Synergizing pharmacometrics and pharmacovigilance for medication error management: the case of secukinumab.

PURPOSE: To demonstrate the effective integration of pharmacometrics and pharmacovigilance in managing medication errors, highlighted by a case involving secukinumab in a patient with hidradenitis suppurativa. METHODS: We present the case of a 41-year-old male with progressive hidradenitis suppurativa, unresponsive to multiple antibiotic regimens and infliximab treatment. Due to a medication error, the patient received 300 mg of secukinumab daily for 4 days instead of weekly, totaling 1200 mg. The regional pharmacovigilance center assessed potential toxicity, and a pharmacometric analysis using a population pharmacokinetic model was performed to inform dosing adjustments. RESULTS: Clinical data indicated that the received doses were within a non-toxic range. No adverse effects were observed. Pharmacometric simulations revealed a risk of underexposure due to the dosing error. Based on these simulations, it was recommended to restart monthly secukinumab injections on day 35 after the initial dose. Measured plasma concentrations before re-administration confirmed the model's accuracy. CONCLUSION: This case highlights the crucial collaboration between clinical services, pharmacovigilance, and pharmacometrics in managing medication errors. Such interdisciplinary efforts ensure therapeutic efficacy and patient safety by maintaining appropriate drug exposure levels.

Dabigatran-related serious medication errors: an analysis using data from VigiBase.

OBJECTIVE: To analyze the serious medication errors (MEs) on dabigatran, and their related factors, in order to avoid or reduce the occurrence of adverse events. METHODS: Serious MEs related to dabigatran were extracted from the WHO global database of reported potential side effects of medicinal products (VigiBase) by using "Medication errors and other product use errors and issues" High Level Group Term (HLGT) of the international Medical Dictionary for Regulatory Activities (MedDRA). Well-documented reports, vigiGrade completeness score ≥ 0.80, or with an informative narrative were analyzed with a focus on the clinical features of the cases. The PCNE Classification for drug-related problems (DRP) was used to classify medication errors in our analysis of cases. RESULTS: Until January 26, 2020, there were 453 cases with serious MEs related to dabigatran in VigiBase, and 113 were well-documented. Among these, 69 patients (61%) were hospitalized or had prolonged hospitalization, 16 (14%) had life-threatening events, and 12 (11%) died. The MEs occurred in the prescription phase in 77 cases, in administration in 35, and at the dispensing stage in one case. The MEs in prescription were related to a drug selection error in 44 cases (24 concerning contraindications and 20 drug interactions) and to dose error in 33 cases (17 with excessive dose; eight with insufficient frequency; four had an incorrect time; in three, the dose was too low; and in one, too frequent). The MEs in administration were medical-staff-related errors in five cases (three with wrong administration route, one administration omission, and one overdose), patient-related errors in 28 (14 insufficient dose or no administration, seven improper drug storage, four wrong administration method, and three over prescribed dose), and other errors in two (without efficacy monitoring). The dispensing error of a wrong drug strength occurred in a pharmacy. The main adverse events in the 113 patients were haemorrhage in 57 cases (50%) and ischemia in 29 cases (26%). CONCLUSION: Based on the analysis of reports in VigiBase, serious MEs related to dabigatran mainly occurred during prescription and administration. Although the incidence of MEs with clinical consequences in the use of dabigatran cannot be determined, attention should be paid to selection of the appropriate dose to a right patient in the prescription, and to patient compliance and storage in drug administration. The patient harm mainly manifested itself as bleeding or ischemia including fatal outcome in rare patients.

Psychology in the operating theatre: the importance of colour and cognition in the redesign of clinical systems for medication safety.

Medication errors in anaesthesia remain a leading cause of patient harm. Compared with conventional methods, use of the international colour-code standard on syringes and medication trays allows significantly more errors to be detected, and does so under conditions of cognitive load. Testing methods from experimental psychology provide important new insights for human factors research in anaesthesia and health care.

Effects of colour-coded compartmentalised syringe trays on anaesthetic drug error detection under cognitive load.

BACKGROUND: Anaesthetic drug administration is complex, and typical clinical environments can entail significant cognitive load. Colour-coded anaesthetic drug trays have shown promising results for error identification and reducing cognitive load. METHODS: We used experimental psychology methods to test the potential benefits of colour-coded compartmentalised trays compared with conventional trays in a simulated visual search task. Effects of cognitive load were also explored through an accompanying working memory-based task. We hypothesised that colour-coded compartmentalised trays would improve drug-detection error, reduce search time, and reduce cognitive load. This comprised a cognitive load memory task presented alongside a visual search task to detect drug errors. RESULTS: All 53 participants completed 36 trials, which were counterbalanced across the two tray types and 18 different vignettes. There were 16 error-present and 20 error-absent trials, with 18 trials presented for each preloaded tray type. Syringe errors were detected more often in the colour-coded trays than in the conventional trays (91% vs 83%, respectively; P=0.006). In signal detection analysis, colour-coded trays resulted in more sensitivity to the error signal (2.28 vs 1.50, respectively; P<0.001). Confidence in response accuracy correlated more strongly with task performance for the colour-coded tray condition, indicating improved metacognitive sensitivity to task performance (r=0.696 vs r=0.447). CONCLUSIONS: Colour coding and compartmentalisation enhanced visual search efficacy of drug trays. This is further evidence that introducing standardised colour-coded trays into operating theatres and procedural suites would add an additional layer of safety for anaesthetic procedures.

Identifying high-risk medications and error types in Danish patient safety database using disproportionality analysis.

BACKGROUND: Medication error (ME) surveillance in Danish healthcare relies on the mandatory national incident reporting system, the Danish Patient Safety Database (DPSD). Individual case reviews and descriptive statistics with frequency counts are the most often used approaches when analyzing MEs in incident reporting systems, including the DPSD. However, incident reporting systems often generate a large number of reports and may suffer from underreporting; consequently, additional approaches are needed to overcome these challenges. Disproportionality analysis (DPA) is a statistical tool used for signal detection of adverse drug reactions in pharmacovigilance reports, but the evidence for using DPA on ME analysis in safety reporting systems is limited. OBJECTIVES: We aimed to test the feasibility of DPA by analysing harmful MEs reported to DPSD 2014-2018. METHODS: We utilized proportional reporting ratios (PRR) to identify signals of diproportionality. RESULTS: We identified well-known high-risk medicines, including anticoagulants, opioids, insulins, antiepileptic, and antipsychotic drugs, and their association with several ME types and stages in a medication process. CONCLUSION: DPA might be suggested as an additional tool for screening MEs and identifying priority areas for further investigation in safety reporting systems.

Analyzing the Impact of Drug Name Similarity on Dispensing Errors: An Examination Using a Drug Name Similarity Index.

Dispensing errors pose a significant health risk, with drug name similarity being a potential contributory factor. To determine the impact of drug name similarity on dispensing errors within clinical settings, we analyzed 563 dispensing errors at an acute hospital in Japan from April 2015 to June 2018. Drug name similarity between two drugs was classified into Name-Similar and Name-Dissimilar groups using the m2-vwhtfrag index, the value of the drug name similarity. Drug efficacy similarity was categorized into Efficacy-Same, Efficacy-Close, and Efficacy-Far. The drug name similarity and drug efficacy similarity of all possible pair combinations were obtained and similarly classified. The proportion of the number of pairs with dispensing errors per the total number of drug pairs in the hospital's drug formulary in each category was calculated. The highest proportion of the number of pairs with dispensing errors was 36% for the Efficacy-Same and Name-Similar group, and the lowest proportion was 0.022% for the Efficacy-Far and Name-Dissimilar group. The proportion of the number of pairs with dispensing errors was significantly higher in the Name-Similar category than in the Name-Dissimilar category for all drug efficacy categories. Our results indicate that drug name similarity increases the risk of dispensing errors, and that m2-vwhtfrag is a useful indicator to assess dispensing errors in clinical practice. Such drug name and efficacy similarity evaluations can help identify factors causing dispensing errors, and predict the risk of dispensing errors for newly adopted drugs, considering the relationship with the whole drug formulary in the hospital dispensary.

Medication error rates in Iranian hospitals: a meta-analysis.

BACKGROUND AND AIM: Medication errors (MEs) in hospitals decrease patient satisfaction, increase hospital mortality, lower hospital productivity, and increase in the costs of the health system. This study was conducted to determine the rate of MEs in Iranian hospitals. METHOD: In this meta-analysis, all published articles on ME rates in Iranian hospitals were identified from five databases and Google Scholar and assessed for quality. The heterogeneity of the studies was examined using the I2 index and a meta-regression model was used to evaluate the variables suspected of heterogeneity at the 0.05 significance level. Finally, 17 articles were eligible to be included in this study and were analyzed using the Comprehensive Meta-Analysis (CMA) software. FINDINGS: Based on the estimation of the random-effects model, the ME rate in Iranian hospitals was 10.9% (5.1%-21.7%; 95% CI). The highest rate was observed in Sanandaj in 2006 at 99.5% (92.6%-100.0%; 95% CI) and the lowest rate was observed in Kashan in 2019 at 0.2% (0.1%-0.3%; 95% CI). In addition, sample size and publication year were significantly correlated with ME rate (P < 0.05). CONCLUSION: According to the results of this study; ME rate in Iran is relatvively high based on the synthesis of the research conducted in Iranian hospitals. In addition to being costly, MEs have negative consequences for patients. Thereofore, it is necessary to emphasize the voluntary nature of medication error reporting in health sytem of Iran.

Registered nurses' emotional responses to medication errors and perceived need for support: A qualitative descriptive analysis.

AIMS: To identify the contributing factors behind the second victim phenomenon, describe the emotional responses of nurses after medication errors, assess the support received by them after errors and recognize the need for a suitable support program for second victims. DESIGN: Qualitative descriptive design. METHODS: Eleven in-depth semi-structured interviews were conducted among registered nurses studying advanced degrees at a University in Finland during November 2021-April 2022. Data were analysed using thematic analysis. RESULTS: The study results revealed four themes with various sub-themes which included: contributing factors behind the second victim phenomenon; emotional responses of nurses after error; support received by nurses; and the desired need for a support program for second victims. The severity of the error and the negative work environment acted as catalysts for the second victim phenomenon among nurses. A "bitter aftermath" of emotions and a sense of insufficient support added further risk to already stressed and anxious nurses. CONCLUSIONS: This study identifies the early exploratory and enduring impact of memories associated with medication errors, some of them haunting nurses for long periods of time. Further, the need for support at different levels is highlighted to reduce the impact of negative emotions generated among nurses after medication errors. IMPLICATIONS FOR THE PROFESSION: Through the lens of this study, it has been possible to identify contributing factors behind the second-victim phenomenon and enduring symptoms that make nurses vulnerable to becoming second victims of medication incidents. IMPACT: This study addresses the aftermath effect of medication errors from the perspective of nurses involved with such incidents. It provides valuable insights for healthcare managers and nurse leaders to establish a just and blame-free culture in healthcare organizations and help emotionally traumatized nurses cope effectively after error. REPORTING METHOD: The research adheres to Consolidated criteria for reporting qualitative research (COREQ) guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Impact of second victim distress on healthcare professionals' intent to leave, absenteeism and resilience: A mediation model of organizational support.

AIMS: To examine the relationship between the second victim distress and outcome variables, specifically: 'turnover intentions, absenteeism and resilience'. Furthermore, this study also assessed how organizational support mediates the relationship between second victim distress and outcome variables. DESIGN: Cross-sectional survey. METHODS: A cross-sectional survey study using regression and mediation analysis with bootstrapping was conducted among (n = 149) healthcare professionals in two university hospitals in Finland from September 2022 to April 2023 during different time periods. The Finnish version of the revised Second Victim Experience and Support Tool (FI-SVEST-R) was used to assess second victim distress, level of organizational support and related outcomes. RESULTS: Psychological distress was the most frequently experienced form of reported second victim distress, and institutional support was the lowest perceived form of support by healthcare professionals. The study found second victim distress to have a significant association with work-related outcomes: turnover intention and absenteeism. However, no significant relationship was found with resilience. Mediation models with organizational support revealed a partially mediated relationship between second victim distress and work-related outcomes. CONCLUSIONS: The findings from this study indicate that second victim experiences if not adequately addressed can lead to negative work-related outcomes such as increased job turnover and absenteeism. Such outcomes not only affect healthcare professionals but can also have a cascading effect on the quality of care. However, the mediating effect of organizational support suggests that if comprehensive support is provided, it is possible to mitigate the negative impact of the second victim phenomenon. IMPACT: Raising awareness regarding the second victim phenomenon, promoting a culture of safety and shifting the paradigm from a blame to just culture helps in identifying the system flaws thus improving both patient and provider safety. REPORTING METHOD: The study adheres to the STROBE reporting guidelines. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution.

Sleep deprivation and medication administration errors in registered nurses-A scoping review.

AIM: To explore whether sleep deprivation contributes to medication errors in registered nurses (RNs). BACKGROUND: Sleep deprivation is a potential issue for RNs, particularly those who work shifts. Sleep deprivation has been found to have a negative impact on numerous cognitive processes. Nurses administer several medications to patients a day, potentially while sleep deprived-anecdotal reports suggest that this could result in an increased risk of error occurring. DESIGN: A scoping review was conducted using the Prisma-ScR extension framework to explore what is known about the effect of RNs' sleep deprivation on medication administration errors. METHODS: A search of databases generated 171 results. When inclusion and exclusion criteria were applied, 18 empirical studies were analysed. Studies included retrospective analysis of errors, surveys of perceptions of causes and observational studies. RESULTS: Data indicated that RNs consider fatigue, which may be caused by sleep deprivation, to be a contributing factor to medication errors. The search only identified three observer studies, which provided conflicting results as to whether lack of sleep contributes to the error rate. Of the numerous tools used to measure sleep, the Pittsburgh Sleep Quality Index was the most frequently used. CONCLUSION: Although RNs anecdotally consider a lack of sleep potentially contributes to medication errors, there is insufficient research to provide robust evidence to confirm this assumption. NO PATIENT OR PUBLIC CONTRIBUTIONS: Patient or public contributions were not required for this scoping review. RELEVANCE TO CLINICAL PRACTICE: Sleep deprivation is a potential issue for nurses, especially those who work shifts. Poor sleep impacts cognitive processes that potentially could increase errors. Nurses should be aware of the impact sleep may have on patient safety.

Factors influencing the reporting of medication errors and near misses among nurses: A systematic mixed methods review.

AIM: This study aimed to systematically review empirical evidence on factors influencing nurses to report medication errors and near misses. BACKGROUND: There is underreporting of medication errors among nurses, in particular among novice and beginner nurses. To improve quality of care, factors influencing the reporting of medication errors and near misses should be documented. METHOD: A systematic mixed methods review was conducted. CINAHL, Cochrane Collaboration, Embase, Medline, PsycINFO and Web of Science databases were explored and analysed from December 1990 to December 2023. Two reviewers independently selected and extracted data using a standardized data extraction grid. Data were analysed using thematic analysis based on the adapted theory of planned behaviour. RESULTS: Forty-two studies met the eligibility criteria. Principal factors influencing the reporting of medication errors and near misses among nurses were associated with perceived behavioural control, subjective norm and attitude. Few studies examined factors influencing reporting medication errors and near misses among novice and beginner nurses, and sociodemographic and professional factors. CONCLUSION: To understand factors influencing reporting of medication errors and near misses, further studies should be conducted to investigate sociodemographic and professional factors.

A Case-Study of Metoclopramide Prescription Error : A Grim Reminder.

The integration of Computerized Provider Order Entry (CPOE) systems in hospitals has been instrumental in reducing medication errors and enhancing patient safety. This study examines the implications of a software oversight in a CPOE system : Metoclopramide had a concentrated formulation (100 mg) delisted (and then not manufactured) in 2014 due to safety concerns. Despite this, the CPOE system continued to accept prescriptions for this formulation because it was not removed from the medication library by the pharmacist. The objective of our study was to describe this specific prescription error related to an outdated the medication library of the CPOE. We analyzed all metoclopramide prescriptions from 2014, to 2023. Our findings showed that errors involving 100 mg or more dosages were relatively rare, at 2.98 per 1000 prescriptions (34 errors in 11,372 prescriptions). Notably, 47.1% of these errors occurred during on-call shifts, and 68% of these errors led to actual administration. These errors correlated with periods of higher nurse workload. The findings advocate for the integration of dedicated pharmacists into ICU teams to minimize medication errors and enhance patient outcomes, and a proactive medication management in healthcare.

Medication administration error prevention among nurses working in intensive care units: A secondary analysis.

BACKGROUND: The intensive care unit (ICU) brings together high-risk patients and interventions in a complex environment. Based on this consideration, medication administration error is the most common type of error that occurs in ICUs. Literature confirms that human factors (lack of knowledge, poor practices and negative attitudes) of nurses are the main contributors to the occurrence of medication administration errors in ICUs. AIM: To examine and compare the knowledge, attitudes and behaviour scores on medication administration error according to nurses' sociodemographic and professional variables. STUDY DESIGN: This is a secondary analysis of data from a cross-sectional international study based on a survey. Descriptive statistics were computed for all items of the questionnaire. Non-parametric tests (Kruskal Wallis and Mann Whitney U tests) were used to carry out the comparison between groups. RESULTS: The international sample consisted of 1383 nurses in 12 different countries. Statistically significant changes were seen in knowledge, attitudes and behaviour scores among several subgroups of the international population. Eastern nurses were more likely to show adequate knowledge about medication administration error prevention than Western nurses; concurrently, Western nurses were significantly more likely to show positive attitudes than Eastern nurses. No statistically significant differences in the behaviour scale were found in this study. CONCLUSIONS: The findings show a difference between knowledge and attitudes in relation to cultural background. RELEVANCE TO CLINICAL PRACTICE: Decision makers in ICUs should consider cultural background when planning and implementing prevention strategies for medication administration errors. Further research is needed to investigate the effectiveness of educational systems on the decrease of the incidence of medication administration errors in ICU.

Unraveling medication errors in enteral tube administration: A cross-sectional study in geriatric patients receiving home health care.

Background: Medication administration through enteral feeding tubes requires careful consideration, as several medications are unsuitable for such administration due to interactions with feeding formulas or adverse effects when crushed. These errors can lead to feeding tube obstruction, reduced drug efficacy, or drug toxicity. Objective: This study aimed to assess medication errors in geriatric patients using enteral feeding tubes who were enrolled in a home health care program. Method: This was a cross-sectional observational study conducted at the Ministry of Health Government Hospital in Makkah City, Saudi Arabia. Medication errors related to chronic oral drugs in geriatric patients using enteral feeding tubes were evaluated, including inappropriate medications for enteral tube administration, inappropriate preparation, drug-nutrient interaction, and availability of liquid formulation, following established guidelines. Results: Of the total 233 medications prescribed to 46 patients receiving enteral tube feeding at home, 49.3% exhibited at least one form of medication error, totaling 135 errors. Medication errors were highly prevalent among the patients (93.4%), with the leading cause being the administration of medications unsuitable for enteral feeding tubes (33.3%), predominantly due to the use of controlled release or enteric-coated formulations. Conclusion: This study underscores the high prevalence of medication errors in older patients receiving enteral feeding at home. To ensure patient safety and optimal outcomes, healthcare professionals should utilize available resources and seek expert advice when selecting medications and dosage forms for tube-fed patients. Pharmacists play a critical role in promoting safe drug use and can greatly contribute by educating patient caregivers on proper medication preparation and administration techniques, thus preventing harm to patients.

Keeping patients safe through medication review and management in the community.

BACKGROUND: There are numerous publications on inpatient medication errors. However, little focus is given to medication errors that occur at home. AIMS: To describe and analyse the types of medication errors among community-dwelling patients following their discharge from an acute care hospital in Singapore. METHOD: This is a retrospective review of a 'good catch' reporting system from December 2018 to March 2022. Medication-related errors were extracted and analysed. FINDINGS: A total of 73 reported medication-related error incidents were reviewed. The mean age of the patients was 78 years old (SD=9). Most patients managed their medications independently at home (45.2%, n=33). The majority of medications involved were cardiovascular medications (51.5%, n=50). Incorrect dosing (41.1%, n=39) was the most common medication error reported. Poor understanding of medication usage (35.6%, n=26) and lack of awareness of medication changes after discharge (24.7%, n=18) were the primary causes of the errors. CONCLUSION: This study's findings provide valuable insights into reducing medication errors at home. More attention must be given to post-discharge care, especially to preventable medication errors. Medication administration and management education can be emphasised using teach-back methods.

Analysis of medication administration in relation to food and beverages in inpatients.

Proper medication administration in relation to beverage or food is one of the essential tools to achieve the pharmacotherapy goals. It is not known whether this is also considered in the care of inpatients. The aim of this study was to describe and analyse the current practice of medication administration in relation to food and beverages to patients hospitalized in four hospitals in the Czech Republic. This study was conducted based on the results of the first phase of a prospective observation study focused on the safety of medication administration performed by nurses. All data, including the timing of medication administration in relation to food and the data on beverages used, were obtained by the method of direct observation. The team of observersaccompanied the nurse during medication administration. The appropriateness of the medication administration in relationto food/beverages was assessed according to the summary of product characteristics and the published literature. In total, the administration of 5718 oral medications and 198 insulins were analysed. Unproper food timing wasobserved in 15.7% of oral medication administrations and 26.8% of insulin administrations. The highest number ofunproper food timing occurred in the proton pump inhibitors, antihypertensives, and prokinetics. Tea (63.4%) was the most used beverage. Errors with clinically serious impact have been observed in some groups of drugs. The necessity of a systemic approach in management of medication administration is required including interdisciplinary cooperation.

[Inability of hospital computerised physician order entry systems to secure the use of concentrated potassium intravenous solutions]. / Incapacité des logiciels d'aide à la prescription hospitaliers à sécuriser l'utilisation des solutions concentrées de potassium injectable.

OBJECTIVES: To determine whether hospital computerised physician order entry (CPOE) systems contribute to securing intravenous potassium chloride (KCl) prescriptions with reference to the recommendations issued by French healthcare agencies. METHODS: We sent a questionnaire to the members of the Association pour le Digital et l'Information en Pharmacie. RESULTS: More than three quarters of the 84 responses received involving 23 CPOE systems indicate that it is possible to: prescribe an ampoule of concentrated potassium chloride 10% 10mL intravenously without any diluents (80%); prescribe 4g of KCl in a bag of 500mL of NaCl 0,9% (98%); prescribe a solution that contains 6 grams of KCl per liter (94%); prescribe the administration of an injectable ampoule orally by means of a free text comment (83%). Nearly half of the responses indicate that it is possible to prescribe: concentrated KCl ampoules as administration solvent (50%); an injectable vial to be administered by oral route (52%). CONCLUSION: At least 23 hospital CPOE systems are unable to secure the prescriptions of injectable KCl. This finding lifts the veil on an unthought, namely the role of CPOE systems in securing high-risk medications. In order to solve this problem, it should be mandatory that health information technology vendors pay particular attention to these drugs. With regard to injectable KCl, the utilisation of a dilution vehicle, maximum concentration and maximum infusion flow rate are the first four constraints to be satisfied.

Regular Medications in the Emergency Department Short Stay Unit (ReMedIES): Can Prescribing be Improved Without Increasing Resources?

Background: Hospital medication errors are frequent and may result in adverse events. Data on non-prescription of regular medications to emergency department short stay unit patients is lacking. In response to local reports of regular medication omissions, a multi-disciplinary team was tasked to introduce corrective emergency department (ED) process changes, but with no additional financing or resources. Aim: To reduce the rate of non-prescription of regular medications for patients admitted to the ED Short Stay Unit (SSU), through process change within existing resource constraints. Methods: A pre- and post-intervention observational study compared regular medication omission rates for patients admitted to the ED SSU. Included patients were those who usually took regular home medications at 08:00 or 20:00. Omissions were classified as clinically significant medications (CSMs) or non-clinically significant medications (non-CSMs). The intervention included reinforcement that the initially treating acute ED doctor was responsible for prescription completion, formal checking of prescription presence at SSU handover rounds, double-checking of prescription completeness by the overnight SSU lead nurse and junior doctor, and ED pharmacist medication reconciliation for those still identified as having regular medication non-prescription at 07:30. Results: For the 110 and 106 patients in the pre- and post-intervention periods, there was a non-significant reduction in the CSM omission rate of -11% (95% CI: -23 to 2), from 41% (95% CI: 32-50) to 30% (95% CI: 21-39). Conclusion: Non-prescription of regular CSMs for SSU patients was not significantly reduced by institution of work practice changes within existing resource constraints.

Adverse drug reaction related to drug shortage: A retrospective study on the French National Pharmacovigilance Database.

AIM: Drug shortages are a growing global health issue. The aim of the study was to evaluate the consequences of drug shortages on patient safety based on data recorded in the French National Pharmacovigilance Database. METHODS: All cases involving drug shortages reported from 1985 to the end of 2019 were extracted from the database. RESULTS: Following the selection process, 462 cases were included. The number of cases increased significantly from 2004 to 2019. Cases mainly involved drugs from the nervous system (22.1%, 95% confidence interval [CI] 17.5-27.0%), the cardiovascular system (16.4%, 95% CI 11.9-21.4%) and anti-infectives for systemic use (14.3%, 95% CI 9.7-19.2%) ATC classes. Most of the cases reported an adverse drug reaction (ADR) belonging to the SOC nervous system (21%, 95% CI 18-24%), skin and subcutaneous (14%, 95% CI 11-17%), general (13%, 95% CI 10-17%) and gastrointestinal (8%, 95% CI 5-11%) disorders. Disease worsening was observed in 15.9% of the cases, mostly related to a lack of efficacy of the replacement drug. Half of the cases were considered as serious. Evolution was favourable in 79.4% of the cases. Death and/or life-threatening situations were reported in 5.8% of the cases. Medication errors (MEs) were identified in 51 cases (11%), mostly occurring at the administration step and involving a human factor. CONCLUSION: This study emphasizes the clinical impact of drug shortage in terms of ADRs, ME and inefficiency. These observations underline the importance of a global health policy programme to limit the occurrence of drug shortages and to reinforce the information provided to patients and health care professionals in this context to limit risk.

Bleomycin overdose in a patient with stage II Hodgkin lymphoma: A case report of a medication error.

Bleomycin is an antibiotic with cytotoxic properties that is commonly used in combination regimens for the treatment of Hodgkin lymphoma. The inconsistency in the dosage nomenclature of bleomycin appears universally, which increases the risk of medication errors. However, to the best of our knowledge, no such cases have been reported. Herein, we present a rare case report of a medication error caused by a bleomycin overdose. At the third cycle of chemotherapy, a 25-year-old patient with stage II Hodgkin lymphoma received a 10 times higher dose of bleomycin (150 USP) than that usually used as part of the doxorubicin, bleomycin, vindesine and dacarbazine protocol (ABVD). After the medication error was discovered, the patient was immediately treated with intravenous rehydration and furosemide to promote drug clearance. Additionally, methylprednisone and acetylcysteine were administered to prevent lung injury. However, the patient developed slight nausea and mild rash, which gradually improved after treatment. After evaluation with positron emission spectrometry-computed tomography (PET-CT), the patient received four cycles of AVD chemotherapy. No other obvious abnormalities were observed during the treatment and 1-year follow-up period. Hence, the toxicities, clinical management and selection of further chemotherapy after bleomycin overdose in such cases deserved serious attention. More importantly, management measures after this error may be used as a reference in other hospitals.