International Journal of Risk & Safety in Medicine - Volume 27, 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: BACKGROUND: Despite efforts to improve the patients’ safety, medical errors especially prescription errors can lead to morbidity and mortality in patients. The present study was conducted to assess the prescription errors in the intensive care units (ICU) in Shiraz, Southwest of Iran. METHODS: We reviewed the all recorded orders in the two ICU wards of the Shiraz largest hospital in the south of Iran. Data were collected from the two wards and hospital archive using a structured checklist. Descriptive statistics, Chi-square and logistic regression tests were used to analyze the data. RESULTS: Among the 2230 recorded…prescriptions for 40 hospitalized patients, 387 prescribed orders (251 in the General ICU and 136 in the Central ICU) had at least one error which occurred in the three months of the study. The study revealed that illegible orders have the highest error frequency in the two wards. The mean prescription error in the two ICU wards was 17.3 (0.19 errors in the General and 0.14 errors in The Central ICU, respectively). Lack of drug dosage was more than that in the larger wards (P = 0.037); moreover, illegible order and mistaken dosage were more in smaller wards (OR 1.84, CI = 1.18–2.86 and OR 2.55, CI = 1.08–6.00, P = 0.007 and P = 0.031, respectively) CONCLUSION: The rate of prescription errors in ICU wards was high and it was higher in crowded wards. Illegible orders were the majority of important errors in prescriptions. In the majority of orders, physicians did not write the drug form and drug dose which could be potentially harmful to patients. It is recommended that a computerized physician order should be used because it can decrease prescription errors.
Abstract: BACKGROUND: Inappropriate medication prescription among the elderly is a major problem with significant negative health consequences. The Beers and STOPP (Screening Tool of Older Persons’ potentially inappropriate Prescription) criteria are common tools used for screening of potentially inappropriate medications. The primary objective of the study was to estimate the incidence of PIM among elderly Nigerian patients using the earlier mentioned tools. METHODOLOGY: This prospective study was conducted among elderly patients attending the general outpatients’ clinics of two tertiary healthcare institutions in the South-Western part of Nigeria. The patients’ age, gender, diagnosis for which the patient was receiving treatment…and prescribed drugs were the information retrieved from the medical records. The WHO drug use indicators were applied in the drug utilization aspect of the study while the Beers and STOPP criteria were used to define the inappropriateness or otherwise of the prescribed medications RESULTS: The mean number of drugs per prescription was 4.1±1.2 while the median number of drugs prescribing by generic name was 46.5% (IQR: 35). Using Beers criteria for the assessment of prescription of potentially inappropriate medications, 106 (30.3%) of all patients had at least one inappropriate medication prescribed with a total of one hundred and twenty six cases recorded. Screening for PIM using the STOPP criteria, we found 55 (15.7%) of the study participants with at least one potential encounter. Female sex, number of prescribed medications and co-morbidities were positively associated with prescription of a PIM using both tools. CONCLUSION: Prescription of PIM is highly prevalent among elderly Nigerian patients. There is a need for continuing education of prescribers on rational prescribing in the elderly using some of the screening tools.
Abstract: BACKGROUND: Complications associated with the use of NSAIDs, antiplatelet agents, and anticoagulants are among the top causes of preventable drug-related ER visits, hospitalizations and death. Although over-the-counter (OTC) NSAIDs and ASA also contribute to this preventable risk, it is unclear how well these medications are documented in primary care records. METHODS: A retrospective electronic and paper chart review was conducted to evaluate the prevalence of 13 evidence-based high-risk prescriptions and the contribution of OTC NSAIDs and ASA to these potentially inappropriate prescriptions (PIPs). RESULTS: Of the 148 patients included in the review, ASA was taken by…117 patients (79%) while OTC NSAIDs were taken by 36 (24%). OTC NSAIDs were never documented within the “medication” section of the electronic record, whereas ASA was documented in 65 (56%) cases. Eighty percent (118/148) taking either OTC NSAIDs or ASA were identified as having at least one PIP. CONCLUSION: OTC NSAIDs and ASA are widely available and are commonly taken without the knowledge of the prescriber. These medications contribute to the overall risk of bleeding. Review and documentation of OTC NSAIDs and ASA use should be part of all relevant patient encounters when prescribing NSAIDs, antiplatelets and anticoagulants.
Abstract: BACKGROUND: Providing safe anaesthesia to children especially in emergency situations goes hand in hand with instant availability of appropriately sized equipment and monitoring. This is best achieved using a designated paediatric anaesthetic trolley containing essential equipment. Guidance for the contents of such trolleys is neither explicit nor standard. We used a survey and a qualitative enquiry to develop a checklist suitable for standardisation of contents and layout of paediatric anaesthetic trolleys. METHODS: We conducted an observational study of our current practice and paediatric anaesthetic trolleys in a tertiary care hospital. We also performed a qualitative enquiry from experienced…paediatric anaesthetists and operating department practitioners. We developed an empirical checklist to ensure the minimum ‘essential’ equipment is available on these trolleys and implemented a standard layout to facilitate its use. RESULTS: We identified 11 areas in our hospital where anaesthesia is provided to children, each with a designated paediatric anaesthetic trolley. There were considerable deficiencies of items in all areas with no standard pattern or layout. Different types of trolleys contributed to the confusion. In addition, overstocking of inappropriate items hindered its efficient use. CONCLUSION: Standardising the contents and layout of the paediatric anaesthetic trolley is an essential pre-requisite for safer paediatric anaesthetic practice.
Abstract: BACKGROUND: Although several guidelines for appropriate prescribing are available, inappropriate drug prescription remains noteworthy problem among older adults. Indian older patients are also not spare from this issue and existing literature indicates a fair level of inappropriate drug use (IDU). OBJECTIVES: Identified potentially IDU and documented their reduction based on provided evidence-based information and also identified possible predictors of IDU in older inpatients. SETTING: Three years prospective study included 1510 inpatients aged 60 years or over, of both sexes. IDU identified using the Modified Updated AGS Beers Criteria 2012. RESULTS: The patients had an…average age of 67.10±0.23 years and on an average were prescribed 9.29±0.11 medications. Using AGS Beers Criteria 2012, total IDU was found to be 21% (n = 325). Of total 287 patients received only one inappropriate drug whereas 38 patients received two or more inappropriate drug(s). According to first list of criteria long acting benzodiazepines, anticholinergics, nitrofurantoin and digoxin were most common IDU. Prescription of theophylline in insomnia followed by aspirin in gastric ulcer and calcium channel blocker in constipation were listed from second list of criteria. 31% reductions in IDU were observed based on evidence-based information regarding each identified inappropriate drugs. CONCLUSIONS: The findings of this study provide evidence that provision of unbiased evidenced based information is the best possible means for improvement of pharmacotherapy in older patients.
Keywords: Older adults, inpatient, IDU, AGS Beers criteria 2012, India
Abstract: INTRODUCTION: Off-label drug use is commonly reported in various disciplines of medicine. Considering the lacunae of studies from prescribers in the Indian subcontinent, the present study was conducted to explore their awareness and views of off-label drug use. METHODS: A validated questionnaire was administered to interns, junior residents and faculty members who were recruited in the present study of various medical and surgical departments of Subharti Medical College, Meerut, India, a tertiary care teaching hospital. Descriptive statistics was used for analyzing the data. RESULTS: A total of 59/85 (69%) stated that they have used a drug…in an off-label manner mainly [31/85 (36.5%)] related to indications. Nearly half of the study participants (41/85, 48.2%) considered prescribing an off-label drug illegal and only 25/85 (29.3%) participants felt that they had adequate knowledge regarding the use of drugs in off-label manner. Out of the total 70 participants who answered the question related to informing parents/relatives while prescribing an off label drug, only 39/70 (55.7%) answered affirmative. Out of the remaining 31/70 (44.3%) of participants who did not inform about prescribing an off label drug, 9/31 (29%) felt that it was illegal and more than two-third (24/31, 77%) felt their knowledge on off-label drug use was insufficient. Surprisingly, 74/82 (90.2%) participants felt that a drug approved to be used in adults cannot be used in children for the same indication despite not having any alternative in pediatric age group. CONCLUSION: We found an inadequate knowledge regarding the off-label drug use amongst the prescribers in a tertiary care medical college hospital. Many of the physicians felt such use as illegal and do not inform the patient’s relatives about such acts. Considering the legal issues, clearly there exists a need to patch up this lacuna in developing countries like India.
Keywords: Rational use of drugs, off-label drug use, questionnaire, tertiary care hospital, India
Abstract: BACKGROUND: The Thai National Pharmacovigilance Center (NPVC) has operated since 1983, but its performance has never been formally assessed. OBJECTIVE: The paper aimed to present the main findings of performance assessment of the Thai NPVC. METHODS: A survey was conducted. Data from January 2011-December 2013 were collected. The performance was assessed through four indicator domains. RESULTS: The NPVC has a clear mission to guide its roles and responsibilities. The center has a well-established structure, adequate budget, qualified personnel, and good IT infrastructure, but it has no in-house IT personnel. Safety surveillance function was considered…excellent. The Thai adverse drug reaction database accumulate a number of quality reports. Typically, new signals of traditional or herbal medicines could be generated from the database. The risk management process was well established and carried out. The National Drug Safety Advisory Sub-Committee was composed of qualified representatives from related disciplines. Not only do these committee members make safety decisions, but they also provide key safety messages and communicate these to their member audiences. The risk communication function was evaluated to be unsatisfactory. It was not effectively distributed to individual health care professionals. CONCLUSIONS: The overall performance of the Thai NPVC was considerably good. The findings suggested that risk communication should be improved. Moreover, organizational performance should be routinely evaluated. If possible, benchmarking with international pharmacovigilance centers should also be performed.
Keywords: Pharmacovigilance (PV), performance assessment, indicators, the Thai National Pharmacovigilance Center (Thai NPVC)