International Journal of Risk & Safety in Medicine - Volume 21, issue 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: Prematurity remains one of the main causes of neonatal mortality and morbidity even in countries that have well-developed comprehensive maternity and neonatal services. Objective: A review of the epidemiology and the short-term complications arising from natural or iatrogenic prematurity in modern practice is necessary to assess the true import of this obstetric complication. Methodology: All deliveries with known gestational age at delivery in the Maltese Islands during the period 1999–2006 were included in the study (23,073 maternities with a total of 23,422 births). These maternities included a total of 1279 delivered at a documented 36 or less completed…weeks of gestation. Results: During the period under review the prematurity rate amounted to 6.2% of all maternities. Iatrogrenic-induced births accounted for 33.9% of the total. A premature birth was statistically more likely to occur in women at their extremes of reproductive life (≤17 years: OR=1.16; or ≥30 years: OR=1.44: p<0.0001), or who gave a history of multiparity (Para 3+: OR=1.56: p=0.008) or previous recurrent miscarriage (OR=1.79: p=0.008) or fetal loss (OR=3.17: p<0.0001). The current pregnancy was statistically more likely to be a multiple pregnancy (OR=13.52: p<0.0001) or be complicated by hypertension (OR=2.62: p<0.0001), pre-existing (OR=7.50: p<0.0001) or gestational (OR=2.4: p<0.0001) diabetes, or antenatal bleeding (OR=9.22: p<0.0001). Premature births were statistically more likely to deliver by Caesarean section (OR=2.13: p<0.0001). The stillbirth and neonatal mortality is significantly higher (OR=73.0: p<0.0001) in premature births; while the premature infant is very much more likely to require resuscitation and life support interventions (low 5 min Apgar score: OR=36.5: p<0.0001). The neonatal period of the premature infant is fraught with risks of significant serious complications such as respiratory distress syndrome (OR=9.14: p<0.0001), hyperbilirubinaemia (OR=16.0: p<0.0001) and sepsis (OR=16.0: p<0.0001). Conclusions: The short-term morto-morbidity and the long-term morbidity associated with preterm births necessitates a determined drive to identify those pregnant women at risk so that proactive intervention management can be instituted.
Abstract: Background to the debate: The financial ties between doctors and drug companies have come under intense scrutiny in recent years. Some commentators – such as Marcia Angell, former Editor-in-Chief of the New England Journal of Medicine – argue that the mission of doctors is fundamentally different to the mission of drug companies and that the ties between them should be completely cut. “Drug companies are investor owned businesses with a responsibility to maximise profits for their shareholders”, says Angell (BMJ 338 (2009), b222). “That is quite different from the mission of the medical profession, which is to provide the best…care possible for patients”. Other commentators have argued that clinicians and drug companies do have some shared goals in aiming to maximize human health. In this debate, Emma D'Arcy, co-founder of a social networking site that facilitates interactions between doctors and drug companies, argues that it would be valuable to the public if we could establish “authentic alliances” between these professionals. But journalist Ray Moynihan argues that such alliances are prone to the corrupting influence of pharmaceutical industry money, and that disentanglement is a healthier alternative.
Abstract: Background and objective: Inappropriate use and storage of pain medications may cause unnecessary wastage and potential harm. The objective of this study was to investigate the type, storage habits, potential wastage and potential harm of pain medications stored in households in Nablus district, Palestine. Methodology: This is a cross-sectional, anonymous, questionnaire-based study. The drug product inventory in the surveyed households was investigated and family members were interviewed. Data were coded, entered and analyzed using statistical package for social sciences software (SPSS 16). Results: A total of 415 households in Nablus district, Palestine were surveyed. The total number of…different types of medications in the surveyed households was 5505; the mean ± SD was 13.3±7.8. The total number of different types of stored pain medications was 1103, constituting 20% of the stored medications. The average number of pain medications was 2.7±1.8 per household. Pain medication storage was not associated with most of the tested demographic variables. More than one third (39.7%) of pain medications were stored in relatively unsafe places around the house within the reach of children. The percentages of unused pain medications, expired, and those with no clear expiration date were 20%, 14.9% and 12.9% respectively. Estimated wastage of pain medications in the 415 households and in the whole Nablus district was 4,000 USD and 384,000 USD respectively. The most common pain medications encountered in households were: acetaminophen (42%), ibuprofen (24%) and diclofenac (18%). Conclusion: Pain medications were frequently encountered in Palestinian households, and relatively large percentage was being wasted. Keeping a limited stock of pain medication may avoid overuse of more expensive health services and might thus be cost-saving as well.
Abstract: Study objective: Resuscitation is a fast paced highly complex process which makes considerable demands on the resuscitation team; even minor errors and failures may reduce the chance of a successful outcome. Failure Mode Effects Analysis (FMEA) is a team-based, systematic proactive step-by-step process which identifies failure modes/hazards within the process which could compromise the progression and outcome of the process and highlights where improvements need to be implemented to mitigate failures from occurring. We applied FMEA to the resuscitation process and highlight specific areas within the currently accepted resuscitation protocol which require further assessment. Methods: We followed the procedure…for FMEA outlined by the Joint Commission but with some modifications of the basic process. Our modified approach made use of 16 individual interviews with healthcare professionals experienced in resuscitation and focus groups in order to gain a more detailed understanding of the different perspectives on the resuscitation process. The interviews prioritised potential failures that exist in the on-ward resuscitation process which enabled the team to identify specific areas which require further assessment and improvements. Results: In total the FMEA found 28 failure modes that carry a degree of risk that require action. It was found that staff perceived failure modes that relate to the patient's airway, breathing or circulation as ones which would result in a severe effect on the patient's outcome, and those that relate to tasks involved in the running of the process were often perceived as likely to occur. Conclusion: The modified FMEA approach proved practical, and was well received by clinicians within the context of resuscitation and fundamentally highlighted areas where quality improvements are necessary. Our research group and design team at the Helen Hamlyn Centre used the FMEA to develop design cues and technology innovations to address current issues of design duplicity that would be incorporated into a new ‘intelligent resuscitation trolley’ which we foresee will support the team by improving communication, coordination and overall efficiency.
Keywords: Failure Mode and Effect Analysis, FMEA, resuscitation, cardiac arrest
Abstract: The aim of this article is to present available strategies to develop healthcare safety systems by merging Hospital Discharge Records and medical malpractice claim data in available regional administrative archives of the Lombardy region (Italy). Firstly, we illustrate the regional database collecting claims and demands of reimbursement declared by patients hospitalized in regional healthcare structures, then we discuss strategies to model the association between quality indicators, obtained by Hospital Discharge Records, and the incidence of clinical errors causing the patient's death or lesions. As first result, the merged database evidences a limited temporal range covered by both informative…systems (2004–2006), essentially imputable to a scarce data quality in Hospital Discharge Cards records before 2004 and to a high incidence of open claims in the claims database after 2004. Further, clinical errors show an extreme sparseness among involved Health structures. The analysis, focused on the triennium 2004–2006, was performed in a cross-sectional perspective using Binomial Negative regression models. Results evidenced that re-admissions rate for the same Major Diagnostic Category and discharges against medical advice rate significantly affect the incidence of errors causing the patient's death, whereas unscheduled surgical readmission rate in operating room significantly affects the incidence of surgical error rate.
Abstract: Adverse drug reaction reporting is an important means of establishing new knowledge and generating early signals of possible drug complications. Several reporting systems exist for adverse events however these reporting systems are associated with relatively low levels of reporting. The quality of the reporting is also important which ultimately depends upon the information furnished by the clinician in the available form. In order to improve the quality of information provided in the form, healthcare professional should know the importance of any information that he/she is providing. In this study hundred filled ADR reporting forms were selected and analyzed with…respect to the quality of information provided. It was observed that the columns which were required to be filled completely, but were not filled correctly were diagnosis, description of the event, outcome attributed to adverse event, relevant test/lab data, concomitant medications. These are important details that must be reported, for evaluation of cause–effect relationship. Thus health care professionals should be aware of the importance of the information they are providing in the form and they should get proper instructions for filling the form, so as to improve the quality of information provided in the form. More CMEs and workshops should be conducted to improve awareness. In this article an attempt is made to provide information on how to fill the form completely.
Keywords: ADR, reporting form, adverse events, reporting systems