International Journal of Risk & Safety in Medicine - Volume 8, issue 3
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The International Journal of Risk and Safety in Medicine is concerned with rendering the practice of medicine as safe as it can be; that involves promoting the highest possible quality of care, but also examining how those risks which are inevitable can be contained and managed.
This is not exclusively a drugs journal. Recently it was decided to include in the subtitle of the journal three items to better indicate the scope of the journal, i.e. patient safety, pharmacovigilance and liability and the Editorial Board was adjusted accordingly. For each of these sections an Associate Editor was invited. We especially want to emphasize patient safety. Our journal wants to publish high quality interdisciplinary papers related to patient safety, not the ones for domain specialists. For quite some time we have also been devoting some pages in every issue to what we simply call WHO news. This affinity with WHO underlines both the International character of the journal and the subject matter we want to cover. Basic research, reports of clinical experience and overviews will all be considered for publication, but since major reviews of the literature are often written at the invitation of the Editorial Board it is generally advisable to consult with the Editor in advance. Submission of news items will be appreciated, as will be the contribution of letters on topics which have been dealt with in the journal.
Abstract: In many countries, birth defect monitoring systems have been set up in order to identify new teratogens as soon as possible. The usual approach to monitoring involves analysis of the frequency of specific birth defects over time. This approach has been criticized as having poor statistical power to detect epidemics due to new rare teratogenic exposures. A proposed alternative approach is the on-going analysis of risk-factor data with a case-control approach. In this paper, we present birth-defects and risk-factor surveillance data from the Northern Netherlands (NNL). For years of birth 1981–1994, 4014 cases had been registered. We investigated combinations of…32 diagnostic categories and 77 risk factors. For 10 combinations a P value < 0.01 was found; for another 25, the P value was between 0.01 and 0.05. We then checked these positive associations against data from the Metropolitan Atlanta Congenital Defects Program (MACDP) and the MAternal DRug Exposure surveillance project (MADRE). In all three data sets, an association between maternal use of psychotropic drugs (psycholeptics) and cleft lip with or without cleft palate (CLP) was present. The highest odds ratio was found for CLP and maternal use of oxazepam in the NNL data (OR = 8.17, 95% CI 1.26–42.2). Both in the MACDP data and in the NNL data, an association between maternal smoking and clubfoot was found. Although the odds ratios were low, the attributable fraction derived from the NNL data was 11%. Methodologic issues that should be considered in this approach include exposure ascertainment and classification, outcome specificity, and type I errors. The strengths of this approach include its population-based nature and the ability of users to check results against results from other similar systems.
Keywords: Congenital defects, psycholeptic drugs, smoking, methodology, sex hormones, anti-epileptic drugs, The Netherlands
Abstract: A total of 445 cervical hip fractures were operated and followed for 1–5 years. Internal fixation was used in 224 fractures, a total hip replacement was used in 98 fractures and hemiarthroplasty was used in 123 fractures. The failure rate for internal fixation was 63/224 = 28%. The most common complication following total hip replacement and hemiarthroplasty was luxation. A total of 28 of these patients had a total of 55 luxations. Closed reduction was sufficient in 12 patients but 16 patients needed futher surgery. The must common reoperation was a total hip replacement used in 56 cases out of…83 reoperations. A total of 32 (7%) patients had a postoperative superficial or deep infection following either the primary operation or an eventual reoperation. Cultures identified Staphylococcus aureus as the cause in 59% and E. coli in 9.4% of these infections. The total wound infection rate was 5.6% following primary operation in contrast to 8.4% following reoperation (P < 0.05). However the difference was not significant for deep infection alone (2.0% and 2.4%).
Abstract: In the mid-1980s, the licensing authorities in Quebec, Ontario and Manitoba have introduced programs to conduct in-depth assessments of the clinical skills and abilities of physicians with suspected deficiencies. These assessments are intended to supplement the provincial licensing authorities' existing peer review or patient-complaint mechanisms by confirming the physicians' overall level of competence and identifying specific clinical strengths and weaknesses. An “educational prescription”, based on the results of the assessment, focuses on aspects of clinical practice in which the physicians need or wish to enhance their skills. In some situations, licensure decisions are based on the assessment information. This article…describes the programs in Quebec, Ontario and Manitoba. Each program comprises a different process of personal assessment and individualized continuing medical education to help physicians improve their clinical competence, and each is built on sound principles of clinical competence assessment and educational planning.
Keywords: Competence, evaluation, assessment, continuing medical education, enhancement
Abstract: On basis of secondary analysis of data obtained from the ‘Dutch National Survey of Morbidity and Intervention in General Practice’, we tried to gain insight into the nature and extent of iatrogenic illnesses in general practice. In this registration project 386,000 contacts of patients with 161 GP's have been recorded, using the International Classification of Primary Care (ICPC). We confined ourselves to ‘side effects of medication’ and ‘complications of medical treatment’. It appears that in two percent of all contacts the GP has made one of these two diagnoses, or has considered these. On average, the patients concerned suffered twice…more often serious invalidating or danger of life. Herewith these two groups of iatrogenic harm constitute an important problem in general practice.
Abstract: Two characteristic historical examples of defensive medicine are referred to and analysed. The first of them relates to the behaviour of the eminent and experienced physician Critobulus, a member of the family of Asclepiades of Cos Island, native island of Hippocrates, who hesitated to undertake the operation on the severely wounded Alexander the Great, who was hurt during the siege of a town of the Mallians in India (326 BC). The second case refers to the Byzantine Emperor, Justin II (578 AD), when his physicians hesitated to undertake an operation for a possible wedging of a stone in the urethra,…which caused painful inflammation. In both cases, the physicians proceeded to the operation after being reassured by their illustrious patients that they would not be punished in the event of failure. Furthermore, in the second case, of the mentally unbalanced Justin II, the physicians requested, obviously in the presence of witnesses, their immunity from punishment with the symbolic gesture of the handing over of the scalpel to them by the patient. This act symbolised the agreement of the patient to the operation.
Keywords: Alexander the Great, defensive medicine, Justin II
Abstract: The question of possibly increased teratogenic risk as a result of usage of multiple drugs during pregnancy (poly therapy) as compared with monotherapy or nonexposure has rarely been explored. The present study summarizes the outcome of pregnancy in terms of children born to women who took multiple drugs during pregnancy in comparison with a drug-free control group. Poly therapy represents 19.8% of all patients who actually have used drugs during pregnancy and called for counselling. The two groups were similar in all maternal and infant characteristics. The outcome of both groups regarding the prevalence of major congenital malformations and postnatal…disorders was favorable. However, caution and close monitoring of the fetus and newborn are needed because definite conclusions cannot yet be reached.
Keywords: Drugs in pregnancy, polytherapy, teratology information service, teratogenic counselling
Abstract: Based on 49,621 prescriptions during a period of 6 months we analysed factors relevant to the use of antibiotics among 137 general practitioners based on the reimbursement by the Danish Health Service. The background population constituted 167,105 adults and 42,392 children. The Danish Health Service refunds either 50 or 75% of the costs of antibiotics. The mean reimbursement per prescription was 96.45 DKK ranging between 56.10 DKK and 141.95 DKK. The total prescribed amount of antibiotics per GP measured in defined daily dose (DDD), the reimbursement per prescription for all other drugs than antibiotics, the proportion of patients above the…age of 65 years and the number of cultures per 1,000 patients were positively associated with the reimbursement per prescription of antibiotics. The four variables explained 29% of the variation. The number of cultures and consultations per general practitioner were positively associated with the total reimbursement for antibiotics per general practitioner, while the number of throat swabs per general practitioner was negatively associated. The prescribed amount of DDD per prescription and the reimbursement per DDD of antibiotics contributed almost equally to the variation in reimbursement for each prescription. The study thus shows that the doctors prescribing the highest amounts of antibiotics measured as DDD also choose the most expensive drugs and that this choice of expensive drugs seems to be a general trend independent of the ATC group.
Keywords: Antibiotics, drug utilization, family practice, epidemiology
Abstract: The aim of the study was to determine the long-term survival in patients undergoing total hip arthroplasty in relation to type of perioperatively administered thromboprophylaxis. Patients from seven randomized controlled trials of the effect of thromboprophylaxis on development of early thromboembolic complications after total hip arthroplasty were included in a follow-up analysis with death as the end-point. There was no difference in survival between groups receiving active thromboprophylaxis, but there was a general trend towards a better survival in the 3 placebo groups compared with low molecular weight heparin (LMWH), (RR: 1.53; C.I.: 1.04–2.25). There was a significant excess of…cardiovascular deaths in the LMWH groups (RR: 2.48; CI: 1.45–4.24). Long-term prospective studies should be performed to assess the long-term effect of various thromboprophylactic regimens on morbidity and mortality after total hip arthoplasty.
Keywords: Long-term survival, hip arthroplasty, thromboprophylaxis