A critical analysis of labeling errors of high-alert medications – Safety assessment and remedial measures through case based approach (original) (raw)
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Analysis of similar drug labeling: potential medication errors
Revista da Associação Médica Brasileira, 2012
Objective: This study aimed to examine drug packaging and labeling, identifying similarities among them that may lead to medication errors, which may occur by unintentional substitution, in different sectors of the pharmacy of a university hospital in northeastern Brazil. Methods: Cross-sectional observational study, which included 300 pharmaceutical presentations (150 pairs) that were photographed from May to December 2010. Concordance analysis of data related to the pictures of possibly similar packaging and labels was validated using the Kappa index. Results: Of all drugs evaluated (n = 150), about 43% of "possibly similar drugs" were in the central pharmacy (n = 65) and were related to small-volume parenteral solutions. The strength of interobserver agreement in the category "very similar to each other" was considered "satisfactory" (Kappa = 0584) in 90.66% of the drugs evaluated (n = 136). The overall Kappa analysis of the study was 0.488. Variables with statistical significance were: "same color label or packaging", with the respective percentages for both primary and secondary packaging (52%-44%), p = 0.028; the variable "same color of drug presentation" obtained similar values and statistical significance to the previous variable; for the variable "same arrangement of words", the values found for both packages were close to 50%, p = 0.001; and for the variable "same color of the words", the percentages were: (50.7% -44%) (p = 0.008). Conclusion: Our results indicate similarities related to the labeling of drugs with potential for errors, especially in dispensing, storage, and administration if preventive measures are not adopted.
Drug Information Journal, 2001
The issue of medication errors is not a new one, although recently it has become a matter of increasing intense public interest and concern. Bristol-Myers Squibb (BMS), an ethical pharmaceutical manufacturel; has always been actively concerned with ensuring the proper use of its drug products, and in the past has made modifications to the labeling of certain products specifically to reduce the risk of error by medical providers. Beginning in 1998, immediately following a public meeting on this topic sponsored by the Food and Drug Administration, the company began a formal initiative to address this issue more generally, working through a special "labeling council" within BMS to determine and then implement practical measures for reducing the risk of medical provider error associated with labeling and packaging of its products. Among these measures were implementation of an internal code of practice adapted from recommendations developed by the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP). BMS is also contributing to industry-wide efforts to address this public health issue through its active support of the Safe Use of Medicines Task Force formed by the Pharmaceutical Research and Manufacturers of America (PhRMA).
Prescription Drug Labeling Medication Errors: A Big Deal for Pharmacists
Today, in the health care profession, all types of medication errors including missed dose, wrong dosage forms, wrong time interval, wrong route, etc., are a big deal for better patient care. Today, problems related to medications are common in the healthcare profession, and are responsible for significant morbidity, mortality, and cost. Several recent studies have demonstrated that patients frequently have difficulty in reading and understanding medication labels. According to the Institute of Medicine report, “Preventing Medication Errors”, cited poor labeling as a central cause for medication errors in the USA. Evidence suggests that specific content and format of prescription drug labels facilitate communication with and comprehension by patients. Efforts to improve the labels should be guided by such evidence, although an additional study assessing the influence of label design on medication-taking behavior and health outcomes is needed. Several policy options exist to require minimal standards to optimize medical therapy, particularly in light of the new Medicare prescription drug benefit. Key words: Health care profession, labeling, medication error
Current practices for labeling medications in hospitals in Riyadh, Saudi Arabia
Saudi Pharmaceutical Journal, 2013
Background: Good medication labeling practices are imperative to ensure safe medication use. Non-adherence to labeling protocols is reported as one major source of medication errors. Objective: This study was intended to evaluate and compare adherence to labeling guidelines for dispensed medications among the hospitals of the five different health sectors in the city of Riyadh, Saudi Arabia. Methods: A descriptive, cross-sectional analysis was conducted among 14 public hospitals in the city of Riyadh, Saudi Arabia. Labeling guidelines issued by the Institute for Safe Medication Practices were used as a standard assessment tool. A total of 218 medication labels were collected and evaluated for labeling adequacy. Descriptive statistics were used to elaborate the study findings. All analyses were performed with Microsoft Access. Results: The study showed a substantial rate of adherence to the labeling guidelines. In terms of the established criteria, community and mail orders were reported to adhere strongly (90.5%), whereas injectables adhered least to the labeling guidelines. The labeling format, contents of the label, instructions on the labels, abbreviations used on the labels and drug names were also consistent with the guidelines (80.0%, 84.0%, 88.0%, 97.7% and 85.5%, respectively). Organizations
Journal of Pharmaceutical Health Care and Sciences, 2015
Background: There are many reports regarding various medical institutions' attempts at incident prevention, but the relationship between incident types and impact on patients in drug name errors has not been studied. Therefore, we analyzed the relationship between them, while also assessing the relationship between preparation and inspection errors. Furthermore, the present study aimed to clarify the incident types that lead to severe patient damage. Methods: The investigation object in this study was restricted to "drug name errors", preparation and inspection errors in them were classified into three categories (similarity of drug efficacy, similarity of drug name, similarity of drug appearance) or two groups (drug efficacy similarity (+) group, drug efficacy similarity (−) group). Then, the relationship between preparation and inspection errors was investigated in three categories, the relationship between incident types and impact on patients was examined in two groups. Results: The frequency of preparation errors was liable to be caused by the following order: similarity of drug efficacy > similarity of drug name > similarity of drug appearance. In contrast, the rate of inspection errors was liable to be caused by the following order: similarity of drug efficacy < similarity of drug name < similarity of drug appearance. In addition, the number of preparation errors in the drug efficacy similarity (−) group was fewer than that in the drug efficacy similarity (+) group. However, the rate of inspection errors in the drug efficacy similarity (−) group was significantly higher than that in the drug efficacy similarity (+) group. Furthermore, the occupancy rate of preparation errors, incidents more than Level 0, 1, and 2 in the drug efficacy similarity (−) group increased gradually according to the rise of patient damage. Conclusions: Our results suggest that preparation errors caused by the similarity of drug appearance and/or drug name are likely to lead to the incidents (inspection errors), and these incidents are likely to cause severe damage to patients subsequently.
Medication errors: A matter of serious concern
Anaesthesia, Pain and Intensive Care
The incidence of medications errors is increasing and the exact incidence is likely greatly underestimated and under-reported. Although the majority of these errors occur due to lack of knowledge of or failure to follow accepted protocols, look alike medication containers are the primary cause in many cases of drug error related morbidity or even mortality. With the number of drugs and the number of pharmaceutical companies manufacturing the same drug on an increase, the incidence is likely to increase. It is a universal problem that can be found in any operating room throughout the world, as demonstrated by the multi-national representation of many reports on this subject in the literature. This editorial supplements a case report, the ‘Clinipics®’ page and a special article on the topic of hazards of look-alike drug containers published in this issue of Anaesthsia, Pain & Intensive Care. The authors also attempt to present strategies to reduce these medication errors. The developm...
Medication labeling practices at in-patient hospital pharmacies: the present dilemma in Pakistan
MOJ Drug Design Development & Therapy
Drug labels provide first hand information to the patients as well as it provides a unique identity to the medical product. Misreading the label, inadequate information on label, inappropriate labeling font, writing style and its placement on the dosage form are the few of the barriers identified for inappropriate labeling practices. Objective: The main objective of the present study was to assess current labeling practices in inpatient departments of health care facilities among public and private sectors in twin cities of Pakistan. Methodology: A descriptive cross-sectional study design was used. A total of twenty healthcare facilities were randomly selected i.e. 10 from public and 10 from private sectors. As per WHO criteria thirty encounters per facility were observed. ISMP guidelines were used to develop a structured observation form. After data collection, data was recorded on structured observation form containing predetermined set of indicators. After data collection, data was cleaned, coded and entered in SPSS version 21. Descriptive statistics of frequency and percentages were calculated. Kruskal-Wallis and Mann-Whitney tests (p≤0.05) were performed to find out differences among variables. Results: Out of total hospitals visited only 10% were having proper IPD pharmacy setup in public sector while in private sector 50% were having proper IPD pharmacy setup. Significant differences (p≤0.05) were found among the labeling practices carried for label identification, label instruction and label layout with respect to city, sector, gender, designation, age, experience and dosage form. Labeling practices carried in private sector and healthcare facilities located in Islamabad were comparatively better than the public sector and healthcare facilities located in Rawalpindi. Pharmacists had relatively more compliance with the standard labeling guidelines. Conclusion: The present study concluded that the labeling practices carried at the hospital pharmacies were not up to the mark. Although labeling practices in terms of labeling identification was appropriately mentioned but labeling instructions and layout were not in compliance with the standard labeling guidelines. This might be due to lack of availability/implementation of national standard labeling guidelines, lack of interest, knowledge and training of dispensers regarding good labeling practices.
Bioinformatics and Biomedical Research Journal
Medication error is any preventable event that may lead inappropriate drug service to patient, although administrated by the healthcare professional. This study aimed to analyze the factor that may lead the medication error and identify the medication error solution to pharmaceutical installation in Indonesian hospital. The research subjects were doctor, pharmacist, pharmaceutical engineering personnel and nurses. Action research was including : diagnosis, reconnaissance, action plan, action, evaluation and monitoring the subject. Diagnosis were obtained from primary and secondary data. Primary data were obtained by interview, observation, and Focus Group Discussion (FGD). Secondary data were obtained from adverse event and near-miss events in medication error data in pharmacy installation. The results indicated that there were four major factor of medication error. First, prescribing error is an unclear written prescription, incomplete administration, and unavailable prescription. Second, transcribe error is a misread of prescription drug that lead to mistreatment. Third, dispensing error is involved the misread of prescription drug by pharmacist, wrong dose, wrong quantity, and incompetent pharmacist personnel. Fourth, administration error is an incorrect administration by hospital personnel. In conclusion, the establishment of safety guideline is important to medication error in pharmaceutical installation. The safety guidelines consist of the policy and standard operational procedure, flowchart of outpatient service, code of conduct of pharmacy safety and monitoring to ensure the quality of medical service.
Medication errors: A challenge to pharmacovigilance
Journal of emerging technologies and innovative research, 2021
Pharmacovigilance is an activity contributing to the protection of health of public. There are many adverse reaction which are due to the special situations like overdose, misuse, accidental drug exposure, off label use and medication errors. Medication errors are found to be difficult for tracking and also these are creating the challenges for pharmacovigilance. Drugs are need to be used as per the given label or company core data sheet to show maximum effect. Many factors like patient education, dispensing and prescription errors contribute for the medication errors which may affect patient compliance. Many unexpected therapeutic benefits have been reported by the patients and health care professional due to medication errors. This will help in research for different pharmacological actions of existing marketed formulations. An effort has been made in this review to collect information about different types of medication errors and the challenge associated with it for pharmacovigilance. Also effort has been made for the effective use of medicines as per label and to improve patient compliance. Data from different websites and published articles has been collected and summary of these articles has been written. From this review it has been concluded that by patient education we can reduce the chances of medication errors.