International Journal of Risk & Safety in Medicine - Volume 15, issue 3-4
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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: We systematically analysed two complementary samples of emails relating to patients' problems with the popular SSRI antidepressant, paroxetine. These mainly concerned serious mood disorders and drug withdrawal symptoms. 1,374 emails were immediate responses to a major BBC‐TV documentary programme. These were contrasted with 862 messages on similar themes sent to a website discussion forum over a period of nearly three years. Despite the limitations of most individual email reports, we judged their collective weight to be profound. We also suggest that the value of “immersion” in a large body of such data may be greater than continuing exposure to a…variable trickle of reports. We discuss the significance of these data in relation to the patient–prescriber relationship and pharmacovigilance. We suggest that the Internet offers unparalleled opportunities for soliciting and monitoring patients' reports of adverse drug reactions, and propose practical initiatives to capture peoples' experiences and thereby promote safer and more effective drug use.
Abstract: At present hospitals keep poor records of the number of patients who die on the premises. Monitoring of runs of deaths amongst the patients of individual surgeons, or other practitioners, is generally absent, or it is informal and erratic. Such up‐to‐date information as is available in a hospital is generally not used to calculate the risk of dying from major surgery and hence provide patients offered surgery with an opportunity, if they so wish, to weigh the risk before accepting. Two examples are provided to show how deaths may be avoided when there is monitoring. One example shows how failing…to monitor allows an increase in the number of deaths to go undetected, and uncorrected. The second example shows how calculating the risk may result in patients being treated elsewhere, and lives saved in consequence. The legal framework encouraging monitoring is described; but evidently existing law has not caused hospitals to introduce the formal procedures that could save lives. The reasons for this are a lack of precision in the legal wording, lack of specific penalties, lack of enforcement, and placing the onus on the doctor, rather than on the hospital's management. New legislation is proposed.
Keywords: Performance monitoring, CRAM chart, risk estimation, surgical deaths, health and safety, Health Act 1999 Section 18(1), medical negligence, coroner
Abstract: Introduction: Medication errors contribute up to 8% of all hospital admissions. Minimising the number of information transferrals and improving communication may increase the quality of drug treatment. Material and methods: The effect of introducing shared charts for prescription and administration on the quality of drug handling in a hospital was evaluated using chart review and observation of medicines administration. Results: Comparison of prescriptions in hospital records and nurse charts for medicines administration for 20 patients prior to introducing common charts revealed in no case consensus regarding all medications. One year after introducing the shared charts prescriptions of the…regular and on demand medication were correct and signed for 88% and 48%, respectively, on a patient basis. Ninety‐five percent of the regular administrations were correct and signed. Potential interactions were identified with 8% of the prescriptions. Discharge medication was stated in 65% of the discharge letters to the family doctors. Complete agreement on admission medication between the patient and family doctor was found in 39%. Conclusion: Shared charts for prescription and administration represent a significant step towards safe and rational medical treatment. However, it is more time consuming. The thorough analysis increased the attention on all aspects of medicine handling. It also provided a firm basis for the succeeding detailed specification of a complete integrated and electronic handling of all aspects of the medication process. Improvement of communication between all parties involved in treatment of the same patient represents an important potential for further improving quality and safety of drug treatment.
Abstract: Failure Mode, Effects and Criticality Analysis (FMECA) is used in industry to prevent process or product failures. We studied the feasibility of this method in the hospital environment. FMECA was used to improve drug prescription in two medical wards. Failure modes were identified and classified hierarchically. Corrective actions were taken. Involvement of all the professionals concerned in this process was secured, and has resulted in real acceptance of the proposed changes and in their effective realization.
Keywords: FMECA, quality improvement, drug prescription
Abstract: The authors carried out a pilot study at the Jury lès Metz hospital in Metz, France. The aim was to test methods of detecting and calculating the rate of medication errors (MER) focussing on four types of MER as they were directly accessible to detection and quantification: prescribing error rate (PER), delivering error rate (DER), i.e. discrepancies between prescribed and dispensed quantities, rate of medicines missing at the time of administration rate (MMR), and the repartition error rate (RER), the rate of errors made by nurses in the repartition of medicines into trays or containers. In total 3398 prescriptions…containing 15699 lines of prescription were analysed. The various mean error rates per prescription (95% confidence interval) were: Prescribing Error Rate=1.92% [1.74–2.10], Delivering Error Rate (DER)=2.7% [2.2–3.2], Missing Medication Rate=6.9% [6.1–7.7] and Picking and Repartition Error Rate=5.9% [4.4–7.4]. On the basis of these results and an analysis of the literature and of a case of a fatal error which was publicized in France the authors reflect on the causes and measures for the prevention of medical errors. They conclude that in order to prevent drug induced morbidity, a systematic reduction of medication errors is needed and this requires setting up a multi‐professional management quality assurance system of the drug utilization process. Furthermore, if medication errors occur they should not be covered up but analysed and remedied if possible.
Keywords: Medication error, drug utilization, quality assurance, patient safety, hospital
Abstract: New drugs are frequently heavily prescribed early in their lifecycle, despite an absence of adequate data documenting their effectiveness, safety and pharmacoeconomic value. Evaluations of new drugs done in Canada, France and the United States are all in substantial agreement that most new medications offer little, if any, incremental value over existing therapies. The combination of inadequate information about new drugs plus their limited value strongly argues against their early use except in exceptional circumstances. One of the major reasons for overuse of new drugs is heavy promotion by pharmaceutical companies, especially through their sales representatives. Better control over the…activities of this group of people is one method of improving use of new drugs. Equally important is the development of a significantly improved system of postmarketing surveillance and evaluation. At present, the Canadian government seems unwilling to both rein in promotion and commit resources to an effective postmarketing system.
Keywords: Canada, drug approval process, effectiveness, new drugs, pharmacoeconomic evaluation, postmarketing surveillance, promotion, safety, sales representatives