-patient (91.8%), training pharmacy and other clinical students (72.2%), reporting on medication errors (70%), and reconciling medications (69.2%). The mean weekly time spent on the activities ranged from 6.5 to 19.8 hours. Participants who had clinical pharmacy related additional qualifications (χ2 = 37.749; p = 0.049) and worked in tertiary care hospitals (χ2 = 26.6; p = 0.377) undertook more medication safety activities than those without. The cited challenges faced by participants included inadequate time available (62.7%), spending most time in managerial activities (47.3%), lack of formal structures of engagement (43.8%), lack of motivation by superiors (34.9%), and no formal schedule by supervisor (32%). Only 7.7% stated they lack interest in performing those activities. CONCLUSIONS: Pharmacists undertake many medication safety activities routinely that they perceive to have impact on patient care outcomes. Restructuring of their managerial roles will contribute to freeing time for pharmacists to engage more in those activities.
Measuring ward round quality in urology
Authors: Darbyshire Daniel , Barrett Charlotte , Ross David , Shackley David
Published: December 2019

BACKGROUND: Ward rounds are the traditional process by which clinical information is interpreted and management plans made in the inpatient setting and the only time during which patient-doctor interaction can reliably occur. Efforts to improve quality and safety have started looking at the ward round but this has mainly been in the acute medical setting. OBJECTIVE: To begin the quality improvement process for Urological ward rounds. METHODS: Twenty indicators thought to relate to quality were recorded for every weekday ward round by the Urology team for one month. RESULTS: Twenty ward rounds, 93 patient encounters, were reviewed. A consultant was present for 37% of the patient encounters. 84% of observation charts were reviewed; drug charts 28% and antibiotics 70%. Plans were communicated to the doctors, patient and nursing staff. All notes were typed directly onto the electronic system, 20% of notes were checked by the lead clinician. Mean time per patient was 6 minutes. CONCLUSIONS: By starting a discussion about ward rounds we aim to align the process with the broader values of the organisation. Ward rounds can be the cornerstone of delivering safe, clean and personal care and measuring this process is vital to understanding efforts to improve them.
Identifying attitudes about drug safety: A sample survey of Ayurvedic physicians
Authors: Rastogi Sanjeev
Published: December 2019

Objective of this study is to identify the attitudes of Ayurvedic physicians about Ayurvedic drug safety in clinical practice. A sample attitude survey among institutionally qualified Ayurvedic physicians from a prespecified part of India through a self administrable questionnaire was adopted as a method to reach at this objective. Survey shows majority of the respondents accepting the potential adversity from Ayurvedic drugs. A substantial number of the respondents have also accepted their ignorance about the idea of pharmacovigilance in Ayurveda. It highlights the need of more guidance about drug safety and usage to Ayurvedic physician to ensure a safe Ayurvedic clinical practice.
Consideration of the desirable features and possible forms of practical indicators of the performance of pharmacovigilance centres
Authors: Kshirsagar Nilima A. , Olsson Sten , Ferner Robin E.
Published: December 2019

Background: The ultimate goal of pharmacovigilance is to protect patients from drug-induced harm and allow them to derive maximum benefits from medicines. All pharmacovigilance centres have an interest in showing the extent to which they achieve this aim. A core activity is spontaneous reporting. We have considered here whether it is possible to construct appropriate performance indicators for this method. Methods: We set out the stages in the process of pharmacovigilance and sought to decide what specific objectives of the centres could be helpful as practical indicators related to desired outcomes of pharmacovigilance and considered criteria to assess the practicality of an indicator. Results: We constructed a model of the pharmacovigilance process, listed the core functions and deduced a series of potential performance indicators that would be used in practice. Examples included number of reports per million population; proportion of valid reports; number of signals identified; regulatory or clinical action taken. For example data from USA compared to African country show how huge resources in USA give myriad reports, signals and regulatory decisions compared to Africa. Discussion: Pharmacovigilance centres have limited influence over the many complex interactions between patient, prescriber, manufacturer, government and media. However the proposed indicators can be measured in different countries, regions and at different times and allow comparisons. Conclusion: The pharmacovigilance system is a subsystem of a larger healthcare system and is affected by many factors. It is not easy to demonstrate the benefits of pharmacovigilance towards patient safety. However pharmacovigilance centres need to show the extent to which they achieve their objective such as number of reports, number of signals identified, regulatory or clinical action taken. These allow comparison between countries and overtime.
Medicines Regulatory Authority websites: Review of progress made since 2001
Authors: Cornips Claire , Rägo Lembit , Azatyan Samvel , Laing Richard
Published: December 2019

Background: Medicines Regulatory Authorities (MRAs), among other core regulatory functions, play a vital role in stimulating the rational use of medicines by providing regulatory information of good quality to all stakeholders. Little research has attempted to report on existence and maintenance of MRA websites at global level, as well as the types of information made publicly available. Objectives: To identify functioning MRA websites on a global level, to update a study carried out in 2001 on the development of the quality and types of information of 51 websites, and to identify model components within existing websites. Methods: The Internet was searched and WHO Medicines Regional Advisers and WHO medicines country advisers (National Professional Officers) were contacted in order to identify MRA websites. The 51 websites assessed in 2001 were assessed again, using the same criteria for the quality and types of information as in 2001. Results: The number of MRA websites identified has risen from 53 to 116. Most criteria, such as frequency of updates, pharmacovigilance information and regulatory guidance for applicants for medicines marketing authorization (registration) have improved substantially. However, navigability of websites has weakened. Conclusion: Quantitative growth of the number of MRA websites is impressive. The quality of information provided on the 51 assessed websites has improved. Exemplary website components are proposed to help MRAs to improve transparency by developing and maintaining high-quality websites.
Are patients with fractured hips giving valid consent for surgery?
Authors: Purohit Neeraj , Kalairajah Yegappan
Published: December 2019

Introduction: Proximal femoral fractures (intracapsular and extracapsular) most commonly occur in the elderly due to falls, with a higher incidence in women. With the UK population ageing, the incidence of fracture neck of femurs (NOF) has been steadily increasing. In 2007 there were 70,000 NOF fractures treated in the NHS. This number is expected to rise to 91,500 per annum by 2015. The aim of this observational prospective study was to see whether consent comprehension was related to AMTS in an elderly patient with a proximal femoral fracture. Materials and methods: Sixty four patients with hip fractures were included in this study. The patient was consented and an abbreviated mental test score (AMTS) was recorded on admission. Preoperative comprehension was judged using a questionnaire. Univariable linear regression analysis was performed. Results: A significant correlation between the AMTS and consent comprehension scores was found r2 = 0.680 (p<0.0001). Conclusion: We showed a strong correlation between the AMTS and consent comprehension in this patient group. We concluded that due to variation in comprehension scores for a defined AMTS, we could not state above what AMTS a patient can be deemed to have significant comprehension of their consent. Consent training should me mandatory for surgical doctors and that it should not be a one off event, but instead a continuum of events.
The costs of pharmacovigilance in clinical research: A survey from Germany
Authors: Kehrel Uwe
Published: December 2019

This paper analyses the cost structure of pharmacovigilance in investigator-initiated clinical trials. A total of 24 cost estimates, which were provided by five different German Coordinating Centers for Clinical Trials, were included in the study. The highest costs were caused by the processes of Safety Management. At least 30% of the total pharmacovigilance costs were connected with the planning phase and 70% were connected with the implementation phase of a clinical trial. The analysis shows the importance of aspects of costing and funding at an early stage in the planning process.
Healthcare professionals’ understanding and awareness of patient safety and quality of care in Africa: A survey study
Authors: Ente Christopher , Oyewumi Ajibike , Mpora Odongkara Beatrice
Published: December 2019

In Africa there is currently not a wide knowledge of patient safety and healthcare quality. There is inadequate data to measure the scale of medical error and its impact on the healthcare. We investigated the frontline staff experience, their awareness of medical error and willingness to participate in patient safety initiatives. This is a qualitative survey involving 60 healthcare professionals in 2 private and 2 public hospitals in Nigeria and Uganda. Findings highlighted that frontline staff have a good knowledge and understanding of medical error. Thirty percent of the participants said errors occur frequently while only 3.3% were not sure of how often errors occur in their hospitals. Inadequate research on patient safety in literature at present does not mean that medical errors or other issues that undermine patient safety do not occur in Africa. Factors that cause medical errors and the impact of such errors are known to healthcare professionals. They are willing to participate in healthcare improvement programmes. Our findings show the relevance of patient safety in the region and provide a focus for further work that would ultimately contribute to the identification of appropriate interventions that could improve patient safety in Africa.
Making medical practice safer: The role of public policy
Authors: Shortt S.E.D. , Green Michael F. , Corbett Stan , Paquette Laure , Zurba Nadia , Darling Margaret
Published: December 2019

Health care quality and safety is a public policy issue. In the past, issues of quality of care have been largely delegated to the medical profession. Now, however, governments may wish to assume a more active role and will need to know what governance tools are likely to be effective. This paper reviews the evidence on effectiveness for seven processes for governing the physician sector: informing; guiding; educating; reporting; incentivizing; re-licensing; and punishing. There is good evidence for modest to moderate effectiveness of the first three approaches, scant evidence for the next two, and no empirical data on the final two.
Antidepressant-induced suicide, violence and mania: Risks for military personnel
Authors: Breggin Peter R.
Published: December 2019

The newer antidepressants frequently cause suicide, violence and manic-like symptoms of activation or over-stimulation, presenting serious hazards to active duty soldiers who carry weapons under stressful conditions. These antidepressant-induced symptoms of activation can mimic Post Traumatic Stress Disorder (PTSD) and are likely to worsen this common disorder in soldiers, increasing the hazard when they are prescribed to military personnel. Antidepressants should not be prescribed to soldiers during or after deployment. Recently concern has been expressed about the increased prescription of psychiatric medications, especially antidepressants, to military personnel [46, 57]. In presentations at military conferences on combat stress [8, 10] and in testimony before the U.S. House of Representatives Veterans Affairs Committee [9], I have pointed to a probable causal relationship between increasing rates of antidepressant prescription and increasing rates of suicide in the military. This paper reviews and evaluates the relevant scientific data.
Deaths after acupuncture: A systematic review
Authors: Ernst E.
Published: December 2019

Context: Several fatalities after acupuncture have been reported. But no critical analysis of these data is currently available. Objective: This systematic review is aimed at summarizing these reports and putting them into a broader context. Data sources: Four electronic databases and my own files were searched for such reports. No restrictions in terms of language or time were imposed. Study selection: Case reports, case series and other types of articles reporting fatalities were considered. Data extraction: Key data were extracted according to pre-defined criteria. Results: Reports of 86 deaths after acupuncture were found. Many are incomplete and causality may therefore be occasionally uncertain. Due to under-reporting, these reports are likely to merely describe the tip of a larger iceberg. Conclusion: Acupuncture has been associated with numerous deaths. These fatalities are avoidable and a reminder of the need to insist on adequate training for all acupuncturists.
HAART induced adverse drug reactions: A retrospective analysis at a tertiary referral health care center in India
Authors: Anwikar S.R. , Bandekar M.S. , Smrati Bajpai , Pazare A.P. , Tatke P.A. , Kshirsagar N.A.
Published: December 2019

Objective: To collect data on suspected adverse drug reactions of HAART therapy; analyze the data; and find out frequency of preventable adverse drug reactions in order to minimize the harm to the patients. Design: Retrospective study. Methods: ADR data associated with the use of HAART from November 2005 to December 2007 was collected retrospectively from records of patients using the ART treatment from NACO at a tertiary referral centre under the National Pharmacovigilance Programme. These ADRs were analyzed for causality (WHO scale), severity (Hartwig et al. scale) and preventability (Schumock and Thornton scale). Results: Data of 1844 patients (1198-Male & 645-Female) enrolled from November 2005 to December 2007 was collected. 222 patients developed about 228 ADRs with prevalence of 12.36%. Peripheral neuropathy and anemia were highly prevalent ADRs. Nevirapine induced rash and SJ syndrome developed within first month of treatment followed by anemia, hepatitis and gastritis which developed within 6 months after initiation of ART. 96.49% ADRs were found to be possible and 3.50% probable by WHO probability scale. 20 (8.77%) were mild, 176 (77.19%) were moderate and 32 (14.02%) were severe in nature. 183 (80.26%) ADRs were found to be non-serious whereas 45 (19.74%) were serious. Only 2.63% ADRs were found to be preventable which included vomiting and rash. Odds ratio with 95% CI was calculated. Conclusion: It has been observed that antiretroviral therapy has many serious and life threatening adverse drug reactions that may affect a variety of organ systems. Zidovudine use was observed as a risk factor for anemia. Stavudine for peripheral neuropathy, where as nevirapine use was identified as a risk factor for skin reactions. Active pharmacovigilance programme should be implemented and awareness should be created among physicians about reporting any suspected adverse drug reaction so that unreported ADRs and unknown risk factors could be identified.
Unexpected aggressive behaviour: Interaction of bupropion and alcohol
Authors: Chandler Percy , Herxheimer Andrew
Published: December 2019

A healthy policeman was prescribed bupropion in 2002 to help him stop smoking. It worked but after 18 months he relapsed. Though it had given him headaches and insomnia he tried using it again in 2009, taking 8 at end: 150 mg/day. Three days after starting the tablets he took his wife out for dinner. They shared a bottle of wine and he also had other drinks. After walking home they quarrelled, he slapped her, she slapped him. He threw the phone at her saying ‘call the police!’. They came and charged him with assault; he was suspended. An expert report attributed the aggressive outburst to an interaction between bupropion and alcohol; the accused was a social drinker and had never been violent. An expert advising the police agreed, and 14 months after the event the court dismissed the case.
Quality information for quality use of medicines; 2nd International Conference, Kazan, 15–16 October 2010
Authors: Ziganshina Lilia E. , Menkes David B. , Herxheimer Andrew
Published: December 2019

Kazan hosted Russia's first international conference on medicines that was entirely independent of the pharmaceutical industry, attracting 414 participants from 9 countries and 20 regions of the Russian Federation. The meeting was greeted and endorsed by world leaders in pharmaceutical information, policy and regulation. Delegates discussed the professional and social problems arising from unethical drug promotion, including compromised evidence from clinical trials and consequent impairments in health service delivery. The Conference adopted a resolution prioritizing policy development and health system needs, notably including the development of clinical pharmacology. A website documents conference materials and provides an interface for future collaboration: http://evidenceupdate-tatarstan.ru/confer.
Planning safe anesthesia: The role of collective resources management
Authors: Cuvelier Lucie , Falzon Pierre , Granry Jean-Claude , Moll Marie Christine , Orliaguet Gilles
Published: December 2019

Objective: Anticipation and planning are essential steps of risk management but the mechanisms of planning behavior are incompletely understood, especially the factors including collective work. The aim of this research is to understand how anesthetists plan safe solution to perform anesthesia. Methods: A study based on interviews was conducted in two French hospitals. Data processing focused on the main decisions made by 20 anesthetists during two simulated pre-anesthetic consultation. The main decisions made have been identified and the decision criteria have been analyzed. Results: To ensure patient safety, all anesthetists do not plan the same solution. The rejection or the selection of solutions by each physician rests on two types of criteria: the assessment of risks for the patient and the assessment of resources available to handle the situation. For the latter, the knowledge on the individual skills of each and the adoption of “local benchmark practices” play an essential role. Conclusion: Ultra safe performance in highly variable systems cannot be achieved only through standardization but also through the possibility and ability of the subjects to adapt their practices to their own skills and to that of their colleagues. The conditions for the development of this “adaptative safety” are discussed.
Adverse effects of aromatherapy: A systematic review of case reports and case series
Authors: Posadzki Paul , Alotaibi Amani , Ernst Edzard
Published: December 2019

Aim: This systematic review was aimed at critically evaluating the evidence regarding the adverse effects associated with aromatherapy. Method: Five electronic databases were searched to identify all relevant case reports and case series. Results: Forty two primary reports met our inclusion criteria. In total, 71 patients experienced adverse effects of aromatherapy. Adverse effects ranged from mild to severe and included one fatality. The most common adverse effect was dermatitis. Lavender, peppermint, tea tree oil and ylang-ylang were the most common essential oils responsible for adverse effects. Conclusion: Aromatherapy has the potential to cause adverse effects some of which are serious. Their frequency remains unknown. Lack of sufficiently convincing evidence regarding the effectiveness of aromatherapy combined with its potential to cause adverse effects questions the usefulness of this modality in any condition.
Patient safety incidents from acupuncture treatments: A review of reports to the National Patient Safety Agency
Authors: Wheway Jayne , Agbabiaka Taofikat B. , Ernst Edzard
Published: December 2019

Background: Acupuncture is frequently employed to treat chronic pain syndromes or other chronic conditions. Nevertheless, there is a growing literature on adverse events (AEs) from treatments including pneumothorax, cardiac tamponade and spinal cord injury. Acupuncture is provided in almost all NHS pain clinics and by an increasing number of GP's and physiotherapists. Considering acupuncture's popularity, its safety has become an important public health issue. Objectives: To evaluate the harm caused to patients through acupuncture treatments within NHS organisations. Methods: The National Reporting and Learning System (NRLS) database was searched for incidents reported from 1st January 2009 to 31st December 2011. The free text fields of all reports received from all healthcare settings and specialties were searched for the keyword ‘acupuncture’. All relevant incidents were reviewed to provide a qualitative theme of the harm to patients. Results: 468 patient safety incidents were identified; 325 met our inclusion criteria for analysis. Adverse events reported include retained needles (31%), dizziness (30%), loss of consciousness/unresponsive (19%), falls (4%), Bruising or soreness at needle site (2%), Pneumothorax (1%) and other adverse reactions (12%). The majority (95%) of the incidents were categorised as low or no harm. Conclusions: A number of AEs are recorded after acupuncture treatments in the NHS but the majority is not severe. However, miscategorisation and under-reporting may distort the overall picture. Acupuncture practitioners should be aware of, and be prepared to manage, any significant harm from treatments.
The personnel factor: Exploring the personal attributes of highly successful employment specialists who work with transition-age youth
Authors: Tilson George , Simonsen Monica
Published: December 2019

Employment specialists play a pivotal role in assisting youth and adults with disabilities find and retain jobs. This requires a unique combination of skills, competencies and personal attributes. While the fields of career counseling, vocational rehabilitation and special education transition have documented the ideal skills sets needed to achieve desired outcomes, the authors characterize these as essential mechanics. What have not been examined are the personal qualities that effective employment specialists possess. Theorizing that these successful professionals exhibit traits and behaviors beyond the mechanics, the authors conducted a qualitative study incorporating in-depth interviews with 17 top-performing staff of a highly successful national program, The Marriott Foundation's Bridges from school to work. Four personal attributes emerged from the interviews: (a) principled optimism; (b) cultural competence; (c) business-oriented professionalism; and (d) networking savvy. In presenting these findings, the authors discuss the implications for recruitment, hiring, training, and advancing truly effective employment specialists, and offer recommendations for further research.
Does workfare policy in the United States promote the rights of people with disabilities?
Authors: Harris Sarah Parker , Owen Randall , Jones Robin , Caldwell Kate
Published: December 2019

BACKGROUND: Policymakers in the United States continue to face challenges in implementing effective strategies to encourage people with disabilities receiving disability benefits to participate in the labor market. Ticket to Work is one such strategy that has undergone considerable scrutiny. However, the experience of people with disabilities within welfare reform is an area that has been under-researched. OBJECTIVE: To explore how this contentious issue affects the provision of Vocational Rehabilitation services. Following the implementation of Ticket to Work, does workfare policy allow people with disabilities to pursue full and equal participation in the labor market, and do they have equality of opportunity to achieve employment? METHODS: This research takes a qualitative approach to social policy, using empirical data from focus groups with people with disabilities and interviews with policymakers, employment service providers and employers. RESULTS: Three themes emerged from an analysis of data framed within the United Nations Convention on the Rights of Persons with Disabilities in relation to disability rights and workfare policy: the rights of people with disabilities; the expectations of people with disabilities; and the practices associated with policy reform. The findings suggest that a collaboration of government actors, community organizations and the business community is necessary in order to achieve human rights.
Moving employment research into practice: Knowledge and application of evidence-based practices by state vocational rehabilitation agency staff
Authors: Graham Carolyn , Inge Katherine , Wehman Paul , Murphy Kathleen , Revell William G. , West Michael
Published: December 2019

The objective of this study was to identify barriers and facilitators to the use of evidence by professional staff of state Vocational Rehabilitation (VR) agencies. Data were collected via an online survey administered to 355 staff at three state VR departments. Over half of respondents could locate and comprehend research findings. Evidence-based practice (EBP) was not widely encouraged, but there was a positive relationship between the agency having sufficient funds and its support for EBP (r = 0.27, p = 0.001). The top two sources of information respondents used on the job were professional collaboration and the Internet, but not social media. State VR agencies tend not to expect that counselors will use EBP and provide limited incentives for them to do so. While VR staff value research and are open to trying new strategies based on research, translating evidence into usable and accessible products and developing efficient delivery strategies present challenges that the authors intend to investigate further in upcoming research. Knowledge translation strategies need to be developed for this audience.
Service stakeholders' perspectives on methadone maintenance treatment, Special Community Employment schemes and client recovery pathways
Authors: Van Hout Marie Claire , Bingham Tim
Published: December 2019

BACKGROUND: Previous Irish research on client perspectives on the ‘lived social world’ of methadone maintenance treatment (MMT) and participation in Special Community Employment (SCE) schemes have illustrated how MMT offers clients the opportunity to commence recovery and community reintegration, with participation in the SCE schemes acting primarily as therapeutic support mechanism with improvement needed in work based support and employment related outcomes. OBJECTIVES: The research aimed to explore service providers' views on MMT client experiences of participation in SCE vocational training, education and employment seeking. METHODS: Five in depth interviews and three focus groups (n = 14) were conducted with key specialist treatment and rehabilitation service providers' in Dublin, Ireland. RESULTS: Narratives were thematically analysed, and indicative of the positive role of MMT in recovery pathways in terms of stimulating initial client stabilisation, reducing client chaotic lifestyles, initiating new positive health and social behaviours with partners, children, families, and facilitating renewed vocational training on SCE schemes. Outcomes whilst positive in terms of personal development when in recovery are compromised by lack of employment prospects and dedicated work-based supports on exit. CONCLUSIONS: Recommendations were made around the need for long term integrated community care, vocational certification, supported volunteer, employment planning and back to work schemes.
Customized transitions: Discovering the best in us
Authors: Phillips William L. , Callahan Mike , Shumpert Norciva , Puckett Kim , Petrey Rebecca , Summers Karen , Phillips Lynn
Published: December 2019

Transitions from school to work are particularly difficult for students with cognitive disabilities. Job placements in appropriate inclusive community work settings have proven to be possible yet job retention is poor. This article focuses on using customization as a strategy for successful transitions. Six students in rural Kentucky will be receiving resources from vocational rehabilitation and special education to create a discovery portfolio, individualized job development, and customized employment. Their transition will be part of a ten year follow-up study that will track their employment history, inclusion in their chosen community, and asset building. Our goal is to place them in full-time employment that provides a living wage.
Helping each other, helping ourselves: A case of employment for an	adult with autism in Nanjing, China
Authors: McCabe Helen , Wu Suxing
Published: December 2019

This article presents the results of research on one case of employment for an individual with autism in a Chinese city. The research investigated the context of this employment, including family and local leaders' and coworkers' responses to it. Interviews and participant observation were conducted and almost daily work notes collected. Two major themes resulted. First, community efforts led to employment for an individual with autism providing a situation that was seen by all as mutually beneficial, to both the individual and her family as well as to the Community and local government, the Street Office. Second, despite this opportunity provided by the government, the mother's role continued to be essential and primary, including a main goal of making sure her daughter with autism could adapt herself to the coworkers' expectations and job requirements.
The Social Security Administration's youth transition	demonstration projects
Authors: Fraker Thomas , Rangarajan Anu
Published: December 2019

The Social Security Administration (SSA) is funding Youth Transition Demonstration (YTD) projects in multiple sites across the country. These projects seek to improve transitions to adulthood for youth whose disabilities are so severe that they either are currently receiving Supplemental Security Income (SSI) or Social Security disability benefits, or are at high risk of receiving them in the future. Youth participating in the projects are eligible for more generous earnings disregards and other incentives under SSA waivers of certain disability program rules. In addition, the projects provide them with individualized employment and benefits planning services. The waivers and services are designed to increase the likelihood that the YTD participants will become employed, earn enough to reduce their disability benefits, and eventually leave the disability rolls. Under contract with SSA, Mathematica Policy Research, Inc. is conducting a rigorous random assignment evaluation of six of the demonstration projects. Approximately 880 youth at each site who agree to participate in the evaluation are being randomly assigned to treatment or control groups. The treatment group members are eligible for the SSA waivers and YTD services; the control group members are eligible for neither, but they can receive standard disability program work incentives and whatever alternative services may be available in their communities. Mathematica is gathering data on the treatment and control group members for up to four years following random assignment through surveys and SSA administrative records. By comparing mean values of outcomes such as earnings and disability benefit amounts for the treatment and control groups, the evaluation will assess whether the YTD projects are successful at improving transitions to adulthood. Findings from the evaluation will be presented in site-specific interim reports in 2010–2012 and in a comprehensive final report in 2014.