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Biomedical subjects

R E Ferner

Publications and source records attributed to R E Ferner.

At least 19 recordsLinked to original sources
PubMed2006

Systematic review and meta-analysis of ethnic differences in risks of adverse reactions to drugs used in cardiovascular medicine.

OBJECTIVE: To review the evidence for ethnic differences in susceptibility to adverse drug reactions (ADRs) to cardiovascular drugs. DESIGN: Systematic review and meta-analysis. DATA SOURCES: We searched Medline and Embase to March 2005. Reference lists of identified articles were hand searched for further relevant articles. REVIEW METHODS: Studies were eligible for inclusion if they included at least two ethnic groups and one or more ADRs. We excluded case reports and case series. RESULTS: 564 studies contained some description of ethnicity and an ADR, and 132 of them related to cardiovascular therapies. Twenty four studies provided data for ADRs for at least two ethnic groups and were therefore eligible for inclusion. In pooled analyses the relative risk of angio-oedema from angiotensin converting enzyme (ACE) inhibitors in black compared with non-black patients was 3.0 (95% confidence interval 2.5 to 3.7); the relative risk of cough from ACE inhibitors was 2.7 (1.6 to 4.5) in East Asian compared with white patients; and the relative risk of intracranial haemorrhage with thrombolytic therapy was 1.5 (1.2 to 1.9) in black compared with non-black patients. CONCLUSION: Patients from different ethnic groups have different risks for important ADRs to cardiovascular drugs. Ethnic group may therefore be one determinant of harms of a given treatment in the individual patient, either because it acts as a surrogate measure of genetic make up or because cultural factors alter the risk. Data are sparse, and regulators should consider asking for better data before licensing.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Monitoring for adverse drug reactions.

Monitoring describes the prospective supervision, observation, and testing of an ongoing process. The result of monitoring provides reassurance that the goal has been or will be achieved, or suggests changes that will allow it to be achieved. In therapeutics, most thought has been given to Therapeutic Drug Monitoring, that is, monitoring of drug concentrations to achieve benefit or avoid harm, or both. Patients and their clinicians can also monitor the progress of a disease, and adjust treatment accordingly, for example, to achieve optimum glycaemic control. Very little consideration has been given to the development of effective schemes for monitoring for the occurrence of adverse effects, such as biochemical or haematological disturbance. Significant harm may go undetected in controlled clinical trials. Even where harm is detected, published details of trials are usually insufficient to allow a practical monitoring scheme to be introduced. The result is that information available to prescribers, such as the Summary of Product Characteristics, frequently provides advice that is incomplete or impossible to follow. We discuss here the elements of logical schemes for monitoring for adverse drug reactions, and the possible contributions that computerized decision support can make. We should require evidence that if a monitoring scheme is proposed, it can be put into practice, will prove effective, and is affordable.

Adverse Drug Reaction Reporting Systems↗
PubMed2006

Doctors charged with manslaughter in the course of medical practice, 1795-2005: a literature review.

OBJECTIVES: To quantify the number of doctors charged with manslaughter in the course of legitimate medical practice and to classify cases, as mistakes, slips (or lapses), and violations, using a recognized classification of human error system. DESIGN: We searched newspaper databases, Medline, Embase, and the Wellcome library catalogue to identify relevant cases from 1795 to December 2005. SETTING: Medical practice in the United Kingdom. MAIN OUTCOME MEASURE: Number of doctors charged with manslaughter in the course of medical practice. RESULTS: We identified 85 doctors charged with manslaughter since 1795. The number of doctors charged was relatively high in the mid-19th century and the inter-war years, and has dramatically increased since 1990. Sixty of the doctors were acquitted, 22 were convicted, and three pleaded guilty. Most doctors were charged as a consequence of mistakes (37) or slips (17), and a minority because of alleged violations (16). CONCLUSIONS: The number of doctors prosecuted for manslaughter has risen steeply since 1990, but the proportion of doctors convicted remains low. Prosecution for deliberately violating rules is understandable, but accounts for only a minority of these cases. Unconscious errors--mistakes and slips (or lapses)--are an inescapable consequence of human actions and prosecution of individuals is unlikely to improve patient safety. That requires improvement to the complex systems of health care.

Homicide↗
PubMed2005

Identification of novel deletion breakpoints bordered by segmental duplications in the NF1 locus using high resolution array-CGH.

BACKGROUND: Segmental duplications flanking the neurofibromatosis type 1 (NF1) gene locus on 17q11 mediate most gene deletions in NF1 patients. However, the large size of the gene and the complexity of the locus architecture pose difficulties in deletion analysis. We report the construction and application of the first NF1 locus specific microarray, covering 2.24 Mb of 17q11, using a non-redundant approach for array design. The average resolution of analysis for the array is approximately 12 kb per measurement point with an increased average resolution of 6.4 kb for the NF1 gene. METHODS: We performed a comprehensive array-CGH analysis of 161 NF1 derived samples and identified heterozygous deletions of various sizes in 39 cases. The typical deletion was identified in 26 cases, whereas 13 samples showed atypical deletion profiles. RESULTS: The size of the atypical deletions, contained within the segment covered by the array, ranged from 6 kb to 1.6 Mb and their breakpoints could be accurately determined. Moreover, 10 atypical deletions were observed to share a common breakpoint either on the proximal or distal end of the deletion. The deletions identified by array-CGH were independently confirmed using multiplex ligation-dependent probe amplification. Bioinformatic analysis of the entire locus identified 33 segmental duplications. CONCLUSIONS: We show that at least one of these segmental duplications, which borders the proximal breakpoint located within the NF1 intron 1 in five atypical deletions, might represent a novel hot spot for deletions. Our array constitutes a novel and reliable tool offering significantly improved diagnostics for this common disorder.

Chromosome Breakage↗
PubMed2005

National differences in publishing papers on adverse drug reactions.

AIMS: To examine how countries differ in attitudes to adverse drug reactions by examining published scientific papers. METHODS: We searched Ovid EMBASE for publications indexed by the category "therapeutic agents", and the subcategory "adverse effects", by country for 43 countries. RESULTS: We counted 1 810 202 papers world-wide regarding therapeutic agents during 14 years, of which 195 154 (10.8%) were included in the adverse effects subcategory. There were substantial differences between countries, not explained by population, economic variation, overall publication rate on therapeutic agents, or the presence of large indigenous pharmaceutical companies. CONCLUSIONS: Many local cultural factors influence the ratio of papers on adverse reactions to all drug effects, so it may be difficult to improve their recognition and reporting by international efforts.

Attitude to Health↗
PubMed2005

The quality of information on monitoring for haematological adverse drug reactions.

AIMS: To examine the adequacy of instructions to monitor for haematological adverse drug reactions in the Summary of Product Characteristics. METHODS: We searched the United Kingdom eMedicines Compendium to identify instructions to monitor for haematological adverse drug reactions, and selected 84 Summaries of Product Characteristics for nonhaematological drugs, which were then scored independently by five clinicians, using a scale we devised, the Systematic Instructions for Monitoring (SIM) score. A subset of comparable summaries from Australian and United States summaries was also examined. RESULTS: The SIM scores for the five clinicians agreed well: Kendall's coefficient of concordance = 0.937, P < 0.0001. The median SIM score for the 84 UK summaries was 13 [95% confidence interval (CI) for median 12, 15] out of a possible 31. Over 40% fell below a hypothetical minimally acceptable score of 12/31. SIM scores were on average 2.0 (95% CI 0.4, 3.8) higher for Australian summaries; US summaries had intermediate scores that did not significantly differ from those in Australia or the UK. CONCLUSIONS: Instructions on monitoring for adverse drug reactions are often inadequate. Pharmaceutical companies and regulatory agencies should produce clear guidance on monitoring, and the data to support it.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Late-onset optic pathway tumors in children with neurofibromatosis 1.

Identification of new optic pathway tumors (OPTs) and progression of pre-existing OPTs in children with neurofibromatosis 1 (NF1) have been reported infrequently after age 6. The authors present eight children with NF1 (mean age 12.2 years) seen in three NF1 centers who had either late-onset (four of eight) or late-progressive (seven of eight) OPT. Continued monitoring of individuals with NF1 into adulthood for the development of OPTs and for progression of known OPTs is warranted.

Adolescent↗
PubMed2004

The impact of PET scanning on management of paediatric oncology patients.

PURPOSE: Limited information is available on the use of positron emission tomography (PET) in paediatric oncology. The aim of this study was to review the impact of PET on the management of paediatric patients scanned over a 10-year period. METHODS: One hundred and sixty-five consecutive oncology patients aged 11 months to 17 years were included. Two hundred and thirty-seven scans were performed. Diagnoses included lymphoma (60 patients), central nervous system (CNS) tumour (59), sarcoma (19), plexiform neurofibroma with suspected malignant change (13) and other tumours (14). A questionnaire was sent to the referring clinician to determine whether the PET scan had altered management and whether overall the PET scan was thought to be helpful. RESULTS: One hundred and eighty-nine (80%) questionnaires for 126 patients were returned (63 relating to lymphoma, 62 to CNS tumours, 30 to sarcoma, 16 to plexiform neurofibroma and 18 to other tumours). PET changed disease management in 46 (24%) cases and was helpful in 141 (75%) cases. PET findings were verified by histology, clinical follow-up or other investigations in 141 cases (75%). The returned questionnaires indicated that PET had led to a management change in 20 (32%) lymphoma cases, nine (15%) CNS tumours, four (13%) sarcomas, nine (56%) plexiform neurofibromas and four (22%) cases of other tumours. PET was thought to be helpful in 47 (75%) lymphoma cases, 48 (77%) CNS tumours, 24 (80%) sarcomas, 11 (69%) neurofibromas and 11 (61%) cases of other tumours. PET findings were verified in 44 (70%) lymphoma cases, 53 (85%) CNS tumours, 21 (70%) sarcomas, 12 (75%) neurofibromas and 11 (61%) other tumour cases. CONCLUSION: PET imaging of children with cancer is accurate and practical. PET alters management and is deemed helpful (with or without management change) in a significant number of patients, and the results are comparable with the figures published for the adult oncology population.

Adolescent↗
PubMed2004

Adverse drug reaction teaching in UK undergraduate medical and pharmacy programmes.

OBJECTIVES: To assess the extent of teaching about the Committee on Safety of Medicine's Yellow Card scheme and adverse drug reactions within UK Schools of Medicine and Pharmacy. METHODS: A self-completed questionnaire sent to all heads of undergraduate schools of medicine and pharmacy within the UK. RESULTS: The majority of undergraduate syllabi feature the Yellow Card Scheme. Knowledge of the Yellow Card Scheme was assessed in 79% of pharmacy programmes and 57% of medical schools. Specialist speakers on the Yellow Card Scheme were infrequently used. Fewer than half of respondents provided students with a guide to reporting ADRs (43% pharmacy and 43% medical). There is some disagreement about the value of supplying students with printed material about the Yellow Card Scheme. Half of medical Schools did not think that supplying 'Current Problems In Pharmacovigilance' would be useful. CONCLUSIONS: It was found that in both medicine and pharmacy, courses differed substantially in teaching about the Yellow Card Scheme and adverse drug reactions (ADRs). There is scope for increased involvement of the Medicines and Healthcare products Regulatory Agency in undergraduate education, in line with recommendations from the National Audit Office.

Adverse Drug Reaction Reporting Systems↗
PubMed2004

Testing the practical aspects of therapeutics by objective structured clinical examination.

Medical students need to have a sound theoretical knowledge of pharmacology and a training in the practical aspects of therapeutics in order to prescribe effectively, safely and rationally when they qualify. Students have traditionally sat written exams and the practical aspects have been largely ignored. At the University of Birmingham we set up an objective structured clinical examination (OSCE) style examination to test the practical aspects of therapeutics. Over the last 2 years, 434 students have been examined in this way to determine competency in various clinical skills including, for example prescription writing, the drawing up and giving of injections, setting up nebulizers, and patient counselling about drug effects. Over that time we found the therapeutics OSCE to be feasible and useful. It has demonstrated serious practical deficiencies that were not apparent from written examinations in some students' ability to prescribe and administer drugs. Since its introduction, performance in the OSCE has improved. Whether this will result in safer and more effective prescribing in the preregistration house officer year has not been formally evaluated but it appears that they approach this aspect of patient care with greater confidence than graduates from other schools.

Clinical Competence↗
PubMed2004

Neurofibromatous neuropathy in neurofibromatosis 1 (NF1).

BACKGROUND: Neurofibromatosis 1 (NF1) is a common, autosomal dominant, neurocutaneous disease that is clinically and genetically distinct from the rare condition neurofibromatosis 2 (NF2). Neurofibromatous neuropathy has been regarded as a common feature of NF2, but is an unusual and unexplained complication of NF1. The clinical and histological features of the NF1 neuropathy are distinct from those encountered in NF2. We describe eight patients with a symmetrical polyneuropathy, which has been called neurofibromatous neuropathy. METHODS: Clinical assessments, laboratory investigations, neuroimaging, and neurophysiology were undertaken in eight individuals with neurofibromatous neuropathy. None were referred because of neuropathic symptoms. Two subjects underwent sural nerve biopsy and three agreed to mutational analysis. RESULTS: The patients had an indolent symmetrical predominantly sensory axonal neuropathy and unusually early development of large numbers of neurofibromas. The biopsied nerves showed diffuse neurofibromatous change and disruption of the perineurium. Two patients developed a high grade malignant peripheral nerve sheath tumour. Disease causing mutations were detected in two individuals and molecular studies did not reveal any whole gene deletions. CONCLUSIONS: Neurofibromatous neuropathy occurred in 1.3% of 600 patients with NF1. Its cause may be a diffuse neuropathic process arising from inappropriate signalling between Schwann cells, fibroblasts, and perineurial cells.

Adult↗
PubMed2004

Improving prescribing using a rule based prescribing system.

OBJECTIVE: To test the hypothesis that the prescribing behaviour of doctors would improve after having experience with a computerised rule based prescribing system. DESIGN: A prospective observational study of changes in prescribing habits resulting from the use of a computerised prescribing system in (1) a cohort of experienced users compared with a new cohort, and (2) a single cohort at the beginning and after 3 weeks of computer aided prescribing. SETTING: 64 bed renal unit in a teaching hospital. INTERVENTION: Routine use of a computerised prescribing system by doctors and nurses on a renal unit from 1 July to 31 August 2001. MAIN OUTCOME MEASURES: Number of warning messages generated by the system; proportion of warning messages overridden; comparison between doctors of different grades; comparison by doctors' familiarity with the system. RESULTS: A total of 51,612 records relating to 5995 prescriptions made by 103 users, of whom 42 were doctors, were analysed. The prescriptions generated 15,853 messages, of which 6592 were warning messages indicating prescribing errors or problems. Doctors new to the system generated fewer warning messages after using the system for 3 weeks (0.81 warning messages per prescription v 0.42 after 3 weeks, p = 0.03). Doctors with more experience of the system were less likely to generate a warning message (Spearman's rho = -0.90, p = 0.04) but were more likely to disregard one (Spearman's rho = -1, p<0.01). Senior doctors were more likely than junior doctors to ignore a warning message. CONCLUSIONS: Doctors are influenced by the experience of using a computerised prescribing system. When judged by the number of warning messages generated per prescription, their prescribing improves with time and number of prescriptions written. Consultants and registrars are more likely to use their clinical judgement to override warning messages regarding prescribed drugs.

Contraindications↗