ORIGINALES

 

Analysis of the medication reconciliation process conducted at hospital admission

Análisis de la actividad de conciliación de la medicación establecida al ingreso hospitalario

 

 

María Beatriz Contreras Rey, Yolanda Arco Prados and Ernesto Sánchez Gómez

Clinical Management Unit (CMU) of Pharmacy. Complejo Hospitalario Universitario de Huelva. Spain.

Correspondence

 

 

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ABSTRACT

Objective: To analyze the outcomes of a medication reconciliation process at admission in the hospital setting. To assess the role of the Pharmacist in detecting reconciliation errors and preventing any adverse events entailed.
Method: A retrospective study was conducted to analyze the medication reconciliation activity during the previous six months. The study included those patients for whom an apparently not justified discrepancy was detected at admission, after comparing the hospital medication prescribed with the home treatment stated in their clinical hospital records. Those patients for whom the physician ordered the introduction of home medication without any specification were also considered. In order to conduct the reconciliation process, the Pharmacist prepared the best pharmacotherapeutical history possible, reviewing all available information about the medication the patient could be taking before admission, and completing the process with a clinical interview. The discrepancies requiring clarification were reported to the physician. It was considered that the reconciliation proposal had been accepted if the relevant modification was made in the next visit of the physician, or within 24-48 hours maximum; this case was then labeled as a reconciliation error. For the descriptive analysis, the Statistics^® SPSS program, version 17.0, was used.
Outcomes: 494 medications were reconciled in 220 patients, with a mean of 2.25 medications per patient. More than half of patients (59.5%) had some discrepancy that required clarification; the most frequent was the omission of a medication that the patient was taking before admission (86.2%), followed by an unjustified modification in dosing or way of administration (5.9%). In total, 312 discrepancies required clarification; out of these, 93 (29.8%) were accepted and considered as reconciliation errors, 126 (40%) were not accepted, and in 93 cases (29,8%) acceptance was not relevant due to a change in the situation of the patient. The highest opportunities for improvement were identified in the Gastroenterology, Internal Medicine and Surgery Units, and in the following therapeutic groups: blood and hematopoietic organs, cardiovascular system, and nervous system.
Conclusions: In our hospital, only a third of interventions were accepted and acknowledged as reconciliation errors. However, the medication reconciliation process conducted at admission by a Pharmacist has proven to be useful in order to identify and prevent medication errors. A better understanding of the cases in which interventions were not accepted could lead to an improvement in outcomes in the future.

Key words: Medication reconciliation; Medication errors; Pharmacist intervention; Drug-related problems; Patient safety.

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RESUMEN

Objetivo: Analizar el resultado de un proceso de conciliación de la medicación al ingreso en el ámbito hospitalario. Valorar la intervención del farmacéutico en la detección de errores de conciliación y en la prevención de acontecimientos adversos que pueden derivarse de ellos.
Método: Estudio retrospectivo en el que se analizó la actividad de conciliación en los seis meses previos. Se incluyeron los pacientes en los que se detectaron discrepancias al ingreso, en apariencia no justificadas, tras comparar la medicación hospitalaria prescrita con el tratamiento domiciliario que constaba en su historia digital. Se consideraron también los pacientes en los que el médico ordenaba introducir la medicación domiciliaria sin especificar de cuál se trataba. Para llevar a cabo la conciliación el farmacéutico elaboró la mejor historia farmacoterapéutica posible revisando la información disponible sobre la medicación que podía estar recibiendo el paciente de forma previa al ingreso y completando el proceso mediante una entrevista clínica. Las discrepancias que requerían aclaración fueron comunicadas al médico. La propuesta de conciliación se consideró aceptada si en la siguiente visita médica o en un plazo no superior a 24-48 horas se realizaba la modificación pertinente, en cuyo caso se denominó error de conciliación. Para el análisis descriptivo se empleó el programa SPSS Statistics^® versión 17.0.
Resultados: Se conciliaron 494 medicamentos en 220 pacientes, con una media de 2,25 fármacos. Más de la mitad de los pacientes (59,5%) presentó alguna discrepancia que requería aclaración, siendo la más frecuente la omisión de un medicamento que recibía previamente al ingreso (86,2%), seguida de la modificación de la posología o vía de administración sin justificar (5,9%). En total 312 discrepancias requirieron aclaración, de las cuales 93 (29,8%) fueron aceptadas y se consideraron errores de conciliación, 126 casos (40%) no lo fueron y en 93 (29,8%) la aceptación no procedía por un cambio en la situación del paciente. Las mayores oportunidades de mejora se identificaron en los servicios de Digestivo, Medicina Interna y Cirugía General y en los grupos terapéuticos: sangre y órganos hematopoyéticos, sistema cardiovascular y sistema nervioso.
Conclusiones: En nuestro hospital solo una tercera parte de las intervenciones fueron aceptadas y reconocidas como errores de conciliación. No obstante, la conciliación de la medicación al ingreso realizada por un farmacéutico mostró ser útil en la identificación y prevención de errores de medicación. Un mejor entendimiento de los casos en los que las intervenciones no fueron aceptadas podría mejorar el resultado en el futuro.

Palabras clave: Conciliación de la medicación; Errores de medicación; Intervención farmacéutica; Problemas relacionados con los medicamentos; Seguridad del paciente.

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Contribution to Scientific Literature

This article provides a detailed description of the identification of reconciliation errors after Pharmacist intervention, designed in the setting of a clinical interview with the patient at the time of admission, and the communication to the rest of the healthcare team of any potential discrepancies observed with the hospital treatment prescribed, to be corrected if necessary. This analysis describes that there are certain clinical departments with a higher rate of acceptance for Pharmacist interventions, and that there can be some association with specific pharmacological classes in their acceptance or rejection. This also entails the likelihood of identifying any points of improvement for subsequent interventions, promoting a higher acceptance of pharmaceutical interventions.

 

Introduction

The main cause of adverse events during patient care is associated with the use of medications; it is considered that over a third part of these adverse events could be prevented¹. The lack of information caused by an incomplete or outdated pharmacotherapeutical record will often lead to these errors during the different healthcare transitions, with the potential risk entailed for patients². The presence of unintentional discrepancies between the medication previously taken by the patient and that prescribed at hospital admission is not uncommon, and it has been estimated that 11% to 59% of cases will have relevant clinical consequences in patients³. During the medication reconciliation process, any unjustified discrepancies found can easily become reconciliation errors^4-6.

The World Health Organization (WHO) has encouraged setting up medication reconciliation processes in different patient care transitions, as these are a key aspect regarding patient safety. Other international organizations, such as the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) and the Institute for Safe Medications Practices (ISMP) are also conducting strategies in this area⁷.

Medication reconciliation is a formal process, which consists in comparing the previous medication taken by the patient with the medication prescribed after a healthcare transition, in order to detect any unintentional discrepancies and report them to the prescribing physician for their correction, if relevant^8,9. The objective of reconciliation is that patients will receive the medication they were receiving chronically; but it must also take into account the adaptation to the patient's current situation¹⁰, because patients can have new therapeutic needs that justify adapting and modifying their previous medication.

The medication reconciliation process can be conducted by different healthcare professionals^7,9, but the Pharmacist, as a medication specialist, must have the opportunity to play an active role^7,11-13 and incorporate it into their daily practice. It has been pointed out that the action by the Pharmacist in this process will reduce the frequency of medication errors which might lead to harm for the patient¹⁴. Setting up standard protocols for action in reconciliation matters, the identification of problems associated with medications, and education for patients regarding the adequate way to take their medications, must be part of their daily clinical practice.

The objective of this study is to analyze the outcomes of a medication reconciliation process conducted in the hospital setting, and to assess the Pharmacist intervention in the detection of errors and the prevention of any entailed adverse events with potential risk for patients.

 

Method

An observational, descriptive and retrospective study was conducted in the Pharmacy Department of a 600-bed hospital, within a University Specialty Hospital. The study analyzed the activity by the Pharmacist regarding reconciliation in adult patients who were admitted to hospital units with a computerized physician order entry (CPOE) system installed (Cardiology, General Surgery, Internal Medicine, Nephrology, Pulmonology) during the previous six months, between January, 15^th and July, 14^th, 2015. The reconciled patient database previously designed for this aim was used as the basis for obtaining records.

Patients had been selected among those admissions where apparently unjustified discrepancies were detected after analyzing the medication prescribed at admission and comparing it with the home treatment appearing in the Single Digital Patient Record. The study also included those patients for whom the prescribing physician had ordered the introduction of home medication without any further specifications. The study excluded those patients admitted to hospitalization units without a CPOE system, those patients who were not receiving any oral medication due to their strict diet, and those cases where clinical interview was not possible due to the patients' clinical or personal situation.

The following information was collected for each patient: clinical record number, gender, age, hospitalization unit, source of the pharmacotherapeutical history, reconciled medications, types of discrepancy and their severity, method of communication of discrepancies, and acceptance or not by the prescribing physician.

The first step in the reconciliation process was preparing the best pharmacotherapeutical history possible. Different sources of information were used for the medication that the patient could be receiving: Primary Care, external and outpatients, discharge report by the ER unit, and anamnesis form of admission to the hospital unit. After reviewing all information available, the Pharmacist visited patients in their own rooms in order to confirm the details with them and/or their caregivers. During this interview, where confidentiality was guaranteed, the patient was asked about the home medication with and without prescription, both in the public healthcare unit and in the private setting, that they were taking before admission, as well as any other pharmacologically active substances and potential allergies or drug-related adverse reactions that they could have experienced.

Discrepancy was defined as any difference between the medication that the patient was taking chronically before admission and the medication prescribed at hospital⁹. The types of reconciliation discrepancies were classified according to the usual criteria established in various publications^9,10, which differentiate between cases of non-discrepancy, justified discrepancy, and discrepancy that requires clarification, with different subtypes¹⁰:

1. No discrepancy.

2. Justified discrepancy.

a. Initiation of drug treatment justified by the clinical situation.

b. Medical decision not to prescribe a medication or to change its dosing, frequency or way of administration, based on the clinical situation.

c. Therapeutical replacement according to the hospital formulary.

3. Discrepancy that requires clarification.

a. Omission of medication. The patient was taking a necessary medication, and it has not been prescribed, without any explicit or clinical justification for this omission.

b. Initiation of medication. Treatment is initiated with a drug that the patient was not taking previously, and there is no explicit or clinical justification for this initiation.

c. Different dosing, way or frequency of administration of a medication. The dosing, way or frequency of administration is modified, without any justification by the clinical situation or other circumstances, such as renal or liver function.

d. Different medication. A different medication within the same class is prescribed, without any clinical justification for the replacement, or reasons of availability in the hospital formulary.

e. Duplicity. The patient presents duplicity between chronic medications, or between their chronic medication and that prescribed at hospital.

f. Interaction. The patient presents a clinically important interaction between chronic medications, or between their chronic medication and that prescribed at hospital.

g. Medication not available at hospital. Prescription of chronic medication not available at hospital without conducting any therapeutical exchange.

h. Incomplete prescription. There is an incomplete prescription for the chronic treatment, and clarification is required.

The severity of error was determined by consensus in each case by the team of three Pharmacists conducting the study. The classification by The National Coordinating Council for Medication Error Reporting and Prevention (NCCMERP)¹⁵, adapted by some authors¹⁰, was used in order to assign the different severity categories to reconciliation errors, based on the likelihood of error and the potential harm to patients:

Category A. No error, but likely to occur.

Category B. An error that does not reach the patient; no harm caused.

Category C. An error that, in case of reaching the patient, is not likely to cause harm.

Category D. An error that, in case of reaching the patient, would require monitoring and/or intervention to prevent harm.

Category E. An error that, in case of reaching the patient, would cause temporary harm.

Category F. An error that, in case of reaching the patient, would cause harm and require initial or prolonged hospitalization.

Category G. An error that, in case of reaching the patient, would cause permanent harm.

Category H. An error that, in case of reaching the patient, would require life support.

Category I. An error that, in case of reaching the patient, would cause the patient's death.

The discrepancies requiring clarification were communicated to the physician managing the patient using one of the following means of communication: oral, by telephone, message through the CPOE application, or register in the patient's clinical record.

It was considered that the reconciliation proposal had been accepted if the relevant modification was made in the following medical visit (within 24-48 hours); in this case, it was considered as a reconciliation error⁹.

The ATC classification (Anatomical, Therapeutic, Chemical Classification System) was used in the analysis of medications with discrepancy, with the list of molecules included in each group¹⁶.

The outcomes of this study were analyzed in a descriptive way through the SPSS Statistics^® Program (version 17.0).

 

Outcomes

The reconciliation process was conducted in 220 patients; 54% were male (and 46% were women), with a mean age of 67 years. In the case of 21 patients (9.5%), the prescribing physician had ordered a reintroduction of home treatment without any specifications.

Patients were hospitalized in the following units: 103 in Internal Medicine (46.8%), 54 in General Surgery (24.5%), 32 in Gastroenterology (14.5%), 17 in Nephrology (7.7%), 10 in Pulmonology (4.5%) and 4 in Cardiology (1.8%).

Before conducting an interview with the patient, in order to prepare the best pharmacotherapeutical history possible, information was searched about the medication that the patient could be taking before admission. In 86% of cases, this information was obtained from the Single Digital Clinical Record; patients provided medical reports in 9% of cases, and there were other sources in 5% of cases.

In total, 494 medications were reconciled for 220 patients (2.25 drugs per patient). The distribution by type of discrepancy appears in table 1. In total, 131 patients (59.5%) presented some discrepancy that required justification; 70 of them (53.4%) presented more than one. These patients grouped 312 medications overall (63.1%) with discrepancies that required clarification; the mean was 2.4 discrepancies. The most frequent was the omission of a medication that the patient was taking before hospitalization in 269 cases, representing 86.2% of all cases; this was followed by unjustified modification of dosing or way of administration (29 cases, 5.9%).

In terms of the channels of communication used, 74% (231) of those 312 medications involved that required clarification were reported through a message to the prescribing physician in the CPOE application; in 15.8% of cases (49) this was not relevant, because it was corrected after the interview and before communicating the discrepancy; an 8% (25) were communicated orally, 1.6% (5) by telephone, and in 0.6% (2) of cases, the message was entered into the patient's clinical record.

Overall, 93 discrepancies (29.8% of all discrepancies requiring clarification, and 35.4% of those reported) were corrected after the Pharmacist intervention, and were then considered as Reconciliation Errors (REs). On the other hand, 126 (40.4%) were not acknowledged, and in 93 cases (29.8%) acceptance was not relevant (exitus, imminent discharge, or correction after the interview and before communicating the discrepancy).

Table 2 shows the classification of those discrepancies that required clarification by hospital unit, the acceptance by these units, and the distribution of reconciliation errors by hospital unit. The three main units with more drugs presenting discrepancies that needed clarification were Internal Medicine, Gastroenterology and General Surgery; and when observing the distribution of errors by hospital unit, these units also presented the highest frequency.

Table 3 shows discrepancies by anatomical-therapeutic group, the number of interventions accepted for each group, as well as the utility of Pharmacist intervention, measured as the number of reconciliation errors corrected compared with the number of discrepancies that required clarification. The majority of the drugs with these discrepancies belonged to the following ATC groups: blood and hematopoietic organs (Group B), cardiovascular system, (Group C) and nervous system (Group N).

Table 4 shows the distribution in these three hospital units in terms of the three most frequent ATC groups, as well as their acceptance rate.

Out of the 93 unjustified discrepancies that were accepted (reconciliation errors), 69 (74.2%) were unjustified cases of omission of medications, 18 (19.4%) were unjustified modifications in dosing or way of administration, 2 (2.2%) were duplicity between medications, 1 (1.1%) was a case of unjustified medication initiation, 1 (1.1%) was the unjustified replacement of a medication by another, 1 (1.1%) was the presence of a clinically relevant interaction, and 1 (1.1%) was an incomplete prescription that required clarification.

There was an analysis of error severity for those reconciliation errors detected, and they were distributed as follows: 49.5% of them were classified as errors that, in case of reaching the patient, would not be likely to cause harm (Category C); 22.6% represented errors that did not reach the patient, and therefore caused no harm (Category B); 19.4 % of errors, if they had reached the patient, would have required monitoring and/ or intervention to prevent harm (Category D); 6.5% of errors would have caused temporary harm if they had reached the patient (Category E), and there was no error in 2.2%, but it was likely to occur (Category A).

The highest severity category obtained in our study corresponded to that designed with the letter E. Six reconciliation errors within this class were found (some of them caused real harm in the patient, while in other cases there was an intervention before the potential harm could occur): omission of antibiotic prophylaxis with ciprofloxacin after an intravitreal injection of ranibizumab, overdosing of clonazepam that required rescue with flumazenil, digoxin overdosing, two cases of omitted nitroglycerin patches, and omission of the weekly dose of oral methotrexate in a patient with Behcet Disease.

Five of these six reconciliation errors occurred in the Internal Medicine Unit, and one in Gastroenterology. At the same time, Internal Medicine made the highest number of reconciliation errors from all severity categories detected.

 

Discussion

Our outcomes show that discrepancies requiring clarification were detected in more than half of the medications analyzed; the most frequent was the omission of a medication, followed by modification of dosing or way of administration. The types of discrepancies that required clarification with higher frequency in our study are similar to those described by other authors^14,17-21.

Approximately half of our patients presented more than one discrepancy requiring clarification; the mean was 2.4 per patient with unjustified discrepancy; these outcomes are similar to the ones by Lessard et al.¹⁷, who found 2.3 per each patient with discrepancy, and are slightly superior to those provided by other authors²².

Vira et al.¹⁹ confirmed that 46% of non-intentional discrepancies detected at admission led after the intervention to prescription modifications by the physician. Other authors showed higher acceptance rates^4-6,23. In our case, approximately one third of the interventions conducted and reported to the prescribing physician were accepted, and therefore considered reconciliation errors between the chronic medication that was the usual treatment taken by the patient before admission and the hospital prescription. The outcomes show that medication errors are frequent in patient care transitions, and are consistent with those obtained in other studies^14,17-19.

It has been stated that in many occasions those reconciliation errors that reach the patient have no potential to cause harm¹⁷. Gleason et al.¹⁴ described in their study on medication reconciliation in hospitalized patients that the majority of the discrepancies where the intervention was accepted were within the A-C severity categories (55%), followed by 23% with Level D and 22% with Level E-F. Rentero et al.⁵ obtained similar outcomes. In our case, the majority of the reported discrepancies that were accepted (reconciliation errors) were included in severity levels A-C (74.3%), while 19.4% were of Level D and 6.5% of Level E; the latter were errors that caused or could have caused temporary harm on patients if there had been no intervention by the Pharmacist. However, other authors have pointed out that more than half of reconciliation errors detected in their study were considered clinically relevant⁶.

According to the data described by Rentero et al.⁵, the majority of reconciliation errors observed in their study were located in surgical units (211/339), and to a lower rate, in medical units (128/339). In our case, the highest frequency of reconciliation errors was detected in medical units, mainly in the Internal Medicine Unit (50.5%), followed by Gastroenterology (20.4%). Our data are justified by the higher weight that medical units have in this hospital over the surgical block; therefore, it is not considered adequate to establish comparisons with the outcomes obtained by other authors, without knowing the distribution of units in their setting.

Unlike the outcomes obtained by Gleason et al.¹⁴ and Lessard et al.¹⁷, where the medications that most frequently generated discrepancies which required clarification were vitamins and electrolytes, followed by medications for the cardiovascular system, in our case, the most frequent pharmacotherapeutical groups were, in descending order: cardiovascular system, nervous system, and blood & hematopoietic organs. Data obtained by other authors show that these pharmacotherapeutical groups, mainly the cardiovascular, are frequently involved in those discrepancies that will usually require clarification^20-25. In our setting, the action of the Pharmacist was more decisive in these groups for detection and prevention of reconciliation errors, because they also presented the higher acceptance rate for interventions.

Our study presents various limitations. Firstly, the selection of patients was restricted to those admitted to hospitalization wards with a CPOE system installed, because it was considered that contact with the prescribing physician could be more direct and effective in this way. Secondly, not all patients admitted to these hospitalization units were included; instead, there was a previous selection of those for whom discrepancies were detected a priori between the medication prescribed at admission and the home medication appearing in the Single Digital Clinical Record; an interview with the patient was subsequently conducted to confirm whether these discrepancies were real. This study also included patients for whom the physician had ordered to re-introduce home medication, without any further specifications.

In our setting, only one third of the interventions conducted were accepted and therefore acknowledged as reconciliation errors; however, the medication reconciliation conducted by a Pharmacist at admission proved to be useful for the identification and prevention of medication errors with potential clinical consequences for the patient.

A better understanding of those cases where the pharmaceutical interventions conducted were not accepted could help to improve the outcomes of our reconciliation process in the future.

 

Conflict of interests

The authors hereby declare there is no conflict of interests.

 

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Correspondence:
Correo electrónico: beatrizconrey@hotmail.com
(María Beatriz Contreras Rey).

Recibido el 7 de octubre de 2015;
Aceptado el 4 de abril de 2016.