INTRODUCTION

Medication reconciliation is “a formal process for creating the most complete and accurate list possible of a patient’s current medications and comparing the list to those in the patient record or medication orders” to avoid medication errors such as duplications and omissions.¹ The medication reconciliation could reduce medication errors and related harms. Providing, recording, and passing along the current and correct medication list of the patient is essential for patient safety, especially during the transition of care (including hospital admission and/or discharge).²

The medication reconciliation can be provided by various healthcare professionals. However, studies have shown that services such as medication reconciliation and discharge patient consultation led by pharmacists increase patients’ knowledge of medication and reduce adverse drug events and medication errors in the transition of care.^3,4 Pharmacists who have diverse knowledge and skills can establish and maintain an effective medication reconciliation process in hospitals and healthcare systems.⁵ The medication reconciliation led by an inpatient pharmacist is an effective method for maintaining the patient’s post-discharge care.⁶ A review published in the Cochrane Library concluded that the impact of pharmacist-involved medication reconciliation services was unclear on medication discrepancies, adverse drug effects, and health values.⁷ Medication discrepancy is defined as the differences between medication regimens given in different care settings and often results from lack of documentation and time to create a complete and accurate list of the patients’ medication history. Therefore, medication reconciliation is an essential component in ensuring safe patient care by preventing medication discrepancy in any setting.^1,7

Clinical pharmacists provide medication reconciliation services in patients with various infectious diseases.^8,9 In the infectious disease ward, medication reconciliation reduces the number of undocumented unintentional discrepancies¹⁰ and hospital readmission within a month after discharge.¹¹

During the coronavirus disease-2019 (COVID-19) pandemic, clinical pharmacists continued to provide services (including medication reconciliation) with different working models.^12,13 Medication reconciliation service is not provided routinely at hospitals in Türkiye. There are few studies in Türkiye about medication reconciliation services provided in hospitalized older patients at admission¹⁴ and in patients admitted to oncology and internal medicine services.¹⁵

The aim of the study was to determine the prevalence and type of medication discrepancies and factors associated with unintentional discrepancies and identify the rate of hospital readmission and emergency service visit within 30 days after discharge among hospitalized patients with infectious diseases and receiving clinical pharmacist-led medication reconciliation during the COVID-19 pandemic. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement was followed to report this observational study.¹⁶

MATERIALS AND METHODS

Study design and setting

This observational study was conducted in the internal medicine and infectious diseases wards of a tertiary university hospital between July 2020 and February 2021 among hospitalized adult patients with any infectious diseases (including COVID-19).

Study population and recruitment

All hospitalized adult patients with infectious diseases who chronically used at least one medication before hospital admission were eligible for this study. All eligible patients were included in the current study without using any specific sampling method. Medication reconciliation services (including gathering the best possible medication history) were provided by clinical pharmacy resident within 48 h after hospital admission in person or by telephone. The patients were excluded from the study, if they were transferred to an intensive care unit or another hospital, stayed in the hospital for less than 24 hours, died, refused the therapy, were unwilling to continue after participating or did not receive medication reconciliation service provided by the clinical pharmacy resident within 48 h after hospital admission.

Medication reconciliation

Neither hospital pharmacists nor clinical pharmacy residents have been involved in medication history taking and medication reconciliation services at this hospital. There was no discharge patient counseling service provided routinely by pharmacists. During this study, medication reconciliation service [both at admission and discharge (including patient counseling service)] was provided in person or by telephone. These services were provided by the clinical pharmacy resident who had theoretical and clinical courses during his education and training for clinical pharmacy services.

Medication reconciliation service flow charts were adapted from previous projects.^17,18 The best possible medication history [including prescribed medications, over-the-counter (OTC) drugs, herbals, and dietary supplements] was taken within 48 h after hospital admission in person and by telephone. At least two resources (such as self-reports of patients and/or caregivers, medication records, and home medicine list) were used for obtaining the best possible medication history.¹⁸

During medication reconciliation service at hospital admission, a current and accurate medication list was provided by comparing the physicians’ orders at admission with their best possible medication history for home medicines. At hospital discharge, medications used in the last 24 h before hospital discharge, the discharge prescription, and the best possible medication history for home medicines were assessed by a clinical pharmacy resident. The medication discrepancies were discussed with the physicians at hospital admission and discharge to provide a current and accurate medication list. At hospital discharge, according to the current and accurate medication list, pill cards (including pictograms),¹⁹ and brochures (including low-molecular-weight heparin prescribed for patients with COVID-19) were provided to the patients by the clinical pharmacy resident. Patient counseling was provided by using the teach-back method.²⁰

Data collection and variables

Data including age, sex, education level, having COVID-19, duration of hospital stay, the number of medications used at home, and Charlson comorbidity index²¹ were collected at baseline. For evaluating the risk of medication error, statistical consolidation of redundant expression measures (SCOREM) index was calculated²². If the total score of  SCOREM index was three or greater, the patients were considered as high risk of medication error. All patients’ medications (including prescribed and OTC medications) were recorded. The risk of mortality and unplanned hospital readmission at hospital discharge was calculated using length of stay, acuity of the admission, comorbidity of the patient (LACE) index.²³ If the score of LACE index was 10 points or higher (out of 19), the patients were considered as having a high risk for mortality and unplanned hospital readmission.

Primary outcomes were prevalence, type of medication discrepancies, and factors associated with unintentional medication discrepancies. The number of discrepancies detected during the medication reconciliation service was evaluated and classified according to medication discrepancy taxonomy (MedTax).²⁴ Resources for obtaining the best possible medication history were recorded. At follow-up, the history of readmission to the hospital or emergency service within 30 days after discharge was assessed by telephone calls.

Ethics approval

The study protocol was approved by Marmara University Clinical Trials Ethical Committee (date: June 12, 2020, and number: 09.2020.508). The required permission to conduct this study was obtained from Ministry of Health, The Republic of Türkiye. Informed consent was obtained from patients and/or caregivers.

Sample size calculation

As in the study by Cornish et al.²⁵, all eligible patients were consecutively included in this study. In a previous study, the rate of patients with at least one unintended medication discrepancy was 47% in internal medicine wards.²⁶ It was assumed that the rate would be 60% in the study population during the COVID-19 pandemic. The sample size was calculated as 96 with alpha at 0.05 and power of 0.80 to detect the prevalence of unintentional discrepancies.²⁷

Statistical analysis

Descriptive statistics were presented as number (n) with percentage and median (interquartile range). P<0.05 was considered statistically significant. According to the findings of the Kolmogorov-Smirnov test, non-parametric statistics were conducted in this study. Fischer’s Exact test was used to compare two groups (w/wo COVID-19 and with high or low risks according to LACE index). Univariate logistic regression analysis was performed to determine factors associated with unintentional discrepancies. The odds ratio (OR) [confidence interval (CI) 95%] was presented. Statistical analysis was done using IBM SPSS (Statistical Package for Social Sciences) 11.0 statistics.

RESULTS

A total of 146 patients, who received medication reconciliation service during hospital admission, were included in the study. Among them, 90 patients (61.6%) received clinical pharmacy resident-led medication reconciliation both at admission and discharge. The flow diagram of the study is displayed in Figure 1. The characteristics of the patients are presented in Table 1.

The most common sources for providing the best possible drug history on admission were the patient’s medical record (93.8%), the patient’s medication boxes (76.0%), and the patient’s self-report (66.4%).

At hospital admission, the median of total discrepancies was 7.0 (5.0-10.0), the median of intentional discrepancies was 6.0 (4.0-9.0), and the median of unintentional discrepancies was 1.0 (0.0-2.0). Among them, 99.3% (n: 145) had at least one intentional discrepancy and 57.5% (n: 84) had at least one unintentional discrepancy at the hospital admission. At hospital discharge (n: 90), the median of total discrepancies was 3.0 (2.0-5.0) and the median of intentional discrepancies was 3.0 (2.0-4.25). Among them (n: 90), 94.4% (n: 85) had at least one intentional discrepancy and only three unintentional discrepancies were determined in three patients at hospital discharge. The most common unintentional discrepancy was drug omission (n: 142; 74.7%) at admission. All the pharmacists’ recommendations for medication discrepancies were accepted by the physicians. The frequency and type of medication discrepancies according to MedTax are presented in Table 2.

Having COVID-19 (OR: 2.25, 95% CI: 1.15-4.40; p<0.05), being at a high risk for medication error according to SCOREM index (OR: 2.01, 95% CI: 1.03-3.92; p<0.05), and a higher number of medications used at home (OR: 1.41, 95% CI: 1.23-1.61; p<0.001) were associated with having at least one unintentional discrepancy. Factors associated with having at least one unintentional discrepancy are presented in Table 3.

Out of 146 patients who received medication reconciliation at admission, 78.8% had a high risk of mortality and unplanned hospital readmission (Table 1). Among these patients (n: 146), the rates of 30 day hospital readmission and emergency medical service visits were 12.3% and 15.8%, respectively. In 90 patients who received medication reconciliation both at hospital admission and discharge, 80.0% had a high risk of mortality and unplanned hospital readmission (Table 1). Among these patients (n: 90), the rates were 10.0% for 30 day hospital readmission and 14.4% for emergency medical service visit. According to LACE index, patients with high risk had a significantly higher rate of emergency medical service visits within 30 days, when compared with patients with low risk (p<0.05). Patients with infectious diseases other than COVID-19 had a significantly higher rate of hospital readmission within 30 days than patients with COVID-19 (p<0.05). Secondary outcomes during follow-up in patients who received medication reconciliation service are presented in Table 4.

DISCUSSION

To the best of our knowledge, this is the first study to determine the prevalence and type of medication discrepancies and factors associated with unintentional discrepancies and identify the rate of hospital readmission and emergency service visit within 30 days after discharge among hospitalized patients with infectious diseases and receiving clinical pharmacist-led medication reconciliation during the COVID-19 pandemic in Türkiye. This service was found useful to detect unintentional discrepancies and all recommendations of the clinical pharmacy resident were accepted by the physicians. More than half of hospitalized patients with infectious diseases had at least one unintentional medication discrepancy at admission. However, the number of patients with at least one unintentional medication discrepancy at discharge was only 3 in patients receiving medication reconciliation both at admission and discharge. Patients with COVID-19 with a high risk for medication errors and higher medications were more likely to have at least one unintentional medication discrepancy at admission during the COVID-19 pandemic.

In Croatia, it was found that 35% of the patients admitted to internal medicine service had at least one unintentional discrepancy.²⁸ In Italy, one-fourth of patients had at least one unintentional discrepancy at hospital admission and discharge.²⁹ Cornish et al.²⁵ determined that half of the patients used four or more medications and had at least one unintentional discrepancy during admission to the internal medicine ward. In China, more than one-fifth of patients had at least one unintentional discrepancy.³⁰ In the present study, an increased rate of having at least one unintentional discrepancy is likely due to the study population including patients with COVID-19. In line with the finding of the present study, previous studies^28,30,31 exhibited a high number of medications as a factor related to unintentional discrepancy at admission. Like the present study, the most common reason for the unintentional discrepancy was the omission of medication in these studies.^25,28,29,31

In this study, the number of unintentional discrepancies was more than half at the hospital admission. On the other hand, only three unintentional discrepancies were detected by the clinical pharmacy resident. Cadman et al.³² demonstrated a reduction in the number of unintentional discrepancies at discharge after providing medication reconciliation at admission.

Study limitations

This study had some limitations, which was conducted in a single center, which limited the generalizability of the findings. Actual or potential harms, including medication errors related to these discrepancies, could not be evaluated with this study protocol. The average time spent providing medication reconciliation was not recorded and assessed because of non-feasibility during the COVID-19 pandemic. Although it was suggested to provide medication reconciliation service within 24 h,¹⁷ medication reconciliation was provided within 48 h during the COVID-19 pandemic. This could impact the effectiveness of this service.

Further studies will evaluate the impact of medication reconciliation services in hospitalized patients with infectious diseases. Implementing this service (in person or by telephone) could decrease the number of unintentional discrepancies in hospitalized patients with COVID-19 and/or high risk of medication errors. This study was conducted during the COVID-19 pandemic by one clinical pharmacy resident. This impact on the rate of patients receiving clinical pharmacy resident-led medication reconciliation both at admission and discharge medication reconciliation at discharge.

CONCLUSION

Medication reconciliation service provided in person or by telephone was useful for detecting and solving unintentional medication discrepancies during the COVID-19 pandemic.

Ethics

Ethics Committee Approval: The study protocol was approved by the Marmara University Clinical Trials Ethical Committee (date: June 12, 2020, and number: 09.2020.508). The required permission to conduct this study was obtained from Ministry of Health, The Republic of Türkiye.

Informed Consent: Informed consent was obtained from patients and/or caregivers.

Peer-review: Externally peer-reviewed.

Authorship Contributions

Concept: B.O., C.E., B.E.Ş., M.S., V.K., Design: B.O., C.E., B.E.Ş., M.S., V.K., Data Collection or Processing: B.O., C.E., B.E.Ş., Analysis or Interpretation: B.O., C.E., B.E.Ş., M.S., V.K., Literature Search: B.O., C.E., B.E.Ş., Writing: B.O., C.E., B.E.Ş., M.S., V.K.

Conflict of Interest: No conflict of interest was declared by the authors.

Financial Disclosure: The authors declared that this study received no financial support.