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Risk management from an Asian/Pacific Rim regulatory perspective

McEwen J

Drug Saf, 2004;27(8):491-7.
PMID: 15154822

This article reviews the state of adverse drug reaction monitoring in five Asian/Pacific Rim countries (Australia, Japan, Malaysia, New Zealand and Singapore). Each country has an active pharmacovigilance programme managed by a national regulatory agency. Current methods for assessing risks and current methods used for risk management and communication are compared with the 'tools' used by the US FDA. Major positive attributes of the programmes in all five countries include active involvement of independent expert clinical advisory committees in identifying and evaluating risks through the assessment of reports of serious and unusual reactions, and regular communications about risks from the national agencies to doctors and pharmacists by means of pharmacovigilance bulletins. Most components of the risk-management toolbox are currently used, in some instances without legislated support. Variations in the way risk-management tools are implemented within individual national health systems are illustrated.

Matched MeSH terms: Risk Management/methods*
Critical incident monitoring in anaesthesia (2)

Choy CY

Curr Opin Anaesthesiol, 2008 Apr;21(2):183-6.
PMID: 18443485 DOI: 10.1097/ACO.0b013e3282f33592

PURPOSE OF REVIEW: Updates on developments in critical incident monitoring in anaesthesia, and assesses its role in improving patient safety.
RECENT FINDINGS: Critical incident reporting has become more widely accepted as an effective way to improve anaesthetic safety, and has continued to highlight the importance of human errors and system failures. The establishment of an international database also improves critical incident reporting. Experiences from the national reporting and learning system in the UK have provided some solutions to the many problems and criticisms faced by the critical incident reporting technique. Direct observations to detect errors are more accurate than voluntary reporting of critical incidents, and may be a promising new approach.
SUMMARY: Critical incident monitoring is a valuable tool in ensuring patient safety due to its low cost and the ability to provide a comprehensive body of detailed qualitative information. The qualitative information gathered can be used to develop strategies to prevent and manage existing problems, as well as to plan further initiatives for patient safety. Novel approaches should complement existing methods to achieve better results. The development of a culture which emphasises safety should go hand in hand with current audit activities.

Matched MeSH terms: Risk Management/methods*
Occurrence and risk assessment of multiclass endocrine disrupting compounds in an urban tropical river and a proposed risk management and monitoring framework

Wee SY, Aris AZ, Yusoff FM, Praveena SM

Sci Total Environ, 2019 Jun 25;671:431-442.
PMID: 30933799 DOI: 10.1016/j.scitotenv.2019.03.243

Endocrine disrupting compounds (EDCs) are an emerging environmental concern and commonly occur as a mixture of compounds. The EDC mixture can be more toxic than any single compound. The present study analyses EDCs in surface water in the case of an urban tropical river, the Langat River, using the multiresidue analytical method of solid phase extraction and liquid chromatography-tandem mass spectrometry (SPE-LC-MS/MS). The Langat River is used as a drinking water source and is treated for Malaysian drinking water supply. A total of 14 EDCs i.e. five hormones, seven pharmaceuticals, one pesticide, and one plasticizer were detected. Caffeine was observed to be highest at 19.33 ng/L, followed by bisphenol A and diclofenac at 8.24 ng/L and 6.15 ng/L, respectively. Using a conservative risk quotient (RQ) method, EDCs were estimated for having negligible risks under acute and chronic exposure (RQ risk related to these compounds in the Langat River riverine ecosystem. However, the presence of EDCs in surface water raises concerns about potential human exposure to EDCs via dietary intake i.e. food and drinking water supply. Although the ecological risks are considered negligible, these risks should not be neglected in terms of future prioritization and risk management. Improvements in water quality monitoring and risk assessment in water source protection are required to support a multibarrier approach to managing drinking water supply systems for safe water supply. The present study proposes a risk management and monitoring framework for EDCs to support the aforementioned multibarrier approach.

Matched MeSH terms: Risk Management/methods*
Implementation of an event reporting system in a transfusion medicine unit: a local experience

Usin MF, Ramesh P, Lopez CG

Malays J Pathol, 2004 Jun;26(1):43-8.
PMID: 16190106

Event reporting can provide data to study the failure points of an organization's work process. As part of the ongoing efforts to improve transfusion safety, a Medical Event Reporting System Transfusion Medicine, (MERS - TM) as designed by Kaplan et al was implemented in the Transfusion Medicine Unit of the University Malaya Medical Centre to provide a standardized means of organized data collection and analysis of transfusion errors, adverse events and near misses. An event reporting form was designed to detect, identify, classify and study the frequency and pattern of events occurring in the unit. Events detected were classified according to Eihdhoven Classification model (ECM) adopted for MERS - TM. Since our system reported all events, we called it Event Reporting System - Transfusion Medicine (ERS-TM). Data was collected and analyzed from the reporting forms for a period of five months from January 15th to June 15th 2002. The initial half of the period was a process of evaluation during which 118 events were reported, coded, analyzed and corrective measures adopted to prevent the recurrence of the same event. The latter half saw the reporting of 122 events following the adoption of corrective measures. There was a reduction in the occurrence of some events and an increase in others, which were mainly beyond the organization's control. A longer period of evaluation is necessary to identify the underlying contributory causes that can be useful to develop plans for corrective and preventive action and thereby reduce the rate of recurrence of errors through proper training and adoption of just culture.

Matched MeSH terms: Risk Management/methods*
Fulltext Cross-continental comparison of safety and protection measures amongst urologists during COVID-19

de la Rosette J, Laguna P, Álvarez-Maestro M, Eto M, Mochtar CA, Albayrak S, et al.

Int J Urol, 2020 11;27(11):981-989.
PMID: 32772434 DOI: 10.1111/iju.14340

OBJECTIVES: To determine the well-being of urologists worldwide during the coronavirus disease 2019 pandemic, and whether they have adequate personal protective equipment knowledge and supplies appropriate to their clinical setting.
METHODS: Urologists worldwide completed a Société Internationale d'Urologie online survey from 16 April 2020 until 1 May 2020. Analysis was carried out to evaluate their knowledge about protecting themselves and others in the workplace, including their confidence in their ability to remain safe at work, and any regional differences.
RESULTS: There were 3488 respondents from 109 countries. Urologists who stated they were moderately comfortable that their work environment offers good protection against coronavirus disease 2019 showed a total mean satisfaction level of 5.99 (on a "0 = not at all" to "10 = very" scale). A large majority (86.33%) were confident about protecting themselves from coronavirus disease 2019 at work. However, only about one-third reported their institution provided the required personal protective equipment (35.78%), and nearly half indicated their hospital has or had limited personal protective equipment availability (48.08%). Worldwide, a large majority of respondents answered affirmatively for testing the healthcare team (83.09%). Approximately half of the respondents (52.85%) across all regions indicated that all surgical team members face an equal risk of contracting coronavirus disease 2019 (52.85%). Nearly one-third of respondents reported that they had experienced social avoidance (28.97%).
CONCLUSIONS: Our results show that urologists lack up-to-date knowledge of preferred protocols for personal protective equipment selection and use, social distancing, and coronavirus disease 2019 testing. These data can provide insights into functional domains from which other specialties could also benefit.

Matched MeSH terms: Risk Management/methods
Knowledge, attitude, and perception of risk management of steam boilers among workers in palm oil mills

Shawal FNS, Guan NY, Mohd Suadi Nata DH, How V, Tamrin SBM

Work, 2018;60(1):153-162.
PMID: 29733040 DOI: 10.3233/WOR-182725

BACKGROUND: People who work with the steam boilers in palm oil mills are vulnerable to accidents, notably to explosions, whenever failures of any kind occur during their operation.
OBJECTIVE: This cross-sectional study was conducted in palm oil mills to determine the knowledge, attitude, and perception (KAP) concerning the risk management of steam boilers among workers in palm oil mills.
METHODS: A total of 50 workers who were working with steam boilers and/or involved in managing the operation of steam boilers with at least three years of working experience in the palm oil industry were purposively sampled. A self-administrated questionnaire consisting of four main parts - socio-demographic and occupational information, knowledge, attitude, and perception of the risk management of steam boilers was distributed. The knowledge, attitude, and perception were calculated based on a Likert-type scale.
RESULTS: This study found that 56% of boiler workers had a good level of knowledge (mean score = 77.22±19.6), 72% had a good attitude toward risk (mean score = 83.17±5.85), and 64% had a good perception of risk (mean score = 79.50±11.22). The prevalence of accidents was 16%, and, for near misses, it was 24%. The cause of the reported accidents was largely attributed to carelessness, specifically at 80%. Apart from that, there was a positive association (χ2 = 6.56; p = 0.010) between attitude and accidents.
CONCLUSION: This study found that the workers had good KAP levels of risk management of steam boilers in palm oil mills. However, there is a need for the employers to revise the training of workers and ensure its effectiveness in heightening the awareness of risks and accidents despite the high level of KAP.

Matched MeSH terms: Risk Management/methods
Fulltext Infodemiological patterns in searching medication errors: relationship with risk management and shift work

Di Simone E, Di Muzio M, Dionisi S, Giannetta N, Di Muzio F, De Gennaro L, et al.

Eur Rev Med Pharmacol Sci, 2019 Jun;23(12):5522-5529.
PMID: 31298407 DOI: 10.26355/eurrev_201906_18224

INTRODUCTION: Western world health care systems have been trying to improve their efficiency and effectiveness in order to respond properly to population aging and non-communicable diseases epidemic. Treatment of the elderly population is becoming complex due to the high number of prescribed drugs because of multimorbidity. Errors in drugs administration in different health care related settings are an actual important issue due to different causes. Aim of this observational study is to measure the online interest in seeking medication errors information related to risk management and shift work.
MATERIALS AND METHODS: We investigated Google Trends® for popular search relating to medication errors, risk management and shift work. Relative search volumes (RSVs) were evaluated from 2008 to 2018. A comparison between RSV curves related to medication errors, risk management and shift work was carried out. Then, we compared the world to Italian search.
RESULTS: RSVs were persistently higher for risk management than for medication errors (mean RSVs 069 vs. 48%) and RSVs were stably higher for medication errors than shift work (mean RSVs 48 vs. 22%). In Italy, RSVs were much lower compared to the rest of the world, and RSVs for medication errors during the study period were negligible. Mean RSVs for risk management and shift work were 3 and 25%, respectively. RSVs related to medication errors and clinical risk management were correlated (r=0.520, p<0.0001).
CONCLUSIONS: Google Trends® search query volumes related to medication errors, risk management and shift work are different. RSVs for risk management are higher, and they are correlated with medication errors. Also, shift work search appears to be lower. These results should be interpreted in order to correctly evaluate how to decrease the number of medication errors in different health care related setting.

Matched MeSH terms: Risk Management/methods
Risk Minimization Measures in Off-Label Drug Use: A Survey of Community Pharmacists in Malaysia

Fatokun O

Curr Drug Saf, 2020;15(3):181-189.
PMID: 32538733 DOI: 10.2174/1573403X16666200615144946

BACKGROUND: While off-label drug use is common and sometimes necessary, it also presents considerable risks. Therefore, measures intended to prevent or reduce the potential exposure to off-label risks have been recommended. However, little is known about community pharmacists' beliefs regarding these measures in Malaysia.
OBJECTIVES: This study examined community pharmacists' beliefs towards risk minimization measures in off-label drug use in Malaysia and assessed the relationship between perceived risk of off-label drug use and beliefs towards risk minimization measures.
METHODS: A cross-sectional survey was conducted among 154 pharmacists practicing in randomly selected community pharmacies in Kuala Lumpur and the State of Selangor, Malaysia.
RESULTS: The majority agreed or strongly agreed that adverse drug events from the off-label drug should be reported to the regulatory authority (90.9%) and the off-label drug should only be used when the benefit outweighs potential risks (88.3%). Less than half (48.1%) agreed or strongly agreed that written informed consent should be obtained before dispensing off-label drugs and a majority (63.7%) agreed or strongly agreed that the informed consent process will be burdensome to healthcare professionals. Beliefs towards risk minimization measures were significantly associated with perceived risk of off-label drug use regarding efficacy (p = 0. 033), safety (p = 0.001), adverse drug rection (p = 0.001) and medication errors (p = 0.002).
CONCLUSION: The community pharmacists have positive beliefs towards most of the risk minimization measures. However, beliefs towards written informed consent requirements are not encouraging. Enhancing risk perception may help influence positive beliefs towards risk minimization measures.

Matched MeSH terms: Risk Management/methods