International Journal of Risk & Safety in Medicine - Volume 26, 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: BACKGROUND: Medication safety is an essential component of patient safety in health care delivery. Providing strategies to effectively prevent medication errors and adverse drug events in hospitals has gained international recognition. OBJECTIVE: The aim of this paper was to review systematically the research literature on the various interventions for providing medication safety in hospitals. METHOD: Eight healthcare databases were searched for full research articles written in English. Reference lists of included studies were also searched. Research studies involving delivery of interventions in hospitals with the aim of preventing or reducing medication errors and adverse drug events were examined. RESULTS: Forty-two…studies were selected. Most of the studies were before and after designs without comparative control groups. Forty studies identified interventions contributing to the prevention and reduction of medication errors. Six broad types of interventions were identified: computerized physician order entry with or without clinical decision support systems, automation, computer assisted, barcode technology, pharmacist role, training and system designs. CONCLUSION: Though studies have provided evidence for individual interventions, there are concerns about the extent of their effectiveness. This has implications for policy makers and clinicians to adopt multifaceted approach in providing medication safety in their hospitals.
Keywords: Medication errors, adverse drug events, drug interventions, medication safety
Abstract: BACKGROUND: Wrong site confusions are among the most common mistakes in operations of twosome organs. PURPOSE: To examine the frequency of wrong sided confusions that could theoretically occur in various surgeries in the absence of preoperative verification. METHODS: Ten cataract surgeons, twelve orthopedic surgeons and 6 ENT surgeons participated in the study. The surgeons were asked to fill a questionnaire that included their demographic data, occupational habits and their approach to and handling of patients preoperatively. On the day of operation the surgeons were asked to recognize the side of the operation from the patient's name only. At the second…stage of the study, surgeons were asked to recognize the side of the operation while standing a two meter distance from the patient's face. Surgeons' answers were compared to the actual operation side. Patients then underwent a full “time out” procedure, which included side marking before the operation. RESULTS: Of a total of 67 ophthalmic patients, 52 orthopedic patients and 26 ENT patients the surgeons correctly identified the operated side in 111 (76.5%) by name and in 126 (87%) by looking at patients' faces. Wrong side identification correlated with the time lapsed from the last preoperative examination (p = 0.034). The number of cataract surgeries performed by the same surgeon (on the same day) also correlated to the number of wrong identifications (p = 0.001) in ophthalmology. Orthopedic surgeons were more accurate in identifying the operated site Surgeon seniority or age did not correlate to the number of wrong identifications. CONCLUSIONS: This study illustrates the high error that can result in the absence of side marking prior to cataract surgery, as well as in operations on other twosome organs.
Keywords: Wrong site surgery, wrong side surgery, side marking, time out
Abstract: BACKGROUND: While yellow card reporting system has started in 1998 in Iran, the ADR reporting rate is very low. OBJECTIVE: In order to explore whether the Iranian Pharmacovigilance system could be modified, and to determine reasons for under-reporting, a study to investigate the role of pharmacists in ADR reporting was done in Shiraz. METHODS: A cross-sectional study was conducted between January and June 2013 in Shiraz, Iran. After describing the study and its goal for each participant, oral consent was taken. RESULTS: 100 out of 120 pharmacists (83.3%) agreed to participate in the interview. 79 out of 100 respondents were…working in private pharmacies, 7% in governmental pharmacies, and 3% in pharmacies located in hospitals. Although level of knowledge regarding ADR was low among pharmacists, all of them admitted that paying attention to ADRs and timely reporting is very important. While 6 (6%) pharmacists thought that they had been taught too much about ADR in the university, 30% believed that it was enough, 41% claimed that it was not satisfactory and 23% admitted that it was little. CONCLUSIONS: Our pharmacists have little knowledge about the process, goal, and importance of ADR spontaneous reporting system. Otherwise, education and training courses will be important in maintaining, improving and enhancing ADR reports by pharmacists.
Keywords: Pharmacists, knowledge, attitude, practice adverse drug reaction reporting, Iran
Abstract: BACKGROUND: Pharmaceutical companies are prohibited from marketing medications for off-label uses in both the United States and Canada. In the United States, there have been several recent multi-billion dollar settlements with pharmaceutical companies based, partly, on off-label promotion. Health Canada has not publicized any investigations into, or prosecutions of, pharmaceutical companies for off-label promotion in Canada even though many of the same medications are marketed here. The prohibition on off-label promotion is largely directed at preventing pharmaceutical companies from circumventing the drug licensing process and attendant safety checks. OBJECTIVE: To determine if sanctions for off-label pharmaceutical promotion in one jurisdiction…can be used to regulate marketing in another. METHODS: We reviewed and compared the laws and regulatory bodies in Canada and the United States to determine if Canadian regulators could use the findings of American regulators. RESULTS: There were no important differences in the laws and regulatory bodies in Canada and the United States related to off-label promotion. CONCLUSIONS: Canadian regulators can use the findings of American regulators to investigate off-label promotion in Canada. All countries should consider using sanctions in other jurisdictions to direct the deployment of limited regulatory resources.
Abstract: BACKGROUND: Iron deficiency anaemia (IDA) is a common nutritional problem. OBJECTIVE: To determine the effect of nutritional education and supplemental iron administration on the prevalence of IDA in Arab infants. METHODS: Three hundred and ten infants were randomized alternately into two groups. Mothers (n = 143) in the control group received standard information on prevention of IDA and mothers in the intervention group (n = 144) received extensive information on the importance of an iron-rich diet. Data was scored regarding diet contents. Mothers in the intervention group were encouraged to give their children an iron polymaltose complex (IPC) preparation starting…from age 4 months to 1 year. Compliance of receiving the medication was evaluated. The groups were compared for outcome by chi-square test. Main outcome measures were haemoglobin (Hb), mean corpuscular volume (MCV), and serum ferritin levels. RESULTS: Anaemia (Hb <11 g/dL) was recorded in 28% and 34% of the intervention and control groups, respectively (p = NS). There was no effect of infant or parental background factors on rate of anaemia. Frequency of anaemia was lower in infants who received ≥6 months of iron medication according to mothers' reports, and in infants breastfed for ≥6 months (p = 0.002). CONCLUSIONS: Questions were raised regarding the strategies of preventing IDA in infancy.
Keywords: Iron deficiency of infancy, iron absorption, polymaltose complex, ferrous gluconate, ferrous sulfate
Abstract: BACKGROUND: Alcohol use and antidepressant prescription are prevalent in many countries, but little is known about their combined effects. OBJECTIVE: Having been surprised by selective serotonin reuptake inhibitor (SSRI) antidepressant-treated patients who became prone to pathological intoxication, we examined this association, searching for relevant literature and cases. METHODS: A detailed literature search showed little or no interaction between SSRIs and alcohol in laboratory studies, and inconsistent effects of these drugs in problem drinkers. We collected cases to study from our own and colleagues' practices, regulatory agencies and web-based discussion fora, and considered evidence for interactions according…to standard criteria. RESULTS: Pathological intoxication, characterized by unexpected and often gross disinhibition, was identified in 100 of 201 reports that provided enough detail to be evaluated. Memory impairment was prominent in just over half (53/100) of these. Outcomes included serious violence; homicide occurred in 8 cases, including two double and one triple homicide (12 deaths). CONCLUSIONS: Multiple lines of evidence amplify a thus far barely recognized signal of interactions of SSRI and related antidepressants with alcohol. Systematic collection of further data is required to further characterize this syndrome, but in the meantime effective warnings must be introduced to alert prescribers and patients to the serious risk of pathological intoxication during antidepressant treatment.