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Enfermería Global

versión On-line ISSN 1695-6141

Enferm. glob. vol.13 no.33 Murcia ene. 2014




Adverse drug event reporting system: a university hospital experience

Experiencia de un sistema de reporte de errores de medicación en un hospital docente



Castro Lara, Ariel*; Sotomayor Nieto, Julia**; Sepúlveda Vargas, Yasna** and Mena Velasquez, Sandra**

*Pharmacist, MSc. Clinical Epidemiology E-mail:
**Nurse. Hospital Clínico Universidad de Chile




Introduction: The medication error (ME) has an impact in the morbi-mortality of the patients, as this way also the economic consequences for the individual, the systems of health and the society. A way of identifying them is across the system of reports. The aim of this communication is to present the experience of use of reports in an teaching hospital.
Methodology: Descriptive Analysis of ME reports. There were in use as sources of information the system of census and the reports of the ME.
Results: The rate of ME's reports was of 1.2x 1000 patients. The reports principally came from medical services (39 %) and 34% from Intensive Care Units 34 %. More frequent MM was in the administration (47 %) and dispensation (27 %). The notified ME 69 % came to the patient, some type of intervention being needed in 68 % of these cases. The gravity of ME was important in 47 % of the cases, being able to preventable 97 %.
Conclusions: ME is a present reality in our hospital, which it is possible to anticipate. The system of ME reports is a useful tool in the identification that causes root.

Keywords: Medication Error; Adverse Drug Events; Reports.


Introducción: Los errores de medicación (EM) tienen un impacto en la morbi-mortalidad de los pacientes, como así también consecuencias económicas para el individuo, los sistemas de salud y la sociedad. Una forma de identificarlos es a través del sistema de reportes.
Objetivo: Presentar la experiencia de uso de reportes en un hospital docente universitario.
Metodología: Análisis descriptivo de reportes de EM. Se utilizaron como fuentes de información el sistema de censo y los reportes de los errores en la medicación.
Resultados: La tasa de reportes de EM fue de 1.2 x 1000 pacientes. Los reportes principalmente provinieron de servicios de tipo médicos (39%) y de Unidades de Pacientes Críticos-Aislamiento (34%). Los EM más frecuentes estuvieron en la administración (47%) y dispensación (27%). El 69% los errores notificados llegaron al paciente, necesitándose algún tipo de intervención en el 68% de esos casos. La gravedad de los EM fue importante en el 47% de los casos, pudiéndose prevenir en el 97%.
Conclusiones: Los EM son una realidad presente en los centros asistenciales, que se puede prevenir. El sistema de reportes de EM es una herramienta útil en la identificación de sus causas.

Palabras clave: Errores de Medicación; Eventos Adversos de Medicamentos; Reporte.



Attributable to medical errors, among which are the medication errors (ME) deaths, according exceed the Institute of Medicine (IOM) of the Accident USA, Breast Cancer and AIDS These ME, are mainly due to System Drug Utilization increasingly becomes more complex, becoming the main factor of ME, which starts with the selection of a therapeutic drug arsenal at different levels (government, province, hospital), then the act of prescribing by health team professionals, mainly doctors, then the dispensation of medication or preparation by the pharmacy unit, to be administered by the nursing staff. The process ends with monitoring patient's clinical response to the procedure performed and accordingly is continued or modified therapy starting the process again.

The ME incidence in hospitals are between 11.5 x 1,000 patient hospitalizations and 6.2 x 100(2, 3).

It can be said with certainty that adverse events related to ME, carry a significant decline in patients quality of life, sometimes for organic impairment and / or physical disabilities and even death(4). The ME economic consequences are mainly due to compensation for malpractice, prolonged length of hospital stay, need for palliative health care and lost productivity, disability or death(5).

Since social point of view increasing the errors in health care intolerance shown. Medication error social impact should be studied from two aspects, first, from patients point of view and their relatives or careers, can be said to be a witness or suffer ME, weakens confidence in the health system and on the other hand, if we consider the health professionals who have made a mistake, we see as being aware it leads them to distrust themselves hereinafter the motivation and fear of making mistakes(6)

Due to the health, economic and social connotation of ME, various actions have been implemented in order to reduce the most of this situation. Among which are electronic prescribing(7) nursing team dedicated specifically medication administration(8), dispensing systems in unit dose(9), among others. However, safe medication implementation of use systems by itself does not ensure success, for it is the evaluation of the implemented measures necessary. Some methodologies used for the assessment and detection ME that have been referred to in literature is the review of medical records(10), direct observation of processes(11), monitoring of laboratory parameters ME indicative(12), etc .

The aim of this paper is to present the experience gained in two years implementation ME reports.



The study was conducted in a university hospital with 600 beds, all medical specialties, which has annually about 21,000 hospital discharges.

The information was obtained from the nursing incident report, which contains a section on medication, it is recorded: the type of incident, he or drugs involved, unit, time and action taken to resolve. Apart from the system of general hospital census demographic data such as age and sex of patients, length of stay, and morbidity data were obtained according to the International Classification of Diseases ICD-10(14). The drugs involved were classified according to the Anatomical-Therapeutic WHO classification(15).

The ME were classified according to the process in which the error (prescribing, dispensing, preparation, dispensing) started and then categorized according to severity by the National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP)(16). The collected data were entered into an MS-Excel®, spreadsheet for analysis and classification.



During the two years in which the reports were reviewed, 59 were considered ME, corresponding to 1.19 reports per 1,000 patients. Which were generated mainly from type and Medical Services, Critical Unit and Isolation (Table 1). Patients who were involved in a report of ME were mainly women (58 %) with a mean age of 55 years and an average of 17 hospital stay days. The most common diseases according to ICD-10 were related to the circulatory system (31%) and neoplasms (25%) (Table 2) The drugs involved in ME according to the ATC classification, 19% belonged to Blood System (Heparin (5%), Acenocoumarol (3%)), and 15 % to the group anti-infective (Vancomycin, 3%). (Table 3) Importantly, most of the drugs involved were for intravenous administration.





Forty seven percents ME reports began in administration process, 27% in the dispensing process (Figure 1).



Of Fifty nine ME reports, 69% of them (41) reached the patient, of which 34% required monitoring, and 39 % required more than one action is taken. While there was attributable to ME reported deaths, 47% were classified as type A, and 97% ME reported could have been avoided (Table 5).




In 46 of 59 ME reports. Attempt to set the ME type occurred in each of the processes (Table 5). In the prescription process, the source of the error was because there was not a recipe (42.9 %) or because the prescribed dose was not correct (28.6 %). The delivery of the wrong medication, which was originated 40 % ME occurred in the dispensing process (35.3%). It occurred in the management process was due to the administration of a drug that is not appropriate.



This work is made by the few in our country who describe ME experience.

The ME reporting rate in our hospital were lower than those reported in international studies(17) because the system had little time to implement, so it is little known. Other reasons may be reluctance to report by the health personnel involved in the ME for any penalties that may receive. Other reasons that have been described in literature as barriers to the reporting ME, is lack of feedback after reporting initiatives, lack information to make a report and the difficulty to access report forms().

Of note is the high number of ME patient arrived, a value close to 70 %, higher than that reported in literature(19) and figure this is probably why they have reported.

The processes of drug use in which ME reports originated, are similar to other published experiments(20). During the analysis it was observed that most of the reported ME occurred due to various faults within the system of drug use(21). It has been estimated that about 50% ME, default procedures and lack of automation in medication use system(22) should be. Among other ME causes are lack of a drug to prescribe or administer, difficulty accessing drug information or protocols, lack of communication between the health team, etc.(23).

The time at which ME occurred (data not shown) in our hospital, concentrated mainly in the daytime, possibly because burden of care that focuses on that schedule (test taking, more frequent drug administration), that is likely to notice at this time is greater for control given by full complement staff, not during night time. These results are similar to other studies in which ME occur between 12pm and 4pm(24), but also because in these times there is more control, as there is fully staffed, it does not occur during at night .

The weakness of this work comes from the quality of the information provided in incidents reports, as many times not complete data patients had not identified precise time incident, and the measures taken to reverse the adverse event, as well as the description of the event itself occurred. We conclude that usefulness of incident reports will be useful only if they contain all the information to be able to identify the causes of ME and take corrective action(25). Medication error report, detect those high clinical significance and have a low rate of false positives(26).

The situation described in this work may have changed actually, as the hospital has made dissemination of standards of good practice in regard to medication administration, which were developed by a joint committee with the participation of nurses of different services, midwives and pharmacists. This is expected to be a consistency in the process, helping to improve clinical practice.



The ME actually a cross all services of our hospital. The ME report, are a useful method for detecting the origin of the ME and ME for those that have a high clinical significance for the patient, however, are sub - notified.

Medication error, are included in Security component in Patient Care must be met by all health care providers to achieve accreditation, which can be achieved with implementation standards care (management standards, guidelines clinical practice), working protocols for the use of drugs with high probability of ME (use of insulin, oral hypoglycemic agents, heparin, etc.), and implementing computer systems for prescribing and dispensing. It is important to consider that ME are not only due to human error, but also must consider the poor planning of work systems and drug delivery systems to patient. In addition it should be noted that in ME is not only involved medical personnel (doctors, pharmacists and nurses), but also pharmaceutical industry, health authorities and even patient himself.




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